高度成長的診斷檢查領域市場之分析與預測

Abstract

There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.

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