Molecular Diagnostics for Pharmacogenetic Testing: Testing volume, cost per test, and market potential

 
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Published Oct 1, 2004 | 118 Pages | Pub ID: KLI1037838

The field of pharmacogenetics promises to open up new opportunities for the diagnostic industry at the same time it opens the door to more effective therapeutics. Pharmacogenetics is based on the principle that the effects of a given medication when administered to a patient are determined, at least in part, by his or her genetic constitution. Differences in drug metabolism may lead to varying adverse events or more pronounced adverse events in different individuals, and differing metabolism may also lead to varying levels of drug effectiveness.

In recent years, it has become increasingly apparent that dozens of human drug metabolism polymorphisms exist. The interindividual variability in drug metabolism that is caused by these polymorphisms do not represent relatively large differences of 10-fold to greater than 1000-fold. When attributed to a single gene, dramatic differences in drug metabolism can be seen, even among family members. In addition, there are chronic effects. Over a patient’s lifetime, striking differences in the metabolism of drugs and environmental substances can lead to interindividual differences in the buildup of DNA damage, leading to toxicity or tumorigenesis.

This summary report, extracted from Kalorama Information’s U.S. Market for Molecular Diagnostics, (2nd Edition, May 2004), focuses on the technologies and application of molecular diagnostics in the field of pharmacogenetics. It is designed to give an overview of the market environment for these types of tests and the future opportunities for growth. The essential data sets include number of tests, estimated cost per test, and market potential (in U.S. dollars) for the years 2003 to 2013 for pharmacogenetic molecular tests in the following areas:

  • HIV/AIDS
  • Neuropsychiatric Disorders
  • Immune Disorders
  • Cancer
  • Others

The report outlines issues and barriers such as costs and regulation, and profiles 10 key industry participants.

OVERVIEW

SCOPE AND METHODOLOGY

MARKET CONTEXT

  • Exhibit 1: Distribution of Molecular Diagnostics Testing in U.S. 2004

PHARMACOGENETICS: TARGETS AND TRENDS
PRODUCTS AND PROGRESS OF NOTE
NUMBER OF TESTS

  • Exhibit 2: Projected Pharmacogenetic Testing by Molecular Diagnostics in U.S. 2003-2013
  • Exhibit 3: Trending in Projected Number of Pharmacogenetic Tests by Molecular Diagnostics in U.S. 2003-2013
  • Exhibit 4: Trending in Percentage Distribution of Pharmacogenetic Tests by Molecular Diagnostics in U.S. 2003-2013

MARKET AND COST PER TEST PROJECTIONS, 2003-2013

  • Exhibit 5: Projected Molecular Diagnostics Pharmacogenetic Testing Market Potential in U.S. 2003-2013
  • Exhibit 6: Trending in Projected Test Volume for Molecular Diagnostics in Pharmacogenetic Testing in U.S. 2003-2013
  • Exhibit 7: Trending in Projected Test Volume Composition for Molecular Diagnostics in Pharmacogenetic Testing in U.S. 2003-2013
  • Exhibit 8: Trending in Projected Market Potential for Molecular Diagnostics inPharmacogenetic Testing in U.S. 2003-2013
  • Exhibit 9: Trending in Projected Market Potential Composition for Molecular Diagnostics in Pharmacogenetic Testing in U.S. 2003-2013
  • Exhibit 10: Trending in Projected Average Cost per Test for Molecular Diagnostics in Pharmacogenetic Testing in U.S. 2003-2013

MAJOR COMPETITORS

  • Affymetrix, Inc.
  • Celera Genomics/Celera Diagnostics (Division of Applera Corporation)
  • Cepheid, Inc.
  • Chiron Corporation
  • Gene Logic, Inc.
  • Gen-Probe Incorporated
  • Myriad Genetics, Inc.
  • Nanogen, Inc.
  • Orchid BioSciences, Inc.
  • Roche Diagnostics Division/Roche Molecular Systems
  • F. Hoffmann-LaRoche Ltd.