Gene and chromosome testing for inherited diseases currently represents the third largest molecular diagnostics testing segment in the U.S. Assays in this market address applications in genetic carrier and predisposition testing. Currently, most testing is for prenatal screening and for assessing clinically suspect newborns for various chromosomal abnormalities (e.g., Down’s syndrome, fragile X syndrome). Some testing is used for genetic counseling for couples planning to have children. Such diagnostics test for the presence of carrier states of diseases such as Tay-Sachs disease, sickle-cell anemia, or cystic fibrosis, where a clinical history of these disease conditions exists in their families. Another type of genetic and chromosomal molecular diagnostic testing is that for disease susceptibility, though this is not a major market factor at this time.

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 inherited disease testing.

The major market effects of new diagnostics—with the potential of a breakthrough product always a possibility—are being seen and are expected to significantly impact the market over the next ten years. The technology trends selected in conjunction with the growing interest in molecular diagnostics and their application to current health priorities (e.g., HIV/AIDS, cancer, sexually transmitted diseases, etc.) present the most informative picture of advances in this field and the markets that result. Market analysis considers various infectious disease diagnostic applications of molecular testing rather than the markets for specific technologies in the U.S. This report does not consider instrumentation, such as thermocyclers, luminometers, sequencers, etc. and their disposable support products. Some mention is made of such instrumentation, but greater emphasis is placed on applications and the technologies that will address those specific applications. The focus of the report is on molecular diagnostics technologies and products with the potential to become first-line methods for use in the clinical laboratory for inherited disease testing, and not for research or genomic data collection and cataloguing. The analysis presented in this report is based on data from a combination of company, government, industry, and institutional and private sources. It includes information from extensive literature reviews, as well as interviews and discussions with experts in the field, including molecular biologists, laboratory medicine professionals, pathologists, research scientists, business development managers and marketing managers.

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