Biomarkers Market

Market Overview:

The global biomarkers market size reached USD 89.4 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 249.4 Billion by 2033, exhibiting a growth rate (CAGR) of 10.8% during 2025-2033. At present, North America dominates the market, attributed to the presence of key market players and favorable regulatory policies. The rising prevalence of chronic diseases, ongoing developments in biotechnology and genomics, the shift toward personalized medicine, continuous advancements in analytical technologies, and increasing awareness among both healthcare professionals and patients about the benefits of biomarkers are some of the major factors propelling the market.

Market Size & Forecasts:

• Biomarkers market was valued at USD 89.4 Billion in 2024.
• The market is projected to reach USD 249.4 Billion by 2033, at a CAGR of 10.8% from 2025-2033.

Dominant Segments:

• Product: Consumables dominate the market driven by continuous expansion of biomarker research in various fields, including oncology, cardiology, and neuroscience, necessitates.
• Type: Safety biomarkers hold the largest share in the market as regulatory agencies, such as the FDA and EMA, mandate the evaluation of safety biomarkers in drug development to assess potential adverse effects and toxicity.
• Disease: Cancer dominates the market as biomarkers play a pivotal role in cancer research, diagnosis, treatment, and patient management. 
• Application: Drug discovery and development hold the largest share in the market as biomarkers are indispensable tools in drug discovery and development.
• End User: Diagnostic and research laboratories dominate the market since biomarkers have a significant impact on the operations of diagnostic and research laboratories, serving a wide range of crucial purposes.
• Region: North America leads the biomarkers market driven high prevalence of chronic diseases, including cancer, cardiovascular disorders, and diabetes. 

 Key Players:

• The leading companies in the market include Agilent Technologies Inc., Bio-Rad Laboratories Inc., Charles River Laboratories International Inc., Epigenomics AG, Eurofins Scientific SE, Merck KGaA, Perkinelmer Inc., Qiagen N.V, Quanterix Corporation, SphingoTec GmbH, Thermo Fisher Scientific Inc., etc.

Key Drivers of Market Growth:

• Increased Incidence of Chronic Diseases: The increasing incidence of diseases like cancer, cardiovascular diseases, and neurodegenerative disorders is leading to increased demand for the early detection and focused therapies, where biomarkers are the key.
• Advances in Personalized Medicine: Biomarkers are at the core of the formation of personalized therapeutic regimens, allowing for better predictions of drug action and disease course, thus fueling the market growth.
• Technological Advancements: Genomic, proteomic, and high-throughput screening technologies are greatly improving the discovery, validation, and use of biomarkers in the clinical environment.
• Government and Regulatory Initiatives: Public and private sector investment, as well as reduced regulatory hurdles for biomarker validation, are driving the market expansion, particularly in the areas of oncology and infectious disease testing.
• Research Expenditures in Pharma: Rising research and development expenditure by pharmaceutical and biotechnology firms is accelerating biomarker discovery activities for drug development, patient stratification, and clinical trial optimization.
• Companion Diagnostic Adoption: The expanding adoption of companion diagnostics that depend significantly on biomarkers to determine appropriate candidates for particular treatments is enhancing the market in precision medicine applications.

Future Outlook:

• Strong Growth Outlook: The market for diagnostic biomarkers is anticipated to register robust and sustained growth as a result of ongoing technology advancements in the field of diagnosis, growing interest in precision medicine, and widening applications to therapeutic classes.
• Market Evolution: The market will transform from research use limitations to extensive clinical use, where biomarkers will be an essential part of standard diagnostics, treatment choices, and monitoring disease in global healthcare systems.

The biomarkers market growth is driven by several crucial factors. Advancing genomic, proteomic, transcriptomic, and metabolomic technologies are continually revolutionizing the discovery and use of biomarkers. Scientists are utilizing next-generation sequencing (NGS), mass spectrometry, and bioinformatics to identify new biomarkers more precisely and accurately. These technological advances are facilitating greater insights into the mechanisms of disease and biological pathways. Pharmaceutical firms are consequently working on more targeted therapies, and diagnostic manufacturers are creating more targeted testing platforms. Universities and research and development (R&D) laboratories are teaming up with technology suppliers to leverage these innovations synergistically.

Biomarkers Market Trends/Drivers:

Increasing disease burden and healthcare expenditure

One of the most major drivers of the biomarkers sector is the increasing worldwide disease burden, most notably chronic diseases such as cancer, cardiovascular diseases, and diabetes. In 2025, it is estimated that there will be 2,041,910 newly diagnosed cancer cases and 618,120 cancer-related deaths in the United States. Biomarkers are critical in the early detection, diagnosis, and monitoring of diseases. They allow clinicians to diagnose disease risks, design treatment plans, and monitor response to therapy more effectively. While healthcare systems struggle to cope with these mounting disease burdens, biomarkers present an essential aid in enhancing patient outcomes and lowering healthcare expenditure through early intervention and focused treatment. The rising worldwide burden of chronic diseases places its stamp on the biomarkers market value, highlighting the pivotal role of biomarkers in earlier disease detection, diagnosis, and monitoring to achieve better patient outcomes and lower costs of healthcare.

Notable breakthroughs in biotechnology

The ongoing evolution of biotechnological tools and methods, such as genomics, proteomics, and high-throughput screening, has turned the process of biomarker discovery and validation around. This has resulted in the discovery of new biomarkers with high sensitivity and specificity, which further boosts their diagnostic and prognostic potential. Additionally, the shift toward personalized medicines is heavily dependent on biomarkers for optimizing the treatments according to individual patient profiles. Biomarker-guided strategies allow healthcare professionals to choose the most appropriate therapies, thus maximizing the efficacy of treatment and reducing side effects. This has not only enhanced patient care but also enhanced the need for biomarker-based therapeutics and tests. The IMARC Group predicts that the biotechnology market is anticipated to reach USD 1,315.9 Billion by 2033.

Increased drug discovery and clinical trials

Biomarkers are increasingly becoming crucial in the drug discovery and development industry, which is fueling drug development, and hence proving to be a foremost growth driver. They enable target identification, stratification of patients for clinical trials, and drug efficacy and safety assessment. This leads to efficient drug development processes, lower costs, and improved success rates for launching new drugs. Regulatory authorities increasingly identify the importance of biomarkers in drug approval, which is further enhancing their adoption into clinical trials and drug development pipelines. The opportunity in the biomarkers market is the creation of advanced biomarkers that align with increasing need for personalized medicine and targeted treatments, improving diagnostic precision and treatment effectiveness. In 2024, The Advanced Research Projects Agency for Health (ARPA-H), part of the U.S. Department of Health and Human Services (HHS), revealed a new funding opportunity via the Ocular Laboratory for Analysis of Biomarkers (OCULAB) program. OCULAB aims to create a biomarker measurement system using tears that can be placed in the tear duct for ongoing health assessment and enable highly accurate medication dosing for individualized treatment through a closed-loop delivery mechanism.

Biomarkers Market Growth Drivers:

Increasing Need for Personalized Medicine (Precision Medicine)

The growing shift towards personalized medicine is essentially changing the face of healthcare, making it one of the strongest drivers for the biomarkers market. Conventional "one-size-fits-all" treatment methodologies tend to lead to suboptimal results, wasteful side effects, and augmented healthcare expenditure. Personalized medicine rectifies this by individualizing medical treatment to the unique features of each patient, such as their genetic profile, molecular fingerprint, lifestyle, and environment. Biomarkers lie at the centre of it all. They make the division of patients into groups based on how they will likely respond to a particular therapy possible. It assists practitioners in choosing the best therapy while eschewing drugs with little or no hope of success or that could be harmful. For instance, in oncology, biomarkers such as HER2 in breast cancer or EGFR mutation in lung cancer enable oncologists to ascertain if a patient is eligible for targeted treatments. Additionally, biomarkers help in anticipating drug response and evaluating the effectiveness of treatment. They also inform the process of dose optimization, which ensures the administration of the most effective dose with least risk of side effects. This not only enhances clinical outcomes but also improves the cost-effectiveness of therapies.

Technological Innovations in 'Omics' Technologies

The sector of biomarker discovery has been profoundly advanced by innovation in omics technologies, specifically genomics, proteomics, metabolomics, and transcriptomics. These high-throughput research areas are providing detailed insights into the molecular basis of disease, enabling scientists to discover new biomarkers with unprecendented depth and precision. Breakthroughs in next-generation sequencing (NGS) are making it possible to sequence entire genomes and exomes quickly at progressively decreasing costs. This makes it possible to find genetic variants related to disease susceptibility, progression, and response to treatment. Methods such as mass spectrometry are enhancing the detection and quantitation of proteins and post-translational modifications. This is necessary to identify protein-based biomarkers, which can be applied to diagnosis and prognosis. Metabolomics and transcriptomics measure metabolic profiles and RNA expression levels, respectively, providing a snapshot in time of cellular behavior. They are becoming crucial to understanding the dynamics of disease and finding early markers of change in physiology. Furthermore, computational biology and bioinformatics are becoming increasingly powerful, enabling researchers to accurately interpret and manage omics data sets with many complexities. Biomarker discovery is giving rise to stronger, clinically meaningful biomarkers through the integration of multi-omics strategies.

Convergence of Artificial Intelligence (AI) and Machine Learning (ML)

The deluge of biological data acquired using omics technologies and clinical trials is giving rise to the requirement for next-generation analytical tools. Artificial Intelligence (AI) and Machine Learning (ML) are emerging as revolutionary drivers in biomarker science, accelerating the velocity, precision, and scalability of discovery and validation protocols. AI and ML algorithms can process enormous, intricate datasets well beyond human capabilities. They can also uncovering latent patterns of gene expression, protein interactions, and clinical response. For example, in cancer diagnosis, ML models are being trained to detect subtle molecular signatures that can predict the occurrence of tumors even before the onset of symptoms. In neurodegenerative disorders, AI is assisting in finding digital biomarkers on wearable devices and brain imaging that can predict cognitive decline. AI platforms are also being applied in pharmaceutical development. Pharmaceutical organizations are leveraging ML models to rank biomarker candidates for clinical trials, cutting the time and cost of development. Such tools are enhancing clinical trial design, assisting researchers in choosing the right patient populations and measuring therapeutic efficacy more effectively. In addition, as healthcare systems implement electronic health records (EHRs) and incorporate real-world data (RWD), AI and ML are being used more and more to mine the data for actionable biomarker insights. This integration is paving the way for more personalized, data-driven, and proactive care.

Biomarkers Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global biomarkers market report, along with forecasts at the global, regional, and country levels for 2025-2033. Our report has categorized the market based on product, type, disease, application, and end user.

Breakup by Product:

• Consumables
• Services
• Software

Consumables dominate the market

The report has provided a detailed breakup and analysis of the market based on the product. This includes consumables, services, and software. According to the report, consumables represented the largest segment.

The demand for consumables in the biomarkers market is driven by several influential factors. Primarily, the continuous expansion of biomarker research in various fields, including oncology, cardiology, and neuroscience, necessitates a steady supply of consumables. Researchers rely on consumables such as assay kits, reagents, and laboratory supplies to conduct experiments and validate biomarkers for clinical applications. The growing adoption of biomarkers for clinical diagnostics fuels demand for consumables used in diagnostic tests. Consumables like test kits, sample collection devices, and assay reagents are essential for accurate biomarker-based diagnosis, enabling early disease detection and monitoring. Biomarkers are integral to drug discovery and development, where consumables like cell culture media, plates, and assay components are essential. The pharmaceutical industry's robust pipeline of biomarker-driven therapies and the need for large-scale screening drive demand for consumables. The trend towards personalized medicine, which relies on biomarkers for treatment tailoring, has increased the need for consumables. Customized therapies based on individual biomarker profiles require specific consumables for their development and administration.

Breakup by Type:

• Efficacy Biomarkers
• Safety Biomarkers
• Validation Biomarkers

Safety biomarkers hold the largest share in the market

The report has provided a detailed breakup and analysis of the market based on the type. This includes efficacy biomarkers, safety biomarkers, and validation biomarkers. According to the report, safety biomarkers represented the largest segment.

The demand for safety biomarkers in the biomarkers industry is influenced by several critical factors. Regulatory agencies, such as the FDA and EMA, mandate the evaluation of safety biomarkers in drug development to assess potential adverse effects and toxicity. Compliance with these regulations drives the demand for safety biomarker assays and testing services. The high costs associated with drug development, including the expenses incurred due to adverse events and late-stage failures, underscore the importance of safety biomarkers. Early detection of safety concerns can significantly reduce development expenses, prompting the pharmaceutical industry to invest in safety biomarker research and implementation. Ensuring patient safety is paramount in clinical trials. The utilization of safety biomarkers helps identify and mitigate potential risks to participants, aligning with ethical and safety considerations. Technological advancements, such as omics technologies (genomics, proteomics, metabolomics), enable the discovery of novel safety biomarkers with enhanced sensitivity and specificity. The availability of cutting-edge tools and assays drives the adoption of safety biomarkers in drug safety assessment.

Breakup by Disease:

• Cancer
• Cardiovascular Disorders
• Neurological Disorders
• Immunological Disorders
• Renal Disorders
• Others

Cancer dominates the market

The report has provided a detailed breakup and analysis of the market based on the disease. This includes cancer, cardiovascular disorders, neurological disorders, immunological disorders, renal disorders, and others. According to the report, cancer represented the largest segment.

Biomarkers play a pivotal role in cancer research, diagnosis, treatment, and patient management. Their applications in cancer are multifaceted and essential. Primarily, biomarkers enable the early detection of cancer, often before symptoms manifest. Blood-based biomarkers, such as circulating tumor DNA (ctDNA) and specific proteins like PSA (Prostate-Specific Antigen), aid in screening and early diagnosis. Biomarkers help confirm cancer diagnoses and classify tumors into specific subtypes. For instance, hormone receptor status (estrogen and progesterone receptors) in breast cancer guides treatment decisions. Biomarkers provide prognostic information, helping predict the course of the disease. Genetic markers and gene expression profiles assist in estimating a patient's likely outcome and risk of recurrence. Biomarkers guide treatment decisions by identifying targeted therapies. For instance, the presence of HER2/neu in breast cancer indicates eligibility for HER2-targeted therapies like trastuzumab. Biomarkers are used to monitor treatment efficacy and disease progression. Imaging biomarkers, like PET scans, assess tumor response to therapy, aiding treatment adjustments.

Breakup by Application:

• Diagnostics
• Drug Discovery and Development
• Personalized Medicine
• Others

Drug discovery and development hold the largest share in the market

The report has provided a detailed breakup and analysis of the market based on the application. This includes diagnostics, drug discovery and development, personalized medicine, and others. According to the report, drug discovery and development accounted for the largest biomarkers market share.

Biomarkers are indispensable tools in drug discovery and development, offering several critical applications that streamline the process and increase its efficiency. Biomarkers help identify and validate potential drug targets by providing insights into their role in disease pathways. This ensures that drug development efforts are focused on biologically relevant targets. Biomarkers aid in assessing the effectiveness of drug candidates during preclinical and clinical trials. They provide quantifiable measurements of the drug's impact on the target and its downstream effects, helping to select the most promising candidates. Safety biomarkers are crucial for evaluating the potential adverse effects of drug candidates. They help identify safety concerns early in the development process, reducing the risk of late-stage failures. Biomarkers enable the stratification of patient populations, identifying subgroups that are more likely to respond to a specific treatment. This supports the development of targeted therapies, optimizing treatment outcomes. Biomarkers play a pivotal role in drug discovery and development, offering indispensable applications that streamline processes and enhance efficiency, as highlighted in the.

Breakup by End User:

• Pharmaceutical and Biotechnology Companies
• Diagnostic and Research Laboratories
• Hospitals and Specialty Clinics
• Others

Diagnostic and research laboratories dominates the market

The report has provided a detailed breakup and analysis of the market based on the end user. This includes pharmaceutical and biotechnology companies, diagnostic and research laboratories, hospitals and specialty clinics, and others. According to the report, diagnostic and research laboratories represented the largest segment.

Biomarkers have a significant impact on the operations of diagnostic and research laboratories, serving a wide range of crucial purposes. Biomarkers are fundamental in clinical diagnostics, aiding in the accurate and early diagnosis of various diseases. They provide measurable indicators of disease presence or progression, enhancing diagnostic precision. Biomarkers enable the categorization of patients into different risk groups or disease subtypes, helping healthcare providers tailor treatment plans to individual profiles. In research and clinical settings, biomarkers are used to monitor disease progression and assess the effectiveness of treatments. This helps in disease management and optimization of therapeutic interventions. Laboratories use biomarkers to evaluate drug responses, assess drug metabolism, and understand the relationship between drug dose and effect. Biomarkers play a role in assessing the safety of drugs and therapies and identifying potential side effects and toxicities. Biomarkers serve as key tools in laboratory research, aiding in the discovery of new disease mechanisms, drug targets, and potential therapeutic interventions. The indispensable role of biomarkers in diagnostic and research laboratories contributes to the biomarkers market growth, driven by their vital functions in disease diagnosis, treatment tailoring, therapeutic monitoring, and drug development.

Breakup by Region:

• North America 
  • United States
  • Canada
• Europe 
  • Germany
  • France
  • United Kingdom
  • Italy
  • Russia
  • Spain
  • Others
• Asia Pacific 
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Latin America 
  • Brazil
  • Mexico
  • Others
• Middle East and Africa

North America exhibits a clear dominance, accounting for the largest market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Russia, Spain, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

The biomarkers industry in North America is driven by several influential factors that contribute to its growth and development. The high prevalence of chronic diseases, including cancer, cardiovascular disorders, and diabetes, in North America has fueled the demand for biomarkers. Biomarkers are crucial for early detection, monitoring, and treatment selection in these conditions. North America boasts a well-developed healthcare infrastructure, including state-of-the-art laboratories and research facilities. This infrastructure supports biomarker research, development, and implementation. The region is home to a robust biotechnology and pharmaceutical industry. Biomarkers play a central role in drug discovery, development, and clinical trials, driving their demand. Regulatory agencies like the FDA in the United States have recognized the importance of biomarkers in drug development and diagnostics. Clear regulatory pathways for biomarker-based products encourage their use. Significant investments in research and development (R&D), both public and private, support biomarker discovery and validation, enhancing their role in healthcare. Ongoing technological advancements in genomics, proteomics, and diagnostic technologies are improving the accuracy and efficiency of biomarker assays.

Competitive Landscape:

Key players in the market are actively engaged in various strategic initiatives to advance research, development, and commercialization in this dynamic field. Leading companies invest heavily in R&D to discover and validate novel biomarkers. They collaborate with academic institutions and research organizations to expand their biomarker portfolios. Many biomarker companies form strategic partnerships with pharmaceutical and biotechnology firms to integrate biomarkers into drug development pipelines. These collaborations aim to identify biomarkers for patient stratification and treatment response prediction. Companies continuously expand their biomarker product portfolios, offering a wide range of assays, kits, and services for diverse applications, from diagnostics to drug development. Leading players invest in cutting-edge technologies, such as next-generation sequencing and mass spectrometry, to enhance the sensitivity and specificity of biomarker detection methods. Some key players focus on developing companion diagnostics, and aligning biomarker tests with specific therapies to ensure precise treatment selection and improve patient outcomes.

The market research report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• Agilent Technologies Inc.
• Bio-Rad Laboratories Inc.
• Charles River Laboratories International Inc.
• Epigenomics AG
• Eurofins Scientific SE
• Merck KGaA
• Perkinelmer Inc.
• Qiagen N.V
• Quanterix Corporation
• SphingoTec GmbH
• Thermo Fisher Scientific Inc.

Recent Developments:

• May 2025: Galmed Pharmaceuticals Ltd., a late-stage clinical biopharmaceutical company for the treatment of liver, cardiometabolic disorders and GI oncological targets, reported a significant scientific and strategic breakthrough: identification of a proprietary pharmacodynamic (PD) blood-based biomarker signature for its lead product candidate, Aramchol, the most clinically advanced stearoyl-CoA desaturase 1 (SCD1) inhibitor in the industry.
• April 2025: Mosaic Therapeutics, a UK oncology biotech firm has revealed it has in-licensed two clinical-stage oncology programs from Astex Pharmaceuticals. The deal turns Mosaic into a clinical-stage company from an R&D-driven entity. Mosaic will use these assets to develop proprietary combination therapies under the direction of its own biomarkers.
• January 2025: Quanterix Corporation, a life sciences company driving scientific discovery by unlocking the power of ultra-sensitive biomarker detection, and Akoya Biosciences, The Spatial Biology Company®, broadcasted a definitive merger agreement to acquire Akoya by Quanterix in an all-stock transaction. The deal will produce the first combined solution for ultra-sensitive blood- and tissue-based protein biomarker detection.
• January 2025: Quibim, a fast-growing healthtech leader in the application of imaging biomarkers for precision medicine, today closed its $50 million Series A round. The firm has seen spectacular growth in the number of patients imaged by its solutions in the last year.
• April 2025: Funded by the Innovative Health Initiative Joint Undertaking (IHI JU) and its partners, Viromarkers unites researchers from public research institutes, European life science industries, and patients' organizations from all over Europe to identify and validate biomarkers capable of revolutionizing the care of patients with HIV, Hepatitis D (HDV), and Cytomegalovirus (CMV) infections.
• April 2025: Nucleai, the artificial intelligence-based spatial biomarkers and diagnostics firm, publicized the release of its deep learning model that normalizes high-plex imaging data automatically, the starting point in the spatial proteomics process. Nucleai provides tools to facilitate spatial profiling of protein expression and immune cell interactions, such as cell architecture and neighborhoods, to aid in the creation of antibody-drug conjugates (ADCs), bispecifics, and immunotherapies.

Biomarkers Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the biomarkers market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global biomarkers market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the biomarkers industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.