Women’s Health Diagnostic Testing

Women’s Health Diagnostic Testing

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.

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