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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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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Key features of the study:
- This report provides in-depth analysis of the companion diagnostics and provides market size (US$ Million) and Cumulative Annual Growth Rate (CAGR (%)) for the forecast period: 2016 – 2024, considering 2015 as the base year
- It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
- This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by the leading players
- It profiles leading players in the global companion diagnostics market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies and future plans
- 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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- Insights from this report would allow marketers and management authorities of companies to make informed decision with respect to their future product launch, technology upgrades, market expansion, and marketing tactics
- The global companion diagnostics market report caters to various stakeholders in this industry, including investors, device manufacturers, distributors and suppliers for companion diagnostics, research and consulting firms, new entrants, and financial analysts
- Various strategy matrices used in analyzing the companion diagnostics market would provide stakeholders vital inputs to make strategic decisions accordingly
About CMI
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