The Global Biomarker Research Services Market size was valued at US$ 5,897.7 million in 2017, and is expected to witness a robust CAGR of 13.5% over the forecast period (2018–2026).

Biomarkers are widely used in development of drugs. One of the primary processes through which biomarkers are accepted for use in drug development, is the drug approval process. The biomarker is included in the regulatory submission process for drug approval such as Investigational New Drug (IND), Biologics License Disease Indications (BLA), or New Drug Disease Indication (NDA), and are then accepted for use in that specific drug development program. Another process through which biomarkers are accepted for use in drug development is the Biomarker Qualification Program (BQP), which qualifies a biomarker for a particular context of use (COU), independent of a drug approval submission. This pathway is intended for biomarkers that are used in multiple drug development programs. Qualified biomarkers have the potential to offer valuable information that may help during drug development.

Market Dynamics

Factors such as increasing initiatives for development of precision medicine, increasing prevalence of chronic diseases, and increasing demand for development of companion diagnostics, is supporting the growth of global biomarker research services market. For instance, in 2017, National Institutes of Health launched Precision Medicine Initiative (PMI) with an investment of US$ 215 million to accelerate biomedical research and offer clinicians new tools to select therapies that can be used in a more individualized approach with patients. Moreover, potential of biomarkers in disease diagnosis, and in companion diagnostics is expected to boost global biomarker research services market growth. Organizations such as Covance, Inc., Charles River, and others are actively involved in providing biomarker research services.

Biomarkers are increasingly being used in all areas of medicine to help predict and characterize disease. The increasing focus on biomarkers is expected to significantly drive demand for biomarkers research services in development and validation of new biomarkers. Biomarker research services are provided by various contract research organizations for discovery, development, validation, and testing of biomarkers. Different companies provide different types of research services to their clients, however, most common types of services include discovery of a candidate biomarker, qualification, verification, research assay optimization, biomarker validation, and commercialization. Research institutes, pharmaceutical organizations, and biotechnology companies partner and collaborate with biomarker research service providers for development, validation, and commercialization of biomarkers, as well as companion diagnostics. Companion diagnostic is a diagnostic test used with a therapeutic drug to determine the drug’s applicability in a specific person. Companion diagnostics are developed based on companion biomarkers, biomarkers that prospectively help predict response, or severe toxicity of a therapeutic drug.

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Some major players operating in the global biomarker research services market include Noble Life Sciences, Inc., Reprocell Corporation, Coriell Institute, BioIVT, ICON Plc., SRI International, Inc., Charles River Laboratories, Inc., Nordic Bioscience A/S, Proteome Sciences Plc., and Covance Inc. (Laboratory Corporation of America Holdings, Inc.)

Increasing diagnostic applications of biomarkers is expected to boost global biomarker research services market growth over the forecast period

The use of biomarkers for diagnostics is increasing due to certain features of biomarkers, which include rapid detection of specific diseases. Biomarkers are used in a wide variety of neurological diseases, metabolic disorders, immune deregulation, and oncology. These help with detection of diseases such as, cancer and Alzheimer’s. Biomarkers are further used to detect Hemolytic disease of the newborn, Huntington disease, hereditary Hemochromatosis, and cystic fibrosis.

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