Companion diagnostics offers a set of tools that facilitates biological and clinical information to the pharmaceutical companies that they have to overcome. Companion diagnostics help physicians to improve the treatment decisions for the patients depending on their response to current treatments. Companion diagnostics approach to medication is transforming the healthcare industry by eliminating unfavorable reactions, improving treatment outcomes, and reducing the cost and time difficulties associated with conventional methods of medication. Companion diagnostic is basically a bio-analytical method designed to evaluate whether the patient will respond favorably to the specific medical treatment or not. The market is fully dependent on discovery of biomarkers, and research and development of new drugs. With the surge in research and development of targeted rehabilitations and innovation of new biomarkers for a range of conditions, the global companion diagnostics market is growing at healthy rate.
Several targeted drugs in association with a companion diagnostics test are developed and have reached to large numbers of consumers. Large and small biopharmaceutical companies actively develop drug diagnostic combination products which are fast to surpass traditional drugs, favoring the concept of one-size-fits-all. U.S. Food and Drug Administration (FDA) have approved companion diagnostics for lung colorectal, breast, and melanoma. Some of the companion diagnostics devices are erbitux vectibix, lynparza, gilotrif, herceptin, exjade, gleevec, zelboraf and tarceva.
On the basis of technology, the companion diagnostics market can be bifurcated as immunohistochemistry test (IHC), polymerase chain reaction tests (PCR), in situ hybridization tests (ISH), and others. Based on the indications, the global companion diagnostics market can be categorized as breast cancer, gastric cancer, colorectal cancer, melanoma, lung cancer, and others. Further on the bases of end users, the global companion diagnostics market can be categorized as reference laboratories, pharmaceutical companies and others.
Regulatory agencies, such as FDA, are encouraging the use of companion diagnostics in the development and use of prescribed drugs. The guidance started in 2004 in the form of FDA critical path initiative and was followed by the drug diagnostic co-development concept in 2005.
Increasing scope for companion diagnostics and emerging technologies, such as next-generation sequencing (NGS), are some of the major opportunities for the global companion diagnostics market. Some of the major factors driving the growth of global companion diagnostics market are growing adoption of companion diagnostics by pharmaceutical companies and reference laboratories, regulatory bodies encouraging implementation of companion diagnostics, increasing demand and developmental of personalized medicine and rising demand for targeted cancer treatment.
Reimbursement scenario, effect of influence of advocacy groups and clinical societies, and extended developmental and approval phases are some of the factors that are restraining the growth of global companion diagnostics market. One of the major challenges for the companion diagnostics market is co-ordination in the development of drugs and diagnostics together.
North America had the largest companion diagnostics market because of the increasing incidence of cancer and increased healthcare awareness. Whereas, Asia-Pacific is the fastest growing market of companion diagnostics owing to the strengthening healthcare services and increasing medical tourism in developing countries such as India and China.
Some of the major competitors in companion diagnostics market are Biogenex Laboratories Inc, Agilent Technologies, Inc., Abbott Laboratories, Inc., Beckman Coulter, Inc., Danaher Corporation, Myriad Genetics, Inc., Qiagen N.V., bioMérieux SA, F. Hoffmann-La Roche AG, and General Electric Company.
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