Women's Health: Diagnostic Testing - Biotechnology, Healthcare and Life Sciences Publishing

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Women's Health: Diagnostic Testing
Publication Date: 01-AUG-08
Pages: 189
Study: TMWH
Format/Price: PDF document / $3,400.00

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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.

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 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 20
3.3.2 U.K. Women's Care Testing Diagnostic Market 22
3.3.2.1 U.K. Market Statistics 23
3.3.2.2 U.K. Competitive Analysis 23
3.3.2.3 U.K. Market Access 25
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 29
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 43
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 53
4.5.2 CA 27-29 53
4.5.3 BRCA1 Breast and Ovarian Cancer Gene 53
4.5.4 BRCA2 Breast Cancer Gene 53
4.5.5 Tissue polypeptide antigen (TPA) 55
4.5.6 DNA Ploidy and S-phase Fraction 55
4.5.7 Estrogen and Progesterone Receptor (ER and PR) 55
4.5.8 HER-2 55
4.5.9 HER-2 and Herceptin 56
4.5.10 p53 56
4.5.11 NMP66 56
4.5.12 Mammastatin 57
4.6 Ovarian Cancer 57
4.6.1 CA 125 II™ 57
4.6.2 Steroid Hormone Receptors 59
4.6.3 Epidermal Growth Factor Receptor (EGFR) 59
4.6.4 HER-2/neu 59
4.6.5 P53 Tumor Suppressor Gene 59
4.6.6 Lysophospholipids 59
4.7 Cervical Cancer 60
4.7.1 Pap Smears 61
4.7.2 Human Papillomavirus (HPV) Testing 64
4.8 Miscellaneous Testing 68
4.8.1 Estriol 68
4.8.2 Fetal Fibronectin (fFN) 69
4.8.3 Vaginal pH and Vaginitis 69
4.9 Human Immunodeficiency Virus (HIV) 70
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 89
5.2.1 Introduction 89
5.2.2 World Mammography Markets Revenue 89
5.2.3 Mammography Markets by Region 90
5.2.4 Total Market Share 90
5.2.5 Competitive Structure 90
5.3 Market Opportunities 91
5.3.1 Resource Management for Mammography Markets 91
5.3.2 Movement to Higher Reimbursement Rates 91
5.3.3 Market Benchmarks for Increased Mammography Utilization 91
5.4 Market Analysis 92
5.4.1 Strategic Partnerships 92
5.4.2 Long Term Trends 92
5.5 Strategic Outlook 92
5.5.1 Competitive Elements of Mammography Markets 92
5.5.2 Higher Reimbursement Rates 92
5.5.3 Volume Requirements 93
5.5.4 Product Innovation 93
5.5.5 Product Leadership 93
5.5.6 Product Line Strategy 93
5.5.7 Pricing Strategy & Reimbursement 93
5.5.8 Strategic Partnerships 95
5.6 Film-Based Mammography Market 97
5.6.1 Market Overview 97
5.6.1.1 Unit and Revenue Forecasts 97
5.6.1.2 Product Analysis 98
5.6.2 Market Drivers 99
5.6.3 Market Restraints 99
5.6.4 Film-Based Mammography Market and Technology Trends 100
5.6.5 U.S. Market for Film-Based Screening Systems 100
5.6.5.1 Unit Shipment and Revenue Forecasts 101
5.6.5.2 Competitive Analysis 101
5.6.5.3 U.S. Installed Base Analysis 101
5.6.6 European Market for Film-Based Mammography Systems 102
5.6.6.1 Unit Shipment and Revenue Forecasts 102
5.6.6.2 Competitive Analysis 102
5.6.6.3 Installed Base Analysis 103
5.6.7 Japanese (Pacific Rim) Market for Film-based Mammography Systems 103
5.6.7.2 Competitive Analysis 103
5.6.7.3 Installed Base Analysis 104
5.6.8 Rest of the World Market for Film-based Mammography Systems 105
5.6.8.1 Unit Shipment and Revenue Forecasts 105
5.6.8.2 Installed Base Analysis 105
5.7 Digital X-Ray Mammography Market 105
5.7.1 Digital Mammography Overview 105
5.7.2 Market Overview 107
5.7.3 Product Background 108
5.7.4 Product Description 108
5.7.5 Market Drivers 114
5.7.6 Market Restraints 115
5.7.7 Unit Shipment and Revenue Forecasts 117
5.7.8 Percentage Breakdown of Revenues by Region 118
5.7.9 Market Share 119
5.7.10 U.S. Market for Digital Mammography Systems 119
5.7.10.1 U.S. Sales 119
5.7.10.2 Competitive Analysis 120
5.7.11 European Market for Digital Mammography Systems 120
5.7.11.1 Unit Shipment and Revenue Forecasts 121
5.7.11.2 Competitive Analysis 121
5.7.11.3 Installed Base Analysis 122
5.7.12 Japanese (Pacific Rim) Market for Digital Mammography Systems 122
5.7.12.1 Unit Shipment and Revenue Forecasts 122
5.7.12.2 Competitive Analysis 122
5.7.12.3 Installed Base Analysis 123
6.0 Women's Health Testing: Growth Regulators 124
6.1 Moderators of Growth 124
6.2 Personnel Acceptance 125
6.3 Key People for Women's Health Testing 125
6.4 Key Elements for Women's Health Testing 125
6.5 Women's Health Testing and Reimbursement 126
6.6 Rapid Near-Patient Testing in Hospitals 127
6.7 Satellite Facilities 128
6.8 Regionalization of Laboratory Care 128
6.9 Requirements for Women's Health Testing 129
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 134
7.5 Government Regulation 135
7.5.1 U.S. Regulation 135
7.5.1.1 Importing Medical Devices into the U.S. 136
7.5.1.2 Exporting Medical Devices from the U.S. 137
7.5.2 U.K. Regulation 137
7.5.3 E.U. Regulation 139
7.5.4 Japanese Regulation 140
7.6 Increased Market Penetration 141
7.7 Legal Issues 141
8.0 Important Technology Trends 142
9.0 Company Profiles 144
9.1 Abbott Diagnostics 144
9.2 Accurex Biomedical, Pvt., Ltd 147
9.3 Adeza Biomedical Corporation (Acquired by Hologic) 147
9.4 Agfa-Gevaert Corporation 147
9.5 Ambri Ltd. 147
9.6 American Biomedica Corp. 148
9.7 Avitar Inc. 149
9.8 Axis-Shield 150
9.9 Bayer Corporation Diagnostics Division (Acquired by Siemens) 150
9.10 Becton Dickinson 150
9.11 Biomerica 151
9.12 Carestream Health 152
9.13 CMT Medical Systems 152
9.14 Cozart Biosciences (Acquired by Concateno PLC) 153
9.15 Cytyc Corporation 153
9.16 Dalsa 153
9.17 Denka Seiken Co., Ltd. 153
9.18 DiaDexus LLC 153
9.19 Enterix, Inc. (Acquired by Quest Diagnostics) 154
9.20 Fischer Imaging (Acquired by Hologic) 154
9.21 FujiFilm Medical Systems 154
9.22 General Electric Healthcare 155
9.23 Genzyme Diagnostics 156
9.24 Hologic Inc. 158
9.25 iCAD, Inc. 160
9.26 Imaging Diagnostic Systems Inc. 160
9.27 Inverness Medical Innovations 161
9.28 Johnson & Johnson 165
9.29 Kyowa Medex Co., Ltd. 167
9.30 L-3 Titan Group 167
9.31 LifePoint, Inc. 167
9.32 LifeScan Corporation 168
9.33 Matritech 168
9.34 Medix Biochemica 170
9.35 Mitsubishi Kagaku Iatron 170
9.36 Myraid Genetics 170
9.37 OraSure Technologies, Inc. 171
9.38 Polymedco 174
9.39 Procrea 175
9.40 QIAGEN 175
9.41 Quidel 176
9.42 Rad-Icon Imaging Corp 179
9.43 Roche Diagnostics 179
9.44 Scanis Inc. 179
9.45 Sectra Imtec AB 180
9.46 Shanghai Kehua Bioengineering Co., Ltd. 180
9.47 Siemens Healthcare 180
9.48 TriPath Imaging (Acquired by BD) 181
9.49 Vidar Systems Corp. 181
10.0 Appendices 182
10.1 Digital Database for Screening Mammography (DDSM) 182
10.2 Sources of National Cancer Institute Information 182
10.3 Screening Mammograms: Questions and Answers 182
10.4 FDA Rule: State Certification of Mammography Facilities 188
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: U.S. Clinical Diagnostic Women's Test Market Segments 2005 16
Table 3.5: Regional Comparison Healthcare and IVD 19
Table 3.6: European Women's Care Testing Market, 2000-2012 19
Table 3.7: European Women's Care Testing Diagnostics Market 20
Table 3.8: German Women's Care Testing Diagnostics Products Market Sales, 2000-2012 20
Table 3.9: The German Patient Care Laboratory Test Market, 2000-2012 21
Table 3.10: The German Alternate Site Testing Market, 2000-2012 21
Table 3.11: The German Hospital Point of Care Market, 2000-2012 21
Table 3.12: German Clinical Diagnostic Rapid Women's Test Market Segments 22
Table 3.13: U.K. Women's Health Diagnostics Products Market Sales, 2006-2012 23
Table 3.14: Major U.K. IVD Manufacturers 24
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 Kingdom 24
Table 3.17: French Women's Health Diagnostics Products Market Sales, 2000-2012 25
Table 3.18: Italian Women's Health Diagnostics Products Market Sales, 2000-2012 26
Table 3.19: Spanish Women's Heath Diagnostics Products Market Sales, 2000-2012 26
Table 3.20: Japan Women's Care Testing Market, 2000-2012 27
Table 3.21: Chinese Women's Care Diagnostics Products Market Sales, 2000-2012 27
Table 3.22: The ROW Women's Care Testing Market, 2000-2012 29
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: The 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 36
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 46
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 55
Table 4.24: HPV Risk Factors 65
Table 4.25: Relationship between HPV and Cervical Carcinoma 65
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 67
Table 4.29: Predictability of HPV Test by Abnormal Pap Smear Type 67
Table 4.30: Incidence of Cervical Cancer and Cytological Abnormalitie 67
Table 4.31: Long Term Trends in HPV Testing 68
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 71
Table 4.34: Births of HIV Infected Babies in U.S., 2002-2006 71
Table 4.35: U.S. Strep Testing Market Size, 2002-2012 73
Table 4.36: U.S. Market for Rapid Point of Care Strep Tests 73
Table 4.37: The U.S. Chlamydia Testing Market, 2000-2012 76
Table 4.38: 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, 2006 83
Table 5.3: U.S. Use of Mammography in Women Over 40, 1987-2005 85
Table 5.4: Annual Mammography Procedures in the U.S., 2000-2008 85
Table 5.5: Annual Mammography Procedures in Europe, 2002-2007 85
Table 5.6: Annual Mammography Procedures in Japan, 2002-2007 86
Table 5.7: Annual Mammography Procedures in the Rest of the World, 2002-2007 86
Table 5.8: U.S. Mammography Facts, 2005 87
Table 5.9: Breast Cancer Survival Rates by Country 87
Table 5.10: Surgical Biopsies Performed in the U.S., 2000-2007 88
Table 5.11: The Worldwide Mammography Instrument Market, 2000-2010 89
Table 5.12: Worldwide Mammography Instrumentation Placements, 2002-2010 90
Table 5.13: Worldwide Film-Based Mammography Instrumentation Placements, 2002-2010 97
Table 5.14: Worldwide Mammography Film-Based Instrument Market, 2000-2010 98
Table 5.15: Worldwide Mammography Film-Based Instrument Market by Region, 2000-2010 100
Table 5.16: U.S. Mammography Film-Based Instrument Market, 2000-2010 101
Table 5.17: U.S. Mammography Film-Based Instrument Market Manufacturer Share 101
Table 5.18: U.S. Film-Based Mammography Instrumentation Placements, 2002-2010 101
Table 5.19: European Mammography Film-Based Instrument Market, 2000-2010 102
Table 5.20: European Film-Based Mammography Instrumentation Placements, 2002-2010 103
Table 5.21: European Mammography Film-Based Instrument Market Manufacturer Share 103
Table 5.22: Japanese Mammography Film-Based Instrument Market, 2000-2010 103
Table 5.23: Japanese Film-Based Mammography Instrumentation Placements, 2002-2010 104
Table 5.24: Japanese Mammography Film-Based Instrument Market Manufacturer Share 105
Table 5.25: ROW Mammography Film-Based Instrument Market, 2000-2010 105
Table 5.26: ROW Film-Based Mammography Instrumentation Placements, 2002-2010 105
Table 5.27: Advantages of Digital Mammography 108
Table 5.28: Worldwide Digital General Radiography Market, 2000-2012 117
Table 5.29: Worldwide Market for Digital Mammography Systems Annual Unit Sales, 2000-2010 117
Table 5.30: Worldwide Market for Digital Mammography Systems, 2000-2010 118
Table 5.31: Worldwide Mammography Digital Instrumentation Placements, 2002-2010 118
Table 5.32: Worldwide Mammography Digital Instrument Market by Region, 2001-2010 119
Table 5.33: Share of Worldwide Market for Digital Mammography Systems by Competitor 119
Table 5.34: U.S. Mammography Digital Instrument Market, 2001-2010 119
Table 5.35: U.S. Digital Mammography Instrumentation Placements, 2002-2010 120
Table 5.36: European Mammography Digital Instrument Market, 2001-2010 121
Table 5.37: European Digital Mammography Instrumentation Placements, 2002-2010 122
Table 5.38: Japanese Mammography Digital Instrument Market, 2001-2007 122
Table 5.39: Japanese Digital Mammography Instrumentation Placements, 2002-2010 123
Table 9.1: Products Marketed By Abbott in the Diagnostic Market 146

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