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.
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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.
Research collaborations to improve the time to market the product
An integrated and more evidence-based approach is driving partnerships in the global companion diagnostics market. According to Wildwood Ventures Ltd., the number of global deal in companion diagnostics 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. This would in-turn augment the growth of companion diagnostics market.
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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