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Breast Cancer Imaging Global Analysis and Market Forecasts

GDME0166MAR / Published May 2013

Executive Summary

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. GDME0166MAR / Published MAY 2013

Breast Cancer Imaging: Key Metrics in 10 Major Device Markets

2011 Market Sales

US $601m

5EU $192m

APAC $142m

Brazil $42m

Total $972m

Key Features of the Report

Number of imaging techniques covered 17

Number of marketed products analyzed 51

Competitors profiled 17

Key Events (2011–2018) Level of Impact

Results of the Oslo Breast Cancer Screening Trial ↑↑↑↑

Results of the TOMMY trial ↑↑↑↑

GE Healthcare acquires U-Systems ↑↑↑

Food and Drug Administration (FDA) approval of GE Healthcare and Siemens Healthcare tomosynthesis systems

↑↑

Philips acquires Sectra ↑↑

Hologic acquires Beijing Healthcome Technology ↑↑

Results from J-START trial ↑↑

2018 Market Sales

US $1,110 m

5EU $241m

APAC $231m

Brazil $71m

Total $1,654m

Source: GlobalData, 2013 5EU = France, Germany, Italy, Spain, and UK; APAC = Asia-Pacific: for the purposes of this report, Japan, China, and India

GlobalData calculated the global breast cancer imaging

market to be worth $972m in 2011 and estimates that it

will be worth $1.7 billion in 2018, increasing at a

Compound Annual Growth Rate (CAGR) of 8% during

this time period.

The key drivers for the global breast cancer imaging

market are:

Increase in the incidence of breast cancer

Increased awareness of the benefits of screening

Increased breast cancer incidence due to an aging

population

FDA reclassification of mammography equipment

New technologies to drive growth in the market

An increase in the age range for screening in the UK

Rapid adoption of digital mammography units

worldwide

The key barriers for the global breast cancer imaging

market are:

A shortage of dedicated breast radiologists

High capital Investment for full-field digital

mammography (FFDM) and tomosynthesis in the

face of reduced hospital budgets

The trend towards buying refurbished equipment

Reimbursement issues

Executive Summary


Significant Unmet Needs and Challenges for the Global Breast Cancer Imaging Market

Even though the global breast cancer imaging market is

a mature one, it has significant needs that still have not

been met. Some of these include exposure to ionizing

radiation during mammographic examinations, patient

discomfort due to compression of the breasts, unreliable

mammograms in breasts that have been operated on and

breasts with implants, a high number of false-positives

and false-negatives, loss of mammography sensitivity in

dense breasts, and limited training provided to

technicians by equipment manufacturers. A few of these

unmet needs are being addressed to a certain extent by

using modalities such as ultrasound imaging and

magnetic resonance imaging (MRI) in conjunction with

mammography. However, there is a still a lot of room for

improvement within the market, and new technologies

currently in development that overcome these drawbacks

show promise for the future.

Future Landscape

The global breast cancer imaging market is primarily

driven by the increasing incidence of breast cancer and

the aging population. It is also fueled by the need to

overcome the drawbacks posed by mammography,

which is the most widely used technique for breast

cancer detection and diagnosis. GlobalData anticipates

that new technologies, such as tomosynthesis, will drive

the future growth of this market. Tomosynthesis is

predicted to be the new gold standard in the near future

due to its promising increase in cancer detection and

reduction of false-positives, which are key concerns with

mammography.

While most experts will argue that tomosynthesis has a

higher radiation dose exposure when compared with

mammography, GlobalData expects that two-dimensional

(2D) synthetic mammograms will provide a means of

reducing the radiation dose when tomosynthesis is

employed on its own.

Since the US is the biggest contributor in the global

breast cancer imaging market, a dip in revenues for new

installations of mammography equipment was observed

after 2009, when the US market started to show signs of

saturation for digital mammography. The US market was

estimated to contribute about 61% of the global breast

cancer imaging market revenues in 2011, which dropped

to 55.8% of the total revenue in 2013.

However, GlobalData estimates that due to the positive

reception of tomosynthesis by the radiology community,

the global breast cancer imaging market is expected to

emerge from its slow growth phase and gain momentum

to reach $1.7 billion by 2018, of which the US will have a

67% share. Meanwhile, the European Union (EU)

member states are expected to show modest growth

during the forecast period, owing to a minor increase in

the number of new FFDM and tomosynthesis systems.

Brazil and the Asia-Pacific (APAC) regions (Japan,

China, and India) will continue to grow, since digital

mammography has yet to be widely adopted in these

regions and the breast cancer incidence is rising steadily.

Executive Summary


On the technology front, GlobalData expects a drastic

decline in the worldwide use of film-screen

mammography (FSM), and estimates that this segment

of the breast cancer imaging market will generate zero

revenues in the developed nations after 2017. FFDM 2D-

only systems are expected to show a decline in the US in

the near future and a modest increase in the 5EU, while

the number of new installations will continue to increase

in the APAC regions and Brazil. New tomosynthesis

installations are expected to increase four fold by 2016 in

the US and will double in the EU states, while a modest

uptake is projected in the APAC regions and Brazil.

What do Physicians Think?

Radiologists feel that mammography is not an ideal tool

for breast screening and there are significant unmet

needs.

‘’Mammography is a useful tool, but it’s a bad technique.’’

Key Opinion Leader, January 2013

‘’The biggest challenge [is] to have… patient

comfort…[during]…mammography, that’s number one, I

think’’


Radiologists feel strongly that tomosynthesis is very

promising and will most likely replace digital

mammography, the current paradigm.

‘’Mammography is a useful tool, but it’s a bad technique.’’


‘’I think there is space for everything...but the word is

digital, the word is 3D….[The] breast is a 3D organ. Why

should we look at [it] in 2D images?”


‘’If it’s [tomosynthesis] going to find more cancers and

fewer recalls, then it should be a win-win.’’

Key Opinion Leader, December 2012

‘’I’ll tell you today that I am 95% sure that tomosynthesis

is mammography’s future and conventional

mammography is gone.’’


‘’If I have to put money in something, I will put it in

tomosynthesis and MRI [in the] short term [and in the]

long term, maybe….. molecular imaging techniques.’’


Radiologists feel that the impact of tomosynthesis

compared with digital mammography is much greater in

comparison to the change from analog to digital

mammography.

‘’The change from analog to digital mammography [in the

US], went so fast, so quickly.…amazing, now almost 90%

[adoption]....If you look at the FDA site…90% [adoption], I

mean it is incredible. So, what my way of thought is, I

say, look if from analog to digital , it was not such a big

deal, by that I mean it was the same technology, only

digital The difference was not so big [so only small

improvement]…, like it is from mammography to

tomosynthesis. You are talking about [image] slices; you

are talking about 3D [imaging] [so large improvement]….I

think, the gain between digital [2D FFDM] and

tomo[synthesis] is much, much, much higher than it was

from analog to digital.’


Executive Summary


Radiologists feel that there is not enough commitment

from the manufacturers towards technician training.

‘’A banker can buy a machine much faster than anyone

out there, right? But I mean the banker cannot get a good

image.’’


‘’Training is needed because if the technician has not

given good positioning, whatever good factors may be

there, good equipment may be there, you won’t be able

to see things.’’


Radiologists feel that in the future, they foresee more

emphasis being placed on lowering radiation dose.

“[On future market trends] there is going to be more

emphasis on low [radiation] dose, understanding breast

density, and being efficient…doing more with less.’’


’If there is a good product which does good imaging and

it has low [radiation] dose and it’s reliable, then it may be

of value.’’


Table of Contents


1 Table of Contents

1 Table of Contents ...............................................................................................................6

1.1 List of Tables.............................................................................................................15

1.2 List of Figures ...........................................................................................................20

2 Introduction.......................................................................................................................24

2.1 Catalyst.....................................................................................................................25

3 Disease Overview.............................................................................................................26

3.1 Anatomy & Physiology of the Breast ..........................................................................26

3.2 Pathophysiology of Breast Cancer.............................................................................27

3.3 Detection of Breast Cancer........................................................................................27

3.4 Types of Breast Cancer.............................................................................................28

3.5 Clinical Presentation..................................................................................................30

3.6 Clinical Outcomes .....................................................................................................31

3.6.1 Assessment Procedure .......................................................................................31

3.6.2 Screening Guidelines ..........................................................................................34

3.7 Epidemiology of Breast Cancer .................................................................................37

3.8 Economic Impact of Breast Cancer Imaging ..............................................................40

4 Imaging Techniques..........................................................................................................41

4.1 Mammography ..........................................................................................................41

4.1.1 Overview.............................................................................................................41

4.1.2 Types of Mammography......................................................................................43

4.2 Non-Mammographic Techniques...............................................................................48

4.2.1 Breast Ultrasound Imaging..................................................................................48

4.2.2 Breast Magnetic Resonance Imaging ..................................................................49

4.3 Comparison of Mammography, Ultrasound, and MRI.................................................50

4.4 Alternative Breast Imaging Techniques......................................................................51

4.4.1 Nuclear Imaging Techniques...............................................................................52

4.4.2 Computed Tomography.......................................................................................53

Table of Contents


4.4.3 Optical Breast Imaging........................................................................................54

4.4.4 Electric Impedance-Based Techniques................................................................54

4.4.5 Thermography ....................................................................................................55

4.4.6 Elastography.......................................................................................................55

4.4.7 Ductogram ..........................................................................................................55

5 Competitive Assessment...................................................................................................56

5.1 Overview...................................................................................................................56

5.2 Film Screen Mammography.......................................................................................57

5.2.1 Performa (GE Healthcare)...................................................................................57

5.2.2 Alpha RT/Alpha ST (GE Healthcare) ...................................................................60

5.2.3 MAMMOMAT 1000 (Siemens Healthcare)...........................................................63

5.2.4 MAMMOMAT 3000 Nova (Siemens Healthcare)..................................................65

5.2.5 M-IV/M-IV Platinum (Hologic) ..............................................................................67

5.2.6 MammoDiagnost (Philips Healthcare)..................................................................69

5.2.7 Planmed Nuance Classic (Planmed) ...................................................................71

5.2.8 Planmed Sophie Classic (Planmed) ....................................................................73

5.2.9 Analog Giotto Image (Internazionale Medico Scientifica) .....................................74

5.2.10 HAWK-2M (Hologic)............................................................................................76

5.2.11 MGU-1000A (Toshiba Medical Systems).............................................................78

5.3 CR Mammography ....................................................................................................79

5.3.1 Fuji Computed Radiography Mammography Suite (FCRMS) (Fujifilm Medical

Systems) ...........................................................................................................79

5.3.2 KODAK DirectView (Carestream Health).............................................................82

5.3.3 Xpress CR System (Konica Minolta)....................................................................83

5.3.4 REGIUS PureView (Konica Minolta)....................................................................85

5.3.5 Agfa CR Mammography Systems (DX-M, CR 30-Xm, and CR 85-X) (Agfa

Healthcare)........................................................................................................86

5.4 Full-Field Digital Mammography ................................................................................88

5.4.1 Selenia Dimensions (Hologic)..............................................................................88

Table of Contents


5.4.2 Selenia (Hologic).................................................................................................91

5.4.3 Selenia S (Hologic) .............................................................................................93

5.4.4 Selenia Performance (Hologic)............................................................................94

5.4.5 Senographe DS (GE Healthcare) ........................................................................96

5.4.6 Senographe Essential (GE Healthcare) ...............................................................97

5.4.7 Senographe Care (GE Healthcare)....................................................................100

5.4.8 SenoBright CESM (GE Healthcare)...................................................................101

5.4.9 MAMMOMAT Inspiration (Siemens Healthcare).................................................103

5.4.10 Aspire HD (US)/Amulet (Outside the US) (Fujifilm) ............................................105

5.4.11 MammoDiagnost DR (Philips Healthcare).......................................................... 108

5.4.12 MicroDose (Philips Healthcare) .........................................................................110

5.4.13 Giotto Image 3D/3DL (Internazionale Medico Scientifica) ..................................112

5.4.14 Planmed Nuance/Nuance Excel (Planmed) ....................................................... 114

5.4.15 Fairy DR (Allengers Medical Systems) .............................................................. 116

5.4.16 Serenity ............................................................................................................117

5.5 3D Mammography...................................................................................................118

5.5.1 Selenia Dimensions 3D System (Hologic).......................................................... 118

5.5.2 True 3D Breast Tomosynthesis (Siemens Healthcare).......................................120

5.5.3 Giotto Tomo (Internazionale Medico Scientifica)................................................122

5.5.4 FUJIFILM 3Dimensional Mammography (Fujifilm) .............................................124

5.6 Breast Ultrasound Imaging ...................................................................................... 126

5.6.1 somo.v Automated Breast Ultrasound (ABUS) (GE Healthcare)......................... 126

5.6.2 SonoCine AWBUS (SonoCine)..........................................................................128

5.6.3 ACUSON S2000 ABVS (Siemens Healthcare) ..................................................129

5.6.4 Terason t3200 Ultrasound System Breast Series (Terason Ultrasound).............131

5.7 Breast MRI..............................................................................................................132

5.7.1 Aurora 1.5T Dedicated Breast MRI System (Aurora Imaging Technology) .........132

5.8 Other Breast Imaging Techniques ...........................................................................134

Table of Contents


5.8.1 PEM Flex Solo II (Naviscan)..............................................................................134

5.8.2 Computerized Tomography Laser Mammography (CTLM) Model 1020 (Imaging

Diagnostic Systems) ........................................................................................ 136

5.8.3 Dilon 6800/Dilon 6800 Acella (Dilon Diagnostics) ..............................................138

5.8.4 LumaGEM (Gamma Medica).............................................................................140

5.8.5 Discovery NM 750b (GE Healthcare).................................................................142

6 Unmet Needs..................................................................................................................145

6.1 Lower Radiation Dose ............................................................................................. 145

6.2 Increase Patient Comfort......................................................................................... 146

6.3 Reduce False-Positives and False-Negatives .......................................................... 148

6.4 Loss of Sensitivity of Mammography in Dense Breasts ............................................150

6.5 Unreliable Mammograms in Surgically-Operated Breasts and Breasts with Implants152

6.6 Commitment to Training .......................................................................................... 153

7 Pipeline Products............................................................................................................155

7.1 Breast Cancer Imaging Pipeline Products Overview ................................................155

7.2 GE Breast Tomosynthesis (GE Healthcare)............................................................. 156

7.2.1 Overview...........................................................................................................156

7.2.2 SWOT Analysis.................................................................................................157

7.3 MAMMOMAT Inspiration PRIME Edition..................................................................158

7.3.1 Overview...........................................................................................................158

7.3.2 SWOT Analysis.................................................................................................158

7.4 MicroDose SI ..........................................................................................................159

7.4.1 Overview...........................................................................................................159

7.4.2 SWOT Analysis.................................................................................................159

7.5 Selenia Dimensions 2D Contrast-Enhanced Digital Mammography (CEDM) ............160

7.5.1 Overview...........................................................................................................160

7.5.2 SWOT Analysis.................................................................................................160

7.6 SenoCase ...............................................................................................................160

7.6.1 Overview...........................................................................................................160

Table of Contents


7.6.2 SWOT Analysis.................................................................................................161

7.7 Electrical Mammogram............................................................................................ 162

7.7.1 Overview...........................................................................................................162

7.7.2 SWOT Analysis.................................................................................................162

8 Industry Overview...........................................................................................................163

8.1 Purchasing Cycle ....................................................................................................163

8.1.1 Product Life Cycle............................................................................................. 163

8.1.2 Cost Effectiveness in Screening Settings........................................................... 165

8.1.3 Cost-Effectiveness in Diagnostic Settings.......................................................... 165

8.2 Market Access.........................................................................................................166

8.2.1 Purchasing Decisions........................................................................................ 166

8.2.2 Regulatory Process........................................................................................... 166

8.3 Quality Assurance ...................................................................................................169

8.3.1 US ....................................................................................................................169

8.3.2 EU ....................................................................................................................169

8.3.3 Brazil ................................................................................................................170

8.3.4 Japan................................................................................................................170

8.3.5 China and India.................................................................................................170

8.4 Adoption of New Technologies ................................................................................171

8.4.1 Influence of Clinical Trials Results.....................................................................171

8.4.2 Reimbursement.................................................................................................172

8.4.3 Economic Resources ........................................................................................ 172

8.4.4 Low Breast Cancer Incidence and Absence of a National Screening Program ...172

8.4.5 Competitive Advantage .....................................................................................173

8.5 Current Reimbursement Trends ..............................................................................174

8.5.1 US ....................................................................................................................174

8.5.2 Europe..............................................................................................................175

8.5.3 France ..............................................................................................................176

Table of Contents


8.5.4 Germany...........................................................................................................176

8.5.5 Italy...................................................................................................................176

8.5.6 Spain ................................................................................................................176

8.5.7 UK ....................................................................................................................177

8.5.8 30TJapan..........................................................................................................177

8.5.9 Brazil ................................................................................................................177

8.5.10 30TChina ..........................................................................................................178

8.5.11 30TIndia............................................................................................................178

8.6 Trends in Detector Technology for Digital Mammography ........................................179

8.7 Evolving Scatter-Removal Mechanisms...................................................................183

8.8 Overdiagnosis .........................................................................................................185

8.9 Malpractice Litigations............................................................................................ 186

8.10 Mergers and Acquisitions/Key Partnerships............................................................. 187

8.10.1 GE Healthcare Acquires U-Systems..................................................................187

8.10.2 Koninklijke Philips Electronics Acquires MicroDose Mammography from Sectra 187

8.10.3 Hologic Acquires Beijing Healthcome Technology .............................................187

8.10.4 Hologic Acquires Sentinelle Medica...................................................................188

8.10.5 Koninklijke Philips Electronics Acquires Shanghai Apex Electronics Technology188

8.10.6 Fujifilm Medical Systems acquired FUJIFILM-RU ..............................................188

8.10.7 Other Key Events.............................................................................................. 189

9 Current and Future Players............................................................................................. 190

9.1 Overview.................................................................................................................190

9.2 Trends in Corporate Strategy...................................................................................191

9.3 Company Profiles....................................................................................................192

9.3.1 GE Healthcare ..................................................................................................192

9.3.2 Hologic .............................................................................................................194

9.3.3 Siemens............................................................................................................196

9.3.4 Koninklijke Philips Electronics ...........................................................................197

Table of Contents


9.3.5 Fujifilm Medical Systems...................................................................................199

9.3.6 Internazionale Medico Scientifica (IMS)............................................................. 200

9.3.7 Planmed ...........................................................................................................201

9.3.8 Konica Minolta Medical Imaging........................................................................202

9.3.9 Agfa Healthcare ................................................................................................ 203

9.3.10 Carestream Health............................................................................................ 204

9.3.11 SonoCine..........................................................................................................205

9.3.12 Aurora Imaging Technology ..............................................................................206

9.3.13 Imaging Diagnostic Systems .............................................................................207

9.3.14 Naviscan...........................................................................................................208

9.3.15 Dilon Diagnostics .............................................................................................. 209

9.3.16 Gamma Medica.................................................................................................209

9.3.17 Allengers Medical Systems ...............................................................................210

10 Market Drivers & Opportunities ....................................................................................... 211

10.1 Market Drivers.........................................................................................................211

10.1.1 Increase in the Incidence of Breast Cancer ....................................................... 211

10.1.2 Increased Awareness of the Benefits of Screening............................................211

10.1.3 Increased Breast Cancer Incidence Due to an Aging Population........................ 212

10.1.4 FDA Reclassification of Mammography Equipment ...........................................212

10.1.5 New Technologies to Drive Market Growth........................................................ 212

10.1.6 Changes in Age Inclusion Criteria in Breast Cancer Screening Programs ..........214

10.1.7 Adoption of Digital Mammography Units Worldwide...........................................214

10.2 Opportunities...........................................................................................................217

10.2.1 Emerging Economies Promise Future Growth ...................................................217

10.2.2 Invest in Emerging Technologies.......................................................................218

10.2.3 Product Improvement........................................................................................ 219

10.3 Market Barriers........................................................................................................219

10.3.1 Shortage of Dedicated Mammography Professionals.........................................219

Table of Contents


10.3.2 Reduced Hospital Budgets................................................................................220

10.3.3 Refurbished Equipment Sales ...........................................................................221

10.3.4 Reimbursement.................................................................................................221

10.3.5 Substitutes........................................................................................................222

11 Country Outlooks & Forecasts ........................................................................................ 223

11.1 Major Markets Overview.......................................................................................... 223

11.2 United States ..........................................................................................................226

11.2.1 United States Market Analysis...........................................................................226

11.3 France ....................................................................................................................230

11.3.1 France Market Analysis.....................................................................................230

11.4 Germany.................................................................................................................231

11.4.1 Germany Market Analysis .................................................................................231

11.5 Italy......................................................................................................................... 232

11.5.1 Italy Market Analysis ......................................................................................... 232

11.6 Spain ...................................................................................................................... 233

11.6.1 Spain Market Analysis....................................................................................... 233

11.7 United Kingdom.......................................................................................................234

11.7.1 United Kingdom Market Analysis.......................................................................234

11.8 Japan...................................................................................................................... 235

11.8.1 Japan Market Analysis ...................................................................................... 235

11.9 Brazil....................................................................................................................... 237

11.9.1 Brazil Market Analysis....................................................................................... 237

11.10 China................................................................................................................238

11.10.1 China Market Analysis .....................................................................................238

11.11 India..................................................................................................................239

11.11.1 India Market Analysis....................................................................................... 239

12 Appendix ........................................................................................................................ 241

12.1 Bibliography ............................................................................................................241

Table of Contents


12.2 Abbreviations ..........................................................................................................271

12.3 Report Methodology................................................................................................ 276

12.3.1 Overview...........................................................................................................276

12.3.2 Coverage..........................................................................................................276

12.3.3 Secondary Research......................................................................................... 276

12.3.4 Forecast Methodology....................................................................................... 277

12.4 Physicians and Specialists Included in this Study ....................................................278

12.5 Primary Research....................................................................................................279

12.6 Physician Survey.....................................................................................................279

12.7 About the Authors ...................................................................................................280

12.7.1 Analysts............................................................................................................280

12.7.2 Global Head of Healthcare ................................................................................281

12.8 Definitions ...............................................................................................................282

12.9 About MediPoint......................................................................................................283

12.10 About GlobalData.............................................................................................. 283

12.11 Contact Us........................................................................................................283

12.12 Disclaimer.........................................................................................................284

Table of Contents


1.1 List of Tables

Table 1: Breast Cancer Types, Including Diagnostic Procedures ............................................29

Table 2: ACR Breast Imaging Reporting and Database System (BI-RADS) ............................31

Table 3: Selected Breast Cancer Incidence Rates, 2002 ........................................................38

Table 4: Comparison of Mammography, Ultrasound, and MRI for Breast Imaging ..................50

Table 5: Performa Product Profile ..........................................................................................58

Table 6: Performa SWOT Analysis.........................................................................................59

Table 7: Alpha RT/Alpha ST Product Profile...........................................................................61

Table 8: Alpha RT/Alpha ST SWOT Analysis .........................................................................62

Table 9: MAMMOMAT 1000 Product Profile...........................................................................63

Table 10: MAMMOMAT 1000 SWOT Analysis .......................................................................64

Table 11: MAMMOMAT 3000 Nova Product Profile................................................................66

Table 12: MAMMOMAT 3000 Nova SWOT Analysis ..............................................................66

Table 13: M-IV/M-IV Platinum Product Profile.........................................................................68

Table 14: M-IV/M-IV Platinum SWOT Analysis.......................................................................68

Table 15: MammoDiagnost Product Profile ............................................................................70

Table 16: MammoDiagnost SWOT Analysis...........................................................................70

Table 17: Planmed Nuance Classic Product Profile................................................................72

Table 18: Planmed Nuance Classic SWOT Analysis ..............................................................72

Table 19: Planmed Sophie Classic Product Profile .................................................................73

Table 20: Planmed Sophie Classic SWOT Analysis ...............................................................74

Table 21: Analog Giotto Image Product Profile.......................................................................75

Table 22: Analog Giotto Image SWOT Analysis .....................................................................75

Table 23: HAWK-2M Product Profile .....................................................................................77

Table 24: HAWK-2M SWOT Analysis.....................................................................................77

Table 25: MGU-1000A Product Profile ..................................................................................78

Table 26: MGU-1000A SWOT Analysis..................................................................................79

Table 27: Fuji Computed Radiography Mammography Suite (FCRMS) Product Profile...........81

Table of Contents


Table 28: Fuji Computed Radiography Mammography Suite (FCRMS) SWOT Analysis ........81

Table 29: KODAK DirectView CR System Product Profile ......................................................82

Table 30: KODAK DirectView CR System SWOT Analysis .....................................................83

Table 31: Xpress CR System Product Profile .........................................................................84

Table 32: Xpress CR System SWOT Analysis........................................................................84

Table 33: REGIUS PureView Product Profile .........................................................................85

Table 34: REGIUS PureView SWOT Analysis........................................................................86

Table 35: Agfa CR Mammography Systems (DX-M, CR 30-Xm, and CR 85-X) Product Profile

...............................................................................................................................87

Table 36: Agfa CR Mammography Systems (DX-M, CR 30-Xm, and CR 85-X) SWOT Analysis

...............................................................................................................................87

Table 37: FFDM SWOT Analysis ...........................................................................................88

Table 38: Selenia Dimensions Product Profile........................................................................89

Table 39: Selenia Dimensions SWOT Analysis ......................................................................90

Table 40: Selenia Product Profile ...........................................................................................92

Table 41: Selenia SWOT Analysis..........................................................................................92

Table 42: Selenia S Product Profile........................................................................................93

Table 43: Selenia S SWOT Analysis ......................................................................................94

Table 44: Selenia Performance Product Profile ......................................................................95

Table 45: Selenia Performance SWOT Analysis.....................................................................95

Table 46: Senographe DS Product Profile..............................................................................96

Table 47: Senographe DS SWOT Analysis ............................................................................97

Table 48: Senographe Essential/Senographe Essential E Product Profile ..............................98

Table 49: Senographe Essential SWOT Analysis ...................................................................99

Table 50: Senographe Care Product Profile .........................................................................100

Table 51: Senographe Care SWOT Analysis........................................................................101

Table 52: SenoBright CESM Product Profile ........................................................................102

Table 53: SenoBright CESM SWOT Analysis.......................................................................103

Table 54: MAMMOMAT Inspiration Product Profile............................................................... 104

Table of Contents


Table 55: MAMMOMAT Inspiration SWOT Analysis ............................................................. 105

Table 56: Aspire HD/Amulet Product Profile .........................................................................106

Table 57: Aspire HD/Amulet SWOT Analysis .......................................................................107

Table 58: MammoDiagnost DR Product Profile ....................................................................108

Table 59: MammoDiagnost DR SWOT Analysis...................................................................109

Table 60: MicroDose Product Profile ....................................................................................111

Table 61: MicroDose SWOT Analysis ..................................................................................111

Table 62: Giotto Image 3D/3DL Product Profile ....................................................................113

Table 63: Giotto Image 3D/3DL SWOT Analysis ..................................................................113

Table 64: Planmed Nuance/Nuance Excel Product Profile....................................................115

Table 65: Planmed Nuance/Nuance Excel SWOT Analysis ..................................................115

Table 66: Fairy DR Product Profile....................................................................................... 116

Table 67: Fairy DR SWOT Analysis .....................................................................................117

Table 68: Serenity Product Profile........................................................................................ 118

Table 69: Serenity SWOT Analysis ...................................................................................... 118

Table 70: Selenia Dimensions 3D System Product Profile ....................................................119

Table 71: Selenia Dimensions SWOT Analysis ....................................................................120

Table 72: True 3D Breast Tomosynthesis Product Profile.....................................................121

Table 73: True 3D Breast Tomosynthesis SWOT Analysis ...................................................122

Table 74: Giotto Tomo Product Profile..................................................................................123

Table 75: Giotto Tomo SWOT Analysis................................................................................124

Table 76: FUJIFILM 3Dimensional Mammography Product Profile .......................................125

Table 77: FUJIFILM 3Dimensional Mammography SWOT Analysis......................................125

Table 78: somo.v ABUS Product Profile ...............................................................................127

Table 79: somo.v ABUS SWOT Analysis .............................................................................127

Table 80: SonoCine AWBUS Product Profile........................................................................128

Table 81: SonoCine AWBUS SWOT Analysis ......................................................................129

Table 82: ACUSON S2000 ABVS Product Profile.................................................................130

Table of Contents


Table 83: Acuson S2000 ABVS SWOT Analysis ..................................................................131

Table 84: Terason t3200 Ultrasound System Breast Series Product Profile .......................... 132

Table 85: Terason t3200 Ultrasound System Breast Series SWOT Analysis......................... 132

Table 86: Aurora 1.5T Dedicated Breast MRI System Product Profile...................................133

Table 87: Aurora 1.5T Dedicated Breast SWOT Analysis ....................................................134

Table 88: PEM Flex Solo II Product Profile...........................................................................135

Table 89: PEM Flex Solo II SWOT Analysis .........................................................................136

Table 90: Computerized Tomography Laser Mammography (CTLM) Model 1020 Product

Profile...................................................................................................................137

Table 91: Computerized Tomography Laser Mammography (CTLM) Model 1020 SWOT

Analysis................................................................................................................138

Table 92: Dilon 6800/Dilon 6800 Acella Product Profile ........................................................ 140

Table 93: Dilon 6800/Dilon 6800 Acella SWOT Analysis ...................................................... 140

Table 94: LumaGEM Product Profile ....................................................................................141

Table 95: LumaGEM SWOT Analysis ..................................................................................142

Table 96: Discovery NM 750b Product Profile ......................................................................143

Table 97: Discovery NM 750b SWOT Analysis.....................................................................144

Table 98: Breast Cancer Imaging Pipeline Products............................................................. 155

Table 99: GE Breast Tomosynthesis SWOT Analysis........................................................... 157

Table 100: MAMMOMAT Inspiration PRIME Edition SWOT Analysis....................................158

Table 101: Philips MicroDose SI SWOT Analysis .................................................................159

Table 102: Selenia Dimensions 2D Contrast Imaging SWOT Analysis..................................160

Table 103: SenoCase SWOT Analysis.................................................................................161

Table 104: Electrical Mammogram SWOT Analysis.............................................................. 162

Table 105: Other Key Events in the Breast Cancer Imaging Market......................................189

Table 106: GE Healthcare SWOT Analysis, 2013.................................................................194

Table 107: Hologic SWOT Analysis, 2013............................................................................196

Table 108: Siemens SWOT Analysis, 2013..........................................................................197

Table 109: Koninklijke Philips Electronics SWOT Analysis, 2013..........................................198

Table of Contents


Table 110: Fujifilm Medical Systems, SWOT Analysis, 2013 ................................................199

Table 111: Internazionale Medico Scientifica SWOT Analysis, 2013.....................................200

Table 112: Planmed, SWOT Analysis, 2013.........................................................................201

Table 113: Konica Minolta Medical Imaging, SWOT Analysis, 2013......................................202

Table 114: Agfa Healthcare, SWOT Analysis, 2013.............................................................. 203

Table 115: Carestream Health, SWOT Analysis, 2013 ......................................................... 204

Table 116: SonoCine, SWOT Analysis, 2013 .......................................................................205

Table 117: Aurora Imaging Technology, SWOT Analysis, 2013............................................206

Table 118: Imaging Diagnostic Systems, SWOT Analysis, 2013...........................................208

Table 119: Naviscan, SWOT Analysis, 2013 ........................................................................208

Table 120: Dilon Diagnostics, SWOT Analysis, 2013........................................................... 209

Table 121: Gamma Medica, SWOT Analysis, 2013 .............................................................. 210

Table 122: Allengers Medical Systems, SWOT Analysis, 2013.............................................210

Table 123: Major Events Affecting the Global Breast Cancer Imaging Market....................... 223

Table 124: Sales Forecasts for Breast Cancer Imaging in the 10 Major Markets, 2009–2018223

Table 125: Global Forecast for Numbers of Breast Cancer Imaging Systems (Installed Base),

2009–2018 ...........................................................................................................224

Table 126: Sales Forecasts for Breast Cancer Imaging in the US, 2009–2018 .....................226

Table 127: Number of Installations of New Breast Imaging Systems in the US, 2011 and 2018

............................................................................................................................. 228

Table 128: Sales Forecasts for Breast Cancer Imaging in France, 2009–2018 .....................230

Table 129: Sales Forecasts for Breast Cancer Imaging in Germany, 2009–2018..................231

Table 130: Sales Forecasts for Breast Cancer Imaging in Italy, 2009–2018.......................... 232

Table 131: Sales Forecasts for Breast Cancer Imaging in Spain, 2009–2018 ....................... 233

Table 132: Sales Forecasts for Breast Cancer Imaging in the UK, 2009–2018 .....................234

Table 133: Sales Forecasts for Breast Cancer Imaging in Japan, 2009–2018....................... 235

Table 134: Sales Forecasts for Breast Cancer Imaging in Brazil, 2009–2018 ....................... 237

Table 135: Sales Forecasts for Breast Cancer Imaging in China, 2009–2018 ....................... 238

Table 136: Sales Forecasts for Breast Cancer Imaging in India, 2009–2018......................... 239

Table of Contents


Table 137: Physicians Surveyed, By Country .......................................................................279

1.2 List of Figures

Figure 1: Anatomy of the Breast.............................................................................................26

Figure 2: Breast Cancer Screening, Diagnostic Evaluation, and Follow-Up.............................32

Figure 3: Percentage Use of Ultrasound Imaging and MRI for Breast Cancer Screening and

Follow-Up, 2009–2016............................................................................................33

Figure 4: Breast Cancer Risk Factors.....................................................................................37

Figure 5: Average Worldwide Breast Cancer Incidence, CAGR, 2012–2018...........................39

Figure 6: Global Trends in Breast Cancer Incidence, 2012–2018 ...........................................39

Figure 7: Comparison Between Digital (FFDM) and Analog (FSM) Mammography .................44

Figure 8: Use of Alternative Breast Imaging Modalities, 2009–2016 .......................................51

Figure 9: Performa.................................................................................................................58

Figure 10: Alpha RT...............................................................................................................60

Figure 11: Alpha ST...............................................................................................................61

Figure 12: MAMMOMAT 1000 ...............................................................................................63

Figure 13: MAMMOMAT 3000 Nova ......................................................................................65

Figure 14: M-IV/M-IV Platinum ...............................................................................................67

Figure 15: MammoDiagnost ...................................................................................................69

Figure 16: Planmed Nuance Classic ......................................................................................71

Figure 17: Planmed Sophie Classic........................................................................................73

Figure 18: Analog Giotto Image..............................................................................................74

Figure 19: HAWK-2M.............................................................................................................76

Figure 20: MGU-1000A..........................................................................................................78

Figure 21: Aspire CRm ..........................................................................................................80

Figure 22: KODAK DirectView CR System.............................................................................82

Figure 23: Xpress CR System................................................................................................83

Figure 24: REGIUS PureView Type M....................................................................................85

Figure 25: DX-M Digitizer.......................................................................................................86

Table of Contents


Figure 26: Selenia Dimensions...............................................................................................89

Figure 27: Selenia..................................................................................................................91

Figure 28: Selenia S ..............................................................................................................93

Figure 29: Selenia Performance.............................................................................................94

Figure 30: Senographe DS ....................................................................................................96

Figure 31: Senographe Essential ...........................................................................................98

Figure 32: Senographe Care................................................................................................ 100

Figure 33: SenoBright CESM*.............................................................................................. 102

Figure 34: MAMMOMAT Inspiration .....................................................................................104

Figure 35: Aspire HD ...........................................................................................................106

Figure 36: MammoDiagnost DR........................................................................................... 108

Figure 37: MicroDose...........................................................................................................110

Figure 38: Giotto Image 3D/3DL........................................................................................... 112

Figure 39: Planmed Nuance/Nuance Excel ..........................................................................114

Figure 40: Fairy DR..............................................................................................................116

Figure 41: Serenity ..............................................................................................................117

Figure 42: Selenia Dimensions 2D System...........................................................................119

Figure 43: True 3D Breast Tomosynthesis* ..........................................................................121

Figure 44: Giotto Tomo ........................................................................................................123

Figure 45: Fujifilm 3D Mammography Viewer .......................................................................125

Figure 46: somo.v ABUS......................................................................................................126

Figure 47: SonoCine AWBUS .............................................................................................. 128

Figure 48: ACUSON S2000 ABVS ....................................................................................... 130

Figure 49: Terason t3200 Ultrasound System Breast Series.................................................131

Figure 50: Aurora 1.5T Dedicated Breast MRI System ......................................................... 133

Figure 51: PEM Flex Solo II .................................................................................................135

Figure 52: CTLM Model 1020............................................................................................... 137

Figure 53: Dilon 6800 Acella ................................................................................................ 139

Table of Contents


Figure 54: Dilon 6800...........................................................................................................139

Figure 55: LumaGEM...........................................................................................................141

Figure 56: Discovery NM 750b............................................................................................. 143

Figure 57: Percentage of False-Positive, False-Negative and Accurate Breast Cancer

Diagnoses from 2011–2012 ..................................................................................149

Figure 58: Senographe Essential ......................................................................................... 156

Figure 59: SenoCase ...........................................................................................................161

Figure 60: Product Life Cycle............................................................................................... 164

Figure 61: Breast Screening Programs in the EU .................................................................175

Figure 62: Detector Evolution............................................................................................... 179

Figure 63: Comparison Between a Typical Direct Conversion Detector and a Direct Optical

Switching Detector................................................................................................ 181

Figure 64: Photon-Counting Detector Technology ................................................................ 183

Figure 65: Linear and High Transmission Cellular Grids ....................................................... 184

Figure 66: Increase in FFDM Systems in the US, 2004–2013...............................................215

Figure 67: Trends in the Use of Mammographic Techniques, 2009–2016............................. 216

Figure 68: Sales Forecasts for Breast Cancer Imaging in the 10 Major Markets, 2009–2018 224

Figure 69: Global Breast Cancer Imaging Market Revenue, by Region, 2011 and 2018........225

Figure 70: Sales Forecasts for Breast Cancer Imaging in the US, 2009–2018 ...................... 226

Figure 71: Total Number of Breast Imaging Facilities and Total Number of Facilities with FFDM

Units in the US, 2008–2013 ..................................................................................227

Figure 72: Percentage of Installations of New Breast Imaging Systems in the US in 2011 and

2018 .....................................................................................................................229

Figure 73: Sales Forecasts for Breast Cancer Imaging in France, 2009–2018 ...................... 230

Figure 74: Sales Forecasts for Breast Cancer Imaging in Germany, 2009–2018...................231

Figure 75: Sales Forecasts for Breast Cancer Imaging in Italy, 2009–2018........................... 232

Figure 76: Sales Forecasts for Breast Cancer Imaging in Spain, 2009–2018 ........................ 233

Figure 77: Sales Forecasts for Breast Cancer Imaging in the UK, 2009-2018 ....................... 234

Figure 78: Sales Forecasts for Breast Cancer Imaging in Japan, 2009–2018 ....................... 236

Table of Contents


Figure 79: Sales Forecasts for Breast Cancer Imaging in Brazil, 2009–2018 ........................ 237

Figure 80: Sales Forecasts for Breast Cancer Imaging in China, 2009–2018........................ 238

Figure 81: Sales Forecasts for Breast Cancer Imaging in India, 2009–2018 ......................... 239

Introduction


2 Introduction

Breast cancer is the most common form of cancer in women in both the developed and developing

world, but is a rare disease in men. The global incidence of breast cancer is increasing due to an

increased lifespan and increasing adoption of a westernized lifestyle, which is associated with an

increased risk of the disease.

Early diagnosis of breast cancer is the foundation for increasing survival rates, and diagnostic

imaging is the most widely used technique to achieve early detection, making it a cornerstone of

breast cancer control. Diagnostic imaging is used for the early detection of breast cancer in

asymptomatic patients in population-based screening programs in most developed countries, or for

opportunistic screening in developing nations. Regardless of these differences, imaging has proved

to be an indispensable tool in fighting breast cancer and has been proven to reduce mortality.

This report provides an analysis of the mammography market in relation to dedicated breast cancer

screening and diagnosis in the US, the 5EU (France, Germany, Italy, Spain, and UK), Brazil, and

the APAC regions, including Japan, China, and India, and identifies the unmet needs in the market.

This report also discusses physician attitudes towards current breast cancer screening and

diagnostic techniques, and the future of breast cancer imaging modalities in the face of rapid

technological advancements.

Introduction


2.1 Catalyst

The global breast cancer imaging market is a mature industry with complex dynamics. The

dynamics of this industry vary greatly from one market to another. The main differences are due to

differences in the breast cancer incidence, the presence or absence of nationwide screening

programs, reimbursement issues, lifestyle factors, and differences in breast density. Therefore, it is

essential to examine the market opportunities and barriers that are specific to each region. This

report provides an in-depth review of the evolving technologies and the regulatory landscape in the

breast cancer screening markets around the world.

Another key issue is that purchasing decisions concerning breast cancer screening and diagnostic

imaging equipment are complex. Firstly, breast cancer screening and diagnosis involves the

challenge of making major purchasing decisions concerning new capital equipment in a

technologically fast-evolving market. Secondly, diagnostic imaging modalities are often

multipurpose in nature, and so equipment purchasing decisions are not solely driven by the needs

of breast cancer screening and diagnosis. For example, a diagnostic mammogram is accompanied

by ultrasound imaging in over 50% of cases, but the ultrasound equipment also has various other

applications for imaging other parts of the human body.

Since the prevalence of breast cancer is higher in women than in men, this report is restricted to

the use of imaging techniques for breast cancer screening and diagnosis in women.

Appendix

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12.9 About MediPoint

MediPoint is the flagship product for GlobalData’s Medical team. Each MediPoint report is built

from the ground up by our team of healthcare analysts in the US and UK. Each report includes

input from experienced physicians and leading Key Opinion Leaders (KOLs). Running throughout

each report in the series, “What Physicians Think” quotes provide a unique insight into how

healthcare professionals are reacting to events within the industry, and what their responses could

mean for industry strategists.

12.10 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 R&D. 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, Boston, London, India, and Singapore.

Appendix

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 284 GDME0166MAR / Published MAY 2013

12.12 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.

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