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Women's Health: Diagnostic Tests

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 Overview8
• 1.1 Statement of Report8
• 1.2 Scope of this Report8
• 1.3 Methodology9
• 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
    • 3.1.1.2 Market Segments for Women's Health Testing13
    • 3.1.1.3 Key Players in the Women's Health Diagnostics Testing Segment14
    • 3.1.1.4 Women's Health Testing Sector Analysis15
• 3.2 U.S. Women's Health Testing Market15
  • 3.2.1 Market Overview15
  • 3.2.2 Diagnostic Test Categories16
• 3.3 Description of the 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 Analysis24
    • 3.3.2.3 U.K. Market Access25
  • 3.3.3 French Women's Care Diagnostic Market25
  • 3.3.4 Italian POC Diagnostic Market25
  • 3.3.5 Spanish POC Diagnostic Market25
• 3.4 Japanese Women's Care Testing Market26
• 3.5 Chinese Women's Care Market26
• 3.6 Rest of the World Women's Care Testing Market28
• 3.7 Women's Health Testing Individual Markets28
  • 3.7.1 Pregnancy Testing28
  • 3.7.2 Osteoporosis Testing32
    • 3.7.2.1 In Vitro Blood Tests36
    • 3.7.2.2 Bone Densitometry Devices38
  • 3.7.3 Prenatal Screening Testing40
  • 3.7.4 Fertility Testing44
  • 3.7.5 Drugs of Abuse Screening47
    • 3.7.5.1 Acetaminophen49
    • 3.7.5.2 Tricyclic Antidepressants49
    • 3.7.5.3 Other Toxic Drugs49
    • 3.7.5.4 Drug Testing Selectivity50
    • 3.7.5.5 Methaqualone and Phencyclidine (PCP)50
    • 3.7.5.6 Tetrahydrocannabinol (THC)50
    • 3.7.5.7 Drug Panels by Toxidromes50
  • 3.7.6 Urine Strip Testing55
  • 3.7.7 Cancer Testing56
    • 3.7.7.1 Breast Cancer56
    • 3.7.7.2 CA 15-357
    • 3.7.7.3 CA 27-2957
    • 3.7.7.4 BRCA1 Breast and Ovarian Cancer Gene57
    • 3.7.7.5 HER-259
    • 3.7.7.6 HER-2 and Herceptin60
    • 3.7.7.7 p5360
    • 3.7.7.8 NMP6660
    • 3.7.7.9 Mammastatin60
    • 3.7.7.10 Ovarian Cancer61
    • 3.7.7.11 Steroid Hormone Receptors62
      • 3.7.7.11.1 Epidermal Growth Factor Receptor (EGF-R)63
    • 3.7.7.12 Cervical Cancer64
  • 3.7.8 Human Papillomavirus (HPV) Testing65
  • 3.7.9 Hemoglobin Testing68
  • 3.7.10 Miscellaneous Testing68
    • 3.7.10.1 Estriol68
    • 3.7.10.2 Fetal Fibronectin69
    • 3.7.10.3 Vaginal pH and Vaginitis70
  • 3.7.11 HIV70
  • 3.7.12 Pap Smears71
  • 3.7.13 Infectious Disease Testing75
    • 3.7.13.1 Strep Testing75
    • 3.7.13.2 Chlamydia78
    • 3.7.13.3 Mononucleosis79
    • 3.7.13.4 Rubella80
    • 3.7.13.5 Staphylococcus Aurea81
    • 3.7.13.6 Hepatitis81
    • 3.7.13.7 Gonorrhea85
    • 3.7.13.8 Urinary Tract Infections86
  • 3.7.14 Infant Jaundice86
  • 3.7.15 Prenatal Genetic Testing87
  
  
• 4.0 World Mammography Market89
• 4.1 Market Overview89
  • 4.1.1 Mammography89
  • 4.1.2 Digital Mammography94
  
  
• 5.0 World Mammography Market96
• 5.1 Market Overview96
  • 5.1.1 Introduction96
  • 5.1.2 World Mammography Markets Revenue96
  • 5.1.3 Mammography Markets by Region97
  • 5.1.4 Total Market Share97
  • 5.1.5 Competitive Structure97
• 5.2 Market Opportunities97
  • 5.2.1 Resource Management for Mammography Markets97
  • 5.2.2 Movement to Higher Reimbursement Rates98
  • 5.2.3 Market Benchmarks for Increased Mammography Utilization98
• 5.4 Strategic Outlook98
  • 5.4.1 Competitive Elements of Mammography Markets98
  • 5.4.2 Higher Reimbursement Rates99
  • 5.4.3 Volume Requirements99
  • 5.4.4 Product Innovation99
  • 5.4.5 Product Leadership100
  • 5.4.6 Product Line Strategy100
  • 5.4.7 Pricing Strategy & Reimbursement100
  • 5.4.8 Strategic Partnerships101
• 5.5 Film-Based Mammography Market103
  • 5.5.1 Market Overview103
  • 5.5.2 Market Drivers105
  • 5.5.3 Market Restraints105
  • 5.5.4 Film-Based Mammography Market and Technology Trends106
  • 5.5.5 U.S. Market for Film-Based Screening Systems106
  • 5.5.6 Unit Shipment and Revenue Forecasts106
  
  
• 6.0 Competitive Analysis107
• 6.1 U.S. Installed Base Analysis107
• 6.2 European Market for Film-Based Mammography Systems107
  • 6.2.1 Unit Shipment and Revenue Forecasts107
  
  
• 7.0 Competitive Analysis108
• 7.1 Installed Base Analysis108
• 7.2 Japanese (Pacific Rim) Market for Analog Screening Systems108


• 8.0 Competitive Analysis109
• 8.1 Installed Base Analysis110


• 9.0 Rest of the World Market for Analog Screening Systems111
• 9.1 Unit Shipment and Revenue Forecasts111
• 9.2 Installed Base Analysis111


• 10.0 Digital X-Ray Mammography Market112
• 10.1 Market Overview112
• 10.2 Product Background113
• 10.3 Product Description114


• 11.0 Market Drivers119


• 12.0 Market Restraints120


• 13.0 Unit Shipment and Revenue Forecasts122


• 14.0 Percentage Breakdown of Revenues by Region124


• 14.1 Market Share124


• 15.0 U.S. Market for Digital Mammography Systems125
• 15.1 U.S. Sales125
• 15.2 Competitive Analysis125


• 16.0 European Market for Digital Mammography Systems126
• 16.1 Unit Shipment and Revenue Forecasts126
• 16.2 Competitive Analysis126
• 16.3 Installed Base Analysis127


• 17.0 Japanese (Pacific Rim) Market for Digital Mammography Systems128
• 17.1 Unit Shipment and Revenue Forecasts128
• 17.2 Competitive Analysis128
• 17.3 Installed Base Analysis128


• 18.0 Women's Health Testing: Growth Regulators129
• 18.1 Moderators of Growth129
• 18.2 Personnel Acceptance130
• 18.3 Key People for Women's Health Testing130
• 18.4 Key Elements for Women's Health Testing130
• 18.5 Women's Health Testing and Reimbursement131
• 18.6 Rapid Near Patient Testing in Hospitals132
• 18.7 Satellite Facilities133
• 18.8 Regionalization of Laboratory Care133
• 18.9 Requirements for Women's Health Testing134
• 18.10 Clinical Laboratory Improvement Act of 1988 (CLIA)135


• 19.0 Business Trends in the Industry137
• 19.1 Sector Consolidation137
• 19.2 Diagnostic Testing Growth Trends137
• 19.3 Acquisition, License Agreements, Internal Development, Partnerships137
• 19.4 Product Testing Depth in Women's Health Testing139
• 19.5 Government Regulation140
  • 19.5.1 U.S. Regulation140
    • 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. Regulation142
  • 19.5.3 E.U. Regulation143
  • 19.5.4 Japanese Regulation145
• 19.6 Increased Market Penetration145
• 19.7 Legal Issues146


• 20.0 Important Technology Trends147


• 21.0 Company Profiles149
• 21.1 TriPath Imaging149
• 21.2 LifeScan Corporation150
• 21.3 OraSure150
• 21.4 Bayer Corporation151
• 21.5 Abbott Diagnostics154
• 21.6 Cytyc Corporation157
• 21.7 Inverness Medical Innovations157
• 21.8 Johnson & Johnson159
• 21.9 Quidel160
• 21.10 Biomerica162
• 21.11 Genzyme Diagnostics163
• 21.12 Adeza Biomedical Corporation164
• 21.13 Jiangnan Biotech165
• 21.14 DiaDexus LLC165
• 21.15 Digene166
• 21.16 Matritech166
• 21.17 General Electric Medical Systems168
• 21.18 Dalsa169
• 21.19 Icad, Inc.169
• 21.20 Imaging Diagnostic Systems Inc.170
• 21.21 FujiFilm Medical Systems171
• 21.22 Fischer Imaging171
• 21.23 Instrumentarium Imaging, Inc.171
• 21.24 Hologic Inc.172
• 21.25 Agfa-Gevaert Corporation173
• 21.26 Sectra Imtec AB174
• 21.27 R2 Technology, Inc174
• 21.28 Rad-Icon Imaging Corp175
• 21.29 Kodak Health Imaging Division175
• 21.30 Siemens Medical Solutions176
• 21.31 CADx Medical Systems176
• 21.32 Vidar Systems Corp.176
• 21.33 CMT Medical Systems176
• 21.34 DBA Systems177
• 21.35 Scanis Inc.177
• 21.36 SmartLight178
• 21.37 Diagnostic Imaging Systems178
• 21.38 Roche Diagnostics178
• 21.39 Myraid Genetics178
• 21.40 Shanghai SIIC Kehua Biotech Co., Ltd. (Kehua Biotech)180
• 21.41 LifePoint, Inc.180
• 21.41 Avitar Inc.180
• 21.42 Cozart Biosciences181
• 21.43 Enterix, Inc.181
• 21.44 Kyowa Medex Co., Ltd.181
• 21.45 Iatron181
• 21.46 Denka Seiken Co., Ltd.181
• 21.47 Accurex Biomedical, Pvt., Ltd181
• 21.48 Ambri Ltd.182
• 21.49 Thermo Biostar182
• 21.50 Axis-Shield182
• 21.51 Polymedco183
• 21.52 Medix Biochemica183
• 21.53 Pheromone Sciences184
• 21.54 Ostex International, Inc.184
• 21.55 Procrea184
• 21.56 American Biomedica Corp.185


• 22.0 Appendices187
• 22.1 Digital Database for Screening Mammography (DDSM)187
• 22.2 Sources of National Cancer Institute Information187
• 22.3 Screening Mammograms: Questions and Answers187
• 22.4 FDA Rule: State Certification of Mammography Facilities192

 

INDEX OF TABLES

Table 1: Worldwide Market Share In Vitro Diagnostic Companies11

Table 2: Worldwide In Vitro Diagnostics Market Size 2001-200711

Table 3: Worldwide In Vitro Central Laboratory Diagnostic Testing 2001-200712

Table 4: Worldwide Near Patient Diagnostic Testing 2001-200712

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 1992-200816

Table 8: U.S. Clinical Diagnostic Women's Test Market Segments 200216

Table 9: Self-Perceived Health Status for European Women 65-74 Years18

Table 10: Percentage with Disability Due to Long-Standing Illness for European Women 65+ Years18

Table 11: Regional Comparison Healthcare and IVD20

Table 12: European Women's Care Testing Market20

Table 13: European Women's Care Testing Diagnostics Market20

Table 14: German Women's Care Testing Diagnostics Products Market Sales20

Table 15: The German Patient Care Laboratory Test Market21

Table 16: The German Alternate Site Testing Market21

Table 17: The German Hospital Point of Care Market21

Table 18: German Clinical Diagnostic Test Market Segments 2002, Revenue from Clinical Laboratory Testing21

Table 19: German Clinical Diagnostic Rapid Women's Test Market Segments 200222

Table 20: The U.K. IVD Market23

Table 21: U.K. Women's Health Diagnostics Products Market Sales23

Table 22: Major U.K. IVD Manufacturers24

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 Kingdom24

Table 25: French Women's Health Diagnostics Products Market Sales25

Table 26: Italian Women's Health Diagnostics Products Market Sales25

Table 27: Spanish Women's Heath Diagnostics Products Market Sales26

Table 28: Japan Women's Care Testing Market26

Table 29: Chinese Women's Care Diagnostics Products Market Sales26

Table 30: The ROW Women's Care Testing Market28

Table 31: U.S. Women's Health Testing Pregnancy Testing Market28

Table 32: U.S. Market Share for Rapid Women's Health Testing Pregnancy Tests28

Table 33: The Pregnancy Test Market for OTC Testing in the U.S.29

Table 34: Home Pregnancy Tests Available in the U.S. Market30

Table 35: Osteoporosis Risk Factors that Cannot Be Changed32

Table 36: Osteoporosis Risk Factors that Can Be Changed33

Table 37: Prenatal Screening Types40

Table 38: History: Parental Genetic Traits40

Table 39: Female Factor Infertility40

Table 40: Frequency of Mutation Based Upon Ethnicity40

Table 41: CF Carrier Risk by Ethnic Group41

Table 42: Reasons for CF Testing41

Table 43: CF Testing Methodology41

Table 44: CF Gene Detection Rates Vary by Ethnic Background41

Table 45: Global Market for CF Diagnostic Testing42

Table 46: U.S. Market for CF Diagnostic Testing42

Table 47: Commercial CF Screening Products42

Table 48: Emerging CF Screening Products42

Table 49: CF Screening Technology Summary42

Table 50: Future Trends in Prenatal Genetic Testing44

Table 51: The Fertility Testing Market in the U.S.44

Table 52: Ovulation Predictors46

Table 53: U.S. Point of Care Drugs of Abuse Testing Market47

Table 54: Global Urine Strip Market56

Table 55: The Glucose Market for OTC Testing in the U.S.56

Table 56: TPA Marker Sensitivity59

Table 57: Facts about HPV Risk Factors65

Table 58: Relationship Between HPV and Cervical Carcinoma66

Table 59: HPV and Cervical Carcinoma Risk66

Table 60: Rationale for Reflex HPV Testing with Cytology67

Table 61: Rationale Against Reflex HPV Testing with Cytology67

Table 62: Predictability of HPV Test by Abnormal Pap Smear Type67

Table 63: Incidence of Cervical Cancer and Cytological Abnormalities67

Table 64: Long Term Trends in HPV Testing68

Table 65: U.S. Women's Health Testing Market for HIV70

Table 66: Countries with the Highest Prevalence of HIV / AIDS70

Table 67: Births of HIV Infected Babies in U.S. 1991-200071

Table 68: U.S. Strep Testing Market Size75

Table 69: U.S. Market for Rapid Point of Care StrepTests76

Table 70: The U.S. Chlamydia Testing Market78

Table 71: Summary of Hepatitis Test Technology84

Table 72: Genetic Screening During Pregnancy87

Table 73: Ultrasound Screening88

Table 74: U.S. Healthcare Expenditures89

Table 75: Spending on Health by Country89

Table 76: U.S. Use of Mammography in Women Over 4090

Table 77: Annual Mammography Procedures in the U.S.91

Table 78: Annual Mammography Procedures in Europe91

Table 79: Annual Mammography Procedures in Japan91

Table 80: Annual Mammography Procedures in the Rest of the World92

Table 81: U.S. Mammography Facts92

Table 82: Breast Cancer Survival Rates by Country93

Table 83: Surgical Biopsies Performed in the U.S.93

Table 84: Benefits of Digital Mammography95

Table 85: The Worldwide Mammography Instrument Market96

Table 86: Worldwide Mammography Instrumentation Placements97

Table 87: Worldwide Film-Based Mammography Instrumentation Placements103

Table 88: Worldwide Mammography Film-Based Instrument Market104

Table 89: Worldwide Mammography Film-Based Instrument Market by Region106

Table 90: U.S. Mammography Film-Based Instrument Market106

Table 91: U.S. Mammography Film-Based Instrument Market Manufacturer Share106

Table 92: U.S. Film-Based Mammography Instrumentation Placements107

Table 93: European Mammography Film-Based Instrument Market107

Table 94: European Film-Based Mammography Instrumentation Placements108

Table 95: European Mammography Film-Based Instrument Market Manufacturer Share108

Table 96: Japanese Mammography Film-Based Instrument Market108

Table 97: Japanese Film-Based Mammography Instrumentation Placements110

Table 98: Japanese Mammography Film-Based Instrument Market Manufacturer Share110

Table 99: ROW Mammography Film-Based Instrument Market111

Table 100: ROW Film-Based Mammography Instrumentation Placements111

Table 101: Advantages of Digital Mammography113

Table 102: Worldwide Digital General Radiography Market122

Table 103: Worldwide Market for Digital Mammography Systems Annual Unit Sales122

Table 104: Worldwide Market for Digital Mammography Systems122

Table 105: Worldwide Mammography Digital Instrumentation Placements123

Table 106: Worldwide Mammography Digital Instrument Market by Region124

Table 107: Share of Worldwide Market for Digital Mammography Systems by Competitor124

Table 108: U.S. Mammography Digital Instrument Market125

Table 109: U.S. Digital Mammography Instrumentation Placements125

Table 110: European Mammography Digital Instrument Market126

Table 111: European Digital Mammography Instrumentation Placements127

Table 112: Japanese Mammography Digital Instrument Market128

Table 113: Japanese Digital Mammography Instrumentation Placements128

Table 114: Products Marketed By Abbott in the Diagnostic Market156

 

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