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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).

The test areas covered include:

• Pregnancy Testing
• Osteoporosis
• Prenatal Screening
• Fertility Testing
• Breast Cancer
• Ovarian Cancer
• Cervical Cancer
• Human Immunodeficiency Virus (HIV)
• Other Infectious Disease
• World Mammography Market

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

• 1.0Overview7
• 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 Market20
  • 3.3.2 U.K. Women\'s Care Testing Diagnostic Market22
    • 3.3.2.1 U.K. Market Statistics23
    • 3.3.2.2 U.K. Competitive Analysis23
    • 3.3.2.3 U.K. Market Access25
  • 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 Market29


• 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 Testing43
  • 4.3.1Cystic Fibrosis44
  • 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 15-353
  • 4.5.2 CA 27-2953
  • 4.5.3 BRCA1 Breast and Ovarian Cancer Gene53
  • 4.5.4BRCA2 Breast Cancer Gene53
  • 4.5.5Tissue polypeptide antigen (TPA)55
  • 4.5.6DNA Ploidy and S-phase Fraction55
  • 4.5.7Estrogen and Progesterone Receptor (ER and PR)55
  • 4.5.8HER-255
  • 4.5.9HER-2 and Herceptin56
  • 4.5.10p5356
  • 4.5.11NMP6656
  • 4.5.12Mammastatin57
• 4.6Ovarian Cancer57
  • 4.6.1CA 125 II™57
  • 4.6.2Steroid Hormone Receptors59
  • 4.6.3Epidermal Growth Factor Receptor (EGFR)59
  • 4.6.4HER-2/neu59
  • 4.6.5P53 Tumor Suppressor Gene59
  • 4.6.6Lysophospholipids59
• 4.7Cervical Cancer60
  • 4.7.1Pap Smears61
  • 4.7.2Human Papillomavirus (HPV) Testing64
• 4.8Miscellaneous Testing68
  • 4.8.1Estriol68
  • 4.8.2Fetal Fibronectin (fFN)69
  • 4.8.3Vaginal pH and Vaginitis69
• 4.9Human Immunodeficiency Virus (HIV)70
• 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 Overview89
  • 5.2.1 Introduction89
  • 5.2.2 World Mammography Markets Revenue89
  • 5.2.3 Mammography Markets by Region90
  • 5.2.4 Total Market Share90
  • 5.2.5 Competitive Structure90
• 5.3 Market Opportunities91
  • 5.3.1 Resource Management for Mammography Markets91
  • 5.3.2 Movement to Higher Reimbursement Rates91
  • 5.3.3 Market Benchmarks for Increased Mammography Utilization91
• 5.4 Market Analysis92
  • 5.4.1 Strategic Partnerships92
  • 5.4.2 Long Term Trends92
• 5.5 Strategic Outlook92
  • 5.5.1 Competitive Elements of Mammography Markets92
  • 5.5.2 Higher Reimbursement Rates92
  • 5.5.3 Volume Requirements93
  • 5.5.4 Product Innovation93
  • 5.5.5 Product Leadership93
  • 5.5.6 Product Line Strategy93
  • 5.5.7 Pricing Strategy & Reimbursement93
  • 5.5.8 Strategic Partnerships95
• 5.6 Film-Based Mammography Market97
  • 5.6.1 Market Overview97
    • 5.6.1.1Unit and Revenue Forecasts97
    • 5.6.1.2Product Analysis98
  • 5.6.2 Market Drivers99
  • 5.6.3 Market Restraints99
  • 5.6.4 Film-Based Mammography Market and Technology Trends100
  • 5.6.5 U.S. Market for Film-Based Screening Systems100
    • 5.6.5.1Unit Shipment and Revenue Forecasts101
    • 5.6.5.2Competitive Analysis101
    • 5.6.5.3U.S. Installed Base Analysis101
  • 5.6.6European Market for Film-Based Mammography Systems102
    • 5.6.6.1Unit Shipment and Revenue Forecasts102
    • 5.6.6.2Competitive Analysis102
    • 5.6.6.3 Installed Base Analysis103
  • 5.6.7 Japanese (Pacific Rim) Market for Film-based Mammography Systems103
    • 5.6.7.2Competitive Analysis103
    • 5.6.7.3 Installed Base Analysis104
  • 5.6.8 Rest of the World Market for Film-based Mammography Systems105
    • 5.6.8.1 Unit Shipment and Revenue Forecasts105
    • 5.6.8.2 Installed Base Analysis105
• 5.7Digital X-Ray Mammography Market105
  • 5.7.1 Digital Mammography Overview105
  • 5.7.2 Market Overview107
  • 5.7.3 Product Background108
  • 5.7.4 Product Description108
  • 5.7.5 Market Drivers114
  • 5.7.6 Market Restraints115
  • 5.7.7Unit Shipment and Revenue Forecasts117
  • 5.7.8Percentage Breakdown of Revenues by Region118
  • 5.7.9 Market Share119
  • 5.7.10U.S. Market for Digital Mammography Systems119
    • 5.7.10.1U.S. Sales119
    • 5.7.10.2Competitive Analysis120
  • 5.7.11European Market for Digital Mammography Systems120
    • 5.7.11.1Unit Shipment and Revenue Forecasts121
    • 5.7.11.2Competitive Analysis121
    • 5.7.11.3 Installed Base Analysis122
  • 5.7.12Japanese (Pacific Rim) Market for Digital Mammography Systems122
    • 5.7.12.1 Unit Shipment and Revenue Forecasts122
    • 5.7.12.2 Competitive Analysis122
    • 5.7.12.3 Installed Base Analysis123
    
    
• 6.0 Women\'s Health Testing: Growth Regulators124
• 6.1 Moderators of Growth124
• 6.2 Personnel Acceptance125
• 6.3 Key People for Women\'s Health Testing125
• 6.4 Key Elements for Women\'s Health Testing125
• 6.5 Women\'s Health Testing and Reimbursement126
• 6.6 Rapid Near-Patient Testing in Hospitals127
• 6.7 Satellite Facilities128
• 6.8 Regionalization of Laboratory Care128
• 6.9Requirements for Women\'s Health Testing129
• 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 Testing134
• 7.5 Government Regulation135
  • 7.5.1 U.S. Regulation135
    • 7.5.1.1Importing Medical Devices into the U.S.136
    • 7.5.1.2 Exporting Medical Devices from the U.S.137
  • 7.5.2 U.K. Regulation137
  • 7.5.3 E.U. Regulation139
  • 7.5.4 Japanese Regulation140
• 7.6 Increased Market Penetration141
• 7.7 Legal Issues141


• 8.0 Important Technology Trends142


• 9.0 Company Profiles144
• 9.1Abbott Diagnostics144
• 9.2Accurex Biomedical, Pvt., Ltd147
• 9.3Adeza Biomedical Corporation (Acquired by Hologic)147
• 9.4Agfa-Gevaert Corporation147
• 9.5Ambri Ltd.147
• 9.6American Biomedica Corp.148
• 9.7Avitar Inc.149
• 9.8Axis-Shield150
• 9.9Bayer Corporation Diagnostics Division (Acquired by Siemens)150
• 9.10Becton Dickinson150
• 9.11Biomerica151
• 9.12Carestream Health152
• 9.13CMT Medical Systems152
• 9.14Cozart Biosciences (Acquired by Concateno PLC)153
• 9.15Cytyc Corporation153
• 9.16Dalsa153
• 9.17Denka Seiken Co., Ltd.153
• 9.18DiaDexus LLC153
• 9.19Enterix, Inc. (Acquired by Quest Diagnostics)154
• 9.20Fischer Imaging (Acquired by Hologic)154
• 9.21 FujiFilm Medical Systems154
• 9.22General Electric Healthcare155
• 9.23Genzyme Diagnostics156
• 9.24Hologic Inc.158
• 9.25iCAD, Inc.160
• 9.26Imaging Diagnostic Systems Inc.160
• 9.27Inverness Medical Innovations161
• 9.28Johnson & Johnson165
• 9.29Kyowa Medex Co., Ltd.167
• 9.30L-3 Titan Group167
• 9.31LifePoint, Inc.167
• 9.32LifeScan Corporation168
• 9.33Matritech168
• 9.34Medix Biochemica170
• 9.35Mitsubishi Kagaku Iatron170
• 9.36Myraid Genetics170
• 9.37OraSure Technologies, Inc.171
• 9.38Polymedco174
• 9.39Procrea175
• 9.40QIAGEN175
• 9.41Quidel176
• 9.42Rad-Icon Imaging Corp179
• 9.43Roche Diagnostics179
• 9.44Scanis Inc.179
• 9.45Sectra Imtec AB180
• 9.46Shanghai Kehua Bioengineering Co., Ltd.180
• 9.47Siemens Healthcare180
• 9.48TriPath Imaging (Acquired by BD)181
• 9.49Vidar Systems Corp.181


• 10.0 Appendices182
• 10.1 Digital Database for Screening Mammography (DDSM)182
• 10.2 Sources of National Cancer Institute Information182
• 10.3 Screening Mammograms: Questions and Answers182
• 10.4 FDA Rule: State Certification of Mammography Facilities188

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: U.S. Clinical Diagnostic Women\'s Test Market Segments 200516

Table 3.5: Regional Comparison Healthcare and IVD19

Table 3.6: European Women\'s Care Testing Market, 2000-201219

Table 3.7: European Women\'s Care Testing Diagnostics Market20

Table 3.8: German Women\'s Care Testing Diagnostics Products Market Sales, 2000-201220

Table 3.9: The German Patient Care Laboratory Test Market, 2000-201221

Table 3.10: The German Alternate Site Testing Market, 2000-201221

Table 3.11: The German Hospital Point of Care Market, 2000-201221

Table 3.12: German Clinical Diagnostic Rapid Women\'s Test Market Segments22

Table 3.13: U.K. Women\'s Health Diagnostics Products Market Sales, 2006-201223

Table 3.14: Major U.K. IVD Manufacturers24

Table 3.15: U.S. IVD Manufacturers Doing Business in the U.K.24

Table 3.16: Other European Companies that Manufacture IVD Products in the United Kingdom24

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

Table 3.18: Italian Women\'s Health Diagnostics Products Market Sales, 2000-201226

Table 3.19: Spanish Women\'s Heath Diagnostics Products Market Sales, 2000-201226

Table 3.20: Japan Women\'s Care Testing Market, 2000-201227

Table 3.21: Chinese Women\'s Care Diagnostics Products Market Sales, 2000-201227

Table 3.22: The ROW Women\'s Care Testing Market, 2000-201229

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: The 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 Changed36

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 Products46

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 Sensitivity55

Table 4.24: HPV Risk Factors65

Table 4.25: Relationship between HPV and Cervical Carcinoma65

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 Type67

Table 4.30: Incidence of Cervical Cancer and Cytological Abnormalitie67

Table 4.31: Long Term Trends in HPV Testing68

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

Table 4.33: Countries with the Highest Prevalence of HIV / AIDS71

Table 4.34: Births of HIV Infected Babies in U.S., 2002-200671

Table 4.35: U.S. Strep Testing Market Size, 2002-201273

Table 4.36: U.S. Market for Rapid Point of Care Strep Tests73

Table 4.37: The U.S. Chlamydia Testing Market, 2000-201276

Table 4.38: Summary of Hepatitis Test Technology79

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

Table 5.2: International Per Capita Healthcare Spending by Country, 200683

Table 5.3: U.S. Use of Mammography in Women Over 40, 1987-200585

Table 5.4: Annual Mammography Procedures in the U.S., 2000-200885

Table 5.5: Annual Mammography Procedures in Europe, 2002-200785

Table 5.6: Annual Mammography Procedures in Japan, 2002-200786

Table 5.7: Annual Mammography Procedures in the Rest of the World, 2002-200786

Table 5.8: U.S. Mammography Facts, 200587

Table 5.9: Breast Cancer Survival Rates by Country87

Table 5.10: Surgical Biopsies Performed in the U.S., 2000-200788

Table 5.11: The Worldwide Mammography Instrument Market, 2000-201089

Table 5.12: Worldwide Mammography Instrumentation Placements, 2002-201090

Table 5.13: Worldwide Film-Based Mammography Instrumentation Placements, 2002-201097

Table 5.14: Worldwide Mammography Film-Based Instrument Market, 2000-201098

Table 5.15: Worldwide Mammography Film-Based Instrument Market by Region, 2000-2010100

Table 5.16: U.S. Mammography Film-Based Instrument Market, 2000-2010101

Table 5.17: U.S. Mammography Film-Based Instrument Market Manufacturer Share101

Table 5.18: U.S. Film-Based Mammography Instrumentation Placements, 2002-2010101

Table 5.19: European Mammography Film-Based Instrument Market, 2000-2010102

Table 5.20: European Film-Based Mammography Instrumentation Placements, 2002-2010103

Table 5.21: European Mammography Film-Based Instrument Market Manufacturer Share103

Table 5.22: Japanese Mammography Film-Based Instrument Market, 2000-2010103

Table 5.23: Japanese Film-Based Mammography Instrumentation Placements, 2002-2010104

Table 5.24: Japanese Mammography Film-Based Instrument Market Manufacturer Share105

Table 5.25: ROW Mammography Film-Based Instrument Market, 2000-2010105

Table 5.26: ROW Film-Based Mammography Instrumentation Placements, 2002-2010105

Table 5.27: Advantages of Digital Mammography108

Table 5.28: Worldwide Digital General Radiography Market, 2000-2012117

Table 5.29: Worldwide Market for Digital Mammography Systems Annual Unit Sales, 2000-2010117

Table 5.30: Worldwide Market for Digital Mammography Systems, 2000-2010118

Table 5.31: Worldwide Mammography Digital Instrumentation Placements, 2002-2010118

Table 5.32: Worldwide Mammography Digital Instrument Market by Region, 2001-2010119

Table 5.33: Share of Worldwide Market for Digital Mammography Systems by Competitor119

Table 5.34: U.S. Mammography Digital Instrument Market, 2001-2010119

Table 5.35: U.S. Digital Mammography Instrumentation Placements, 2002-2010120

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

Table 5.37: European Digital Mammography Instrumentation Placements, 2002-2010122

Table 5.38: Japanese Mammography Digital Instrument Market, 2001-2007122

Table 5.39: Japanese Digital Mammography Instrumentation Placements, 2002-2010123

Table 9.1: Products Marketed By Abbott in the Diagnostic Market146

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