Advances in Biomarker Testing Drives Cancer Management to Soon Resemble Chronic Disease Management, Finds Frost & Sullivan
Health plans require clear evidence of the clinical utility of biomarker tests
MOUNTAIN VIEW, Calif., Sept. 25, 2012 /PRNewswire/ -- With technological advances in diagnostics, physicians may shortly have real-time information about the tumor at various stages of patient management. Future cancer biomarker tests will also be multiplexed and comprise multiple biomarker types. As personalized medicine involves matching effective treatments to individuals based on their genetic disposition and other reliable factors, highly specific biomarkers are critical for identifying likely responders from non-responders.
New analysis from Frost & Sullivan's (http://www.healthcare.frost.com/) Analysis of the U.S. Cancer Biomarker Testing Market research finds that the health plan reimbursement market earned revenues of $7.86 billion in 2011 and estimates this to reach $11.46 billion in 2017.
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"Effective cancer patient management relies on specific and useful biomarkers that enable oncologists to diagnose, determine suitable therapies, continuously monitor response to therapy, or monitor tumor progression," said Frost & Sullivan Industry Analyst Winny Tan , Ph.D. "Consequently, personalized medicine is becoming a mainstream concept and the approaches to personalized medicine are increasingly understood by physicians and patients."
Market participants are gearing up for exciting times in the market, as generation sequencing becomes more affordable and cost competitive with the prices of current tests that look at a single-mutation. Additionally, the accelerated trend of out-licensing and therapy-companion diagnostic co-development across the industry is likely to raise the number of new cancer biomarker tests entering the market.
These new tests will be highly complex to perform and interpret. Following this, cancer testing will become centralized and more cancer biomarker tests are likely to be commercialized from multi-center research consortiums.
Furthermore, the large number and variety of industry partnerships suggest that collaboration is vital to compete in the market. Companies could partner with each other for companion diagnostic development, licensing agreements, clinical trial collaboration, R&D collaborations, distribution agreements, and other commercialization interests.
While technology is advancing cancer patient management, it is also escalating the costs of cancer biomarker testing. Currently, new detection platforms such as next-generation sequencing are still more expensive than traditional slide-based cancer testing, and this deters several potential buyer groups.
The commercial success of any diagnostic test depends on the clear evidence of its clinical utility; however, few biomarker discovery programs participate in the clinical validation of new biomarkers. The high costs of clinical validation and limited ROI are some of the reasons that few biomarkers have translated to diagnostic tests.
The market will also be affected by changes in the regulatory sphere. The increasing frequency of warning letters issued to clinical laboratories offering laboratory developed tests (LDTs) precedes the fact that the Food and Drug Administration (FDA) will exercise greater oversight over LDTs in the future. The final guidance on this issue will be announced by the FDA next year.
"Test developers should anticipate greater demands for proof for both assay performance and clinical utility," noted Tan. "Private and government health plans will require clear evidence of the clinical utility and the impact of the test on patient health to compare it with the best alternative."
Once participants demonstrate the value of new biomarker types, their pipeline will expand and subsequently, the market will grow at a faster rate.
Analysis of the U.S. Cancer Biomarker Testing Market is part of the Life Sciences Growth Partnership Services program, which also includes research in the following markets: Analysis of the U.S. Clinical Laboratory Market, Diagnostics Testing and Technologies for Solid Tumor (FFPE) Specimens End-user Analysis, and Demand Analysis of U.S. Cancer Sample Prep Market. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.
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Analysis of the U.S. Cancer Biomarker Testing Market
Corporate Communications – North America
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