healthcare & medical technologies japan market study

Healthcare & Medical Technologies

Japan Market Study

JANUARY 2018

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The information and views set out in this study are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. The contents of this publication are the sole responsibility of EU Gateway | Business Avenues and can in no way be taken to reflect the views of the European Union. The purpose of this report is to give European companies selected for participation in the EU Gateway | Business Avenues Programme an introductory understanding of the target markets countries and support them in defining their strategy towards those markets. For more information, visit www.eu-gateway.eu.

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Healthcare & Medical Technologies – Japan Market Study - of 121

EU Gateway to Japan

Central Management Unit

Japan Market Study

JANUARY 2018

Submitted to the European Commission on 10 January 2018


Table of Contents

TABLE OF FIGURES .................................................................................................................................................. 7

LIST OF ABBREVIATIONS ........................................................................................................................................ 9

1. EXECUTIVE SUMMARY HEALTHCARE & MEDICAL TECHNOLOGIES .......................................................... 11

1.1. JAPANESE MARKET AND THE EU ........................................................................................................... 11

1.2. HEALTHCARE MARKET IN JAPAN ............................................................................................................ 12

1.3. MARKET TRENDS HEALTHCARE & MEDICAL TECHNOLOGIES ................................................................... 13

1.4. ASSISTIVE TECHNOLOGIES ..................................................................................................................... 15

1.5. MEDICAL EQUIPMENT ............................................................................................................................ 15

1.6. ICT FOR HEALTHCARE & MEDICAL TECHNOLOGIES ................................................................................ 16

1.7. TELEMEDICINE AND REMOTE HEALTH MONITORING ................................................................................. 17

1.8. NANOTECHNOLOGY FOR HEALTHCARE & MEDICAL TECHNOLOGIES ........................................................ 17

1.9. BIOTECHNOLOGY FOR HEALTHCARE & MEDICAL TECHNOLOGIES ............................................................ 18

1.10. DENTAL PRODUCTS AND TECHNOLOGIES ............................................................................................. 18

1.11. HEALTHCARE & MEDICAL TECHNOLOGIES REGULATIONS ..................................................................... 19

2. WHAT ARE THE CHARACTERISTICS OF JAPAN? .......................................................................................... 23

2.1. POLITICAL OVERVIEW ............................................................................................................................ 25

2.2. ECONOMIC OVERVIEW ........................................................................................................................... 25

2.3. TRADE OVERVIEW BETWEEN EU AND JAPAN .......................................................................................... 28

3. HEALTHCARE & MEDICAL TECHNOLOGIES MARKET OVERVIEW AND EU ENTRY OPPORTUNITIES .......... 32

3.1. JAPANESE HEALTHCARE & MEDICAL TECHNOLOGIES MARKET ............................................................... 32

3.1.1. Short Historic Healthcare & Medical Technologies Market Overview ........................................... 32

3.1.2. Market Overview Healthcare & Medical Technologies .................................................................. 33

3.1.3. Market Trends Healthcare & Medical Technologies ...................................................................... 40

3.1.4. Import Market of Healthcare & Medical Technologies ................................................................... 42

3.2. ASSISTIVE TECHNOLOGIES ..................................................................................................................... 43

3.2.1. Market Overview Assistive Technologies ...................................................................................... 43

3.2.2. EU Entry Opportunities Assistive Technologies ............................................................................ 47

3.2.3. Japanese Market Players .............................................................................................................. 55

3.3. MEDICAL EQUIPMENT ............................................................................................................................ 58

3.3.1. Market Overview Medical Equipment ............................................................................................ 58

3.3.2. Trends in Medical Device Market .................................................................................................. 62

3.3.3. EU Entry Opportunities Medical Equipment .................................................................................. 63

3.4. ICT FOR HEALTHCARE & MEDICAL TECHNOLOGIES ................................................................................ 66


3.4.1. Market Overview ICT for Healthcare & Medical Technologies ...................................................... 66

3.4.2. Market Trends ICT for Healthcare & Medical Technologies .......................................................... 67

3.4.3. EU Entry Opportunities for ICT in Healthcare & Medical Technologies ........................................ 69

3.5. TELEMEDICINE AND REMOTE HEALTH MONITORING ................................................................................. 73

3.5.1. Market Overview Telemedicine and Remote Health Monitoring ................................................... 73

3.5.2. Market Trends Telemedicine and Remote Health Monitoring ....................................................... 76

3.5.3. EU Entry Opportunities Telemedicine and Remote Health Monitoring ......................................... 76

3.6. NANOTECHNOLOGY HEALTHCARE .......................................................................................................... 77

3.6.1. Market Overview Nanotechnology Healthcare .............................................................................. 77

3.6.2. Market Trends Nanotechnology Healthcare .................................................................................. 78

3.6.3. EU Entry Opportunities Nanotechnology Healthcare .................................................................... 80

3.7. LIFE SCIENCE / BIOTECHNOLOGY FOR HEALTHCARE ............................................................................... 81

3.7.1. Market Overview Life Science / Biotechnology for Healthcare ...................................................... 81

3.7.2. Market Trends Life Science / Biotechnology for Healthcare ......................................................... 82

3.7.3. EU Entry Opportunities Life Science / Biotechnology for Health ................................................... 83

3.8. DENTAL PRODUCTS AND TECHNOLOGIES ............................................................................................... 85

3.8.1 Market Overview Dental Products .................................................................................................. 85

3.8.2. Market Trends Dental Products ..................................................................................................... 87

3.8.3. EU Entry Opportunities Dental Products ....................................................................................... 88

4. HEALTHCARE & MEDICAL TECHNOLOGIES REGULATIONS ....................................................................... 91

4.1. HEALTHCARE & MEDICAL TECHNOLOGIES REGULATIONS ....................................................................... 91

4.1.1. Pharmaceuticals and Medical Device Act (PMD Act) .................................................................... 91

4.1.2. Application and Approval ............................................................................................................... 92

4.1.3. Long-Term Care Insurance (LCTI) system .................................................................................. 100

4.1.4. Medical Fees and Insurance Reimbursement ............................................................................. 103

4.1.5. Other Regulations ........................................................................................................................ 104

5. ANNEXES............................................................................................................................................................ 106

5.1. HEALTHCARE & MEDICAL TECHNOLOGIES INDUSTRY ASSOCIATIONS ..................................................... 106

5.2. HEALTHCARE & MEDICAL TECHNOLOGIES TRADE FAIRS ....................................................................... 108

5.3. LIST OF HEALTHCARE & MEDICAL TECHNOLOGIES COMPANIES IN JAPAN .............................................. 110

5.3.1. Terumo Corporation ..................................................................................................................... 110

5.3.2. Olympus Corporation ................................................................................................................... 110

5.3.3. Nipro Corporation ........................................................................................................................ 111

5.3.4. Hitachi Healthcare Manufacturing ............................................................................................... 111

5.3.5. Fukuda Denshi ............................................................................................................................. 112

5.3.6. Nihon Kohden .............................................................................................................................. 112


5.4. EUROPEAN HMT COMPANIES IN JAPAN ................................................................................................ 113

5.4.1. Philips Electronics Japan ............................................................................................................. 113

5.4.2. LivaNova ...................................................................................................................................... 113

5.5. BIBLIOGRAPHY AND REFERENCES ........................................................................................................ 116


Table of Figures

Figure 1: Various sources, total market value approx. 6.76 trillion JPY in FY2014, Telemedicine is below 1% market share..................................................................... 13

Figure 2: various sources ........................................................................................................... 15

Figure 3: Pharmaceuticals and Medical Devices Agency, https://www.pmda.go.jp/english/review-services/outline/0001.html ............................ 21

Figure 4: Japan Factsheet, several sources .............................................................................. 23

Figure 5: © Abenomics, Cabinet of the Prime Minister website .................................................. 26

Figure 6: EU-Japan Trade Relationship-Facts and Figures, European Commission, 2017 ....... 28

Figure 7: The EU-Japan EPA in 60 seconds, European Commission, Trade, 2017 .................. 29

Figure 8: Eurostat, European Commission, Directorate-General for Trade, May 2017 .............. 29

Figure 9: © Cabinet Public Relations Office, July 2017............................................................... 30

Figure 10: © Five Decades of Universal Health Insurance Coverage in Japan: Lessons and future challenges, Japanese Society of Medical Sciences, Yasuki KOBAYASHI ..... 32

Figure 11: various online resources ........................................................................................... 34

Figure 12: Overview of National Medical Expenditures for 2013, Ministry of Health Labour and Welfare (MLHW) ................................................................................................ 34

Figure 13: United Nations, World Population Prospects, the 2015 Revision .............................. 35

Figure 14: The World Pharmaceutical Markets Fact Book 2014, Espicom ................................ 36

Figure 15: © Basic Review Process for Drug of Medical Device Application, Pharmaceutical and Medical Devices Agency (PMDA) ...................................................................... 37

Figure 16: © Supply Chain of Medical Devices in Japan, Pharmaceutical and Medical Devices Agency (PMDA) .......................................................................................... 37

Figure 17: © Demystifying Device Reimbursement in Japan-Device Talk, EMERGO, 2017 ...... 39

Figure 18: Compiled by JETRO based on the “International Comparison of Regulations for Regenerative Medicine and Cell Therapy 2013” by the National Institute of Health Sciences ................................................................................................................... 40

Figure 19: JETRO, Attractive Sectors: Life Science, 2016 ......................................................... 42

Figure 20: Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016 .................................................................................................................. 44

Figure 21: Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016 .................................................................................................................. 45

Figure 22: Services available under Long-Term Care Insurance (LTCI) .................................... 46

Figure 23: Assistive Devices available for Rental Services ........................................................ 48

Figure 24: Commercialised Products developed by NRDPMWA ............................................... 50

Figure 25: © Healthcare Support System to Remotely Monitor the Elderly, Fujitsu Journal Online, 2014 .......................................................................................................................... 52

Figure 26: TrendForce, May 2015 .............................................................................................. 54

Figure 27: © AFP/GETTY and © Professor SANKAI, University of Tsukuba/Cyberdyne: Cyberdyne employees wearing a HAL robot-suit walking in Tokyo .......................... 55


Figure 28: © RIKEN-TRI Collaboration Centre for Human-Interactive Robot Research. RIBA uses two arms to lift a person lying in bed or sitting on a wheelchair, moves and sets the person down ............................................................................. 56

Figure 29: © Robot Seal PARO, Tom Battey .............................................................................. 57

Figure 30: © Annual Report on the Survey of Pharmaceutical Industry Productions 2014, MHLW ....................................................................................................................... 59


Figure 32: Gyokai Search, FY2015 Medical Device Industry Sales Ranking, 2016 ................... 61


Figure 34: ICT in Healthcare Questionnaire, Ministry of Internal Affairs and Communications, 2016 .......................................................................................................................... 67

Figure 35: © ICT Trends in Japan’s Healthcare Policy, Fujitsu Science Technology, July 2015 .................................................................................................................. 68

Figure 36: © Global Wearable Device Market: Key Research Findings 2016, Yano Research Institute, 2016 ........................................................................................................... 72

Figure 37: © The Japan Times: Prime Minister Shinzo Abe tries out a telemedicine system offered by the city of Minamisoma in Fukushima Prefecture, 2017........................... 74

Figure 38: © Nano Bio First, Kazunori KATAOKA, Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST), 2012 .................................... 79

Figure 39: Nanotechnology Products Database, www.statnano.com ........................................ 80

Figure 40: Attractive Sectors-Biotechnology, JETRO, 2007 ....................................................... 84

Figure 41: Figure 36: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA), 2017 ............................................ 85

Figure 42: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA), 2017 ..................................................................... 87

Figure 43: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA), 2017 ..................................................................... 88

Figure 44: Websites MHLW, MIC and others, 2017 ................................................................... 89

Figure 45: © Japan: The Regulatory Process for Medical Devices, Emergo, 2017 .................... 94

Figure 46: © Japan: The Time, Cost and Complexity of Registration, Emergo, 2017 ................. 97

Figure 47: Outline of the Law for Partial Revision of the Pharmaceutical Affairs Law (Act No.84 of 2013) ................................................................................................... 98

Figure 48: Overview LTCI, MHLW 2016 .................................................................................. 100




Figure 52: New Orange Plan, LTCI, MHLW, 2016 ................................................................... 104


List of Abbreviations

ADEM Agency for Medical Research and Development

AI Artificial Intelligence

AIST National Institute of Advanced Industrial Science and Technology

app(s) Application(s)

ASEAN Association of Southeast Asian Nations

b billion

CAGR Compound Annual Growth Rate

CE Conformité Européene

CT Computed Tomography

DDS Drug Delivery Systems

DPJ Democratic Party of Japan

EHR Electronic Health Record

EPA Economic Partnership Agreement

EU European Union

EUR Euro

FDA Food and Drug Administration

FDI Foreign Direct Investment

FFOPs Follow-On Protein Products

FY Fiscal Year

GDP Gross Domestic Product

HAL Hybrid Assistive Limbo

HHC Home Health Care

HI Health Insurance

IBM International Business Machines

ICT Information and Communication Technology

IoT Internet of Things

iPS Induced Pluripotent Stem

iPSC Induced Pluripotent Stem Cells

IT Information Technology

JASPA Japan Assistive Products Association

JBA Japan Bioindustry Association

JDA Japan Dental Association

JETRO Japan External Trade Organisation

JMDN Japanese Medical Device Nomenclature

JPY Japanese Yen

k thousand


LDP Liberal Democratic Party

LTCI Long-term Care Insurance

m million

METI Ministry of Economy, Trade and Industry

MEXT Ministry of Education, Culture, Sports, Science and Technology

MHLW Ministry of Health Labour and Welfare

MIC Ministry of Internal Affairs and Communications

MRI Magnetic Resonance Imaging

NHI National Health Insurance

NRDPMWA National Research and Development Program for the Medical and Welfare Apparatus

OECD Organisation for Economic Co-operation and Development

PAL Pharmaceutical Affairs Law

PHR Personal Health Record

PMD Act Pharmaceutical and Medical Device Act

PMDA Pharmaceuticals and Medical Devices Agency

QMS Quality Management Systems

R&D Research and Development

RHS Remote Healthcare Systems

RIBA Robot for Interactive Body Assistance

t trillion

US United States of America

USB Universal Serial Bus

WHO World Health Organisation


1. Executive Summary Healthcare & Medical Technologies

1.1. Japanese Market and the EU

Japan remains the third largest global economic powerhouse, following the US and China. It aims

to achieve a Gross Domestic Product (GDP) of JPY 600 trillion (EUR 5 trillion) by FY2020, when

the Olympics will be hosted in Tokyo. Prime Minister Shinzo ABE and his cabinet hope to reach

this milestone goal based on his Abenomics strategy containing 3 main “arrows” of boosting the

economy, energising corporate activities and driving innovation and trade.

One of the main steps to reaching this GDP goal is the principal platform for the Economic

Partnership Agreement (EPA) between the EU and Japan. This EPA was signed in Brussels on

6 July 2017 during the 24th EU-Japan Summit in the presence of Prime Minister Abe, European

Commission President Juncker and European Council President Tusk, after nearly five years of

negotiations. The final approval is expected by mid-2018.

The EU currently exports on an annual basis goods worth EUR 58 billion and services valued at

EUR 28 billion to Japan. The EPA predicts an average 20% growth of EU exports, pushing up the

nominal GDP by 1% and possible creation of 420,000 new jobs.1

In 2015, 8.1% of total EU healthcare and medical device exports were to Japan. For European

companies, the EPA will further reduce costs for export certifications of medical devices, following

Japan’s joining International Standards on Quality Management Systems (QMS) in 2014.

1 Eurostat, European Commission, Directorate-General for Trade, May 2017


1.2. Healthcare Market in Japan

In 1922, Japan launched its Health Insurance (HI) for industrial workers, followed in 1938 with the

voluntary National Health Insurance (NHI), to additionally include farmers and self-employed

people. From 1961, Japan had implemented a universal health insurance system that covered

nearly all citizens. The last major addition to the system was the Long-Term Care Insurance for

the Elderly, implemented from 2000.2

The public healthcare system is supported by working contributors via a 30% co-payment, but for

older patients this co-payment can vary from 10 to 20% depending upon their income.

Currently and following the 15 September 2017 announcements by the Ministry of Internal Affairs

and Communications (MIC), the Japanese population aged over 65 represents 27.7% of the total

population, equal to 35.14 million inhabitants. Additionally, for the first time, more that 2 million

people are over 90 years old. The average male life expectancy is almost 80 years, while women

average around 86 years. By FY2050, it is estimated that almost 40% of the population will be

over 65, ranking Japan as the highest in the world.

In FY2015, Japan ranked third on the Health Spending Index of the Organisation for Economic

Co-operation and Development (OECD) with 11.2% of its GDP, just behind the US and

Switzerland. Total social security costs, including pensions, healthcare and welfare, stands at

around 23% of the GDP.

This demographic situation creates interesting business opportunities for EU companies in the

Healthcare & Medical Technologies market that wish to increase or begin exports to Japan.

The FY2014 revision of the former Pharmaceuticals Affairs Law (PAL) into the Pharmaceutical

and Medical Device Act (PMD Act) will support future HMT sector growth at an annual rate of 3%.

Japan holds about 10% of the global HMT market share for both drugs and medical devices.

2 Five Decades of Universal Health Insurance Coverage in Japan: Lessons and future challenges, Japanese Society of Medical Sciences,

Yasuki KOBAYASHI


Market Share Healthcare & Medical Technologies Sub-Sectors in Japan

Figure 1: Various sources, total market value approx. 6.76 trillion JPY in FY2014, Telemedicine is below 1% market share

1.3. Market Trends Healthcare & Medical Technologies

In addition to changing demographic trends in Japan, drastic reformation of the healthcare market

in general is among the key policies of the Abe cabinet. It aims to achieve this through high quality

Research and Development (R&D) and manufacturing of medical devices, together with innovative

healthcare services supported by strong ICT infrastructure. Customised medical care, based upon

Personal Health Records and anonymous cloud-based big data are another key priority. Approval

processes for both new drugs and medical devices will also be shortened substantially.

The total market value for medical devices was JPY 2.68 trillion (EUR 22.3 billion) in FY2013.

This was JPY 1.375 trillion (EUR 11.458 billion) of domestically manufactured medical devices

and JPY 1.30 trillion (EUR 10.84 billion) of imported medical devices, commanding 49% market

Assistive Technologies

21%

Medical Equipment 40%

ICT Healthcare5%

Nanotechnology4%

Biotechnology26%

Dental Equipment4%


share.3 The revised PMD Act should be a big push due to eased import regulations, which will

drive continued growth of imported medical devices.

Concrete export business opportunities for European companies to Japan, can be found in the

following summary.

Healthcare & Medical Technology Sector Business Opportunities

Assistive Technologies ▪ Continued strong demand for railings, silver cars, walking devices,

walkers and walking assistants following enclosing into long-term rental systems by local governments

▪ Nursing Robot Market to increase to JPY 1.5 trillion (EUR 12.45 billion) by FY2020 (15-fold from FY2015)

▪ Orthopaedic Devices and Surgical Implants demand as Japan’s demand alone is +50% of all Asian-Pacific market

Medical Equipment ▪ Almost 50% of all medical equipment is imported

▪ Future growth potential for endoscopic surgery equipment

▪ Replacement demand of existing MRI equipment

ICT for Healthcare & Medical Technologies

▪ Electronic Medical Record Systems: +23% by FY2020

▪ Community Healthcare Coordination Systems: +66% by FY2020

▪ IoT Technologies: +20% annually between FY2015-2020

Telemedicine and Remote Health Monitoring

▪ Remote monitoring service market to grow to JPY 13.9 billion (EUR 115.83 million) by FY 2025 (almost 50% increase versus FY2016)

▪ Following FY2015 deregulations, telemedicine demand will be brisk for Remote Nursing Care and Remote Healthcare Systems (RHS)

Nanotechnology ▪ Market to triple in value by FY2020 to EUR 94.4 billion

▪ Nanotech applications in Dentistry and Sanitary sectors

▪ Medical equipment with nanotechnology for less invasive surgeries

Life Science / Biotechnology ▪ Market to 10-fold in value by FY2030 to EUR 166 billion

▪ Business potential in participation and collaboration with biotechnology clusters nationwide

Dental Products and Technologies ▪ Dental examination equipment and dental laboratory equipment

(high import ratio)

3 JETRO, Attractive Sectors: Life Science, 2016


Healthcare & Medical Technology Sector Business Opportunities

▪ CAD/CAM devices for dentistry, dental implant materials, dental impression and reproduction materials, total and partial floor denture materials (+80% import ratio)

Figure 2: various sources

1.4. Assistive Technologies

In Japan, assistive devices and technologies are part of the welfare segment that includes nursing

care, rehabilitation and the home care sector. In FY2014, the Japanese market for the welfare

equipment industry was JPY 1.4 trillion 4 (EUR 11.65 billion) and it is forecasted to reach

JPY 4,5 trillion (EUR 37.5 billion) by FY2025.5

Responding to this trend and driven by the scheduled revision of the Long-Term Nursing Care

Insurance system in FY2018, new business opportunities for European manufacturers in this sub-

sector are emerging.

The market will show especially strong demand for advanced and innovative assistive devices

that meet the needs of Japan’s rapidly ageing population particularly in areas such as mobility

impairment equipment, home care devices and nursing homes, remote monitoring services,

orthopaedic devices and surgical implants.

Further, nursing care robots will play a very significant role, not only in the nursing care sector but

also in the medical sector from general to rehabilitation uses.

1.5. Medical Equipment

The Japanese medical equipment and materials market is the third largest in the world, and it is

expected to grow further as Japan’s ageing population rapidly increases. By FY2050, Japan is

expected to be a “super-aged” society with 40% of its population over 65 years.

4 Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016 5 Current Situation and Outlook of the Welfare Market in 2017, Fuji Keizai Group, Japanese, 2017


Almost 50% or JPY 1.37 trillion (EUR 11.37 billion) of Japan’s medical device and materials

market consists of imported products, particularly sophisticated medical technologies.6

European companies might find it difficult to compete with domestic manufacturers in

e.g. diagnostic imaging, therapeutic and surgical equipment, and biophenomena measuring and

monitoring systems. However, thanks to the amended Pharmaceutical and Medical Device (PMD)

Act, the import market is expected to continue expanding. Business opportunities for European

healthcare manufacturers lie in innovative technologies like cardiology equipment, pacemakers,

orthopaedic implants and medical devices that alleviate pain in general and improve the quality

of life for patients. Furthermore, given Japan's ageing population and the increasing number of

patients with chronic and life-style diseases, the markets for in-home care devices, technologies,

and health ICT related products is expected to grow accordingly.

1.6. ICT for Healthcare & Medical Technologies

At the end of FY2013, the ICT healthcare market was an estimated JPY 374.3 billion

(EUR 3.11 billion), but is predicted to grow to JPY 420.4 billion (EUR 3.5 billion) by FY2020.7

Areas like Electronical Medical Records like Electronic Health Records (EHR) and Personal

Health Records (PHR), Supplier Information Sharing and Remote Safety Check and Confirmation

Systems, Remote Diagnostic Imaging Systems and Internet of Things (IoT) devices are expected

to show double-digit growth on an annual basis8 through FY2020.

Also, wearable devices with healthcare applications, including Smart Watches and Smart Bands,

are estimated to exceed 11 million devices by FY2020 from 3.5 million devices in FY2016.9

Currently, nearly 30% of the Japanese population is aged over 65 years, there will be stronger

demand to alleviate the burden on nursing care workers. This is the opportunity for Robotic

6 Annual Report on Statistics of Production by Pharmaceutical Industry in 2013, Ministry of Health, Labour and Welfare (MHLW) 7 Invest in Tokyo website, 2016 8 ICT in Healthcare Questionnaire, MIC, 2016 9 Global Wearable Device Market: Key Research Findings 2016, Yano Research Institute, 2016


Devices to emerge. This specific market segment is predicted to grow from JPY 16.7 billion

(EUR 139.15 million) in FY2015 to JPY 404.3 billion (EUR 3.36 billion) by FY2035.10

1.7. Telemedicine and Remote Health Monitoring

Closely linked to the ICT Healthcare market segment, this niche market is still small but is expected

to grow by 30% to JPY 13.2 billion (EUR 110 million) by FY2020. Further growth aims to enhance

nationwide coverage of rural and remote areas mainly occupied by the elderly at present. Sub-

sectors like remote medical/nursing care and remote healthcare systems (RHS) look promising but

attention is currently focused on the telemedicine subsector, given the deregulatory measurements

taken by the Abe government in 2017. New inroads into telemedicine is not limited to customised

telemedicine software as some hospitals and doctors already provide similar services with existing

platforms like Skype, Facebook Messenger and iPhone FaceTime video.

1.8. Nanotechnology for Healthcare & Medical Technologies

Within the nanotechnology field in Japan, healthcare is taking the biggest share at nearly 50%.

The market is predicted to grow to EUR 95 billion by FY2020 and up to EUR 189 billion by

FY2030.11

Currently, R&D and manufacturing is done mainly between universities, research centres and

private companies, with applications focusing on nanomedicines, dentistry, tissue engineering

and medical supplies. Like global trends, Japan is also working rapidly on creating a pinpoint

Nano-Drug Delivery System (DDS) for cancer imaging and target therapy.12

In this phase, cooperation among private Japanese companies like Unicharm and Tokuyama

Dental, or leading academic and research institutes like Kyoto University, Tokyo Institute of

Technology or National Institute for Materials Science, seem to be the most efficient market

10 5-year Plan for Development of Robotic Devices for Nursing Care, METI, 2014 11 Nanotech Cluster and Industry Landscape in Japan, Andrej Zagar, EU-Japan Centre for Industrial Cooperation, 2014 12 Nano Bio First, Kazunori KATAOKA, Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST), 2012


entrance strategies for EU companies specialising in nanotechnology applications for healthcare

and medical equipment.

1.9. Biotechnology for Healthcare & Medical Technologies

Very closely related to the nanotechnology sector, defined broadly in Japan as life science, this

is one of the Abe cabinet priorities given Japan’s rapidly ageing society and resulting medical

healthcare expenditures.

In FY2015, the Japanese biotech market was JPY 3.11 trillion (EUR 25.91 billion)13 of which 55%

was directly linked to the healthcare and medical industry and valued at JPY 1.74 trillion

(EUR 14.5 billion). The Ministry of Economy, Industry and Trade (METI) also announced its

intention to grow the Japanese biotech market to JPY 20 trillion (EUR 166 billion) by FY2030.14

The Government of Japan also established the Agency for Medical Research and Development

(ADEM) with JPY 126.5 billion (EUR 1.05 billion) budgeted for FY2016 to focus on stem cells,

pharma and medical device cooperation among all market players.

Participation and collaboration in clusters focusing on biotechnology as well as collaboration

projects between private companies and research institutes (eg. NIPRO and Kyoto University on

iCeMS) are likely the best ways to enter the Japanese market for European companies.

1.10. Dental Products and Technologies

Japan’s ageing population has dramatic impact on the nation’s healthcare system in general, and

oral healthcare and dentistry specifically. It has been widely recognised that oral health is

fundamental to general health and the relationship between the medical and dental fields is

starting to further mature and expand.

13 Nikkei Biotechnology and Business, 2015 14 METI Policy announcement to 6-fold bio market to JPY 20 trillion by FY2030, Nikkei, 2015


Globally, Japan is the second largest dental market with dental examination medical expenditures

of JPY 380 billion (EUR 3.16 billion) in FY2014. Japan imported dental x-ray equipment, dental

equipment and dental materials valued at JPY 60.1 billion (EUR 500 million) in FY2015.15

Japan has a very low percentage of edentulousness because dental professionals practise under

a “treat the original teeth as much as possible” policy. Although often neglected in the past,

patients are now focusing more and more on oral health and aesthetic (cosmetic) dental services.

This has led to increased demand for dental services such as teeth straightening, overbite

correction and bad breath prevention.

Emerging opportunities exist for European manufacturers in advanced dental examination and

diagnostic technologies, preventive technologies, CAD/CAM devices, materials for dental implants,

dental reproduction materials about preventive dental care and modern dental treatment.

1.11. Healthcare & Medical Technologies Regulations

At the end of 2014, the Abe cabinet drastically revised the strict Pharmaceutical Affairs Law (PAL)

and renamed it the Pharmaceutical Medical Device Act (PMD Act) which created eased import

regulations, reduced costs for obtaining certifications and faster review approvals.

Medical devices are now separated from drugs with their own Marketing Authorisation and

Manufacturing License. Also, private third parties can now provide certification services for

Specially Controlled Medical Devices if the established standards and procedures are followed.

The permission system for Manufacturing Licenses of Medical Devices is now simplified to

registration. Lastly, the Standards Compliance Investigation for manufacturing and quality of

medical devices has been rationalised. With the implementation of these deregulations, Japan

aims to create a registration and approval process that is faster than that of the Food and Drug

Administration (FDA) in the US.

15 New Dental Medical Equipment and Dental Medical Technology Industry Vision, JDA, 2017


The Pharmaceuticals and Medical Devices Agency (PMDA), an independent entity under

jurisdiction of the Ministry of Health, Labour and Welfare (MHLW), is the responsible body for

evaluations and approvals of both domestic and imported medical devices. Japan does not levy

any custom duties on imported medical devices.

Japan’s medical device classification system is based on four risk level classes as defined by the

Japanese Medical Device Nomenclature (JMDN) codes, which are different from US and

European classifications.

Class I (lowest risk to the human body) is defined as general medical devices (e.g., scalpels,

x-ray film, items for dental techniques…)

Class II (relatively low risk) is defined as controlled medical devices (e.g., MRI equipment,

catheters, dental alloys…)

Class III (relatively high risk) is defined as having a relatively high risk to the human body in

case of failure (e.g., dialyzers, artificial bones, artificial respirators…)

Class IV (highest risk) is defined as specifically controlled devices (e.g., pace makers,

artificial heart valves, stent grafts…)


Regulatory Review Process Medical Equipment

Figure 3: Pharmaceuticals and Medical Devices Agency, https://www.pmda.go.jp/english/review-services/outline/0001.html

Notably, Japan does not currently accept the CE mark or an FDA certificate, but the principal

agreement on the EPA in 2017 should eliminate this hurdle in the future.

For European companies, to fully understand future business potential of the healthcare and

medical device market in Japan, an important law is the Long-Term Care Insurance (LCTI) for the

https://www.pmda.go.jp/english/review-services/outline/0001.html


elderly, originally issued in April 2000. This law aims to resolve issues facing its rapidly ageing

society, namely, support in the best way possible independent living and a customer-oriented,

user chosen approach to medical and welfare services, all backed by a robust social insurance

system with clear benefits and burdens. The next major revision of the LCTI is planned for FY2018

will further address these issues and opportunities.


2. What are the Characteristics of Japan?

Japan Factsheet

Population (last census FY2014) 127,220,000 inhabitants

Land Area 377,962 km2

Capital Tokyo

Currency Japanese Yen (JPY)

Gross Domestic Product (GDP) FY2017 (est.) JPY 554 trillion16 (EUR 4.616 trillion)

Sovereign Debt FY2016 (247% of GDP) JPY 1,371 trillion17 (EUR 11.43 trillion)

Foreign Direct Investment (FDI) FY2016 JPY 27.8 trillion18 (EUR 231 billion)

Country Competitiveness Index FY2016 Global Rank19: 8th

Tax Revenues FY2016 JPY 57.6 trillion20 (EUR 480 billion)

Consumption Tax (Value Added Tax) 8%

Unemployment Rate 2017 2.8%21

Life Expectancy (Men) 80 years

Life Expectancy (Women) 87 years

Figure 4: Japan Factsheet, several sources

It is well known that Japan rapidly strengthened its position in the global economy during the post-

war period. Historically, the primary drivers of Japan’s strong economic growth have been high

rates of investment in production plants and equipment, applications of industrial efficiency, high

education standards, good relations between labour and management, ready access to leading

technologies with significant investments in research and development, increasingly open world

16 www.japan.go.jp/abenomics/index.html 17 www.reuters.com/article/markets-debt-global-idUSL8N1G95BD 18 www.japan.go.jp/abenomics/index.html 19 Top 10 Most Competitive Global Economies, The Global Competitiveness Report 2016-2017 20 www.japan.go.jp/abenomics/index.html 21 www.japan.go.jp/abenomics/index.html

http://www.japan.go.jp/abenomics/index.html

http://www.reuters.com/article/markets-debt-global-idUSL8N1G95BD





trade framework and a large domestic market of discerning consumers – all of which have given

Japanese businesses an advantage in scale and operations effectiveness.

At the same time, the rapid ageing of the population has created tremendous structural

implications on the future workforce, the savings rate of the working population, and hence, the

government tax revenue budget.

From a global point of view, in FY2014, Japan was the 2nd biggest Medical Device Market with a

market share of 9.1%, behind the US with 39.3% but ahead of Germany with a share of 7.9%.22

The market share of imported medical devices has historically been hovering just below the 50%

line, but following the enactment of the revised and liberalised PMD Act in FY2014, it is expected

that the import share from overseas medical devices will exceed the 50% threshold from now on.

On average, the device market itself grows at a CAGR of 3% per annum.23

The medical device market is divided between generic domestic manufacturers like Olympus

Medical Systems, Hitachi Medical, Toshiba Medical Systems and foreign capital players like

GE Healthcare Japan, Philips Medical Japan, Siemens Japan and Stryker Japan. Promising

business areas for overseas manufacturers are related to endoscopic surgery, surgical support

robots and image diagnosis equipment like MRI and CT scanners.

In the healthcare service market, Japan expects this segment to grow from JPY 4 trillion

(EUR 33 billion) in FY2013 to JPY 10 trillion (EUR 83 billion) by FY2020. Specifically, promising

sub-segments include nursing care ICT, self-care health equipment and community care systems.

Domestic players include Cyberdyne, Fuji Machine Manufacturing, Panasonic, Omron

Healthcare, Terumo, Fujitsu, NEC and Konica Minolta but showing growth potential for

EU companies that can provide localised Japanese language ICT solutions with maintenance

services after delivery and installation.24

22 Worldwide Medical Market Forecasts to 2019, Espicom, 2014 23 Annual Report on Statistics of Production by the Pharmaceutical Industry, Yano Research Institute, 2014 24 Attractive Sectors: Life Science, JETRO-Invest in Japan, July 2016


2.1. Political Overview

Japan is a constitutional monarchy, with the Emperor as the symbolic head of state. The system

is a parliamentary democracy with the National Diet as the sole legislative body. The Diet is

composed of an Upper House (House of Councillors) and a Lower House (House of

Representatives), and a Prime Minister, chosen by a Diet ballot, who appoints a cabinet, with a

majority required to be Diet members.

Japan’s voting system is non-obligatory, and the voting age was lowered from 20 to 18 years in

2015, resulting in 104 million eligible voters.

The Liberal Democratic Party (LDP) has governed Japan for most of the last 70 years, and was

only out of power briefly in 1993-1994 and in 2009 when the Democratic Party of Japan (DPJ),

led by Yukio Hatoyama, secured a historical victory that put the DPJ into governing powers.

Since then, following a landslide election victory by the Liberal Democratic Party (LDP), Prime

Minister Shinzo Abe took office as Japan’s 97th re-elected Prime Minister in 2014. Since

August 2016, Abe’s Cabinet has 20 ministers, including the Prime Minister himself. As a result,

Japan’s economic and financial situations have undergone noticeable changes.

2.2. Economic Overview

Today, aiming for a future GDP of JPY 600 trillion (EUR 5 trillion), Japan is still the 3rd largest

global economy, after the US and China. Japan’s main industries are automotive, consumer

electronics, computers, other electronics and pharmaceuticals. Services represent 75% of the

GDP, industrial activities 23.5% and agriculture 1.5%.

Following the financial and real estate bubble bursting in the early 1990’s, and after more than

two decades of economic stagnation, Prime Minister Shinzo Abe and his Cabinet unveiled a

comprehensive economic policy package to revive and sustain the Japanese economy while

maintaining fiscal discipline. This programme became known as Abenomics.


The centrepiece of Abenomics is the “Three Arrow Policy” targeted at an active monetary policy,

a flexible and stimulant fiscal policy and a sustainable long-term growth strategy - all carried out

through structural reforms to encourage private investments. The economic parameters focus

mainly on boosting productivity, driving innovation and trade, and stimulating corporate activity.

Figure 5: © Abenomics, Cabinet of the Prime Minister website

Internationally, the Brexit (UK) in July 201625 and the inauguration of US President Donald Trump

in early 2017 had strong but temporary impact on the exchange rates between the JPY and the

Euro. Since the middle of 2017, the rate is back to usual trade levels and has been hovering

around JPY 130 for EUR 1.

Given the long-term low and negative interest rates by the Central Bank of Japan, it is believed

that the Japanese Yen will remain relatively strong for the near future against other global

currencies, including the Euro, thus creating export business opportunities for overseas

manufacturers and suppliers.

25 http://www.reuters.com/article/us-global-forex/yen-advances-on-brexit-impact-fears-pound-plunges-to-31-year-low-idUSKCN0ZM00T

http://www.reuters.com/article/us-global-forex/yen-advances-on-brexit-impact-fears-pound-plunges-to-31-year-low-idUSKCN0ZM00T


In recent years, multinationals like Apple (US), Nokia (Finland), Continental (Germany) and BASF

(Germany), have created major Research and Development (R&D) centres in Japan. Internet

companies like Facebook, Google and Amazon (all US) have also had presence in the country

for some time now. Recently, however, newer internet companies like TripAdvisor, Airbnb, Uber,

Netflix, Hulu and Spotify also have established representative offices in Japan. For FY2020,

Japan is targeting JPY 35 trillion (EUR 291 billion) of inbound Foreign Direct Investment (FDI).

Tokyo is and continues to be the favourite city to establish a presence (35%) in Japan, while Osaka

represents 16% of total FDI value. Nagoya remains a popular destination for automotive

manufacturing and related businesses, given Toyota Motors has its global headquarters there.

Yokohama is especially popular for larger scaled R&D centres. Both cities have an FDI share of 11%

each. These four major cities combined represent almost 75% of total FDI value in Japan. Across all

foreign direct investments in Japan, Asia represents 40%, Europe 31% and the USA 29%.26

Since Prime Minister Abe took office in 2012, annual corporate profits have increased to

JPY 68.2 trillion (EUR 568 billion) in May 2017. As an indicator, the Nikkei Index has remained in

the JPY 19,000 range since the beginning of 2017. These results were mainly obtained through

large-scale monetary easing policies, consecutive tax reforms (corporate tax ratio was 37% in

2013 and Abe’s cabinet is aiming for 29.74% by 2018).

26 JETRO, Invest Japan Report 2016


2.3. Trade Overview between EU and Japan

2.3.1 Japan and EU business in Figures

EPA Facts and Figures Infographic

Figure 6: EU-Japan Trade Relationship-Facts and Figures, European Commission, 2017


Exports of EU Goods & Services to Japan 2016:

Figure 7: The EU-Japan EPA in 60 seconds, European Commission, Trade, 2017

In 2015, EU medical device manufacturers exported 8.1% of their medical devices to Japan, while

imports from Japan stood at 6.1%.27

The graph below shows the Total Goods: EU Trade Flows and Balance, Annual Data 2006-2016

Figure 8: Eurostat, European Commission, Directorate-General for Trade, May 2017

27 EU Export and Import Destinations: EDMA- European IVD Market Statistics Report 2015


2.3.2 EU-Japan Economic Partnership Agreement (EPA)

The EU and Japan together account for 33% of the world’s GDP and have a combined population

of 632 million people. On 6 July 2017, during the 24th EU-Japan Summit held in Brussels, the

President of the European Commission Jean-Claude Juncker, the President of the European

Council Donald Tusk and the Prime Minister of Japan Shinzo Abe announced the principle

agreement of the Economic Partnership Agreement between the EU and Japan.

Figure 9: © Cabinet Public Relations Office, July 2017

Negotiations between both parties started back in 2013 and took in total 18 rounds on technical

and political levels to conclude the most important bilateral trade deal ever. Upon ratification of

the agreement, predictions are that EU exports to Japan could increase by 33% while Japan’s

exports to the EU are expected to grow 24%. The EPA is said to boost trade in goods and

services, with an estimated GDP growth up to 0.8% for the EU and up to 1% for Japan, while

creating investment opportunities for both economic blocks that might result in 420,000 new jobs.

It also includes the protection of EU standards and will further eliminate trade barriers and ease

regulatory standards over the next decade. In addition, the EU will gain improved access to

Japan’s public procurement systems at both government and private enterprise levels. In return,

Japan will gain eased market entrance for automotive, pharmaceutical and home electronics

industries.


Final agreement and approval of the EPA is expected by mid-2018 with full implementation

targeted for early 2019.

Concretely, for European Healthcare & Medical Technologies companies, this EPA will mean

profoundly reduced costs for certifications of exported medical devices following the adaptation

of the International Standards on Quality Management Systems (QMS) by Japan in 2014.


3. Healthcare & Medical Technologies Market Overview and EU Entry Opportunities

3.1. Japanese Healthcare & Medical Technologies Market

3.1.1. Short Historic Healthcare & Medical Technologies Market Overview

As early as 1922, the Japanese government launched the Health Insurance (HI) (Kenko Hoken

in Japanese) covering industrial workers in its first phase. Just before World War II in 1938,

the government added the voluntary National Health Insurance (NHI) (Kokumin Kenko Hoken in

Japanese) to the health insurance system, aiming to also cover farmers and self-employed people

with this new nationwide system.

From 1958 on, following a major revision of the National Health Insurance Law, the NHI became

mandatory. Three years later, in 1961, Japan established a universal health insurance system

covering all Japanese citizens.

Brief history of Japan’s Health Insurance System

1922 Introduction of Health Insurance (HI)

1927 Nationwide Enforcement of HI

1938 Introduction of National Health Insurance (NHI)

1950s Encouragement of the Merger of Towns and Villages

1958 Revision of NHI

1961 Establishment of Universal Coverage

1983 Introduction of Health Services Law for the Aged

2000 Introduction of Long-term Care Insurance for the Elderly

2008 Introduction of Health Care Program for the Elderly aged 75 and over

Figure 10: ©Five Decades of Universal Health Insurance Coverage in Japan: Lessons and future challenges, Japanese Society of Medical Sciences, Yasuki KOBAYASHI


In 1961, the timing for the introduction of a universal health insurance system was perfect given

the costs of health care at that moment were low, Japan’s economy was growing quickly and

there was a strong feeling of solidarity amongst its people.

At the end of FY2014, Japan had a total of almost 177,500 medical care institutions of which

roughly 8,500 are hospitals, 100,500 are medical clinics and 68,500 are dental clinics, which are

operated by 104,000 dentists. About 2,150 hospitals have 50 to 99 beds, giving them the biggest

share at 25%. The specialty of Internal Medicine practice is offered by 6,838 hospitals and almost

64,000 medical clinics. Other specialties include cardiovascular, gastroenterological and

respiratory medicine.28

In the same period, the total number of beds was 1,681,000, while general beds have been

decreasing over the past 2 decades, the beds for long-term care have been increasing, keeping

the total number almost stable.

At present, Japan has 13.4 hospital beds per 1,000 people, making it rank 1st among OECD

countries and its ratio of nurse to physicians is ranked 2nd.29

3.1.2. Market Overview Healthcare & Medical Technologies

Key Market Indicators for the Healthcare & Medical Technology Sector

Average Life Expectancy Male: 79.55 years

Female: 86.30 years

+65 years old 27.7% (35.14 million persons) of total population; 49% of medical costs

+90 years old 2.06 million persons

+65 years old by 2050 38.8%, highest in the world

Causes of Death for +65 years 1. Osteo Arthritis & Rheumatoid Arthritis: 24% 2. Dementia: 24%

3. Cancer: 23%

Low Birth rate Low birth rate of 1.37 births/couple for FY2009

28 Survey of Medical Institutions, MHLW, 2015 29 OECD Factbook, OECD, 2016


Key Market Indicators for the Healthcare & Medical Technology Sector

Infant Mortality 1/1,000 new born

Market Growth 2.2% annual growth expected till at least FY2018

Public Healthcare System Privately supported via co-payment by patient at 30%

Co-payments by elder patients vary from 10-20%

Healthcare Costs 11.2% of Japan’s GDP in FY2015

Total Social Security Costs (Pensions, Healthcare, Welfare ...)

Approximately 23% of GDP

Figure 11: various online resources

According to the Organisation for Economic Co-operation and Development (OECD) Health

Statistics released in June 2016, Japan’s total health spending accounted for 11.2% of its Gross

Domestic Product (GDP) in FY2015. Japan is ranked third out of 35 OECD member states, trailing

only the US (16.9%) and Switzerland (11.5%).

Figure 12: Overview of National Medical Expenditures for 2013, Ministry of Health Labour and Welfare (MLHW)


Percentage of Population over Age 65 by 2050

Figure 13: United Nations, World Population Prospects, the 2015 Revision

As for the domestic market size of medical devices, it was JPY 2.675 trillion (EUR 22.2 billion) for

FY2013, representing a growth rate of +3% in FY2012. The market is expected to continue

expanding at a similar rate for the immediate future, following the enactment of the

Pharmaceutical and Medical Device (PMD) Act in FY2014 and the continuous, rapidly ageing

population. At present, Japan is and remains the second-largest global market after the US and

it holds an approximate 10% global market share.


Global Medical Device Market: Share by Country 2014

Figure 14: The World Pharmaceutical Markets Fact Book 2014, Espicom

Contrary to most business segments in Japan, the medical devices and technologies sector is one

of the few market segments where Japan imports more than it exports – this clearly shows both the

present market size and the future growth potential for European companies in this segment.

Presently, the Pharmaceuticals and Medical Devices Agency (PMDA) is in charge of reviewing

applications for domestically manufactured and imported medical devices, through using

transparent methods bearing in mind quality, safety and efficacy through experts, while promoting

international harmonisation between existing quality and approval standards.

USA39%

Japan9%

Germany8%

China6%

France4%

UK3%

Italy3%

Canada2%

Russia2%

Others24%

Global Medical Device Market

USA Japan Germany China France UK Italy Canada Russia Others


Basic Review Process of Medical Device Application in Japan30

Figure 15: © Basic Review Process for Drug of Medical Device Application, Pharmaceutical and Medical Devices Agency (PMDA)

Standard Supply Chain Flow of Medical Devices in Japan31

Figure 16: © Supply Chain of Medical Devices in Japan, Pharmaceutical and Medical Devices Agency (PMDA)

30 http://www.pmda.go.jp/english/review-services/reviews/0001.html 31 QMS for Medical Device in Japan, PMDA, 2016

http://www.pmda.go.jp/english/review-services/reviews/0001.html


Marketing approval in Japan is required for any new medical devices, prior to domestic distribution

and sales, and can be obtained by the following bodies:

Marketing Authorisation Holder (MAH): Japanese organisation who obtains the marketing

approval. MAH needs to comply with Japanese Quality Manufacturing Standards (QMS) and

released medical devices need to meet Japan’s approved specifications

Foreign Restrictive Authorisation Holder (FRAH): Foreign organisation who obtains the

marketing approval but will need to designate a MAH in Japan

Designated MAH: Japanese organisation designated by FRAH to conduct manufacturing

and quality control duties in Japan. Needs to take necessary measures to prevent public

health hazards

The basic document flow for marketing approval of medical devices is straightforward, especially

since the PMD Act revision in FY2014, but specific device and equipment related questions and

extra document requests can be expected.

Pre-Market Submission (Todokede in Japanese): This is a pre-market notification request for

General Medical Devices (Class I) to the PDMA but no actual reviews or assessments will

be conducted by the PMDA for Class I devices

Pre-Market Certification (Ninsho in Japanese): Class II (and a limited number of Class III)

medical devices, with an associated certification standard like Japan Industrial Standards

(JIS), often based upon existing ISO/IEC standards, are subject to pre-market certification.

MAH will file the application with a Registered Certification Body (RCB), comparable with

European CE Marking process where reviews are also handled by external third parties

Pre-Market Approval (Shonin in Japanese): Class II and III devices without a specific

certification standard are subject to the pre-market approval process, and it is the same for


all Class IV medical devices. MAH needs to file a pre-market approval application with the

PMDA and ultimately obtain approval from the MHLW.32

Reimbursement Categories of Medical Devices in Japan

Figure 17: © Demystifying Device Reimbursement in Japan-Device Talk, EMERGO, 2017

For pricing of medical devices, usually Japanese companies have their standard price list but the

actual sales prices are not really known, as this depends on typical commercial talks between

manufacturer and final customer. The final sales price varies in relation to ordered quantities,

required delivery terms, agreed payment terms, past business volume and price quotes of

competitors, too name only a few.

The market shows a trend of more direct business transactions between manufacturer and

customer, especially in the segment of large and expensive medical devices. For consumables

32 PMDA Medical Device Registration Approval Process, Emergo, 2017


and high-volume equipment, the final customer tends to procure through major wholesalers

specialised in medical equipment and devices.

3.1.3. Market Trends Healthcare & Medical Technologies

Continuous improvements and adaptations to the national healthcare system are an important

cornerstone within the Abenomics Revival Strategy. The focus is to create a flexible regulatory

framework with both a fast R&D process and license approval system for regenerative medicines.

This should allow Japan to become a central hub for regenerative medicines, with an estimated

market value of JPY 26 trillion (EUR 216 billion) by FY2020.

Seamless connection from R&D to commercialisation for the manufacturing of world's

top-class medical services

Promotion and development of innovative health care services for medical treatment,

nursing care, health promotion, disease prevention and daily life support

Realising efficient and high-quality medical services by ICT

Figure 18: Compiled by JETRO based on the “International Comparison of Regulations for Regenerative Medicine and Cell Therapy 2013” by the National Institute of Health Sciences


Separate from the aforesaid main policies, Japan is also optimising and liberalising the following

healthcare regulations that will determine the future trends in the domestic market for healthcare

and medical devices:

Further amendments of the Pharmaceutical Affairs Law (PAL)

Enforcement of the New Act for Regenerative Medicines

Creation of a faster R&D process in regenerative medicine

Promotion of R&D of orphan drugs fulfilling unmet medical needs

Establishment of laws for medical treatment of patients with intractable diseases

Establishment of government policies for drug prices

Lower premium drug prices with generic drugs

Establishment of policies for promoting usage of generic drugs

Promotion of market entries from overseas healthcare and medical device companies

Enhancement of nursing care by optimal ICT implementation

Promotion of self-care health equipment and related service markets

Enhancement of remote and preventive medical care services and face-to-face medical

examinations (effects to be evaluated based on a FY2018 revision of medical service fees)

Integration and storage of personal medical information using big data to provide customised

medical care by FY2020

Analysis of aggregated anonymous medical records to advance medical research

Creation of National Strategic Special Zones as hubs for cardiac, neurologic and ophthalmic

treatment

Acceleration of development of Advanced Heart Failure treatment, such as myoblast

cell-sheet and cardiomyocyte sheet transplantation therapy


Enhancement of world-class R&D on iPS like the world’s first successful iPS origin retinal

cell transplant operation for age-related macular degeneration

3.1.4. Import Market of Healthcare & Medical Technologies

The total market value for medical devices is JPY 2.676 trillion (EUR 22.3 billion), representing a

combined value of JPY 1.375 trillion (EUR 11.458 billion) of domestic production and

JPY1.301 trillion (EUR 10.84 billion), equal to almost 49% market share, of imported medical

devices and equipment in FY2013.33

Figure 19: JETRO, Attractive Sectors: Life Science, 2016



3.2. Assistive Technologies

3.2.1. Market Overview Assistive Technologies

According to World Health Organisation (WHO), assistive devices and technologies are those

whose primary purpose is to maintain or improve an individual’s functioning and independence to

facilitate participation and to enhance overall well-being. They can also help prevent impairments

and secondary health conditions. Examples of assistive devices and technologies include

wheelchairs, prostheses, hearing aids, visual aids, and specialised computer software and

hardware that increases, respectively, mobility, hearing, vision, or communication capacities.

In Japan, slightly different from Europe, assistive devices and technologies are part of the welfare

segment that also includes nursing care, rehabilitation and the home-care sector. The Japan

Assistive Products Association (JASPA) has assistive/welfare devices defined as follows.34

Assistive devices that support autonomy and nursing care for elderly and disabled persons

in daily life, regardless of home or facility, and assistive devices that improve the living

environment

Assistive devices (including computer systems and assistive technologies) that are used in

care facilities to improve services for elderly and/or disabled people, and contribute to

labour-saving within the facilities. Devices and technologies that support independence of

residents, nursing care support, and improvement of the environment, different from the

above-mentioned definition

Welfare equipment, devices and social infrastructures that support the actions of elderly

and/or disabled people in public places like elevators in public buildings (train stations being

most common), braille blocks, and audio signals for the visually impaired, amongst others

34 Ageing Population, National Health Insurance, Japanese, March 2017


Categories and Examples of Assistive Devices and Technologies in Japan

Products covered by care insurance Electric bed for medical care or nursing care, manual wheelchair, electric wheelchair, bedsore prevention mat, handrail, silver car (walker for an aged or disabled person), wandering sensing equipment for people with dementia and elderly people, walking aid cane, slope, automatic excretion treatment device, transfer devices (patient lifts for vertical transfer), bathing assistant, toilet seat, simple bathtub

Nursing care and disposable products Adult disposable diapers, urine leakage pants, elderly underwear, shoes for the elderly, waterproof sheets, wet tissues for nursing care, oral wet tissues for nursing care, mouth sponge brush for nursing care, mouth moisturizing agent, cleanser, nursing gloves

Nursing devices and instruments Special bathing equipment, rehabilitation equipment for exercise therapy, evaluation measuring equipment for rehabilitation, radio paging equipment for home, care robot, communication robot

Systems and services Senior citizen home delivery service, housekeeping substitution for the elderly, emergency response system, sensor type home safety confirmation, infrastructure monitoring, dialogue confirmation, support for nursing care and welfare facilities, school lunch for nursing care and welfare facilities, linen for hospitals/nursing care/welfare facilities, security for nursing care and welfare facilities, prevention of long-term care and rehabilitation, dispensing pharmacies for nursing care and welfare facilities, collaboration support for long-term care

Figure 20: Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016

The global assistive technology market is estimated at EUR 17 billion in 2015, with a Compound

Annual Growth Rate (CAGR) of 6% during the period from 2015 to 2020.

The market size of the Japanese welfare equipment industry in FY2014 totalled JPY 1.399 trillion

(EUR 11.65 billion), up 3.8% from the previous year. The overall market size has shown steady

growth since FY2009. Looking at specific products per category, we see that general products

such as wigs, dentures, hot water washing toilet seats, seat shifts for cars, home elevators,

glasses and hearing aids were up 3.9% compared to the previous year FY2013.35 Materials and

devices subject to the nursing-care insurance are showing a recovering trend up 7.4% in FY2014.

35 Market Size of Welfare Equipment, Japan Assistive Products Association (JASPA), 2014


Market Size in Japan of Assistive Devices and Technologies

FY2010 (JPY/EUR) FY2014 (JPY/EUR)

Total Assistive Devices & Technologies 1,165b/9.7b 1,399b/11.65b

Assistive Devices & Technologies (Total Type A) 1,123b/9.35b 1,340b/11.16b

Home Treatment Equipment (Type A) 73.9b/615m 70.3b/585m

Prostheses and Braces (Type A) 171.3b/1.42b 222.4b/1.85b

Personal Care related products (Type A) 334.6b/2.78b 427.5b/3.56b

Moving Equipment and related products (Type A) 97.5b/812m 128.8b/1.07b

Furniture & Fixtures (Type A) 78.8b/656m 102.3b/852m

Communication Equipment (Type A) 325.5b/2.71b 346b/2.88b

Home Nursing Equipment and related products (Type A) 40.3b/335m 40.9b/340m

Miscellaneous (Type A) 2b/16.6m 2b/16.6m

Nursing Home Equipment and Systems (Type B) 4b/33.3m 6.7b/55.8m

Support and Assistive Devices for return to Society (Type C) 37.3b/310m 44.6b/371m

Assistive Devices covered by Long-term care insurance 218.7b/1.82b 286.2b/2.38b

Figure 21: Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016

According to the above table, the market size of welfare equipment in FY2014 is about

JPY 1.4 trillion (EUR 11.65 billion), and home treatment equipment, prostheses and braces, and

personal care-related products have the biggest share in the market.

The main driver is the scheduled revision by Abe’s Cabinet of the current long-term nursing care

insurance system in FY2018. The study also foresees a strong need for convenient purchasing

of lower-priced assistive devices and technology products. Additionally, Japan will need to

formulate an adequate response to the needs of almost 80% of the elderly population who do not


require special nursing care but do want to enjoy an active retirement, often referred to in Japan

as “Silver Life.”

Figure 22: Services available under Long-Term Care Insurance (LTCI)

Purchase Conditions for above Assistive Devices under LTCI:

Purchasing Limit: Maximum JPY 100,000 (EUR 833) total per fiscal year

Users pay 10% or 20% of the total cost

Same products can only be purchased once per year to receive eligible support

Conditions for Home Renovation under LTCI:

Purchasing Limit: Maximum JPY 200,000 (EUR 1,666) total per fiscal year

Users pay 10% or 20% of the total cost

Total amount of JPY 200,000 can be spread out over several renovations

Products: Handrail installations; step elimination; resurfacing floors to prevent slipping; replacing

hinged doors with sliding doors; replacing Japanese-style toilets with Western-style toilets


The recent study "Current Situation and Outlook of the Welfare Market in 2017," published by the

Fuji Keizai Group, states that many new assistive products and services will find their way into

the Japanese welfare market.

The same research paper predicts the total market value of assistive devices and technologies

to reach almost JPY 4.5 trillion (EUR 37.5 billion) by FY2025 with a breakdown of almost 40% of

all care products covered by health insurance, approximately 50% for care products and

disposables not covered by the aforementioned insurance, and the remaining 10% for nursing

devices and equipment.36

3.2.2. EU Entry Opportunities Assistive Technologies

For FY2017, the market is expected to expand following new market development by wholesalers

and rental companies of assistive devices now that the personal liability of people with mild

cognitive impairment has been abandoned.

The market will show particularly strong demand for railings, silver cars, walking devices, walkers

and walking assistants as these are also a necessity for elderly people who prefer to maintain

independent living and care prevention. Furthermore, local government services are expected to

purchase these products of durable quality for long-term use for their rental systems, thereby

creating promising business opportunities for European manufacturers.

36 Current Situation and Outlook of the Welfare Market in 2017, Fuji Keizai Group, Japanese, June 2016


Figure 23: Assistive Devices available for Rental Services


Long-term market expansion is also expected for nursing care equipment and devices in general.

At present, the market share of special bathing equipment and exercise therapy rehabilitation

equipment is growing annually.

For the near future, growth in the nursing robots market segment looks especially promising. Data

released in a market survey by Yano Economic Research Institute forecasts the domestic care

robot market to reach JPY 1.5 trillion (EUR 12.45 billion) by FY2020. This represents a 15-fold

increase of the domestic care robot market from FY2015, also creating new business

opportunities for EU companies active in this specific segment.37

Japan also successfully introduces continuously innovative healthcare and medical technology

devices to the market through the National Research and Development Program for the Medical

and Welfare Apparatus (NRDPMWA) support system.38

Healthcare Products Developed by NRDPMWA

Project Equipment Manufacturer

Modulated motorised wheelchair Motorised wheelchair Suzuki Motor

Braille duplicating system Braille master Matsushita Electric Industries

Foam ink Toppan Printing

Gait pattern analyser for the disabled Position sensitive detector; position sensor system

Hamamatsu Photonics

Force plate Kyowa Electronic Instruments

Multifunctional bed for the bedridden Separated urinal; motorised, patient-controlled bed with toilet

Paramount Bed

Vocal and speech training device Vocal and speech training device Matsushita Communication Industries

Position sensor Rion

Three-dimensional working chair Three-dimensional working chair Imasen Engineering Corporation

Automatic body temperature adjuster Cool best Phoenix

37 Current Situation and Outlook of Welfare Device Rental Market, Yano Research Institute, Japanese, June 2017 38 Commercialised Products developed by NRDPMWA


Healthcare Products Developed by NRDPMWA

Middle ear implant Middle ear implant Rion

Figure 24: Commercialised Products developed by NRDPMWA

Lastly, any kind of advanced and innovative assistive device that meets the needs of Japan’s

rapidly ageing population will continue to see increasing demand over the next several decades.

A brief overview of promising assistive device and technology market segments that are

interesting for European manufacturers is described below.

3.2.2.1. Orthopaedic Devices & Surgical Implants

As Japan has one of the oldest populations globally, the country has seen a high prevalence of

osteoarthritis, driving the demand for joint replacement devices. The extensive joint reconstruction

and replacement market ranges from large to small devices, and covers shoulder reconstruction

devices, elbow reconstruction devices, knee and hip implants, hand and wrist devices and foot

and ankle devices, amongst others.

The total market value for these devices was estimated to be approximately JPY 157.5 billion

(EUR 1.31 billion) in FY2015. The market is expected to maintain robust growth for the next

decade, and in terms of revenue, Japan already accounts for approximately 50% of the complete

Asia-Pacific orthopaedic device market.

According to several iData Research market reports, the largest segment of the Japanese small

bone and joint orthopaedic device market is the hand and wrist devices segment, which

represents over 70% of the total market. This segment is expected to exceed JPY 12.5 billion

(EUR 104 million) by FY2022, increasing from JPY 10 billion (EUR 83 million) in FY2015. Another

promising growing sub-sector for imports is the shoulder reconstruction market, following its

approval by the Japanese Ministry of Health, Labour, and Welfare (MHLW) in FY2014.39

39 Japan Market Report for Small Bone and Joint Orthopaedic Devices 2016, iData Research, 2016


Other surgical implantable devices that meet the needs of the elderly, such as cochlear and vision

correction implants, are also seeing increasing demand in Japan, since Abbott’s implantable

Tecnis lenses for cataract patients were approved in FY2013.

Prominent Japanese orthopaedic device industry players include Japan MDM, Kyocera

Corporation, Seikagaku Corporation and Teijin Nakashima Medical.

3.2.2.2. Home care devices and nursing homes

The Japanese tradition of elderly parents moving in with their children has been declining

continuously over the past decades. In 1960, about 80% of elders were living with their children

but this figure has dropped by roughly half to approximately 40% at present. Hence the number

of private, semi-public and public nursing homes has exploded, growing more than 450% over

the past ten years. Presently, the waiting list of people wishing to enter nursing homes exceeds

400,000.40

Also, the number of home healthcare service providers has grown by 400% over the past

15 years. The market for medical devices, portable elder care devices such as respiratory

equipment (global market share of Japan is approximately 8% but expected CAGR of 9.2% by

FY202741) and hemodialysis systems (the Japanese market has been growing on average 3%

on an annual basis since 201342) that can be used in both home healthcare and nursing homes

is showing continued robust growth.

Due to demographic challenges, the Japanese government has also been promoting advanced

technology for elder care like assistive robots that can help with tasks like lifting or placing elderly

patients in/out of bed or bath.

40 Bold steps: Japan’s remedy for a rapidly ageing society, The Globe and Mail online, 2015 41 Global Respiratory Devices Market Share, Future Market Insights, 2017 42 Global Hemodialysis Industry Report 2013-2016, ResearchMoz, 2015


3.2.2.3. Remote Monitoring Service

The total market size for remote monitoring services was estimated at JPY 9.8 billion

(EUR 81.6 million) in FY2016 and is expected to increase 46.3% to JPY 13.9 billion

(EUR 115.83 million) by FY2025.

Emergency response systems, sensor-type home security confirmation systems, infrastructure

monitoring systems, and interactive confirmation systems currently hold the biggest market share.

Demand is increasing annually given the heightened awareness of family environment and elderly

safety.

At present, the largest market share is for emergency response systems, given brisk demand by

elderly people living by themselves and those afraid of sudden attacks. An increase in demand is

also visible for sensor-type home safety confirmation products for people concerned about

sudden changes in physical condition or those with dementia.

One well-known example is Fujitsu’s remote system for checking the status of patients in bed.

Figure 25: © Healthcare Support System to Remotely Monitor the Elderly, Fujitsu Journal Online, 2014


3.2.2.4. Nursing care Robots (Hi-tech Devices)

Japan is a global leading country when it comes to robotics. Long used in industrial settings,

Japanese researchers and manufacturers are now looking at whether robots can help as the

country ages, from robot suits that help rehabilitation to fully functional humanoid robots.

For physical disabilities, affecting around 3.94 million Japanese in FY2014 (1 out of 32 people in

Japan), there are diverse needs that can be positively impacted by the use of robot assistants.

Patients with impairments or disabilities in the lower limbs, for example, benefit particularly from

therapy with walking assistance robots, walking frames or exoskeletons.

The planned revision of the nursing care insurance system planned for FY2018 will lead to a

growing demand of nursing care robots. Also, the Ministry of Economy, Trade and Industry (METI)

and Ministry of Health, Labour and Welfare (MHLW) announced its “New Strategy for Robots”

Plan in 2015.

Under this five-year plan, the government plans to support the use of robots in different sectors

of the economy, such as manufacturing, infrastructure, and other industries. The government has

set the biggest share of the programme’s budget to the nursing and medical sector, amounting to

nearly JPY 5.3 billion (EUR 44.16 million). Japan has forecasted that the market for “care service”

robots will rise to JPY 370 billion (EUR 3.07 billion) within 20 years. Currently, the market value

is estimated to be JPY 15.5 billion (EUR 129 million).43

Transfer Aids: Wearable transfer devices that are worn by the caregiver, using robot

technologies to provide powered assistance to alleviate the physical workload of the

caregiver. Also, non-wearable transfer aids powering assistance to the caregiver in

performing lifting motions, such as when transferring an individual from bed to wheelchair

Mobility Aids: Including mobile support equipment and motorised walking support devices, in

addition to walking support equipment that helps the elderly move around, stand up, and sit

down indoors, go to and return from the restroom

43 http://www.meti.go.jp/english/press/2015/pdf/0123_01b.pdf

http://www.meti.go.jp/english/press/2015/pdf/0123_01b.pdf


Toilet Aids: Installation of adjustable restrooms that use robot technology for excretion that is

movable and can be placed anywhere in a room

Bath Aids: Uses robot technologies to support elderly people in a series of motions required

for getting in and out of bathtubs, and are usable by a single person with or without the help

of an assistant

Monitoring Systems: Including equipment and platforms that use sensors and external

communication functions to support the monitoring of the elderly in long-term care facilities

as well as in private homes

Major Developers and Manufacturers of Nursing Care Robots in Japan

Bed Assistance (wearable) Cyberdyne, Kikuchi Seisakusho, Toshiba

Bed Assistance (non-wearable) Panasonic, Yasakawa Electric Corporation, Fuji Machine, Toyota

Mobility Assistance Azbil, Nabtesco, Yasakawa Electric Corporation

Bath and Toilet Assistance Toto

Meal Assistance Secom

Support for Alzheimer Patients Sumitomo Riko, Clarion

Figure 26: TrendForce, May 2015


3.2.3. Japanese Market Players

3.2.3.1. Cyberdyne

Cyberdyne focuses on the development and manufacturing of medical robot bionic suits and

home-health aides to be used in rehabilitation and elderly care. Cyberdyne’s exoskeleton is

already used in more than 160 hospitals and nursing homes all over Japan. Other Japanese

companies, like Toyota and Honda, also develop mobility assistive robots.

Figure 27: © AFP/GETTY and © Professor SANKAI, University of Tsukuba/Cyberdyne: Cyberdyne employees wearing a HAL

robot-suit walking in Tokyo

Robot Suit Hybrid Assistive Limbo® (HAL), is a robot system for walking support, co-developed

by Professor Yoshiyuki SANKAI of the University of Tsukuba and Cyberdyne. The robot suit

comes with a pair of limb frames made of fibre-reinforced plastic. They cover the outside of a

person's limbs, from the waist to both feet and are a substitute for a person's impaired legs or

weakened leg muscles, helping the user overcome walking difficulties by detecting bioelectric

signals sent from the brain to relevant parts of the body and activating power units attached to

the robot's joints.


3.2.3.2 Panasonic

Panasonic also develops care robots that work in pharmacies, hospitals and personal homes.

One robot model splits in half to transform from a bed into a wheelchair. This robot eliminates the

risk of injury to the patient and caregiver during the transfer of the patient from their bed to a

wheelchair.

3.2.3.3. Riken-Tri: Robot for Interactive Body Assistance (RIBA)

The Robot for Interactive Body Assistance (RIBA) is developed by RIKEN-TRI Collaboration

Centre for Human-Interactive Robot Research and is a nursing care assistance robot specifically

developed to move a person from the bed to other places. The newest RIBA II is humanoid in

appearance, stands tall at 137cm by 82cm across, and can lift a person weighing up to 80 kg.

Figure 28: © RIKEN-TRI Collaboration Centre for Human-Interactive Robot Research. RIBA uses two arms to lift a person lying in bed or sitting on a wheelchair, moves and sets the person down


3.2.3.4. National Institute of Advanced Industrial Science and Technology: PARO

Communication robots are mainly developed for mental care patients. PARO is a seal-shaped

robot, also sometimes referred to as "mental commitment robot" or “therapeutic seal robot,” giving

joy and comfort to people who play with it. It measures 57 cm, weighs 2.7 kg and is covered with

artificial fur for a pleasant touch. PARO was developed by The National Institute of Advanced

Industrial Science and Technology (AIST) in Japan.

When the patient caresses or speaks to PARO, the robot seal responds as if it were alive including

movement nuances as blinking, moving limbs and tilting its head. PARO understands basic

greetings and words of praise, and responds accordingly with a body movement or a trill.

Figure 29: © Robot Seal PARO, Tom Battey


3.3. Medical Equipment

3.3.1. Market Overview Medical Equipment

The global market of medical equipment is estimated to grow at a CAGR of 7.2% from 2016 to

2021.44 The Japanese medical equipment and materials market is the 3rd largest in the world after

the US and the EU. Moreover, the market is expected to further grow due to the rapidly increasing

rate of Japan’s ageing population. The percentage of +65 seniors will rise from 27% in FY2015

to 40% by FY2050. This increase will drive continued demand for advanced medical technologies,

in combination with expansions and new openings of both hospitals and nursing homes.

Following the FY2016 revision of medical fee remuneration and hospital capital investment

regulations, the market is expected to increase 1.6% reaching JPY 2.73 trillion

(EUR 22.75 billion). Based on the growth rate of medical expenses additional growth of 2.9% is

expected for FY2017. With the advance of the ageing Japanese society, demand for medical

equipment will remain strong but the pace might slow slightly over the next couple of years given

the government's suppression of medical expenses and maturity of existing medical equipment.

In general, the Japanese medical equipment market consists 1/3 of insurance-covered Medical

Materials like catheters, artificial joints and pacemakers. The remaining 2/3 are high valued

medical devices like Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and

electrocardiographs.

In Japan, medical devices are usually categorised as follows:

Treatment Devices (catheters, artificial joints, pacemakers, syringes, artificial heart

beat systems)

Diagnostic Devices (endoscope, PET/PET-CT systems, MRI, ultrasonic wave devices,

X-ray films, thermometers, sphygmomanometers, electrocardiograph meters)

Others (dental devices, surgical gloves, contact lenses, home massage chairs)

44 Global Medical Device Technologies Market Growth, Trends & Forecasts 2014 – 2020, Mordor Intelligence


The Japanese medical device and materials market relies heavily on imported products,

particularly for sophisticated medical technologies. According to the latest official figures of the

Annual Report of the Pharmaceutical Industry Productions, released by the Ministry of Health,

Labour and Welfare (MHLW), the domestic market for medical devices and materials in FY2014

was JPY 2,786 billion (EURO 23.21 billion), of which 49% or JPY 1,365 billion

(EUR 11.37 billion) was imported medical equipment.45

Figure 30: © Annual Report on the Survey of Pharmaceutical Industry Productions 2014, MHLW

45 http://www.mhlw.go.jp/topics/yakuji/2013/nenpo/dl/insathu_e.pdf

http://www.mhlw.go.jp/topics/yakuji/2013/nenpo/dl/insathu_e.pdf


Domestic Production by Medical Device Type


Top Japanese medical device companies, in terms of sales, include Olympus Medical Systems,

Terumo, NIPRO, Sysmex, Nihon Koden Kogyo, Fukuda Denshi, Omron, Menicon, Shimadzu and

JMS amongst others. Their sales and market share are listed in the table below:

Sales Ranking of Japanese Manufacturers of Medical Devices and Equipment FY2015

Company Name Sales JPY/EUR in billions Market Share

1. Olympus Medical Systems JPY 608.9 (EUR 5.074) 22.9%

2. Terumo JPY 525 (EUR 4.375) 19.7%

3. Nipro JPY 366.6 (EUR 3.055) 13.8%

4. Sysmex JPY 253.1 (EUR 2.109) 9.5%

5. Nihon Koden Kogyo JPY 165.5 (EUR 1.379) 6.2%

6. Fukuda Denshi JPY 117.2 (EUR 0.976) 4.4%


Sales Ranking of Japanese Manufacturers of Medical Devices and Equipment FY2015

Company Name Sales JPY/EUR in billions Market Share

7. Omron JPY 108.4 (EUR 0.903) 4.1%

8. Menicon JPY 67.3 (EUR 0.560) 2.5%

9. Shimadzu JPY 64.5 (EUR 0.537) 2.4%

10. JMS JPY 57.6 (EUR 0.480) 2.2%

Figure 32: Gyokai Search, FY2015 Medical Device Industry Sales Ranking, 2016

Japanese medical device manufacturers hold a high market share in the following product

segments but among them, the competition is fierce for both price setting and market share.

diagnostic imaging equipment

therapeutic and surgical equipment

biophenomena measuring and monitoring systems

home therapeutic equipment

dialysers

endoscopes

Currently, both domestically-manufactured and imported medical devices are regulated under the

Pharmaceutical and Medical Device Law (PMDL or PMD Act) in Japan, but since the medical

industry is one of the priority business sectors for the Japanese Government, numerous actions

are being taken resulting in overall reform of the sector.

On November 2015, the former strict Pharmaceutical Affairs Law (PAL) was amended and

renamed to the PMDL. The PMDL will enable further improvements to the regulatory review

process, including the establishment of a device-specific regulatory framework in addition to

increasing reviewers from 34 to 105, introduction of a three-track evaluation system and

clarification of the evaluation criteria. Finally, a pre-application evaluation system for new medical


devices will be launched aiming to shorten the current approval time to 19 months within the

coming years.

The import market of medical devices is expected to continue to expand thanks to this enactment

of the Pharmaceutical and Medical Device (PMD) Act.


3.3.2. Market Trends in Medical Device Market

Both imports and exports of medical devices have been increasing since FY2012, but the growth

rate of imports is exceeding that of exports. Hence, Japan's reliance on imported medical devices

and technologies is expected to continue to be strong for the foreseeable future.

It is important to bear in mind that 15~20% of all imported medical products are consumables like

diapers and general-purpose goods like catheters manufactured by Japanese pharmaceutical

plants in low-cost ASEAN (Association of South East Asian Nations) countries and then

re-imported into Japan. Many types of artificial joints are often manufactured by foreign-affiliated

companies’ active in the Japanese healthcare market.


This current trend is expected to continue in the medium to long term, and forecasts are that the

imports of medical devices will increase annually at a CAGR of 4.4% through FY2021.46

As mentioned before, given Japan's ageing population and the increasing number of patients with

chronic and lifestyle diseases, the markets for in-home care devices, technologies, and health-

related ICT products are expected to grow accordingly. Other promising growth areas include

self-care and preventive care medical devices and products.

As the Japanese health care system increasingly emphasises improved treatment and health

maintenance, it will generate future business opportunities for European healthcare

manufacturers with innovative technologies like cardiology equipment, pacemakers, orthopaedic

implants and medical devices that alleviate pain in general, to improve the quality of life of elderly

and patients.

Furthermore, Prime Minister Abe’s growth strategy calls for promotion of the pharmaceutical,

medical device and biotechnology industries. Although these policy programs are basically

targeted to enhance the international competitiveness of Japanese pharmaceutical and medical

equipment industries, these programmes will also be beneficial to European medical companies

that can offer innovative medical products to Japanese patients.

Another part of this strategy, is the revision of the formerly known Pharmaceutical Affairs Law

(PAL) by the Diet in 2014, to reflect the characteristics of medical devices separately from

pharmaceuticals. The medical review process is expected to be further improved through the new

PDM Act and related regulations.

3.3.3. EU Entry Opportunities Medical Equipment

The Japan External Trade Organisation (JETRO), through their Invest in Japan division, has been

highlighting both the current situation, trends and business opportunities of the medical device

market in Japan as described below.47

46 Pharmaceutical Industry Production Statistics, by Mizuho Bank Industry Research Department for Ministry of Health, Labour and Welfare 47 JETRO, Invest in Japan website


3.3.3.1. Medical devices for endoscopic surgery

Robust demand for medical equipment and devices for endoscopic surgery is expected, being

favoured nowadays as an innovative surgery system given the limited physical burden on the

patients.

The market was worth JPY 24.5 billion (EUR 204 million) in FY2014, a 5.4% increase over the

previous year. The Yano Research Institute predicts that the market will keep expanding to reach

JPY 27.6 billion (EUR 230 million) by FY2018.

Market players that supply a full line of devices and equipment in this market segment include

Olympus Medical Systems, MC Medical (importer and distributor of Karl Storz products in the

Japanese market) and Stryker Japan.

3.3.3.2. Surgical support robots

The most common surgical support robot in the market is currently deployed in endoscopic

surgery. Especially university hospitals in Japan are increasingly introducing surgical support

robots into their surgery rooms, and it is estimated that at least 200 units48 have been installed in

Japan to date.

Olympus Medical Systems is tepidly developing intelligent surgical support robots for thoracic

surgery. This often happens in collaboration with renowned medical institutions of higher learning,

including Tokyo University, amongst others.

3.3.3.3. Image diagnosis devices (MRI equipment)

Japan has the largest per capita number of MRI devices in the world. Although the number of MRI

devices installed is lower than that of X-ray CT scanners, the market size in value of MRI devices

was JPY 53.1 billion (EUR 442.5 million) for FY2014. Replacement of older existing devices will



lead future demand, and Yano Research Institute estimates the market to grow to JPY 54.7 billion

(EUR 455.83 million) by FY2018.

The MRI market in Japan is dominated by major companies Hitachi Medical, Toshiba Medical

Systems, GE Healthcare Japan, Philips Healthcare Japan and Siemens Healthineers Japan.

Espicom Business Intelligence picks orthopaedics and prosthetics (4.7% CAGR in local currency

terms) and diagnostic imaging (3.9%) as top growth performers until FY2018 given the rapidly

ageing population of Japan. At the end of FY2015, the total market value was estimated to be

JPY 157.5 billion (EUR 1.31 billion).


3.4. ICT for Healthcare & Medical Technologies

3.4.1. Market Overview ICT for Healthcare & Medical Technologies

The total ICT Healthcare market size was valued at JPY 374.3 billion (EUR 3.11 billion) in

FY2013, while forecasts see the market grow to JPY 420.4 billion (EUR 3.5 billion) by FY2020,

representing a 12.3% increase compared to FY2013.49

ICT Systems in Medical and Nursing Care (n=733)

Currently

Implemented (%)

Future

Implementation (%)

Radiological image diagnosis/remote diagnosis 14.2 7.8

Remote emergency medical care 5.0 8.1

Electronic medical records 11.3 13.3

Remote meeting systems for doctors 8.3 4.7

Remote diagnosis at home 1.4 7.0

Visiting nurse support 3.7 6.5

Home care support 2.3 5.2

Medical regional information cooperation 5.2 7.6

Health promotion information 3.7 4.9

ICT Systems in Welfare (n=733)

Currently

Implemented (%)

Future

Implementation (%)

Provide child-rearing support information 29.7 9.3

Electronic maternity child notebook 0.9 2.9

Barrier-free information 11.0 4.7

Supplier information sharing 20.0 12.3

49 Invest in Tokyo website, 2016


ICT Systems in Medical and Nursing Care (n=733)

Remote safety check and confirmation system 16.6 10.6

Life support system 4.1 6.4

Figure 34: ICT in Healthcare Questionnaire, Ministry of Internal Affairs and Communications, 2016

Currently, several innovative ICT pilot projects are promoted by local and rural municipalities.

Often these pilots are collaborations between academic institutes and private companies.

Other hot key words in the ICT Healthcare sub-sector in Japan, like global trends, are optimisation

of services via big data, artificial intelligence (AI) and Internet of Things (IoT) devices.

3.4.2. Market Trends ICT for Healthcare & Medical Technologies

On a macro-level, the Japanese Government is mainly focusing on the following fields to

invigorate rapid applications of ICT systems in the healthcare and medical technologies market

in Japan:

Efficient and high-quality medical services by utilizing information and communication

technology (ICT)

Data sharing among medical health care providers: Sharing patient data among all medical

professionals and care providers through an electronic medical record keeping system and

other medical data storage systems

ICT for improvement of operational efficiency: Systems to help improve the efficiency of

administrative operations for home healthcare service providers

Expand use of electronic medical records in 90% of large hospitals to prevent duplication of

inspection and administration of medications (by FY2020)

Expand the regional healthcare information collaboration network nationwide for sharing

patient information among medical institutions (by FY2018)


Use personal number cards as health insurance certificates from FY2017 on and promote

the use of electronic medicine record notebooks across the nation by FY2018.50

Digitisation and ICT use in healthcare, medical care and nursing care fields

Figure 35: © ICT Trends in Japan’s Healthcare Policy, Fujitsu Science Technology, July 2015

At Level 1 of the figure above, Japan aims to digitise systems at medical, nursing and healthcare

sites. Level 2 allows the construction of an overall digital infrastructure for the same markets.

Finally, Level 3 aims to apply the information from this digital infrastructure to optimise and

streamline healthcare expenditures.

ICT and Robotic Devices in Nursing Care

In the home nursing care field, robotic devices for nursing care are expected to be used broadly

onsite to solve the current labour shortage in combination to prevent backaches nursing care

workers are liable to suffer.

50 Note: aforesaid healthcare fields include nursing care ICT, tailor-made medicine and self-care health promotion devices


Currently, the market size of robotic devices for nursing care is projected to expand from

JPY 16.7 billion (EUR 139.16 million) in FY2015 to JPY 404.3 billion (EUR 3.36 billion) by

FY2035.

Since FY2014, with the aim of the rapid and widespread use of robotic devices for nursing care,

the Ministry of Economy, Trade and Industry (METI) and the Ministry of Health, Labour and

Welfare (MHLW) has implemented a “5-year Plan for Development of Robotic Devices for Nursing

Care” which promotes the development of economical and practical robotic devices such as for

lifting aids, mobility aids and monitoring system for people with senile dementia, through a public

contest. Past winners included companies such as Kikuchi Seisakusho, Cyberdyne, Fuji Machine

Manufacturing and Panasonic.

The MHLW is aiming to realise an integrated, community comprehensive care system by FY2025

that provides sufficient housing, medical care, nursing care, prevention services, and living

assistance, so that people will be able to live out their lives as they wish in familiar locations, even

if they eventually require intensive nursing care. Making this integrated community care system a

reality requires cooperation and information-sharing through ICT. Collaboration between the

healthcare, IT and robotics manufacturing sectors is currently under way.

The bigger players like Fujitsu, NEC and Konica-Minolta are especially active in this market of

Medical Information Platforms and Cloud Services.

3.4.3. EU Entry Opportunities for ICT in Healthcare & Medical Technologies

The opportunities for European companies to enter the Japanese market in this sub-sector are

diverse, with growth expected in several key product areas:

Electronic Medical Record Systems: Projected growth of 23.2% from FY2013 to

JPY 149 billion (EUR 1.24 billion). Expected strong in smaller hospitals with 300 beds or

less, for low initial cost and user-friendly cloud services demand should be especially strong


Community Healthcare Coordination Systems: Market is estimated to expand by 66.7% from

FY2013 to JPY 5 billion (EUR 41.6 million) by FY2020 with rural areas looking especially

promising

Remote Diagnostic Imaging Systems: Estimated five-fold growth from FY2013 to

JPY 38.5 billion (EUR 320 million) by FY202051

ICT Home Health Care (HHC) Market:52 Market is expected to double from JPY 11.8 billion

(EUR 98.33 million) in FY2012 to JPY 26 billion (EUR 216 million) in FY2020. Backed by

government support, numerous domestic and overseas players are entering the healthcare

market with innovative ICT home health care services and devices

HHC patient data sharing:

FY 2013: JPY 3 billion (EUR 25 million); FY2020: JPY 10.4 billion (EUR 86 million)

HHC improving operation efficiency:

FY 2013: JPY 1.66 billion (EUR 13.8 million); FY2020: JPY 1.75 billion (EUR 14.5 million)

HHC remote elderly activity monitoring:

FY 2013: JPY 11.52 billion (EUR 96 million); FY2020: JPY 13.23 billion

(EUR 110.2 million)

HHC remote medical/nursing care:

FY 2013: JPY 100 million (EUR 833,000); FY2020: JPY 550 million (EUR 4.58 million)

Internet of Things (IoT) devices in healthcare: Expected annual growth rate of 20% between

FY2015-2020.53

Continuously increased implementation of digital Electronic Health Record (EHR) and

Personal Health Record (PHR) systems nationwide for medical and nursing care

51 Market Report Medical Devices and Welfare Equipment 2021 Forecast, Fuji Keizai Marketing Research & Consulting Group, 2016, Japanese 52 ICT in Home Health Care in Japan, Ministerie van Buitenlandse Zaken, 2013 53 Ministry of Internal Affairs and Communications, 2016


Mobile Carriers enhancing mobile cloud applications: NTT DoCoMo with MyMove; KDDI (au)

with Karada Manager; and Softbank Mobile with Softbank Healthcare App

New or improved equipment for enhanced healthcare: Miniaturised and cheaper electronics

and sensors, high-density memory, micro-electromechanically systems and novel

combinations of existing devices

ICT for more Efficient Health Management: Market is projected to expand moderately from

JPY 1.6 billion (EUR 13.3 million) in FY2012 to JPY 1.75 billion (EUR 14.5 million) by

FY2020.54

Innovative ICT applications in the medical field will continue to save considerable amounts of time

spent on administrative work for doctors, nurses and hospital staff. To further improve daily

operation efficiency, particular expertise and know-how in home healthcare should be built into

the systems and devices.

Separate from the aforesaid, the Japanese market has also seen strongly increased imports and

sales of health and sports related wearables with USB (Universal Serial Bus), apps and cloud service

connectivity in recent years. This trend will also continue to be strong over the next few years.

The graph on the next page shows the transition and forecast of the Domestic Market Size of

Wearable Devices:

54 ICT in Home Health Care in Japan, Ministerie van Buitenlandse Zaken, 2013


Figure 36: © Global Wearable Device Market: Key Research Findings 2016, Yano Research Institute, 2016


3.5. Telemedicine and Remote Health Monitoring

3.5.1. Market Overview Telemedicine and Remote Health Monitoring

3.5.1.1. Remote activity monitoring of the elderly

The remote activity market is growing steadily each year as more Japanese elderly tend to live

alone if their health allows it. In FY2012, the market was worth approximately JPY 10.1 billion

(EUR 84.16 million) and it is expected to grow by 30% to JPY 13.2 billion (EUR 110 million) by

FY2020. Key innovative and unique selling points will be a necessity for new market entrants as

well as for existing players. Some of the services assure speedy contacts with doctors or

hospitals, while others offer ambulance services to take the patients to hospitals for proper

medical treatment in case of emergency.

3.5.1.2. Remote medical/nursing care

Numerous pilot projects to test the feasibility of remote medicine are being carried out by the

relevant ministries such as Ministry of Internal Affairs and Communications (MIC), MHLW and

Ministry of Education, Culture, Sports, Science and Technology (MEXT). The market in FY2015

stood at JPY100 million (EUR 832,000) and is estimated to increase fivefold to JPY 550 million

(EUR 4.16 million) by FY2020.55

3.5.1.3. Remote Healthcare Systems (RHS)

RHS are anticipated to be employed in healthcare environments requiring high precision, such as

instructing surgical procedures in remote rural areas where often a large part of the population is

+65 years old. One of the main reasons why demand of Remote Healthcare Systems will be

strong over the next decade is due to lacking specialists living in remote communities.

55 ICT in Home Health Care in Japan, Ministerie van Buitenlandse Zaken, 2013


3.5.1.4. Telemedicine

Figure 37: © The Japan Times: Prime Minister Shinzo Abe tries out a telemedicine system offered by the city of Minamisoma in

Fukushima Prefecture, 2017

However, the telemedicine market is expected to grow rapidly from the current levels following

deregulation and liberalisation by the government in 2017.


3.5.1.5. Japanese Market Players Telemedicine and Remote Health Monitoring

Fukuda Denshi: http://fukuda.com

Nichii Gakkan: http://www.nichiigakkan.co.jp

Omron Healthcare: http://www.healthcare.omron.co.jp

Philips Healthcare: https://www.philips.co.jp/healthcare

SBS Information Systems: http://www.sbs-infosys.co.jp

Secom: https://www.secom.co.jp

Asahi Kasei Corporation: http://www.asahi-kasei.co.jp

Hitachi Medical Corporation: http://www.hitachi.com/businesses/healthcare/

NTT Group: http://www.ntt.co.jp/index_e.html

Teijin: https://www.teijin.com

Toshiba Corporation: www.toshiba.co.jp

Fujitsu: http://www.fujitsu.com/global

NTT East Corporation: https://www.ntt-east.co.jp/en

Panasonic: http://www.panasonic.com/global/home.html

Sony Corporation: https://www.sony.net

Yuyama: http://www.yuyama.co.jp

http://fukuda.com/

http://www.nichiigakkan.co.jp/

http://www.healthcare.omron.co.jp/

https://www.philips.co.jp/healthcare

http://www.sbs-infosys.co.jp/

https://www.secom.co.jp/

http://www.asahi-kasei.co.jp/

http://www.hitachi.com/businesses/healthcare/

http://www.ntt.co.jp/index_e.html

https://www.teijin.com/

http://www.toshiba.co.jp/

http://www.fujitsu.com/global

https://www.ntt-east.co.jp/en

http://www.panasonic.com/global/home.html

https://www.sony.net/

http://www.yuyama.co.jp/


3.5.2. Market Trends Telemedicine and Remote Health Monitoring

Following the MHLW deregulations issued in August 2015, telemedicine really started to gain

momentum. The first phase focused on big metropolitan areas. Currently many hospitals provide

an online consultation option for busy workers, patients having difficulties reaching the hospital

due to physical disabilities, and patients that are receiving recurring check-ups and treatments.

The first appointment conventionally remains face-to-face with the doctor in charge.

Some doctors provide telemedicine services via an iPhone video app that allows patients to make

appointments and chat with them, while others also connect with their patients via existing generic

communication platforms like Skype or Facebook messenger and even email.

One of the major university hospitals, Juntendo, announced in July 2017 that it will start providing

telemedicine services to Parkinson’s patients. Juntendo University Hospital decided to work with

IBM’s telemedicine applications, although patients will need to have an iPad. The hospital aims

to reach 10% of its 3,000 patients in the short term.56

3.5.3. EU Entry Opportunities Telemedicine and Remote Health Monitoring

European companies offering home care, telecommunication networks, radiographs and

pathology freeze frames are looking forward to a bright future of exports to Japan. Also,

manufacturers of examination, observation and patient treatment systems, combined with

personnel training on how to use these telemedicine communications systems, will have good

business opportunities in the Japanese market.

56 The Japan Times: Once sceptical Japan embraces telemedicine as regulatory hurdles fall, 2017


3.6. Nanotechnology Healthcare

3.6.1. Market Overview Nanotechnology Healthcare

The global market for nanotechnology in healthcare and medicines was estimated at almost

USD 30 billion in FY2014 and is forecast to grow USD 80 billion by FY2019, with a Compound

Annual Growth Rate (CAGR) of 22%. The future growth of the subsector Drug Delivery Systems

(DDS) is particularly promising. In addition, fields like in vivo imaging, in-vitro diagnostics,

biomaterials and active materials are promising sectors globally.57

Market size of the Japanese nanotech sector reached EUR 29.6 billion in

FY2010 and is projected to grow extensively in the future reaching EUR

94.4 billion in FY2020 and should be worth EUR 188.9 billion in FY2030.58

Together with the US and the EU, Japan is one of the world’s leaders in nanotechnology. This is

done by fostering collaboration between private companies and universities or research centres,

while the government is launching development platforms for nanotechnology clusters amongst

various market players. Most relevant examples are the Development of MicroRNA liquid biopsy

for early detection of cancer, led by the National Cancer Center Research Institute, and the

ImPACT Research Center for Advanced Nanobiodevices by the University of Nagoya.59

Nowadays nanotechnology and medical robotics are becoming a key factor in daily life, and this is an

area where Japan is one of the most advanced countries. However, legal and ethical guidelines on

nanotechnology and robotics have not been sufficiently implemented in Japan to date.60

At present, nanotechnology and materials are regulated by the Science and Technology Basic

Law, which promotes Life Science, IT, Environment and Nanotechnology and Materials.

Nanomedicines are regulated within the PMD Act on a product-by-product basis and similar to

normal drugs, without specific nanomedicine regulations.

57 BCC Research, www.bccresearch.com, 2014 58 Nanotech Cluster and Industry Landscape in Japan, Andrej Zagar, EU-Japan Centre for Industrial Cooperation, 2014 59 Special Symposium Life Nanotechnology, Nano Tech Expo 2017, 2017 60 Nanotechnology and Medical Robotics; Legal and Ethical Responsibility, Katsunori KAI, Waseda University, 2014

http://www.bccresearch.com/


3.6.2. Market Trends Nanotechnology Healthcare

Currently, Japan has 41 nanotechnology healthcare products made by seven companies, of which

32 are in dentistry, seven in tissue engineering and two in medical supplies, as shown below:61

Disinfectant: Miracle Titanium MVX Antimicrobial surface coating, Maeda Kogyo

Sanitary Napkin: Sofy Antibacteria, Unicharm

Dentistry: Contra Angle (various models), Nakanishi

Dentistry: Various Products, Yamamoto Precious Metal

Dentistry: Various Products, Tokuyama Dental

Dentistry: Various Products, Sangi

Tissue Engineering: Various Products, Organogenix

Examples of Nanomedicines approved in the past in Japan (classified based upon actual

measurements of the medicines classified as Nanomedicine):62

Lipid microspheres (Palux, Liple, Limethason, Diprivan, Popion)

Liposomes (AmBisome, Doxil, Visudyne)

Polymer-conjugated proteins (Smancs, Pegasys, PegIntron, Somavert)

Antibody-conjugated drugs (Mylotarg, Zevalin)

Nanocrystal drug (Emend)

Imaging agent (Resovist)

61 Nanotechnology Products Database, www.statnano.com 62 Current Initiatives in Japan for Nanomedicines, MHLW,

http://www.statnano.com/


Examples of Nanotechnology applied in Healthcare & Medical Technologies:

Creation of Nano-Diagnosis System: Rapid

and Handy Nano-Device for Ultra Early

Cancer Detection

Creation of Nano-Reconstruction System:

Reconstruction of Regeneration-Inducing

Implant Device

Creation of Nano-Drug Delivery System

(Nano-DDS): Pinpoint DDS for Cancer

Imaging and Target Therapy

Creation of Minimally Invasive Nano-Treatment

System: Minimally Invasive Surgery by Nano

Bio Technology

Figure 38: © Nano Bio First, Kazunori KATAOKA, Funding Program for World-Leading Innovative R&D on Science and

Technology (FIRST), 2012


3.6.3. EU Entry Opportunities Nanotechnology Healthcare

Opportunities exist for European Companies in cooperation with the aforementioned private

companies, but also with nanotechnology research institutions or major universities.

The universities and institutes mentioned below could be the channels for the fastest and easiest

market access for applied nanotechnology in the healthcare sector in Japan.

Universities and Research Centres for Nanotechnology

Name (2016) h-index Number of Articles

National Institute for Materials Science 16 691

Kyoto University 12 614

Tokyo Institute of Technology 9 441

Hokkaido University 9 378

Nagoya University 8 337

Riken 8 270

University of Tsukuba 7 227

Tokyo University of Science 7 177

Keio University 6 143

Hiroshima University 5 122

Figure 39: Nanotechnology Products Database, www.statnano.com

http://www.statnano.com/


3.7. Life Science / Biotechnology for Healthcare

3.7.1. Market Overview Life Science / Biotechnology for Healthcare

Global biotech drugs (vaccines, biologics) continue to gain traction in the life sciences sector.

Of the top 10 pharma products by sales in 2014, the majority of them were biotech drugs,

including monoclonal antibodies and recombinant products.

Treatments for rheumatoid arthritis, Hepatitis C, and cancer figure most prominently in the list of

the most sales-generating drugs. Biotech drug sales were an estimated USD 289 billion in 2014

and are projected to grow to USD 445 billion by 2019.63

In Japan, biotech is an integral part of the Abe Administration’s growth strategy and an area which

could offer substantial opportunities for EU exports of biotech products, technologies, and

services.

In 2015, the estimated size of the market was JPY 3.11 trillion (EUR 25.91 billion) (versus

FY2010: JPY 2.4 trillion / EUR 20 billion), according to Nikkei Biotechnology &

Business. Approximately 2/3 of this market is focused on the healthcare and medical industry.

Antibody drugs and Fc fusion protein drugs have been and will to be the two largest growth drivers

here. Healthcare and Medical have a combined share of 56%, JPY 1.74 trillion (EUR 14.5 billion)

with the total biotechnology industry sector. The METI announced in FY2015, to further develop

the Japanese Biotech Market to JPY 20 trillion (EUR 166 billion) by FY2030.64

Also expected to grow further are biosimilar/FOPPs (follow-on protein products) under the Abe

Administration’s “Basic Policy on Economic and Fiscal Management and Reform 2015.”

Innovation in the healthcare sector is a key priority for the present Government of Japan. It has

established the Agency for Medical Research and Development (ADEM), which will support and

fund new product development in both the pharma and medical device sectors.

63 Global Life Sciences Outlook, Deloitte, 2016 64 METI Policy announcement to 6-fold bio market to JPY 20 trillion by FY2030, Nikkei, 2015


AMED will receive budgetary funding of JPY 126.5 billion in FY2016 (up 1.3% from

JPY 124.8 billion from FY2015). The MHLW has launched a forum in the form of a private panel

for the health minister to promote healthcare start-ups in the country.

3.7.2. Market Trends Life Science / Biotechnology for Healthcare

The Japan Bioindustry Association (JBA) mentions the following ongoing biotechnology research

in healthcare in their FY2015 activity report:65

Development of cell manufacturing and processing systems for the industrialisation of

regenerative medicine, for regenerative medicine products derived from human pluripotent

stem cells (cardiac, nerve, retinal pigment epithelium, liver cells) and for regenerative

medicine products derived from human mesenchymal stem cells

Development of a basic technology for the creation of next-generation pharmaceuticals for

individualised and customised medicine. This project is usually referred to as the

“Technology for the Manufacturing of Next-Generation Therapeutic Antibodies in

Accordance with International Standards”.

In FY2014, the Abe government budgeted JPY 17.2 billion (EUR 143.33 million) for cancer

treatment initiatives involving 3 agencies, with the main recipient being the in April 2015 newly

established Japan Agency for Medical Research and Development (AMED) following the

establishment of the Office for Healthcare Policy in FY2013 and the Act on Promotion of

Healthcare Policy in FY2014. The AMED focuses on integrated medical research from clinical

trials to actual application, amongst which cancer research is featured, but AMED also contributes

to the development of innovative medical devices. 66 Abe’s government also allocated

JPY 4.5 billion (EUR 37.5 million) in the same fiscal year to a consortium of 24 companies and

two universities, which formed a pilot platform for biologic drugs at the end of FY2013.

65 A New Age of Bio-Business: Toward the Creation of New Industry Clusters, JBA, 2015 66 Japan’s Healthcare in 2030, Nomura Research Institute, 2015, Japanese


Separately, the government also committed JPY 110 billion (EUR 916 million), spread out over

ten years, towards increased research of Induced Pluripotent Stem Cells (iPSCs), building further

on the research by Kyoto University researcher and 2012 Nobel laureate Professor Shinya

Yamanaka, who announced plans to establish an international iPSC bank involving more than

ten countries, including the US and UK.67

Another key trend in the Japanese Pharmaceutical sector is related to the patent expirations of

well-known, long and best-selling drugs in the domestic market. This trend will result in enhanced

nano- and biotechnology R&D and commercial applications given the strong promotion by the

present Japanese government. It is still too early to judge how the government-pushed generic

drug and personalised drug policy will evolve in relation to patent expiration of brand drugs.

3.7.3. EU Entry Opportunities Life Science / Biotechnology for Health

Following the Industrial Cluster Plan, launched in April 2001 to strengthen the capabilities of

regional areas for developing innovative technologies and products, Japan now has nationwide

biotech clusters to foster the growth of business ventures and start-ups. These centres are

frequently procuring biotechnology related devices like fully closed automatic cultivation devices,

flow cytometers and incubators.

The Japanese Government also launched the “Pharmaceutical Industry Vision” policy by the

MHLW to open these markets to innovative international pharmaceutical and medical companies

to further enhance Japan’s international competitiveness in the pharmaceutical industry. It aims

to strengthen R&D and commercialisation of products, regardless of whether they were funded

with international or domestic capital.

Participation and collaboration in clusters focusing on biotechnology as well as collaboration

projects between private companies and research institutes (eg. NIPRO and Kyoto University on

iCeMS) are likely the best market entrance for European companies wishing to enter Japan.

67 Japan Moves to Regain Prominence in Biotech, GEN, 2014


Figure 40: Attractive Sectors-Biotechnology, JETRO, 2007


3.8. Dental Products and Technologies

3.8.1 Market Overview Dental Products

Total dental examination medical expenditures stood at about JPY 380 billion (EUR 3.16 billion)

in FY2014, making Japan the number two dental market globally, after the US. Japan imported

dental x-ray equipment, dental equipment and dental materials of value JPY 60.1 billion

(EUR 500 million) as opposed to an export value of JPY 31.6 billion (EUR 263 million) in

FY2015.68 For FY2015, imports increased by 6.6% and exports grew by 5.7% compared to

FY2014. During the period 2016-2020, a CAGR of 6.75% market growth is estimated.69

Currently, Japan has almost 70,000 dental clinics providing dental care to the public nationwide.

Export-Import Ratio of Dental Equipment FY2015

+80% export ratio Drive unit for inside tooth; Hand pieces

High export ratio Equipment for endodontic treatment; Diagnostic imaging system for dentistry; Dental units and related products; Adhesive fillers

Similar export-import ratio Dental ceramics; Small crack dental closure material; Orthodontic equipment and related products

High import ratio Equipment for dental examination; Dental laboratory equipment (except CAD/CAM)

+80% import ratio CAD/CAM devices for dentistry; Materials for dental implants; Dental model material; Dental impression material and reproduction impression material; Total dentures and partial floor denture materials

Figure 41: Figure 36: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association

(JDA), 2017

Dental Computed Tomography (CT) devices and laser devices, which have become quite popular

in recent years, are not included in the description. It is also important to note that devices like

dental computers do not fall under the definition of medical devices in the present Pharmaceutical

and Medical Device Act (PMD Act).

Dental care costs are handled differently depending on factors like cavity development, cavity

numbers and patients covered or not by a health insurance program. All surgical and conservative

68 New Dental Medical Equipment and Dental Medical Technology Industry Vision, JDA, 2017 69 Japan Dental Devices Market, Growth, Trends and Forecasts 2016-2020, Mordor Intelligence, 2016


treatments and even certain prosthetic treatments are included in the scope of benefits under the

National Health Insurance programme. Certain prosthetic, aesthetic implants such as ceramic,

hybrid ceramic and Gold fillings and crowns; orthodontic treatments like braces, mouth pieces

and back teeth correction are not covered.

The top three Japanese dental equipment manufacturers, with a combined market share of 68.8%

are Yoshida with 27%, J. Morita with 25.8% and Takara Belmont with a 16% market share.

Other key dental equipment market players are GC Corporation, Shofu, 3M Health Care,

Dentsply-Sankin, Kuraray Noritake Dental, Nisshin Japan, Ishifuku Metal Industry, Yamamoto

Precious Metal, Tokuriki Honten, Ohura Precious Metal Industry, IDS and Heraeus Kulzer Japan.

3.8.1.1. 8020 Campaign

The most commonly used international measure for oral health is the prevalence of

edentulousness, or the percentage of people with no teeth. In Japan, the ratio of edentulousness

in the age group 65 to 74 years old is 10%, much lower than all other Organisation for Economic

Co-operation and Development (OECD) countries. For comparison, in Europe and the US, this

percentage is between 25–30% for the same demographic bracket.

This is in part thanks to safe and reliable dental treatment using the highest standards of

technology and state-of-the-art equipment and materials, both domestically manufactured and

imported. In general, Japanese dentists practice under a "treating the original teeth as much as

possible" policy which further sustains this low percentage of edentulousness.

To further promote oral and dental healthcare, the Japan Dental Association (JDA), together with

the MHWL, started the 8020 (Hachimaru Nimaru in Japanese, or ‘Eighty Twenty’) campaign in

1989. The main and simple objective was for elderly “to keep 20 or more of their own healthy

teeth until the age of 80."


In 1989, the average life expectancy of females surpassed 80 years, and at the age of 80 then,

only 7% had 20 or more healthy teeth. A follow-up survey in FY2016 showed a record high of

more than 50% of Japanese achieved the goal set out by the campaign.

Changes in Percentage of Persons Having 20 or More Teeth by Age Group

Figure 42: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA),

2017

3.8.2. Market Trends Dental Products

Domestic production or imported dental medical instruments are shipped from the manufacturing

and sales business and are offered to dental clinics and dental laboratories throughout the country

by distribution organisations consisting of primary wholesalers and secondary wholesalers

(retailers).

As Japanese elderly value their dental care, even when they are no longer able to visit their usual

dentist, one can expect robust demand for mobile dental equipment that can be used during visits

to patients’ homes.


Figure 43: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA),

2017

3.8.3. EU Entry Opportunities Dental Products

As mentioned above, for European Dental Products and Technologies like dental examination,

dental equipment, CAD/CAM devices, materials for dental implants, dental reproduction materials

and denture materials for total and partial dentures, future export opportunities will be strong as

import volumes will remain high for many years.

The growth in imports in general (as seen in Figure 44) suggests that the opportunities for dental

products from foreign sources is substantial.


Japan Market Size for Growing Dental Materials and Equipment (unit: JPY 1 million)

FY2014 FY2015 FY2016

Dental X-Ray Equipment 3,216 3,156 4,260

Dental General X-ray Equipment 1,164 1,224 1,236

Dental Use Special X-ray Equipment 2,052 1,932 3,024

Moisture-proof Materials 73.2 92.4 99.6

Dental Electrical Diagnostic Equipment 624 576 852

Dental Suction Device 2,244 2,436 3,156

Orthodontic Equipment 6,636 5,472 6,420

Other Orthodontic Instruments 16.8 33.6 60.0

Ligation or Band Environment Pressure 144 168 228

Dental Laboratory Rotary Equipment 1,800 1,872 2,004

Other Tooth Crown Materials 864 1,188 1,932

Bandage Materials 1.2 28.8 46.8

Dental Root Canal Filling Materials 1,524 1,536 1,716

Dental Model Materials 2,592 2,748 2,880

Dental Diamond Abrasives 252 300 360

Dental Gloves 660 732 1,128

Figure 44: Websites MHLW, MIC and others, 2017

Other dental products related to diagnostic technologies, preventive technologies, oral hard tissue

disease treatment technologies, regenerative medical technologies and dental laboratory

technologies in general will continue to see high demand.70

An example of a successful entrant into the dental market in Japan is Dentsply Sirona, a German

manufacturer that has specialised in dental equipment for over 130 years. As a leader in dental

70 Global Dental Market to Expand at a CAGR of 5.6% in the 2016~2021 article, Trendforce, 2017


technological innovation, Sirona invented the first electric dental drill in 1887. Sirona established

its Japanese subsidiary in 2004. Sirona Japan expanded rapidly and successfully embedded the

Sirona brand deeply in this sub-sector in Japan. At present, Sirona Japan employs 180 people at

11 locations in the country.

The Sirona CAD/CAM restoration system is now installed in over than 5,700 Sirona treatment

centres and 1,700 Japanese dentists.

On 17 March 2017, Dentsply Sirona and Kuraray Noritake Dental concluded a material

partnership for CAD/CAM blocks business in Japan. Based on this partnership, Dentsply Sirona

will offer professional dental laboratory dedicated and optimised milling strategies for use with

Kuraray Noritake Dental multi-layered zirconia discs.71

71 10 Years of Sirona Japan: A Success Story, https://blog.dentsplysirona.com/en/10-years-sirona-japan-success-story/

https://blog.dentsplysirona.com/en/10-years-sirona-japan-success-story/


4. Healthcare & Medical Technologies Regulations

4.1. Healthcare & Medical Technologies Regulations

4.1.1. Pharmaceuticals and Medical Device Act (PMD Act)

On 25 November 2014, the Japanese Pharmaceutical Affairs (PAL) Law, long known for its

strictness, was completely revised by the Abe Government under a renaming to “Act on Securing

Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular

Therapy Products, Gene Therapy Products, and Cosmetics” or “Pharmaceuticals and Medical

Device Act” (PMD Act) in short.

The current PMD Act separates medical devices from pharmaceutical products in its technical

treatment, which were handled in the same way in the former PAL. As a result, medical device

regulations have eased, thus leading to reduced development costs and faster approval reviews.

Furthermore, to respond to progress in medical technologies, including reinforcement of safety

measures for pharmaceutical products and medical devices and the creation of an approval

system toward earlier commercialisation of regenerative medicine, the Act was revised with the

aim of quickening the practical application process for technologies while ensuring safety.

The amended Law brought five main changes to secure a safe and expedited supply of medicinal

products and medical devices:

A charter for Marketing Authorisation License and Manufacturing License of medical devices

stated separately from that of pharmaceutical products, quasi-drugs and cosmetics

Private third parties can now also offer certification services for Specially Controlled Medical

Devices, following the newly established standards

Monolithic programme for diagnoses is handled as medical devices so it can be subject to

approval or certification of the Marketing Authorisation License (In PAL, it was not

considered for approval or certification). Standalone software became a Class II device


The approval system for attaining a Manufacturing License of medical devices was simplified

to a registration system. This also allowed quality inspections to be conducted for product

groupings as opposed to individual products

Standards compliance investigation into manufacturing and quality control of medical

devices was rationalised

In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA), an independent

administrative agency under the jurisdiction of the MHLW, is responsible for implementing

evaluations for approval of pharmaceutical products and medical devices.

As a member of the International Medical Device Regulators Forum (IMDRF), Japan is also doing

serious efforts to harmonise with international standards of the global healthcare market. In

FY2016, the MHLW adapted the local regulations on quality management for medical devices to

conform with the global ISO standard (ISO13485:2016).

4.1.2. Application and Approval

Japan’s medical device classification system is based on the Japanese Medical Device

Nomenclature (JMDN) codes, and are different from US and European classifications. The review

processes for medical devices also differ depending on classification.

Medical devices are classified into 4 classes (Class I, Class II, Class III and Class IV) designating

risk level.

Class I (lowest risk to the human body) is defined as general medical devices

Class II (relatively low risk) is defined as controlled medical devices

Class III (relatively high risk) is defined as having a relatively high risk to the human body in

case of failure

Class IV (highest risk) is defined as specifically controlled devices


The aforesaid PMD Act revision in FY2014, has profoundly eased applications and approvals of

imported medical devices and equipment but it is important to not lose sight of the former strict

PAL mindset, when exporting to Japan, especially for the first time.

To date, calculating sufficient approval time and financial resources for market entrance and

approval are necessary. Potential Japanese business partners will take a long-term stance and

research if similar devices are already available in Japan or not. Also, the business partner will

perform a profound background check to see if all necessary regulations and rules are cleared or

not, as they need to assure extremely short delivery times once an order has been issued by their

domestic healthcare customers.

In general, the higher the hazard class to which the imported medical device belongs to,

the longer the approval process will take, as it gets more complex. Hence, the cost will also

increase. For devices belonging to the aforesaid Class III and IV, approval fees to the regulators

will vary between EUR 50 to EUR 100,000, not including any consulting fees of external parties.

The complete approval process will take at least 1.5 years from original application.

Also, it is important to bear in mind that almost all regulations and documents are published

exclusively in Japanese and that the PMD Act imposes strict requirements and clinical standards

for foreign manufacturers, hence an experienced regulatory partner with a presence in Japan is

quite essential for business success in the long term.

Finally, overseas manufacturers of high-end and innovative medical equipment should expect

fierce competition from Japanese healthcare manufacturers, especially in promising business

areas like diagnostic imaging, surgical equipment, monitoring systems, dialysers and

endoscopes.

The chart below explains in detail the necessary approval process, step-by-step, per specific

hazard Class, in accordance with the new and simplified PMD Act.


Regulatory Process for Medical Devices in Japan72

Figure 45: © Japan: The Regulatory Process for Medical Devices, Emergo, 2017

72 https://www.emergogroup.com/resources/japan-process-chart

https://www.emergogroup.com/resources/japan-process-chart


“The Regulatory Process for Medical devices in Japan

Step 1: Determine classification of your device according to the Pharmaceuticals and Medical

Devices Act (PMD Act) and Japanese Medical Device Nomenclature (JMDN) codes.

There are 5 classes of increasing risk:

• Class I - General medical devices

• Class II - Specified Controlled medical devices

• Class II - Controlled medical devices

• Class III73 - Highly Controlled medical devices

• Class IV - Highly Controlled medical devices

Step 2: For Class I devices, appoint an MAH in Japan. For all other classes, Appoint Marketing

Authorisation Holder (MAH or D-MAH) to manage your device registration in Japan.

Your MAH or D-MAH will control your device registration.

Step 3: All classes: Japanese manufacturers must register domestic facilities with local

prefectural authorities. Foreign manufacturers must submit a Foreign Manufacturer

Registration (FMR) application to the Pharmaceuticals and Medical Devices Agency

(PMDA).

Step 4: All classes: Implement Quality Management System (QMS) that complies with the PMD

Act and Ministry of Health, Labour and Welfare (MHLW) Ordinance #169. Ordinance

#169 is based on ISO 13485.

Step 5: For Class I devices, submit Pre-Market Submission to Pharmaceutical and Medical

Devices Agency (PMDA). All documents must be in Japanese.

For Class II (Specified Controlled) devices, submit Pre-Market Certification application

to a Registered Certified Body (RCB) authorised to issue certifications. All documents

must be in Japanese.

73 Some Class III medical devices are considered “Specified Highly Controlled” devices and follow the same approval route as Class II

"Specified Controlled" devices


For Class II (Controlled) through IV devices, prepare Pre-Market Approval application

as well as registration dossier in Summary Technical Document (STED) format. Submit

documents to PMDA. All documents must be in Japanese

Step 6: Most74 Class I devices do not require QMS conformity assessment.

For Class II (Specified Controlled) devices, QMS audit by Registered Certification Body

(RCB).

For Class II (Controlled) through IV devices, QMS audit by PMDA. On-site audits are

typically required for “New” devices with no existing JMDN code, Class IV devices, and

those requiring clinical investigations.

Step 7: For all Class II through IV devices, your QMS certificate will be issued by the PMDA or

your Registered Certification Body.

Step 8: For Class II (Specified Controlled) devices, Pre-Market Certificate issued by RCB.

For Class II (Controlled) through Class IV devices, Pre-Market Approval certificate

issued by MHLW.

Step 9: For all devices, a reimbursement application should be filed with Economic Affairs

Division of MHLW if applicable.

Step 10: You may now begin marketing your device in Japan. Approvals do not expire.75

This is a simplified overview of the process. The PMDA may choose to audit your

submission and request more documents, which will add time to your approval.”76

74 MHLW Ordinance #169 documentation is not required for most Class I device applications. However, some Class I device manufacturers do

require QMS certification, including Class I NEW devices (i.e., no JMDN code) 75 Device registrations do not expire. However, QMS certificates are valid for five years and must be renewed six months prior to expiration. Pre-

Market Certification applications may also be subject to annual surveillance audits. The schedule will be determined by the RCB or PMDA 76 https://www.emergogroup.com/resources/japan-process-chart



Estimated Time, Cost and Complexity of Registration77

Figure 46: © Japan: The Time, Cost and Complexity of Registration, Emergo, 2017

The company Emergo, part of the UL Group with an office in Tokyo, specialises in Device

Classification support, PMDA Registration and Foreign Manufacturer Registration. Till date, they

have executed +770 projects in de Medical Device sector in Japan for numerous global healthcare

and medical device manufacturers.78

General and initial inquiries about medical devices in regard to marketing approval can also be

directed to the Pharmaceuticals and Medical Devices Agency (PMDA).79

77 https://www.emergogroup.com/resources/japan-process-chart 78 https://www.emergogroup.com/resources/japan/all/all 79 http://www.pmda.go.jp/english/index.html


https://www.emergogroup.com/resources/japan/all/all

http://www.pmda.go.jp/english/index.html


Classification of Exemplary Medical Devices in Japan

Figure 47: Outline of the Law for Partial Revision of the Pharmaceutical Affairs Law (Act No.84 of 2013)

General medical devices can be marketed by submitting a notification to the Pharmaceutical

and Medical Device Agency (PMDA). Controlled medical devices, with established certification

standards, can be reviewed by Certified Third-Party bodies. Controlled medical devices without

certification standards and specifically controlled devices must be reviewed by the PMDA and

approved by the MHLW.

Japan does not levy customs duties on imported medical devices. However, medical devices are

heavily regulated under the Pharmaceutical and Medical Device Act (PMD Act). The PMD Act will

enable further improvements to the regulatory review process, including the establishment of a

device-specific regulatory framework.

Japan’s medical device market authorisation process has long been considered one of the most

rigorous, lengthy, and intensive in the world; however, PMD Act greatly streamlined these

regulatory requirements. Although regulations are still stringent, the final aim is to make the


registration and approval process faster than that of the Food and Drug Administration (FDA) in

the US.

Currently, Japan does not accept CE (Conformité Européene) marking and/or an FDA certificate,

although European and US approval does help speed up the review process. However, the

principle agreement on the Economic Partnership Agreement (EPA) between EU and Japan from

July 2017 will most likely accelerate or completely remove approvals if standards are harmonised

internationally. It is also expected that the recently established Japan Agency for Medical

Research and Development (AMED) will facilitate in the harmonisation between Japanese,

global, and aforementioned recognised medical device standards.


4.1.3. Long-Term Care Insurance (LCTI) system

Figure 48: Overview LTCI, MHLW 2016

In April 2000, the Japanese government launched its fifth social insurance scheme, the Long-

term Care Insurance, as a mechanism to enable society to provide long-term care to the elderly.


The ultimate purpose stated in the LTCI Act is to help individuals in need of LTC “to maintain

dignity and an independent daily life routine according to each person’s level of abilities.” To do

so, the government set up three goals when it established the LTCI program.

These three goals are:

Support for independence: The LTCI System aims to support the independence of elderly

people, rather than simply providing personal care

User-oriented: A system in which users, based on their own choice, can receive integrated

services of health, medicine, and welfare from diverse agents

Social insurance system: Adoption of a social insurance system where the relationship

between benefits and burdens is clear



Supporting benefits from nursing-care insurance is not limited to nursing care services, but it also

covers welfare equipment that supports the lives of elderly people requiring long-term care,

including canes, wheelchairs and bathing equipment used at nursing facilities.

This furthermore includes equipment and technologies that are used in nursing-care facilities by

caretakers: Equipment used for rehabilitation, training, and tools for users to lead a self-reliant

daily life in their residence. These are subject to insurance benefits for things that help to make

the LTCI objectives possible. Specific target items are announced by the MHLW.

Long-term care insurance services are provided when people aged 65 or over require care or

support for whatever reason, and when people aged 40-64 develop age-related diseases, such

as terminal cancer or rheumatoid arthritis. Initially, co-payment by patients was set as 10%

regardless of income, but as of August 2015, this was increased to 20% for persons with income

above certain level.



The next revision of the LTCI System is planned for FY2018 as Japan continues to work towards

a Community-based Integrated Care System by FY2025.

4.1.4. Medical Fees and Insurance Reimbursement



4.1.5. Other Regulations

The Japanese government of Prime Minister Abe has both launched and reinforced also other

Healthcare Sector Policies in recent years:

Establishment of Japan Agency for Medical Research and Development (AMED) in 2015 to

streamline a global and integrated medical R&D strategy, including medical device

development, from clinical trials till actual application

Barrier-Free Act: Originally issued in 2006 aiming to promote easy mobility and accessibility

for the elderly and disabled in public spaces like dedicated parking spots, building entrance

approaches, stairs with handrails, wheelchair spots, elevators and multi-purpose toilets

amongst others

Regenerative Medicine Law

The Orange Plan FY2013: Co-housing with dementia patients instead of nursing care

facilities

Figure 52: New Orange Plan, LTCI, MHLW, 2016


The PMDL will enable further improvements to the regulatory review process, including the

establishment of a new product category for regenerative medicine products. Regenerative

medicine is a branch of medical research in tissue engineering and molecular biology which deals

with replacing, engineering or regenerating human cells, tissues or organs to restore or establish

normal function. The rapid approval system on regenerative medical products was introduced

with the enforcement of the law, which raised Japan to the forefront of regenerative medicine.


5. Annexes

5.1. Healthcare & Medical Technologies Industry Associations

Japan Medical Industry Association (JMIA):

http://www.med.or.jp/

Medical Technology Association of Japan (MTJAPAN):

www.mtjapan.or.jp

Japan Association of Medical Devices Industries (JAMDI):

http://www.jfmda.gr.jp/

Japanese Surgical Society (JSS):

http://www.jssoc.or.jp/

Japan Association of Health Industry Distributors (JAHID):

http://www.jahid.gr.jp/

Japan Analytical Instruments Manufacturers' Association (JAIMA):

http://www.jaima.or.jp/

Japan Dental Trade Association (JDTA):

http://www.jdta.org/

Japan Home Health Care Association (JHHC):

http://www.jhhc.jp/

Japan Hearing Instruments Manufacturers Association (JHIMA):

http://www.hochouki.com/

Japan Hygiene Products Industry Association (JHPIA):

http://www.jhpia.or.jp/

http://www.med.or.jp/

http://www.mtjapan.or.jp/

http://www.jfmda.gr.jp/

http://www.jssoc.or.jp/

http://www.jahid.gr.jp/

http://www.jaima.or.jp/

http://www.jdta.org/

http://www.jhhc.jp/

http://www.hochouki.com/

http://www.jhpia.or.jp/


Japan Industries Association of Physical Therapy Devices (JIPT):

http://nichirikiko.gr.jp/

Japan Medical Imaging and Radiological Systems Industries Association (JIRA):

http://www.jira-net.or.jp/

Japan Medical-Optical Equipment Industrial Association (JMOIA):

http://www.jmoia.jp/

Japan Ophthalmic Instruments Association (JOIA):

https://www.joia.or.jp/

Japan Contact Lens Association (JCLA):

http://www.jcla.gr.jp/

http://nichirikiko.gr.jp/

http://www.jira-net.or.jp/

http://www.jmoia.jp/

https://www.joia.or.jp/

http://www.jcla.gr.jp/


5.2. Health and Medical Technology Trade Fairs

2nd CareTEX 2016 (March, Tokyo)

http://caretex.jp/

34th Health Expo 2016 (March, Tokyo)

http://www.this.ne.jp/

16th Japan Drugstore Show (March, Chiba)

http://www.drugstoreshow2016.jp/

37th Kansai Health Industry Fair (April, Osaka)

http://www.newmagazine.jp/

2016 International Exhibition of Medical Imaging (ITEM 2016) (April, Yokohama)

http://www.jira-net.or.jp/event/event_088.html

CPhI Japan 2016 (International Pharma Ingredient Fair) (April, Tokyo)

http://www.cphijapan.com/

P-MEC Japan 2016 (Medicine Ingredients, Devices) (April, Tokyo)


MEDTEC Japan 2016 (April, Tokyo)

http://www.medtecjapan.com/

22nd Barrier Free 2016 (April, Osaka)

http://www.tvoe.co.jp/bmk/

15th BIO-tech 2016 (May, Tokyo)

http://www.bio-t.jp/

Medical & Imaging Expo 2016 (May, Yokohama)

http://www.opie.jp/mi/index.php

http://caretex.jp/

http://www.this.ne.jp/

http://www.drugstoreshow2016.jp/

http://www.newmagazine.jp/

http://www.jira-net.or.jp/event/event_088.html



http://www.medtecjapan.com/

http://www.tvoe.co.jp/bmk/

http://www.bio-t.jp/

http://www.opie.jp/mi/index.php


19th International Welfare & Health Industry Expo (June, Nagoya)

http://www.nagoya-trade-expo.jp/welfare/

7th Medical Device, Development and Manufacturing Fair (June, Tokyo)

http://www.medix-tokyo.jp/

91st Medical Show & Business Expo 2016 (June, Osaka)

http://www.jsmi.gr.jp/connection/

10th in-PHARMA Japan (International Medicine Ingredients) (June, Tokyo)

http://www.pijapan.jp/

29th Interphex Japan (Medicine, Cosmetics R&D and Manufacturing International Expo)

(July, Tokyo)

http://www.interphex.jp/

RE-CARE Japan 2016 (Rehabilitation and Nursing Care Industry Expo) (August, Tokyo)

http://www.re-care.jp/

BioOpto Japan 2016 (September, Yokohama)

http://www.optojapan.jp/bio/

JACLaS EXPO 2016 (Clinical Testing Devices, Reagents and Systems) (September,

Yokohama)

http://jaclas.or.jp/exhibitions/index.html

43rd International Welfare Equipment Expo 2016 (October, Tokyo)

http://www.hcr.or.jp/

HealthCare IT 2018 (April, Tokyo)

http://www.healthcarejapan.com/information/en-index.html

http://www.nagoya-trade-expo.jp/welfare/

http://www.medix-tokyo.jp/

http://www.jsmi.gr.jp/connection/

http://www.pijapan.jp/

http://www.interphex.jp/

http://www.re-care.jp/

http://www.optojapan.jp/bio/

http://jaclas.or.jp/exhibitions/index.html

http://www.hcr.or.jp/

http://www.healthcarejapan.com/information/en-index.html


5.3. List of Healthcare Medical Technology Companies in Japan

5.3.1. Terumo Corporation

http://www.terumo.co.jp/

Terumo Corporation was founded in 1921 as Sekisen Ken-onki Corporation by a group of medical

scientists. The company's first product was "Jintan Taionkei", the first Japanese-made

thermometer available for sale, and it has since expanded into a medical devices manufacturer,

producing medical disposables, cardiovascular systems and diabetes care products.

In 1971, Terumo opened its first overseas office in the United States. Since then, the company

has established subsidiaries in Europe (1971), South America, China, India, Philippines, Vietnam,

Thailand and Australia. The company later expanded its product range to include coronary stents

and catheters, and acquired, among others, the cardiovascular specialty companies Vascutek

and Microvention in 2002 and 2006 respectively.

5.3.2. Olympus Corporation

https://www.olympus.co.jp/product/medical/

Olympus Corporation is a Japanese manufacturer of optics and reprography products. Olympus

was established on 12 October 1919, initially specializing in microscope and thermometer

businesses. Olympus manufactures endoscopic, ultrasound, electrocautery, endotherapy, and

cleaning and disinfection equipment. The first flexible Endoscope in the world was co-developed

and manufactured by Olympus in Tokyo. Through its comprehensive product range and its

reactivity to market innovations, Olympus enjoys a virtual stranglehold of the world market in

gastro-intestinal endoscopes. It has roughly 70% share of the global market whose estimated

value is US$ 2.5 billion. On 28 September 2012, Olympus and Sony announced a joint venture

to develop new surgical endoscopes with 4K resolution (or higher) and 3D capability.

http://www.terumo.co.jp/

https://www.olympus.co.jp/product/medical/


5.3.3. Nipro Corporation

http://www.nipro.co.jp/en/

Nipro Corporation is a Japanese medical equipment manufacturing company specializing in

medical, pharmaceutical and glass products. Founded in 1954, the company is headquartered in

Osaka and is listed on the Tokyo Stock Exchange and the Osaka Securities Exchange. As of

2013 the company has 58 subsidiaries in Japan, Asia, North and South America and Europe.

5.3.4. Hitachi Healthcare Manufacturing

http://www.hitachi.co.jp/

Hitachi Healthcare Manufacturing, Ltd. engages in the development, manufacturing, sale,

installation, and maintenance of medical equipment, medical information systems, general

purpose analysers, and medical analysers. Its medical equipment includes MRI systems,

CT systems, diagnostic ultrasound systems, digital radiography and fluoroscopy systems with

FPDs/image intensifiers, general radiography systems, X-ray and mobile X-ray systems, optical

topography systems, bone densitometry systems, nuclear medicine systems, and radiotherapy

systems.

The company’s medical information systems comprise medical administration systems, hospital

information systems, medical image management systems, and comprehensive medical checkup

systems; general analysis systems include radiation measuring and control instruments; and

medical analysis systems consist of laboratory test systems and pipettors. It serves National and

other public hospitals, university hospitals, general hospitals, private hospitals and clinics, etc. in

Japan and internationally. Hitachi Healthcare Manufacturing, Ltd. was formerly known as Hitachi

Medical Corporation and changed its name to Hitachi Healthcare Manufacturing, Ltd. in April

2016. The company was founded in 1949 and is headquartered in Tokyo, Japan with various

branch, sales, and service offices in Japan.

http://www.nipro.co.jp/en/

http://www.hitachi.co.jp/


5.3.5. Fukuda Denshi

http://www.fukuda.co.jp/

Fukuda Denshi Co., Ltd. develops, manufactures, and sells medical electronic equipment

worldwide. It provides resting electrocardiograph products; data management software; stress

test products; Holter products and software; and patient monitoring systems, including central and

bedside monitors, digital transmitters, and central viewer workstations. The company also offers

defibrillator monitors; ultrasound scanners; and vascular screening systems. Fukuda Denshi Co.,

Ltd. was founded in 1948 and is based in Tokyo, Japan.

5.3.6. Nihon Kohden

http://www.nihonkohden.co.jp/

Nihon Kohden Corporation is a Tokyo-based leading manufacturer, developer and distributor of

medical electronic equipment, which include EEGs, EMG measuring systems, ECGs, patient

monitors and clinical information systems, with subsidiaries in the US, Europe and Asia.

The company's products are now used in more than 120 countries, and it is the largest supplier

of EEG products worldwide.

In 1972, Takuo Aoyagi, a researcher at the company, invented and patented the basic principles

of pulse oximetry. Two years later he developed the world's first pulse oximeter, which has helped

improve patient safety during anaesthesia.

http://www.fukuda.co.jp/

http://www.nihonkohden.co.jp/


5.4. European HMT Companies in Japan

5.4.1. Philips Electronics Japan

Philips Electronics Japan, Ltd. imports, distributes, and markets electronic equipment for

healthcare, lighting, and consumer lifestyle markets. The company offers medical devices

including imaging systems, acute and critical care equipment, ultrasound equipment, clinical

informatics, patient monitoring systems, emergency care products, ventilators, airway

management systems, asthma, allergy, and respiratory management products, home oxygen

equipment, sleep and breathing disorder management systems, home monitoring products,

medical alerts, and anaesthesia machines for hospitals and home health care applications.

It provides domestic appliances and personal care consumer products including shavers, electric

toothbrushes, and oral healthcare.

www.philips.co.jp

5.4.2. LivaNova

Livanova Co., Ltd. imports and sells LivaNova's main products such as artificial lungs, artificial

heart-lung machines, other extracorporeal circulation systems and autologous blood collection

devices.

LivaNova PLC, headquartered in London, UK, is a global medical technology company formed

by the merger of Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and

Cyberonics Inc., a medical device company with core expertise in neuromodulation.

LivaNova, PLC has received approval from Japan’s Pharmaceutical and Medical Devices Agency

(PMDA) for its Solo Smart stentless tissue valve, the only valve designed to provide superior

hemodynamics with the ease of a stented bioprosthesis implantation.

https://www.livanova.co.jp/company/about/

http://www.philips.co.jp/

https://www.livanova.co.jp/company/about/


Air Liquide Japan

B. Braun Aesculap Japan Co

Biotronik Japan

Coloplast

Dornier MedTech Japan

Draeger Medical Japan

Edaptechnomed

Elekta

Hollister

Integral Corporation

Intuitive Surgical

Japan Lifeline

Japan MDC

JIMRO

Laerdal Medical Japan

Lima Japan

Medis Medical Imaging Systems

Molnlycke Health Care

Nippon Becton Dickinson

Nippon BXI

Nobel Biocare Japan

Novocure

Otto Bock Japan


Philips Electronics Japan

Radiometer

Siemens Healthcare

Smith & Nephew Wound Management

Sorin Group Japan

TKB Corporation

Vorpal Technologies

Roche Diagnostics

SML (Sceti Medical Labo)

Sysmex bioMerieux


5.5. Bibliography and References

2016 Top Markets Report Health IT Country Case Study Japan, International Trade

Administration, English, 5p, 2016

A New Age of Bio-Business: Toward the Creation of New Industry Clusters, Japan

Bioindustry Association, English, 16p, 2015

Abenomics, The Government of Japan, English, 16p, 2017

About Healthcare Projects in Biotechnology, NEDO, Japanese, 32p, 2013

Annual Report on Statistics of Production by Pharmaceutical Industry in 2015, MHLW,

English, 52p, 2015

Attractive Sector: Healthcare, JETRO, English, 8p, 2012

Attractive Sectors: Life Science, JETRO, English, 10p, 2016

Attractive Sectors-Biotechnology, JETRO, English, 16p, 2007

Basic Information about Dental Oral Health, Japan Dental Association, Japanese, 173p,

2015

Bioeconomy Vision of Japan for 2030, Japan Association of Bioindustries Executives,

English, 8p, 2016

Current Initiatives in Japan for Nanomedicines, National Institute of Health Sciences,

English, 16p, 2010

Dental Devices and Materials in Japan, Susanne Walloscheck, Mihoko Kohinata, EU-Japan

Centre for Industrial Cooperation, English, 38p, 2014

Dental Devices and Materials Market in Japan: Key Research Findings 2014, Yano

Research Institute, English, 2p, 2014

Development of Innovative Diagnostics and Therapeutic Systems based on

Nanobiotechnology, NanoBio First Research Support Office, English, 8p, 2012

Domestic Healthcare Market Trends, AMED, Japanese, 16p, 2015


Domestic Market Outlook for Nursing Care and Welfare Equipment and Services, Fuji Keizai

Marketing Research and Consulting Group, Japanese, 6p, 2016

European Union, Trade in Goods with Japan, European Commission-Directorate General for

Trade, English, 10p, 2017

EY Life Sciences Sector Update Asia-Pacific and Japan, Ernst & Young, English, 48p, 2017

Five Decades of Universal Health Insurance Coverage in Japan: Lessons and future

challenges, Japanese Society of Medical Sciences, Yasuki KOBAYASHI, English, 6p, 2009

Health and Medical Services, MHLW, Japanese, 79p, 2016

Healthcare and Welfare Services for the Elderly, MHLW, Japanese, 10p, 2016

Healthcare Industry Mini Book, Development Bank of Japan, Japanese, 56p, 2017

ICT and Information Use in the Medical, Nursing and Healthcare Fields, Mizuho Information

Research, Japanese, 7p, 2017

ICT in Home Health Care in Japan: Kansendossier, Agentschap NL Ministerie van

Buitenlandse Zaken, English, 9p, 2013

ICT Trends in Japan’s Healthcare Policy, Fujitsu Science Technology Japan, English, 17p,

2015

Japan Moves to Regain Prominence in Biotech, GEN, English, 5p, 2014

Japan’s Bold Steps, The Globe and Mail, English, 18p, 2016

Japan’s buckling health care system at a crossroads, The Japan Times, English, 8p, 2017

Japanese Dental Manufacturers: Committed to Innovation, Dental Product Shopper, English,

6p, 2016

Japanese Elder Care Market: Key Medical Device Segments, Pacific Bridge Medical,

English, 6p, 2014

Japan-EU EPA, Ministry of Foreign Affairs, English, 5p, 2017

Long-Term Care Insurance System of Japan, MHLW, English, 24p, 2016


Market Penetration Potential for Medical Equipment Manufacturers, Development Bank of

Japan, Japanese, 80p, 2017

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Ondernemend Nederland, English, 5p, 2016

Medical Devices in Japan: Regulatory Outlook for 2017, Clarivate Analytics, English, 10p,

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Medical Devices Industry Opportunities in Japan & China, Main International Trade Center,

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Medical Devices, Mizuho Bank, Japanese, 12p, 2016

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Japanese, 41p, 2015

Nanotech Cluster and Industry Landscape in Japan, Andrej Zagar, EU-Japan Centre for

Industrial Cooperation, English, 61p, 2014

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Once sceptical Japan embraces telemedicine as regulatory hurdles fall, The Japan Times,

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Policies for the Medical Equipment Industry, METI, Japanese, 47p, 2017

QMS (Quality Management System) for Medical Device in Japan, Naoko Sato, PMDA,

English, 37p, 2016

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Research about the Export and Diffusion of Welfare Equipment in Japan, Japanese, 17p,

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Japanese, 4p, 2016

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healthcare & medical technologies japan market study

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