Table of Contents
1 Executive Summary
- 1.1 Focus of this Report
- 1.1.1 This Report Discusses IVD Tests According to Applications
- 1.1.2 How Companies are Discussed
- 1.1.3 Forecasts Include Laboratory-Only Companies
- 1.2 Crucial Points
- 1.2.1 Worldwide IVD Market Will Grow Well for the Next 15 Years
- 1.2.2 Short-Term Growth Led by Pregnancy, Influenza and Oncology Tests
- 1.2.3 SWOT Analysis
- 1.3 Aim, Scope and Format of this Report
- 1.4 Research Methods
2 In Vitro Diagnostics (IVD) and Point of Care
- 2.1 What Are IVD Tests?
- 2.2 How IVDs are Regulated by the FDA
- 2.3 Types of IVD Tests
- 2.4 Diagnostics Historically Separate from Pharmacological Treatment
- 2.5 Relative Costs of IVDs
- 2.6 Point of Care Tests (POCTs)
- 2.6.1 POCTs and Hospital Stays
- 2.6.2 What Home POCTs Say About the IVD Market
- 2.7 Laboratory IVD Tests versus Point of Care Testing
- 2.7.1 Diagnosis Turnover Rates
- 2.7.2 How Quickly Are Results Needed?
- 2.7.3 How Much do Shorter Turnaround Times Improve Treatment?
- 2.7.4 Economies of Scale
3 IVD Market Summary
- 3.1 Whole Market Analysis
- 3.2 Market Summary of Five IVD Tests with 2008 Sales of Over $5bn
- 3.3 Market Summary of Four IVD Tests with 2008 Sales Under $5bn
4 Genetic Tests
- 4.1 Genetic Tests: Medicine of the Future?
- 4.1.1 Genetic Tests and Tailored Medicine
- 4.2 Market Forecast, 2009-2024
- 4.3 2009 Call for Genetic Test Standards
- 4.4 Genetics and Oncology
- 4.4.1 BRCA1 and BRCA2 Genetic Tests
- 4.4.2 Genetics and HER2: Success Story
- 4.4.3 HER2 and Cancer: How IVDs and Therapy Interconnect
- 4.4.4 Genetics and Response to Gleevec for Gastrointestinal Cancer
- 4.5 Genetics and Statins
- 4.5.1 Celera' s Genetic Test for Statin Responsiveness: the KIF6 Allele
- 4.5.2 Interview with Thomas White, PhD, Chief Scientific Officer and VP
of Research, Celera
- 4.6 Genetic Test Companies
- 4.6.1 Myriad Genetics
- 4.6.2 deCODE Genetics
- 4.6.3 23andMe
- 4.6.4 Navigenics
- 4.7 Market by Region: Forecast Discussion
- 4.7.1 US
- 4.7.2 Japan and China
- 4.7.3 Europe
5 Oncology Tests
- 5.1 How Cancer is Diagnosed: Currently and in the Future
- 5.2 Market Forecast: 2009-2024
- 5.3 Lung Cancer
- 5.3.1 Almac Diagnostics
- 5.3.2 Lung Cancer IVD: Worldwide Unmet Need
- 5.4 Prostate Cancer
- 5.4.1 Gen-Probe Incorporated
- 5.4.2 Gen-Probe and DiagnoCure Incorporated
- 5.4.3 Timeline for a PCA3 Point of Care Test
- 5.5 Colorectal Cancer
- 5.5.1 Quest Diagnostics
- 5.5.2 DiagnoCure Inc.: Molecular Diagnostics for Cancer
- 5.5.3 Aventir Biotech LLC: First FDA-Approved Faecal Occult Blood Test
- 5.5.4 Alpha Laboratories
- 5.6 Human Papillomavirus (HPV) and Cervical Cancer
- 5.6.1 Digene/Qiagen
- 5.6.2 Cytyc and Hologic
6 Diabetes/Glucose Tests and Monitoring
- 6.1 Brief Overview of Diabetes
- 6.2 Market Forecast, 2009-2024
- 6.3 Glucose IVD Market by Subdivision: Diagnostic Tests and Monitoring
Devices
- 6.4 Types of Tests
- 6.4.1 Blood Tests
- 6.4.2 Urine Tests
- 6.5 Diabetes IVD Assessment Targets
- 6.5.1 Ketones
- 6.5.2 Microalbuminurea
- 6.5.3 Glucose
- 6.6 Top Diabetes IVD Companies
- 6.6.1 Lifescan/Johnson & Johnson
- 6.6.2 Roche
- 6.6.3 Abbott
- 6.6.4 Bayer Diagnostics
- 6.6.5 Home Diagnostics, Inc.
- 6.7 Immediate Results: Crucial for Glucose Monitoring and Point of Care
Testing
- 6.8 Future Opportunities in the Diabetes/Glucose IVD Market
- 6.9 Market by Region: Forecast Discussion
- 6.9.1 India and China
- 6.9.2 United States
- 6.9.3 Europe
7 Cholesterol Tests
- 7.1 Market Forecast, 2009-2024
- 7.2 Cholesterol Testing Companies
- 7.2.1 Polymer Technology Systems (PTS)
- 7.2.2 Roche Diagnostics
- 7.2.3 Home Access Health Corporation
- 7.2.4 Atherotech, Inc.
- 7.3 Market by Region: Forecast Discussion
- 7.3.1 Europe
- 7.3.2 US
- 7.3.3 India
- 7.3.4 South America
8 HIV Tests
- 8.1 Market Forecast, 2009-2024
- 8.2 OTC HIV Tests: The Debate
- 8.2.1 Home Testing vs. Home Sampling
- 8.2.2 Home Tests and Home Results Not Approved
- 8.3 HIV Testing Companies
- 8.3.1 Home Access Health Corporation
- 8.3.2 OraSure Technologies
- 8.3.3 MedMira
- 8.3.4 Novartis/Chiron
- 8.4 Market by Region: Forecast Discussion
- 8.4.1 Europe
- 8.4.2 US
- 8.4.3 Asia
- 8.4.4 Africa: Where the HIV Problem is Worst
9 Influenza Tests
- 9.1 Market Forecast, 2009-2024
- 9.2 Test Targets
- 9.3 Typing: A and B Strains
- 9.3.1 Rapid Tests: 15 Minutes or Less
- 9.4 Rapid Test Companies
- 9.4.1 Becton, Dickinson and Company
- 9.4.2 Inverness Medical Innovations, Inc.
- 9.4.3 Quidel
- 9.4.4 SA Scientific, Ltd.
- 9.4.5 Meridian Bioscience, Inc.
- 9.5 2009 Swine Flu as Case Study
- 9.6 Avian Flu: H5N1
- 9.6.1 IVD Market Forecast and Avian Flu
- 9.6.2 Avian Flu Tests
- 9.6.3 Arbor Vita Corporation
- 9.7 Market by Region: Forecast Discussion
- 9.7.1 US
- 9.7.2 Japan: The Second-Largest Flu Market
- 9.7.3 Europe
- 9.7.4 Hong Kong: Site of Original Avian Flu Outbreak in Human Beings
- 9.7.5 Sites of Recent Avian Flu Outbreaks
10 Drugs of Abuse Tests
- 10.1 Market Forecast
- 10.2 Types of Tests: Individual and Multiple Assays
- 10.3 OTC Test Companies
- 10.3.1 Inverness Medical Innovations/First Check Diagnostics
- 10.3.2 BTNX Inc.
- 10.3.3 Phamatech
- 10.3.4 Alfa Scientific
- 10.3.5 ACON Laboratories/Inverness Medical Innovations
- 10.4 Market by Region: Forecast Discussion
- 10.4.1 US
- 10.4.2 Europe: The European Workplace Drug Testing Society
11 Fertility, Ovulation and Pregnancy Tests
- 11.1 Market Forecast
- 11.2 Male and Fertility Tests: Relative Sales
- 11.3 Over-the-Counter Tests: The Largest Market?
- 11.3.1 Pregnancy Tests
- 11.3.2 Ovulation Tests: As Contraceptive and Pro-Conception Tools
- 11.3.3 Female Fertility Tests
- 11.3.4 Male Fertility Tests: Improving Products
- 11.4 OTC Test Companies
- 11.4.1 Church & Dwight Co, Inc.
- 11.4.2 Swiss Precision Diagnostics: Inverness Medical Innovations and
Procter & Gamble
- 11.4.3 Johnson & Johnson
- 11.4.4 Genosis PLC/The LifeStyle Company
- 11.5 Market by Region: Forecast Discussion
- 11.5.1 US
- 11.5.2 Europe
- 11.5.3 Japan
- 11.5.4 South America
12 Conclusions
- 12.1 Most IVD Test Markets are Growth Markets
- 12.2 Growth Drivers
- 12.2.1 The Greatest Unmet IVD Need
- 12.3 Growth-Limiting Factors
- 12.3.1 Growth-Limiting Factors for Specific Markets
- 12.3.2 Saturated Markets
- 12.4 Over the Counter Tests: The Added Value of Convenience
- 12.5 Diagnostic Innovation: Improving the Future of Medicine
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