Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
Author: Lucy J. Sannes, PhD, MBA
Molecular diagnostic applications in the areas of oncology, personalized medicine, inherited disorders, prediction of genetic disease risk, and many others are rapidly increasing in number as this burgeoning field expands beyond infectious disease testing. This report focuses on these newer applications of molecular diagnostics, analyzing:
- Established and up-and-coming technologies
- The activities of more than 35 companies
- More than 300 current and emerging molecular diagnostic tests for disease applications and genetic testing
- Business considerations associated with product development, commercialization, and marketing
- Regulatory issues
- Challenges facing companies developing molecular diagnostics and/or companion diagnostics and targeted therapies
- Major trends in the molecular diagnostics market, such as the increasing number of tests that are commercially available
The molecular diagnostics market is exploding. New genes and biomarkers are continually being identified and clinically validated, increasing the number of different tests available. The requisite technology and instruments are advancing in tandem. While many companies offer tests that detect only one or a few genetic changes, some companies have now developed tests capable of detecting large numbers of these changes. Many companies are taking their tests through the traditional diagnostics market strategy of gaining FDA clearance, while others have chosen a different strategy and are offering tests through their own CLIA-certified laboratories. These and other dynamics are effecting rapid change in this evolving field. Molecular Diagnostics: A Dynamic and Rapidly Broadening Market analyzes the emerging applications and technologies, marketplace trends, and business considerations for companies in this space.
The molecular diagnostics market is already quite large. It is estimated that the worldwide market for in vitro diagnostic kits and reagents sold by diagnostic companies to clinical laboratories may be approximately $3 billion or greater in 2008. It is more difficult to estimate the market size for proprietary clinical tests offered by companies through either their own CLIA-certified laboratories or other clinical laboratories. However, this can be a promising opportunity. For example, Myriad Genetics and Genomic Health saw a jump in molecular diagnostic revenues of 53% and 132%, respectively, over the past two years.
Molecular Diagnostics: A Dynamic and Rapidly Broadening Market considers major trends, including movement toward near-patient testing, growth in the number of new biomarkers, increased effort on clinical validation of tests, increased competition, consolidation in the field, regulatory issues and their impact on laboratories and companies, and the increasing role played by personalized medicine, among others. Technologies discussed include non-amplified probe-based assays, cytogenetics and fluorescent in situ hybridization, amplification technologies, microarrays, and DNA methylation assays.
Current and emerging applications of molecular diagnostics are reviewed and grouped into the following categories: oncology (diagnostic, prognostic, and personalized medicine tests); personalized medicine, pharmacogenomics and companion diagnostics outside of oncology; genetic testing for inherited disorders and prenatal diagnosis; and predicting genetic risk of disease. The activities of more than 35 companies are discussed. We also consider some of the challenges facing molecular diagnostic and pharmaceutical companies developing pharmacogenomic therapies, such as issues regarding reimbursement, patient and physician education, and the validation of new biomarkers and diagnostic tests. We conclude with 10 exclusive industry expert interviews.
About the Author:Lucy J. Sannes, PhD, MBA, is president of Sannes & Associates, a consulting firm specializing in evaluation and management of the biosciences. Before forming Sannes & Associates, she held management positions at Genetic Systems and Abbott Laboratories in product development, product support, and technical marketing. Dr. Sannes received her PhD in biological chemistry from the University of Michigan and her MBA from Seattle Pacific University.