Companion Diagnostics Market to Reach USD 5.0 Billion by 2024 and at estimated CAGR of 12.0% to 2024

SEATTLE, WA, 2018-Mar-27 — /openPR/ —

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.

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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.

Potential lowering of cost and clinical benefits driving the companion diagnostics market

Growth of companion diagnostics market relies on the ecosystem of pharmaceuticals industry. A more collaborative approach would benefit payors and providers of healthcare products and services. CDx supports drug developers in reducing development costs, develop highly effective therapeutic product, and improve the time to market by identifying the effectiveness of a drug against particular biomarkers. The payors (patients) benefit from better treatment outcomes and lower morbidity risk. Moreover, with the advent of advanced technologies such as PCR, immunohistochemistry and gene sequencing, accurate diagnosis, and determination of targeted cancer therapy is much easier.

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Advancements in technology and increasing research on CDx has resulted in increasing approval of drug therapies with diagnostic tests alongside it. As per the Regulatory Affirms Professionals Society (RAPS), the share of drugs and biologics approved alongside a diagnostic test, by the U.S. FDA, increased from 20% in 2014 to 28% in 2015.

Increasing number of research collaborations is expected to improve the time to market of highly effective targeted drug therapies. This would in-turn augment the growth of companion diagnostics market.

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