High-Growth Diagnostic Tests Markets

Table of Contents

1. Overview

• 1.1 Statement of Report
• 1.2 Objectives of this Report
• 1.3 Scope of this Report
• 1.4 Methodology
• 1.5 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 - Overview
  • 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
• 3.6 High-Growth Testing Individual Markets
  • 3.6.1 Hepatitis Serologic Markers and Nucleic Acid Testing
    • 3.6.1.1 Hepatitis B Virus (HBV)
    • 3.6.1.2 Hepatitis C Virus (HCV) Testing
    • 3.6.1.3 Hepatitis B virus/Hepatitis C Virus Viral Load and Drug Resistance
  • 3.6.2 Cardiac Markers
    • 3.6.2.1 Market Overview
      • 3.6.2.1.1 American Market
      • 3.6.2.1.2 European Market
    • 3.6.2.2 Acute Myocardial Infarction
    • 3.6.2.3 Heart Failure (BNP)
    • 3.6.2.3.1 Market Overview
    • 3.6.2.3.2 Commercial Assays for BNP and NT-proBNP
    • 3.6.2.3.3 Market Share
    • 3.6.2.4 Myoglobin
    • 3.6.2.5 Homocysteine
    • 3.6.2.6 CRP
    • 3.6.2.7 Pulmonary Embolism (D-Dimer Test)
    • 3.6.2.8 LDL and HDL
    • 3.6.2.9 Key Players
  • 3.6.3 Cytogenetic Testing
    • 3.6.3.1 Cancer Testing
    • 3.6.3.2 Pre-natal Testing and Cytogenetics
      • 3.6.3.2.1 Cystic Fibrosis Testing
    • 3.6.3.3 Key Players in Segment
  • 3.6.4 Fertility Testing
  • 3.6.5 Clinical Laboratory Genomics
    • 3.6.5.1 Introduction
    • 3.6.5.2 Clinical Laboratory Genomics Testing
    • 3.6.5.3 Developments in Clinical Laboratory Genomics
      • 3.6.5.3.1 Nucleic Acid Amplification Techniques
      • 3.6.5.3.2 Chromosome Imaging
      • 3.6.5.3.3 Genomics Technologies
      • 3.6.5.3.4 Proteomics Technology
      • 3.6.5.3.5 Current Pharmacogenomic Tests
      • 3.6.5.3.6 Future Pharmacogenomic Testing
  • 3.6.6 Glycosylated Hemoglobin Glucose Monitoring
    • 3.6.6.1 Overview of Market Segment
    • 3.6.6.2 Competitive Strategies
    • 3.6.6.3 Analyses of the Current Market Conditions, Competition and Product Mix
      • 3.6.6.3.1 First-Generation Monitors
      • 3.6.6.3.2 Second-Generation Monitors
      • 3.6.6.3.3 Third-Generation SMBG Technologies
      • 3.6.6.3.4 Other Monitoring Device Advancements
  • 3.6.7 Cancer BioMarker Testing
    • 3.6.7.1 Segment Overview
    • 3.6.7.2 The Cancer Testing Market
    • 3.6.7.3 Competition
    • 3.6.7.4 Individual Markets
      • 3.6.7.4.1 Cancer Pathology: Testing
        • 3.6.7.4.1.1 Rare Cell/Micro Metastasis Detection
        • 3.6.7.4.1.2 Cancer Pathology: High Throughput Screening
        • 3.6.7.4.1.3 Competition
        • 3.6.7.4.1.4 Drivers
      • 3.6.7.4.2 Breast Cancer
        • 3.6.7.4.2.1 CA 15-3
        • 3.6.7.4.2.2 CA 27-
        • 3.6.7.4.2.3 BRCA1 and BRCA2 Breast and Ovarian Cancer Genes
        • 3.6.7.4.2.4 Estrogen and Progesterone Receptor (ER and PR)
        • 3.6.7.4.2.5 HER-2
        • 3.6.7.4.2.6 Herceptin
        • 3.6.7.4.2.7 p
        • 3.6.7.4.2.8 NMP
        • 3.6.7.4.2.9 Mammastatin
        • 3.6.7.4.2.10 Drivers for Breast Cancer Test Development
      • 3.6.7.4.3 Ovarian Cancer
        • 3.6.7.4.3.1 CA 125 II™
        • 3.6.7.4.3.2 BRCA1 and BRCA2
        • 3.6.7.4.3.3 Steroid Hormone Receptors
        • 3.6.7.4.3.4 Epidermal Growth Factor Receptor (EGF-R)
        • 3.6.7.4.3.5 Lysophospholipids
      • 3.6.7.4.4 Cervical Cancer
      • 3.6.7.4.5 Colon Cancer DNA Testing
    • 3.6.7.5 Pharmocogenomic Cancer Testing
  • 3.6.8 HPV Testing
    • 3.6.8.1 Overview
    • 3.6.8.2 U.S. Market
    • 3.6.8.3 European Market
    • 3.6.8.4 Other Markets
    • 3.6.8.5 The Association of HPV and Cervical Cancer
    • 3.6.8.6 Assays for HPV
  • 3.6.9 Biochips for Clinical Applications
    • 3.6.9.1 Roche AmpliChip
    • 3.6.9.2 Amersham CodeLink
    • 3.6.9.3 Breast Cancer DNA Chips
    • 3.6.9.4 Motorola eSensor
    • 3.6.9.5 Affymetrix GeneChip System 3000Dx
    • 3.6.9.6 Caliper and Cepheid
    • 3.6.9.7 Agilent Technologies 5100 Lab-on-a-Chip
  • 3.6.10 HIV
    • 3.6.10.1 U.S. Testing Market
    • 3.6.10.2 World Testing Market
      • 3.6.10.2.1 Asia
      • 3.6.10.2.2 Japan
      • 3.6.10.2.3 Sub-Saharan Africa
    • 3.6.10.3 Major Players
  • 3.6.11 Cellular Imaging Cytopathology and Histopathology
    • 3.6.11.1 Segment Overview
    • 3.6.11.2 The Market
    • 3.6.11.3 Market Drivers:
    • 3.6.11.4 Market Restraints
    • 3.6.11.5 Cytology and Histology Technology Platforms
      • 3.6.11.5.1 Cytology Screening Procedures and Pap Smear Technology
      • 3.6.11.5.2 Histology
      • 3.6.11.5.3 Market Drivers
      • 3.6.11.5.4 ISH Staining
      • 3.6.11.5.5 Special Stains Staining
    • 3.6.11.6 Third Party Reimbursement
    • 3.6.11.7 Competition
  • 3.6.12 Infectious Disease Testing
    • 3.6.12.1 Streptococcus Testing
    • 3.6.12.2 Chlamydia Testing
    • 3.6.12.3 Mononucleosis
    • 3.6.12.4 Gonorrhea
    • 3.6.12.5 Influenza

4. High-Growth Testing Diagnostic Trends

• 4.1 Genetic Testing
• 4.2 Quality measures
• 4.3 Moderators of Growth
  • 4.3.1 Diagnostics and the Aging Population
  • 4.3.2 Individualized Medicine
  • 4.3.3 Patient Safety and Quality Measures
  • 4.3.4 Genetic Testing
  • 4.3.5 Preventive medicine
• 4.4 Workforce Issues
• 4.5 Reimbursement
  • 4.5.1 Cardiovascular
  • 4.5.2 Screening for Diabetes
  • 4.5.3 Other Reimbursement Concerns for 20
  • 4.5.4 New CPT Test Codes and Payment Amounts for 20
• 4.6 Rapid Near Patient Testing In Hospitals
• 4.7 Satellite Facilities
• 4.8 Regionalization of Laboratory Care
• 4.9 Requirements for High-Growth Testing
• 4.10 Clinical Laboratory Improvement Act (CLIA)

5. Business Trends in the Industry

• 5.1 Sector Consolidation
• 5.2 Diagnostic Testing Growth Trends
• 5.3 Acquisition, License Agreements, Internal Development, Partnerships
• 5.4 Product Testing Depth in High-Growth Testing
• 5.5 Government Regulation
  • 5.5.1 United States Regulations
    • 5.5.1.1 Importing Medical Devices into the U.S.
    • 5.5.1.2 Exporting Medical Devices from the U.S.
  • 5.5.2 U.K Regulations
  • 5.5.3 E.U. Regulations
  • 5.5.4 Japanese Regulations
• 5.6 Increased Market Penetration in High-Growth Testing
• 5.7 Legal Issues

6. Important Technology Trends

7. Company Profiles

• 7.1 TriPath Imaging
• 7.2 Lifescan Corporation
• 7.3 OraSure
• 7.4 Bayer Corporation
• 7.5 Abbott Diagnostics
• 7.6 Cytyc Corporation
• 7.7 Inverness Medical Innovations
• 7.8 Johnson & Johnson
• 7.9 Quidel
• 7.10 Biomerica
• 7.11 Genzyme Diagnostics
• 7.12 Adeza Biomedical Corporation
• 7.13 Jiangnan Biotech
• 7.14 diaDexus LLC
• 7.15 Digene
• 7.16 Matritech
• 7.17 Roche Diagnostics
• 7.18 Myraid Genetics
• 7.19 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)
• 7.20 LifePoint, Inc.
• 7.21 Avitar, Inc.
• 7.22 Cozart Bioscience
• 7.23 Enterix, Inc.
• 7.24 Kyowa Medex Co., Ltd.
• 7.25 Iatron
• 7.26 Denka Seiken Co., Ltd.
• 7.27 Accurex Biomedical, Pvt., Ltd.
• 7.28 Ambri Ltd.
• 7.29 Thermo Biostar
• 7.30 Axis-Shield
• 7.31 Polymedco
• 7.32 Medix Biochemica
• 7.33 Pheromone Sciences
• 7.34 Ostex International, Inc.
• 7.35 Procrea
• 7.36 American Bio Medica Corp.
• 7.37 Third Wave Technologies
• 7.38 Biosite, Inc.
• 7.39 Spectral Diagnostics, Inc.
• 7.40 Dade Behring
• 7.41 Beckman-Coulter
• 7.42 Ani Biotech
• 7.43 Applied Spectral Imaging
• 7.44 Applied Imaging Corp.
• 7.45 Shionogi & Co.
• 7.46 Biorad, Inc.

8. Appendix 1 - Opportunities in the Chinese Biotech Market

INDEX OF TABLES

• Table 1: U.S. Population Dynamics in Millions
• Table 2: World Population and Growth Through 2024
• Table 3: Total Japanese Population and Aging Demographics Forecast
• Table 4: Worldwide Market Share In Vitro Diagnostic Companies
• Table 5: Worldwide In Vitro Diagnostics Market Size 2001-2007
• Table 6: U.S. In Vitro Central Lab Diagnostic Testing 2001-2007
• Table 7: Worldwide Near Patient Diagnostic Testing 2001-2007
• Table 8: High-Growth Market Segments Overview
• Table 9: U.S. High-Growth Diagnostic Testing Market Segments
• Table 10: Regional Comparison of 1999 GDP, Healthcare, and IVD
• Table 11: German Diagnostics Products Market Sales
• Table 12: The German Patient Care Lab Test Market
• Table 13: The German Alternate Site Testing Market (POL)
• Table 14: The German Hospital Point-of-Care Market
• Table 15: German Clinical Diagnostic Rapid Test Market Segments
• Table 16: The U.K. IVD Market ($ Millions)
• Table 17: Major U.K. IVD Manufacturers
• Table 18: U.S. IVD Manufacturers Doing Business in the U.K.
• Table 19: Other European Companies that Manufacture IVD Products in the U.K.
• Table 20: Japanese Diagnostic Testing Market
• Table 21: Chinese Diagnostics Products Market Sales
• Table 22: Global Market for HBV Diagnostic Testing
• Table 23: U.S. Market for HBV Diagnostic Testing
• Table 24: HBV Markers
• Table 25: Serological Diagnosis of Hepatitis B Virus Infections
• Table 26: Unusual Hepatitis B Serologic Profiles Requiring Further Evaluation
• Table 27: Recommendations for Diagnostic Testing for Hepatitis B
• Table 28: Lower Detection Limits of HBV DNA Assays
• Table 29: Recommendations for Hepatitis B Testing
• Table 30: Summary of Hepatitis Test Technology
• Table 31: Global Market for HCV Diagnostic Testing
• Table 32: U.S. Market for HCV Diagnostic Testing
• Table 33: Recommendations for Diagnostic Testing for Hepatitis C
• Table 34: Hepatitis C Statistics
• Table 35: Gen-Probe Clinical Diagnostic Products Test for the Detection of HCV
• Table 36: Acute Myocardial Infarction Facts
• Table 37: Emergency Room Admissions in the U.S.
• Table 38: Specific Cardiac Markers
• Table 39: Cardiac Markers after Onset of Myocardial Infarction
• Table 40: The Cardiac Marker Market for Testing in the U.S.
• Table 41: Market Share of Cardiac Marker Segment
• Table 42: U.S. Market for Point-of-Care Cardiac Marker Testing
• Table 43: BNP Characteristics
• Table 44: BNP Testing Dollar Volume
• Table 45: Market Share of BNP Assays in the U.S.
• Table 46: Market Share of NT-proBNP Assays in the U.S.
• Table 47: Clinical Characteristics of D-Dimer
• Table 48: Global Market for Cancer Cytogenetic Diagnostic Testing
• Table 49: U.S. Market for Cancer Cytogenetic Diagnostic Testing
• Table 50: CF Carrier Risk by Ethnic Group
• Table 51: Reasons for CF Testing
• Table 52: CF Testing Methodology
• Table 53: CF Gene Detection Rates Vary by Ethnic Background
• Table 54: Global Market for CF Diagnostic Testing
• Table 55: U.S. Market for CF Diagnostic Testing
• Table 56: Commercial CF Screening Products
• Table 57: Emerging CF Screening Products
• Table 58: CF Screening Technology Summary
• Table 59: The Fertility Testing Market in the U.S.
• Table 60: Rite Aid and other OEM Ovulation Predictors
• Table 61: U.S. Population of Diabetics by Group
• Table 62: Percentage of Adults with Diabetes Using Diabetes Medication, by Age, U.S., 1997-2002 Age Group
• Table 63: Health Care Utilization by the Diabetes Patient
• Table 64: The Global Population of Persons with Diabetes (in Millions)
• Table 65: The Glucose Market for OTC Testing in the U.S.
• Table 66: The Glucose Market for OTC Testing Worldwide
• Table 67: Major Players in the Point-of-Care and Near Patient Testing for Glucose - OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements
• Table 68: Womens Cancers - 2004 Cancer Estimates (U.S.) Incidence
• Table 69: Five Year Disease-Free Survival by Stage at Diagnosis
• Table 70: TPA Marker Sensitivity
• Table 71: Facts About HPV Risk Factors
• Table 72: HPV and Cervical Carcinoma
• Table 73: HPV and Cervical Carcinoma Risk
• Table 74: Rationale for Reflex HPV Testing with Cytology
• Table 75: Rationale against Reflex HPV Testing with Cytology
• Table 76: Predictability of HPV Test by Abnormal Pap Smear Type
• Table 77: Incidence of Cervical Cancer and Cytological Abnormalities
• Table 78: Long Term Trends in HPV Testing
• Table 79: Biochip Revenues and Growth Rates by Application
• Table 80: Total Biochip Market: Revenue Forecasts by Segment (World)
• Table 81: Total Biochip Market: Revenue Forecasts by Segment (U.S)
• Table 82: U.S. HIV Positive Population 1998-20
• Table 83: U.S. High-Growth Testing Market for HIV
• Table 84: Countries with the Highest Prevalence of HIV/AIDS
• Table 85: Births of HIV Infected Babies in U.S.
• Table 86: Number (Millions) of Pap Smears Performed by Country
• Table 87: Estimated Cervical Cancer Cases/Deaths Worldwide
• Table 88: Medicare Reimbursement for Cervical Pathology Procedures
• Table 89: U.S. Strep Testing Market Size
• Table 90: U.S. Market for Rapid Point of Care Strep Tests
• Table 91: The U.S. Chlamydia Testing Market
• Table 92: Products Marketed by Abbott in the Diagnostic Market
• Table 93: China Biotech Reagents Market
• Table 94: Biotechnology Projects between China and the West

INDEX OF FIGURES

• Figure 1: Lab Industry Market Shares 2003
• Figure 2: Major Lab Testing Segments