The U.S. Market for Molecular Diagnostics

Countries covered: United States In recent years molecular diagnostics has become a growing part of the clinical laboratory. The trend will not only continue but will show significant growth in the future. This report from Kalorama Information examines the current and future opportunities associated with Molecular Diagnostic Technologies. Areas covered include: Applications DNA-Based Technologies Genomics Amplification systems Probe technologies Chip-based technologies Protein-Based Technologies Proteomics Protein probes Chip-based technologies Market size and share for traditional Molecular Diagnostic products and the commercial outlook for new and/or emerging technologies.

This report focuses on the technologies and applications of molecular diagnostics, the options that they present, and the progress that is being made in these fields. The major market effects of new diagnostics, with the potential of a breakthrough product always a possibility, are expected to begin to be seen soon, that is, within two to three years. The technology trends selected in conjunction with the growing interest in molecular diagnostics and their application to current public 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.

This report covers current molecular diagnostics technologies in a broad sense. It does not go into the details of genetics, heredity, the mechanisms of the various diagnostic products in the marketplace or the relative merits of various amplification and other technologies. The ability to do so is limited by several factors, including the extensive foundation material that would have to be presented in order to form the basis for such discussion, and the myriad of small details that are simply too many in number to include in a report of this nature. This report does discuss, however, the impacts that advanced technologies and applications will have on existing diagnostics markets in the whole, and their place in the diagnostics/therapeutics relationship.

Market analysis for this report considers the various applications of molecular testing rather than the markets for specific technologies in the United States. 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 or blood bank, and not for research or genomic data collection and cataloging.

The analysis presented in this report is based on data from a combination of company, government, industry, 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.

Press Release

Molecular Diagnostics to Lead 21st Century Industry Renaissance

New York, September 26,2001/PR Newswire -- The U.S. market for molecular diagnostics is poised to experience rapid growth over the next six years, soaring to well over $10 billion by 2007. According to a new report on the industry released today by Kalorama Information and available through MarketResearch.com, molecular technologies will drive a phenomenal increase in both market size and range of application for the diagnostics industry. On average, revenue growth will exceed 30% annually, with some sectors experiencing growth in excess of 80%.

According to the new study, “The U.S. Market for Molecular Diagnostics,” infectious disease testing and blood-banking applications will lead the way, but various pharmacogenetic applications, some as yet unrealized, should be close behind. Molecular cancer diagnostics, too, should post strong numbers in the years to come.

“For various reasons, the clinical diagnostics industry has been moribund for nearly two decades,” notes Kenneth Krul, PhD, the author of the report. “Its previous reputation as a source of continuing innovation and technological development has been lost recently, but the promise of diagnostics based on genes and miracle therapeutics based on these same genes may be the source of revival the clinical lab’s been looking for.”

But despite the optimistic growth picture, the industry will face some challenges in the near future, according to the study. The competition will be fierce and the FDA’s policy of benign neglect looks like it may be coming to an end. The report discusses these and other trends and details the technologies, applications, and competitors in the market.

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