Mammography World Markets

Breast cancer is the most common type of cancer in women, affecting one in eight during their lives. Mammography is the most valuable method for detecting potentially cancerous anomalies in the breast. As such, the mammography equipment segment is poised for a major new phase of growth fueled by the availability of new technologies. Mammograms are images of the breast tissue produced from low radiation X-rays. The three types of mammography systems are: 1) analog systems, 2) computed tomography (CR) systems and 3) full-field digital mammography (FFDM). The analog systems are the conventional types, and they use X-ray films for capturing the breast images. The CR systems are also film-based, but are retrofitted with digital detectors. In FFDM, the X-ray film is replaced by solid-state detectors that convert X-rays into electrical signals. Digital tomosynthesis is a new technology with improved diagnostic capabilities over standard digital mammography. Moreover, scintimammography (nuclear medicine breast imaging) is an additional breast exam available. This TriMark Publications report thoroughly reviews: 1) existing and emerging mammography technologies, 2) known risk factors for breast cancer, 3) breast cancer treatments and drugs, 4) types of mastectomy procedures, 5) breast reconstruction surgery, and 6) funding for breast cancer research. The study examines almost all of the companies known to be marketing, manufacturing or developing mammography equipment and breast cancer therapies in the world. Each company is discussed in extensive depth with a section on its history, product lines, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included.
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1. Overview 15
1.1 Statement of Report 15
1.2 Scope of this Report 16
1.3 Methodology 16
1.4 Executive Summary 17

2. Technology Trends in Mammography 19
2.1 Rationale for Digital Mammography 19
2.1.1 The Technology 20
2.1.1.2 Mammography Reading 21
2.2 Research Studies 22
2.3 Contrast Injection Mammography 22
2.4 Digital Breast Tomosynthesis (DBT) 22
2.5 Dedicated CT of the Breast 23

3. Mammography Overview 24
3.1 Early Mammography 24
3.2 The First Digital Mammography System 24
3.3 Mammography Technique and Types 24
3.3.1 Screening Mammogram 25
3.3.1.1 Cost of Screening Mammogram in the U.S. 26
3.3.1.2 Interpretation of Mammogram 26
3.4 Signs and Symptoms of Breast Cancer 27
3.4.1 Need for MRI 27
3.5 Most Common Breast Conditions Seen in Screening Mammography 28
3.5.1 Fibroadenoma 28
3.5.2 Galactocele 29
3.5.4 Adenosis 30
3.5.5 Phyllodes Tumor 30
3.5.6 Infiltrating Duct Carcinoma 30
3.5.7 Duct Carcinoma in situ 31
3.6 Diagnostic Mammography 31
3.6.1 Views with Diagnostic Mammography 31
3.6.2 Anomalies Detected by Diagnostic Mammography 32
3.7 Other exams to Evaluate Breast Anomaly 33
3.7.1 Computer-Aided Detection in Breast Imaging 33
3.7.2 Ductal Lavage 34
3.7.3 Scintimammography 34
3.7.4 Positron Emission Tomography (PET) in Breast Imaging 35
3.8 Staging and Survival Rates of Breast Cancer 35
3.8.1 Numerical Stages of Breast Cancer 36
3.9 Breast Cancer Stages and Survival Rate 37
3.9.1 Histologic Grading of Breast Cancer 37
3.10 Hormone Receptor Status in Breast Cancer 38
3.11 Metastatic Breast Cancer (MBC) 39
3.12 Breast Cancer Treatments 42
3.12.1 Breast Cancer Surgery 42
3.12.1.1 Breast Conserving Surgery 42
3.12.1.2 Total Mastectomy 43
3.12.1.3 Modified Radical Mastectomy 43
3.12.2 Radiation Therapy 44
3.12.2.1 External Radiation Therapy 44
3.12.2.2 Internal Radiation Therapy 44
3.12.3 Hormone Therapy 44
3.12.4 Targeted Therapy 45
3.12.5 Chemotherapy 45
3.12.5.1 Classes of Breast Cancer Drugs 45
3.12.5.1.1 Selective Estrogen-Receptor Modulators (SERMs) 46
3.12.5.1.2 Aromatase Inhibitors 46
3.12.5.1.3 Biologic Response Modifiers 46
3.12.6 Profiles of Breast Cancer Drugs 46
3.12.6.1 Abraxane (paclitaxel protein-bound particles for injectable suspension) 47
3.12.6.2 Adriamycin (doxorubicin) 47
3.12.6.3 Aredia (pamidronate disodium) 47
3.12.6.4 Arimidex (anastrozole) 48
3.12.6.5 Aromasin (exemestane) 48
3.12.6.6 Chemotherapy Regimens 48
3.12.6.7 Cytoxan (cyclophosphamide) 49
3.12.6.8 Ellence (epirubicin) 49
3.12.6.9 Evista (raloxifene) 49
3.12.6.10 Fareston (toremifene) 49
3.12.6.11 Femara (letrozole) 50
3.12.6.12 Herceptin (trastuzumab) 50
3.12.6.13 Megace (megestrol) 50
3.12.6.14 Tamoxifen 51
3.12.6.15 Taxol (paclitaxel) 51
3.12.6.16 Taxotere (docetaxel) 51
3.12.6.17 Xeloda (capecitabine) 51
3.12.6.18 Zoladex (goserelin acetate) 52
3.12.6.19 Zometa (zoledronic acid) 52
3.13 Breast Reconstruction after Breast Cancer Surgery and Radiation Therapy 52
3.13.1 Delayed Reconstruction and Radiation 53
3.13.2 Reconstructing the Irradiated Lumpectomy Breast Deformity 53
3.13.3 Genetic Testing and Prophylactic Mastectomy 53
3.14 Types of Mastectomy 54
3.14.1 Skin-Sparing Mastectomy 54
3.14.2 Nipple-Sparing Mastectomy 54
3.14.3 Areola-Sparing Mastectomy 54
3.14.4 Skin-Reducing Mastectomy 55
3.14.5 Expander Implant Post Mastectomy Reconstruction 55
3.14.6 Direct Implant ("One-Step") Breast Reconstruction 55
3.14.7 Latissimus Dorsi Flap 55
3.14.8 TRAM Flap Reconstruction 56
3.14.9 TUG Flap - Inner Thigh Flap Breast Reconstruction 56
3.14.10 GAP Flap, Other Free Flaps 56
3.14.11 Implants Used in Breast Reconstruction 57
3.14.11.1 Types of Breast Implants 57
3.15 Known Risk Factors for Breast Cancer 57
3.15.1 Increasing Age 58
3.15.2 Family History of Breast Cancer and Genetic Predisposition 59
3.15.3 Hormonal Factors 59
3.15.4 Clinical Factors 59
3.15.5 Radiation 60
3.16 Prevention of Breast Cancer 60
3.16.1 Obesity 60
3.16.2 Alcohol Consumption 60
3.16.3 Tobacco 61
3.16.4 Menopausal Hormones 61

4. Breast Cancer and Mammography Data 62
4.1 Global Breast Cancer Incidence and Mortality 62
4.2 Characteristics of Breast Cancer Cases 69
4.3 U.S. Data on Breast Cancer and Mammography 72
4.3.1 New Breast Cancer Incidence in the U.S. 72
4.3.2.1 Breast Cancer and Mammography in White Women 72
4.3.2.2 Breast Cancer and Mammography in Hispanic Women 73
4.3.2.3 Breast Cancer and Mammography in African-Americans 74
4.3.2.4 Breast Cancer and Mammography in Asian Pacific Islanders 75
4.3.2.5 Breast Cancer and Mammography in Native Americans 76
4.3.2.6 Breast Cancer and Mammography in Ashkenazi Jews 77
4.3.3 Educational Level and Breast Cancer Incidence in the U.S. 78
4.3.4 Mammography Percentages by Age in the U.S. 79
4.3.5 Financial Impact of Breast Reconstruction 80
4.3.5.1 Payment and Reimbursement Guidelines in 2008 for Intraoperative Electron Radiation Therapy (IOERT) 82
4.3.5.2 Medicare Inpatient Hospital Payment 83
4.3.5.3 Rise in Payments for Breast Cancer in the U.S. 84
4.3.6 Research Funding for Cancer Research in the U.S. 84
4.3.6.1 NIH Funding Mechanisms 85
4.3.6.2 Percent Share of Total NCI Dollars 86
4.3.6.3 Actual Obligations by Mechanism 86
4.3.7 Funding Trends 87
4.3.7.1 Research Project Grants 88
4.3.7.2 Research Career Awards - "K" Program 90
4.3.7.3 NCI Funding by Cancer Type 90
4.3.7.4 Funding for Breast Cancer Research 91
4.3.7.5 Research Areas in Breast Cancer 92
4.3.7.6 NCI-Designated Cancer Centers 92
4.3.7.7 NCI's Funding by State 94
4.3.7.8 2011 Professional Judgment Budget Request 96
4.4 Breast Cancer Screening in E.U. 96
4.4.1 Number of People Affected by Screening in E.U. 97
4.4.2 Program Implementation Status in E.U. 98
4.4.3 Variation between Member States in E.U. 99
4.4.4 Breast Cancer Incidence and Mortality in the U.K. 99
4.4.4.1 Socio-Economic Variations 101
4.4.4.2 Breast Cancer Trends in U.K. 101
4.4.4.3 Breast Cancer Incidence in U.K. 102
4.4.4.4 Mastectomy and Breast Reconstruction Surgery in U.K. 103
4.4.4.5 Outcomes of Mastectomy and Reconstruction 104
4.4.4.6 Patient Characteristics and Patterns of Care 104
4.4.4.7 Types of Primary Breast Reconstruction in U.K. 105
4.4.4.8 Types of Contralateral and Secondary Reconstructive Procedures 106
4.4.4.9 National-Level Inpatient Complication Rates 107
4.4.4.10 Breast Cancer Research in U.K. 108
4.4.4.11 Breast Screening Programs in England as of 2009 109
4.4.5 Breast Cancer Screening in Australia 109
4.4.5.1 Breast Cancer Projections in Australia 110
4.4.5.2 Trends in Medicare Benefits Schedule (MBS) Funded Mammography 110
4.4.5.3 Analysis of MBS Funded Mammography by Age 110
4.4.5.4 MBS Funded Diagnostic Services for Breast Cancer 114

5. Market Analysis 118
5.1 Points to be considered Before Buying a Mammography System 118
5.1.1 Cost Containment in Mammography Systems 119
5.2 Global Market for Mammography 121
5.2 Global Market for Film-Based Mammography Systems 122
5.3 Global Market for Digital Mammography 123
5.4 Global Breast Cancer Drugs Market 123
5.5 Global Cancer Biomarkers Market 124
5.6 Leading Players in Global Cancer Pharmaceuticals 127
5.7 Global Spending on Cancer Drugs 129
5.8 Mammogram Procedure Growth in the U.S. 130
5.8.1 Approved Mammography Facilities in the U.S. 130
5.8.2 Mammography Quality Standards Act (MQSA) National Statistics 132
5.8.3 Decline in the Number of Mammography Facilities in the U.S. 132
5.8.4 Number of Mammography Units in the U.S. 133
5.8.5 U.S. Mammography Equipment Market 133
5.8.6 Digital Mammography: Market Penetration in the U.S. 134
5.9 Business Plan for Digital Mammography 136
5.10 Breast Cancer and Genetic Testing in the U.S. 137
5.11 U.S. Market for Brachytherapy Products 138
5.12 U.S. Market for Breast Irradiation 139
5.13 Reimbursement for Mammography Procedures 140
5.14 Global Market for Breast Cancer Drugs 143
5.14.1 Avastin 143
5.14.2 Herceptin 144
5.14.3 Xeloda 145
5.15 Global Market for Cancer Therapies 146
5.16 Global Market for Biological Therapies in Cancer 147
5.16.2 U.S. Market for Biological Therapies in Cancer 148
5.16.3 European Market for Biological Cancer Therapies 149
5.16.4 Market for Biological Cancer Therapies in Japan 149
5.16.6 Market for Biological Cancer Therapies in Rest of the World 150
5.17 Market for Other Imaging Modalities 151
5.17.1 Popular Medical Imaging Systems 151
5.18 Global Market for Medical Imaging 152
5.18.1 Global Medical Imaging Market by Modality 153
5.18.2 Global Market for General X-rays 154
5.18.3 Global Market for Ultrasound (US) 155
5.18.4 Global Market for Portable Ultrasound 156
5.18.5 Global Market for Magnetic Resonance Imaging 157
5.18.6 Global Market for Computed Tomography 158
5.18.7 Global Market for Nuclear Medicine 160
5.18.8 Global Market for SPECT/PET 161
5.18.9 Global Market for PET/CT 162
5.18.10 Global Medical Displays and Post-Processing Software Market 162
5.19 North American Market for Medical Imaging 163
5.19.1 North American Market for Magnetic Resonance Imaging (MRI) 165
5.19.2 U.S. Market for Computed Tomography 166
5.19.3 U.S. Market for Multi-Slice CT Scanners 167
5.19.4 U.S. Market for SPECT and PET Radiopharmaceuticals 168
5.19.5 U.S. Market for SPECT 169
5.19.6 U.S. Market for Positron Emission Tomography (PET) 169
5.19.7 Medical Imaging in Canada 170
5.20 Medical Imaging Market in Europe 171
5.20.1 Medical Imaging Market in Central Europe 172
5.20.2 European Market for Digital Radiography (DR) 173
5.20.3 European Market for Computed Radiography 174
5.20.4 European Market for MRI 174
5.20.5 European Market for Digital Radiography (DR) 175
5.20.6 European Market for Computed Radiography (CR) 176
5.21 Emerging Markets in Medical Imaging 177
5.21.1 Medical Imaging in China and India 178
5.21.2 Medical Imaging Market in China 179
5.21.3 Market for Ultrasound in China 180
5.21.4 Medical Imaging Market in India 181

6. Company Profiles 182
6.1 Abviva, Inc. 182
6.1.1 Mammastatin Serum Assay (MSA) 182
6.2 Agendia B.V. 182
6.2.1 MammaPrint 182
6.2.2 BluePrint 182
6.2.3 TargetPrint 183
6.3 Agfa Healthcare 183
6.4 Amgen, Inc. 184
6.4.1 Amgen's Cancer Drugs 184
6.4.1.1 Aranesp (darbepoetin alfa) 184
6.4.1.2 Xgeva (denosumab) 184
6.4.1.3 Vectibix (panitumumab) 184
6.4.1.4 Neulasta (pegfilgrastim) 185
6.5 Analogic Corporation 185
6.5.1 Analogic's CT Systems and Subsystems 186
6.5.2 Analogic's MRI Power Solutions 186
6.5.3 Analogic's Specialized Ultrasound Solutions 186
6.5.4 Analogic's Digital Radiography Subsystems 186
6.5.5 Analogic's Radiation Therapy Solutions 186
6.6 Ardent Sound, Inc 186
6.7 AstraZeneca 187
6.7.1 Arimidex 187
6.7.2 Faslodex 187
6.7.3 Casodex 188
6.7.4 Zoladex 188
6.7.5 Iressa 188
6.8 Aurora Imaging Technology, Inc. 189
6.8.1 Aurora 1.5T Dedicated Breast MRI System 189
6.9 C.R. Bard, Inc. 189
6.10 Biosound Esaote, Inc 190
6.11 Bristol-Myers Squibb 191
6.11.1 Ixempra (ixabepilone) 191
6.11.2 Erbitux (cetuximab) 192
6.11.3 Sprycel (dasatinib) 192
6.12 Canon U.S.A., Inc 192
6.13 Chison Medical Imaging, Co., Ltd 192
6.14 Clarient, Inc. 193
6.15 Dako 194
6.15.1 Dako's Products 194
6.16 deCODE Genetics 195
6.16.1 deCODE BreastCancer 195
6.17 Dilon Technologies, Inc. 195
6.17.1 Dilon 6800 Gamma Camera 195
6.17.2 The GammaLoc System 195
6.17.3 PenRad Mammography Information System 196
6.18 Dexela 196
6.18.1 Dexela Digital Mammography Workstation 196
6.19 Eli Lilly 197
6.19.1 Eli Lilly's Oncology Products 197
6.20 Encapsule Medical Devices, LLC. 198
6.21 Fonar Corporation 198
6.21.1 Fonar's Upright MRI 198
6.21.2 Fonar 3600 199
6.22 Fujifilm Medical Systems USA, Inc. 199
6.23 Fukuda Denshi Co., Ltd. 200
6.24 GE Healthcare 200
6.25 Genentech, Inc. 205
6.25.1 Genentech's Oncology Products 206
6.25.1.1 Avastin (bevacizumab) 206
6.25.1.2 Herceptin (Trastuzumab) 206
6.25.1.3 Rituxan 206
6.25.1.4 Tarceva (erlotinib) 206
6.25.1.5 Xeloda (capecitabine) 207
6.26 Hitachi Medical Corporation 207
6.27 Hologic, Inc. 208
6.27.1 Hologic's Breast Health Products 208
6.27.1.1 Selenia Full Field Digital Mammography System 208
6.27.1.2 Breast Tomosynthesis 209
6.27.1.3 Screen-Film Mammography Systems 209
6.27.1.4 SecurView Workstation 210
6.27.1.5 CAD Systems 210
6.27.1.6 Stereotactic Breast Biopsy Systems 210
6.27.1.7 Breast Biopsy Products 211
6.27.1.8 Breast Brachytherapy Products 211
6.27.1.9 MammoPad Breast Cushion 211
6.27.1.10 Photoconductor Coatings 211
6.27.1.11 Sentinelle Medical MRI Breast Coils and Workstation 211
6.28 Imaging Diagnostic Systems, Inc. 212
6.28.1 Computed Tomography Laser Mammography (CTLM) 212
6.29 Konica Minolta Medical Imaging USA, Inc. 212
6.29.1 Xpress CR 212
6.29.2 REGIUS PureView System 213
6.30 MacKay LifeSciences 213
6.30.1 Breast Cancer Diagnostic System (BDS) 213
6.31 Lantheus Medical Imaging, Inc. 214
6.32 Medis Medical Imaging Systems BV 214
6.33 Medical Tactile, Inc 215
6.33.1 SureTouch System 215
6.34 Medison America, Inc. 215
6.35 Medtronic Navigation and Imaging 216
6.35.1 PoleStar Surgical MRI system 216
6.35.2 StealthStation i7 216
6.35.3 O-arm Surgical Imaging System 217
6.35.4 StealthViz Advanced Visualization and Planning 217
6.36 MeVis Medical Solutions AG 217
6.36.1 MeVis Software for Digital Mammography 218
6.36.2 Syngo MammoReport 218
6.36.3 SecurView DX 218
6.36.4 DynaCAD 219
6.37 Naviscan PET Systems, Inc. 219
6.37.1 Naviscan PEM Scanner 219
6.38 NeoMatrix LLC 220
6.38.1 HALO Breast Pap Test 220
6.39 Novartis AG 220
6.39.1 Femara 220
6.39.1.1 The Action of Femara 220
6.40 Philips Healthcare 222
6.40.1 Philips PCR Eleva CosimaX system 222
6.40.2 Integral Breast Workspace solution from Philips Healthcare 224
6.40.3 Breast Ultrasound from Philips Healthcare 225
6.40.4 MammoDiagnost 225
6.40.5 MammoDiagnost DR 226
6.40.6 MammoDiagnost with PCR Eleva 226
6.41 Pfizer, Inc. 227
6.41.1 Pfizer's Pipeline of Therapeutics 227
6.42 Roche Holdings, Ltd. 228
6.42.1 Roche's Cancer Pharmaceuticals 228
6.42.2 Avastin 229
6.42.3 MabThera/Rituxan 229
6.42.4 Herceptin (trastuzumab) 229
6.42.5 Xeloda (capecitabine) 229
6.42.6 Tarceva (erlotinib) 229
6.42.7 Regulatory Approvals for Roche's Cancer Drugs 230
6.43 Sanarus Technologies, LLC 230
6.43.1 Sanarus Visica cryoablation treatment system 230
6.44 Sanofi-Aventis 230
6.44.1 Taxotere 231
6.44.2 Eloxatine (oxaliplatin) 231
6.44.3 Sanofi's Oncology Pipeline 231
6.45 Sectra Medical Systems 233
6.45.1 Sectra MicroDose Mammography 233
6.45.2 Sectra Breast Imaging RIS/PACS 233
6.46 Planmed 233
6.47 Scanis, Inc. 235
6.47.1 Mammex MammoCAD System 235
6.48 Siemens Healthcare 235
6.48.1 Digital Mammography from Siemens 235
6.48.2 3D Breast Tomosynthesis 236
6.48.3 Mammomat Novation 236
6.49 SenoRx, Inc. 237
6.49.1 EnCor Breast Biopsy System 237
6.49.2 SenoRx Family of Markers 237
6.49.3 Contura Multi-Lumen Balloon (MLB) 237
6.49.4 Gamma Finder 237
6.50 Shimadzu Medical Systems 238
6.51 SonoCine, Inc. 239
6.51.1 SonoCine 239
6.52 TechniScan Medical Systems 239
6.52.1 Svara Warm Bath Ultrasound (WBU) 240
6.53 Toshiba America Medical Systems, Inc. 240
6.53.1 Infinix-i systems 240
6.53.2 Aquilion ONE CT System 241
6.53.3 Vantage Titan 241
6.53.4 Viamo 241
6.53.5 Radrex-i 242
6.54 U-Systems, Inc. 242
6.54.1 SomoV Automated 3D Breast Ultrasound System 242
6.55 Varian Medical Systems 242
6.55.1 Varian's Oncology Business 243
6.55.2 Varian's X-Ray Business 243
6.56 VuCOMP, Inc. 244
6.56.1 M-Vu CAD system 244
6.56.2 M-Vu Digital CAD system 244
6.56.3 M-Vu Viewer Station 245
6.56.4 M-Vu Digitize + Archive 245


APPENDIX

Appendix 1: Breast Cancer Nutrition 245
Appendix 1.1: Vegetables and Fruits 245
Appendix 1.2: Grains 245
Appendix 1.3: Meat and Fish 245
Appendix 1.4: Alcohol and Beverages 245
Appendix 2: Breast Cancer Statistics 246
Appendix 3: Integration of Digital Mammography on PACS 247
Appendix 3.1: Considerations in Deploying Digital Mammography 247
Appendix 4: CAD for Digital Mammography Using Syngo MammoCAD 250
Appendix 5: BRIDGE Metastatic Breast Survey 252
Appendix 5.1: BRIDGE Metastatic Breast Cancer (MBC) Survey 252
Appendix 5.2: Psychological Impact of Breast Cancer 253
Appendix 5.3: Preast Cancer Patients' Outlook on Life 254
Appendix 5.4: Role of Information in Helping Women to Cope with MBC 255
Appendix 5.5: Clinical Trial Awareness and Experience in MBC 255
Appendix 5.6: Reasons for Not Participating in Clinical Trial 256
Appendix 5.7: The Role of Information and "Inforemation Seeking Women" 257
Appendix 6: Clinical Trials in Mammography as of December 2010 258
Appendix 7: Advances against Cancer in the Past 150 years 262
Appendix 8: Emerging Technologies in Breast Cancer Detection 275
Appendix 8.1: Digital Mammography 276
Appendix 8.2: Indirect-Conversion Digital Detectors 276
Appendix 8.3: Direct-Conversion Digital Detectors 277
Appendix 8.4: Contrast-Enhanced Mammography 277
Appendix 8.5: Breast Tomosynthesis 277
Appendix 8.6: Digital Mammography/Ultrasound Fusion 279
Appendix 8.7: Computer-Aided Detection 279
Appendix 8.8: Magnetic Resonance Imaging (MRI) 280
Appendix 8.9: Breast Ultrasound 280
Appendix 8.10: Breast Thermography 280
Appendix 8.11: Positron Emission Tomography (PET) 281
Appendix 8.12: Scintimammography 281
Appendix 8.13: Near Infrared Optical Imaging 281
Appendix 8.14: Bioelectric Imaging 281
Appendix 9: Medical Imaging Technologies 282
Appendix 9.1: Ultrasound Systems 282
Appendix 9.2: Computed Tomography (CT) 283
Appendix 9.3: Magnetic Resonance Imaging (MRI) 283
Appendix 9.4: Digital X-Ray 284
Appendix 9.5: Positron Emission Tomography (PET) 285
Appendix 10: The Supply of Medical Radioisotopes 287
Appendix 10.1: Potential for New Reactors 288
Appendix 10.2: Processing Capacities and Restraints 289
Appendix 11: Opportunities in the Middle East for Healthcare and Medical Imaging 291
Appendix 11.1: The largest U.S. Customers in the Middle East Region 291
Appendix 11.2: U.S. Exports of Medical Imaging Products to the Middle East, 2009 292
Appendix 12: Value of Radiation Therapy and Medical Imaging 294
Appendix 12.1: Effective Use of Medical Radiation 295
Appendix 12.2: Innovations to Reduce Radiation Dose 295
Appendix 12.3: Innovation in CT Imaging 295
Appendix 12.4: Effectiveness of Radiation Therapy 296
Appendix 12.5: Efforts to Minimize Radiation Dose 297
Appendix 12.6: New Dose-Check Features 297
Appendix 13: Health and Medical Imaging Expenditures in OECD Countries 298
Appendix 13.1: Medical Imaging Equipment and Utilization Statistics 299
Appendix 13.2: CT Scanners per Million 300
Appendix 13.3: Gamma Cameras per Million of Population in OECD Countries 301
Appendix 13.4: Mammography Units per Million of Population in OECD Countries 302
Appendix 13.5: MRI Scanners per Million Population in OECD Countries 303
Appendix 13.6: PET Scanners per Million of Population in OECD Countries 304
Appendix 13.7: Utilization of Medical Imaging Modalities in OECD Countries 304
Appendix 13.8: CT Exams per 1,000 of Population in OECD Countries 306
Appendix 13.9: MRI Exams per Scanner in OECD Countries 307
Appendix 13.10: MRI Exams per 1,000 of Population in OECD Countries 308
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Figure 1.1: Growth of Digital Mammography in the U.S., 2003-2008 19
Figure 1.2: Digital Mammography System that Uses a Direct Conversion Flat-Panel Detector 20
Figure 1.3: Digital Mammography Plate Reading Station 21
Figure 1.4: A Digital Mammography Workstation 21
Figure 1.5: Tomosynthesis Scanner from GE 23
Figure 1.6: Standard 2D and Tomosynthesis Slice Breast Images 23
Figure 3.1: Attention Given to MBC Compared with EBC in Different Countries, 2008 40
Figure 3.2: Patients' Emotions When Given a Diagnosis of Metastatic Breast Cancer (MBC) 40
Figure 3.3: Patients' Concerns when Given a Diagnosis of Metastatic Breast cancer (MBC) 41
Figure 4.1: Percent Incidence of Sporadic and Familial Breast Cancer 67
Figure 4.2: Global Breast Cancer Incidence and Mortality in Select Regions as of 2008 69
Figure 4.3: Number of Women Diagnosed with Breast Cancer by Age and Type of Disease, 1996-2008 69
Figure 4.4: Number of Women Diagnosed with Breast Cancer by Year and Type of Disease, 1996-2008 70
Figure 4.5: Distribution of Number of Screening Mammograms per Woman for 1996-2008 71
Figure 4.6: Distribution of U.S. Women in 2008 by Race/Ethnicity 71
Figure 4.7: New Breast Cancer Incidence in North America, 2009-2017 72
Figure 4.8: Percent of White Women in the U.S. Opted for Mammogram, 2000-2008 73
Figure 4.9: Percent Hispanic or Latina Women in the U.S. Opted for mammogram, 2000-2008 74
Figure 4.10: Percent of African-American Women in the U.S. Opted for Mammograms, 2000-2008 75
Figure 4.11: Percent of Asian Women in the U.S. Opted for Mammograms, 2000-2008 76
Figure 4.12: Percent of Native American Women Opted for Mammograms, 2000-2008 77
Figure 4.13: Percentage of U.S. Women Aged 40 Years and Older Who Have Had a Mammogram by Race and Ethnicity, 2000-2008 78
Figure 4.14: Percentage of U.S. Women Aged 40 Years and Older Who Have Had a Mammogram by Education Level, 2000-2008 79
Figure 4.15: Percentage of U.S. Women Aged 40 Years and Older Who Have Had a Mammogram by Age, 2000-2008 79
Figure 4.16: Physician Reimbursement for Unilateral Breast Reconstruction by Operating Room Time Utilization 80
Figure 4.17: Blue Cross/Blue Shield Physician Reimbursement for Unilateral Breast Reconstruction 81
Figure 4.18: Total Cost per Episode in the U.S., 2003-2007 84
Figure 4.19: National Cancer Institute 2009 Actual Obligations by Mechanism ($4.967 Millions) 86
Figure 4.20: National Cancer Institute % Share of Total RPG Funds, 2009 89
Figure 4.21: Research Dollars Allocated by NCI for Breast Cancer, 2005-2009 91
Figure 4.22: NCI Breast Cancer Research Portfolio: Percentage of Total Dollars by Scientific Area, 2008 92
Figure 4.23: Type and Status of Breast Cancer Screening Programs in E.U. Member States in 2007 97
Figure 4.24: Type and Status of Breast Cancer Screening Programs in Women aged 50 to 69 in the E.U. Member States in 2007 99
Figure 4.25: Incidence and Mortality Rates in Six of the E.U. 27 Countries, 2008 100
Figure 4.26: Breast Cancer Incidence and Mortality Rates in U.K., 1975-2007 101
Figure 4.27: Age Specific Breast Cancer Incidence Rates in the U.K., 1975-2007 102
Figure 4.28: Age-Specific Incidence Rate of Breast Cancer in U.K., 2007 103
Figure 4.29: Percentage coverage for women aged 53-70, 53-64 and 65-70, England 2006-2009 109
Figure 4.30: Incidence of Breast Cancer in Australia: Projections from 2007 to 2015 110
Figure 4.31: Annual Numbers of Mammograms, Both Breasts and One Breast, Women 50-69 years, 1987-2007 112
Figure 4.32: Age-Specific Rate of Mammograms, Both Breasts, by Age Group, 2006 and 2007 113
Figure 4.33: Age-Specific Rate of Mammograms, Both Breasts by Age Group, 2007 114
Figure 4.34: Age-Specific Rate of mammograms, one breast (MBS item 59303) by age group, 2007 114
Figure 5.1: Global Market for Mammography, 2010-2016 122
Figure 5.2: Global Market for Film-Based Mammography Systems, 2010-2016 122
Figure 5.3: Global Market for Digital Mammography Equipment, 2010-2016 123
Figure 5.4: Global Market for Breast Cancer Drugs, 2010-2016 124
Figure 5.5: Global Market for Biomarkers, 2010-2016 124
Figure 5.6: Biomarker Patent Filings by Type of Cancer, 2010 127
Figure 5.7: Top Ten Companies in Global Cancer Therapeutics Market, 2009 127
Figure 5.8: Projected Sales of Avastin, 2008-2015 128
Figure 5.9: Top Ten Therapies in Global Cancer Therapeutics Market, 2008 128
Figure 5.10: Oncology Drug Spending in Major European Countries, 2009 129
Figure 5.11: U.S. Mammogram Procedure Growth, 2010-2016 130
Figure 5.12: Number of Certified Mammography Facilities, 2000-2010 132
Figure 5.13: Number of Mammography Units in the U.S., 2000-2010 133
Figure 5.14: U.S. Mammography Equipment market, 2009-2016 134
Figure 5.15: U.S. Market for Breast Cancer Genetic Testing, 2010-2016 137
Figure 5.16: U.S. Market for Brachytherapy Products, 2010-2016 139
Figure 5.17: U.S. Market for Partial Breast Irradiation, 2008-2016 139
Figure 5.18: Avastin: HER2-negative metastatic Breast Cancer (mBC) 2010 Population 143
Figure 5.19: Herceptin: HER2+ Early Breast Cancer (eBC) 2010 Population 144
Figure 5.20: Herceptin: HER2+ Metastatic Breast Cancer (mBC) 2010 Population 145
Figure 5.21: Xeloda: Adjuvant Breast Cancer (eBC) 2010 Population 145
Figure 5.22: Xeloda: Metastatic Breast Cancer (mBC) 2010 Population 146
Figure 5.23: Global Cancer Market by Therapy Area, 2009 147
Figure 5.24: Global Market for Biological Therapies in Cancer, 2009-2014 147
Figure 5.25: U.S. Market for Biological Cancer Therapies, 2009-2014 148
Figure 5.26: Europe/ROW market for Biological Cancer Therapies, 2009-2014 149
Figure 5.27: Japanese Market for Biological Cancer Therapies, 2009-2014 150
Figure 5.28: Market for Biological Cancer Therapies in Rest of the World, 2009-2014 150
Figure 5.29: Global Medical Imaging Market (%) by Region, 2009 152
Figure 5.30: Global Medical Imaging Market (%) by Modality, 2009 153
Figure 5.31: Global Market for General X-rays, 2010-2016 154
Figure 5.32: Global Market for Ultrasound, 2010-2016 155
Figure 5.33: Global Market for Portable Ultrasound Equipment, 2009-2014 156
Figure 5.34: Global Percent MRI Market by Geography, 2010 157
Figure 5.35: Global Market for MRI, 2010-2016 158
Figure 5.36: Global Market for CT, 2004-2009 159
Figure 5.37: Global Market for Computed Tomography, 2010-2016 159
Figure 5.38: Global Market for Nuclear Medicine, 2010-2016 160
Figure 5.39: Global Market for SPECT/PET, 2010-2015 161
Figure 5.40: Global Market for PET/CT, 2010-2015 162
Figure 5.41: Global Market for Medical Displays and Post-Processing Software, 2009-2014 163
Figure 5.42: North American Market for Medical Imaging Equipment, 2010-2016 164
Figure 5.43: North American Market for MRI, 2010-2015 165
Figure 5.44: U.S. Market for Computed Tomography, 2010-2016 166
Figure 5.45: Market for Multi-Slice CT Scanners in the U.S., 2010-2016 167
Figure 5.46: U.S. Market for Radiopharmaceuticals, 2009-2017 168
Figure 5.47: U.S. Market for SPECT, 2009-2017 169
Figure 5.48: U.S. Market for PET, 2009-2017 170
Figure 5.49: Market for Medical Imaging Modalities in Canada, 2009-2014 171
Figure 5.50: Percent Distribution of Diagnostic Imaging Examinations in Canadian Hospitals 171
Figure 5.51: Western European Market for Medical Imaging, 2009-2016 172
Figure 5.52: Imaging Diagnostics Market in Central Europe, 2009-2012 173
Figure 5.53: European Market for Digital Radiography, 2009-2016 173
Figure 5.54: European Market for Computed Radiography, 2009-2016 174
Figure 5.55: European Market for MRI, 2010-2015 175
Figure 5.56: European Market for Digital Radiography (DR), 2009-2016 176
Figure 5.57: European Market for Computed Radiography, 2009-2016 177
Figure 5.58: Medical Imaging in Emerging Markets, 2010-2016 177
Figure 5.59: Market for Medical Imaging Equipment in Greater China, 2010-2016 180
Figure 5.60: Market for Ultrasound Equipment in China, 2009-2014 180
Figure 5.61: Medical Imaging Market in India, 2010-2016 181
Figure 6.1: Performance of Eli Lilly's Cancer Drugs by Geography, 2009 197
Figure 6.2: Eleva User Interface 223
Figure 6.3: Roche's Performance in Pharmaceuticals in the first Six Months of 2010 228
Figure 6.4: Volume Growth in Net Orders for Varian's Oncology Systems, 2007-2009 243
Figure 6.5: Volume Growth in Net Orders for Varian's X-Ray Products, 2007-2009 244
Figure App. 3.1: Workflow using Philips' iSite Radiology for mammography SCR 249
Figure App. 3.2: Workflow using third party workstation for mammography SCR 250
Figure App. 4.1: Digital Workflow with CAD 252
Figure App. 5.1: Public Attention Given to MBC 254
Figure App. 5.2: Women Afraid to Talk Openly About their Experiences with MBC 255
Figure App. 5.3: MBC Patient's Outlook on life 255
Figure App. 5.4: Women with MBC Who Have Participated in a Clinical Trial 257
Figure App. 5.5: Reasons for Not Participating in a Clinical Trial 257
Figure App. 5.6: Respondents who have looked for Information on Clinical Trials 258
Figure App. 9.1: Block Diagram of Imaging Ultrasound Equipment 283
Figure App. 9.2: Block Diagram of Medical CT System 284
Figure App. 9.3: Block Diagram of Medical MRI 285
Figure App. 9.4: Block Diagram of Digital X-Ray 286
Figure App. 9.5: Block Diagram of PET 287
Figure App. 10.1: Current Supply and Demand for Medical Radioisotopes, 2010-2024 289
Figure App. 10.2: Percent Market Share of Medical Radioisotopes by Reactor, 2010 290
Figure App. 11.1: U.S. Exports of Medical Products to the Middle East, 1996-2009 292
Figure App. 11.2: U.S. Exports of Medical Products to Israel, Saudi Arabia and Turkey, 2009 293
Figure App. 11.3: U.S. Exports of Medical Imaging Products to Israel, Saudi Arabia and Turkey, 1996-2009 294
Figure App. 13.1: Public and Private Expenditure on Health % of GDP in Select OECD Countries 299
Figure App. 13.2: Angiography Units per Million of Population in OECD Countries 300
Figure App. 13.3: CT Scanners per Million of Population in OECD Countries 301
Figure App. 13.4: Gamma Cameras per Million of Population in OECD Countries 302
Figure App. 13.5: Mammography Units per Million of Population in OECD Countries 303
Figure App. 13.6: MRI Scanners per Million of Population in OECD Countries 304
Figure App. 13.7: PET Scanners per Million of Population in OECD Countries 305
Figure App. 13.8: CT Exams per Scanner in OECD Countries 306
Figure App. 13.9: CT Exams per 1,000 of Population in OECD Countries 307
Figure App. 13.10: MRI Exams per Scanner in OECD Countries 308
Figure App. 13.11: MRI Exams per 1,000 of Population in OECD Countries 309

Table 3.1: Percent of American Women Who Had Mammograms in the Past Two years 26
Table 3.2: Size of Tumors Found by Mammography and Breast Self-Examination 26
Table 3.3: BI-RADS Assessment Categories 27
Table 3.4: Screening Guidelines for the Early Detection of Breast Cancer in Average-risk, Asymptomatic Women Aged 20 Years and Older 28
Table 3.5: Pros and Cons of Ultrasound and MRI in Breast Imaging 33
Table 3.6: Staging of Breast Cancer 36
Table 3.7: Breast Cancer Survival Rate by Stage 37
Table 3.8: Histologic Grade System for Breast Cancer 38
Table 3.9: Breast Cancer Grades and Description 38
Table 3.10: Activities and Materials Women with MBC value 42
Table 3.11: Classes of Tests Used to Treat Breast Cancer 45
Table 3.12: Silicone vs. Silicone Implants 57
Table 3.13: Factors That Increase the Relative Risk for Breast Cancer in Women 58
Table 3.14: Age-specific Probabilities of Developing Invasive Female Breast Cancer 59
Table 4.1: Global Breast Cancer Incidence Rate as of 2008 62
Table 4.2: Female Breast Cancer Risk Factors 66
Table 4.3: Female Breast Cancer Risk Factors: Relative Risk Range 2.1-4.0 67
Table 4.4: Female Breast Cancer Risk Factors: Relative Risk Range >4.0 68
Table 4.5: Probability of U.S. Women for being diagnosed With Breast Cancer 68
Table 4.6: Reconstructive Breast Procedures in the U.S., 2009 81
Table 4.7: Physician Coding and Payment 82
Table 4.8: Medicare Inpatient Hospital Payment 83
Table 4.9: Hospital Outpatient Services 83
Table 4.10: NCI Dollars Spent by Mechanism, 2008-2009 85
Table 4.11: Percent Share of Total NCI Dollars, 2005-2009 86
Table 4.12: NCI and its Historical Funding Trends, 2005-2009 87
Table 4.13: Percent Growth by Mechanism, 2005-2009 87
Table 4.14: NCI Research Project Grants, 2008-2009 88
Table 4.15: National Cancer Institute Extramural vs. In-house Funding 89
Table 4.16: NCI's Research Career Awards, 2008-2009 90
Table 4.17: Research Dollars by Various Cancers, 2005-2009 91
Table 4.17: Cancer Centers by State (P30 Core Grants), 2009 93
Table 4.18: Grant and Contract Awards by State, 2009 94
Table 4.19: National Cancer Institute New Investments, 2011 96
Table 4.20: Breast Cancer Screening Programs in the E.U. Member States in 2007 98
Table 4.21: Number of New Cases and Rates of Breast Cancer in U.K., 2007 100
Table 4.22: Number of New Cases and Rates of Breast Cancer in U.K., 2007 102
Table 4.23: Women Opting for Three Types of Procedures in U.K. 104
Table 4.24: Tumor Characteristics and Prognostic Factors, by type of Tumor 105
Table 4.25: Types of Primary Breast Reconstruction in U.K. 106
Table 4.26: Symmetrization Surgery and its Timing 106
Table 4.27: Postoperative Complications 107
Table 4.28: Complication Rates by Type of Surgery 107
Table 4.29: Some Breast Cancer Research Programs in U.K. as of January 2011 108
Table 4.30: Rates of Mammograms, Both Breasts and One Breast of All Ages 1996 to 2007 111
Table 4.31: Annual Numbers for Both Breasts for ages 20-85+ years, 1987- 2007 111
Table 4.32: Annual Number of Ultrasound Diagnostic Services for Breast Cancer (20 to 85+), 1993-2007 115
Table 4.33: Annual Number of Fine-Needle Aspiration Services for Breast Cancer (20 to 85+), 1993-2007 116
Table 4.34: Annual Number of Core Biopsy Services for Breast Cancer (20 to 85+), 1993-2007 116
Table 4.35: Annual Number of Ductogram Services for Breast Cancer (20 to 85+), 1995-2007 117
Table 5.1: Top Mammography System Companies, 2011 119
Table 5.2: Biomarkers Used in Cancer Diagnosis 126
Table 5.3: MQSA Certified Facilities and Accredited Mammography Units in the U.S., 2000-2010 131
Table 5.4: Number of Hospitals in the U.S. 131
Table 5.5: MQSA National Statistics on Number of Mammography Facilities and Procedures, 2011 132
Table 5.6: Digital Mammography Market Penetration in the U.S. 135
Table 5.7: U.S. Digital Mammography Market Model 136
Table 5.8: Business Plan for Digital Mammography 137
Table 5.9: Reimbursement Rate for Mammography Procedures in the U.S. 140
Table 5.10: MRI Biopsy Reimbursement: Facility Billing, 2010 141
Table 5.11: MRI Biopsy Reimbursement: Physician Billing, 2010 141
Table 5.12: Ultrasound Biopsy Reimbursement: Facility Billing, 2010 141
Table 5.13: Ultrasound Biopsy Reimbursement: Physician Billing, 2010 142
Table 5.14: Breast-Specific Gamma Imaging Reimbursement: Hospital Outpatient Department (Medicare Billing), 2010 142
Table 5.16: Radiologist and/or Surgeon Global Billing, 2010 143
Table 5.17: Top Ten Imaging Systems Purchased, 2006-2009 151
Table 5.18: Medical Imaging Equipment Installations in China and India, 2000-2009 178
Table 5.19: Availability of Medical Imaging Equipment per Million Populations in China and India, 2009 178
Table 5.20: Affordability for Medical Imaging in Emerging Economies 179
Table 6.1: Agfa's Medical Imaging Products 183
Table 6.2: Amgen's Cancer Product Pipeline as of 2010 185
Table 6.3: Ardent's Product Portfolio 187
Table 6.4: AstraZeneca's Marketed Products in Oncology, 2009-2010 187
Table 6.5: AstraZeneca's Performance in Oncology, 2007-2009 188
Table 6.6: Bard's Breast Products 190
Table 6.7: Biosound Esaote's Ultrasound Systems 190
Table 6.8: Performance of Bristol's Oncology Products, 2007-2009 191
Table 6.9: Canon's Imaging Products 192
Table 6.10: Chison's Ultrasound Product Portfolio 193
Table 6.11: Selected Clarient's Cancer Tests 193
Table 6.12: Encapsule's Products 198
Table 6.13: Fujifilm's Product Portfolio 199
Table 6.14: Fukuda's Ultrasound Products 200
Table 6.15: GE Healthcare's Medical Imaging Equipment and Contrast Media 201
Table 6.16: Genentech's Oncology/Hematology Pipeline 205
Table 6.17: Hitachi's Medical Imaging Product Portfolio 207
Table 6.18: Lantheus' Contrast Agent Products 214
Table 6.19: Medis' Software for Various Medical Imaging Modalities 214
Table 6.20: Medison's Medical Imaging Products 215
Table 6.21: Features of PCR Eleva CosimaX image plate reader 223
Table 6.22: Eleva workspot 223
Table 6.23: Application and Pixel Matrix of Eleva 224
Table 6.24: Pfizer's Oncology Pipeline as of 2010 227
Table 6.25: Pfizer's Clinical Trial Programs in Breast Cancer as of 2010 227
Table 6.26: Roche's Cancer Drugs, 2010 229
Table 6.27: Roche's Regulatory Filings for Cancer Drugs in the First Half of 2010 230
Table 6.28: Sanofi's Performance in Cancer Drugs 231
Table 6.29: Planmed's Mammography Systems 233
Table 6.30: Shimadzu's Product Portfolio 238
Table App. 4.1: Hardware Specifications 252
Table App. 5.1: Bridge Survey at a Glance 253
Table App. 5.2: Types of Information Women with MBC Find Important 256
Table App. 6.1: Clinical Trials in Mammography as of December 2010 259
Table App. 8.1: New and Near-Term Technologies for Breast Cancer Detection 276
Table App. 10.1: The Major Medical Radioisotope Producing Reactors, 2010 288
Table App. 10.1: Potential Reactor-Based Projects for 99MO Production, 2010-2024 289
Table App. 10.2: Processing Capacity of Major Reactors, 2010 290
Table App. 10.3: Demand Scenarios for 99Mo, 2010-2025 291
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