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Women\'s Health: Diagnostic Testing

The purpose of this report is to describe the specific segment of the in vitro diagnostics (IVDs) market called women\'s health testing. This study includes contemporary and generally accepted clinical and analytical activities. This analysis examines clinical measurement devices, as well as their reagents and supplies, as utilized in hospitals, clinics and doctor\'s offices.

Some diagnostic tests, which are marketed primarily as over-the-counter products, are included in this report. This report also includes other important tests like mammography, (i.e., tests which are not generally associated with IVD tests, but which are an important component of the overall women\'s health market).

This study deals with analysis related to the common chemical constituents of blood, plasma or serum of concern to patient testing in the field of women\'s health. Emphasis is on those companies and products that are actively developing and marketing clinical laboratory instrumentation, reagents and supplies for performing diagnostic tests related to women\'s health.

This study concentrates on the women\'s health testing market segment in important worldwide markets such as the U.S., Japan and Europe.

Table of Contents

• 1.0Overview 7
• 1.1Statement of Report7
• 1.2 Scope of this Report7
• 1.3 Methodology8
• 1.4 Executive Summary9


• 2.0 Introduction - Sector Overview11
• 2.1 Global Diagnostic Products Industry11


• 3.0 Women\'s Health Testing Market Analysis in Size, Growth and Share13
• 3.1 Global Women\'s Health Testing Markets13
  • 3.1.1 Market Drivers in the Women\'s Health Diagnostics Testing Sector13
    • 3.1.1.1 Market Segments for Women\'s Health Testing13
    • 3.1.1.2 Key Players in the Women\'s Health Diagnostics Testing Segment14
    • 3.1.1.3 Women\'s Health Testing Sector Analysis15
• 3.2 U.S. Women\'s Health Testing Market15
  • 3.2.1 Market Overview15
  • 3.2.2Diagnostic Test Categories16
• 3.3 European Women\'s Health Diagnostic Test Market17
  • 3.3.1 German Women\'s Care Diagnostic Market19
  • 3.3.2 U.K. Women\'s Care Testing Diagnostic Market22
    • 3.3.2.1 U.K. Market Statistics22
    • 3.3.2.2 U.K. Competitive Analysis23
    • 3.3.2.3 U.K. Market Access24
  • 3.3.3 French Women\'s Care Diagnostic Market25
  • 3.3.4 Italian Women\'s Care Diagnostic Market25
  • 3.3.5 Spanish Women\'s Care Diagnostic Market26
• 3.4 Japanese Women\'s Care Testing Market26
• 3.5 Chinese Women\'s Care Market27
• 3.6 Rest of the World Women\'s Care Testing Market28


• 4.0 Women\'s Health Testing Individual Markets30
• 4.1 Pregnancy Testing30
• 4.2 Osteoporosis Testing36
  • 4.2.1 In Vitro Blood Tests40
  • 4.2.2 Bone Densitometry Devices42
• 4.3 Prenatal Screening Testing44
  • 4.3.1Cystic Fibrosis45
  • 4.3.2Prenatal Genetic Testing47
  • 4.3.3Fragile X Syndrome49
  • 4.3.4Tay-Sachs Disease49
• 4.4 Fertility Testing49
• 4.5 Breast Cancer52
  • 4.5.1 CA 15-354
  • 4.5.2 CA 27-2954
  • 4.5.3 BRCA1 Breast and Ovarian Cancer Gene54
  • 4.5.4BRCA2 Breast Cancer Gene54
  • 4.5.5Tissue polypeptide antigen (TPA)56
  • 4.5.6DNA Ploidy and S-phase Fraction56
  • 4.5.7Estrogen and Progesterone Receptor (ER and PR)56
  • 4.5.8HER-256
  • 4.5.9HER-2 and Herceptin57
  • 4.5.10p5357
  • 4.5.11NMP6657
  • 4.5.12Mammastatin57
• 4.6Ovarian Cancer58
  • 4.6.1CA 125 II™58
  • 4.6.2Steroid Hormone Receptors60
  • 4.6.3Epidermal Growth Factor Receptor (EGFR)60
  • 4.6.4HER-2/neu60
  • 4.6.5P53 Tumor Suppressor Gene60
  • 4.6.6Lysophospholipids60
• 4.7Cervical Cancer61
  • 4.7.1Pap Smears62
  • 4.7.2Human Papillomavirus (HPV) Testing65
• 4.8Miscellaneous Testing69
  • 4.8.1Estriol69
  • 4.8.2Fetal Fibronectin (fFN)70
  • 4.8.3Vaginal pH and Vaginitis70
• 4.9Human Immunodeficiency Virus (HIV)71
• 4.10Infectious Disease Testing72
  • 4.10.1Strep Testing72
  • 4.10.2Chlamydia75
  • 4.10.3Methicillin-Resistant Staphylococcus Aurea (MRSA)76
  • 4.10.4Hepatitis77
  • 4.10.4Gonorrhea81
  • 4.10.5Urinary Tract Infections81
• 4.11Infant Jaundice81


• 5.0 World Mammography Market83
• 5.1 Mammography Overview84
• 5.2 Market Overview91
  • 5.2.1 Introduction91
  • 5.2.2 World Mammography Markets Revenue91
  • 5.2.3 Mammography Markets by Region92
  • 5.2.4 Total Market Share92
  • 5.2.5 Competitive Structure92
• 5.3 Market Opportunities93
  • 5.3.1 Resource Management for Mammography Markets93
  • 5.3.2 Movement to Higher Reimbursement Rates93
  • 5.3.3 Market Benchmarks for Increased Mammography Utilization93
• 5.4 Market Analysis93
  • 5.4.1 Strategic Partnerships93
  • 5.4.2 Long Term Trends94
• 5.5 Strategic Outlook94
  • 5.5.1 Competitive Elements of Mammography Markets94
  • 5.5.2 Higher Reimbursement Rates94
  • 5.5.3 Volume Requirements95
  • 5.5.4 Product Innovation95
  • 5.5.5 Product Leadership95
  • 5.5.6 Product Line Strategy95
  • 5.5.7 Pricing Strategy & Reimbursement95
  • 5.5.8 Strategic Partnerships96
• 5.6 Film-Based Mammography Market99
  • 5.6.1 Market Overview99
    • 5.6.1.1Unit and Revenue Forecasts99
    • 5.6.1.2Product Analysis99
  • 5.6.2 Market Drivers100
  • 5.6.3 Market Restraints101
  • 5.6.4 Film-Based Mammography Market and Technology Trends102
  • 5.6.5 U.S. Market for Film-Based Screening Systems102
    • 5.6.5.1Unit Shipment and Revenue Forecasts102
    • 5.6.5.2Competitive Analysis103
    • 5.6.5.3U.S. Installed Base Analysis103
  • 5.6.6European Market for Film-Based Mammography Systems103
    • 5.6.6.1Unit Shipment and Revenue Forecasts104
    • 5.6.6.2Competitive Analysis104
    • 5.6.6.3 Installed Base Analysis104
  • 5.6.7 Japanese (Pacific Rim) Market for Film-based Mammography Systems105
    • 5.6.7.2Competitive Analysis105
    • 5.6.7.3 Installed Base Analysis106
  • 5.6.8 Rest of the World Market for Film-based Mammography Systems106
    • 5.6.8.1 Unit Shipment and Revenue Forecasts107
    • 5.6.8.2 Installed Base Analysis107
• 5.7Digital X-Ray Mammography Market107
  • 5.7.1 Digital Mammography Overview107
  • 5.7.2 Market Overview108
  • 5.7.3 Product Background110
  • 5.7.4 Product Description110
  • 5.7.5 Market Drivers115
  • 5.7.6 Market Restraints116
  • 5.7.7Unit Shipment and Revenue Forecasts118
  • 5.7.8Percentage Breakdown of Revenues by Region119
  • 5.7.9 Market Share120
  • 5.7.10U.S. Market for Digital Mammography Systems120
    • 5.7.10.1U.S. Sales120
    • 5.7.10.2Competitive Analysis120
  • 5.7.11European Market for Digital Mammography Systems121
    • 5.7.11.1Unit Shipment and Revenue Forecasts121
    • 5.7.11.2Competitive Analysis122
    • 5.7.11.3 Installed Base Analysis123
  • 5.7.12Japanese (Pacific Rim) Market for Digital Mammography Systems123
    • 5.7.12.1 Unit Shipment and Revenue Forecasts123
    • 5.7.12.2 Competitive Analysis123
    • 5.7.12.3 Installed Base Analysis124
    
    
• 6.0 Women\'s Health Testing: Growth Regulators125
• 6.1 Moderators of Growth125
• 6.2 Personnel Acceptance125
• 6.3 Key People for Women\'s Health Testing126
• 6.4 Key Elements for Women\'s Health Testing126
• 6.5 Women\'s Health Testing and Reimbursement126
• 6.6 Rapid Near-Patient Testing in Hospitals128
• 6.7 Satellite Facilities128
• 6.8 Regionalization of Laboratory Care129
• 6.9Requirements for Women\'s Health Testing130
• 6.10 Clinical Laboratory Improvement Act of 1988 (CLIA)130


• 7.0 Business Trends in the Industry132
• 7.1Sector Consolidation132
• 7.2 Diagnostic Testing Growth Trends132
• 7.3 Acquisition, License Agreements, Internal Development and Partnerships133
• 7.4 Product Testing Depth in Women\'s Health Testing135
• 7.5 Government Regulation135
  • 7.5.1 U.S. Regulation136
    • 7.5.1.1Importing Medical Devices into the U.S.137
    • 7.5.1.2 Exporting Medical Devices from the U.S.138
  • 7.5.2 U.K. Regulation138
  • 7.5.3 E.U. Regulation139
  • 7.5.4 Japanese Regulation141
• 7.6 Increased Market Penetration141
• 7.7 Legal Issues141


• 8.0 Important Technology Trends143


• 9.0 Company Profiles145
• 9.1Abbott Diagnostics145
• 9.2Accurex Biomedical, Pvt., Ltd148
• 9.3Adeza Biomedical Corporation (Acquired by Hologic)148
• 9.4Agfa-Gevaert Corporation148
• 9.5Ambri Ltd.148
• 9.6American Biomedica Corp. (ABMC)149
• 9.7 Analogic Corporation150
• 9.8Axis-Shield Plc.150
• 9.9Becton Dickinson (BD)151
• 9.10Biomerica, Inc.151
• 9.11Capintec, Inc.152
• 9.12Carestream Health, Inc.152
• 9.13CMT Medical Technologies Ltd.153
• 9.14Concateno Plc.153
• 9.15Dalsa Corp.154
• 9.16Denka Seiken Co., Ltd.154
• 9.17DiaDexus, Inc.154
• 9.18Dilon Diagnostics155
• 9.19FujiFilm Medical Systems USA155
• 9.20 General Electric Healthcare156
• 9.21Genzyme Corp.157
• 9.22Hologic Inc.159
• 9.23iCAD, Inc.160
• 9.24Imaging Diagnostic Systems, Inc.160
• 9.25Inverness Medical Innovations, Inc. (Alere)161
• 9.26Invivo Corp.165
• 9.27Johnson & Johnson, Inc.165
• 9.28Kyowa Medex Co., Ltd.167
• 9.29Lantheus Medical Imaging, Inc.167
• 9.30LifeScan Corporation167
• 9.31Matritech (Acquired by Inverness Medical Innovations)168
• 9.32Medix Biochemica169
• 9.33Mitsubishi Kagaku Iatron170
• 9.34Myraid Genetics, Inc.170
• 9.35OraSure Technologies, Inc.171
• 9.36Polymedco, Inc.173
• 9.37Procrea Cliniques174
• 9.38QIAGEN in USA174
• 9.39Quest Diagnostics, Inc.175
• 9.40Quidel Corp.175
• 9.41Rad-Icon Imaging Corp178
• 9.42Roche Ltd.178
• 9.43Scanis Inc.178
• 9.44Sectra Imtec AB179
• 9.45Shanghai Kehua Bioengineering Co., Ltd.179
• 9.46Siemens Medical Solutions USA, Inc.179
• 9.47Vidar Systems Corp.180


• 10.0 Appendices181
• 10.1 Digital Database for Screening Mammography (DDSM)181
• 10.2 Sources of National Cancer Institute Information181
• 10.3 Screening Mammograms: Questions and Answers181
• 10.4 FDA Rule: State Certification of Mammography Facilities187

INDEX OF TABLES

Table 2.1: Worldwide Market Share In Vitro Diagnostic Companies11

Table 2.2: Worldwide In Vitro Diagnostics Market Size, 2001-201211

Table 2.3: Worldwide In Vitro Clinical Laboratory Diagnostic Testing 2003-201212

Table 2.4: Worldwide Point-of-Care Diagnostic Testing 2001-201212

Table 3.1: Top Drugstore Retailers in the U.S.13

Table 3.2: Top Drugstore Wholesalers in the U.S.13

Table 3.3: U.S. Women\'s Health Diagnostics Products Market Sales 2000-201216

Table 3.4: Regional Comparison Healthcare and IVD19

Table 3.5: European Women\'s Care Testing Market, 2000-201219

Table 3.6: European Women\'s Care Testing Diagnostics Market19

Table 3.7: German Women\'s Care Testing Diagnostics Products Market Sales, 2000-201220

Table 3.8: German Patient Care Laboratory Test Market, 2000-201220

Table 3.9: German Alternate Site Testing Market, 2000-201221

Table 3.10: German Hospital Point of Care Market, 2000-201221

Table 3.11: German Clinical Diagnostic Rapid Women\'s Test Market Segments21

Table 3.12: U.K. Women\'s Health Diagnostics Products Market Sales, 2006-201223

Table 3.13: Major U.K. IVD Manufacturers23

Table 3.14: U.S. IVD Manufacturers Doing Business in the U.K.24

Table 3.15: Other European Companies that Manufacture IVD Products in the United Kingdom24

Table 3.16: French Women\'s Health Diagnostics Products Market Sales, 2000-201225

Table 3.17: Italian Women\'s Health Diagnostics Products Market Sales, 2000-201225

Table 3.18: Spanish Women\'s Heath Diagnostics Products Market Sales, 2000-201226

Table 3.19: Japan Women\'s Care Testing Market, 2000-201226

Table 3.20: Chinese Women\'s Care Diagnostics Products Market Sales, 2000-201227

Table 3.21: ROW Women\'s Care Testing Market, 2000-201228

Table 4.1: U.S. Women\'s Health Testing Pregnancy Testing Market, 2001-201230

Table 4.2: U.S. Market Share for Rapid Women\'s Health Testing Pregnancy Tests30

Table 4.3: Pregnancy Test Market for OTC Testing in the U.S., 2000-201231

Table 4.4: Home Pregnancy Tests Available in the U.S. Market32

Table 4.5: Osteoporosis Risk Factors that Cannot Be Changed37

Table 4.6: Osteoporosis Risk Factors that Can Be Changed37

Table 4.7: Prenatal Screening Types44

Table 4.8: History: Parental Genetic Traits44

Table 4.9: Female Factor Infertility44

Table 4.10: Frequency of Mutation Based Upon Ethnicity44

Table 4.11: Reasons for CF Testing45

Table 4.12: CF Testing Methodology45

Table 4.13: CF Gene Detection Rates Vary by Ethnic Background45

Table 4.14: Global Market for CF Diagnostic Testing, 2000-201246

Table 4.15: U.S. Market for CF Diagnostic Testing, 2000-201246

Table 4.16: Commercial CF Screening Products46

Table 4.17: Emerging CF Screening Products47

Table 4.18: CF Screening Technology Summary47

Table 4.19: Genetic Screening During Pregnancy48

Table 4.20: Ultrasound Screening48

Table 4.21: Future Trends in Prenatal Genetic Testing, 2000-201249

Table 4.22: Ovulation Predictors52

Table 4.23: TPA Marker Sensitivity56

Table 4.24: HPV Risk Factors65

Table 4.25: Relationship between HPV and Cervical Carcinoma66

Table 4.26: HPV and Cervical Carcinoma Risk66

Table 4.27: Rationale for Reflex HPV Testing with Cytology67

Table 4.28: Rationale against Reflex HPV Testing with Cytology67

Table 4.29: Predictability of HPV Test by Abnormal Pap Smear Type68

Table 4.30: Incidence of Cervical Cancer and Cytological Abnormalitie68

Table 4.31: Long Term Trends in HPV Testing69

Table 4.32: U.S. Women\'s Health Testing Market for HIV, 2001-201271

Table 4.33: Countries with the Highest Prevalence of HIV / AIDS72

Table 4.34: U.S. Strep Testing Market Size, 2002-201273

Table 4.35: U.S. Market for Rapid Point of Care Strep Tests73

Table 4.36: The U.S. Chlamydia Testing Market, 2000-201276

Table 4.37: Summary of Hepatitis Test Technology79

Table 5.1: U.S. Healthcare Expenditures, 2000-201083

Table 5.2: International Per Capita Healthcare Spending by Country, 200784

Table 5.3: U.S. Use of Mammography in Women Over 40, 1987-200886

Table 5.4: Annual Mammography Procedures in the U.S., 2000-200886

Table 5.5: Annual Mammography Procedures in Europe, 2002-200887

Table 5.6: Annual Mammography Procedures in Japan, 2002-200887

Table 5.7: Annual Mammography Procedures in the Rest of the World, 2002-200887

Table 5.8: U.S. Mammography Facts, 200888

Table 5.9: Breast Cancer Survival Rates by Country89

Table 5.10: Surgical Biopsies Performed in the U.S., 2000-200989

Table 5.11: The Worldwide Mammography Instrument Market, 2000-201091

Table 5.12: Worldwide Mammography Instrumentation Placements, 2002-201092

Table 5.13: Worldwide Film-Based Mammography Instrumentation Placements, 2002-201099

Table 5.14: Worldwide Mammography Film-Based Instrument Market, 2000-201099

Table 5.15: Worldwide Mammography Film-Based Instrument Market by Region, 2000-2010102

Table 5.16: U.S. Mammography Film-Based Instrument Market, 2000-2010102

Table 5.17: U.S. Mammography Film-Based Instrument Market Manufacturer Share103

Table 5.18: U.S. Film-Based Mammography Instrumentation Placements, 2002-2010103

Table 5.19: European Mammography Film-Based Instrument Market, 2000-2010104

Table 5.20: European Film-Based Mammography Instrumentation Placements, 2002-2010104

Table 5.21: European Mammography Film-Based Instrument Market Manufacturer Share105

Table 5.22: Japanese Mammography Film-Based Instrument Market, 2000-2010105

Table 5.23: Japanese Film-Based Mammography Instrumentation Placements, 2002-2010106

Table 5.24: Japanese Mammography Film-Based Instrument Market Manufacturer Share106

Table 5.25: ROW Mammography Film-Based Instrument Market, 2000-2010107

Table 5.26: ROW Film-Based Mammography Instrumentation Placements, 2002-2010107

Table 5.27: Advantages of Digital Mammography110

Table 5.28: Worldwide Digital General Radiography Market, 2000-2012118

Table 5.29: Worldwide Market for Digital Mammography Systems Annual Unit Sales, 2000-2010119

Table 5.30: Worldwide Market for Digital Mammography Systems, 2000-2010119

Table 5.31: Worldwide Mammography Digital Instrumentation Placements, 2002-2010119

Table 5.32: Worldwide Mammography Digital Instrument Market by Region, 2001-2010120

Table 5.33: Share of Worldwide Market for Digital Mammography Systems by Competitor120

Table 5.34: U.S. Mammography Digital Instrument Market, 2001-2010120

Table 5.35: U.S. Digital Mammography Instrumentation Placements, 2002-2010121

Table 5.36: European Mammography Digital Instrument Market, 2001-2010121

Table 5.37: European Digital Mammography Instrumentation Placements, 2002-2010123

Table 5.38: Japanese Mammography Digital Instrument Market, 2001-2010123

Table 5.39: Japanese Digital Mammography Instrumentation Placements, 2002-2010124

Table 9.1: Products Marketed By Abbott in the Diagnostic Market147

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