The women’s mammography segment is poised for a major new phase of growth fueled by the availability of new technology coming out of the computer and digital areas and the higher interest of individual patients and general healthcare consumers to take charge of their own health status.
Continuous improvements in technology are resulting in a growing number of new imaging diagnostic tests that combine high levels of accuracy with rapid, easy-to-use product formats. Digital mammography is driving more screening programs.
The emphasis in this TriMark Publications report is on those companies and products that are actively developing and marketing clinical laboratory instrumentation and reagents and supplies for performing diagnostic tests on conditions specifically related to women’s health. This study concentrates on the mammography market segment in large worldwide markets such as the U.S., Japan and Europe.
Certain areas that are not covered include what is generally characterized as digital imaging techniques instruments and reagents, PACS or other data storage methods, or other medical imaging technologies, although many of the instruments, reagents and techniques in the mammography market segment are intimately associated with these broader areas.
Specialty areas in medical imaging are touched upon, since these segments are frequently a part of the overall analytical focus of companies marketing general mammography equipment. However, no effort is made to quantify the size of this broader market.
# 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
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# 2 Overview of the Medical Imaging Market 10
# 2.1 Medical Imaging Industry Market Size 10
# 2.1.1 Global Medical Imaging Market 10
# 2.1.2 U.S. Medical Imaging Market 11
# 2.2 Medical Imaging Infrastructure 12
# 2.2.1 Total Healthcare Expenditures and Demographics 12
# 2.2.2 Number of Hospitals 16
# 2.2.3 Number of Radiologists 17
# 2.2.4 Radiologic Services 18
# 2.2.5 Overview of Medical Imaging Market Segments 20
# 2.2.6 Market Drivers 20
# 2.2.6.1 Product Enhancements Drive Adoption of Imaging Procedures among End Users 20
# 2.2.6.2 Potential of Novel Contrast Agents Development to Drive Imaging Procedure Volumes 20
# 2.2.6.3 Rapid Pace of Innovation Narrows Product Lifecycles and Restricts Spending 21
# 2.2.7 Market Restraints 21
# 2.2.8 Market Segments for Medical Imaging 22
# 2.2.8.1 Discovery 22
# 2.2.8.2 Clinical Applications 22
# 2.2.8.3 Clinical Trials 22
# 2.2.8.4 Outpatient Facilities Best Growth Market 23
# 2.2.8.5 Diagnostic Imaging Modalities Witness Several Technology Advancements 23
# 2.2.8.6 Safety and Ergonomics Concerns Drive Technology Growth 23
# 2.2.8.7 Volumetric Imaging and Post-image Processing Techniques Develop Rapidly 23
# 2.2.8.8 Increasing Implementation of PACS Pushes Digital Radiography into High Gear 24
# 2.2.8.9 Future Price Reduction Set to Stimulate Wider Acceptance of DR Systems 24
# 2.2.8.10 High-performance Imaging Combined with Lower Radiation Doses Spurs Growth of DR 24
# 2.3 Contrast Media 24
# 2.3.1 Market Share 25
# 2.3.2 Market Drivers 25
# 2.4 Picture Archiving Communications Systems 25
# 2.4.1 Picture Archiving Communications Systems and Radiology Information Systems 26
# 2.4.2 Increasing Digitization of Cardiology-Image Storage and Management Creates Market Growth Opportunities 27
# 2.4.3 Enterprise-Wide Integration Is an Important Area for Future Market Development 27
# 2.4.4 Competition among Large Companies Intensifies 27
# 2.4.5 Benefits of This Service 27
# 2.4.6 Market Sectors 28
# 2.4.7 Digital Imaging Technology Platforms 28
# 2.5 Medical Imaging Companies 28
# 2.5.1 A Few Firms Dominate the Industry 29
# 2.6 Medical Imaging Industry Forecasts 33
# 2.7 Market Niches and Digitalization 34
# 2.8 Digital Imaging Techniques 35
# 2.8.1 Clinical Uses 35
# 2.8.2 Product Enhancements Drive Adoption of Imaging Devices among End-Users 35
# 2.8.3 Rapid Pace of Innovation Narrows Product Lifecycles and Restricts Spending 35
# 2.8.4 Current and New Digital Imaging Procedures 36
# 2.8.5 The Digital Impact on Clinical Imaging Markets 39
# 2.8.7 Enhancing Computed Radiography 40
# 2.8.8 Digital Radiography vs. Computed Radiography 41
# 2.8.9 DR Products 41
# 2.8.10 Vasodilator Perfusion Imaging 43
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# 3 World Mammography Market 44
# 3.1 Mammography Overview 44
# 3.2 Market Overview 51
# 3.2.1 Introduction to Market Overview 51
# 3.2.2 World Mammography Markets Revenue 51
# 3.2.3 Mammography Markets by Region 52
# 3.2.4 Total Market Share 52
# 3.2.5 Competitive Structure 53
# 3.3 Market Opportunities 54
# 3.3.1 Resource Management for Mammography Markets 54
# 3.3.2 Movement to Higher Reimbursement Rates 54
# 3.3.3 Market Benchmarks for Increased Mammography Utilization 54
# 3.4 Market Analysis 54
# 3.4.1 Strategic Partnerships 54
# 3.4.2 Long Term Trends 55
# 3.5 Strategic Outlook 55
# 3.5.1 Competitive Elements of Mammography Markets 55
# 3.5.2 Higher Reimbursement Rates 55
# 3.5.3 Volume Requirements 56
# 3.5.4 Product Innovation 56
# 3.5.5 Product Leadership 56
# 3.5.6 Product Line Strategy 56
# 3.5.7 Pricing Strategy and Reimbursement 56
# 3.5.8 Strategic Partnerships 58
# 3.6 Film-based Mammography Market 60
# 3.6.1 Market Overview 60
# 3.6.1.1 Unit and Revenue Forecasts 61
# 3.6.1.2 Product Analysis 61
# 3.6.2 Market Drivers 63
# 3.6.3 Market Restraints 64
# 3.6.4 Film-based Mammography Market and Technology Trends 64
# 3.6.5 U.S. Market for Film-based Screening Systems 65
# 3.6.5.1 Unit Shipment and Revenue Forecasts 65
# 3.6.5.2 Competitive Analysis 65
# 3.6.5.3 U.S. Installed Base Analysis 66
# 3.6.6 European Market for Film-based Mammography Systems 66
# 3.6.6.1 Unit Shipment and Revenue Forecasts 66
# 3.6.6.2 Competitive Analysis 67
# 3.6.6.3 Installed Base Analysis 67
# 3.6.7 Japanese (Pacific Rim) Market for Film-based Mammography Systems 67
# 3.6.7.1 Unit Shipment and Revenue Forecasts 68
# 3.6.7.2 Competitive Analysis 68
# 3.6.7.3 Installed Base Analysis 69
# 3.6.8 Rest of the World Market for Analog Screening Systems 70
# 3.6.8.1 Unit Shipment and Revenue Forecasts 70
# 3.6.8.2 Installed Base Analysis 70
# 3.7 Digital X-ray Mammography Market 71
# 3.7.1 Digital Mammography Overview 71
# 3.7.2 Market Overview 72
# 3.7.3 Product Background 73
# 3.7.4 Product Description 74
# 3.7.5 Market Drivers 80
# 3.7.6 Market Restraints 80
# 3.7.7 Unit Shipment and Revenue Forecasts 83
# 3.7.8 Percentage Breakdown of Revenues by Region 85
# 3.7.9 Market Share 86
# 3.7.10 U.S. Market for Digital Mammography Systems 86
# 3.7.10.1 Unit Sales 86
# 3.7.10.2 Competitive Analysis 87
# 3.7.10.3 U.S. Installed Base Analysis 88
# 3.7.11 European Market for Digital Mammography Systems 88
# 3.7.11.1 Unit Shipment and Revenue Forecasts 88
# 3.7.11.2 Competitive Analysis 89
# 3.7.11.3 Installed Base Analysis 90
# 3.7.12 Japanese (Pacific Rim) Market for Digital Mammography Systems 90
# 3.7.12.1 Unit Shipment and Revenue Forecasts 90
# 3.7.12.2 Competitive Analysis 90
# 3.7.12.3 Installed Base Analysis 91
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# 4 Mammography: Growth Regulators 92
# 4.1 Moderators of Growth 92
# 4.2 Personnel Acceptance 93
# 4.3 Key People for Mammography 93
# 4.4 Key Elements for Mammography 93
# 4.5 Satellite Facilities 93
# 4.6 Reimbursement for Mammography 94
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# 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 99
# 5.5 Government Regulation 100
# 5.5.1 U.S. Regulation 100
# 5.5.1.1 Importing Medical Devices into the U.S. 101
# 5.5.1.2 Exporting Medical Devices from the U.S. 102
# 5.5.2 U.K. Regulation 102
# 5.5.3 E.U. Regulation 104
# 5.5.4 Japanese Regulation 105
# 5.6 Increased Market Penetration 106
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# 6 Important Technology Trends 107
# 6.1 Stereoscopic Digital Mammography (SDM) 107
# 6.2 Magnetic Resonance Imaging (MRI) 107
# 6.3 Mammography Trends 107
# 6.4 Computer-Aided Detection (CAD) 109
# 6.5 Laser Image Development 111
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# 7 Company Profiles 112
# 7.1 Agfa-Gevaert Corporation 112
# 7.2 Capintec, Inc. 113
# 7.3 Carestream Health, Inc. 113
# 7.4 CMT Medical Technologies 114
# 7.5 Del Medical Systems Group 114
# 7.6 Dilon Diagnostics 115
# 7.7 FujiFilm Medical Systems USA, Inc. 115
# 7.8 GE Healthcare 116
# 7.9 Hitachi Medical Systems America, Inc. 117
# 7.10 Hologic, Inc. 117
# 7.11 iCAD, Inc. 118
# 7.12 Imaging Diagnostic Systems, Inc. 119
# 7.13 Invivo Corp. 120
# 7.14 Lantheus Medical Imaging, Inc. 120
# 7.15 Philips Healthcare 120
# 7.16 Scanis, Inc. 121
# 7.17 Sectra Imtec, AB 121
# 7.18 Siemens Healthcare 121
# 7.19 Toshiba America Medical Systems 122
# 7.20 Vidar Systems Corp. 123
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# 8 Appendices 124
# 8.1 Digital Database for Screening Mammography (DDSM) 124
# 8.2 Sources of National Cancer Institute Information 124
# 8.3 Screening Mammograms: Questions and Answers 125
# 8.4 FDA Rule: State Certification of Mammography Facilities 130
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# INDEX OF FIGURES
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# Figure 2.1: Worldwide Annual Percent Increase in Imaging Market Size, 2002-2012 11
# Figure 2.2: U.S. Annual Percent Increase in Imaging Market Size, 2002-2012 12
# Figure 2.3: Total Spending on Healthcare in the U.S., 1960-2008 13
# Figure 2.4: International Per Capita Healthcare Spending by Country, 2007 13
# Figure 2.5: Number Uninsured and Uninsured Rate in the U.S., 1987-2008 15
# Figure 2.6: Worldwide Market Share of Medical Imaging and Diagnostic Companies 29
# Figure 3.1: Worldwide Market for Mammography Systems by Region 52
# Figure 3.2: Worldwide Market for Digital Mammography Systems by Region 86
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#
# INDEX OF TABLES
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# Table 2.1: Global Medical Imaging Market Size, 2001-2012 10
# Table 2.2: U.S. Medical Imaging Market Size, 2001-2012 11
# Table 2.3: U.S. User Expenditures for Medical Imaging Equipment and Related Products, 2000-2007 14
# Table 2.4: Millions of Americans Over 65 Years of Age, 2000-2050 14
# Table 2.5: Insured and Uninsured Breakdown in the U.S., 2001-2008 15
# Table 2.6: Percentage of Population Without Health Insurance in the U.S., 2008 16
# Table 2.7: Total Number of U.S. Hospitals, 2008 16
# Table 2.8: U.S. Radiological Images Taken, 1999-2010 19
# Table 2.9: Worldwide Market Share of Medical Imaging and Diagnostic Companies 29
# Table 2.10: Worldwide Imaging Procedures, 2006 to 2012 33
# Table 3.1: U.S. Use of Mammography in Women Over 40, 1987-2008 46
# Table 3.2: Annual Mammography Procedures in the U.S., 2000-2008 46
# Table 3.3: Annual Mammography Procedures in Europe, 2002-2007 47
# Table 3.4: Annual Mammography Procedures in Japan, 2002-2007 47
# Table 3.5: Annual Mammography Procedures in the Rest of the World, 2002-2007 47
# Table 3.6: Mammography Facts (U.S.), 2008 48
# Table 3.7: Breast Cancer Survival Rates by Country 49
# Table 3.8: Surgical Biopsies Performed in the U.S., 2000-2009 49
# Table 3.9: Worldwide Mammography Instrument Market, 2000-2010 52
# Table 3.10: Worldwide Mammography Instrumentation Placements, 2002-2010 53
# Table 3.11: Worldwide Film-based Mammography Instrumentation Placements, 2002-2010 61
# Table 3.12: Worldwide Mammography Film-based Instrument Market, 2000-2010 61
# Table 3.13: Worldwide Mammography Film-based Instrument Market by Region, 2000-2010 64
# Table 3.14: U.S. Mammography Film-based Instrument Market, 2000-2010 65
# Table 3.15: U.S. Mammography Film-based Instrument Market Manufacturer Share, 2007 65
# Table 3.16: U.S. Film-based Mammography Instrumentation Placements, 2002-2010 66
# Table 3.17: European Mammography Film-based Instrument Market, 2000-2010 66
# Table 3.18: European Film-based Mammography Instrumentation Placements, 2002-2010 67
# Table 3.19: European Mammography Film-based Instrument Market Manufacturer Share, 2007 67
# Table 3.20: Japanese Mammography Film-based Instrument Market, 2000-2010 68
# Table 3.21: Japanese Film-based Mammography Instrumentation Placements, 2002-2010 69
# Table 3.22: Japanese Mammography Film-based Instrument Market Manufacturer Share 69
# Table 3.23: ROW Mammography Film-based Instrument Market, 2000-2010 70
# Table 3.24: ROW Film-based Mammography Instrumentation Placements, 2002-2010 70
# Table 3.25: Advantages of Digital Mammography 73
# Table 3.26: Worldwide Digital General Radiography Market, 2000-2012 84
# Table 3.27: Worldwide Market for Digital Mammography Systems Annual Unit Sales 2000-2010 84
# Table 3.28: Worldwide Market for Digital Mammography Systems Dollar Volume 2000-2010 85
# Table 3.29: Worldwide Mammography Digital Instrumentation Placements, 2002-2010 85
# Table 3.30: Worldwide Mammography Digital Instrument Market by Region, 2000-2010 86
# Table 3.31: Share of Worldwide Market for Digital Mammography Systems by Competitor, 2007 86
# Table 3.32: U.S. Mammography Digital Instrument Market, 2001-2010 87
# Table 3.33: U.S. Digital Mammography Instrumentation Placements, 2002-2010 88
# Table 3.34: European Mammography Digital Instrument Market, 2001-2010 88
# Table 3.35: European Digital Mammography Instrumentation Placements, 2002-2010 90
# Table 3.36: Japanese Mammography Digital Instrument Market, 2001-2010 90
# Table 3.37: Japanese Digital Mammography Instrumentation Placements, 2002-2010 91
# Table 4.1: Medicare Reimbursement for Mammography Services, 2009 96
# Table 6.1: CAD Mammography Systems 111
Agfa-Gevaert Corporation
Carestream Health
CMT Medical Systems
Fischer Imaging (Acquired by Hologic)
FujiFilm Medical Systems
General Electric Healthcare
Hitachi Medical Systems America, Inc.
Hologic Inc.
iCAD, Inc.
Imaging Diagnostic Systems Inc.
Philips Medical Systems
R2 Technology, Inc (Acquired by Hologic)
Scanis Inc.
Sectra Imtec AB
Siemens Healthcare
Toshiba America Medical Systems
Vidar Systems Corp.
Other selected research from the 'Markets' category:
Patient Monitoring Markets
Key Diagnostic Testing Markets
Other selected research from the 'Diagnostic Imaging' category:
The Digitized Medical Image Archiving Outlook to 2015
Medical Imaging Markets, Volume I: Radiography (X-Ray, Digital X-Ray, Fluoroscopy, Mammography, and CT Markets)