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Women's Health Diagnostic Testing

  • ID: 28413
  • June 2010
  • Region: Global
  • 187 Pages
  • TriMark Publications
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FEATURED COMPANIES

  • Abbott Diagnostics
  • Becton Dickinson (BD)
  • Dalsa Corp
  • Hologic Inc
  • LifeScan Corporation
  • Polymedco, Inc
  • MORE

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.

Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • Abbott Diagnostics
  • Becton Dickinson (BD)
  • Dalsa Corp
  • Hologic Inc
  • LifeScan Corporation
  • Polymedco, Inc
  • MORE

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. (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

10.0 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: 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

Note: Product cover images may vary from those shown
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- Abbott Diagnostics
- Accurex Biomedical, Pvt., Ltd
- Adeza Biomedical Corporation (Acquired by Hologic)
- Agfa-Gevaert Corporation
- Ambri Ltd
- American Biomedica Corp. (ABMC)
- Analogic Corporation
- Axis-Shield Plc
- Becton Dickinson (BD)
- Biomerica, Inc
- Capintec, Inc
- Carestream Health, Inc
- CMT Medical Technologies Ltd
- Concateno Plc
- Dalsa Corp
- Denka Seiken Co., Ltd
- DiaDexus, Inc
- Dilon Diagnostics
- FujiFilm Medical Systems USA
- General Electric Healthcare
- Genzyme Corp
- Hologic Inc
- iCAD, Inc
- Imaging Diagnostic Systems, Inc
- Inverness Medical Innovations, Inc. (Alere)
- Invivo Corp
- Johnson & Johnson, Inc
- Kyowa Medex Co., Ltd
- Lantheus Medical Imaging, Inc
- LifeScan Corporation
- Matritech (Acquired by Inverness Medical Innovations)
- Medix Biochemica
- Mitsubishi Kagaku Iatron
- Myraid Genetics, Inc
- OraSure Technologies, Inc
- Polymedco, Inc
- Procrea Cliniques
- QIAGEN in USA
- Quest Diagnostics, Inc
- Quidel Corp
- Rad-Icon Imaging Corp
- Roche Ltd
- Scanis Inc
- Sectra Imtec AB
- Shanghai Kehua Bioengineering Co., Ltd
- Siemens Medical Solutions USA, Inc
- Vidar Systems Corp

Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown

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