Biomarker Testing Services Market Size, Share & Trends Analysis Report By Service (Biomarker Assay Development & Validation, Flow Cytometry), By Type (Molecular Biomarkers, Cellular Biomarkers), By End Use, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global biomarker testing services market size was estimated at USD 602.8 million in 2023 and is projected to grow at a CAGR of 8.46% from 2024 to 2030. The market growth is mainly due to increasing demand for personalized medicine, prevalence rate of chronic diseases, and growing demand for biomarkers in drug development and clinical trials. Biomarkers are critical in drug development and clinical trials to assess drug efficacy, safety, and patient stratification. Pharmaceutical companies and biotechnology firms mainly outsource these activities to streamline drug development processes, reduce development costs, and accelerate regulatory approvals further contributing to the market growth.

The pandemic has further accelerated the demand for biomarker testing services. A substantial proportion of research was focused on COVID-19, with several products in clinical trials aimed at developing safe and effective therapeutics. Several advancements happened in the drug discovery field which consequently accelerated the need for biomarkers to facilitate thorough analysis. Thus, the aforementioned factors further contributed to the market growth.

Increasing research and development activities by several market players is major aspect contributing to the market growth. For instance, in November 2023 , Charles River Laboratories entered into a partnership agreement with Aitia, Inc.to incorporate Logica, an innovative platform, into their discovery programs focused on oncology and neurodegenerative diseases. This collaboration aims to leverage Logica's capabilities in biomarker identification and validation, thereby enhancing the efficacy of drug discovery efforts. The integration is expected to drive advancements in biomarker testing services within the biopharmaceutical industry.

Increasing prevalence of cancer globally enhanced the need for effective diagnostic and prognostic biomarkers. Biomarkers play a critical role in oncology by aiding in early detection, monitoring disease progression, predicting treatment response, and assessing recurrence risk. According to an article published in CancerCare in April 2023, biomarker testing has proven to be a valuable tool in determining optimal therapies for eligible cancer patients, ensuring timely and appropriate treatment while also yielding cost savings and improving patient outcomes.

Biomarkers, which includes several disease-specific types, are increasingly adopted by researchers to facilitate faster and accurate disease diagnoses. This not only streamlines the execution of clinical trials but also accelerates the drug development process by enabling more precise targeting of therapies. For instance, in oncology field biomarker testing services are crucial for identifying genetic mutations and molecular signatures that provides personalized treatment strategies, thereby improving patient outcomes. Therefore, the increasing need for enhanced diagnostic precision and therapeutic efficacy in clinical research and healthcare settings would further expand the market.

Biomarker testing services are rapidly expanding because they can increase the production of novel and innovative medicines and biologic products needed to combat the pandemic. For instance, in March 2021, the U.S. FDA provided EUA for the Tiger Tech COVID plus Monitor which is used to diagnose COVID-19 in asymptomatic individuals by using biomarkers; this also helps in the prevention of the disease. Similar initiatives by the regulatory authorities in the coming years are expected to support the market in the post-pandemic period.

Market Concentration & Characteristics

The market growth stage is medium, and the pace is accelerating. The market is characterized advancing medical diagnostics and therapeutic development. This sector is driven by increasing demand across various fields of clinical research, particularly in oncology and infectious diseases.

The market fortify a high degree of innovation owing to continuous advancements aimed at enhancing diagnostic accuracy, expanding biomarker panels, and improving assay sensitivity and specificity.Innovations in this field encompass technological developments such as next-generation sequencing (NGS), digital PCR, and multiplex assays, which enable simultaneous detection of multiple biomarkers with high precision and efficiency.

The level of M&A activities in the market is high on the dynamic market landscape characterized by strategic collaborations and partnerships. Companies in this field often engage in M&A to expand their service offerings, acquire new technologies, and gain access to broader customer bases or geographic markets.

Regulations have a high impact on the market. As, regulations mandate rigorous validation of biomarkers to demonstrate their clinical utility, accuracy, and reproducibility. This ensures that biomarker tests provide reliable results for disease diagnosis, prognosis, and treatment monitoring. Moreover, compliance with regulatory requirements is essential for obtaining market approval or clearance to commercialize biomarker tests. Regulatory submissions often involve rigorous documentation of clinical data, analytical performance, and manufacturing processes.

Service expansion in the market is medium owing to several companies are expanding their service offerings by developing and commercializing new biomarker panels that cover a wider range of diseases and conditions. This includes biomarkers for oncology, infectious diseases, autoimmune disorders, and genetic disorders, among others.

The market is experiencing significant regional expansion, with numerous market participants are expanding their geographic footprint by establishing laboratories or partnering with local providers in new regions and markets. This allows them to cater to a broader patient population and healthcare network, addressing regional healthcare needs and regulatory requirements.

Service Insights

Based on service, the biomarker assay development & validation segment led the market with the largest revenue share of 45.61% in 2023. The dominance is mainly due to its potential role in clinical research, stringent regulatory requirements, technological advancements, and the growing demand for personalized medicine solutions.Regulatory agencies such as the FDA in the U.S. require rigorous validation of biomarker assays to ensure their accuracy, precision, and reliability. Compliance with regulatory standards is necessary for obtaining approval or clearance for biomarker-based diagnostics and therapies, driving demand for robust assay development and validation services.

The flow cytometry segment is expected to witness at the fastest CAGR over the forecast period, as it provides highly detailed information on any single cell in a heterogeneous population, and due to this reason, it is used in preclinical and clinical settings for generating data. Flow cytometry supports dose selection in clinical trials and is also suitable for patients who receive transplants. Technological advancements such as the launch of microfluidic flow cytometry for biomarker analysis are further accelerating biomarker testing. Thus, these factors are contributing to market growth.

Type Insights

Based on type, the molecular biomarkers segment led the market with the largest revenue share of 69.2% in 2023. Molecular biomarkers, such as genetic mutations, RNA expression levels, and protein markers, offer critical insights into disease mechanisms, diagnosis, prognosis, and treatment response. They are widely used across various therapeutic areas, including oncology, infectious diseases, cardiovascular diseases, and neurology, due to their ability to provide precise and actionable information.

The cellular biomarkers segment is projected to witness at the fastest CAGR during the forecasted period. The rapid growth of immunotherapy and cell-based therapies, such as CAR-T cell therapy and stem cell therapies has increased the demand for cellular biomarkers. These includes immune cell subsets, activation markers, and functional assays, are crucial for monitoring treatment responses, predicting efficacy, and managing treatment-related toxicities.

End Use Insights

Based on end use, the pharmaceutical and biotechnology companies segment led the market with the largest revenue share of 45.7% in 2023. Increased funding for clinical research by pharmaceutical and biotechnology is one of the key reasons supporting the segment growth. Moreover, growing interest among pharmaceutical companies to develop targeted therapies for cancer treatment is also contributing to the segment growth. For instance, in September 2022, AstraZeneca and Roche entered into a partnership agreement to redefine the treatment and diagnosis of cancer in the Middle East and North Africa. partnership aims to remove barriers in biomarker testing and expand access to precision medicines.

The CRO segment is expected to grow at the fastest CAGR during the forecast period. Pharmaceutical and biotechnology companies are increasingly outsourcing research and development activities to CROs to reduce costs, accelerate timelines, and access specialized expertise. CROs offer a range of services including clinical trials, biomarker testing, regulatory affairs, pharmacovigilance, and data management, making them integral to the drug development process.

Regional Insights

North America dominated the biomarker testing services market with the revenue share of 46.2% in 2023, owing to advanced healthcare infrastructure, supportive regulatory environment, and constant technological advancements. Strong presence of key market players providing biomarker testing services in this region; a rise in chronic disease burden that leads to an increase in laboratory diagnostic testing; the presence of advanced healthcare infrastructure; and growing R&D investment by the public organizations in the region are key factors supporting the market in the region.

U.S. Biomarker Testing Services Market Trends

The biomarker testing services market in the U.S. held the largest share in North America in 2023, owing to increasing demand for personalized medicine in the country coupled with growing research and development initiatives by the market players. Academic and research institutions in the U.S. are constantly conducting research in biomarker discovery and validation which is further contributing to the country’s market growth.

Europe Biomarker Testing Services Market Trends

The biomarker testing services market in Europe is expected to grow at a significant CAGR during the forecast period, owing to the presence of key service providers offering specialized biomarker assays and diagnostics. Market competition, coupled with investments from healthcare companies are driving the innovation and overall market growth.

The UK biomarker testing services market is anticipated to witness at a significant CAGR during the forecast period, owing to growing emphasis on personalized medicine. Biomarker testing services play a pivotal role in identifying biomarkers that guide treatment decisions based on individual patient characteristics, thereby improving treatment efficacy and patient outcomes.

The biomarker testing services market in Germany held the largest share in 2023 in Europe. Germany has a well-developed healthcare system with state-of-the-art medical facilities, specialized laboratories, and a robust network of healthcare providers. This infrastructure supports the adoption and implementation of biomarker testing services across clinical and research settings.

Asia Pacific Biomarker Testing Services Market Trends

The biomarker testing services market in Asia Pacific is expected to grow at the fastest CAGR over the forecast period.APAC countries, including China, Japan, India, and South Korea, are experiencing rapid economic growth and increasing healthcare expenditures. This growth supports investments in healthcare infrastructure, including advanced diagnostic capabilities and biomarker testing services.

The China biomarker testing services market held the largest share in Asia Pacific in 2023. The China market is also anticipated to grow at a considerable CAGR during the forecast period, owing to the prevalence of chronic diseases such as cancer, cardiovascular diseases, and diabetes is rising in APAC countries due to aging populations, urbanization, and lifestyle changes. Biomarker testing plays a crucial role in early detection, prognosis assessment, and therapeutic management of these diseases, driving overall market demand.

The biomarker testing services market in Japan is expected to grow at the fastest CAGR over the forecast period. Japan boasts a highly advanced healthcare system with modern medical facilities, specialized laboratories, and a strong network of healthcare providers. This infrastructure supports the adoption and integration of biomarker testing services across clinical settings.

The India biomarker testing services market is driven by rising healthcare expenditure and investments in the country are supporting the adoption of advanced diagnostic technologies, including biomarker testing, to improve healthcare outcomes and patient care. These factors are driving the country’s market growth.

Latin America Biomarker Testing Services Market Trends

The biomarker testing services market in Latin America is expected to witness at a considerable CAGR during the forecast period. The growth in the region is due to advancements in healthcare infrastructure and increasing awareness regarding personalized medicine. Countries like Brazil, Mexico, and Argentina are witnessing significant demand for biomarker testing across various applications including cardiovascular diseases, and infectious, and oncology diseases.

The Brazil biomarker testing services market is driven by increasing government support aimed at enhancing healthcare infrastructure and access, as well as growing awareness among healthcare professionals and patients regarding the benefits of biomarker-based diagnostics.

Middle East & Africa Biomarker Testing Services Market Trends

The biomarker testing services market in Middle East and Africa is expected to witness at a lucrative CAGR during the forecast period. The growth in the region is due to growing chronic diseases, further increasing the demand for better treatment options. Moreover, increasing awareness among healthcare providers and patients about the benefits of personalized medicine, which relies heavily on biomarker testing for personalized treatment plans is also contributing to the regions market growth.

The South Africa biomarker testing services market is driven by rising prevalence of chronic diseases in the country. Biomarker testing plays an important role in early detection, prognosis, and treatment selection for these conditions, which will further drive the market growth.

Key Biomarker Testing Services Company Insights

The key industry players operating across the biomarkers testing services market implementing numerous strategic initiatives such as mergers, partnerships, collaborations, acquisitions, etc. The prominent strategies companies undertaking are service launches, mergers & acquisitions/joint ventures, mergers, partnership & agreements, expansions, and others to increase market presence & revenue and gain a competitive edge driving market growth. For instance, in June 2022, Labcorp entered into a collaboration agreement with BML to increase its biomarker testing facility in Japan. The partnership broadened company’s regional presence.

Recent Developments

• In April 2024, Labcorp expanded its precision oncology portfolio to support biopharma, clinical research and pharmaceutical companies in accelerating drug development programs. This expansion broadened company’s offerings in the significant market

• In March 2024, Labcorp launched a blood biomarker test for pTau217 to expedite Alzheimer's disease diagnosis and facilitate clinical trial support. Labcorp's integration of pTau217 as an independent test expanded the company's Alzheimer's diagnostic offerings, augmenting its comprehensive suite of blood-based biomarker tests

• In June 2024, Thermo Fisher Scientific Inc., expanded its clinical research laboratory in Wisconsin. The launch of new laboratory will enhance services in the emerging and new therapeutic areas

Biomarker Testing Services Market Report Scope

Global Biomarker Testing Services Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global biomarker testing services market report based on services, type, end-use, and region.

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Biomarker Assay Development & Validation

  • Flow Cytometry

  • Others

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Molecular Biomarkers

  • Cellular Biomarkers

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical and Biotechnology Companies

  • Research Institutes

  • CROs

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Indonesia

    • Malaysia

    • Singapore

    • South Korea

    • Australia

    • Taiwan

    • Thailand

  • Latin America

    • Brazil

    • Argentina

    • Colombia

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait

    • Israel