Biomarkers in Drug Discovery - Earlier Usage of Biomarkers in Optimization Stage to Reduce Drug Attrition Rate Significantly
- Published: October 2011
This research service analyzes the U.S. cancer biomarker testing market from 2009 to 2017. Topics include an overview of the market, along with definitions, metrics, drivers, and restraints. Also offered is an evaluation of ongoing technology trends and major market competitors and their corresponding market shares and product offerings. Based on this analysis, revenue forecasts and growth rates are projected for each segment of the market. This study also provides cancer epidemiology trends, voice-of-customer research on oncologists, and the challenges and strategies for cancer biomarker validation.
-Figures for The United States cancer biomarker testing market fi r 2011 and that which it is projected to reach by 2017
-Figures for the The molecular cancer testing market segment includes mutational and sequencing analysis and is expected to grow from 2011 to 2017.
-Important market opportunities that are predicted with high certainty include clinical integration of clinical sequencing technologies and active participation in strategic partnerships. Epigenetic markers, microRNA, and circulating tumor cells are still being clinically validated.
-The falling cost of targeted next-generation sequencing will be extremely cost competitive with the current single-mutation tests. Additional advantages ensure that clinical sequencing will play a role in the future of cancer patient management.
-The primary market restraint is the bottleneck in successful translation of biomarker discoveries into useful clinical tests.
-When making coverage decisions for new tests, private and government health plans want to see evidence of clinical utility and understand the impact of the tests on patient health outcomes as compared to the best alternative.
-The market will continue to consolidate as participants fill in the gaps in their technology set, skill set, or expertise through acquisitions of specialized laboratories.
-Cancer laboratories that are a component of a larger company focused on total cancer patient management, which includes laboratory, imaging, and patient data management services, to provide a stronger value proposition for this dynamic market.
-Voice-of-customer research on oncologists determined that clinical data, test sensitivity, test reimbursement, FDA approval, journal publications, and other endorsements are important for successful test adoption.
-Future cancer biomarker tests will be multiplexed and consist of multiple biomarker types. Key-opinion-leaders (KOLs) predict that the future pathology report will integrate a combination of pathologic and genomic information.
Diagnostic Biomarkers Predictive Biomarkers
-Predict likelihood to respond to therapeutic agent
-Predict likelihood to have adverse reaction to therapeutic agent
-Forecast disease progression
-Monitor response to therapy
Market Overview—Definitions (continued)
-Market revenue represents the average reimbursement for laboratory-based cancer biomarker tests. Market participants include hospital laboratories, commercial laboratories, and certain cancer research centers.
-Revenue forecast models primarily depend upon:
-National volume estimates of various cancer biomarker tests.
-Average test reimbursement by private and government health plans for various cancer biomarker tests.
-The cancer biomarker tests that comprise revenue forecasts are reimbursable clinical
laboratory tests for screening, diagnosis, therapy prediction, monitoring, and other needs in patient management. The cancer biomarker tests span multiple platforms.
-Imaging modalities like positron emission tomography (PET) and computer tomography (CT). Point-of-care tests are not included in this market analysis.
-Revenue forecasts are segmented by:
-Molecular cancer biomarker tests include single-gene mutation, comparative genomic hybridization (CGH) array, single-nucleotide polymorphism (SNP) array, clinical sequencing, and other reimbursable genomic-based cancer tests.
-Traditional cancer biomarker tests includes serum-based cancer biomarker tests and in situ immunohistochemistry (IHC) and in situ hybridization (ISH) tests.
-Segmentation by cancer type was not chosen for this study because reliable patient numbers for both new diagnoses and cancer survivors were not available.
Additionally, the cancer biomarker testing for each patient group is highly variable and dependent on the course of treatment.
-Although patient forecasts were not used to generate the revenue forecast, new annual patient forecasts for breast, prostate, lung, colorectal, and other cancer sites* are included for reference in the Epidemiology section of this study.
Market Overview—Key Questions This Study Will Answer
What percent of total cancer biomarker testing revenue is the molecular cancer biomarker testing segment? How fast is the molecular segment growing?
How will next-generation sequencing be applied in cancer testing and how quickly will this develop?
Will FFPE specimens ever disappear with the maturation of molecular-based technologies? Will single-mutation tests become obsolete?
What is the current state of companion diagnostics and what will be the next companion diagnostics?
How do private and government health plans make decisions on insurance coverage for new cancer biomarker tests?
What is the potential of microRNA and epigenetic biomarkers in cancer testing and what is their time frame? SHOW LESS READ MORE >
Total U.S. Cancer Biomarker Testing Market
-External Challenges: Drivers and Restraints
-Forecasts and Trends
-Market Share and Competitive Analysis
-Cancer Biomarker Validation Challenges and Strategies
Molecular Cancer Biomarker Testing Segment Breakdown
Traditional Cancer Biomarker Testing Segment Breakdown
The Last Word (Conclusions and Implications)