High-Growth Diagnostic Testing Markets

Table of Contents

1. Overview

• 1.1 Statement of Report
• 1.2 Scope of this Report
• 1.3 Methodology
• 1.4 Executive Summary

2. Sector Overview

• 2.1 Global Diagnostic Products Industry

3. High-Growth Testing Markets: Market Segment Analysis: Size, Growth and Share

• 3.1 Global High-Growth Diagnostic Testing Markets
  • 3.1.1 Market Drivers in the High-Growth Diagnostics Testing Sector
  • 3.1.2 Market Segments for High-Growth Testing
  • 3.1.3 Key Players in the High-Growth Diagnostics Testing Segment
  • 3.1.4 High-Growth Testing Sector Analysis
• 3.2 U.S. High-Growth Testing Market
  • 3.2.1 Market Overview
  • 3.2.2 Diagnostic Test Categories
• 3.3 European High-Growth Diagnostic Test Market
  • 3.3.1 German Diagnostic Markets
  • 3.3.2 U.K. 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
• 3.4 Japanese Diagnostic Testing Market
• 3.5 Chinese Diagnostic Testing Market

4. High-Growth Testing Individual Markets

• 4.1 Hepatitis Serologic Markers and Nucleic Acid Testing
  • 4.1.1 Hepatitis B Virus (HBV)
  • 4.1.2 Hepatitis C Virus (HCV) Testing
  • 4.1.3 Hepatitis B Virus/Hepatitis C Virus Viral Load and Drug Resistance

5. Cardiac Markers

• 5.1 Market Overview
  • 5.1.1 American Market
  • 5.1.2 European Market
• 5.2 Acute Myocardial Infarction
• 5.3 Heart Failure (BNP)
  • 5.3.1 Market Overview
  • 5.3.2 Commercial Assays for BNP and NT-proBNP
  • 5.3.3 Market Share
• 5.4 CRP
• 5.5 Pulmonary Embolism (D-dimer Test)
• 5.6 Key Players

6. Cytogenetic Testing

• 6.1 Cancer Testing
• 6.2 Prenatal Testing and Cytogenetics
  • 6.2.1 Cystic Fibrosis Testing
    • 6.2.1.1 CF Testing Methodology
    • 6.2.1.2 CF Screening Technology Summary
• 6.3 Key Players in Segment

7. Fertility Testing

8. Clinical Laboratory Genomics

• 8.1 Introduction
• 8.2 Clinical Laboratory Genomics Testing
• 8.3 Developments in Clinical Laboratory Genomics
  • 8.3.1 Nucleic Acid Amplification Techniques
  • 8.3.2 Chromosome Imaging
  • 8.3.3 Genomics Technologies
  • 8.3.4 Proteomics Technology
  • 8.3.5 Current Pharmacogenomic Tests
  • 8.3.6 Future Pharmacogenomic Testing

9. Glucose Monitoring

• 9.1 Overview of Market Segment
• 9.2 Competitive Strategies
• 9.3 Analyses of the Current Market Conditions, Competition and Product Mix
  • 9.3.1 First-Generation Monitors
  • 9.3.2 Second-Generation Monitors
  • 9.3.3 Third-Generation SMBG Technologies
  • 9.3.4 Other Monitoring Device Advancements

10. Cancer Biomarker Testing

• 10.1 Segment Overview
• 10.2 The Cancer Testing Market
• 10.3 Competition
• 10.4 Individual Markets
  • 10.4.1 Cancer Pathology: Testing
    • 10.4.1.1 Rare Cell/Micro Metastasis Detection
    • 10.4.1.2 Cancer Pathology: High-Throughput Screening
    • 10.4.1.3 Competition
    • 10.4.1.4 Drivers
  • 10.4.2 Breast Cancer
    • 10.4.2.1 CA 15-3
    • 10.4.2.2 CA 27-29
    • 10.4.2.3 BRCA1 and BRCA2 Breast and Ovarian Cancer Genes
    • 10.4.2.4 Estrogen and Progesterone Receptor (ER and PR)
    • 10.4.2.5 HER-2
    • 10.4.2.6 Herceptin
    • 10.4.2.7 p53
    • 10.4.2.8 NMP66
    • 10.4.2.9 Mammastatin
    • 10.4.2.10 Drivers for Breast Cancer Test Development
  • 10.4.3 Ovarian Cancer
    • 10.4.3.1 CA 125 IItrade;
    • 10.4.3.2 BRCA1 and BRCA2
    • 10.4.3.3 Steroid Hormone Receptors
    • 10.4.3.4 Epidermal Growth Factor Receptor (EGFR)
    • 10.4.3.5 Lysophospholipids
  • 10.4.4 Cervical Cancer
  • 10.4.5 Colon Cancer DNA Testing
• 10.5 Pharmacogenomic Cancer Testing

11. HPV Testing

• 11.1 Overview
• 11.2 U.S. Market
• 11.3 European Market
• 11.4 Other Markets
• 11.5 The Association of HPV and Cervical Cancer
• 11.6 Assays for HPV

12. Biochips for Clinical Applications

• 12.1 Roche AmpliChip
• 12.2 Amersham CodeLink
• 12.3 Breast Cancer DNA Chips
• 12.4 Osmetech eSensor
• 12.5 Affymetrix GeneChip System 3000Dx v.2
• 12.6 Caliper and Cepheid
• 12.7 Agilent Technologies 2100 Lab-on-a-Chip

13. HIV

• 13.1 U.S. Testing Market
• 13.2 World Testing Market
  • 13.2.1 Asia
  • 13.2.2 Japan
  • 13.2.3 Sub-Saharan Africa
  • 13.2.4 Rest of World
• 13.3 Major Players

14. Cellular Imaging Cytopathology and Histopathology

• 14.1 Segment Overview
• 14.2 The Market
• 14.3 Market Drivers
• 14.4 Market Restraints
• 14.5 Cytology and Histology Technology Platforms
  • 14.5.1 Cytology Screening Procedures and Pap Smear Technology
  • 14.5.2 Histology
  • 14.5.3 Market Drivers
  • 14.5.4 ISH Staining
  • 14.5.5 Special-Stains Staining
• 14.6 Third-Party Reimbursement
• 14.7 Competition

15. Infectious Disease Testing

• 15.1 Streptococcus Testing
• 15.2 Chlamydia Testing
• 15.3 Mononucleosis
• 15.4 Gonorrhea
• 15.5 Influenza
• 15.6 Malaria
• 15.7 Tuberculosis
• 15.8 Methicillin-Resistant Staphylococcus aureus (MRSA)

16. High-Growth Testing Diagnostic Trends

• 16.1 Genetic Testing
• 16.2 Quality Measures
• 16.3 Moderators of Growth
  • 16.3.1 Diagnostics and the Aging Population
  • 16.3.2 Individualized Medicine
  • 16.3.3 Genetic Testing
• 16.4 Workforce Issues
• 16.5 Reimbursement
  • 16.5.1 Cardiovascular
  • 16.5.2 Screening for Diabetes
  • 16.5.3 CPT Test Codes and Payment Amounts
• 16.6 Rapid Near-Patient Testing in Hospitals
• 16.7 Satellite Facilities
• 16.8 Regionalization of Laboratory Care
• 16.9 Requirements for High-Growth Testing
• 16.10 Clinical Laboratory Improvement Act (CLIA)

17. Business Trends in the Industry

• 17.1 Sector Consolidation
• 17.2 Diagnostic Testing Growth Trends
• 17.3 Acquisition, License Agreements, Internal Development, Partnerships
• 17.4 Product Testing Depth in High-Growth Testing
• 17.5 Government Regulation
  • 17.5.1 U.S. Regulations
    • 17.5.1.1 Importing Medical Devices into the U.S.
    • 17.5.1.2 Exporting Medical Devices from the U.S.
  • 17.5.2 U.K Regulations
  • 17.5.3 E.U. Regulations
  • 17.5.4 Japanese Regulations
• 17.6 Increased Market Penetration in High-Growth Testing

18. Important Technology Trends

19. Company Profiles

• 19.1 Accurex Biomedical, Pvt., Ltd.
• 19.2 Adeza Biomedical Corporation (Hologic)
• 19.3 Agilent Technologies, Inc.
• 19.4 Ambri, Ltd.
• 19.5 American Bio Medica Corp.
• 19.6 Ani Biotech
• 19.7 Applied Spectral Imaging
• 19.8 Avitar, Inc.
• 19.9 Axis-Shield
• 19.10 Bayer Corporation
• 19.11 Beckman Coulter
• 19.12 Becton Dickinson
• 19.13 Biomerica
• 19.14 Bio-Rad, Inc.
• 19.15 Cozart Bioscience
• 19.16 Denka Seiken Co., Ltd.
• 19.17 diaDexus LLC
• 19.18 Enterix, Inc. (Subsidiary of Quest Diagnostics)
• 19.19 Genetix
• 19.20 Genzyme Diagnostics
• 19.21 Hologic, Inc.
• 19.22 Iatron
• 19.23 Inverness Medical Innovations
• 19.24 Jiangnan Biotech
• 19.25 Johnson & Johnson
• 19.26 Kyowa Medex Co., Ltd.
• 19.27 LifePoint, Inc.
• 19.28 LifeScan
• 19.29 Matritech
• 19.30 Medix Biochemica
• 19.31 Myriad Genetics
• 19.32 OraSure
• 19.33 Pheromone Sciences
• 19.34 Polymedco
• 19.35 Procrea
• 19.36 QIAGEN
• 19.37 Quidel
• 19.38 Roche Diagnostics
• 19.39 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)
• 19.40 Shionogi & Co.
• 19.41 Siemens
• 19.42 Spectral Diagnostics, Inc.
• 19.43 Third Wave Technologies

20. Appendix 1: Opportunities in the Chinese Biotech Market

21. Appendix 2: Opportunities in the Indian Diagnostics Market

INDEX OF TABLES

• Table 1.1: Emerging Technology Platforms Driving High-Growth Diagnostics Market Segments
• Table 1.2: Market Trends in the High-Growth Diagnostics Space
• Table 2.1: U.S. Population Dynamics, 2005-2015
• Table 2.2: World Population and Growth, 2000-2025
• Table 2.3: Total Japanese Population and Aging Demographics Forecast
• Table 2.4: Worldwide Market Share In Vitro Diagnostic Companies, 2007
• Table 2.5: Worldwide In Vitro Diagnostics Market Size, 2003-2012
• Table 2.6: U.S. In Vitro Central Lab Diagnostic Testing, 2003-2012
• Table 2.7: Worldwide Near-Patient Diagnostic Testing, 2002-2012
• Table 3.1: High-Growth Market Segments Overview, 2008
• Table 3.2: U.S. High-Growth Diagnostic Testing Market Segments, 2007
• Table 3.3: Regional Comparison of GDP, Healthcare and IVD, 2006
• Table 3.4: German Diagnostics Products Market Sales, 2000-2008
• Table 3.5: The German Patient Care Lab Test Market, 2002-2012
• Table 3.6: The German Alternate Site Testing Market (POL), 2002-2012
• Table 3.7: The German Hospital Point of Care Market, 2002-2012
• Table 3.8: German Clinical Diagnostic Rapid Test Market Segments
• Table 3.9: List of Diagnostics Companies in the U.K.
• Table 3.10: Major U.K. IVD Manufacturers
• Table 3.11: U.S. IVD Manufacturers Doing Business in the U.K.
• Table 3.12: Other European Companies That Manufacture IVD Products in the U.K.
• Table 3.13: Japanese In Vitro Diagnostic Testing Market, 2000-2012
• Table 3.14: Japan' s Diagnostics Market Sales, 1997-2006
• Table 3.15: Companies with Leading Market Share of Japanese Diagnostics, by Segment
• Table 3.16: Chinese Diagnostics Products Market Sales, 2000-2012
• Table 3.17: Disease Burden in China: Urban and Rural
• Table 4.1: Global Market for HBV Diagnostic Testing, 2000-2012
• Table 4.2: U.S. Market for HBV Diagnostic Testing, 2000-2012
• Table 4.3: Serological Diagnosis of Hepatitis B Virus Infections
• Table 4.4: Lower Detection Limits of HBV DNA Assays
• Table 4.5: Summary of Hepatitis B Test Technology
• Table 4.6: Global Market for HCV Diagnostic Testing, 2000-2008
• Table 4.7: U.S. Market for HCV Diagnostic Testing, 2000-2008
• Table 4.8: Efficiency of Available HCV Screening Tests
• Table 4.9: Recommendations for Diagnostic Testing for Hepatitis C
• Table 4.10: Hepatitis C Statistics
• Table 4.11: Gen-Probe Clinical Diagnostic Products Test for the Detection of HCV
• Table 5.1: Biomarkers in Heart Failure
• Table 5.2: Medication Chart for Cardiovascular Disease
• Table 5.3: Acute Myocardial Infarction Facts
• Table 5.4: Emergency Room Admissions in the U.S., 1997-2005
• Table 5.5: Market Growth Drivers for Cardiac Markers
• Table 5.6: Market Barriers to Growth for Cardiac Markers
• Table 5.7: Specific Cardiac Markers
• Table 5.8: Cardiac Markers after Onset of Myocardial Infarction
• Table 5.9: The Cardiac Marker Market for Testing in the U.S., 2001-2010
• Table 5.10: Market Share of Cardiac Marker Segment
• Table 5.11: U.S. Market for Point of Care Cardiac Marker Testing, 2000-2010
• Table 5.12: BNP Characteristics
• Table 5.13: Global Sales of BNP Diagnostic Tests, 2000-2010
• Table 5.14: Market Share of BNP Assays in the U.S.
• Table 5.15: Market Share of NT-proBNP Assays in the U.S.
• Table 5.16: Cardiovascular Risk Classification by CRP Level
• Table 5.17: Clinical Characteristics of D-dimer
• Table 6.1: Global Market for Cancer Cytogenetic Diagnostic Testing, 2000-2012
• Table 6.2: U.S. Market for Cancer Cytogenetic Diagnostic Testing, 2000-2012
• Table 6.3: Genetic Testing: Consequences and Challenges
• Table 6.4: CF Carrier Risk by Ethnic Group
• Table 6.5: Reasons for CF Testing
• Table 6.6: CF Gene Detection Rates Vary by Ethnic Background
• Table 6.7: Global Market for CF Diagnostic Testing, 2000-2010
• Table 6.8: U.S. Market for CF Diagnostic Testing, 2000-2010
• Table 6.9: Commercial CF Screening Products
• Table 6.10: Emerging CF Screening Products
• Table 7.1: The Fertility Testing Market in the U.S., 2000-2008
• Table 9.1: U.S. Population of Diabetics by Group
• Table 9.2: Percentage of U.S. Adults Using Diabetes Medication, by Age, 1997-2006
• Table 9.3: Health Care Utilization by the Diabetes Patient
• Table 9.4: The Global Population of Persons with Diabetes, 1995 and 2025
• Table 9.5: Market for Glucose Testing in the U.S., 2001-2012
• Table 9.6: The Worldwide Market for Glucose Testing, 2000-2012
• Table 9.7: Major Players in Point of Care and Near-Patient Testing for OTC Glucose Meters
• Table 10.1: Women' s Cancer Incidence Estimates in the U.S., 2008
• Table 10.2: Five-Year Disease-Free Survival by Stage at Diagnosis
• Table 10.3: TPA Marker Sensitivity
• Table 11.1: HPV Risk Factors
• Table 11.2: HPV and Cervical Carcinoma
• Table 11.3: Global HPV-Testing Market Size, 2003-2011
• Table 11.4: HPV and Cervical Carcinoma Risk
• Table 11.5: Reflex HPV Testing with Cytology
• Table 11.6: Predictability of HPV Test by Abnormal Pap Smear Type
• Table 11.7: Incidence of Cervical Cancer and Cytological Abnormalities
• Table 11.8: Long-Term Trends in HPV Testing
• Table 12.1: Biochip Revenues and Growth Rates by Application
• Table 12.2: Total Biochip Market: Worldwide Revenue Forecasts, 2000-2010
• Table 12.3: Total Biochip Market: U.S. Revenue Forecasts, 2000-2010
• Table 13.1: AIDS Statistics for the U.S.: Diagnoses, Deaths and Burden, 2002-2006
• Table 13.2: U.S. HIV Statistics, 2007
• Table 13.3: Births of HIV Infected Babies in U.S., 2000-2009
• Table 13.4: Rapid HIV Tests on the Market
• Table 13.5: U.S. High-Growth Testing Market for HIV, 2001-2012
• Table 13.6: Global HIV Statistics, 2007
• Table 14.1: Estimated Cervical Cancer Cases/Deaths Worldwide
• Table 14.2: Medicare Reimbursement for Cervical Pathology Procedures
• Table 15.1: U.S. Strep Testing Market Size, 2000-2008
• Table 15.2: Rapid Strep Tests on the Market
• Table 15.3: U.S. Market for Rapid Point of Care Strep Tests
• Table 15.4: The U.S. Chlamydia Testing Market, 2001-2009
• Table 15.5: Rapid Tests for Chlamydia
• Table 15.6: Rapid Tests for Gonorrhea
• Table 15.7: Commercially-Available Rapid Tests for Malaria
• Table 15.8: FIND Partners
• Table 15.9: Global Market Potential for TB Diagnostic Testing, 2000-2010
• Table 15.10: MRSA Diagnostics Currently on the Market
• Table 16.1: New CPT Test Codes Introduced in 2008
• Table 18.1: Employment of Clinical Laboratory Workers, 2006-2016
• Table 20.1: China Biotech Reagents Market
• Table 20.2: Biotechnology Projects Between China and the West
• Table 21.1: Overview of Healthcare in India

INDEX OF FIGURES

• Figure 2.1: U.S. Lab Industry Market Share, 2007
• Figure 2.2: Major Lab Testing Segments, U.S.
• Figure 3.1: Total Spending on Healthcare in the U.S., 2007
• Figure 3.2: International Per Capita Spending on Healthcare, 2006
• Figure 3.3: Japan IVD Sales by Segment, 2006
• Figure 14.1: Worldwide Incidence Rates of Cervical Cancer Per 100,000 Females
• Figure 15.1: Global Incidence of Malaria
• Figure 15.2: Mode of Action of Common Malaria RDT Format
• Figure 15.3: FIND Pipeline for TB Diagnostics
• Figure 21.1: Indian Diagnostics Market Segments, 2007