Abstract
Introduction
DNA-based testing is moving into a new phase. Transformational technologies
are allowing complex genetic (specific gene) and genomic (large numbers of
genes) tests to move from research-only labs into medical and clinical labs
that perform tests for individual patients to identify genes associated with
specific medical conditions. Progress in this young industry is happening fast
and furious. New discoveries about the genetic basis of disease are being made
every day. And even though DNA-based tests have a relatively small impact on
how medicine is practiced today, each new and encouraging development is a
step closer to a day when healthcare can be tailored or personalized to an
individual' s genetic makeup.
This report examines the U.S. market for DNA-based test products that are
commercially available today, or will be soon, to screen for disease, confirm
a diagnosis in someone with disease symptoms or even determine if you carry a
gene that predisposes you to disease - before it causes symptoms. Particular
emphasis is given to adult genetic tests that predict risk of disease and
predict the best treatment regimens for diagnosed disease.
Even as DNA-based diagnostic tests gain in popularity, matters of genetic
privacy and ethics, as well as issues of reimbursement and regulation, are
still being debated. The report also evaluates these potential obstacles to
DNA-based tests becoming standard medical practice where they can be offered
through a physician or directly to the public.
Research Objectives and Targets
- Brief history of DNA-based testing and market development
- Broad look at the market players, distribution structure, and regulatory
paths to commercializing DNA test products in the United States
- Analysis of U.S. market structure and size, by major product segments:
predisposition, diagnostic and predictive pharmacodiagnostic tests for
cancers, infectious diseases and other chronic diseases
- Analysis of product development trends and technology advances in
multiplexed diagnostic systems and next-generation ultrahigh-throughput
sequencers
- Status of regulations and policies related to genetic privacy, genetic
testing insurance coverage and DNA counseling
- Future market potential through 2012 - including market drivers and
obstacles
- Activities and strategy of 10 notable companies that serve this market and
their relevant test products