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High-Growth Diagnostic Testing Markets
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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 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
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