Biomarkers Market Size, Share & Trends Analysis Report By Type (Safety, Efficacy), By Application (Diagnostic, Drug Discovery & Development), By Disease (CVD, Cancer), By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global biomarkers market size was valued at USD 51.18 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 14.2% from 2021 to 2028. The increasing prevalence of chronic diseases, advancements in the techniques used for the development of biomarker-based diagnostics, and the growing geriatric population are the key factors projected to boost the market growth over the forecast period. The rising number of COVID-19 cases across the globe and an increasing number of researches on the use of biomarkers for facilitating the detection & treatment of COVID-19 will also support market growth. For instance, a novel biomarker-based non-diagnostic screening device was approved by the U.S. FDA in March 2021 called Tiger Tech COVID Plus Monitor. This device is used to identify indicative biomarkers for COVID-19 and other hyperinflammatory & hypercoagulable conditions in individuals aged 5 years and above.

Recent advancements in biomarkers, such as biomarker signatures, are making neurological diseases more treatable. This has resulted in non-invasive testing, faster drug development, and early diagnosis. R&D is leading to the discovery of novel biomarkers. For instance, as per Nature Journal in 2020, tetranectin is a potential biomarker for heart failure diagnosis. Similarly, in 2020, sTNFR2 was revealed as a novel biomarker for the diagnosis of acute adult T-cell leukemia/lymphoma. The market is likely to witness lucrative growth over the forecast period due to such discoveries and technological advancements.

The use of biomarkers in infectious disease diagnosis is anticipated to become increasingly common in the coming years. For instance, as per Frontiers in Microbiology in 2020, potential MicroRNA-based biomarkers have been identified for the diagnosis of infections, such as influenza infections, rhinoviruses, HIV, tuberculosis, malaria, Ebola, and Hendra virus. These miRNA-based biomarkers are aimed at facilitating the early onset of infectious diseases.

Moreover, Amgen announced the launch of the Biomarker Assist program in April 2021 to improve access to advanced biomarker testing for non-small cell lung cancer patients. Such programs are anticipated to escalate the adoption rate of novel biomarker tests, thereby facilitating correct and on-time treatment.

A rise in the prevalence of fatal diseases has been observed over the past few years, which includes cancer, diabetes, Cardiovascular Disorders (CVDs), and other chronic diseases. One of the major factors leading to a rise in their prevalence is lifestyle changes. As per the WHO in 2019, ischemic heart disease and stroke have become the leading cause of death globally, accounting for around 8.9 million deaths globally followed by stroke and COPD.

Type Insights

The safety biomarkers segment held the largest market share of more than 38% in 2020, driven by the high awareness about routine health checkups, lowered drug attrition rate, and a rise in population that is at high risk of developing various diseases, such as cancer, cardiovascular conditions, and kidney disorders. The use of safety biomarkers in preclinical trials assists in the selection of drug candidates likely to be well-tolerated by humans, which thereby reduces the time and cost required for preclinical safety evaluation & drug development.

The validation biomarkers segment is expected to exhibit the second-fastest growth over the forecast period owing to the use of these biomarkers in the pharmaceutical sector to predict the therapeutic failure of pharmaceutical molecules with low therapeutic profiles and distinct genetic profiles. For instance, in January 2020, Biocept, Inc. launched the Target Selector platform and assays that allow physicians to evaluate circulating tumor cells and breast/lung cancer-associated biomarkers in the CSF of patients.

Application Insights

The drug discovery & development segment dominated the biomarkers market in 2020 with a revenue share of more than 31.5% owing to extensive R&D initiatives for the development of targeted therapeutics, the ability to predict drug efficacy more easily, and a fast-track approval process. One such instance is the launch of targeted therapy for EGFR mutation in Non-small Cell Lung Cancer (NSCLC) patients by Halozyme, Inc.

The diagnostics segment is estimated to register the fastest CAGR over the forecast period owing to advantages in early-stage detection of disease, this creates an opportunity for the diagnostic segment to propel early diagnosis and improve the rate of diagnosis. It facilitates the detection & treatment of COVID-19. 

Disease Insights

The cancer segment held the largest market share of more than 37% in 2020, driven by a rise in demand for rapid and accurate diagnostic tools, an increase in global cancer burden, and an unmet need for more specific, personalized, therapeutic targets for cancer patients. Its use for early detection of cancer, estimate prognosis, and monitor response to the treatment is expected to drive the market. According to the American Cancer Society, 1.8 million new cases were observed and 606,520 died due to the disease in the U.S. in 2020.

The CVD segment is anticipated to register the second-fastest CAGR over the forecast period. The use of cardiac biomarkers in patients suffering from COVID-19 with an increased risk of developing heart disease facilitates early detection and risk stratification. As per BMJ in 2020, around 50.0% of COVID-19 patients had an increased risk of developing cardiac conditions.

Regional Insights

In 2020, North America accounted for the highest revenue share of more than 44% of the global market. The increasing disease burden, growing consumer awareness, proactive government actions, technological breakthroughs, and improvements in healthcare infrastructure can be attributed to this growth. For instance, in 2020, the Canadian Government-funded USD 78,000 research project for COVID-19 biomarkers. The research was aimed at identifying biomarkers for COVID-19 severity detection.

Europe is projected to be the second-largest market by 2028 due to the presence of prominent research institutes and market players operating in this region. The market growth can be attributed to increasing collaborations between European universities and biomarker solution providers. Rapid growth in the availability of biomarker testing is expected to improve healthcare services in the region and boost the market.

Key Companies & Market Share Insights

Diagnostic biomarker kits are widely used in drug development and clinical research. Innovative noninvasive techniques involving the use of biomarkers as a diagnostic tool to identify chronic diseases are expected to act as a key driver. For instance, Immunovia AB in collaboration with CREATE Health Cancer Center developed a biomarker-based technology that can improve the sensitivity of NGS, thereby propelling the development & discovery of new biomarkers to fulfill the unmet needs. Some prominent players in the global biomarkers market include:

• F. Hoffmann-La Roche Ltd.

• Abbott Laboratories

• Epigenetics AG

• General Electric

• Johnson & Johnson Services, Inc.

• Thermo Fisher Scientific, Inc.

• Bio-Rad Laboratories, Inc.

• Siemens Healthineers AG

• Qiagen

Biomarkers Market Report Scope

Segments Covered in the Report

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 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global biomarkers market report based on type, application, disease, and region:

• Type Outlook (Revenue, USD Million, 2017 - 2028)

  • Safety

  • Efficacy

  • Validation

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • Diagnostics

  • Drug Discovery & Development

  • Personalized Medicines

  • Others

• Disease Outlook (Revenue, USD Million, 2017 - 2028)

  • Cancer

    • Safety

    • Efficacy

    • Validation

  • Cardiovascular Diseases

    • Safety

    • Efficacy

    • Validation

  • Neurological Diseases

    • Safety

    • Efficacy

    • Validation

  • Immunological Diseases

    • Safety

    • Efficacy

    • Validation

  • Others

    • Safety

    • Efficacy

    • Validation

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • Spain

    • France

    • Italy

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE