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

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Report Description

Women's Health: Diagnostic Tests
Publication Date: 06-DEC-04
Pages: 193
Study: TMWH
Format/Price: PDF document / $999.00

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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 8
1.1 Statement of Report 8
1.2 Scope of this Report 8
1.3 Methodology 9
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
3.1.1.2 Market Segments for Women's Health Testing 13
3.1.1.3 Key Players in the Women's Health Diagnostics Testing Segment 14
3.1.1.4 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 Description of the 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 24
3.3.2.3 U.K. Market Access 25
3.3.3 French Women's Care Diagnostic Market 25
3.3.4 Italian POC Diagnostic Market 25
3.3.5 Spanish POC Diagnostic Market 25
3.4 Japanese Women's Care Testing Market 26
3.5 Chinese Women's Care Market 26
3.6 Rest of the World Women's Care Testing Market 28
3.7 Women's Health Testing Individual Markets 28
3.7.1 Pregnancy Testing 28
3.7.2 Osteoporosis Testing 32
3.7.2.1 In Vitro Blood Tests 36
3.7.2.2 Bone Densitometry Devices 38
3.7.3 Prenatal Screening Testing 40
3.7.4 Fertility Testing 44
3.7.5 Drugs of Abuse Screening 47
3.7.5.1 Acetaminophen 49
3.7.5.2 Tricyclic Antidepressants 49
3.7.5.3 Other Toxic Drugs 49
3.7.5.4 Drug Testing Selectivity 50
3.7.5.5 Methaqualone and Phencyclidine (PCP) 50
3.7.5.6 Tetrahydrocannabinol (THC) 50
3.7.5.7 Drug Panels by Toxidromes 50
3.7.6 Urine Strip Testing 55
3.7.7 Cancer Testing 56
3.7.7.1 Breast Cancer 56
3.7.7.2 CA 15-3 57
3.7.7.3 CA 27-29 57
3.7.7.4 BRCA1 Breast and Ovarian Cancer Gene 57
3.7.7.5 HER-2 59
3.7.7.6 HER-2 and Herceptin 60
3.7.7.7 p53 60
3.7.7.8 NMP66 60
3.7.7.9 Mammastatin 60
3.7.7.10 Ovarian Cancer 61
3.7.7.11 Steroid Hormone Receptors 62
3.7.7.11.1 Epidermal Growth Factor Receptor (EGF-R) 63
3.7.7.12 Cervical Cancer 64
3.7.8 Human Papillomavirus (HPV) Testing 65
3.7.9 Hemoglobin Testing 68
3.7.10 Miscellaneous Testing 68
3.7.10.1 Estriol 68
3.7.10.2 Fetal Fibronectin 69
3.7.10.3 Vaginal pH and Vaginitis 70
3.7.11 HIV 70
3.7.12 Pap Smears 71
3.7.13 Infectious Disease Testing 75
3.7.13.1 Strep Testing 75
3.7.13.2 Chlamydia 78
3.7.13.3 Mononucleosis 79
3.7.13.4 Rubella 80
3.7.13.5 Staphylococcus Aurea 81
3.7.13.6 Hepatitis 81
3.7.13.7 Gonorrhea 85
3.7.13.8 Urinary Tract Infections 86
3.7.14 Infant Jaundice 86
3.7.15 Prenatal Genetic Testing 87
4.0 World Mammography Market 89
4.1 Market Overview 89
4.1.1 Mammography 89
4.1.2 Digital Mammography 94
5.0 World Mammography Market 96
5.1 Market Overview 96
5.1.1 Introduction 96
5.1.2 World Mammography Markets Revenue 96
5.1.3 Mammography Markets by Region 97
5.1.4 Total Market Share 97
5.1.5 Competitive Structure 97
5.2 Market Opportunities 97
5.2.1 Resource Management for Mammography Markets 97
5.2.2 Movement to Higher Reimbursement Rates 98
5.2.3 Market Benchmarks for Increased Mammography Utilization 98
5.4 Strategic Outlook 98
5.4.1 Competitive Elements of Mammography Markets 98
5.4.2 Higher Reimbursement Rates 99
5.4.3 Volume Requirements 99
5.4.4 Product Innovation 99
5.4.5 Product Leadership 100
5.4.6 Product Line Strategy 100
5.4.7 Pricing Strategy & Reimbursement 100
5.4.8 Strategic Partnerships 101
5.5 Film-Based Mammography Market 103
5.5.1 Market Overview 103
5.5.2 Market Drivers 105
5.5.3 Market Restraints 105
5.5.4 Film-Based Mammography Market and Technology Trends 106
5.5.5 U.S. Market for Film-Based Screening Systems 106
5.5.6 Unit Shipment and Revenue Forecasts 106
6.0 Competitive Analysis 107
6.1 U.S. Installed Base Analysis 107
6.2 European Market for Film-Based Mammography Systems 107
6.2.1 Unit Shipment and Revenue Forecasts 107
7.0 Competitive Analysis 108
7.1 Installed Base Analysis 108
7.2 Japanese (Pacific Rim) Market for Analog Screening Systems 108
8.0 Competitive Analysis 109
8.1 Installed Base Analysis 110
9.0 Rest of the World Market for Analog Screening Systems 111
9.1 Unit Shipment and Revenue Forecasts 111
9.2 Installed Base Analysis 111
10.0 Digital X-Ray Mammography Market 112
10.1 Market Overview 112
10.2 Product Background 113
10.3 Product Description 114
11.0 Market Drivers 119
12.0 Market Restraints 120
13.0 Unit Shipment and Revenue Forecasts 122
14.0 Percentage Breakdown of Revenues by Region 124
14.1 Market Share 124
15.0 U.S. Market for Digital Mammography Systems 125
15.1 U.S. Sales 125
15.2 Competitive Analysis 125
16.0 European Market for Digital Mammography Systems 126
16.1 Unit Shipment and Revenue Forecasts 126
16.2 Competitive Analysis 126
16.3 Installed Base Analysis 127
17.0 Japanese (Pacific Rim) Market for Digital Mammography Systems 128
17.1 Unit Shipment and Revenue Forecasts 128
17.2 Competitive Analysis 128
17.3 Installed Base Analysis 128
18.0 Women's Health Testing: Growth Regulators 129
18.1 Moderators of Growth 129
18.2 Personnel Acceptance 130
18.3 Key People for Women's Health Testing 130
18.4 Key Elements for Women's Health Testing 130
18.5 Women's Health Testing and Reimbursement 131
18.6 Rapid Near Patient Testing in Hospitals 132
18.7 Satellite Facilities 133
18.8 Regionalization of Laboratory Care 133
18.9 Requirements for Women's Health Testing 134
18.10 Clinical Laboratory Improvement Act of 1988 (CLIA) 135
19.0 Business Trends in the Industry 137
19.1 Sector Consolidation 137
19.2 Diagnostic Testing Growth Trends 137
19.3 Acquisition, License Agreements, Internal Development, Partnerships 137
19.4 Product Testing Depth in Women's Health Testing 139
19.5 Government Regulation 140
19.5.1 U.S. Regulation 140
19.5.1.1 Importing Medical Devices into the U.S. 141
19.5.1.2 Exporting Medical Devices from the U.S. 142
19.5.2 U.K. Regulation 142
19.5.3 E.U. Regulation 143
19.5.4 Japanese Regulation 145
19.6 Increased Market Penetration 145
19.7 Legal Issues 146
20.0 Important Technology Trends 147
21.0 Company Profiles 149
21.1 TriPath Imaging 149
21.2 LifeScan Corporation 150
21.3 OraSure 150
21.4 Bayer Corporation 151
21.5 Abbott Diagnostics 154
21.6 Cytyc Corporation 157
21.7 Inverness Medical Innovations 157
21.8 Johnson & Johnson 159
21.9 Quidel 160
21.10 Biomerica 162
21.11 Genzyme Diagnostics 163
21.12 Adeza Biomedical Corporation 164
21.13 Jiangnan Biotech 165
21.14 DiaDexus LLC 165
21.15 Digene 166
21.16 Matritech 166
21.17 General Electric Medical Systems 168
21.18 Dalsa 169
21.19 Icad, Inc. 169
21.20 Imaging Diagnostic Systems Inc. 170
21.21 FujiFilm Medical Systems 171
21.22 Fischer Imaging 171
21.23 Instrumentarium Imaging, Inc. 171
21.24 Hologic Inc. 172
21.25 Agfa-Gevaert Corporation 173
21.26 Sectra Imtec AB 174
21.27 R2 Technology, Inc 174
21.28 Rad-Icon Imaging Corp 175
21.29 Kodak Health Imaging Division 175
21.30 Siemens Medical Solutions 176
21.31 CADx Medical Systems 176
21.32 Vidar Systems Corp. 176
21.33 CMT Medical Systems 176
21.34 DBA Systems 177
21.35 Scanis Inc. 177
21.36 SmartLight 178
21.37 Diagnostic Imaging Systems 178
21.38 Roche Diagnostics 178
21.39 Myraid Genetics 178
21.40 Shanghai SIIC Kehua Biotech Co., Ltd. (Kehua Biotech) 180
21.41 LifePoint, Inc. 180
21.41 Avitar Inc. 180
21.42 Cozart Biosciences 181
21.43 Enterix, Inc. 181
21.44 Kyowa Medex Co., Ltd. 181
21.45 Iatron 181
21.46 Denka Seiken Co., Ltd. 181
21.47 Accurex Biomedical, Pvt., Ltd 181
21.48 Ambri Ltd. 182
21.49 Thermo Biostar 182
21.50 Axis-Shield 182
21.51 Polymedco 183
21.52 Medix Biochemica 183
21.53 Pheromone Sciences 184
21.54 Ostex International, Inc. 184
21.55 Procrea 184
21.56 American Biomedica Corp. 185
22.0 Appendices 187
22.1 Digital Database for Screening Mammography (DDSM) 187
22.2 Sources of National Cancer Institute Information 187
22.3 Screening Mammograms: Questions and Answers 187
22.4 FDA Rule: State Certification of Mammography Facilities 192
INDEX OF TABLES
Table 1: Worldwide Market Share In Vitro Diagnostic Companies 11
Table 2: Worldwide In Vitro Diagnostics Market Size 2001-2007 11
Table 3: Worldwide In Vitro Central Laboratory Diagnostic Testing 2001-2007 12
Table 4: Worldwide Near Patient Diagnostic Testing 2001-2007 12
Table 5: Top Drugstore Retailers in the U.S. 13
Table 6: Top Drugstore Wholesalers in the U.S. 13
Table 7: U.S. Women's Health Diagnostics Products Market Sales 1992-2008 16
Table 8: U.S. Clinical Diagnostic Women's Test Market Segments 2002 16
Table 9: Self-Perceived Health Status for European Women 65-74 Years 18
Table 10: Percentage with Disability Due to Long-Standing Illness for European Women 65+ Years 18
Table 11: Regional Comparison Healthcare and IVD 20
Table 12: European Women's Care Testing Market 20
Table 13: European Women's Care Testing Diagnostics Market 20
Table 14: German Women's Care Testing Diagnostics Products Market Sales 20
Table 15: The German Patient Care Laboratory Test Market 21
Table 16: The German Alternate Site Testing Market 21
Table 17: The German Hospital Point of Care Market 21
Table 18: German Clinical Diagnostic Test Market Segments 2002, Revenue from Clinical Laboratory Testing 21
Table 19: German Clinical Diagnostic Rapid Women's Test Market Segments 2002 22
Table 20: The U.K. IVD Market 23
Table 21: U.K. Women's Health Diagnostics Products Market Sales 23
Table 22: Major U.K. IVD Manufacturers 24
Table 23: U.S. IVD Manufacturers Doing Business in the U.K. 24
Table 24: Other European Companies that Manufacture IVD Products in the United Kingdom 24
Table 25: French Women's Health Diagnostics Products Market Sales 25
Table 26: Italian Women's Health Diagnostics Products Market Sales 25
Table 27: Spanish Women's Heath Diagnostics Products Market Sales 26
Table 28: Japan Women's Care Testing Market 26
Table 29: Chinese Women's Care Diagnostics Products Market Sales 26
Table 30: The ROW Women's Care Testing Market 28
Table 31: U.S. Women's Health Testing Pregnancy Testing Market 28
Table 32: U.S. Market Share for Rapid Women's Health Testing Pregnancy Tests 28
Table 33: The Pregnancy Test Market for OTC Testing in the U.S. 29
Table 34: Home Pregnancy Tests Available in the U.S. Market 30
Table 35: Osteoporosis Risk Factors that Cannot Be Changed 32
Table 36: Osteoporosis Risk Factors that Can Be Changed 33
Table 37: Prenatal Screening Types 40
Table 38: History: Parental Genetic Traits 40
Table 39: Female Factor Infertility 40
Table 40: Frequency of Mutation Based Upon Ethnicity 40
Table 41: CF Carrier Risk by Ethnic Group 41
Table 42: Reasons for CF Testing 41
Table 43: CF Testing Methodology 41
Table 44: CF Gene Detection Rates Vary by Ethnic Background 41
Table 45: Global Market for CF Diagnostic Testing 42
Table 46: U.S. Market for CF Diagnostic Testing 42
Table 47: Commercial CF Screening Products 42
Table 48: Emerging CF Screening Products 42
Table 49: CF Screening Technology Summary 42
Table 50: Future Trends in Prenatal Genetic Testing 44
Table 51: The Fertility Testing Market in the U.S. 44
Table 52: Ovulation Predictors 46
Table 53: U.S. Point of Care Drugs of Abuse Testing Market 47
Table 54: Global Urine Strip Market 56
Table 55: The Glucose Market for OTC Testing in the U.S. 56
Table 56: TPA Marker Sensitivity 59
Table 57: Facts about HPV Risk Factors 65
Table 58: Relationship Between HPV and Cervical Carcinoma 66
Table 59: HPV and Cervical Carcinoma Risk 66
Table 60: Rationale for Reflex HPV Testing with Cytology 67
Table 61: Rationale Against Reflex HPV Testing with Cytology 67
Table 62: Predictability of HPV Test by Abnormal Pap Smear Type 67
Table 63: Incidence of Cervical Cancer and Cytological Abnormalities 67
Table 64: Long Term Trends in HPV Testing 68
Table 65: U.S. Women's Health Testing Market for HIV 70
Table 66: Countries with the Highest Prevalence of HIV / AIDS 70
Table 67: Births of HIV Infected Babies in U.S. 1991-2000 71
Table 68: U.S. Strep Testing Market Size 75
Table 69: U.S. Market for Rapid Point of Care StrepTests 76
Table 70: The U.S. Chlamydia Testing Market 78
Table 71: Summary of Hepatitis Test Technology 84
Table 72: Genetic Screening During Pregnancy 87
Table 73: Ultrasound Screening 88
Table 74: U.S. Healthcare Expenditures 89
Table 75: Spending on Health by Country 89
Table 76: U.S. Use of Mammography in Women Over 40 90
Table 77: Annual Mammography Procedures in the U.S. 91
Table 78: Annual Mammography Procedures in Europe 91
Table 79: Annual Mammography Procedures in Japan 91
Table 80: Annual Mammography Procedures in the Rest of the World 92
Table 81: U.S. Mammography Facts 92
Table 82: Breast Cancer Survival Rates by Country 93
Table 83: Surgical Biopsies Performed in the U.S. 93
Table 84: Benefits of Digital Mammography 95
Table 85: The Worldwide Mammography Instrument Market 96
Table 86: Worldwide Mammography Instrumentation Placements 97
Table 87: Worldwide Film-Based Mammography Instrumentation Placements 103
Table 88: Worldwide Mammography Film-Based Instrument Market 104
Table 89: Worldwide Mammography Film-Based Instrument Market by Region 106
Table 90: U.S. Mammography Film-Based Instrument Market 106
Table 91: U.S. Mammography Film-Based Instrument Market Manufacturer Share 106
Table 92: U.S. Film-Based Mammography Instrumentation Placements 107
Table 93: European Mammography Film-Based Instrument Market 107
Table 94: European Film-Based Mammography Instrumentation Placements 108
Table 95: European Mammography Film-Based Instrument Market Manufacturer Share 108
Table 96: Japanese Mammography Film-Based Instrument Market 108
Table 97: Japanese Film-Based Mammography Instrumentation Placements 110
Table 98: Japanese Mammography Film-Based Instrument Market Manufacturer Share 110
Table 99: ROW Mammography Film-Based Instrument Market 111
Table 100: ROW Film-Based Mammography Instrumentation Placements 111
Table 101: Advantages of Digital Mammography 113
Table 102: Worldwide Digital General Radiography Market 122
Table 103: Worldwide Market for Digital Mammography Systems Annual Unit Sales 122
Table 104: Worldwide Market for Digital Mammography Systems 122
Table 105: Worldwide Mammography Digital Instrumentation Placements 123
Table 106: Worldwide Mammography Digital Instrument Market by Region 124
Table 107: Share of Worldwide Market for Digital Mammography Systems by Competitor 124
Table 108: U.S. Mammography Digital Instrument Market 125
Table 109: U.S. Digital Mammography Instrumentation Placements 125
Table 110: European Mammography Digital Instrument Market 126
Table 111: European Digital Mammography Instrumentation Placements 127
Table 112: Japanese Mammography Digital Instrument Market 128
Table 113: Japanese Digital Mammography Instrumentation Placements 128
Table 114: Products Marketed By Abbott in the Diagnostic Market 156

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