Breast Cancer Imaging Global Analysis and Market Forecasts. GDME0166MAR / Published May 2013

Breast Cancer Imaging Global Analysis and Market Forecasts GDME0166MAR / Published May 2013

Executive Summary 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) 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 Level of Impact $1,110 m 5EU $241m APAC $231m Brazil $71m Total Source: GlobalData, 2013 5EU = France, Germany, Italy, Spain, and UK; APAC = Asia-Pacific: for the purposes of this report, Japan, China, and India $1,654m 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 Page 2 GDME0166MAR / Published MAY 2013

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. Page 3 GDME0166MAR / Published MAY 2013

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 2Donly 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 Key Opinion Leader, January 2013 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. Key Opinion Leader, January 2013 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. Key Opinion Leader, January 2013 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. Key Opinion Leader, January 2013 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. Key Opinion Leader, January 2013 Key Opinion Leader, January 2013 Page 4 GDME0166MAR / Published MAY 2013

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. Key Opinion Leader, January 2013 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. Key Opinion Leader, December 2012 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. Key Opinion Leader, December 2012 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. Key Opinion Leader, December 2012 Page 5 GDME0166MAR / Published MAY 2013

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 Page 6 GDME0166MAR / Published MAY 2013

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 Page 7 GDME0166MAR / Published MAY 2013

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 Page 8 GDME0166MAR / Published MAY 2013

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 Page 9 GDME0166MAR / Published MAY 2013

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 Page 10 GDME0166MAR / Published MAY 2013

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 Page 11 GDME0166MAR / Published MAY 2013

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 Page 12 GDME0166MAR / Published MAY 2013

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 Page 13 GDME0166MAR / Published MAY 2013

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 Page 14 GDME0166MAR / Published MAY 2013

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 Page 15 GDME0166MAR / Published MAY 2013

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 Page 16 GDME0166MAR / Published MAY 2013

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 Page 17 GDME0166MAR / Published MAY 2013

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 Page 18 GDME0166MAR / Published MAY 2013

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 Page 19 GDME0166MAR / Published MAY 2013

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 Page 20 GDME0166MAR / Published MAY 2013

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 Page 21 GDME0166MAR / Published MAY 2013

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 Page 22 GDME0166MAR / Published MAY 2013

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 Page 23 GDME0166MAR / Published MAY 2013

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. Page 24 GDME0166MAR / Published MAY 2013

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. Page 25 GDME0166MAR / Published MAY 2013

Appendix 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. Page 283 GDME0166MAR / Published MAY 2013

Appendix 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. Page 284 GDME0166MAR / Published MAY 2013