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Mammography World Markets

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 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.

Table of Contents

• 1Overview6
  • 1.1Statement of Report6
  • 1.2Scope of this Report6
  • 1.3Methodology7
  • 1.4Executive Summary8
  
  
• 2Overview of the Medical Imaging Market10
  • 2.1Medical Imaging Industry Market Size10
    • 2.1.1Global Medical Imaging Market10
    • 2.1.2U.S. Medical Imaging Market11
  • 2.2Medical Imaging Infrastructure12
    • 2.2.1Total Healthcare Expenditures and Demographics12
    • 2.2.2Number of Hospitals16
    • 2.2.3Number of Radiologists17
    • 2.2.4Radiologic Services18
    • 2.2.5Overview of Medical Imaging Market Segments20
    • 2.2.6Market Drivers20
      • 2.2.6.1Product Enhancements Drive Adoption of Imaging Procedures among End Users20
      • 2.2.6.2Potential of Novel Contrast Agents Development to Drive Imaging Procedure Volumes20
      • 2.2.6.3Rapid Pace of Innovation Narrows Product Lifecycles and Restricts Spending21
    • 2.2.7Market Restraints21
    • 2.2.8Market Segments for Medical Imaging22
      • 2.2.8.1Discovery22
      • 2.2.8.2Clinical Applications22
      • 2.2.8.3Clinical Trials 22
      • 2.2.8.4Outpatient Facilities Best Growth Market23
      • 2.2.8.5Diagnostic Imaging Modalities Witness Several Technology Advancements23
      • 2.2.8.6Safety and Ergonomics Concerns Drive Technology Growth23
      • 2.2.8.7Volumetric Imaging and Post-image Processing Techniques Develop Rapidly 23
      • 2.2.8.8Increasing Implementation of PACS Pushes Digital Radiography into High Gear24
      • 2.2.8.9Future Price Reduction Set to Stimulate Wider Acceptance of DR Systems24
      • 2.2.8.10High-performance Imaging Combined with Lower Radiation Doses Spurs Growth of DR 24
  • 2.3Contrast Media24
    • 2.3.1Market Share25
    • 2.3.2Market Drivers25
  • 2.4Picture Archiving Communications Systems26
    • 2.4.1Picture Archiving Communications Systems and Radiology Information Systems26
    • 2.4.2Increasing Digitization of Cardiology-Image Storage and Management Creates Market Growth Opportunities27
    • 2.4.3Enterprise-Wide Integration Is an Important Area for Future Market Development27
    • 2.4.4Competition among Large Companies Intensifies28
    • 2.4.5Benefits of This Service28
    • 2.4.6Market Sectors28
    • 2.4.7Digital Imaging Technology Platforms28
  • 2.5Medical Imaging Companies29
    • 2.5.1A Few Firms Dominate the Industry30
  • 2.6Medical Imaging Industry Forecasts33
  • 2.7Market Niches and Digitalization35
  • 2.8Digital Imaging Techniques36
    • 2.8.1Clinical Uses36
    • 2.8.2Product Enhancements Drive Adoption of Imaging Devices among End-Users 36
    • 2.8.3Rapid Pace of Innovation Narrows Product Lifecycles and Restricts Spending36
    • 2.8.4Current and New Digital Imaging Procedures37
    • 2.8.5The Digital Impact on Clinical Imaging Markets40
    • 2.8.6Trends in Digital Imaging40
    • 2.8.7Enhancing Computed Radiography41
    • 2.8.8Digital Radiography vs. Computed Radiography42
    • 2.8.9DR Products42
    • 2.8.10Vasodilator Perfusion Imaging43
    
    
• 3World Mammography Market45
  • 3.1Mammography Overview45
  • 3.2Market Overview 50
    • 3.2.1Introduction to Market Overview 50
    • 3.2.2World Mammography Markets Revenue50
    • 3.2.3Mammography Markets by Region51
    • 3.2.4Total Market Share52
    • 3.2.5Competitive Structure52
  • 3.3Market Opportunities53
    • 3.3.1Resource Management for Mammography Markets53
    • 3.3.2Movement to Higher Reimbursement Rates 53
    • 3.3.3Market Benchmarks for Increased Mammography Utilization54
  • 3.4Market Analysis 54
    • 3.4.1 Strategic Partnerships54
    • 3.4.2 Long Term Trends54
  • 3.5 Strategic Outlook55
    • 3.5.1 Competitive Elements of Mammography Markets55
    • 3.5.2 Higher Reimbursement Rates55
    • 3.5.3 Volume Requirements 55
    • 3.5.4 Product Innovation55
    • 3.5.5 Product Leadership56
    • 3.5.6Product Line Strategy56
    • 3.5.7 Pricing Strategy and Reimbursement56
    • 3.5.8 Strategic Partnerships57
  • 3.6Film-based Mammography Market59
    • 3.6.1Market Overview59
      • 3.6.1.1Unit and Revenue Forecasts60
      • 3.6.1.2Product Analysis60
    • 3.6.2Market Drivers62
    • 3.6.3Market Restraints62
    • 3.6.4Film-based Mammography Market and Technology Trends63
    • 3.6.5U.S. Market for Film-based Screening Systems63
      • 3.6.5.1Unit Shipment and Revenue Forecasts64
      • 3.6.5.2Competitive Analysis64
      • 3.6.5.3U.S. Installed Base Analysis65
    • 3.6.6European Market for Film-based Mammography Systems65
      • 3.6.6.1Unit Shipment and Revenue Forecasts65
      • 3.6.6.2Competitive Analysis66
      • 3.6.6.3Installed Base Analysis 66
    • 3.6.7Japanese (Pacific Rim) Market for Film-based Mammography Systems67
      • 3.6.7.1Unit Shipment and Revenue Forecasts67
      • 3.6.7.2Competitive Analysis67
      • 3.6.7.3Installed Base Analysis 68
    • 3.6.8Rest of the World Market for Analog Screening Systems69
      • 3.6.8.1Unit Shipment and Revenue Forecasts69
      • 3.6.8.2Installed Base Analysis 69
  • 3.7Digital X-ray Mammography Market70
    • 3.7.1Digital Mammography Overview70
    • 3.7.2Market Overview 71
    • 3.7.3Product Background72
    • 3.7.4Product Description73
    • 3.7.5Market Drivers78
    • 3.7.6 Market Restraints79
    • 3.7.7Unit Shipment and Revenue Forecasts81
    • 3.7.8Percentage Breakdown of Revenues by Region83
    • 3.7.9Market Share84
    • 3.7.10U.S. Market for Digital Mammography Systems84
      • 3.7.10.1Unit Sales84
      • 3.7.10.2Competitive Analysis85
      • 3.7.10.3U.S. Installed Base Analysis86
    • 3.7.11European Market for Digital Mammography Systems 86
      • 3.7.11.1 Unit Shipment and Revenue Forecasts86
      • 3.7.11.2 Competitive Analysis87
      • 3.7.11.3 Installed Base Analysis 88
    • 3.7.12Japanese (Pacific Rim) Market for Digital Mammography Systems88
      • 3.7.12.1 Unit Shipment and Revenue Forecasts88
      • 3.7.12.2 Competitive Analysis88
      • 3.7.12.3 Installed Base Analysis 89
      
      
• 4Mammography: Growth Regulators90
  • 4.1Moderators of Growth90
  • 4.2Personnel Acceptance91
  • 4.3Key People for Mammography91
  • 4.4Key Elements for Mammography92
  • 4.5Satellite Facilities92
  • 4.6Reimbursement for Mammography92
  
  
• 5Business Trends in the Industry 96
  • 5.1Sector Consolidation96
  • 5.2Mammographic Testing Growth Trends96
  • 5.3Acquisition, License Agreements, Internal Development and Partnerships96
  • 5.4Product Testing Depth in Mammography97
  • 5.5Government Regulation97
    • 5.5.1U.S. Regulation 97
      • 5.5.1.1Importing Medical Devices into the U.S. 99
      • 5.5.1.2Exporting Medical Devices from the U.S.100
    • 5.5.2U.K. Regulation 100
    • 5.5.3E.U. Regulation 101
    • 5.5.4Japanese Regulation103
  • 5.6Increased Market Penetration103
  
  
• 6Important Technology Trends104
  • 6.1Stereoscopic Digital Mammography (SDM)104
  • 6.2Magnetic resonance imaging (MRI)104
  • 6.3Mammography Trends104
  • 6.4Computer-Aided Detection (CAD)106
  • 6.5Laser Image Development108
  
  
• 7Company Profiles109
  • 7.1Agfa-Gevaert Corporation109
  • 7.2Carestream Health109
  • 7.3CMT Medical Systems110
  • 7.4Fischer Imaging (Acquired by Hologic)110
  • 7.5 FujiFilm Medical Systems110
  • 7.6General Electric Healthcare111
  • 7.7Hitachi Medical Systems America, Inc.112
  • 7.8Hologic Inc.112
  • 7.9iCAD, Inc.114
  • 7.10Imaging Diagnostic Systems Inc. 115
  • 7.11Philips Medical Systems 115
  • 7.12R2 Technology, Inc (Acquired by Hologic)115
  • 7.13Scanis Inc.116
  • 7.14Sectra Imtec AB 116
  • 7.15Siemens Healthcare116
  • 7.16Toshiba America Medical Systems 117
  • 7.17Vidar Systems Corp.117
  
  
• 8Appendices118
  • 8.1Digital Database for Screening Mammography (DDSM)118
  • 8.2Sources of National Cancer Institute Information118
  • 8.3Screening Mammograms: Questions and Answers119
  • 8.4FDA 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, 2002-201212

Figure 2.3: Total Spending on Healthcare in the U.S., 1960-2007 13

Figure 2.4: International Per Capita Healthcare Spending by Country, 200613

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, 200630

Figure 3.1: Worldwide Market for Mammography Systems by Region, 200752

Figure 3.2: Worldwide Market for Digital Mammography Systems by Region, 200783

INDEX OF TABLES

Table 2.1: Global Medical Imaging Market Size, 2001-201210

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, 2000-205014

Table 2.5: Insured and Uninsured Breakdown in the U.S., 2001-200515

Table 2.6: Percentage of Population Without Health Insurance in the U.S., 200716

Table 2.7: Total Number of U.S. Hospitals, 2007 16

Table 2.8: U.S. Radiological Images Taken, 1999-201019

Table 2.9: Global Market Share of Contrast Media Markets, 2006 25

Table 2.10: Worldwide Market Share of Medical Imaging and Diagnostic Companies, 200629

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, 2002-200747

Table 3.4: Annual Mammography Procedures in Japan, 2002-200747

Table 3.5: Annual Mammography Procedures in the Rest of the World, 2002-200747

Table 3.6: Mammography Facts (U.S.), 200548

Table 3.7: Breast Cancer Survival Rates by Country49

Table 3.8: Surgical Biopsies Performed in the U.S., 2000-200749

Table 3.9: The Worldwide Mammography Instrument Market, 2000-201051

Table 3.10: Worldwide Mammography Instrumentation Placements, 2002-2010 52

Table 3.11: Worldwide Film-based Mammography Instrumentation Placements, 2002-201060

Table 3.12: Worldwide Mammography Film-based Instrument Market, 2000-201060

Table 3.13: Worldwide Mammography Film-based Instrument Market by Region, 2000-201063

Table 3.14: U.S. Mammography Film-based Instrument Market, 2000-201064

Table 3.15: U.S. Mammography Film-based Instrument Market Manufacturer Share, 200764

Table 3.16: U.S. Film-based Mammography Instrumentation Placements, 2002-201065

Table 3.17: European Mammography Film-based Instrument Market, 2000-201065

Table 3.18: European Film-based Mammography Instrumentation Placements, 2002-201066

Table 3.19: European Mammography Film-based Instrument Market Manufacturer Share, 200766

Table 3.20: Japanese Mammography Film-based Instrument Market, 2000-201067

Table 3.21: Japanese Film-based Mammography Instrumentation Placements, 2002-201068

Table 3.22: Japanese Mammography Film-based Instrument Market Manufacturer Share68

Table 3.23: ROW Mammography Film-based Instrument Market, 2000-201069

Table 3.24: ROW Film-based Mammography Instrumentation Placements, 2002-201069

Table 3.25: Advantages of Digital Mammography72

Table 3.26: Worldwide Digital General Radiography Market, 2000-201282

Table 3.27: Worldwide Market for Digital Mammography Systems Annual Unit Sales 2000-201082

Table 3.28: Worldwide Market for Digital Mammography Systems Dollar Volume 2000-201083

Table 3.29: Worldwide Mammography Digital Instrumentation Placements, 2002-201083

Table 3.30: Worldwide Mammography Digital Instrument Market by Region, 2000-201084

Table 3.31: Share of Worldwide Market for Digital Mammography Systems by Competitor, 200784

Table 3.32: U.S. Mammography Digital Instrument Market, 2001-201085

Table 3.33: U.S. Digital Mammography Instrumentation Placements, 2002-201086

Table 3.34: European Mammography Digital Instrument Market, 2001-201086

Table 3.35: European Digital Mammography Instrumentation Placements, 2002-201088

Table 3.36: Japanese Mammography Digital Instrument Market, 2001-201088

Table 3.37: Japanese Digital Mammography Instrumentation Placements, 2002-201089

Table 4.1: Medicare Reimbursement for Mammography Services, 200795

Table 6.1: CAD Mammography Systems108

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