Companion Diagnostics: Growth Companion for Personalized Medicine

Personalized medicine is the new segment in discussion among healthcare experts around the globe. Also, encouragement from the regulatory bodies such as the FDA and EMEA in erms of providing a defined structure for companion diagnostic development is driving research activities in personalized medicine. Diagnosis at molecular level for each individual is of prime importance to identify the target biomarker before deciding the therapy. Companion diagnostic is one such emerging field for target biomarker identification reducing clinical trial cost and time to market the product.

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Pharmaceutical companies need to constantly innovate and integrate latest technological breakthroughs in order to sustain in the market, given the looming threat of new technologies posing threat to existing product portfolio and research pipeline. Novartis AG focuses on R&D for biomarkers with the help of its partner SomaLogic, Inc., once they begin the process of finalizing the drug candidate. Such pre-work is now part of the routine of drug development, something that was an alien practice till around a decade ago. The U.S. FDA released a draft guideline for companion diagnostics in July 2016, providing a structure for the pharmaceutical companies to co-develop CDx test along with the drug therapies.

The global companion diagnostics market was valued at US$ 1,614.5 million in 2015 and is expected to witness a robust CAGR of 12.0% during the forecast period (2016 – 2024).

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

Growth of companion diagnostics 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.

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.

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Research collaborations to improve the time to market

An integrated and more evidence-based approach is driving partnerships in the field of companion diagnostics. According to Wildwood Ventures Ltd., the number of global deal in CDx market has increased from 13 in 2007 to 66 in 2013. Since, developing CDx test along with drug therapy is a capital intensive and complex process, industry players are collaborating to leverage on each other’s expertise. For instance:

• Invivoscribe Technologies Inc., collaborated with Novartis AG and Astellas Pharma Inc. to develop companion diagnostics for their drugs under pipeline.

• Invivoscribe also announced a long-term partnership with Thermo Fisher Scientific in January 2017, develop and commercialize IVD assays for Applied Biosystems® 3500 Dx Series Genetic Analyzers. Invivoscribe Technologies Inc. is a global company engaged in providing clonality and biomarker test solutions for oncology and personalized molecular diagnostics.

• AstraZeneca plc entered into a deal with Abbott Laboratories, Inc. in 2015, to develop a companion diagnostic test for tralokinumab, used for treating severe asthma.

• Singulex, Inc. entered into a strategic collaboration with QIAGEN N.V. in January 2017 to develop companion diagnostics using Singulex's proprietary Single Molecule Counting (SMC) immunodiagnostic platform

Increasing number of research collaborations is expected to improve the time to market of highly effective targeted drug therapies.

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