Companion diagnostics (CD) refer to a type of in vitro diagnostic tests or assays that are intended to help physicians in making effective treatment decisions based on the patient’s response to a specific drug targeted toward a specific biomarker, expressed in a particular disease or indication. The patient’s response to an ongoing therapy is mapped with the help of companion diagnostics in terms of changes in gene amplification, nullifying the effect of mutations, changes in protein overexpression and receptor-substrate interaction, and so on.
These tests aim at providing insights into the patient’s likely response pattern to a particular therapy, thereby enabling optimization of appropriate dosing concentrations and course of administration. The increasing importance of personalized medicine and commercialization of targeted therapeutics have driven the demand for companion diagnostics, which in turn is projected to observe a rise in trend of adoption by patients as well as health care service providers.
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Companion diagnostics help in cost reduction for drug manufacturers by narrowing the target patient population who are likely to benefit from the targeted therapy. These tests enable physicians to rule out therapeutic options which are not likely to be as effective as a particular targeted drug, and thus eliminate the need for use of higher-priced cancer therapeutics and other unnecessary treatments. The consideration of a defined patient population and resultant higher efficacy of targeted therapeutics further increase the chances of the drug’s approval and aid in streamlining of the drug development process (such as fasten the approval process). In addition, companion diagnostics are important to rule out the possibility of side effects and alleviate health care costs related to management of side effects.
The demand for personalized medicine has been on a rise since the significant development in genomics research and biomarkers. This can be attributed to the efficiency and target-specific nature of personalized medicine with better patient outcomes. In addition, the targeted therapies have minimal or no side effects compared to the conventional therapies. With the paradigm shift in the drug discovery and development process, pharmaceutical companies are shifting their focus toward the development of novel targeted therapies (genotype or phenotype specific therapies).
The adoption of this paradigm shift marked the gradual termination of traditional blockbuster model. Hence, these factors increase the demand and uptake of personalized medicine which in turn drives the growth of the companion diagnostics market. Increase in the number of cancer incidence, demand for personalized medicine, and reduction in drug development cost have contributed to augment the growth of the digital companion diagnostics market. However, poor reimbursement policies, and longer developmental and approval phase are factors that are restraining the growth of the market.
The market for digital companion diagnostics can be segmented on the basis of technology, disease indication, end-user, and geography. Based on technology, it is segmented into molecular diagnostics and immunohistochemistry. The molecular diagnostics segment is further sub-segmented into PCR, in situ hybridization, and next generation sequencing. This segment is anticipated to be a fast growing market due to advancement in technology, adoption of precise and accurate techniques by users, and reduction of cost and time associated with use of these methods.
Based on disease indication, the market is segmented into breast cancer, melanoma, lung cancer, colorectal cancer, and infectious disease. The breast cancer segment is estimated to hold a large market size during the forecast period. The major factors fueling growth of this market are rise in global incidence rates of breast cancer, shift toward development of targeted therapies, and increase in acceptance level of the test due to the enhanced specificity and efficiency.
Based on end-user, the market is segmented into hospitals, pharmaceutical companies, and laboratories. Based on geography, the market for digital companion diagnostics has been distributed over North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is estimated to dominate the market due to increase in health care expenditure and rise in demand for personalized treatment.
Key potential players operating in the digital companion diagnostics market are Qiagen N.V., Agilent Technologies, Inc., Agendia N.V., Life Technologies Corporation, GE Healthcare Ltd., Roche Holdings AG, Abbott Laboratories, and Genomic Health, Inc.
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