Biomarkers Market Size, Share, Forecast, & Trends Analysis by Type (Efficacy, Validation, Safety) Mechanism (Genetic, Epigenetic, Proteomic) Technology (ELISA, Microarray, PCR, NGS), Offering, Application, Disease Type, End User – Global Forecast to 2031

The Biomarkers Market was valued at $69.76  billion in 2023. This market is expected to reach $201.33  billion by 2031, from an estimated $79  billion in 2024, at a CAGR of 14.3% during the forecast period 2024-2031.

Biomarkers Market Size & Forecast

The growth of this market can be attributed to various factors, such as the increasing pharmaceutical research spending, rising prevalence of target diseases, technological advancements in biomarker detection, rising focus on clinical research, increasing funding for biomarker research, rising focus on early disease diagnosis, and application of biomarkers in multiple research areas. Furthermore, a rising focus on companion diagnostics, ongoing research on biomarkers, and a shift toward precision oncology are expected to offer growth opportunities.

Biomarkers Market Growth Drivers

Rising Prevalence of Target Diseases

Biomarkers are either released by the human body in response to various diseases or by organs that are affected by the disease, such as tumors. Biomarkers are being used increasingly to detect several infectious and chronic diseases, such as cancer, neurological disorders, cardiovascular diseases, and others.

In the case of cancer, clinical biomarker testing involves the detection of molecules of DNA, protein metabolites, RNA, or transcription factors that are either produced by the tumor or as a response to the tumor. These biomarkers help in cancer diagnostics and also provide predictive and prognostic information to guide patient care. The prevalence of cardiovascular diseases, cancer, and infectious diseases is increasing. According to GLOBOCAN, the global prevalence of all types of cancer is expected to increase by 63.4% by 2045 from 2022. The rising prevalence of cancer is increasing the demand for biomarker testing.

Increasing Funding for Biomarker Research

Biomarker research has gained traction in recent years owing to its applications in early disease diagnosis. The key players operating in the market and government agencies are raising funding and providing grants for advancements in biomarkers research and testing. For instance,

• In November 2023, the Michael J. Fox Foundation (U.S.), a non-profit organization working on the treatment of Parkinson’s disease, provided Octave Bioscience, Inc. (U.S.) with a USD 10 million grant to discover, develop, and validate a custom protein biomarker panel to measure Parkinson’s disease activity and progression in the clinic.
• In August 2023, the National Comprehensive Cancer Network (U.S.), an alliance of 33 cancer centers in the U.S. in partnership with Fight Colorectal Cancer (U.S.), a patient empowerment organization and Pfizer Inc. (U.S.), announced new grants awarded to improve initiatives focused on optimizing biomarker-directed therapy in metastatic colorectal cancer.

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Biomarkers Market Trends

Digital Biomarkers

Digital biomarkers are referred to as the objective, quantifiable behavioral and psychological data that is measured and collected with the help of digital devices such as ingestible, portables, implantable, or wearables. This data is used for the prediction of health-related outcomes. During drug discovery, digital biomarkers provide more scalability and flexibility than traditional methods; thus, many companies are focusing on the use of digital biomarkers. The digital biomarkers help pharmaceutical companies to provide supplementary data that can be used during clinical trials for accurate patient-centric metrics. Chugai Pharmaceutical Co., Ltd. (Japan), a subsidiary of F. Hoffmann-La Roche AG (Germany), is using digital biomarker technology to collect and analyze patient physiological data. The data is further used for drug development, understanding disease mechanisms, and visualizing patient outcomes.

Microfluidics in Biomarker Detection

Microfluidic immunoassay is majorly used for the detection of biomarkers associated with diseases for understanding disease mechanisms for drug development and disease detection. Microfluidic platforms provide real-time in situ detection of exosomes, proteins, and other biomarkers released during cell physiological processes, thus providing insights into cellular processes, which can be further used to understand the disease mechanism.

Microfluidic immunoassays are increasingly used for oncology and cardiovascular disease biomarker detection. At present, commercially available microfluidic immunoassays for detecting cardiac biomarker tests are based on the detection of cardiac troponins, natriuretic peptides (NPS), creatine kinase (CK-MB), D-Dimer, C-reactive protein (CRP), and myoglobin. The tests are available either for single biomarker analysis or in the form of multiplexed assay (panel tests) for the detection of more than one biomarker.

Biomarkers Market Opportunity

Increasing Focus on Companion Diagnostics

Companion diagnostics is a test used to match a patient with a specific therapy or drug. For instance, a companion diagnostic test detects a patient's tumor for a specific biomarker that is targeted by the drug. This helps determine whether the patient should receive the drug or not. The development of companion diagnostics begins with the discovery and validation of biomarkers. Thus, the emphasis on biomarker discovery and validation is increasing. Biomarkers in companion diagnostics contribute to more precise, efficient, and personalized healthcare delivery.

The rising focus on companion diagnostic research and recent approvals for companion diagnostics is increasing the demand for biomarkers. In October 2022, F. Hoffmann-La Roche AG (Switzerland) received U.S. FDA approval for PATHWAY anti-HER2 (4B5) test, a companion diagnostic test. The test is used for the assessment of HER2 low status in metastatic breast cancer patients.

Biomarkers Market Analysis: Key Findings

By Biomarker Type: In 2024, the Safety Biomarkers Segment to Dominate the Biomarkers Market

Based on biomarker type, the biomarkers market is segmented into efficacy biomarkers, validation biomarkers, and safety biomarkers. In 2024, the safety biomarkers segment is expected to account for the largest share of 42.4% of the biomarkers market. Safety biomarkers are used to assess the safety or potential risks after and before exposure to a medical product or environmental agent. The large share of the segment is attributed to the increase in drug discovery research and availability of funding. The key pharmaceutical manufacturers heavily invest in R&D. The companies like Roche (Switzerland), Novartis AG (Switzerland), Abbott (U.S.), and Merck (U.S.) are investing 15%-30% of their revenue annually dedicated to R&D. Thus, high spending on drug discovery is accelerating the demand for safety biomarkers.

However, the efficacy biomarkers segment is projected to witness the highest growth rate of 15.8% during the forecast period of 2024–2031. Efficacy biomarkers are used to assess the effectiveness or therapeutic response of a drug. These biomarkers help determine whether a treatment is producing desired effects or not. Growing number of clinical trials globally is driving the market growth. For instance, as per WHO data published in February 2023, the number of clinical trials in 2022 has reached 744,100 compared to 487,002 in 2019. Thus, the rise in the number of candidates in phases III and IV of clinical trials is driving market growth.

By Offering: In 2024, the Consumables Segment to Dominate the Biomarkers Market

Based on offering, the biomarkers market is segmented into consumables and services & software. In 2024, the consumables segment is expected to account for the largest share of the biomarkers market. The continuous advancements in terms of the development of reagents and kits, high adoption and recurring consumption of biomarker identification and testing kits, and wide availability of consumables support the largest share of the market. The adoption of biomarker kits in clinical diagnostics is high due to rising disease prevalence, thereby supporting the segment’s largest share.

By Mechanism: In 2024, the Epigenetic Biomarkers Segment to Dominate the Biomarkers Market

Based on mechanism, the biomarkers market is segmented into genetic biomarkers, epigenetic biomarkers, proteomic biomarkers, lipidomic biomarkers, and other mechanisms. In 2024, the epigenetic biomarkers segment is expected to account for the largest share of the biomarkers market. Epigenetic biomarkers are used to assess biological processes such as disease development, progression, and response to the treatment. The rise in the prevalence of infectious and non-infectious diseases, coupled with the rising need to bring novel therapies to the market, is generating demand for epigenetic markets.

The key players are also collaborating with other industry players to boost research in epigenetic markers. For instance, in November 2023, Bayer AG partnered with Hurdle (U.K.) to advance precision health and increase patients' access to novel epigenetic and multi-omics for at-home biomarker tests.

By Profiling Technology: In 2024, the Immunoassay Segment to Dominate the Biomarkers Market

Based on profiling technology, the biomarkers market is segmented into immunoassay, NGS, PCR, mass spectrometry, chromatography, and other technologies. In 2024, the immunoassay segment is expected to account for the largest share of the biomarkers market. Immunoassays are bioanalytical techniques that use the specificity of an antigen-antibody reaction to detect and quantify target molecules in biological samples. The wide utilization of immunoassays in clinical diagnostics, drug discovery, and drug monitoring for biomarker detection contributes to the largest share of the market. Immunoassays are fast, simple, and a cost-effective technique, with better sensitivity and specificity comparable to or better than the conventional methods, owing to which their adoption is the highest.

By Disease Type: In 2024, the Oncology Segment to Dominate the Biomarkers Market

Based on disease type, the biomarkers market is segmented into oncology, cardiovascular diseases, infectious diseases, neurological disorders, diabetes and other metabolic diseases, and other diseases. In 2024, the oncology segment is expected to account for the largest share of the biomarkers market. In cancer research, biomarkers are used for wide applications such as early detection, diagnosis, prognosis, and treatment. Cancer (malignant tumor) is a major health concern globally and is one of the leading causes of morbidity and mortality across the world. According to GLOBOCAN, the number of all cancer types diagnosed in 2020 was 19.29 million, and it is expected to reach 24.59 million by 2030. The evolving landscape of biomarker research in cancer and the availability of funding to support cancer research are supporting the segment’s largest share.

By Application: In 2024, the Drug Discovery & Development Segment to Dominate the Biomarkers Market

Based on application, the biomarkers market is segmented into diagnostics, drug discovery & development, personalized medicine, clinical research, and other applications. In 2024, the drug discovery & development segment is expected to account for the largest share of 33% of the biomarkers market. The largest share of the segment is attributed to the wide applications of biomarkers in research & development, focus on developing precision therapeutics, and high growth in the cancer biomarker research supports the largest share of the market. The rising funding for drug discovery and the increasing need for developing novel therapies are supporting the largest share of the segment. For instance, in June 2023, the Commonwealth Government’s Medical Research Future Fund (MRFF) (Australia) invested USD 9.75 million in establishing MedChem Australia, a new national medicinal chemistry initiative, to accelerate the identification of early-stage drug candidates in clinical studies.

However, the diagnostics segment is projected to witness the highest growth rate of 16.0% during the forecast period of 2024–2031. The high growth of the segment is attributed to the increasing use of biomarkers in disease risk assessment, staging to categorize disease severity, treatment selection, and patient monitoring. The rising prevalence of infectious and non-infectious diseases, coupled with the availability of funding for clinical diagnostics, are supporting the segment’s high growth. For instance, in April 2024, the U.S. National Science Foundation awarded a USD 275,000 Phase 1 Small Business Innovation Research (SBIR) grant to Amplified Sciences, a clinical-stage life sciences diagnostic company based in the U.S. The company is developing tests for early, more accurate detection of challenging diseases such as pancreatic cancer.

By End User: In 2024, the Pharmaceutical & Biotechnology Companies Segment to Dominate the Biomarkers Market

Based on end user, the biomarkers market is segmented into pharmaceutical & biotechnology companies, hospitals, diagnostic laboratories, and other end users. In 2024, the pharmaceutical & biotechnology companies segment is expected to account for the largest share of the biomarkers market. The largest share of the segment is attributed to high spending on R&D by pharmaceutical companies, a focus on developing novel therapies, and a growing focus on personalized medicines.

Pharmaceutical and biotechnology companies allocate significant resources to their research activities. The rising spending on R&D by pharmaceutical companies is contributing to the largest share of the market. For instance, in 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) member companies spent USD 102.3 billion in R&D, compared to USD 91.1 Billion in 2020 (Source: 2022 PhRMA member annual survey).

Geographical Analysis

In 2024, North America is expected to account for the largest share of the 49.2% of the biomarkers market. The large share of the region is attributed to the substantial R&D investments by pharmaceutical companies for drug discovery & development, the presence of key market players in the region, government initiatives supporting research and development, and the high adoption of advanced diagnostic products. The regional government is focusing on biomarker research, further supporting the largest share in the region. For instance, in June 2023, the FDA launched a voluntary pilot program using cancer biomarkers for certain oncology drug products with certain corresponding in-vitro diagnostic tests. The program aims to help clinicians select suitable cancer treatments for patients.

Moreover, the market in Asia-Pacific is slated to register the highest growth rate of 17.2% during the forecast period. The countries in Asia-Pacific, including China, India, and South Korea, are projected to offer significant growth opportunities for the vendors in this market. The growing prevalence of diseases due to the growing geriatric population, increasing funding for drug discovery, and rising research initiatives for biomarkers in the country are driving the market growth. For instance, in October 2023, the Indian Institute of Technology (IIT), Madras, India, established a Centre of Excellence for research purposes to develop biomarkers for early detection of pancreatic cancer. Similarly, in May 2023, Fujitsu Limited (Japan), Kyoto University (Japan), and Chordia Therapeutics, Inc. (Japan) launched AI trials to discover biomarkers for new cancer drugs.

Biomarkers Market: Key Companies

The report offers a competitive landscape based on an extensive assessment of the product offerings and geographic presence of leading market players and the key growth strategies adopted by them over the past few years (2020–2024). The key players operating in the global biomarkers market are F. Hoffmann-La Roche AG (Switzerland), Merck KGaA (Germany), Epigenomics AG (Germany), Abbott Laboratories (U.S.), QIAGEN N.V. (Germany), Bio-Rad Laboratories (U.S.), Revvity Inc. (U.S.), Siemens Healthineers AG (Germany), Mindray (China), Thermo Fisher Scientific Inc. (U.S.), Eurofins Scientific SE (France), bioMérieux SA (France), Agilent Technologies, Inc. (U.S.), and Quanterix Corp. (U.S.).

Biomarkers Market Overview: Latest Developments from Key Industry Players

• In March 2024, Labcorp (U.S.) launched a pTau217 blood biomarker test. The test helps diagnose Alzheimer's disease and monitor patients undergoing treatment with new therapies.
• In January 2024, Merck KGaA (Germany) partnered with Quibim (Spain) to develop precision medicine technology for the treatment of a wide range of cancers. Both companies are using radiomics and biomarkers to predict a cancer patient’s response to immunotherapy.
• In October 2023, Mindray (China) launched a high-sensitivity troponin I (hs-cTnI) and NT-proBNP cardiac biomarker assay for the diagnosis of cardiovascular diseases. The launch enhances Mindray’s diverse portfolio of cardiac biomarkers.
• In July 2023, Quanterix Corp. (U.S.) launched a LucentAD biomarker blood test. The test evaluates patients experiencing cognitive symptoms consistent with the early signs of Alzheimer’s disease (AD).
• In June 2023, Sysmex Corporation (Japan) launched a HISCL β-Amyloid 1-42 Assay Kit and the HISCL β-Amyloid 1-40 assay kit for the diagnosis of Alzheimer’s Disease. The product helps in detecting the level of accumulation of Aβ in the brain by measuring the ratio of Aβ peptides, which are blood biomarkers approved as in vitro diagnostics.

Biomarkers Market Research Summary

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