Companion Diagnostics (CDx) Market Share (2018-2025)
Over the years, advancement in molecular diagnostics have subsequently increased the understanding of disease mechanism and variability of pharmacotherapy. Within last ten years (2007-2017), number of commercialized predictive biomarker assays has increased tremendously to assist application of targeted therapeutics, especially in case of chronic diseases. This type of biomarker-based test or assay is known as companion diagnostics, which is mostly developed in parallel to the targeted drug development process by pursuing drug-diagnostic co-development model.
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Companion diagnostics provides essential information for patient classification, which enables effective and safe use of corresponding drug or biological products. Moreover, companion diagnostics help healthcare professionals to assess the benefits and side-effects or risk of any therapeutic products on a patient. Also, its implementation in the monitoring of patient’s response to any therapeutic agents facilitates in adjusting treatment to improve safety or effectiveness. Further, in the era of precision medicine, the drug developers must conduct clinical trials that utilize validated companion diagnostic assays. This would facilitate determination and validation of therapeutic target molecule to successfully deliver precision medicine. As a result, companion diagnostics has become an integral part of the precision medicine practice.
Companion diagnostics have a critical role in precision medicine approach, for ensuring safe and effective application of a targeted therapeutics. Therefore, several diagnostics and pharmaceutical companies are working collaboratively to develop NGS, PCR, IHC, or ISH based companion diagnostics for the application in oncology as well as non-oncology indications, in order to enable efficient diagnosis, treatment selection, dosage selection, and treatment monitoring. Aside from discovery of effective biomarker for the development of efficient CDx, obtaining regulatory approval is essential. Approval for a CDx primarily depends upon its efficiency and effectiveness in classifying the patient population in responders and non-responders. Therefore, it necessitates close collaboration between the manufacturer of the targeted drug and the manufacturer of corresponding molecular test. Besides pharma and biotech companies, reference laboratories are also prominent end users of CDx and have a major role in the co-development of CDx.
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