Women’s Health Diagnostic Testing

The purpose of this TriMark Publications 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.
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1.0 Overview 7
1.1 Statement of Report 7
1.2 Scope of this Report 7
1.3 Methodology 8
1.4 Executive Summary 9

2.0 Introduction - Sector Overview 11
2.1 Global Diagnostic Products Industry 11

3.0 Women's Health Testing Market Analysis in Size, Growth and Share 13
3.1 Global Women's Health Testing Markets 13
3.1.1 Market Drivers in the Women's Health Diagnostics Testing Sector 13
3.1.1.1 Market Segments for Women's Health Testing 13
3.1.1.2 Key Players in the Women's Health Diagnostics Testing Segment 14
3.1.1.3 Women's Health Testing Sector Analysis 15
3.2 U.S. Women's Health Testing Market 15
3.2.1 Market Overview 15
3.2.2 Diagnostic Test Categories 16
3.3 European Women's Health Diagnostic Test Market 17
3.3.1 German Women's Care Diagnostic Market 19
3.3.2 U.K. Women's Care Testing Diagnostic Market 22
3.3.2.1 U.K. Market Statistics 22
3.3.2.2 U.K. Competitive Analysis 23
3.3.2.3 U.K. Market Access 24
3.3.3 French Women's Care Diagnostic Market 25
3.3.4 Italian Women's Care Diagnostic Market 25
3.3.5 Spanish Women's Care Diagnostic Market 26
3.4 Japanese Women's Care Testing Market 26
3.5 Chinese Women's Care Market 27
3.6 Rest of the World Women's Care Testing Market 28

4.0 Women's Health Testing Individual Markets 30
4.1 Pregnancy Testing 30
4.2 Osteoporosis Testing 36
4.2.1 In Vitro Blood Tests 40
4.2.2 Bone Densitometry Devices 42
4.3 Prenatal Screening Testing 44
4.3.1 Cystic Fibrosis 44
4.3.2 Prenatal Genetic Testing 47
4.3.3 Fragile X Syndrome 49
4.3.4 Tay-Sachs Disease 49
4.4 Fertility Testing 49
4.5 Breast Cancer 52
4.5.1 CA 15-3 54
4.5.2 CA 27-29 54
4.5.3 BRCA1 Breast and Ovarian Cancer Gene 54
4.5.4 BRCA2 Breast Cancer Gene 54
4.5.5 Tissue polypeptide antigen (TPA) 56
4.5.6 DNA Ploidy and S-phase Fraction 56
4.5.7 Estrogen and Progesterone Receptor (ER and PR) 56
4.5.8 HER-2 56
4.5.9 HER-2 and Herceptin 57
4.5.10 p53 57
4.5.11 NMP66 57
4.5.12 Mammastatin 57
4.6 Ovarian Cancer 58
4.6.1 CA 125 II' 58
4.6.2 Steroid Hormone Receptors 60
4.6.3 Epidermal Growth Factor Receptor (EGFR) 60
4.6.4 HER-2/neu 60
4.6.5 P53 Tumor Suppressor Gene 60
4.6.6 Lysophospholipids 60
4.7 Cervical Cancer 61
4.7.1 Pap Smears 62
4.7.2 Human Papillomavirus (HPV) Testing 65
4.8 Miscellaneous Testing 69
4.8.1 Estriol 69
4.8.2 Fetal Fibronectin (fFN) 70
4.8.3 Vaginal pH and Vaginitis 70
4.9 Human Immunodeficiency Virus (HIV) 71
4.10 Infectious Disease Testing 72
4.10.1 Strep Testing 72
4.10.2 Chlamydia 75
4.10.3 Methicillin-Resistant Staphylococcus Aurea (MRSA) 76
4.10.4 Hepatitis 77
4.10.4 Gonorrhea 81
4.10.5 Urinary Tract Infections 81
4.11 Infant Jaundice 81

5.0 World Mammography Market 83
5.1 Mammography Overview 84
5.2 Market Overview 91
5.2.1 Introduction 91
5.2.2 World Mammography Markets Revenue 91
5.2.3 Mammography Markets by Region 92
5.2.4 Total Market Share 92
5.2.5 Competitive Structure 92
5.3 Market Opportunities 93
5.3.1 Resource Management for Mammography Markets 93
5.3.2 Movement to Higher Reimbursement Rates 93
5.3.3 Market Benchmarks for Increased Mammography Utilization 93
5.4 Market Analysis 93
5.4.1 Strategic Partnerships 93
5.4.2 Long Term Trends 94
5.5 Strategic Outlook 94
5.5.1 Competitive Elements of Mammography Markets 94
5.5.2 Higher Reimbursement Rates 94
5.5.3 Volume Requirements 95
5.5.4 Product Innovation 95
5.5.5 Product Leadership 95
5.5.6 Product Line Strategy 95
5.5.7 Pricing Strategy & Reimbursement 95
5.5.8 Strategic Partnerships 96
5.6 Film-Based Mammography Market 99
5.6.1 Market Overview 99
5.6.1.1 Unit and Revenue Forecasts 99
5.6.1.2 Product Analysis 99
5.6.2 Market Drivers 100
5.6.3 Market Restraints 101
5.6.4 Film-Based Mammography Market and Technology Trends 102
5.6.5 U.S. Market for Film-Based Screening Systems 102
5.6.5.1 Unit Shipment and Revenue Forecasts 102
5.6.5.2 Competitive Analysis 103
5.6.5.3 U.S. Installed Base Analysis 103
5.6.6 European Market for Film-Based Mammography Systems 103
5.6.6.1 Unit Shipment and Revenue Forecasts 104
5.6.6.2 Competitive Analysis 104
5.6.6.3 Installed Base Analysis 104
5.6.7 Japanese (Pacific Rim) Market for Film-based Mammography Systems 105
5.6.7.2 Competitive Analysis 105
5.6.7.3 Installed Base Analysis 106
5.6.8 Rest of the World Market for Film-based Mammography Systems 106
5.6.8.1 Unit Shipment and Revenue Forecasts 107
5.6.8.2 Installed Base Analysis 107
5.7 Digital X-Ray Mammography Market 107
5.7.1 Digital Mammography Overview 107
5.7.2 Market Overview 108
5.7.3 Product Background 110
5.7.4 Product Description 110
5.7.5 Market Drivers 115
5.7.6 Market Restraints 116
5.7.7 Unit Shipment and Revenue Forecasts 118
5.7.8 Percentage Breakdown of Revenues by Region 119
5.7.9 Market Share 120
5.7.10 U.S. Market for Digital Mammography Systems 120
5.7.10.1 U.S. Sales 120
5.7.10.2 Competitive Analysis 120
5.7.11 European Market for Digital Mammography Systems 121
5.7.11.1 Unit Shipment and Revenue Forecasts 121
5.7.11.2 Competitive Analysis 122
5.7.11.3 Installed Base Analysis 123
5.7.12 Japanese (Pacific Rim) Market for Digital Mammography Systems 123
5.7.12.1 Unit Shipment and Revenue Forecasts 123
5.7.12.2 Competitive Analysis 123
5.7.12.3 Installed Base Analysis 124

6.0 Women's Health Testing: Growth Regulators 125
6.1 Moderators of Growth 125
6.2 Personnel Acceptance 125
6.3 Key People for Women's Health Testing 126
6.4 Key Elements for Women's Health Testing 126
6.5 Women's Health Testing and Reimbursement 126
6.6 Rapid Near-Patient Testing in Hospitals 128
6.7 Satellite Facilities 128
6.8 Regionalization of Laboratory Care 129
6.9 Requirements for Women's Health Testing 130
6.10 Clinical Laboratory Improvement Act of 1988 (CLIA) 130

7.0 Business Trends in the Industry 132
7.1 Sector Consolidation 132
7.2 Diagnostic Testing Growth Trends 132
7.3 Acquisition, License Agreements, Internal Development and Partnerships 133
7.4 Product Testing Depth in Women's Health Testing 135
7.5 Government Regulation 135
7.5.1 U.S. Regulation 136
7.5.1.1 Importing Medical Devices into the U.S. 137
7.5.1.2 Exporting Medical Devices from the U.S. 138
7.5.2 U.K. Regulation 138
7.5.3 E.U. Regulation 139
7.5.4 Japanese Regulation 141
7.6 Increased Market Penetration 141
7.7 Legal Issues 141

8.0 Important Technology Trends 143

9.0 Company Profiles 145
9.1 Abbott Diagnostics 145
9.2 Accurex Biomedical, Pvt., Ltd 148
9.3 Adeza Biomedical Corporation (Acquired by Hologic) 148
9.4 Agfa-Gevaert Corporation 148
9.5 Ambri Ltd. 148
9.6 American Biomedica Corp. (ABMC) 149
9.7 Analogic Corporation 150
9.8 Axis-Shield Plc. 150
9.9 Becton Dickinson (BD) 151
9.10 Biomerica, Inc. 151
9.11 Capintec, Inc. 152
9.12 Carestream Health, Inc. 152
9.13 CMT Medical Technologies Ltd. 153
9.14 Concateno Plc. 153
9.15 Dalsa Corp. 154
9.16 Denka Seiken Co., Ltd. 154
9.17 DiaDexus, Inc. 154
9.18 Dilon Diagnostics 155
9.19 FujiFilm Medical Systems USA 155
9.20 General Electric Healthcare 156
9.21 Genzyme Corp. 157
9.22 Hologic Inc. 159
9.23 iCAD, Inc. 160
9.24 Imaging Diagnostic Systems, Inc. 160
9.25 Inverness Medical Innovations, Inc. (Alere) 161
9.26 Invivo Corp. 165
9.27 Johnson & Johnson, Inc. 165
9.28 Kyowa Medex Co., Ltd. 167
9.29 Lantheus Medical Imaging, Inc. 167
9.30 LifeScan Corporation 168
9.31 Matritech (Acquired by Inverness Medical Innovations) 168
9.32 Medix Biochemica 170
9.33 Mitsubishi Kagaku Iatron 170
9.34 Myraid Genetics, Inc. 170
9.35 OraSure Technologies, Inc. 171
9.36 Polymedco, Inc. 173
9.37 Procrea Cliniques 174
9.38 QIAGEN in USA 175
9.39 Quest Diagnostics, Inc. 175
9.40 Quidel Corp. 175
9.41 Rad-Icon Imaging Corp 178
9.42 Roche Ltd. 178
9.43 Scanis Inc. 179
9.44 Sectra Imtec AB 179
9.45 Shanghai Kehua Bioengineering Co., Ltd. 179
9.46 Siemens Medical Solutions USA, Inc. 180
9.47 Vidar Systems Corp. 180

10.0 Appendices 181
10.1 Digital Database for Screening Mammography (DDSM) 181
10.2 Sources of National Cancer Institute Information 181
10.3 Screening Mammograms: Questions and Answers 181
10.4 FDA Rule: State Certification of Mammography Facilities 187
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INDEX OF TABLES

Table 2.1: Worldwide Market Share In Vitro Diagnostic Companies 11
Table 2.2: Worldwide In Vitro Diagnostics Market Size, 2001-2012 11
Table 2.3: Worldwide In Vitro Clinical Laboratory Diagnostic Testing 2003-2012 12
Table 2.4: Worldwide Point-of-Care Diagnostic Testing 2001-2012 12
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 2000-2012 16
Table 3.4: Regional Comparison Healthcare and IVD 19
Table 3.5: European Women's Care Testing Market, 2000-2012 19
Table 3.6: European Women's Care Testing Diagnostics Market 19
Table 3.7: German Women's Care Testing Diagnostics Products Market Sales, 2000-2012 20
Table 3.8: German Patient Care Laboratory Test Market, 2000-2012 20
Table 3.9: German Alternate Site Testing Market, 2000-2012 21
Table 3.10: German Hospital Point of Care Market, 2000-2012 21
Table 3.11: German Clinical Diagnostic Rapid Women's Test Market Segments 21
Table 3.12: U.K. Women's Health Diagnostics Products Market Sales, 2006-2012 23
Table 3.13: Major U.K. IVD Manufacturers 23
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 U.K. 24
Table 3.16: French Women's Health Diagnostics Products Market Sales, 2000-2012 25
Table 3.17: Italian Women's Health Diagnostics Products Market Sales, 2000-2012 25
Table 3.18: Spanish Women's Heath Diagnostics Products Market Sales, 2000-2012 26
Table 3.19: Japan Women's Care Testing Market, 2000-2012 26
Table 3.20: Chinese Women's Care Diagnostics Products Market Sales, 2000-2012 27
Table 3.21: ROW Women's Care Testing Market, 2000-2012 28
Table 4.1: U.S. Women's Health Testing Pregnancy Testing Market, 2001-2012 30
Table 4.2: U.S. Market Share for Rapid Women's Health Testing Pregnancy Tests 30
Table 4.3: Pregnancy Test Market for OTC Testing in the U.S., 2000-2012 31
Table 4.4: Home Pregnancy Tests Available in the U.S. Market 32
Table 4.5: Osteoporosis Risk Factors that Cannot Be Changed 37
Table 4.6: Osteoporosis Risk Factors that Can Be Changed 37
Table 4.7: Prenatal Screening Types 44
Table 4.8: History: Parental Genetic Traits 44
Table 4.9: Female Factor Infertility 44
Table 4.10: Frequency of Mutation Based Upon Ethnicity 44
Table 4.11: Reasons for CF Testing 45
Table 4.12: CF Testing Methodology 45
Table 4.13: CF Gene Detection Rates Vary by Ethnic Background 45
Table 4.14: Global Market for CF Diagnostic Testing, 2000-2012 46
Table 4.15: U.S. Market for CF Diagnostic Testing, 2000-2012 46
Table 4.16: Commercial CF Screening Products 46
Table 4.17: Emerging CF Screening Products 47
Table 4.18: CF Screening Technology Summary 47
Table 4.19: Genetic Screening During Pregnancy 48
Table 4.20: Ultrasound Screening 48
Table 4.21: Future Trends in Prenatal Genetic Testing, 2000-2012 49
Table 4.22: Ovulation Predictors 52
Table 4.23: TPA Marker Sensitivity 56
Table 4.24: HPV Risk Factors 65
Table 4.25: Relationship between HPV and Cervical Carcinoma 66
Table 4.26: HPV and Cervical Carcinoma Risk 66
Table 4.27: Rationale for Reflex HPV Testing with Cytology 67
Table 4.28: Rationale against Reflex HPV Testing with Cytology 68
Table 4.29: Predictability of HPV Test by Abnormal Pap Smear Type 68
Table 4.30: Incidence of Cervical Cancer and Cytological Abnormalitie 68
Table 4.31: Long Term Trends in HPV Testing 69
Table 4.32: U.S. Women's Health Testing Market for HIV, 2001-2012 71
Table 4.33: Countries with the Highest Prevalence of HIV / AIDS 72
Table 4.34: U.S. Strep Testing Market Size, 2002-2012 73
Table 4.35: U.S. Market for Rapid Point of Care Strep Tests 73
Table 4.36: U.S. Chlamydia Testing Market, 2000-2012 76
Table 4.37: Summary of Hepatitis Test Technology 79
Table 5.1: U.S. Healthcare Expenditures, 2000-2010 83
Table 5.2: International Per Capita Healthcare Spending by Country, 2007 84
Table 5.3: U.S. Use of Mammography in Women Over 40, 1987-2008 86
Table 5.4: Annual Mammography Procedures in the U.S., 2000-2008 86
Table 5.5: Annual Mammography Procedures in Europe, 2002-2008 87
Table 5.6: Annual Mammography Procedures in Japan, 2002-2008 87
Table 5.7: Annual Mammography Procedures in the Rest of the World, 2002-2008 87
Table 5.8: U.S. Mammography Facts, 2008 88
Table 5.9: Breast Cancer Survival Rates by Country 89
Table 5.10: Surgical Biopsies Performed in the U.S., 2000-2009 89
Table 5.11: Worldwide Mammography Instrument Market, 2000-2010 91
Table 5.12: Worldwide Mammography Instrumentation Placements, 2002-2010 92
Table 5.13: Worldwide Film-Based Mammography Instrumentation Placements, 2002-2010 99
Table 5.14: Worldwide Mammography Film-Based Instrument Market, 2000-2010 99
Table 5.15: Worldwide Mammography Film-Based Instrument Market by Region, 2000-2010 102
Table 5.16: U.S. Mammography Film-Based Instrument Market, 2000-2010 102
Table 5.17: U.S. Mammography Film-Based Instrument Market Manufacturer Share 103
Table 5.18: U.S. Film-Based Mammography Instrumentation Placements, 2002-2010 103
Table 5.19: European Mammography Film-Based Instrument Market, 2000-2010 104
Table 5.20: European Film-Based Mammography Instrumentation Placements, 2002-2010 104
Table 5.21: European Mammography Film-Based Instrument Market Manufacturer Share 105
Table 5.22: Japanese Mammography Film-Based Instrument Market, 2000-2010 105
Table 5.23: Japanese Film-Based Mammography Instrumentation Placements, 2002-2010 106
Table 5.24: Japanese Mammography Film-Based Instrument Market Manufacturer Share 106
Table 5.25: ROW Mammography Film-Based Instrument Market, 2000-2010 107
Table 5.26: ROW Film-Based Mammography Instrumentation Placements, 2002-2010 107
Table 5.27: Advantages of Digital Mammography 110
Table 5.28: Worldwide Digital General Radiography Market, 2000-2012 118
Table 5.29: Worldwide Market for Digital Mammography Systems Annual Unit Sales, 2000-2010 119
Table 5.30: Worldwide Market for Digital Mammography Systems, 2000-2010 119
Table 5.31: Worldwide Mammography Digital Instrumentation Placements, 2002-2010 119
Table 5.32: Worldwide Mammography Digital Instrument Market by Region, 2001-2010 120
Table 5.33: Share of Worldwide Market for Digital Mammography Systems by Competitor 120
Table 5.34: U.S. Mammography Digital Instrument Market, 2001-2010 120
Table 5.35: U.S. Digital Mammography Instrumentation Placements, 2002-2010 121
Table 5.36: European Mammography Digital Instrument Market, 2001-2010 121
Table 5.37: European Digital Mammography Instrumentation Placements, 2002-2010 123
Table 5.38: Japanese Mammography Digital Instrument Market, 2001-2010 123
Table 5.39: Japanese Digital Mammography Instrumentation Placements, 2002-2010 124
Table 9.1: Products Marketed By Abbott in the Diagnostic Market 147
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