Biomarkers Market Report Size, Industry Share, Business Opportunities, Growth and Expansion, Forecast to 2026

The growth of the global Biomarkers Market can be attributed to factors such as hospital budget cuts, a large inventory of used or old medical devises, rising demand for capital-intensive diagnostic imaging equipment, e-commerce platform enhancing the ease of purchase of refurbished medical equipment, growing preference for eco-friendly products, an increasing number of diagnostic centers hospitals, and the growing opportunities in emerging economies.

According MarketsandMarkets Research Report – [238 Pages Report] The global biomarkers market size was valued at USD 43.1 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 12.6% from 2021 to 2026. Growth in the biomarkers market is mainly driven by factors such as the growing importance of companion diagnostics, increasing prevalence of cancer worldwide, increasing funds grants for biomarker research, and continuous product innovations.

Biomarkers Market Dynamics

Driver: Growing importance of companion diagnostics

Companion diagnostics and biomarkers have become increasingly relevant in the practice of medicine, leading to improved diagnosis, treatment, and monitoring across several disease areas. It can be used to identify patients likely to respond well to certain drugs or treatment options. These diagnostics are often used in conjunction with a specific drug. For instance, the Oncomine Dx Target Test (Thermo Fisher Scientific, Inc.) helps in biomarker testing of non-small cell lung cancer (NSCLC) patients eligible for ROZLYTREK (entrectinib).

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Challenge: Challenges associated with biomarker validation

The biomarker validation process includes the evaluation of assays or measurement of performance characteristics such as sensitivity, specificity, and reproducibility. Validation is critical for establishing biomarkers as reliable tools to support development, medical care, and biopharma investment decisions. However, the high costs involved in biomarker validation are a major concern for companies, especially small organizations. Furthermore, factors such as the inherent variability in biomarker levels and molecular heterogeneity pose additional challenges in the biomarker validation process. Another challenge is the length of time required for assay development, due to which the ability to develop assays does not keep pace with the ability to generate biomarkers.

The use of biomarker-based tests in clinical settings requires evidence of the biomarker’s clinical validity and utility. This is important not just to help physicians in their decision-making process within the practice of evidence-based medicine but also to gain regulatory approvals and appropriate reimbursements for the test. However, collecting the data necessary to show clinical validity and utility may be a time-consuming and expensive process, which is further complicated by the lack of standards. There are also questions regarding sharing, protecting, and analyzing data. All these factors may pose a major challenge for the biomarkers market.

By product service segment, the consumables segment accounted for the largest share of the biomarkers market in 2020.

By product, the biomarkers market is segmented into consumables, services, and software. In 2020, the consumables segment accounted for the largest share of the global biomarkers market. The large share of this segment can primarily be attributed to the increasing use of kit-based products for biomarker testing and the repeated purchase of consumables.

By type, the efficacy biomarkers segment accounted for the largest share of the biomarkers market in 2020.

Based on type, the biomarkers market is segmented into efficacy biomarkers, safety biomarkers, and validation biomarkers. In 2020, the efficacy biomarkers segment accounted for the largest share of the global biomarkers market. The large share of this segment can be attributed to the ability of these biomarkers to evaluate the therapeutic efficacy of drug products.

By disease indication, infectious diseases segment accounted for the largest share of the biomarkers market in 2020.

Based on disease indication, the biomarkers market is segmented into cancer, infectious diseases, neurological disorders, immunological disorders, cardiovascular disorders, and other disease indications. In 2020, the infectious diseases segment accounted for the largest share of the biomarkers market. The large share of this segment can be attributed to the growing prevalence of infectious diseases, coupled with the outbreak of the COVID-19 pandemic.

By application, the diagnostics application segment accounted for the largest share of the biomarkers market in 2020.

Based on application, the biomarkers market is segmented into diagnostics, drug discovery development, personalized medicine, disease risk assessment, and other applications. In 2020, the diagnostics segment accounted for the largest share of the application segment in the biomarkers market. The use of biomarkers for the diagnosis of multiple diseases, including cancer, infectious diseases, cardiovascular disorders, and neurological disorders, is on the rise. The increasing use of biomarkers is a major factor that drives the growth of the diagnostics segment of the biomarkers market.

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Recent Developments

In April 2021, F. Hoffmann-La Roche Ltd. (Switzerland) launched two cardiac biomarker tests for high sensitive cardiac troponin T (cTnT-hs) and N-terminal pro-brain natriuretic peptide test (NT-proBNP). These gold standard biomarkers support cardiovascular disease management and can help clinicians diagnose heart attacks and manage heart failure better.
In May 2021, QIAGEN N.V. (Netherlands) launched the first FDA-approved tissue companion diagnostic, therascreen KRAS RGQ PCR Kit, to identify the KRAS G12C mutation in NSCLC tumors and expand precision medicine options in lung cancer.
In July 2020, Thermo Fisher Scientific (US) entered into an agreement with Chugai Pharmaceutical to expand the use of the Oncomine Dx Target Test and expedite local biomarker testing of non-small cell lung cancer (NSCLC) patients eligible for ROZLYTREK (entrectinib) treatment in Japan.
In January 2020, Merck KGaA (Germany) opened a non-profit, high-tech skill development center in collaboration with the Council of Scientific and Industrial Research’s Institute of Microbial Technology (CSIR-IMTECH) in Chandigarh, India. The center is equipped with genome-editing, single-molecule biomarker detection, and other technologies to help local students build life science skills.
In April 2019, PerkinElmer, Inc. (US) acquired Cisbio Bioassays, a leading life sciences company that develops, manufactures, and markets high-quality kits and reagents for the drug discovery and life science markets. This acquisition complements PerkinElmer’s Alpha, DELFIA and LANCE assay technologies, including biomarker assays.