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Women's Health


Women’s Health Diagnostic Tests


Publication Date   December 2004
Publisher   TriMark Publications
Product Type   Report
Pages   193
ISBN Number   TMRWOM04-1206
Product Code   TRI031
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Summary


The purpose of this 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.

Content


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