Description
Genetic testing is already in widespread use and will continue to grow in many application areas in the next five years. The number of companies offering genetic testing services and/or commercial genetic testing products continues to grow around the world. There are at least 50 companies offering genetic testing services or commercial products for a genetic test in medical, GMO food safety, forensics, and paternity applications.
In the area of medical genetics, tests and services can vary by disease. Under the category of “medical genetics” there is screening for genetic disease and susceptibility and the emerging fields of pharmacogenomics and OTC (or direct-to-consumer) tests in the areas of nutrition and alcoholism. Much of the growth in genetically modified organism (GMO) testing, forensic DNA testing, and paternity testing is due to new industry regulation and legal proceedings. Regulations, patents, costs, and ease of use of a technology are all forces that drive the development of genetic testing application markets.
This study used a survey tool to track end-user attitudes and understand the basis of competition for these testing products and services.
Scope and Methodology
This report focuses on genetic testing application markets in worldwide with a particular emphasis on markets in the United States. Information has been collected from numerous industry, government, and academic sources. In addition to interviewing industry participants and conducting exhaustive literature reviews, this study used a survey tool to track end-user attitudes and understand the basis of competition for these testing products and services.
For this discussion, the genetic testing application markets are divided into segments by applications.
- Medical genetics
- inherited diseases
- direct-to-consumer, and
- pharmacogenetics/pharmacogenomics
- Forensics
- Paternity
- Genetically modified organism (GMO) testing
The report provides market size and growth for the various genetic testing applications;
identifies and discusses clinical, regulatory, and business trends; and profiles more than 25 industry participants.
Table of Contents
Chapter One: Executive Summary
- Introduction
- Scope and Methodology
- Summary of Findings
- Market Size and Growth
- Trends and Conclusions
Chapter Two: Clinical Genetic Disease Testing
- What Are the Diseases Generating Revenue?
- Newborn Screening
- Competitive Analysis
Chapter Three: Direct-to-Consumer/ Over-the-Counter Genetic Testing
- Why Consumers and Not Doctors?
- DTC Marketing
Chapter Four: Pharmacogenetic Testing
- The Tests
- Her-2/Neu testing
- HIV Resistance Testing
- P450
- Thiopurine Methyltransferase (TPMT)
- Osteoporosis/Bone Loss
- Cardiovascular
- Immune Response
- Areas of Pharmacogenetic Development
- Preimplantation Genetic Diagnostics
- Cancer, Cardiovascular, Mental Illness
Chapter Five: Pharmacogenetic Testing—An End-User Survey
- Her2/Neu End User Survey
- Summary of Results
- Conclusions
- Pharmacogenetic Testing Survey
- Summary of Results
- Conclusions
Chapter Six: GMO Testing
- Introduction
- Grain Inspectors Packers Standard Association (GIPSA)
- European Network of GMO Laboratories (ENGL)
- The Market & Market Players
Chapter Seven: Forensics and Paternity
- The Forensic DNA Market
- U.S. Forensic DNA Laboratories
- International Forensic DNA Testing
- Paternity Testing
Chapter Eight: Conclusions & Strategic Implications
- First Conclusion
- Second Conclusion
- Third Conclusion
- Fourth Conclusion
Chapter Nine: Company Profiles
- Arup Laboratories
- Athena Diagnostics
- Biogenetic Services, Inc.
- California Seed & Plant, Inc.
- DNA Sciences, Inc.
- Eurofins
- Gene Scan AG
- GeneLex
- GeneLink, Inc.
- Genetic ID
- Genzyme
- Great Smokies Diagnostic Laboratory
- HealthCheck
- HerediLab
- Investigen
- Investigen
- Labcorp
- LGC
- Medallion Labs
- Myriad Genetics, Inc.
- Neo Gen Screening
- OMIC
- Orchid Biosciences
- Quest Diagnostics
- Sciona Limited
- Silliker Labs
- Specialty Labs
- Visible Genetics/Bayer Diagnostics
Appendix A: A Note on Standards for DNA-Based Testing
Appendix B: Pharmacogenetic Tests End User Questionnaires
Appendix C: Genetic Testing Glossary
Appendix D: Company Directory
List of Exhibits
Chapter One: Executive Summary
- Table 1-1: Genetic Testing Revenue by Application 2000-2008
Chapter Two: Clinical Genetic Disease Testing
- Table 2-1: Number of Clinical Genetic Disease Tests 2000-2003
- Table 2-2: Clinical Genetic Disease Testing Revenue 2000-2008
- Table 2-3: Top Ten Genetic Diseases by Number of Clinical Laboratories, 2003
- Table 2-4: Number of Labs Performing Genetic Disease Tests by Disease, 1998, 2000, 2002
- Figure 2-1: Trending of Number of Laboratories Conducting the Top Five Clinical Genetic Test 1998-2003
- Table 2-5: LabCorp Genetic Testing Volumes 1999-2002
- Table 2-6: Market Share of Inherited Genetic Testing Service Providers by Leading Competitor 2002
- Figure 2-2: Market Share of Inherited Genetic Testing Service Providers by Leading Competitor 2002
Chapter Three: Direct-to-Consumer/ Over-the-Counter Genetic Testing
- Table 3-1: Number of Companies with DTC/OTC Genetic Tests on the Market by Disease, 2002
- Table 3-2: DTC/OTC Test Areas by Company
- Table 3-3: Common Inherited Genetic Disease Tests List Price by Company
- Table 3-4: Sciona Nutrigenetic Panel
- Table 3-5: Myriad Breast Cancer & Cardia Risk Revenue 1997 and 2001
Chapter Four: Pharmacogenetic Testing
- Table 4-1: Pharmacogenetic Tests by Company
- Table 4-2: Number of Her2/Neu Testing Procedures 2000-2008
- Table 4-3: Diseases for Which Tests Were Available 2000
Chapter Six: GMO Testing
- Table 6-1: Pecentage of Global Crops Genetically Modified by Type 2001-2002
- Table 6-2: Global Genetically Modified Crop Production by Country
- Table 6-3: Pecentage of GM-Crop Used in the United States
- Table 6-4: Number of “Deficient” DNA Testing Laboratories
- Table 6-5: Number of Public GIPSA DNA GMO Labs by Country
- Table 6-6: DNA GMO Testing Revenue 2000-2008
- Table 6-7: DNA GMO Testing Laboratories
- Table 6-8: Market Share of the DNA GMO Testing Players 2002
Chapter Seven: Forensics and Paternity
- Table 7-1: Number of DNA Database Laws by State
- Table 7-2: Number of State All Felon DNA Database Laws
- Table 7-3: Current Backlog of Forensic DNA Samples
- Table 7-4: Forensic DNA Sample Revenue 2000-2008
- Table 7-5: Total Forensic DNA Samples, 2001-2002
- Table 7-6: Number of Forensic DNA Samples and Laboratories, 2001-2002
- Table7-7: Number of CODIS DNA Samples in the Database, 2000-2003
- Table 7-9: Number of Canadian Forensic DNA Samples, 2001-2003
- Table 7-10: Number of Parentage Testing Cases 1998-2001
- Table 7-11: Laboratories by Volume of Cases Reported
- Table 7-12: Share Utilization of Various Technologies in Paternity Testing 1998-2003
Chapter Eight: Conclusions & Strategic Implications
- Table 8-1: Tests Offered by Both Traditional Physician and DTC Services
