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November 2005 

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Molecular Diagnostics: 
New Growth, New Markets

Leslie A. Pray, Ph.D.

New Page 1

Molecular Diagnostics: New Growth, New Markets highlights current trends in the molecular diagnostic industry and the major prospects and challenges ahead. Advancing technologies are pushing the diagnostics industry to the fore, and the molecular diagnostics industry in particular is emerging as a powerful health care player with tremendous potential. Advances in PCR (polymerase chain reaction), multiplexing, sequencing, and other technologies are propelling both new and old companies forward with novel capabilities.

The molecular diagnostic industry is characterized by a very diverse, constantly changing technology base that continuously produces new opportunities and applications. Similarly, a growing understanding of the molecular basis of cancer and other chronic diseases is opening up new realms of medicine to the possibilities of molecular diagnostic testing. While the infectious disease sector, particularly viral load testing, will continue to occupy the largest sector of the molecular diagnostics market, other areas, particularly oncology, will see greater rates of growth in the near future.

Molecular Diagnostics: New Growth, New Markets offers a comprehensive evaluation of this dynamic market. Highlights include the following:

• A historical overview of molecular diagnostics, an analysis of the role of diagnostics in the growing field of personalized medicine, and a summary of major market trends and drivers.

• A review of the dominant and emerging applications of molecular diagnostics, with a focus on major areas of robust growth. Although PCR is the most important molecular diagnostic technology, there are other dominant techniques generating considerable profits. The report identifies and evaluates the tremendous opportunities in the marketplace for new, improved technologies.

• An assessment of the industry-landscape in terms of key non-technological trends and challenges, with a focus on regulation, consumer and health care provider education and marketing, and reimbursement.

• An evaluation of the emergence and growth of personalized, or pharmacogenomic, medicine, which is providing tremendous revenue opportunities for molecular diagnostics. The challenge for molecular diagnostics companies will be to generate profits while forming cooperative relationships with pharma, regulatory agencies, consumers, and other stakeholders in ways that facilitate drug-diagnostic co-development and end in a win-win-win situation for all parties.

• An examination of molecular diagnostic business models in the context of factors that are expected to drive the industry forward.

• Profiles of a select list and description of companies that have shown remarkable progress in the field, smaller companies that are expected to emerge as dominant players in particular content or technological areas, and companies that exemplify a noteworthy aspect of molecular diagnostic business.

Related Report--
Pharmacodiagnostics: Technologies, Competition, and Market Models

About the Author

Leslie A. Pray, Ph.D., is a geneticist, writer, and independent consultant. She prepares policy reports for the Board on Global Health at the National Academy of Sciences and has written extensively on a range of genetic, biotechnology, infectious disease, biomedical, and public health issues for The Scientist, Genomics and Proteomics, Orion, the American Chemical Society, the American Association for the Advancement of Science, Oak Ridge National Laboratory, and the CBR Institute for Biomedical Research, among others. Dr. Pray received her Ph.D. in population genetics from the University of Vermont and her B.A. degree from the University of California, Berkeley. She has been the recipient of numerous scientific research awards, including an American Society of Naturalists Young Investigator Award. Dr. Pray can be reached at lpray@nasw.org.

 


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