Mammography World Markets

1 Overview 6
1.1 Statement of Report 6
1.2 Scope of this Report 6
1.3 Methodology 7
1.4 Executive Summary 8

2 Overview of the Medical Imaging Market 9
2.1 Medical Imaging Industry Market Size 9
2.1.1 Global Medical Imaging Market 9
2.1.2 U.S. Medical Imaging Market 10
2.2 Medical Imaging Infrastructure 11
2.2.1 Total Healthcare Expenditures and Demographics 11
2.2.2 Number of Hospitals 15
2.2.3 Number of Radiologists 16
2.2.4 Radiologic Services 17
2.2.5 Overview of Medical Imaging Market Segments 19
2.2.6 Market Drivers 19
2.2.6.1 Product Enhancements Drive Adoption of Imaging Procedures among End
Users 19
2.2.6.2 Potential of Novel Contrast Agents Development to Drive Imaging
Procedure Volumes 19
2.2.6.3 Rapid Pace of Innovation Narrows Product Lifecycles and Restricts
Spending 20
2.2.7 Market Restraints 20
2.2.8 Market Segments for Medical Imaging 21
2.2.8.1 Discovery 21
2.2.8.2 Clinical Applications 21
2.2.8.3 Clinical Trials 21
2.2.8.4 Outpatient Facilities Best Growth Market 22
2.2.8.5 Diagnostic Imaging Modalities Witness Several Technology Advancements 22
2.2.8.6 Safety and Ergonomics Concerns Drive Technology Growth 22
2.2.8.7 Volumetric Imaging and Post-image Processing Techniques Develop Rapidly
22
2.2.8.8 Increasing Implementation of PACS Pushes Digital Radiography into High
Gear 23
2.2.8.9 Future Price Reduction Set to Stimulate Wider Acceptance of DR Systems
23
2.2.8.10 High-performance Imaging Combined with Lower Radiation Doses Spurs
Growth of DR 23
2.3 Contrast Media 23
2.3.1 Market Share 24
2.3.2 Market Drivers 24
2.4 Picture Archiving Communications Systems 24
2.4.1 Picture Archiving Communications Systems and Radiology Information Systems
25
2.4.2 Increasing Digitization of Cardiology-Image Storage and Management Creates
Market Growth Opportunities 26
2.4.3 Enterprise-Wide Integration Is an Important Area for Future Market
Development 26
2.4.4 Competition among Large Companies Intensifies 26
2.4.5 Benefits of This Service 27
2.4.6 Market Sectors 27
2.4.7 Digital Imaging Technology Platforms 27
2.5 Medical Imaging Companies 27
2.5.1 A Few Firms Dominate the Industry 29
2.6 Medical Imaging Industry Forecasts 32
2.7 Market Niches and Digitalization 33
2.8 Digital Imaging Techniques 34
2.8.1 Clinical Uses 34
2.8.2 Product Enhancements Drive Adoption of Imaging Devices among End-Users 34
2.8.3 Rapid Pace of Innovation Narrows Product Lifecycles and Restricts Spending
35
2.8.4 Current and New Digital Imaging Procedures 35
2.8.5 The Digital Impact on Clinical Imaging Markets 38
2.8.6 Trends in Digital Imaging 38
2.8.7 Enhancing Computed Radiography 39
2.8.8 Digital Radiography vs. Computed Radiography 40
2.8.9 DR Products 41
2.8.10 Vasodilator Perfusion Imaging 42

3 World Mammography Market 43
3.1 Mammography Overview 43
3.2 Market Overview 50
3.2.1 Introduction to Market Overview 50
3.2.2 World Mammography Markets Revenue 50
3.2.3 Mammography Markets by Region 51
3.2.4 Total Market Share 51
3.2.5 Competitive Structure 52
3.3 Market Opportunities 53
3.3.1 Resource Management for Mammography Markets 53
3.3.2 Movement to Higher Reimbursement Rates 53
3.3.3 Market Benchmarks for Increased Mammography Utilization 53
3.4 Market Analysis 53
3.4.1 Strategic Partnerships 53
3.4.2 Long Term Trends 54
3.5 Strategic Outlook 54
3.5.1 Competitive Elements of Mammography Markets 54
3.5.2 Higher Reimbursement Rates 54
3.5.3 Volume Requirements 55
3.5.4 Product Innovation 55
3.5.5 Product Leadership 55
3.5.6 Product Line Strategy 55
3.5.7 Pricing Strategy and Reimbursement 55
3.5.8 Strategic Partnerships 57
3.6 Film-based Mammography Market 59
3.6.1 Market Overview 59
3.6.1.1 Unit and Revenue Forecasts 60
3.6.1.2 Product Analysis 60
3.6.2 Market Drivers 62
3.6.3 Market Restraints 63
3.6.4 Film-based Mammography Market and Technology Trends 63
3.6.5 U.S. Market for Film-based Screening Systems 64
3.6.5.1 Unit Shipment and Revenue Forecasts 64
3.6.5.2 Competitive Analysis 64
3.6.5.3 U.S. Installed Base Analysis 65
3.6.6 European Market for Film-based Mammography Systems 65
3.6.6.1 Unit Shipment and Revenue Forecasts 65
3.6.6.2 Competitive Analysis 66
3.6.6.3 Installed Base Analysis 66
3.6.7 Japanese (Pacific Rim) Market for Film-based Mammography Systems 66
3.6.7.1 Unit Shipment and Revenue Forecasts 67
3.6.7.2 Competitive Analysis 67
3.6.7.3 Installed Base Analysis 68
3.6.8 Rest of the World Market for Analog Screening Systems 69
3.6.8.1 Unit Shipment and Revenue Forecasts 69
3.6.8.2 Installed Base Analysis 69
3.7 Digital X-ray Mammography Market 70
3.7.1 Digital Mammography Overview 70
3.7.2 Market Overview 71
3.7.3 Product Background 72
3.7.4 Product Description 73
3.7.5 Market Drivers 79
3.7.6 Market Restraints 80
3.7.7 Unit Shipment and Revenue Forecasts 82
3.7.8 Percentage Breakdown of Revenues by Region 84
3.7.9 Market Share 85
3.7.10 U.S. Market for Digital Mammography Systems 85
3.7.10.1 Unit Sales 85
3.7.10.2 Competitive Analysis 86
3.7.10.3 U.S. Installed Base Analysis 87
3.7.11 European Market for Digital Mammography Systems 87
3.7.11.1 Unit Shipment and Revenue Forecasts 87
3.7.11.2 Competitive Analysis 88
3.7.11.3 Installed Base Analysis 89
3.7.12 Japanese (Pacific Rim) Market for Digital Mammography Systems 89
3.7.12.1 Unit Shipment and Revenue Forecasts 89
3.7.12.2 Competitive Analysis 89
3.7.12.3 Installed Base Analysis 90

4 Mammography: Growth Regulators 91
4.1 Moderators of Growth 91
4.2 Personnel Acceptance 92
4.3 Key People for Mammography 92
4.4 Key Elements for Mammography 92
4.5 Satellite Facilities 93
4.6 Reimbursement for Mammography 93

5 Business Trends in the Industry 97
5.1 Sector Consolidation 97
5.2 Mammographic Testing Growth Trends 97
5.3 Acquisition, License Agreements, Internal Development and Partnerships 97
5.4 Product Testing Depth in Mammography 98
5.5 Government Regulation 98
5.5.1 U.S. Regulation 98
5.5.1.1 Importing Medical Devices into the U.S. 100
5.5.1.2 Exporting Medical Devices from the U.S. 101
5.5.2 U.K. Regulation 101
5.5.3 E.U. Regulation 102
5.5.4 Japanese Regulation 104
5.6 Increased Market Penetration 104

6 Important Technology Trends 105
6.1 Stereoscopic Digital Mammography (SDM) 105
6.2 Magnetic Resonance Imaging (MRI) 105
6.3 Mammography Trends 105
6.4 Computer-Aided Detection (CAD) 107
6.5 Laser Image Development 109

7 Company Profiles 110
7.1 Agfa-Gevaert Corporation 110
7.2 Capintec, Inc. 111
7.3 Carestream Health, Inc. 111
7.4 CMT Medical Technologies 112
7.5 Del Medical Systems Group 112
7.5 Dilon Diagnostics 113
7.6 FujiFilm Medical Systems USA, Inc. 113
7.7 GE Healthcare 114
7.8 Hitachi Medical Systems America, Inc. 115
7.9 Hologic, Inc. 115
7.10 iCAD, Inc. 116
7.11 Imaging Diagnostic Systems, Inc. 117
7.12 Invivo Corp. 118
7.13 Lantheus Medical Imaging, Inc. 118
7.14 Philips Healthcare 118
7.15 Scanis, Inc. 119
7.16 Sectra Imtec, AB 119
7.17 Siemens Healthcare 119
7.18 Toshiba America Medical Systems 120
7.19 Vidar Systems Corp. 121

8 Appendices 122
8.1 Digital Database for Screening Mammography (DDSM) 122
8.2 Sources of National Cancer Institute Information 122
8.3 Screening Mammograms: Questions and Answers 123
8.4 FDA Rule: State Certification of Mammography Facilities 128

INDEX OF FIGURES

Figure 2.1: Worldwide Annual Percent Increase in Imaging Market Size, 2002-2012
10
Figure 2.2: U.S. Annual Percent Increase in Imaging Market Size, 2002-2012 11
Figure 2.3: Total Spending on Healthcare in the U.S., 1960-2008 12
Figure 2.4: International Per Capita Healthcare Spending by Country, 2007 12
Figure 2.5: Number Uninsured and Uninsured Rate in the U.S., 1987-2008 14
Figure 2.6: Worldwide Market Share of Medical Imaging and Diagnostic Companies
28
Figure 3.1: Worldwide Market for Mammography Systems by Region 51
Figure 3.2: Worldwide Market for Digital Mammography Systems by Region 85

INDEX OF TABLES

Table 2.1: Global Medical Imaging Market Size, 2001-2012 9
Table 2.2: U.S. Medical Imaging Market Size, 2001-2012 10
Table 2.3: U.S. User Expenditures for Medical Imaging Equipment and Related
Products, 2000-2007 13
Table 2.4: Millions of Americans Over 65 Years of Age, 2000-2050 13
Table 2.5: Insured and Uninsured Breakdown in the U.S., 2001-2008 14
Table 2.6: Percentage of Population Without Health Insurance in the U.S., 2008
15
Table 2.7: Total Number of U.S. Hospitals, 2008 15
Table 2.8: U.S. Radiological Images Taken, 1999-2010 18
Table 2.9: Global Market Share of Contrast Media Markets, 2006 24
Table 2.10: Worldwide Market Share of Medical Imaging and Diagnostic Companies,
2006 28
Table 2.11: Worldwide Imaging Procedures, 2006 to 2012 32
Table 3.1: U.S. Use of Mammography in Women Over 40, 1987-2008 45
Table 3.2: Annual Mammography Procedures in the U.S., 2000-2008 45
Table 3.3: Annual Mammography Procedures in Europe, 2002-2007 46
Table 3.4: Annual Mammography Procedures in Japan, 2002-2007 46
Table 3.5: Annual Mammography Procedures in the Rest of the World, 2002-2007 46
Table 3.6: Mammography Facts (U.S.), 2008 47
Table 3.7: Breast Cancer Survival Rates by Country 48
Table 3.8: Surgical Biopsies Performed in the U.S., 2000-2009 48
Table 3.9: The Worldwide Mammography Instrument Market, 2000-2010 51
Table 3.10: Worldwide Mammography Instrumentation Placements, 2002-2010 52
Table 3.11: Worldwide Film-based Mammography Instrumentation Placements,
2002-2010 60
Table 3.12: Worldwide Mammography Film-based Instrument Market, 2000-2010 60
Table 3.13: Worldwide Mammography Film-based Instrument Market by Region,
2000-2010 63
Table 3.14: U.S. Mammography Film-based Instrument Market, 2000-2010 64
Table 3.15: U.S. Mammography Film-based Instrument Market Manufacturer Share,
2007 64
Table 3.16: U.S. Film-based Mammography Instrumentation Placements, 2002-2010 65
Table 3.17: European Mammography Film-based Instrument Market, 2000-2010 65
Table 3.18: European Film-based Mammography Instrumentation Placements,
2002-2010 66
Table 3.19: European Mammography Film-based Instrument Market Manufacturer
Share, 2007 66
Table 3.20: Japanese Mammography Film-based Instrument Market, 2000-2010 67
Table 3.21: Japanese Film-based Mammography Instrumentation Placements,
2002-2010 68
Table 3.22: Japanese Mammography Film-based Instrument Market Manufacturer Share
68
Table 3.23: ROW Mammography Film-based Instrument Market, 2000-2010 69
Table 3.24: ROW Film-based Mammography Instrumentation Placements, 2002-2010 69
Table 3.25: Advantages of Digital Mammography 72
Table 3.26: Worldwide Digital General Radiography Market, 2000-2012 83
Table 3.27: Worldwide Market for Digital Mammography Systems Annual Unit Sales
2000-2010 83
Table 3.28: Worldwide Market for Digital Mammography Systems Dollar Volume
2000-2010 84
Table 3.29: Worldwide Mammography Digital Instrumentation Placements, 2002-2010
84
Table 3.30: Worldwide Mammography Digital Instrument Market by Region, 2000-2010
85
Table 3.31: Share of Worldwide Market for Digital Mammography Systems by
Competitor, 2007 85
Table 3.32: U.S. Mammography Digital Instrument Market, 2001-2010 86
Table 3.33: U.S. Digital Mammography Instrumentation Placements, 2002-2010 87
Table 3.34: European Mammography Digital Instrument Market, 2001-2010 87
Table 3.35: European Digital Mammography Instrumentation Placements, 2002-2010
89
Table 3.36: Japanese Mammography Digital Instrument Market, 2001-2010 89
Table 3.37: Japanese Digital Mammography Instrumentation Placements, 2002-2010
90
Table 4.1: Medicare Reimbursement for Mammography Services, 2009 96
Table 6.1: CAD Mammography Systems 109