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.

Market Taxonomy

This report segments the global companion diagnostics market on the basis of application, technology, and geography. On the basis of application, the market is categorized into breast cancer, lung cancer, colorectal cancer, gastric cancer, melanoma, and others. On the basis of technology, the market is segmented into immunohistochemistry, real-time PCR, gene sequencing, Fluorescence in situ hybridization (FISH), and others. For comprehensive understanding of market dynamics, the global companion diagnostics market is analyzed across key geographical regions namely North America, Europe, Asia Pacific, Latin America, Africa, and Middle East. Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.

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Low cost and clinical benefits of companion diagnostics is expected to drive growth of the market

The ecosystem of pharmaceuticals industry is one of the major factors driving growth of the companion diagnostics market. The providers of healthcare products and services, and patients who utilize these products and services is expected to be benefitted by a collaborative approach. The innovation of CDx helped drug developers in reducing the development costs, developing highly effective therapeutic products, and improving the time to market by identifying the effectiveness of a drug against particular biomarkers. Moreover, better treatment outcomes and lower morbidity risk are benefits offered to the patients. Also, accurate diagnosis and determination of targeted cancer therapy has become much easier due to advanced technologies such as PCR, immunohistochemistry, and gene sequencing.

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.

Key companies covered as a part of this study include Abbott Laboratories, Inc., Agilent Technologies, Inc., Danaher Corporation, GE Healthcare, Qiagen N.V., Roche Diagnostics, Myriad Genetics, Inc., bioMérieux SA, Illumina, Inc. and Siemens Healthcare

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