Biomarker Research Services Market – Insights
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.
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. In February 2018, U.S. Food and Drug Administration (FDA) granted marketing authorization to Banyan Biomarkers, Inc. for the first diagnostic blood test for traumatic brain injury, named Banyan BTI. Such innovations that target different indications are expected to increase demand for biomarkers. Therefore, increasing use of biomarkers in diagnosis of various diseases is expected to propel global biomarker research services market growth. Moreover, pharmaceuticals as well as biotechnology organizations are still lacking biomarker research capability for which they will need to employ services of contract research organizations.
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).
Figure 1. Global Biomarker Research Services Market Share (%), by Region
Source: Coherent Market Insights Analysis (2017)
High prevalence of chronic diseases is expected to boost growth of the global biomarker research services market over the forecast period
High prevalence of diseases such as cancer, cardiovascular diseases, and neurological diseases is expected to increase demand of biomarkers for diagnosis and treatment of these diseases. This, in turn, is expected to lead to high demand for biomarker research services, thereby boosting the market growth over the forecast period. For instance, according to World Health Organization (WHO), in February 2018, cancer was the second-leading cause of death worldwide, accounting for 8.8 million deaths. According to the data published by American Heart Association, in 2018, cardiovascular diseases, listed as the underlying cause of death, accounted for around 836,546 deaths in the U.S. which is around 1 in every 3 deaths in the U.S. Moreover, around 2,300 deaths are registered in the U.S due to cardiovascular diseases each day, with an average of 1 death in every 38 seconds. Furthermore, increasing application and approval of companion diagnostics is expected to spur manufacturers to invest in research and development of companion diagnostics. For instance, in April 2019, Qiagen N.V. announced the U.S. launch of the therascreen FGFR RGQ RT-PCR Kit (therascreen FGFR Kit) as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA (erdafitinib), developed by Janssen Biotech, Inc. (Janssen).
Figure 2. Global Biomarker Research Services Market Share (%) by Service Type
However, development of biomarkers requires high investments due to cumbersome biomarker validation and testing processes. This, in turn, is expected to hamper global biomarker research services market growth.
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.)
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.
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.
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