The Global Companion Diagnostics (CDx) Market was valued at US$ 1,614.5 million in 2015 and is projected to expand at a CAGR of 12.0% during the forecast period (2016–2024), as highlighted in a new report published by Coherent Market Insights. Development of multiple biomarkers and targeted drug therapy is boosting research and development collaboration among the industry players. This is expected to improve the time to market for companion diagnostic (CDx) test products.
The U.S. FDA lays emphasis on regulatory clearance of companion diagnostics, in its recent draft guidance in 2016, before approving any oncology product that requires and in-vitro diagnostic (IVD) companion diagnostic device for tis safe and effective use.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.
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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 takeaways of the global companion diagnostics market:
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