Abstract
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.
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