Women's Health Diagnostic Testing

Product Code TRI00034
Publication Date June 2010
Publisher TriMark Publications
Product Type Report
Pages 187
ISBN Number not applicable
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Women's Health Diagnostic Testing

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.

Contents

  • 1 Overview
    • 1.1 Statement of Report
    • 1.2 Scope of this Report
    • 1.3 Methodology
    • 1.4 Executive Summary
  • 2 Introduction - Sector Overview
    • 2.1 Global Diagnostic Products Industry
  • 3 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
        • 3.1.1.1 Market Segments for Women's Health Testing
        • 3.1.1.2 Key Players in the Women's Health Diagnostics Testing Segment
        • 3.1.1.3 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 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 Women's Care Diagnostic Market
      • 3.3.5 Spanish Women's Care 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
  • 4 Women's Health Testing Individual Markets
    • 4.1 Pregnancy Testing
    • 4.2 Osteoporosis Testing
      • 4.2.1 In Vitro Blood Tests
      • 4.2.2 Bone Densitometry Devices
    • 4.3 Prenatal Screening Testing
      • 4.3.1 Cystic Fibrosis
      • 4.3.2 Prenatal Genetic Testing
      • 4.3.3 Fragile X Syndrome
      • 4.3.4 Tay-Sachs Disease
    • 4.4 Fertility Testing
    • 4.5 Breast Cancer
      • 4.5.1 CA
      • 4.5.2 CA
      • 4.5.3 BRCA1 Breast and Ovarian Cancer Gene
      • 4.5.4 BRCA2 Breast Cancer Gene
      • 4.5.5 Tissue polypeptide antigen (TPA)
      • 4.5.6 DNA Ploidy and S-phase Fraction
      • 4.5.7 Estrogen and Progesterone Receptor (ER and PR)
      • 4.5.8 HER-2
      • 4.5.9 HER-2 and Herceptin
      • 4.5.10 p53
      • 4.5.11 NMP66
      • 4.5.12 Mammastatin
    • 4.6 Ovarian Cancer
      • 4.6.1 CA 125 II™
      • 4.6.2 Steroid Hormone Receptors
      • 4.6.3 Epidermal Growth Factor Receptor (EGFR)
      • 4.6.4 HER-2/neu
      • 4.6.5 P53 Tumor Suppressor Gene
      • 4.6.6 Lysophospholipids
    • 4.7 Cervical Cancer
      • 4.7.1 Pap Smears
      • 4.7.2 Human Papillomavirus (HPV) Testing
    • 4.8 Miscellaneous Testing
      • 4.8.1 Estriol
      • 4.8.2 Fetal Fibronectin (fFN)
      • 4.8.3 Vaginal pH and Vaginitis
    • 4.9 Human Immunodeficiency Virus (HIV)
    • 4.10 Infectious Disease Testing
      • 4.10.1 Strep Testing
      • 4.10.2 Chlamydia
      • 4.10.3 Methicillin-Resistant Staphylococcus Aurea (MRSA)
      • 4.10.4 Hepatitis
      • 4.10.4 Gonorrhea
      • 4.10.5 Urinary Tract Infections
    • 4.11 Infant Jaundice
  • 5 World Mammography Market
    • 5.1 Mammography Overview
    • 5.2 Market Overview
      • 5.2.1 Introduction
      • 5.2.2 World Mammography Markets Revenue
      • 5.2.3 Mammography Markets by Region
      • 5.2.4 Total Market Share
      • 5.2.5 Competitive Structure
    • 5.3 Market Opportunities
      • 5.3.1 Resource Management for Mammography Markets
      • 5.3.2 Movement to Higher Reimbursement Rates
      • 5.3.3 Market Benchmarks for Increased Mammography Utilization
    • 5.4 Market Analysis
      • 5.4.1 Strategic Partnerships
      • 5.4.2 Long Term Trends
    • 5.5 Strategic Outlook
      • 5.5.1 Competitive Elements of Mammography Markets
      • 5.5.2 Higher Reimbursement Rates
      • 5.5.3 Volume Requirements
      • 5.5.4 Product Innovation
      • 5.5.5 Product Leadership
      • 5.5.6 Product Line Strategy
      • 5.5.7 Pricing Strategy & Reimbursement
      • 5.5.8 Strategic Partnerships
    • 5.6 Film-Based Mammography Market
      • 5.6.1 Market Overview
        • 5.6.1.1 Unit and Revenue Forecasts
        • 5.6.1.2 Product Analysis
      • 5.6.2 Market Drivers
      • 5.6.3 Market Restraints
      • 5.6.4 Film-Based Mammography Market and Technology Trends
      • 5.6.5 U.S. Market for Film-Based Screening Systems
        • 5.6.5.1 Unit Shipment and Revenue Forecasts
        • 5.6.5.2 Competitive Analysis
        • 5.6.5.3 U.S. Installed Base Analysis
      • 5.6.6 European Market for Film-Based Mammography Systems
        • 5.6.6.1 Unit Shipment and Revenue Forecasts
        • 5.6.6.2 Competitive Analysis
        • 5.6.6.3 Installed Base Analysis
      • 5.6.7 Japanese (Pacific Rim) Market for Film-based Mammography Systems
        • 5.6.7.2 Competitive Analysis
        • 5.6.7.3 Installed Base Analysis
      • 5.6.8 Rest of the World Market for Film-based Mammography Systems
        • 5.6.8.1 Unit Shipment and Revenue Forecasts
        • 5.6.8.2 Installed Base Analysis
    • 5.7 Digital X-Ray Mammography Market
      • 5.7.1 Digital Mammography Overview
      • 5.7.2 Market Overview
      • 5.7.3 Product Background
      • 5.7.4 Product Description
      • 5.7.5 Market Drivers
      • 5.7.6 Market Restraints
      • 5.7.7 Unit Shipment and Revenue Forecasts
      • 5.7.8 Percentage Breakdown of Revenues by Region
      • 5.7.9 Market Share
      • 5.7.10 U.S. Market for Digital Mammography Systems
        • 5.7.10.1 U.S. Sales
        • 5.7.10.2 Competitive Analysis
      • 5.7.11 European Market for Digital Mammography Systems
        • 5.7.11.1 Unit Shipment and Revenue Forecasts
        • 5.7.11.2 Competitive Analysis
        • 5.7.11.3 Installed Base Analysis
      • 5.7.12 Japanese (Pacific Rim) Market for Digital Mammography Systems
        • 5.7.12.1 Unit Shipment and Revenue Forecasts
        • 5.7.12.2 Competitive Analysis
        • 5.7.12.3 Installed Base Analysis
  • 6 Women's Health Testing: Growth Regulators
    • 6.1 Moderators of Growth
    • 6.2 Personnel Acceptance
    • 6.3 Key People for Women's Health Testing
    • 6.4 Key Elements for Women's Health Testing
    • 6.5 Women's Health Testing and Reimbursement
    • 6.6 Rapid Near-Patient Testing in Hospitals
    • 6.7 Satellite Facilities
    • 6.8 Regionalization of Laboratory Care
    • 6.9 Requirements for Women's Health Testing
    • 6.10 Clinical Laboratory Improvement Act of 1988 (CLIA)
  • 7 Business Trends in the Industry
    • 7.1 Sector Consolidation
    • 7.2 Diagnostic Testing Growth Trends
    • 7.3 Acquisition, License Agreements, Internal Development and Partnerships
    • 7.4 Product Testing Depth in Women's Health Testing
    • 7.5 Government Regulation
      • 7.5.1 U.S. Regulation
        • 7.5.1.1 Importing Medical Devices into the U.S
        • 7.5.1.2 Exporting Medical Devices from the U.S
      • 7.5.2 U.K. Regulation
      • 7.5.3 E.U. Regulation
      • 7.5.4 Japanese Regulation
    • 7.6 Increased Market Penetration
    • 7.7 Legal Issues
  • 8 Important Technology Trends
  • 9 Company Profiles
    • 9.1 Abbott Diagnostics
    • 9.2 Accurex Biomedical, Pvt., Ltd
    • 9.3 Adeza Biomedical Corporation (Acquired by Hologic)
    • 9.4 Agfa-Gevaert Corporation
    • 9.5 Ambri Ltd
    • 9.6 American Biomedica Corp. (ABMC)
    • 9.7 Analogic Corporation
    • 9.8 Axis-Shield Plc
    • 9.9 Becton Dickinson (BD)
    • 9.10 Biomerica, Inc
    • 9.11 Capintec, Inc
    • 9.12 Carestream Health, Inc
    • 9.13 CMT Medical Technologies Ltd
    • 9.14 Concateno Plc
    • 9.15 Dalsa Corp
    • 9.16 Denka Seiken Co., Ltd
    • 9.17 DiaDexus, Inc
    • 9.18 Dilon Diagnostics
    • 9.19 FujiFilm Medical Systems USA
    • 9.20 General Electric Healthcare
    • 9.21 Genzyme Corp
    • 9.22 Hologic Inc
    • 9.23 iCAD, Inc
    • 9.24 Imaging Diagnostic Systems, Inc
    • 9.25 Inverness Medical Innovations, Inc. (Alere)
    • 9.26 Invivo Corp
    • 9.27 Johnson & Johnson, Inc
    • 9.28 Kyowa Medex Co., Ltd
    • 9.29 Lantheus Medical Imaging, Inc
    • 9.30 LifeScan Corporation
    • 9.31 Matritech (Acquired by Inverness Medical Innovations)
    • 9.32 Medix Biochemica
    • 9.33 Mitsubishi Kagaku Iatron
    • 9.34 Myraid Genetics, Inc
    • 9.35 OraSure Technologies, Inc
    • 9.36 Polymedco, Inc
    • 9.37 Procrea Cliniques
    • 9.38 QIAGEN in USA
    • 9.39 Quest Diagnostics, Inc
    • 9.40 Quidel Corp
    • 9.41 Rad-Icon Imaging Corp
    • 9.42 Roche Ltd
    • 9.43 Scanis Inc
    • 9.44 Sectra Imtec AB
    • 9.45 Shanghai Kehua Bioengineering Co., Ltd
    • 9.46 Siemens Medical Solutions USA, Inc
    • 9.47 Vidar Systems Corp
  • 10 Appendices
    • 10.1 Digital Database for Screening Mammography (DDSM)
    • 10.2 Sources of National Cancer Institute Information
    • 10.3 Screening Mammograms: Questions and Answers
    • 10.4 FDA Rule: State Certification of Mammography Facilities
  • List of Tables
    • Table 2.1: Worldwide Market Share In Vitro Diagnostic Companies
    • Table 2.2: Worldwide In Vitro Diagnostics Market Size, 2001-2012
    • Table 2.3: Worldwide In Vitro Clinical Laboratory Diagnostic Testing 2003-2012
    • Table 2.4: Worldwide Point-of-Care Diagnostic Testing 2001-2012
    • Table 3.1: Top Drugstore Retailers in the U.S
    • Table 3.2: Top Drugstore Wholesalers in the U.S
    • Table 3.3: U.S. Women's Health Diagnostics Products Market Sales 2000-2012
    • Table 3.4: Regional Comparison Healthcare and IVD
    • Table 3.5: European Women's Care Testing Market, 2000-2012
    • Table 3.6: European Women's Care Testing Diagnostics Market
    • Table 3.7: German Women's Care Testing Diagnostics Products Market Sales, 2000-2012
    • Table 3.8: German Patient Care Laboratory Test Market, 2000-2012
    • Table 3.9: German Alternate Site Testing Market, 2000-2012
    • Table 3.10: German Hospital Point of Care Market, 2000-2012
    • Table 3.11: German Clinical Diagnostic Rapid Women's Test Market Segments
    • Table 3.12: U.K. Women's Health Diagnostics Products Market Sales, 2006-2012
    • Table 3.13: Major U.K. IVD Manufacturers
    • Table 3.14: U.S. IVD Manufacturers Doing Business in the U.K
    • Table 3.15: Other European Companies that Manufacture IVD Products in the U.K
    • Table 3.16: French Women's Health Diagnostics Products Market Sales, 2000-2012
    • Table 3.17: Italian Women's Health Diagnostics Products Market Sales, 2000-2012
    • Table 3.18: Spanish Women's Heath Diagnostics Products Market Sales, 2000-2012
    • Table 3.19: Japan Women's Care Testing Market, 2000-2012
    • Table 3.20: Chinese Women's Care Diagnostics Products Market Sales, 2000-2012
    • Table 3.21: ROW Women's Care Testing Market, 2000-2012
    • Table 4.1: U.S. Women's Health Testing Pregnancy Testing Market, 2001-2012
    • Table 4.2: U.S. Market Share for Rapid Women's Health Testing Pregnancy Tests
    • Table 4.3: Pregnancy Test Market for OTC Testing in the U.S., 2000-2012
    • Table 4.4: Home Pregnancy Tests Available in the U.S. Market
    • Table 4.5: Osteoporosis Risk Factors that Cannot Be Changed
    • Table 4.6: Osteoporosis Risk Factors that Can Be Changed
    • Table 4.7: Prenatal Screening Types
    • Table 4.8: History: Parental Genetic Traits
    • Table 4.9: Female Factor Infertility
    • Table 4.10: Frequency of Mutation Based Upon Ethnicity
    • Table 4.11: Reasons for CF Testing
    • Table 4.12: CF Testing Methodology
    • Table 4.13: CF Gene Detection Rates Vary by Ethnic Background
    • Table 4.14: Global Market for CF Diagnostic Testing, 2000-2012
    • Table 4.15: U.S. Market for CF Diagnostic Testing, 2000-2012
    • Table 4.16: Commercial CF Screening Products
    • Table 4.17: Emerging CF Screening Products
    • Table 4.18: CF Screening Technology Summary
    • Table 4.19: Genetic Screening During Pregnancy
    • Table 4.20: Ultrasound Screening
    • Table 4.21: Future Trends in Prenatal Genetic Testing, 2000-2012
    • Table 4.22: Ovulation Predictors
    • Table 4.23: TPA Marker Sensitivity
    • Table 4.24: HPV Risk Factors
    • Table 4.25: Relationship between HPV and Cervical Carcinoma
    • Table 4.26: HPV and Cervical Carcinoma Risk
    • Table 4.27: Rationale for Reflex HPV Testing with Cytology
    • Table 4.28: Rationale against Reflex HPV Testing with Cytology
    • Table 4.29: Predictability of HPV Test by Abnormal Pap Smear Type
    • Table 4.30: Incidence of Cervical Cancer and Cytological Abnormalitie
    • Table 4.31: Long Term Trends in HPV Testing
    • Table 4.32: U.S. Women's Health Testing Market for HIV, 2001-2012
    • Table 4.33: Countries with the Highest Prevalence of HIV / AIDS
    • Table 4.34: U.S. Strep Testing Market Size, 2002-2012
    • Table 4.35: U.S. Market for Rapid Point of Care Strep Tests
    • Table 4.36: U.S. Chlamydia Testing Market, 2000-2012
    • Table 4.37: Summary of Hepatitis Test Technology
    • Table 5.1: U.S. Healthcare Expenditures, 2000-2010
    • Table 5.2: International Per Capita Healthcare Spending by Country, 2007
    • Table 5.3: U.S. Use of Mammography in Women Over 40, 1987-2008
    • Table 5.4: Annual Mammography Procedures in the U.S., 2000-2008
    • Table 5.5: Annual Mammography Procedures in Europe, 2002-2008
    • Table 5.6: Annual Mammography Procedures in Japan, 2002-2008
    • Table 5.7: Annual Mammography Procedures in the Rest of the World, 2002-2008
    • Table 5.8: U.S. Mammography Facts, 2008
    • Table 5.9: Breast Cancer Survival Rates by Country
    • Table 5.10: Surgical Biopsies Performed in the U.S., 2000-2009
    • Table 5.11: Worldwide Mammography Instrument Market, 2000-2010
    • Table 5.12: Worldwide Mammography Instrumentation Placements, 2002-2010
    • Table 5.13: Worldwide Film-Based Mammography Instrumentation Placements, 2002-2010
    • Table 5.14: Worldwide Mammography Film-Based Instrument Market, 2000-2010
    • Table 5.15: Worldwide Mammography Film-Based Instrument Market by Region, 2000-2010
    • Table 5.16: U.S. Mammography Film-Based Instrument Market, 2000-2010
    • Table 5.17: U.S. Mammography Film-Based Instrument Market Manufacturer Share
    • Table 5.18: U.S. Film-Based Mammography Instrumentation Placements, 2002-2010
    • Table 5.19: European Mammography Film-Based Instrument Market, 2000-2010
    • Table 5.20: European Film-Based Mammography Instrumentation Placements, 2002-2010
    • Table 5.21: European Mammography Film-Based Instrument Market Manufacturer Share
    • Table 5.22: Japanese Mammography Film-Based Instrument Market, 2000-2010
    • Table 5.23: Japanese Film-Based Mammography Instrumentation Placements, 2002-2010
    • Table 5.24: Japanese Mammography Film-Based Instrument Market Manufacturer Share
    • Table 5.25: ROW Mammography Film-Based Instrument Market, 2000-2010
    • Table 5.26: ROW Film-Based Mammography Instrumentation Placements, 2002-2010
    • Table 5.27: Advantages of Digital Mammography
    • Table 5.28: Worldwide Digital General Radiography Market, 2000-2012
    • Table 5.29: Worldwide Market for Digital Mammography Systems Annual Unit Sales, 2000-2010
    • Table 5.30: Worldwide Market for Digital Mammography Systems, 2000-2010
    • Table 5.31: Worldwide Mammography Digital Instrumentation Placements, 2002-2010
    • Table 5.32: Worldwide Mammography Digital Instrument Market by Region, 2001-2010
    • Table 5.33: Share of Worldwide Market for Digital Mammography Systems by Competitor
    • Table 5.34: U.S. Mammography Digital Instrument Market, 2001-2010
    • Table 5.35: U.S. Digital Mammography Instrumentation Placements, 2002-2010
    • Table 5.36: European Mammography Digital Instrument Market, 2001-2010
    • Table 5.37: European Digital Mammography Instrumentation Placements, 2002-2010
    • Table 5.38: Japanese Mammography Digital Instrument Market, 2001-2010
    • Table 5.39: Japanese Digital Mammography Instrumentation Placements, 2002-2010
    • Table 9.1: Products Marketed By Abbott in the Diagnostic Market