The purpose of this report is to describe the specific segment of the in vitro diagnostics (IVDs) market called womens 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 doctors 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 womens 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 womens 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 womens health. This study concentrates on the womens health testing market segment in important worldwide markets such as the U.S., Japan and Europe.

Table of Contents :
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 Womens Health Testing Market Analysis in Size, Growth and Share 13
3.1 Global Womens Health Testing Markets 13
3.1.1 Market Drivers in the Womens Health Diagnostics Testing Sector 13
3.1.1.1 Market Segments for Womens Health Testing 13
3.1.1.2 Key Players in the Womens Health Diagnostics Testing Segment 14
3.1.1.3 Womens Health Testing Sector Analysis 15
3.2 U.S. Womens Health Testing Market 15
3.2.1 Market Overview 15
3.2.2 Diagnostic Test Categories 16
3.3 European Womens Health Diagnostic Test Market 17
3.3.1 German Womens Care Diagnostic Market 19
3.3.2 U.K. Womens 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 Womens Care Diagnostic Market 25
3.3.4 Italian Womens Care Diagnostic Market 25
3.3.5 Spanish Womens Care Diagnostic Market 26
3.4 Japanese Womens Care Testing Market 26
3.5 Chinese Womens Care Market 27
3.6 Rest of the World Womens Care Testing Market 28

4.0 Womens 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 Womens Health Testing: Growth Regulators 125
6.1 Moderators of Growth 125
6.2 Personnel Acceptance 125
6.3 Key People for Womens Health Testing 126
6.4 Key Elements for Womens Health Testing 126
6.5 Womens 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 Womens 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 Womens 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

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