Global Companion Diagnostics Market
The U.S. FDA lays emphasis on regulatory clearance of companion diagnostics, in its recent draft guidance in 2016, before approving any oncology product that requires and in-vitro diagnostic (IVD) companion diagnostic device for tis safe and effective use. Therefore, drug developers and diagnostic test manufacturers need to work in close collaborations in order to avoid any regulatory bottlenecks. AstraZeneca plc struck a deal with Abbott Laboratories, Inc. in 2015 to develop a companion diagnostic test for tralokinumab, used for treating severe asthma. If successful, this would be the first companion diagnostic test developed for asthma. Moreover, AstraZeneca expects half of its drug launches to include companion diagnostic by 2020. This is a major factor implying the importance of companion diagnostics in treating chronic diseases.
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Simultaneous development of a companion diagnostic test and the drug candidate has its own set of pros and cons that act as a trade-off for pharmaceutical companies. Developing companion diagnostic risks holding up of effective drug therapies, and making major investments on companion diagnostics early is a perceived risk, as many drug candidates fail to make it to the market. However, personalized medicine is the emerging therapeutic approach for cancer and other chronic therapies. Thus, developing a companion diagnostic for faster FDA approval makes it imperative for researchers to invest in the development of CDx tests.
Agilent technologies, Inc. announced the extended use of its CE approved Dako PD-L1 IHC 22C3 pharmDx in January 2017, in determining PD-L1 expression status in patients with metastatic non-small cell lung cancer (NSCLC). This device helps determine the expression level of PD-L1 in both untreated and previously treated metastatic NSCLC patients with KEYTRUDA (pembrolizumab), a first-line treatment drug for metastatic NSCLC. With this approval, patients with metastatic NSCLC and in the second-line or later treatment settings can also be identified for treatment with KEYTRUDA.
Invivoscribe Technologies Inc., has companion diagnostics development deal with Novartis AG and Astellas Pharma Inc. Invivoscribe Technologies Inc. has developed a companion diagnostic test for FLT3, a biomarker for the stratification and prognosis of acute myeloid leukemia (AML). This CDx is under the U.S. FDA review for its use with PKC412 (midostaurin) an investigational drug for adults with newly-diagnosed AML and who are FLT3 mutation-positive. If granted approval the LeukoStrat CDx FLT3 Mutation Assay would be the first CDx for AML.
Approval of the drug and CDx test at the same time is difficult. However, the endeavor to develop effective targeted therapies at low cost and faster time to market would encourage more drug developers to conduct clinical trials with diagnostics as part of the inclusion/exclusion criteria.
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Key take aways of the global companion diagnostics market:
The global companion diagnostics market is expected to expand at a CAGR of 12% during the forecast period (2016–2024). Improved clinical outcomes, reduced total research cost and faster time to market are some of the major factors driving collaborations and CDx development globally
The breast cancer application in the global companion diagnostics market was estimated to be the largest in 2015 and is expected to dominate the companion diagnostics market throughout the forecast period in terms of value. This is owing to high number of approved brands with CDx tests, driving adoption of these products in treatment of breast cancer.
In terms of technology, the gene sequencing method segment is expected to expand at a CAGR of 12.6% during the forecast period. Growth of the segment is mainly attributed to increasing focus on identification of genetic mutations that can help in precise identification of the treatment approach for cancer therapies.
The global companion diagnostics market is characterized by strategic research and development collaborations among the drug and diagnostic test developers. According to the Wildwood Ventures Ltd., the number of global deal in companion diagnostics market has increased from 13 in 2007 to 66 in 2013.
Some of the major players in the global companion diagnostics market include Abbott Laboratories, Inc., Agilent Technologies, Inc., Danaher Corporation, GE Healthcare, Qiagen N.V., Roche Diagnostics, Biomérieux, Myriad Genetics, Inc., bioMérieux SA, and Siemens Healthcare
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