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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.
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Table of Contents:
- 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 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 26
- 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 28
- 2.4.5 Benefits of This Service 28
- 2.4.6 Market Sectors 28
- 2.4.7 Digital Imaging Technology Platforms 28
- 2.5 Medical Imaging Companies 29
- 2.5.1 A Few Firms Dominate the Industry 30
- 2.6 Medical Imaging Industry Forecasts 33
- 2.7 Market Niches and Digitalization 35
- 2.8 Digital Imaging Techniques 36
- 2.8.1 Clinical Uses 36
- 2.8.2 Product Enhancements Drive Adoption of Imaging Devices among End-Users 36
- 2.8.3 Rapid Pace of Innovation Narrows Product Lifecycles and Restricts Spending 36
- 2.8.4 Current and New Digital Imaging Procedures 37
- 2.8.5 The Digital Impact on Clinical Imaging Markets 40
- 2.8.6 Trends in Digital Imaging 40
- 2.8.7 Enhancing Computed Radiography 41
- 2.8.8 Digital Radiography vs. Computed Radiography 42
- 2.8.9 DR Products 42
- 2.8.10 Vasodilator Perfusion Imaging 43
- 3 World Mammography Market 45
- 3.1 Mammography Overview 45
- 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 52
- 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 54
- 3.4 Market Analysis 54
- 3.4.1 Strategic Partnerships 54
- 3.4.2 Long Term Trends 54
- 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 55
- 3.5.4 Product Innovation 55
- 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 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 62
- 3.6.4 Film-based Mammography Market and Technology Trends 63
- 3.6.5 U.S. Market for Film-based Screening Systems 63
- 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 67
- 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 78
- 3.7.6 Market Restraints 79
- 3.7.7 Unit Shipment and Revenue Forecasts 81
- 3.7.8 Percentage Breakdown of Revenues by Region 83
- 3.7.9 Market Share 84
- 3.7.10 U.S. Market for Digital Mammography Systems 84
- 3.7.10.1 Unit Sales 84
- 3.7.10.2 Competitive Analysis 85
- 3.7.10.3 U.S. Installed Base Analysis 86
- 3.7.11 European Market for Digital Mammography Systems 86
- 3.7.11.1 Unit Shipment and Revenue Forecasts 86
- 3.7.11.2 Competitive Analysis 87
- 3.7.11.3 Installed Base Analysis 88
- 3.7.12 Japanese (Pacific Rim) Market for Digital Mammography Systems 88
- 3.7.12.1 Unit Shipment and Revenue Forecasts 88
- 3.7.12.2 Competitive Analysis 88
- 3.7.12.3 Installed Base Analysis 89
- 4 Mammography: Growth Regulators 90
- 4.1 Moderators of Growth 90
- 4.2 Personnel Acceptance 91
- 4.3 Key People for Mammography 91
- 4.4 Key Elements for Mammography 92
- 4.5 Satellite Facilities 92
- 4.6 Reimbursement for Mammography 92
- 5 Business Trends in the Industry 96
- 5.1 Sector Consolidation 96
- 5.2 Mammographic Testing Growth Trends 96
- 5.3 Acquisition, License Agreements, Internal Development and Partnerships 96
- 5.4 Product Testing Depth in Mammography 97
- 5.5 Government Regulation 97
- 5.5.1 U.S. Regulation 97
- 5.5.1.1 Importing Medical Devices into the U.S. 99
- 5.5.1.2 Exporting Medical Devices from the U.S. 100
- 5.5.2 U.K. Regulation 100
- 5.5.3 E.U. Regulation 101
- 5.5.4 Japanese Regulation 103
- 5.6 Increased Market Penetration 103
- 6 Important Technology Trends 104
- 6.1 Stereoscopic Digital Mammography (SDM) 104
- 6.2 Magnetic resonance imaging (MRI) 104
- 6.3 Mammography Trends 104
- 6.4 Computer-Aided Detection (CAD) 106
- 6.5 Laser Image Development 108
- 7 Company Profiles 109
- 7.1 Agfa-Gevaert Corporation 109
- 7.2 Carestream Health 109
- 7.3 CMT Medical Systems 110
- 7.4 Fischer Imaging (Acquired by Hologic) 110
- 7.5 FujiFilm Medical Systems 110
- 7.6 General Electric Healthcare 111
- 7.7 Hitachi Medical Systems America, Inc. 112
- 7.8 Hologic Inc. 112
- 7.9 iCAD, Inc. 114
- 7.10 Imaging Diagnostic Systems Inc. 115
- 7.11 Philips Medical Systems 115
- 7.12 R2 Technology, Inc (Acquired by Hologic) 115
- 7.13 Scanis Inc. 116
- 7.14 Sectra Imtec AB 116
- 7.15 Siemens Healthcare 116
- 7.16 Toshiba America Medical Systems 117
- 7.17 Vidar Systems Corp. 117
- 8 Appendices 118
- 8.1 Digital Database for Screening Mammography (DDSM) 118
- 8.2 Sources of National Cancer Institute Information 118
- 8.3 Screening Mammograms: Questions and Answers 119
- 8.4 FDA Rule: State Certification of Mammography Facilities 124
- INDEX OF FIGURES
- 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., 1960-2007 13
- Figure 2.4: International Per Capita Healthcare Spending by Country, 2006 13
- Figure 2.5: Number Uninsured and Uninsured Rate in the U.S., 1987-2006 15
- Figure 2.6: Global Market Share of Contrast Media Markets, 2006 25
- Figure 2.7: Worldwide Market Share of Medical Imaging and Diagnostic Companies, 2006 30
- Figure 3.1: Worldwide Market for Mammography Systems by Region, 2007 52
- Figure 3.2: Worldwide Market for Digital Mammography Systems by Region, 2007 83
- INDEX OF TABLES
- 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., 2001-2005 15
- Table 2.6: Percentage of Population Without Health Insurance in the U.S., 2007 16
- Table 2.7: Total Number of U.S. Hospitals, 2007 16
- Table 2.8: U.S. Radiological Images Taken, 1999-2010 19
- Table 2.9: Global Market Share of Contrast Media Markets, 2006 25
- Table 2.10: Worldwide Market Share of Medical Imaging and Diagnostic Companies, 2006 29
- Table 2.11: Worldwide Imaging Procedures, 2001 to 2012 34
- Table 3.1: U.S. Use of Mammography in Women Over 40, 1987-2005 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.), 2005 48
- Table 3.7: Breast Cancer Survival Rates by Country 49
- Table 3.8: Surgical Biopsies Performed in the U.S., 2000-2007 49
- 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 82
- Table 3.27: Worldwide Market for Digital Mammography Systems Annual Unit Sales 2000-2010 82
- Table 3.28: Worldwide Market for Digital Mammography Systems Dollar Volume 2000-2010 83
- Table 3.29: Worldwide Mammography Digital Instrumentation Placements, 2002-2010 83
- Table 3.30: Worldwide Mammography Digital Instrument Market by Region, 2000-2010 84
- Table 3.31: Share of Worldwide Market for Digital Mammography Systems by Competitor, 2007 84
- Table 3.32: U.S. Mammography Digital Instrument Market, 2001-2010 85
- Table 3.33: U.S. Digital Mammography Instrumentation Placements, 2002-2010 86
- Table 3.34: European Mammography Digital Instrument Market, 2001-2010 86
- Table 3.35: European Digital Mammography Instrumentation Placements, 2002-2010 88
- Table 3.36: Japanese Mammography Digital Instrument Market, 2001-2010 88
- Table 3.37: Japanese Digital Mammography Instrumentation Placements, 2002-2010 89
- Table 4.1: Medicare Reimbursement for Mammography Services, 2007 95
- Table 6.1: CAD Mammography Systems 108
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