MOUNTAIN VIEW, Calif., May 5 /PRNewswire/ -- As early diagnosis of cancer is critical for faster cure, longer survival, and better quality of life for patients, better access to diagnostics is the uppermost priority for primary care. Innovative molecular technologies have generated a wave of cancer diagnostics developed by dynamic new market entrants. These efforts will go a long way in addressing the unmet needs in the early diagnosis of cancer.
Biomarker development is a major area of focus of the FDA-driven Critical Path Initiative. The biomarker development initiative will streamline the clinical trials process and ensure the development of diagnostics, targeted therapeutics, and relevant dosage regimens. Recent changes initiated by the European Medicines Agency (EMEA) in Europe are expected to have a spillover effect on the U.S. cancer molecular diagnostics (CMD) market and fuel growth in the companion diagnostics segment.
New analysis from Frost & Sullivan (http://www.drugdiscovery.frost.com), U.S. Cancer Molecular Diagnostics Markets, finds that this market earned revenues of over $270.1 million in 2007 and estimates this to reach $1.83 billion by 2014.
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"The development of companion diagnostics is a game-changing phenomenon, which will impact the structure and dynamics of the pharmaceutical and biotechnology industry in the near future," advises Frost & Sullivan Senior Analyst Dr. Sudeep Basu. "Companion diagnostics will drive M&A activity and strategic partnerships in this market, in addition to encouraging a systems biology approach in attacking pathways as opposed to single targets."
The National Institute of Health-National Cancer Institute (NIH-NCI) programs, the FDA's Critical Path Initiative, and the availability of advanced tools have also speeded up market momentum. The Oncology Biomarkers Qualification Initiative (OBQI) program marshals public and private support to collaborate and develop the new rules of the game.
Considering the obvious benefits offered by this method and the lack of any deleterious effect observed with the testing, the likelihood of FDA granting approval for this method is high.
The flux in the regulatory environment surrounding the U.S. CMD market poses a major challenge to companies operating in this domain. Frequent adjustments to changing time lines and interim guidelines have proved to be an impediment for new entrants attempting to introduce novel tests to market.
"While FDA approval is no guarantee of market success, it surely helps the process," adds Dr. Basu. "FDA approval is based on a host of factors, and importantly, is an approval of the high levels of clinical relevance of the test, and low levels of risk which stems from the significant clinical studies carried out by the company for validating the diagnostic assay."
Besides adjusting to the ever-changing regulatory environment, participants must skillfully navigate the reimbursement space to ensure that growth continues on an upward trajectory.
A dual-pronged strategy -- bringing products to market through the Clinical Laboratory Improvement Amendments (CLIA) route and gaining early market dominance as well as going through the FDA process -- must be devised to tackle the regulatory and reimbursement barriers and achieve the speedy commercialization of molecular diagnostic tests.
This two-pronged approach will promote overall market visibility. It also ratchets up the awareness quotient among physicians. This serves to increase the overall branding and visibility of the test in the market. In order to interact smoothly with reimbursement agencies and convince them, U.S. CMD companies must accomplish insightful pharmacoeconomic analysis to display the value proposition of CMD.
U.S. Cancer Molecular Diagnostics Markets is part of the Drug Discovery and Clinical Diagnostics Growth Partnership Service program, which also includes research in the following markets: U.S. molecular diagnostics markets for emerging infectious disease tests, U.S. flow cytometry markets, and U.S. reference laboratory markets. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.
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U.S. Cancer Molecular Diagnostics Markets
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