Global Companion Diagnostics Market Analysis and Forecast till 2026

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 companion diagnostics 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).

Companion diagnostic (CDx) is a diagnostic tool used to determine the suitability of a drug therapy to the patient. It has become a critical part of targeted cancer therapy that allows for development of personalized therapy can be developed and administered to the patient. Whole blood samples, tissues samples, or buccal samples are collected and tested for diagnosis and identification of targeted disease biomarker. CDx is usually utilized in identifying genetic mutations and the health and treatment approach implications. In July 2016, the U.S. FDA released a draft guideline for development of a therapeutic product accompanying an IVD companion diagnostic. Companion diagnostics include Gleevec (imatinib mesylate) and BCR-ABL LDT and DAKO C-KIT PharmDx, Herceptin (trastuzumab) and DAKO Herceptest; and Nolvaldex (tamoxifen) and laboratory-developed estrogen receptor positive test.

Market Dynamics

Companion diagnostics are beneficial for pharmaceutical companies who face challenges with respect to high drug development cost, safety and outcome of clinical trials, and long product approval time. Companion diagnostics lowers development costs, improves time to market and enhances drug safety by enabling rapid identification of target biomarker and the most effective drug therapy. For patients, the technology provides better treatment outcomes and lower morbidity risk. Use of technologies such as PCR, immunohistochemistry, and gene sequencing has enabled accurate diagnosis and determination of targeted cancer therapy. As the CDx tests also aid in revealing the off-target effects of a drug along with identification of a molecular target, CDx have become and indispensable tool for oncologists.

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.

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This release was published on openPR.