Biomarkers Market Size to Surpass USD 366.64 Billion by 2035 | Nova One Advisor

The global biomarkers market size is reached at USD 118.32 billion in 2026 and is projected to hit USD 366.64 billion by 2035, growing at impressive CAGR of 13.39% from 2026 to 2035.

Ottawa, Jan. 28, 2026 (GLOBE NEWSWIRE) -- The global biomarkers market size stood at USD 104.35 billion in 2025 and is predicted to grow from USD 118.32 billion in 2026 to reach around USD 366.64 billion by 2035, registering a robust CAGR of 13.39% from 2026 to 2035. A study published by Nova One Advisor, a sister firm of Precedence Research.

The growth of the market is driven by the rising adoption of personalized medicine and targeted therapies, increasing use of biomarkers in drug discovery and diagnostics, and continuous advancements in omics technologies and AI-based biomarker identification.

Biomarkers Market Key Takeaways

The safety segment contributed the largest market share of 37.62% in 2025.
The efficacy biomarkers segment is predicted to grow at the remarkable CAGR from 2026 to 2035.
The consumables segment registered the maximum market share in 2025.
The services segment is expected to expand at the highest CAGR over the projected period.
The drug discovery and development segment generated the maximum market share in 2025.
The diagnostics segment is estimated to expand the fastest CAGR from 2026 to 2035.
The cancer segment captured the maximum market share in 2025 and is expected to grow from 2026 to 2035.
The immunological diseases segment is estimated to expand the fastest CAGR from 2026 to 2035.
North America dominated the largest market share of 44.0% in 2025.
Asia Pacific is expected to expand at the highest CAGR during the forecast period.

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What is the Biomarkers Market?

The biomarkers market is growing as biomarkers are applied not only to detect people with a disease, but to redefine the classification of the disease. They improve disease monitoring, enhance treatment response assessment, and allow early intervention approaches. They improve disease monitoring, enhance treatment response assessment, and allow early intervention strategies. The integration of biomarkers with targeted medicine shows a significant breakthrough.

Biomarkers in research hold marvelous potential. Continuing technological development and increasing understanding of molecular pathways lead to expanding their applications. Medical care providers and scientists increasingly rely on biomarkers to advance more efficient, personalized treatment strategies.

What are the Key Drivers in the Biomarkers Market?

Biomarkers plays are significant role in healthcare as they offer valuable insights into disease diagnosis, prognosis, treatment response, and targeted medicine. They aid as objective indicators, allowing early identification and intervention, causing to enhanced patient results and lower costs. Biomarkers assist treatment decisions by predicting disease outcomes and simplifying individualized treatment plans, which drives the growth of the market.

What are the Ongoing Trends in the Biomarkers Market?

In November 2025, Servier India, the Indian arm of the French pharmaceutical group Servier, launched a patient-centric biomarker testing initiative in collaboration with leading genomic laboratories MedGenome and Strand Life Sciences.
In April 2025, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium announced the launch of the Precision Dosimetry Imaging Biomarker (PDIB) project. This ground-breaking initiative brings together government, academic institutions, and industry in a collaboration to develop more efficient radiopharmaceutical therapies (RPTs), also known as radioligand therapies (RLTs).

What is the Emerging Challenge in the Biomarkers Market?

Major challenges faced in biomarker discovery are biological and clinical issues. Biological challenges significantly account for the biologicals complexity of the challenging network of molecular pathways; the clinical issues indicate favourable clinical results in a particular group of patients.

Biomarkers Market Regional Analysis

Why did North America Dominate the Market in 2025?

North America is dominant in the market as increasing investment from the government in the healthcare sector, such as federal research funding programs include the National Institutes of Health (NIH), National Science Foundation (NSF), Food and Drug Administration (FDA), Department of Defense, and Veterans Administration (VA), which accelerates the discovery and validation of novel biomarkers. An increasing network of academic medical centers and dedicated reference laboratories in this region, which drives the growth of the market.

How did the Asia Pacific Grow Notably in the Market in 2025?

Asia Pacific is the fastest growing market as increasing cases of chronic disease in Asia and the Pacific are due to lifestyle shifts, rising aging populations, and unhealthy eating. APAC countries have spending massively in high-tech research centers, genomics, and AI-driven technology, driving advanced biomarker analysis. The increasing adoption of digital tools facilitates the collection of high-quality data during clinical trials, which drives the growth of the market.

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Biomarkers Market Report Scope

Report Attribute	Details
Market Size in 2026	USD 118.32 Billion
Market Size by 2035	USD 366.64 Billion
Growth Rate From 2026 to 2035	CAGR of 13.39%
Base Year	2025
Forecast Period	2026-2035
Segments Covered	By Type, By Product, By Application, By Disease, By Region
Report Coverage	North America, Europe, Asia Pacific, Latin America, MEA
Key Companies Profiled	F. Hoffmann-La Roche AG.; Abbott; Epigenomics AG; General Electric; Johnson & Johnson Services, Inc.; Thermo Fisher Scientific Inc.; Bio-Rad Laboratories, Inc.; Siemens Healthineers AG; QIAGEN; Merck KGaA; PerkinElmer Inc.; Agilent Technologies, Inc.; Eurofins Scientific

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Biomarkers Market Segmental Insights

By Type Insights

Which Type Led the Biomarkers Market in 2025?

The efficacy biomarkers segment accounted for the dominating share of the market in 2025, as it is evaluated and measured as an indicator of normal biological, pathogenic, or pharmacologic responses to a therapeutic intervention. They allow scientists to see a therapeutic biological response early, making drug development rapid and more focused.

Whereas the predictive biomarkers segment is predicted to register rapid expansion in the forecasting period, as predictive biomarker is applied to detect patients who are more likely to respond to a specific treatment or environmental agent. The response could be a symptomatic advantage, enhanced survival, or an adverse effect.

By Product Insights

Which product dominates the market in 2025?

In 2025, the consumables segment captured the biggest share of the biomarkers market, as major consumables are all-in-one microplate readers, highly efficient tissue homogenizers, easy-to-use ELISA kits, powerful monochromator-based microplate readers, and multi-purpose fluorescent microplate readers. These consumables are single-use or frequently substituted items necessary to detect, measure, and analyse biological markers in samples such as blood, tissue, or saliva.

Although the software segment will expand fastest during 2026-2035, as digital software-based biomarkers support novel PD therapies and drive the value of therapeutic assets. The medicinal industry continues to develop. By incorporating traditional and digital software, scientists gain a more comprehensive understanding of an animal's health status and the effects of experimental interferences.

By Application Insights

How did Diagnostics Dominate the Market in 2025?

In 2025, the diagnostics segment had the largest share in the biomarkers market, as biomarkers used in the detection of challenges, in screening, and as diagnostic testing are well established, and they provide distinct and obvious benefits. These are applied to identify or confirm a specific disease or condition. They expose the nature of the disease.

On the other hand, the drug discovery and development segment is expected to grow most rapidly between 2026-2035, as advanced and validated biomarkers are required to enhance diagnosis, monitor drug activity and therapeutic response, and direct the advancement of safer and personalized therapies for different chronic diseases.

By Disease Insights

How did Cancer Dominate the Market in 2025?

The cancer segment held the largest share of the biomarkers market in 2025, as biomarkers are used to identify symptoms of cancer early in people, or to supports to diagnose cancer in someone who already has signs or symptoms. Biomarker testing is applied during or after treatment for some cancers to see how well the treatment is working.

Whereas the neurological diseases segment will expand fastest during 2026-2035, as biomarkers have huge potential to identify neurological disease at an initial stage, to offer a process for homogeneous classification of a disease, and to spread knowledge base concerning the fundamental disease pathogenesis. Biomarkers used in risk identification, in screening, and as diagnostic tests are well developed, and they provide distinct and clear advantages.

Biomarkers Market Key Players List

F. Hoffmann-La Roche AG: A global leader in diagnostics and pharmaceuticals, Roche develops advanced biomarker-based tests for oncology and personalized medicine. Its strong focus on companion diagnostics supports targeted therapy decisions.
Epigenomics AG: Epigenomics specializes in blood-based biomarker tests, mainly for early cancer detection. The company is known for its work in DNA methylation biomarkers.
Abbott: Abbott provides a wide range of diagnostic solutions, including biomarker assays for chronic and infectious diseases. Its platforms are widely used in hospitals and clinical laboratories worldwide.
Thermo Fisher Scientific Inc.: Thermo Fisher offers comprehensive tools for biomarker discovery, validation, and clinical testing. Its technologies support genomics, proteomics, and precision medicine research.
General Electric (GE Healthcare): GE Healthcare integrates imaging and diagnostic biomarkers to support disease detection and monitoring. The company focuses on combining imaging data with molecular insights.
Eurofins Scientific: Eurofins delivers biomarker testing and analytical services for clinical research and drug development. It supports pharmaceutical and biotech companies across multiple therapeutic areas.
Johnson & Johnson Services, Inc.: Johnson & Johnson uses biomarkers to advance drug development and personalized treatment approaches.The company applies biomarker insights across oncology, immunology, and neuroscience.
QIAGEN: QIAGEN develops sample preparation and molecular diagnostic solutions for biomarker analysis. Its products enable precise detection of genetic and molecular biomarkers.
Bio-Rad Laboratories, Inc.: Bio-Rad provides life science research tools used in biomarker discovery and validation. Its technologies support protein analysis, genomics, and clinical diagnostics.
Siemens Healthineers AG: Siemens Healthineers offers diagnostic imaging and laboratory testing solutions using biomarkers. It focuses on improving clinical decision-making through integrated diagnostics.
Merck KGaA: Merck KGaA supports biomarker research through advanced reagents and life science tools. The company plays a key role in biomarker-driven drug discovery.
PerkinElmer Inc.: PerkinElmer provides analytical instruments and biomarker solutions for clinical and research applications. Its offerings are widely used in diagnostics, screening, and drug development.
Agilent Technologies, Inc.: Agilent supplies high-precision instruments for biomarker identification and analysis. The company supports genomics, proteomics, and metabolomics research.

What are the Recent Developments in the Biomarkers Market?

In January 2026, Tempus AI, Inc., a technology company leading the adoption of AI to advance precision medicine, announced the launch of Paige Predict, a suite of cutting-edge digital pathology applications that analyze hematoxylin and eosin (H&E) whole slide images to help inform testing decisions.
In November 2025, Quibim, a worldwide leader in medical imaging AI and quantitative imaging biomarkers, announced the launch of its next-generation oncology ecosystem platform and will present it at the Radiological Society of North America (RSNA)
In July 2025, Quanterix Corporation, a company driving scientific discovery through ultra-sensitive biomarker detection, announced that it has completed its previously announced acquisition of Akoya Biosciences, Inc., establishing a scaled leader in the early detection of disease for the neurology, oncology, and immunology markets.
In August 2025, BioMark Diagnostics Inc. announced the completion of a strategic laboratory tools leasing agreement, substantially doubling BioMark’s testing capacity and positioning the Company for the imminent commercial launch of its lung cancer assay.

More Insights Nova One Advisor:

Digital Biomarkers Market: The digital biomarkers market size was exhibited at USD 5.44 billion in 2025 and is projected to hit around USD 42.77 billion by 2035, growing at a CAGR of 22.9% during the forecast period 2026 to 2035.
Neurological Biomarkers Market: The neurological biomarkers market size was exhibited at USD 9.45 billion in 2024 and is projected to hit around USD 31.82 billion by 2034, growing at a CAGR of 12.91% during the forecast period 2025 to 2034.
Immunoassay for Neurological Biomarkers Market: The immunoassay for neurological biomarkers market size was exhibited at USD 839.5 million in 2024 and is projected to hit around USD 4356.69 million by 2034, growing at a CAGR of 17.9% during the forecast period 2025 to 2034.
U.S. Telemedicine Market: The U.S. telemedicine market size was exhibited at USD 41.54 billion in 2025 and is projected to hit around USD 188.05 billion by 2035, growing at a CAGR of 16.3% during the forecast period 2026 to 2035.
U.S. Ophthalmic Sutures Market: The U.S. ophthalmic sutures market size was exhibited at USD 356.35 million in 2025 and is projected to hit around USD 632.17 million by 2035, growing at a CAGR of 5.9% during the forecast period 2026 to 2035.
U.S. Nanomedicine Market: The U.S. nanomedicine market size was exhibited at USD 114.55 billion in 2025 and is projected to hit around USD 351.35 billion by 2035, growing at a CAGR of 11.86% during the forecast period 2026 to 2035.
Immunotherapy Drugs Market: The global immunotherapy drugs market size was valued at USD 337.15 billion in 2025 and is projected to surpass around USD 1,856.39 billion by 2035, registering a CAGR of 18.4% over the forecast period of 2026 to 2035.
U.S. Antisense And RNAi Therapeutics Market: The U.S. antisense and RNAi therapeutics market size was valued at USD 4.82 billion in 2025 and is projected to surpass around USD 27.75 billion by 2035, registering a CAGR of 19.13% over the forecast period of 2026 to 2035.
Blood Based Biomarkers Market: The blood based biomarkers market size was exhibited at USD 9.15 billion in 2025 and is projected to hit around USD 18.86 billion by 2035, growing at a CAGR of 7.5% during the forecast period 2026 to 2035.

Segments Covered in the Report

By Type

Safety Biomarkers
Efficacy Biomarkers
Predictive Biomarkers
Surrogate Biomarkers
Pharmacodynamic Biomarkers
Prognostics Biomarkers
Validation Biomarkers

By Product

Consumable
Services
Software

By Application

Diagnostics
Drug Discovery & Development
Personalized Medicine
Disease Risk Assessment
Others

By Disease

Cancer
- Safety Biomarkers
- Efficacy Biomarkers
- Predictive Biomarkers
- Surrogate Biomarkers
- Pharmacodynamic Biomarkers
- Prognostics Biomarkers
- Validation Biomarkers

Cardiovascular Diseases
- Safety Biomarkers
- Efficacy Biomarkers
- Predictive Biomarkers
- Surrogate Biomarkers
- Pharmacodynamic Biomarkers
- Prognostics Biomarkers
- Validation Biomarkers
Neurological Diseases
- Safety Biomarkers
- Efficacy Biomarkers
- Predictive Biomarkers
- Surrogate Biomarkers
- Pharmacodynamic Biomarkers
- Prognostics Biomarkers
- Validation Biomarkers
Immunological Diseases
- Safety Biomarkers
- Efficacy Biomarkers
- Predictive Biomarkers
- Surrogate Biomarkers
- Pharmacodynamic Biomarkers
- Prognostics Biomarkers
- Validation Biomarkers
Others
- Safety Biomarkers
- Efficacy Biomarkers
- Predictive Biomarkers
- Surrogate Biomarkers
- Pharmacodynamic Biomarkers
- Prognostics Biomarkers
- Validation Biomarkers

By Region

North America
- U.S.
- Canada
Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
Latin America
- Brazil
- Mexico
- Argentina
Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait

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