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Breast Cancer Imaging South America Analysis and Market Forecasts

GDME1036CFR / 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. GDME1036CFR / Published MAY 2013

Breast Cancer Imaging: Key Metrics in South American* markets

2011 Market Sales

Brazil $42m

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 ↑↑↑↑

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

↑↑

2018 Market Sales

Brazil $71m

Source: GlobalData, 2013 South America = Brazil breast cancer imaging market

GlobalData calculated the South American (Brazil) breast

cancer imaging market to be worth $42m in 2011 and

estimates that it will be worth $71m in 2018, increasing at

a Compound Annual Growth Rate (CAGR) of 8% during

this time period.

The key drivers for the South American 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

Adoption of digital mammography units in South

America

The key barriers for the South American 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

Refurbished equipment sales

Reimbursement issues

Executive Summary


Significant Unmet Needs and Challenges for the South American Breast Cancer Imaging Market

Even though the South American 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 South American breast cancer imaging market is

primarily driven by the increasing incidence of breast

cancer. It is also fueled by the need to overcome the

drawbacks posed by film – screen mammography, which

is the most widely used technique for breast cancer

detection and diagnosis in this region. GlobalData

anticipates that newer technologies, such as digital

mammography and tomosynthesis, will drive the future

growth of this market. Tomosynthesis is predicted to be

the new gold standard in the near future, with high

adoption is western countries, including the US, due to its

promising increase in cancer detection and reduction of

false-positives, which are key concerns with

mammography.

In Brazil, FFDM systemswill continue to grow rapidly with

a modest uptake in tomosynthesis, since digital

mammography has yet to be widely adopted in these

regions and the breast cancer incidence is rising steadily.

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.’’


Executive Summary


‘’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.’


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 ............................................................................................................... 5

1.1 List of Tables .......................................................................................................... 13

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

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

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

3 Disease Overview ............................................................................................................. 22

3.1 Anatomy & Physiology of the Breast ....................................................................... 22

3.2 Pathophysiology of Breast Cancer .......................................................................... 23

3.3 Detection of Breast Cancer ..................................................................................... 23

3.4 Types of Breast Cancer .......................................................................................... 24

3.5 Clinical Presentation ............................................................................................... 26

3.6 Clinical Outcomes ................................................................................................... 27

3.6.1 Assessment Procedure ....................................................................................... 27

3.6.2 Screening Guidelines .......................................................................................... 30

3.7 Epidemiology of Breast Cancer ............................................................................... 31

3.8 Economic Impact of Breast Cancer Imaging ............................................................ 33

4 Imaging Techniques.......................................................................................................... 34

4.1 Mammography ........................................................................................................ 34

4.1.1 Overview............................................................................................................. 34

4.1.2 Types of Mammography ...................................................................................... 36

4.2 Non-Mammographic Techniques ............................................................................ 41

4.2.1 Breast Ultrasound Imaging .................................................................................. 41

4.2.2 Breast Magnetic Resonance Imaging .................................................................. 42

4.3 Comparison of Mammography, Ultrasound, and MRI .............................................. 43

4.4 Alternative Breast Imaging Techniques ................................................................... 44

4.4.1 Nuclear Imaging Techniques ............................................................................... 45

4.4.2 Computed Tomography....................................................................................... 46

Table of Contents


4.4.3 Optical Breast Imaging ........................................................................................ 47

4.4.4 Electric Impedance-Based Techniques ................................................................ 47

4.4.5 Thermography .................................................................................................... 48

4.4.6 Elastography ....................................................................................................... 48

4.4.7 Ductogram .......................................................................................................... 48

5 Competitive Assessment ................................................................................................... 49

5.1 Overview ................................................................................................................ 49

5.2 Film Screen Mammography .................................................................................... 50

5.2.1 Performa (GE Healthcare) ................................................................................... 50

5.2.2 Alpha RT/Alpha ST (GE Healthcare) ................................................................... 53

5.2.3 MAMMOMAT 1000 (Siemens Healthcare) ........................................................... 56

5.2.4 MAMMOMAT 3000 Nova (Siemens Healthcare) .................................................. 58

5.2.5 M-IV/M-IV Platinum (Hologic) .............................................................................. 60

5.2.6 MammoDiagnost (Philips Healthcare).................................................................. 62

5.2.7 Planmed Nuance Classic (Planmed) ................................................................... 64

5.2.8 Planmed Sophie Classic (Planmed) .................................................................... 66

5.2.9 Analog Giotto Image (Internazionale Medico Scientifica) ..................................... 68

5.2.10 HAWK-2M (Hologic) ............................................................................................ 70

5.2.11 MGU-1000A (Toshiba Medical Systems) ............................................................. 72

5.3 CR Mammography .................................................................................................. 74

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

Systems) ........................................................................................................... 74

5.3.2 KODAK DirectView (Carestream Health) ............................................................. 77

5.3.3 Xpress CR System (Konica Minolta) .................................................................... 79

5.3.4 REGIUS PureView (Konica Minolta) .................................................................... 81

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

Healthcare) ........................................................................................................ 83

5.4 Full-Field Digital Mammography .............................................................................. 85

5.4.1 Selenia Dimensions (Hologic).............................................................................. 86

Table of Contents


5.4.2 Selenia (Hologic) ................................................................................................. 89

5.4.3 Selenia S (Hologic) ............................................................................................. 91

5.4.4 Selenia Performance (Hologic) ............................................................................ 93

5.4.5 Senographe DS (GE Healthcare) ........................................................................ 95

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

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

5.4.8 SenoBright CESM (GE Healthcare) ................................................................... 102

5.4.9 MAMMOMAT Inspiration (Siemens Healthcare)................................................. 104

5.4.10 Aspire HD (US)/Amulet (Outside the US) (Fujifilm) ............................................ 106

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 ............................................................................................................ 118

5.5 3D Mammography ................................................................................................ 120

5.5.1 Selenia Dimensions 3D System (Hologic).......................................................... 120

5.5.2 GE Breast Tomosynthesis (GE Healthcare) ....................................................... 122

5.5.3 True 3D Breast Tomosynthesis (Siemens Healthcare) ....................................... 124

5.5.4 Giotto Tomo (Internazionale Medico Scientifica) ................................................ 126

5.5.5 FUJIFILM 3Dimensional Mammography (Fujifilm) ............................................. 128

5.6 Breast Ultrasound Imaging .................................................................................... 130

5.6.1 somo.v Automated Breast Ultrasound (ABUS) (GE Healthcare)......................... 130

5.6.2 SonoCine AWBUS (SonoCine).......................................................................... 132

5.6.3 ACUSON S2000 ABVS (Siemens Healthcare) .................................................. 134

5.6.4 Terason t3200 Ultrasound System Breast Series (Terason Ultrasound) ............. 136

5.7 Breast MRI ........................................................................................................... 138

5.7.1 Aurora 1.5T Dedicated Breast MRI System (Aurora Imaging Technology) ......... 138

Table of Contents


5.8 Other Breast Imaging Techniques ......................................................................... 140

5.8.1 PEM Flex Solo II (Naviscan) .............................................................................. 140

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

Diagnostic Systems) ........................................................................................ 142

5.8.3 Dilon 6800/Dilon 6800 Acella (Dilon Diagnostics) .............................................. 144

5.8.4 LumaGEM (Gamma Medica) ............................................................................. 146

5.8.5 Discovery NM 750b (GE Healthcare) ................................................................. 148

6 Unmet Needs.................................................................................................................. 150

6.1 Lower Radiation Dose ........................................................................................... 150

6.2 Increase Patient Comfort ...................................................................................... 152

6.3 Reduce False-Positives and False-Negatives........................................................ 154

6.4 Loss of Sensitivity of Mammography in Dense Breasts .......................................... 156

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

158

6.6 Commitment to Training ........................................................................................ 159

7 Pipeline Products ............................................................................................................ 162

7.1 Breast Cancer Imaging Pipeline Products Overview .............................................. 162

7.2 MAMMOMAT Inspiration PRIME Edition ............................................................... 163

7.2.1 Overview........................................................................................................... 163

7.2.2 SWOT Analysis ................................................................................................. 163

7.3 MicroDose SI ........................................................................................................ 164

7.3.1 Overview........................................................................................................... 164

7.3.2 SWOT Analysis ................................................................................................. 164

7.4 Selenia Dimensions 2D Contrast-Enhanced Digital Mammography (CEDM) .......... 165

7.4.1 Overview........................................................................................................... 165

7.4.2 SWOT Analysis ................................................................................................. 165

7.5 SenoCase............................................................................................................. 166

7.5.1 Overview........................................................................................................... 166

7.5.2 SWOT Analysis ................................................................................................. 167

Table of Contents


7.6 Electrical Mammogram ......................................................................................... 168

7.6.1 Overview........................................................................................................... 168

7.6.2 SWOT Analysis ................................................................................................. 168

8 Industry Overview ........................................................................................................... 169

8.1 Purchasing Cycle .................................................................................................. 169

8.1.1 Product Life Cycle ............................................................................................. 169

8.1.2 Cost Effectiveness in Screening Settings........................................................... 171

8.1.3 Cost-Effectiveness in Diagnostic Settings .......................................................... 171

8.2 Market Access ...................................................................................................... 172

8.2.1 Purchasing Decisions ........................................................................................ 172

8.2.2 Regulatory Process ........................................................................................... 172

8.3 Quality Assurance ................................................................................................. 173

8.4 Adoption of New Technologies .............................................................................. 174

8.4.1 Influence of Clinical Trials Results ..................................................................... 174

8.4.2 Reimbursement................................................................................................. 175

8.4.3 Economic Resources ........................................................................................ 175

8.4.4 Competitive Advantage ..................................................................................... 176

8.5 Current Reimbursement Trends ............................................................................ 176

8.6 Trends in Detector Technology for Digital Mammography...................................... 177

8.7 Evolving Scatter-Removal Mechanisms ................................................................ 181

8.8 Overdiagnosis ....................................................................................................... 183

8.9 Malpractice Litigations .......................................................................................... 184

8.10 Mergers and Acquisitions/Key Partnerships .......................................................... 185

8.10.1 GE Healthcare Acquires U-Systems .................................................................. 185

8.10.2 Koninklijke Philips Electronics Acquires MicroDose Mammography from Sectra 185

8.10.3 Hologic Acquires Beijing Healthcome Technology ............................................. 185

8.10.4 Hologic Acquires Sentinelle Medical .................................................................. 185

8.10.5 Koninklijke Philips Electronics Acquires Shanghai Apex Electronics Technology 186

Table of Contents


8.10.6 Fujifilm Medical Systems acquired FUJIFILM-RU .............................................. 186

8.10.7 Other Key Events .............................................................................................. 186

9 Current and Future Players ............................................................................................. 187

9.1 Overview .............................................................................................................. 187

9.2 Trends in Corporate Strategy ................................................................................ 188

9.3 Company Profiles ................................................................................................. 189

9.3.1 GE Healthcare .................................................................................................. 189

9.3.2 Hologic ............................................................................................................. 191

9.3.3 Siemens............................................................................................................ 193

9.3.4 Koninklijke Philips Electronics ........................................................................... 194

9.3.5 Fujifilm Medical Systems ................................................................................... 196

9.3.6 Internazionale Medico Scientifica (IMS) ............................................................. 197

9.3.7 Planmed ........................................................................................................... 198

9.3.8 Konica Minolta Medical Imaging ........................................................................ 199

9.3.9 Agfa Healthcare ................................................................................................ 200

9.3.10 Carestream Health ............................................................................................ 201

9.3.11 SonoCine .......................................................................................................... 202

9.3.12 Aurora Imaging Technology .............................................................................. 203

9.3.13 Imaging Diagnostic Systems ............................................................................. 204

9.3.14 Naviscan ........................................................................................................... 206

9.3.15 Dilon Diagnostics .............................................................................................. 207

9.3.16 Gamma Medica................................................................................................. 208

9.3.17 Allengers Medical Systems ............................................................................... 209

10 Market Drivers & Opportunities ....................................................................................... 210

10.1 Market Drivers ...................................................................................................... 210

10.1.1 Increase in the Incidence of Breast Cancer ....................................................... 210

10.1.2 Increased Awareness of the Benefits of Screening ............................................ 210

10.1.3 Increased Breast Cancer Incidence Due to an Aging Population ........................ 210

Table of Contents


10.1.4 FDA Reclassification of Mammography Equipment ........................................... 211

10.1.5 New Technologies to Drive Market Growth ........................................................ 211

10.1.6 Adoption of Digital Mammography Units in South America ................................ 212

10.2 Opportunities ........................................................................................................ 215

10.2.1 Emerging Economies Promise Future Growth ................................................... 215

10.2.2 Invest in Emerging Technologies ....................................................................... 216

10.2.3 Product Improvement ........................................................................................ 217

10.3 Market Barriers ..................................................................................................... 218

10.3.1 Shortage of Dedicated Mammography Professionals......................................... 218

10.3.2 Reduced Hospital Budgets ................................................................................ 218

10.3.3 Refurbished Equipment Sales ........................................................................... 219

10.3.4 Reimbursement................................................................................................. 220

10.3.5 Substitutes ........................................................................................................ 220

11 Country Outlooks & Forecasts ........................................................................................ 221

11.1 Brazil .................................................................................................................... 221

11.1.1 Brazil Market Analysis ....................................................................................... 221

12 Appendix ........................................................................................................................ 222

12.1 Bibliography .......................................................................................................... 222

12.2 Abbreviations ........................................................................................................ 248

12.3 Report Methodology.............................................................................................. 253

12.3.1 Overview........................................................................................................... 253

12.3.2 Coverage .......................................................................................................... 253

12.3.3 Secondary Research ......................................................................................... 253

12.3.4 Forecast Methodology ....................................................................................... 254

12.4 Physicians and Specialists Included in this Study .................................................. 255

12.5 Primary Research ................................................................................................. 256

12.6 Physician Survey .................................................................................................. 256

12.7 About the Authors ................................................................................................. 257

Table of Contents


12.7.1 Analysts ............................................................................................................ 257

12.7.2 Global Head of Healthcare ................................................................................ 258

12.8 Definitions............................................................................................................. 259

12.9 About MediPoint ................................................................................................... 260

12.10 About GlobalData ................................................................................................. 260

12.11 Contact Us ............................................................................................................ 260

12.12 Disclaimer ............................................................................................................. 261

Table of Contents


1.1 List of Tables

Table 1: Breast Cancer Types, Including Diagnostic Procedures ....................................... 25

Table 2: ACR Breast Imaging Reporting and Database System (BI-RADS) ....................... 27

Table 3: Breast Cancer Incidence Rates in Brazil, 2002 .................................................... 31

Table 4: Comparison of Mammography, Ultrasound, and MRI for Breast Imaging ............. 43

Table 5: Performa Product Profile ..................................................................................... 51

Table 6: Performa SWOT Analysis ................................................................................... 52

Table 7: Alpha RT/Alpha ST Product Profile ...................................................................... 54

Table 8: Alpha RT/Alpha ST SWOT Analysis .................................................................... 55

Table 9: MAMMOMAT 1000 Product Profile ...................................................................... 56

Table 10: MAMMOMAT 1000 SWOT Analysis .................................................................... 57

Table 11: MAMMOMAT 3000 Nova Product Profile............................................................. 59

Table 12: MAMMOMAT 3000 Nova SWOT Analysis ........................................................... 59

Table 13: M-IV/M-IV Platinum Product Profile ..................................................................... 61

Table 14: M-IV/M-IV Platinum SWOT Analysis .................................................................... 61

Table 15: MammoDiagnost Product Profile ......................................................................... 63

Table 16: MammoDiagnost SWOT Analysis........................................................................ 63

Table 17: Planmed Nuance Classic Product Profile............................................................. 65

Table 18: Planmed Nuance Classic SWOT Analysis ........................................................... 65

Table 19: Planmed Sophie Classic Product Profile .............................................................. 66

Table 20: Planmed Sophie Classic SWOT Analysis ............................................................ 67

Table 21: Analog Giotto Image Product Profile .................................................................... 69

Table 22: Analog Giotto Image SWOT Analysis .................................................................. 69

Table 23: HAWK-2M Product Profile .................................................................................. 71

Table 24: HAWK-2M SWOT Analysis ................................................................................. 71

Table 25: MGU-1000A Product Profile ............................................................................... 72

Table 26: MGU-1000A SWOT Analysis .............................................................................. 73

Table 27: Fuji Computed Radiography Mammography Suite (FCRMS) Product Profile ....... 75

Table of Contents


Table 28: Fuji Computed Radiography Mammography Suite (FCRMS) SWOT Analysis ..... 76

Table 29: KODAK DirectView CR System Product Profile ................................................... 78

Table 30: KODAK DirectView CR System SWOT Analysis.................................................. 78

Table 31: Xpress CR System Product Profile ...................................................................... 79

Table 32: Xpress CR System SWOT Analysis .................................................................... 80

Table 33: REGIUS PureView Product Profile ...................................................................... 82

Table 34: REGIUS PureView SWOT Analysis ..................................................................... 82

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

........................................................................................................................... 84

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

Analysis .............................................................................................................. 84

Table 37: FFDM SWOT Analysis ........................................................................................ 85

Table 38: Selenia Dimensions Product Profile ..................................................................... 87

Table 39: Selenia Dimensions SWOT Analysis ................................................................... 88

Table 40: Selenia Product Profile ........................................................................................ 90

Table 41: Selenia SWOT Analysis ...................................................................................... 90

Table 42: Selenia S Product Profile .................................................................................... 92

Table 43: Selenia S SWOT Analysis ................................................................................... 92

Table 44: Selenia Performance Product Profile ................................................................... 94

Table 45: Selenia Performance SWOT Analysis ................................................................. 94

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

Table 47: Senographe DS SWOT Analysis ......................................................................... 96

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

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

Table 50: Senographe Care Product Profile ...................................................................... 101

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

Table 52: SenoBright CESM Product Profile ..................................................................... 103

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

Table 54: MAMMOMAT Inspiration Product Profile ........................................................... 105

Table of Contents


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

Table 56: Aspire HD/Amulet Product Profile ...................................................................... 107

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 .................................................................................... 117

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

Table 68: Serenity Product Profile..................................................................................... 119

Table 69: Serenity SWOT Analysis ................................................................................... 119

Table 70: Selenia Dimensions 3D System Product Profile ................................................. 121

Table 71: Selenia Dimensions SWOT Analysis ................................................................. 121

Table 72: GE Breast Tomosynthesis Product Profile ......................................................... 123

Table 73: GE Breast Tomosynthesis SWOT Analysis ....................................................... 123

Table 74: True 3D Breast Tomosynthesis Product Profile ................................................. 125

Table 75: True 3D Breast Tomosynthesis SWOT Analysis ................................................ 125

Table 76: Giotto Tomo Product Profile .............................................................................. 127

Table 77: Giotto Tomo SWOT Analysis ............................................................................. 127

Table 78: FUJIFILM 3Dimensional Mammography Product Profile .................................... 129

Table 79: FUJIFILM 3Dimensional Mammography SWOT Analysis .................................. 129

Table 80: somo.v ABUS Product Profile ............................................................................ 131

Table 81: somo.v ABUS SWOT Analysis .......................................................................... 131

Table 82: SonoCine AWBUS Product Profile .................................................................... 133

Table of Contents


Table 83: SonoCine AWBUS SWOT Analysis ................................................................... 133

Table 84: ACUSON S2000 ABVS Product Profile ............................................................. 135

Table 85: Acuson S2000 ABVS SWOT Analysis ............................................................... 135

Table 86: Terason t3200 Ultrasound System Breast Series Product Profile ....................... 137

Table 87: Terason t3200 Ultrasound System Breast Series SWOT Analysis ..................... 137

Table 88: Aurora 1.5T Dedicated Breast MRI System Product Profile................................ 139

Table 89: Aurora 1.5T Dedicated Breast SWOT Analysis ................................................. 139

Table 90: PEM Flex Solo II Product Profile ....................................................................... 141

Table 91: PEM Flex Solo II SWOT Analysis ...................................................................... 141

Table 92: Computerized Tomography Laser Mammography (CTLM) Model 1020 Product

Profile ............................................................................................................... 143

Table 93: Computerized Tomography Laser Mammography (CTLM) Model 1020 SWOT

Analysis ............................................................................................................ 143

Table 94: Dilon 6800/Dilon 6800 Acella Product Profile ..................................................... 145

Table 95: Dilon 6800/Dilon 6800 Acella SWOT Analysis ................................................... 145

Table 96: LumaGEM Product Profile ................................................................................. 147

Table 97: LumaGEM SWOT Analysis ............................................................................... 147

Table 98: Discovery NM 750b Product Profile ................................................................... 149

Table 99: Discovery NM 750b SWOT Analysis ................................................................. 149

Table 100: Breast Cancer Imaging Pipeline Products.......................................................... 162

Table 101: MAMMOMAT Inspiration PRIME Edition SWOT Analysis .................................. 163

Table 102: Philips MicroDose SI SWOT Analysis ................................................................ 164

Table 103: Selenia Dimensions 2D Contrast Imaging SWOT Analysis ................................ 165

Table 104: SenoCase SWOT Analysis................................................................................ 167

Table 105: Electrical Mammogram SWOT Analysis ............................................................ 168

Table 106: Other Key Events in the Breast Cancer Imaging Market .................................... 186

Table 107: GE Healthcare SWOT Analysis, 2013 ............................................................... 190

Table 108: Hologic SWOT Analysis, 2013........................................................................... 192

Table 109: Siemens SWOT Analysis, 2013 ......................................................................... 193

Table of Contents


Table 110: Koninklijke Philips Electronics SWOT Analysis, 2013 ........................................ 195

Table 111: Fujifilm Medical Systems, SWOT Analysis, 2013 ............................................... 196

Table 112: Internazionale Medico Scientifica SWOT Analysis, 2013 ................................... 197

Table 113: Planmed, SWOT Analysis, 2013 ....................................................................... 198

Table 114: Konica Minolta Medical Imaging, SWOT Analysis, 2013 .................................... 199

Table 115: Agfa Healthcare, SWOT Analysis, 2013 ............................................................ 200

Table 116: Carestream Health, SWOT Analysis, 2013 ........................................................ 201

Table 117: SonoCine, SWOT Analysis, 2013 ...................................................................... 202

Table 118: Aurora Imaging Technology, SWOT Analysis, 2013........................................... 203

Table 119: Imaging Diagnostic Systems, SWOT Analysis, 2013 ......................................... 205

Table 120: Naviscan, SWOT Analysis, 2013 ....................................................................... 206

Table 121: Dilon Diagnostics, SWOT Analysis, 2013 ......................................................... 207

Table 122: Gamma Medica, SWOT Analysis, 2013 ............................................................. 208

Table 123: Allengers Medical Systems, SWOT Analysis, 2013 ........................................... 209

Table 124: Sales Forecasts for Breast Cancer Imaging in Brazil, 2009–2018 ...................... 221

Table 125: Physicians Surveyed, By Country ...................................................................... 256

Table of Contents


1.2 List of Figures

Figure 1: Anatomy of the Breast ......................................................................................... 22

Figure 2: Breast Cancer Screening, Diagnostic Evaluation, and Follow-Up ......................... 28

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

Follow-Up, 2009–2016 ........................................................................................ 29

Figure 4: Breast Cancer Risk Factors ................................................................................. 31

Figure 5: Projected Breast Cancer Incidence in Brazil, 2012–2018 ..................................... 32

Figure 6: Comparison Between Digital (FFDM) and Analog (FSM) Mammography ............. 37

Figure 7: Use of Alternative Breast Imaging Modalities, 2009–2016 ................................... 44

Figure 8: Performa ............................................................................................................. 51

Figure 9: Alpha RT............................................................................................................. 53

Figure 10: Alpha ST ............................................................................................................. 54

Figure 11: MAMMOMAT 1000 ............................................................................................. 56

Figure 12: MAMMOMAT 3000 Nova .................................................................................... 58

Figure 13: M-IV/M-IV Platinum ............................................................................................. 60

Figure 14: MammoDiagnost ................................................................................................. 62

Figure 15: Planmed Nuance Classic .................................................................................... 64

Figure 16: Planmed Sophie Classic ..................................................................................... 66

Figure 17: Analog Giotto Image ........................................................................................... 68

Figure 18: HAWK-2M ........................................................................................................... 70

Figure 19: MGU-1000A ........................................................................................................ 72

Figure 20: Aspire CRm ........................................................................................................ 75

Figure 21: KODAK DirectView CR System ........................................................................... 77

Figure 22: Xpress CR System .............................................................................................. 79

Figure 23: REGIUS PureView Type M ................................................................................. 81

Figure 24: DX-M Digitizer ..................................................................................................... 83

Figure 25: Selenia Dimensions ............................................................................................ 86

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

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

Table of Contents


Figure 28: Selenia Performance ........................................................................................... 93

Figure 29: Senographe DS .................................................................................................. 95

Figure 30: Senographe Essential ......................................................................................... 97

Figure 31: Senographe Care .............................................................................................. 100

Figure 32: SenoBright CESM*............................................................................................ 102

Figure 33: MAMMOMAT Inspiration ................................................................................... 104

Figure 34: Aspire HD ......................................................................................................... 106

Figure 35: MammoDiagnost DR ......................................................................................... 108

Figure 36: MicroDose ........................................................................................................ 110

Figure 37: Giotto Image 3D/3DL ........................................................................................ 112

Figure 38: Planmed Nuance/Nuance Excel ........................................................................ 114

Figure 39: Fairy DR ........................................................................................................... 116

Figure 40: Serenity ............................................................................................................ 118

Figure 41: Selenia Dimensions 2D System ........................................................................ 120

Figure 42: Senographe Essential ....................................................................................... 122

Figure 43: True 3D Breast Tomosynthesis* ........................................................................ 124

Figure 44: Giotto Tomo ...................................................................................................... 126

Figure 45: Fujifilm 3D Mammography Viewer ..................................................................... 128

Figure 46: somo.v ABUS ................................................................................................... 130

Figure 47: SonoCine AWBUS ............................................................................................ 132

Figure 48: ACUSON S2000 ABVS ..................................................................................... 134

Figure 49: Terason t3200 Ultrasound System Breast Series............................................... 136

Figure 50: Aurora 1.5T Dedicated Breast MRI System ....................................................... 138

Figure 51: PEM Flex Solo II ............................................................................................... 140

Figure 52: CTLM Model 1020 ............................................................................................ 142

Figure 53: Dilon 6800 Acella .............................................................................................. 144

Figure 54: Dilon 6800 ........................................................................................................ 145

Figure 55: LumaGEM ........................................................................................................ 146

Table of Contents


Figure 56: Discovery NM 750b ........................................................................................... 148

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

Diagnoses from 2011–2012 .............................................................................. 155

Figure 58: SenoCase ......................................................................................................... 166

Figure 59: Product Life Cycle ............................................................................................. 170

Figure 60: Detector Evolution ............................................................................................. 177

Figure 61: Comparison Between a Typical Direct Conversion Detector and a Direct Optical

Switching Detector ............................................................................................ 178

Figure 62: Photon-Counting Detector Technology .............................................................. 180

Figure 63: Linear and High Transmission Cellular Grids ..................................................... 182

Figure 64: Increase in FFDM Systems in the US, 2004–2013 ............................................. 213

Figure 65: Trends in the Use of Mammographic Techniques, 2009–2016 ........................... 214

Figure 66: Sales Forecasts for Breast Cancer Imaging in Brazil, 2009–2018 ...................... 221

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 South America (Brazil) 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.

2.1 Catalyst

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

Therefore, it is essential to examine the market opportunities and barriers that are specific to this

region. This report provides an in-depth review of the evolving technologies and the regulatory

landscape in the South American breast cancer imaging market.

Another key issue, that is discussed, 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

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 260 GDME1036CFR / Published MAY 2013

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 261 GDME1036CFR / 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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