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Page 1: GDME0208MAR-Nuclear Imaging- PET and SPECT Equipment … · Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts NUCLEAR IMAGING- PET AND SPECT EQUIPMENT

REFERENCE CODE GDME0208MAR | PUBLICATION DATE DECEMBER 2014

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

Page 2: GDME0208MAR-Nuclear Imaging- PET and SPECT Equipment … · Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts NUCLEAR IMAGING- PET AND SPECT EQUIPMENT

Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

Executive Summary

Nuclear Imaging Market Overview

GlobalData estimates the global nuclear imaging

market to have been worth $1.77 billion in 2012

and $1.83 billion in 2013. GlobalData estimates

that this market will be worth $2.2 billion in 2020,

increasing at a Compound Annual Growth Rate

(CAGR) of 3.3% during the period of 2014 to 2020.

The key drivers for the global nuclear imaging

market are:

Aging population and increasing disease

prevalence

Increasing referring physician awareness

Increasing defensive medicine

Increasing patient awareness

Increasing self-referral behavior

Increasing implementation of comparative

effectiveness research

Improved accreditation of imaging facilities

Availability of new imaging reagents

Increasing demand for cancer diagnoses

Increasing demand for imaging-based

companion diagnostics

Replacement of positron emission tomography

(PET)/computed tomography (CT) by

PET/magnetic resonance imaging (MRI)

Replacement of single-photon emission

computed tomography (SPECT)-only systems

The key barriers of the global nuclear imaging

market are:

Legislation affecting reimbursements

The lobbying efforts of medical insurance

companies and consequent reduction in the

number of procedures performed

Greater scrutiny of electronic medical records

by healthcare payers, leading to a reduction in

the number of procedures performed.

Increased use of appropriateness criteria,

resulting in reduced examinations

Practice guidelines reducing unnecessary

procedures

Loss of nuclear medicine skills

High cost of instruments and reagents

Supply difficulties and increasing cost of radio-

pharmaceuticals

Medical Device Excise tax increasing

development costs

Hospital consolidation reducing the number of

scanning facilities

The nuclear imaging market is a moderately

growing market with a 2014-2020 CAGR of 3.3%

globally. It is a mature sector of the diagnostic

imaging market; continued growth is expected

along with continued technological developments

and the emerging markets’ acceptance of

products.

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

Executive Summary

Below mentioned Table presents the key metrics of

the nuclear imaging industry during 2012-2020.

Nuclear Imaging Key Metrics: Key Events and Pipeline Assessment

2012 Market Sales ($m)

US $1,216.4m

5EU $212.6m

APAC $286.1m

Brazil $55.4m

Total $1,770.6m

Key Events (2012–2020) Level of Impact

Patient Protection and Affordable Care Act of 2010 ↑↑↑↑↑↑

Affordable Care Act of 2011 ↑↑↑↑↑↑

Approval by European Council on new EU Medical Device Regulations in 2015 ↑↑↑↑

Implementation of new EU Medical Device Regulations during 2018 to 2020 ↑↑↑↑

Reform of CFDA Medical Device Regulation in 2014 ↑↑

Conclusion of Philips PET Alpha Ring trials in 2014 ↑

GE Healthcare PET/CT & PET/MRI Comparison Trial 2014 ↑↑

Pipeline and Competitive Landscape Assessment

Total pipeline products profiled 11

Total companies profiled 26

2020 Market Sales ($m)

US $1,165.6m

5EU $308.2m

APAC $631.5m

Brazil $91.2m

Total $2,196.3m Source: GlobalData, primary research interviews with leading nuclear medicine specialist in 10 markets (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India). 5EU = France, Germany, Italy, Spain, and UK; APAC = Asia-Pacific (Japan, China, and India)

US Dominates the Nuclear Imaging Market

In 2012, the US dominated the global nuclear

imaging market, accounting for 69% of sales

globally. The market is dominated by three

companies: the market leader is Philips Healthcare

with around 35% of the market by revenue,

followed closely by GE Healthcare with around

33% of the market, and Siemens Healthcare at just

under 30%.

Global Nuclear Imaging Market in 2012

United States69%

APAC16%

5EU12%

Brazil3%

Source: GlobalData APAC = Asia Pacific; 5EU = France, Germany, Italy, Spain, and UK

Demand for Nuclear Imaging in US to Become Static

The US is the largest market for nuclear imaging,

in terms of the number of systems sold and the

number of procedures carried out. However, a

period of a rapid increase in procedures in the US,

particularly PET and PET/CT, has led to measures

to reduce the number of procedures that can be

reimbursed, and thus reduce the demand for

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

Executive Summary

nuclear imaging systems. Prior to healthcare

reform, the major threat to the US nuclear imaging

market was the limited supply of

radiopharmaceuticals.

APAC to Foster Future Growth

APAC economies, especially China and Japan, will

continue to provide immense opportunities for

increasing sales within the global nuclear imaging

market. GlobalData projects that Japan will

increase its market share by 75% and that China

will almost double its market share.

GlobalData expects that the growth of sales in

China will be attributed in part to the sale of more

PET/CT and SPECT/CT systems, whereas in

Japan, growth will be due to increasing demand for

SPECT/CT and PET/MRI systems.

Future Outlook

The economic downturn has been a continued

concern within the whole of the diagnostic imaging

market. Indeed, the high cost of nuclear imaging

equipment and procedures has made the nuclear

imaging market more susceptible to the downturn.

The market growth for nuclear imaging in the US

and EU is heavily dependent on the replacement of

already existing systems because, as is the case in

most of the developed countries, the capacity for

new installations is limited. As the US and EU

economies recover, it can be expected that the

equipment will be replaced.

However, at this point in time, the key opinion

leaders (KOLs) that GlobalData interviewed for this

report indicated that not all equipment is replaced

at the end of the average product lifecycle,

negatively affecting sales in the US and EU

markets.

The rising prevalence of disease, an aging

population, and a growing global population will act

as major drivers of the increased use of nuclear

imaging. However, cost-containment measures

implemented by healthcare authorities will affect

which nuclear imaging technologies are favored.

What do Physicians Think?

GlobalData interviewed a number of KOLs in the

nuclear imaging setting; they discussed a wide

variety of points and concerns, providing insight

into clinicians’ view of the technologies found in

nuclear imaging, both existing and future. In

addition, the KOLs provided viewpoints into the

healthcare regimes related to nuclear imaging, and

how these might affect access to imaging.

Physicians provided insight into the major imaging

modalities, PET/CT, SPECT/CT and PET/MRI.

PET/CT will eventually replace many SPECT/CT

procedures, but this is dependent upon progress in

developing new radiotracer compounds.

“Whenever a tracer appears that can replace

SPECT/CT by PET/CT, SPECT/CT will tend to

disappear, but this will be a very slow [process]….

In the next ten years probably the number of

PET/CT examinations will [double] and those by

SPECT/CT [will halve].”

EU KOL

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

Executive Summary

But there is still space for SPECT, provided that

the major manufacturer promotes it as a technique.

“[It’s] only very recently that manufacturers have

started promoting SPECT as a competitive tool. I’m

surprised; I don’t know why it took so long. Maybe

it’s because they were pretty overwhelmed in their

expanding PET market.”

EU KOL

While SPECT is well-established, SPECT/CT still

struggles to be reimbursed.

“Reimbursements are down, and specifically

talking about nuclear medicine, we have been

doing SPECT but there isn’t any reimbursement for

SPECT/CT; for those hybrid modalities… there

isn’t a separate reimbursement, and that is where

people are providing a service when needed and

doing SPECT/CTs, but not getting any additional

remuneration for these services provided.”

US KOL

Physicians remain to be convinced that PET/MRI

will revolutionize nuclear imaging.

“The real question is whether, given the expense

and the complexity, if [PET/MRI] ever gets out of

the academic medical centers and into general

clinical practice. There hasn’t been an application

that really … justifies the complexity and the added

cost.

US KOL

Stricter policies by insurance companies are

affecting patient access to nuclear imaging.

“More and more insurance companies are using

appropriateness criteria strictly, and regulating

access to PET/CT procedures especially the

cancer population….”

US KOL

US healthcare reforms may eventually increase

patient access to nuclear imaging, but may not

necessarily benefit the physician.

“As the effects of the Affordable Care Act kick

in…It may balance out where the volumes are

increasing, because more people have insurance,

but the reimbursements are going down.”

US KOL

Changes in reimbursement policies, leading to a

reduction in the number of nuclear imaging

procedures, are affecting hiring at hospitals and

leading to a potential loss of skills.

“These days they are hiring people with skills in the

rest of radiology, such as CT, MR, and not just

nuclear medicine, so that’s the reason why nuclear

medicine jobs are shrinking.”

US KOL

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 6 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

Executive Summary

Ultimately, changes in reimbursement affecting the

career prospects of specialist physicians may also

result in the dilution of nuclear imaging skills might

affect the effectiveness of diagnosing disease.

“Radiologists who read PET/CT studies are also

not certified….. only have four months of nuclear

medicine, so imagine the life of a cancer patient or

a management position dependent on a person

who has had only four months of training in that

specialty.”

US KOL

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

1 Table of Contents

1 Table of Contents ....................................................................................................................... 7

1.1 List of Tables .................................................................................................................... 14

1.2 List of Figures ................................................................................................................... 18

2 Introduction ............................................................................................................................... 21

2.1 Catalyst ............................................................................................................................. 21

2.2 Related Reports ................................................................................................................ 22

3 Industry Overview ..................................................................................................................... 23

3.1 Nuclear Imaging Techniques ............................................................................................. 23

3.1.1 Positron Emission Tomography ..................................................................................... 23

3.1.2 Single-Photon Emission Computed Tomography .......................................................... 25

3.1.3 Planar Scintigraphy ....................................................................................................... 25

3.1.4 Hybrid Imaging .............................................................................................................. 26

3.2 Clinical Applications of Nuclear Imaging Technology ........................................................ 31

3.2.1 Cancer .......................................................................................................................... 31

3.2.2 Cardiology ..................................................................................................................... 33

3.2.3 Neurology ...................................................................................................................... 35

3.2.4 Infection and Inflammation ............................................................................................ 37

3.3 Advantages and Disadvantages of Nuclear Imaging Technologies ................................... 40

3.4 Market Access .................................................................................................................. 41

3.4.1 Product Life Cycle ......................................................................................................... 41

3.4.2 Purchasing Decisions .................................................................................................... 43

3.4.3 Equipment Leasing........................................................................................................ 49

3.4.4 Replacement of PET/CT by PET/MRI............................................................................ 49

3.5 Reimbursement ................................................................................................................. 54

3.5.1 Overview ....................................................................................................................... 54

3.5.2 US ................................................................................................................................. 55

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 8 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

3.5.3 France ........................................................................................................................... 55

3.5.4 Germany ....................................................................................................................... 57

3.5.5 Italy ............................................................................................................................... 58

3.5.6 Spain ............................................................................................................................. 59

3.5.7 UK ................................................................................................................................. 60

3.5.8 Japan ............................................................................................................................ 61

3.5.9 Brazil ............................................................................................................................. 61

3.5.10 China ............................................................................................................................ 62

3.5.11 India .............................................................................................................................. 63

3.6 Procedure Trends ............................................................................................................. 64

3.6.1 US ................................................................................................................................. 64

3.6.2 France ........................................................................................................................... 67

3.6.3 Germany ....................................................................................................................... 69

3.6.4 Italy ............................................................................................................................... 73

3.6.5 Spain ............................................................................................................................. 75

3.6.6 UK ................................................................................................................................. 77

3.6.7 Japan ............................................................................................................................ 80

3.6.8 Brazil ............................................................................................................................. 82

3.6.9 China ............................................................................................................................ 85

3.6.10 India .............................................................................................................................. 87

3.7 Regulatory Issues/Recalls ................................................................................................. 90

3.8 M&As and Key Partnerships ............................................................................................. 91

3.9 Economic Impact .............................................................................................................. 94

3.9.1 US ................................................................................................................................. 94

3.9.2 Europe .......................................................................................................................... 97

4 Unmet Needs ............................................................................................................................ 98

4.1 Overview ........................................................................................................................... 98

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

4.2 Improved Reimbursement for New Techniques ................................................................. 98

4.3 Lack of Binding Clinical Guidelines ................................................................................. 102

4.4 Patient Comfort and Convenience................................................................................... 102

4.5 Reducing Radiation Exposure ......................................................................................... 103

4.6 Improved Scanner Performance ..................................................................................... 105

4.7 Image Processing Software Improvements ..................................................................... 106

4.8 Increased Risk of Artifacts in Hybrid Images ................................................................... 108

4.9 Demand for New Radiotracers ........................................................................................ 109

4.10 Improved Clinical Input into the Design Process ............................................................. 111

5 Market Opportunity Analysis ................................................................................................... 112

5.1 Cheaper, Simpler Nuclear Imaging Devices .................................................................... 112

5.2 SPECT/CT in Developing Countries ................................................................................ 112

5.3 Increased Demand for Teleradiology Services ................................................................ 115

6 Market Drivers and Barriers .................................................................................................... 117

6.1 Driver: Aging Population and Increasing Disease Prevalence ......................................... 117

6.2 Driver: Referring Physician Awareness ........................................................................... 118

6.3 Driver: Defensive medicine ............................................................................................. 119

6.4 Driver: Patient Awareness ............................................................................................... 121

6.5 Driver: Self-Referral ........................................................................................................ 121

6.6 Driver: New Imaging Agents............................................................................................ 122

6.7 Driver: Increasing Demand for Cancer Diagnostic Tests ................................................. 122

6.8 Driver: Companion Diagnostic Testing ............................................................................ 123

6.9 Barrier: Comparative Effectiveness Research ................................................................. 124

6.10 Barrier: Reimbursement Legislation ................................................................................ 126

6.11 Barrier: Increasing Demand for Nuclear Imaging in Developing Markets ......................... 126

6.12 Barrier: Insurance Company Lobbying to Reduce Unnecessary Imaging ....................... 128

6.13 Barrier: Greater Payer Scrutiny of EMRs ......................................................................... 128

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 10 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

6.14 Barrier: Increased Use of Appropriateness Criteria ......................................................... 129

6.15 Barrier: Practice Guidelines to Reduce Unnecessary Procedures ................................... 131

6.16 Barrier: Imaging Facility Accreditation ............................................................................. 131

6.17 Barrier: Loss of Nuclear Medicine Skills .......................................................................... 132

6.18 Barrier: High Cost of Instruments and Reagents ............................................................. 133

6.19 Barrier: Radiopharmaceutical Cost and Supply Difficulties .............................................. 134

6.20 Barrier: Medical Device Excise Tax ................................................................................. 137

6.21 Barrier: Hospital Consolidation ........................................................................................ 137

7 Competitive Assessment ........................................................................................................ 139

7.1 Overview ......................................................................................................................... 139

7.2 Dedicated PET Systems ................................................................................................. 139

7.2.1 Overview ..................................................................................................................... 139

7.2.2 Product Profile............................................................................................................. 140

7.2.3 SWOT Analysis ........................................................................................................... 141

7.3 PET/CT Systems ............................................................................................................ 141

7.3.1 Overview ..................................................................................................................... 141

7.3.2 Product Profiles ........................................................................................................... 142

7.3.3 SWOT Analysis ........................................................................................................... 144

7.4 PET/MRI Systems ........................................................................................................... 144

7.4.1 Overview ..................................................................................................................... 144

7.4.2 Product Profile............................................................................................................. 146

7.4.3 SWOT Analysis ........................................................................................................... 147

7.5 Dedicated SPECT Systems ............................................................................................ 147

7.5.1 Overview ..................................................................................................................... 147

7.5.2 Product Profile............................................................................................................. 149

7.5.3 SWOT Analysis ........................................................................................................... 150

7.6 SPECT/CT Systems........................................................................................................ 151

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

7.6.1 Overview ..................................................................................................................... 151

7.6.2 Product Profile............................................................................................................. 153

7.6.3 SWOT Analysis ........................................................................................................... 154

7.7 PET/Ultrasound and SPECT/Ultrasound Systems .......................................................... 155

7.7.1 Overview ..................................................................................................................... 155

7.7.2 Product Profile............................................................................................................. 155

7.7.3 SWOT Analysis ........................................................................................................... 156

8 Pipeline Assessment............................................................................................................... 157

8.1 Overview ......................................................................................................................... 157

8.2 Pipeline by Phases in Development ................................................................................ 158

8.3 Product Profiles ............................................................................................................... 158

8.3.1 Brain Biosciences CerePET ........................................................................................ 158

8.3.2 ECORAD Dual Modality Imager .................................................................................. 160

8.3.3 FMI Technologies ScintiStar PET/CT .......................................................................... 161

8.3.4 IntraMedical Imaging Marginator Beta Camera ........................................................... 163

8.3.5 INSERT SPECT/MRI ................................................................................................... 164

8.3.6 Nucare/Zecotek Photonics New Generation PET Scanning Device ............................. 167

8.3.7 Philips Healthcare PET Alpha Ring Detector ............................................................... 168

8.3.8 Photo Diagnostic Systems NeuroPET/CT ................................................................... 169

8.3.9 SynchroPET Breast PET/MRI ..................................................................................... 170

8.3.10 SynchroPET Wrist Scanner ......................................................................................... 171

8.3.11 SurgicEye SPECT Hybrid ............................................................................................ 172

9 Clinical Trials to Watch ........................................................................................................... 174

9.1 Overview ......................................................................................................................... 174

9.2 Clinical Trial Profiles........................................................................................................ 174

10 Current and Future Players ..................................................................................................... 177

10.1 Overview ......................................................................................................................... 177

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 12 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

10.2 Trends in Corporate Strategy .......................................................................................... 177

10.3 Company Profiles ............................................................................................................ 178

10.3.1 DDD-Diagnostic .......................................................................................................... 178

10.3.2 Digirad......................................................................................................................... 180

10.3.3 GE Healthcare............................................................................................................. 184

10.3.4 GVI Medical Devices ................................................................................................... 189

10.3.5 Mediso Medical Imaging Systems ............................................................................... 191

10.3.6 NeuroLogica ................................................................................................................ 193

10.3.7 Neusoft Medical Systems ............................................................................................ 196

10.3.8 NuCare Medical Systems ............................................................................................ 199

10.3.9 Oncovision .................................................................................................................. 201

10.3.10 Philips Healthcare ....................................................................................................... 203

10.3.11 Shimadzu .................................................................................................................... 210

10.3.12 Siemens Healthcare .................................................................................................... 215

10.3.13 SurgicEye .................................................................................................................... 221

10.3.14 Toshiba Medical .......................................................................................................... 224

10.3.15 Other Companies ........................................................................................................ 229

11 Market Outlooks...................................................................................................................... 232

11.1 Company Market Share Analysis .................................................................................... 232

11.1.1 Global Overview .......................................................................................................... 232

11.1.2 US ............................................................................................................................... 233

11.1.3 France ......................................................................................................................... 233

11.1.4 Germany ..................................................................................................................... 234

11.1.5 Italy ............................................................................................................................. 235

11.1.6 Spain ........................................................................................................................... 236

11.1.7 UK ............................................................................................................................... 237

11.1.8 Japan .......................................................................................................................... 238

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NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

11.1.9 Brazil ........................................................................................................................... 239

11.1.10 China .......................................................................................................................... 240

11.1.11 India ............................................................................................................................ 241

11.2 Market Segment Share ................................................................................................... 242

11.2.1 SPECT & SPECT/CT .................................................................................................. 242

11.2.2 PET, PET/CT & PET/MRI ............................................................................................ 243

11.3 By Geography ................................................................................................................. 245

11.3.1 Global Overview .......................................................................................................... 245

11.3.2 US ............................................................................................................................... 248

11.3.3 France ......................................................................................................................... 250

11.3.4 Germany ..................................................................................................................... 252

11.3.5 Italy ............................................................................................................................. 254

11.3.6 Spain ........................................................................................................................... 257

11.3.7 UK ............................................................................................................................... 259

11.3.8 Japan .......................................................................................................................... 261

11.3.9 Brazil ........................................................................................................................... 264

11.3.10 China .......................................................................................................................... 267

11.3.11 India ............................................................................................................................ 270

12 Appendix................................................................................................................................. 273

12.1 Abbreviations .................................................................................................................. 273

12.2 Bibliography .................................................................................................................... 278

12.3 Methodology ................................................................................................................... 309

12.3.1 Overview ..................................................................................................................... 309

12.3.2 Coverage .................................................................................................................... 309

12.3.3 Secondary Research ................................................................................................... 309

12.4 Physicians and Specialists Included in This Study .......................................................... 311

12.5 Primary Research ........................................................................................................... 312

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Nuclear Imaging- PET and SPECT Equipment - Global Analysis and Market Forecasts 14 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

12.5.1 Primary Research – Key Opinion Leader Interviews.................................................... 312

12.5.2 Expert Panel Validation ............................................................................................... 313

12.5.3 Stakeholder Survey ..................................................................................................... 314

12.6 Forecasting Methodology ................................................................................................ 316

12.7 About the Authors ........................................................................................................... 317

12.7.1 Andrew Thompson, PhD, Senior Analyst ..................................................................... 317

12.7.2 Priya Radhakrishnan, MBA, Director, Medical Devices ............................................... 317

12.7.3 Bonnie Bain, PhD, Global Head of Healthcare ............................................................ 318

12.8 About GlobalData ............................................................................................................ 319

12.9 Disclaimer ....................................................................................................................... 319

1.1 List of Tables

Table 1: Applications of Nuclear Imaging .................................................................................................. 31

Table 2: FDG-PET Diagnostic Accuracy for Specific Cancers .................................................................... 32

Table 3: Potential Clinical Benefits of Hybrid Nuclear Imaging in Cardiology .............................................. 35

Table 4: Applications of PET Imaging in Non-Cancer Neurology................................................................ 36

Table 5: Applications of SPECT Imaging in Non-Cancer Neurology ........................................................... 36

Table 6: Characteristics of SPECT, PET, Ultrasound, CT, and MRI ........................................................... 41

Table 7: The Age of Canada’s Hospital-Based Medical Technology Inventories, Relative to ECCREI Rules,

2009............................................................................................................................................ 42

Table 8: Nuclear Imaging Trends in US, 2012–2020 ................................................................................. 67

Table 9: Nuclear Imaging Trends in France, 2012–2020............................................................................ 69

Table 10: Nuclear Imaging Trends in Germany, 2012–2020 ........................................................................ 72

Table 11: Nuclear Imaging Trends in Italy, 2012–2020 ................................................................................ 74

Table 12: Nuclear Imaging Trends in Spain, 2012–2020 ............................................................................. 76

Table 13: Nuclear Imaging Trends in UK, 2012–2020 ................................................................................. 79

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Table 14: Nuclear Imaging Trends in Japan, 2012–2020 ............................................................................. 81

Table 15: Nuclear Imaging Trends in Brazil, 2012–2020 .............................................................................. 84

Table 16: Nuclear Imaging Trends in China 2012-2020 ............................................................................... 87

Table 17: Nuclear Imaging Trends in India, 2012–2020 ............................................................................... 89

Table 18: Recent Device Recalls in the Nuclear Imaging Market ................................................................. 91

Table 19: Recent Key Events in the Nuclear Imaging Market ...................................................................... 93

Table 20: Nuclear Imaging Market Drivers and Barriers ............................................................................. 117

Table 21: Duplicate Diagnostic Test Incidence in France, Germany, UK, and US ...................................... 129

Table 22: Dedicated PET Scanners .......................................................................................................... 140

Table 23: Dedicated PET SWOT Analysis ................................................................................................. 141

Table 24: PET/CT Scanners ..................................................................................................................... 142

Table 25: PET/CT SWOT Analysis ............................................................................................................ 144

Table 26: PET/MRI Systems ..................................................................................................................... 146

Table 27: PET/MRI SWOT Analysis .......................................................................................................... 147

Table 28: Dedicated SPECT Systems ....................................................................................................... 149

Table 29: Dedicated SPECT SWOT Analysis ............................................................................................ 150

Table 30: SPECT/CT Systems .................................................................................................................. 153

Table 31: SPECT/CT SWOT Analysis ....................................................................................................... 154

Table 32: SPECT-Ultrasound Systems ..................................................................................................... 155

Table 33: SPECT/Ultrasound SWOT Analysis ........................................................................................... 156

Table 34: Nuclear Imaging Pipeline, 2014 ................................................................................................. 158

Table 35: CerePET SWOT Analysis .......................................................................................................... 160

Table 36: ECORAD Dual Modality Imager SWOT Analysis ....................................................................... 161

Table 37: ScintiStar PET/CT SWOT Analysis ............................................................................................ 163

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Table 38: Marginator SWOT Analysis ....................................................................................................... 164

Table 39: INSERT SPECT-MRI SWOT Analysis ....................................................................................... 167

Table 40: Nucare/Zecotek Photonics New Generation PET Scanning Device SWOT Analysis................... 168

Table 41: PET Alpha Ring Detector........................................................................................................... 169

Table 42: NeuroPET/CT Scanner SWOT Analysis .................................................................................... 170

Table 43: SynchroPET Breast PET/MRI SWOT Analysis .......................................................................... 171

Table 44: SynchroPET Wrist Scanner ....................................................................................................... 172

Table 45: SurgicEye SPECT/Ultrasound device SWOT Analysis ............................................................... 173

Table 46: Key Clinical Trials ...................................................................................................................... 175

Table 47: Company Profile – DDD-Diagnostic ........................................................................................... 178

Table 48: DDD-Diagnostic SWOT Analysis ............................................................................................... 180

Table 49: Company Profile – Digirad ......................................................................................................... 181

Table 50: Digirad SWOT Analysis ............................................................................................................. 184

Table 51: Company Profile – GE Healthcare ............................................................................................. 185

Table 52: GE Healthcare Product Portfolio ................................................................................................ 186

Table 53: GE Healthcare SWOT Analysis ................................................................................................. 189

Table 54: Company Profile – GVI Medical Devices.................................................................................... 190

Table 55: GVI Medical Devices SWOT Analysis ........................................................................................ 191

Table 56: Company Profile – Mediso Medical Imaging Systems ................................................................ 192

Table 57: Mediso Medical Imaging Systems SWOT Analysis .................................................................... 193

Table 58: Company Profile – Neurologica ................................................................................................. 194

Table 59: Neurologica SWOT Analysis ..................................................................................................... 196

Table 60: Company Profile – Neusoft Medical Systems ............................................................................. 197

Table 61: Neusoft Medical Systems SWOT Analysis ................................................................................. 199

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Table 62: Company Profile – NuCare Medical Systems ............................................................................. 200

Table 63: Nucare Medical Systems SWOT Analysis .................................................................................. 201

Table 64: Company Profile – Oncovision ................................................................................................... 202

Table 65: Oncovision SWOT Analysis ....................................................................................................... 203

Table 66: Company Profile – Philips Healthcare ........................................................................................ 204

Table 67: Philips Healthcare SWOT Analysis ............................................................................................ 210

Table 68: Company Profile – Shimadzu .................................................................................................... 211

Table 69: Shimadzu SWOT Analysis ......................................................................................................... 215

Table 70: Company Profile – Siemens Healthcare..................................................................................... 216

Table 71: Siemens Healthcare SWOT Analysis ......................................................................................... 221

Table 72: Company Profile – SurgicEye .................................................................................................... 222

Table 73: SurgicEye SWOT Analysis ........................................................................................................ 224

Table 74: Company Profile – Toshiba Medical .......................................................................................... 225

Table 75: Toshiba Medical SWOT Analysis ............................................................................................... 228

Table 76: Other Companies in the Nuclear Imaging Market, 2014 ............................................................. 229

Table 77: Global Market Value Forecast by Market Segment for SPECT & SPECT/CT (2012–2020) ......... 243

Table 78: Global Market Value Forecast by Market Segment for PET, PET/CT & PET/MRI (2012–2020) .. 244

Table 79: Global Sales of PET and SPECT Imaging Systems, 2012–2020 ................................................ 246

Table 80: United States Market Value Forecast by Market Sub-segment (2012–2020) .............................. 248

Table 81: France Market Value Forecast by Market Sub segment (2012–2020) ........................................ 250

Table 82: Germany Market Value Forecast by Market Sub segment (2012–2020) ..................................... 252

Table 83: Italy Market Value Forecast by Market Sub-segment (2012–2020)............................................. 255

Table 84: Spain Market Value Forecast by Market Sub-segment (2012–2020) .......................................... 257

Table 85: UK Market Value Forecast by Market Sub-segment (2012–2020) .............................................. 259

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Table 86: Japan Market Value Forecast by Market Sub-segment (2012–2020).......................................... 262

Table 87: Brazil Market Value Forecast by Market Sub-segment (2012–2020) .......................................... 264

Table 88: China Market Value Forecast by Market Sub-segment (2012–2020) .......................................... 267

Table 89: India Market Value Forecast by Market Sub-segment (2012–2020) ........................................... 270

Table 90: Primary Research Summary ...................................................................................................... 314

Table 91: Primary Research Participants Affiliation ................................................................................... 315

1.2 List of Figures

Figure 1: Cyclotron Distribution in 10 Countries .......................................................................................... 24

Figure 2: Localization of Tumor in Chest Cavity by PET, CT, and PET/CT .................................................. 28

Figure 3: Mutually Beneficial Effects of PET/MRI Imaging........................................................................... 30

Figure 4: Nuclear Imaging Trends in US, 2012–2020 ................................................................................. 66

Figure 5: Nuclear Imaging Trends in France, 2012–2020............................................................................ 69

Figure 6: Nuclear Imaging Trends in Germany, 2012–2020 ........................................................................ 72

Figure 7: Nuclear Imaging Trends in Italy, 2012–2020 ................................................................................ 74

Figure 8: Nuclear Imaging Trends in Spain, 2012–2020 ............................................................................. 76

Figure 9: Nuclear Imaging Trends in UK, 2012–2020 ................................................................................. 79

Figure 10: Nuclear Imaging Trends in Japan, 2012–2020 ............................................................................. 81

Figure 11: Nuclear Imaging Trends in Brazil, 2012–2020 .............................................................................. 84

Figure 12: Nuclear Imaging Trends in China, 2012–2020 ............................................................................. 86

Figure 13: SPECT and PET Imaging Trends in India, 2012–2020 ................................................................. 89

Figure 14: Total Medicare Expenditures for Imaging Services Paid Under the Physician Fee Schedule, 2000–

2006............................................................................................................................................ 95

Figure 15: Imaging Utilization Rates (Number of Outpatient Visits with MRI/CT per 1,000 Persons), by Year in

the US ....................................................................................................................................... 118

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Figure 16: Global Company Market Shares for Nuclear Imaging Equipment (2012) .................................... 232

Figure 17: US Company Market Shares for Nuclear Imaging Equipment (2012) ......................................... 233

Figure 18: France Company Market Shares for Nuclear Imaging Equipment (2012) ................................... 234

Figure 19: Germany Company Market Shares for Nuclear Imaging Equipment (2012) ................................ 235

Figure 20: Italy Company Market Shares for Nuclear Imaging Equipment (2012) ........................................ 236

Figure 21: Spain Company Market Shares for Nuclear Imaging Equipment (2012) ..................................... 237

Figure 22: UK Company Market Shares for Nuclear Imaging Equipment (2012) ......................................... 238

Figure 23: Japan Company Market Shares for Nuclear Imaging Equipment (2012) ..................................... 239

Figure 24: Brazil Company Market Shares for Nuclear Imaging Equipment (2012) ..................................... 240

Figure 25: China Company Market Shares for Nuclear Imaging Equipment (2012) ..................................... 241

Figure 26: India Company Market Shares for Nuclear Imaging Equipment (2012) ....................................... 242

Figure 27: Global Market Value Forecast by Market Segment for SPECT & SPECT/CT (2012–2020) ......... 243

Figure 28: Global Market Value Forecast by Market Segment for PET, PET/CT, and PET/MRI (2012–2020)

................................................................................................................................................. 245

Figure 29: Global Sales of PET and SPECT Imaging Systems, 2012–2020 ................................................ 246

Figure 30: Global Market Share of Nuclear Imaging, 2012 and 2020 .......................................................... 247

Figure 31: United States Market Value Forecast by Market Sub-segment (2012–2020) .............................. 249

Figure 32: France Market Value Forecast by Market Subsegment (2012–2020) ......................................... 251

Figure 33: Germany Market Value Forecast by Market Sub segment (2012–2020) ..................................... 253

Figure 34: Italy Market Value Forecast by Market Sub segment (2012–2020) ............................................. 255

Figure 35: Spain Market Value Forecast by Market Sub-segment (2012–2020) .......................................... 258

Figure 36: UK Market Value Forecast by Market Sub-segment (2012–2020) .............................................. 260

Figure 37: Japan Market Value Forecast by Market Sub segment (2012–2020) .......................................... 262

Figure 38: Brazil Market Value Forecast by Market Sub segment (2012–2020) .......................................... 265

Figure 39: China Market Value Forecast by Market Sub-segment (2012–2020) .......................................... 268

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Figure 40: India Market Value Forecast by Market Sub segment (2012–2020) ............................................ 271

Figure 41: Primary Research Summary ...................................................................................................... 314

Figure 42: Primary Research Participants Affiliation ................................................................................... 315

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NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

Introduction

2 Introduction

An early diagnosis of disease is the foundation of increasing survival rates. Single-photon emission

computed tomography (SPECT) and positron emission tomography (PET) imaging are diagnostic

imaging techniques that are widely used in a variety of disease areas including oncology,

cardiovascular disease, bone disease, and infectious disease. This report provides an analysis of

the nuclear imaging market, with a particular focus on SPECT and PET imaging and hybrid

modalities within the US, the 5EU (France, Germany, Italy, Spain, and UK), Brazil, and the Asia-

Pacific (APAC) region (Japan, China, and India). This report identifies the drivers and barriers to

nuclear imaging, as well as unmet needs in this market. This report also discusses physician

attitudes towards current diagnostic nuclear imaging modalities, and the future of nuclear imaging

in the face of rapid technological advancement and an increasingly challenging reimbursement

environment.

2.1 Catalyst

PET and SPECT imaging are well-established techniques in the nuclear imaging market. The

advent of hybrid imaging has enabled PET/CT imaging to undergo explosive growth, but this has

increased demand on struggling healthcare budgets. New developments in hybrid nuclear imaging

promise to further increase the utility of these technologies, while significantly improving patient

cost savings and safety by reducing the repeated or examinations. However, these improvements

come with a significant increase in the capital cost of equipment. This report examines how new

technologies can emerge in the face of healthcare reform and other economic pressures that may

affect the demand for nuclear imaging. Further, it focuses on the industry trends, promising pipeline

products, and competitive landscape of nuclear imaging.

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NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

Introduction

2.2 Related Reports

GlobalData (2013). MediFocus: Future of Molecular Imaging, August, 2013, GDME002MFR.

GlobalData (2013). MediPoint: Breast Cancer Imaging – Global Analysis and Market

Forecasts, May, 2013, GDME0166MAR.

GlobalData (2014). MediPoint: Diagnostic Ultrasound Imaging - Global Analysis and Market

Forecasts, January 2014, GDME0182MAR.

GlobalData (2014). MediPoint: Diagnostic X-ray Imaging - Global Analysis and Market

Forecasts, July 2014, GDME0203MAR.

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Appendix

NUCLEAR IMAGING- PET AND SPECT EQUIPMENT - GLOBAL ANALYSIS AND MARKET FORECASTS

12.8 About GlobalData

GlobalData is a leading global provider of business intelligence in the Healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug research, disease analysis, and clinical research and development. Our integrated business

intelligence solutions include a range of interactive online databases, analytical tools, reports and

forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan,

Singapore, and Australia.

12.9 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any

form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior

permission of the publisher, GlobalData.