Women's Health Diagnostic Testing

Table of Contents

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
    • 3.1.1.1 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

4.0 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 15-3
  • 4.5.2 CA 27-29
  • 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

5.0 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

6.0 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)

7.0 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

8.0 Important Technology Trends

9.0 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.
• 9.7 Avitar Inc.
• 9.8 Axis-Shield
• 9.9 Bayer Corporation Diagnostics Division (Acquired by Siemens)
• 9.10 Becton Dickinson
• 9.11 Biomerica
• 9.12 Carestream Health
• 9.13 CMT Medical Systems
• 9.14 Cozart Biosciences (Acquired by Concateno PLC)
• 9.15 Cytyc Corporation
• 9.16 Dalsa
• 9.17 Denka Seiken Co., Ltd.
• 9.18 DiaDexus LLC
• 9.19 Enterix, Inc. (Acquired by Quest Diagnostics)
• 9.20 Fischer Imaging (Acquired by Hologic)
• 9.21 FujiFilm Medical Systems
• 9.22 General Electric Healthcare
• 9.23 Genzyme Diagnostics
• 9.24 Hologic Inc.
• 9.25 iCAD, Inc.
• 9.26 Imaging Diagnostic Systems Inc.
• 9.27 Inverness Medical Innovations
• 9.28 Johnson & Johnson
• 9.29 Kyowa Medex Co., Ltd.
• 9.30 L-3 Titan Group
• 9.31 LifePoint, Inc.
• 9.32 LifeScan Corporation
• 9.33 Matritech
• 9.34 Medix Biochemica
• 9.35 Mitsubishi Kagaku Iatron
• 9.36 Myraid Genetics
• 9.37 OraSure Technologies, Inc.
• 9.38 Polymedco
• 9.39 Procrea
• 9.40 QIAGEN
• 9.41 Quidel
• 9.42 Rad-Icon Imaging Corp
• 9.43 Roche Diagnostics
• 9.44 Scanis Inc.
• 9.45 Sectra Imtec AB
• 9.46 Shanghai Kehua Bioengineering Co., Ltd.
• 9.47 Siemens Healthcare
• 9.48 TriPath Imaging (Acquired by BD)
• 9.49 Vidar Systems Corp.

10.0 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

INDEX 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: U.S. Clinical Diagnostic Women' s Test Market Segments 2005
• Table 3.5: Regional Comparison Healthcare and IVD
• Table 3.6: European Women' s Care Testing Market, 2000-2012
• Table 3.7: European Women' s Care Testing Diagnostics Market
• Table 3.8: German Women' s Care Testing Diagnostics Products Market Sales, 2000-2012
• Table 3.9: The German Patient Care Laboratory Test Market, 2000-2012
• Table 3.10: The German Alternate Site Testing Market, 2000-2012
• Table 3.11: The German Hospital Point of Care Market, 2000-2012
• Table 3.12: German Clinical Diagnostic Rapid Women' s Test Market Segments
• Table 3.13: U.K. Women' s Health Diagnostics Products Market Sales, 2006-2012
• Table 3.14: Major U.K. IVD Manufacturers
• Table 3.15: U.S. IVD Manufacturers Doing Business in the U.K.
• Table 3.16: Other European Companies that Manufacture IVD Products in the United Kingdom
• Table 3.17: French Women' s Health Diagnostics Products Market Sales, 2000-2012
• Table 3.18: Italian Women' s Health Diagnostics Products Market Sales, 2000-2012
• Table 3.19: Spanish Women' s Heath Diagnostics Products Market Sales, 2000-2012
• Table 3.20: Japan Women' s Care Testing Market, 2000-2012
• Table 3.21: Chinese Women' s Care Diagnostics Products Market Sales, 2000-2012
• Table 3.22: The 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: The 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: Births of HIV Infected Babies in U.S., 2002-2006
• Table 4.35: U.S. Strep Testing Market Size, 2002-2012
• Table 4.36: U.S. Market for Rapid Point of Care Strep Tests
• Table 4.37: The U.S. Chlamydia Testing Market, 2000-2012
• Table 4.38: Summary of Hepatitis Test Technology
• Table 5.1: U.S. Healthcare Expenditures, 2000-2010
• Table 5.2: International Per Capita Healthcare Spending by Country, 2006
• Table 5.3: U.S. Use of Mammography in Women Over 40, 1987-2005
• Table 5.4: Annual Mammography Procedures in the U.S., 2000-2008
• Table 5.5: Annual Mammography Procedures in Europe, 2002-2007
• Table 5.6: Annual Mammography Procedures in Japan, 2002-2007
• Table 5.7: Annual Mammography Procedures in the Rest of the World, 2002-2007
• Table 5.8: U.S. Mammography Facts, 2005
• Table 5.9: Breast Cancer Survival Rates by Country
• Table 5.10: Surgical Biopsies Performed in the U.S., 2000-2007
• Table 5.11: The 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, 2001-2007
• Table 5.39: Japanese Digital Mammography Instrumentation Placements, 2002-2010
• Table 9.1: Products Marketed By Abbott in the Diagnostic Market