Biomarker Testing Services Market Size, Share & Trends Analysis Report By Services (Biomarker Assay Development & Validation, Flow Cytometry), By End-user (Research Institutes, CROS), By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global biomarker testing services market size was valued at USD 759.6 million in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 6.9% from 2022 to 2030. Growing demand for biomarkers in diagnosis; awareness about biomarkers among researchers, and high demand for outsourcing biomarker testing services among the pharmaceutical and biopharmaceutical companies are some of the key drivers supporting the market growth.  During the pandemic, the majority of studies were conducted for COVID-19. Clinical studies on COVID-19 therapeutics are still being conducted, as there is a growing need to find a safe and effective treatment for all the new variants of the virus. The increasing research is expected to improve drug discovery activities, which will require biomarkers for analysis. This is expected to support the market in the post-pandemic period.

R&D is leading to the discovery of novel biomarkers. For instance, in 2020, sTNFR2 was revealed as a novel biomarker for the diagnosis of acute adult T-cell leukemia/lymphoma. Similarly, in 2018, FDA qualified Plasmodium 18S rRNA/rDNA biomarker for the treatment of malaria. The market is likely to witness lucrative growth during the forecast period due to such discoveries and technological advancements.

There is a growing demand for biomarkers in clinical studies.  These are various types of disease-specific biomarkers, that provide more rapid and accurate disease diagnosis. This reduces the duration of clinical medicine trials and assists in speeding the medicine development process. Biomarker testing services are widely used in cancer medicine discovery as it identifies changes in a cell’s genetic material. Such advantages of biomarkers are expected to support the market's growth throughout the forecasted period.

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 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.

Service Insights

The biomarker assay development & validation segment is anticipated to hold the highest market share of 59.8% in 2021 in the biomarker testing services market. Based on service, the market is segmented into biomarker assay development & validation, flow cytometry, and others. One of the key reasons supporting the segment's growth is the growing number of clinical research and drug discovery activities that require biomarker assay development and validation.

Biomarkers accounted for the FDA’s approval for 40.0% of personalized medicines in 2018; a high number of biomarker-based approvals promotes demand for biomarker assay development & validation. There is a growing demand for the companion diagnostics such as immunohistochemistry kits for testing biomarkers in cancer diseases. For instance, in August 2022, Roche received approval for its VENTANA MMR RxDx Panel IHC panel used to detect biomarkers in endometrial cancer patients. This further supports the demand for biomarker assay development.

The flow cytometry segment is expected to grow with a CAGR of 7.8% during the forecast period  Flow cytometry 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 biomarker 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 improving biomarker testing. Thus supporting its demand in the market

End-User Insights

The Pharmaceutical and biotechnology companies segment held the largest share of 44.0% in 2021. The key end-user includes pharmaceutical and biotechnology companies, research institutes, and CROs.  An increase in the funding for clinical research by pharmaceutical and biotechnology is one of the key reasons supporting the segment growth. Moreover, there is a growing interest among pharmaceutical companies to develop targeted therapies for cancer. Owing to this in September 2022, AstraZeneca and Roche entered into a partnership to redefine the treatment and diagnosis of cancer in the Middle East and North Africa. The aim of the partnership was to remove barriers in biomarker testing and expand access to precision medicines in the region. 

The CRO segment is expected to expand with a CAGR of 8.3% during the forecast period. Small and medium-sized CRO’s may lack biomarker testing service units, in order to avoid equipment costs and, reduce the expenses associated with hiring personnel intended for the biomarker testing used for medical research. CRO’s try to outsource biomarker testing to service providers. This is the key reason for supporting the market.

Regional Insights

In terms of the region, North America held the largest market share of 46.2% in 2021. The presence of key market players providing biomarker testing services in this region; a rise in 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 the factors supporting the market in the region.  For instance, in 2020, the Canadian government funded USD 78,000 to support research on COVID-19 biomarkers. The research was aimed at identifying biomarkers for COVID-19 severity detection.

Asia Pacific is anticipated to witness the fastest growth of 7.2% CAGR during the forecast period. The growing demand for companion diagnostics in the region, followed by the increasing geriatric population is supporting demand for the biomarker testing services in the region. Moreover, initiatives by the government to promote clinical trials in the region are further supporting the market. For instance, in September 2019, the Ministry of Food and Drug Safety of South Korea announced a 5-year plan to improve clinical trials in South Korea. Such initiatives are expected to promote regional market growth.

Key Companies & Market Share Insights

The market is highly competitive and companies are adopting strategies such as regional expansions, product launches, partnerships and M&A deals to stay competitive in the market. For instance, in June 2022, Labcorp announced a collaboration with BML to expand its biomarker testing facilities in Japan. The partnership will help Labcorp strengthen its global presence. Some of the prominent players in the global biomarker testing services market include:

• Bio Agilytix Labs

•  Euro fins Scientific

• SGS SA

• Charles River Laboratories

• Labcorp Drug Development

• Thermo Fisher Scientific Inc.(PPD, Inc.)

• ICON Plc

• IQVIA

• Syneos Health

• Intertek Group Plc

Biomarker Testing Services Market Report Scope

Global Biomarker Testing Services Market Segmentation

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

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

  • Biomarker Assay Development

  • Flow Cytometry

  • Others

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

  • Pharmaceutical and biotechnology companies

  • Research Institutes

  • CRO

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

  • North America

  • U.S.

  • Canada

  • Europe

  • U.K.

  • Germany

  • France

  • Italy

  • Spain

  • Netherlands

  • Sweden

  • Switzerland

  • Asia Pacific

  • Japan

  • China

  • India

  • Indonesia

  • Malaysia

  • Singapore

  • South Korea

  • Thailand

  • Taiwan

  • Australia

  • Latin America

  • Brazil

  • Mexico

  • Argentina

  • Colombia

  • Middle East & Africa

  • South Africa

  • Saudi Arabia

  • Israel

  • UAE