Biomarkers Market – By Product and Services, By Biomarker Type, By Application, By Disease Type, By End Use – Global Forecast 2025 - 2034

Biomarkers Market Size

The global biomarkers market size was estimated at USD 77.6 billion in 2024. The market is expected to grow from USD 85.9 billion in 2025 to USD 244.8 billion by 2034 at a CAGR of 12.3% during the forecast period.
 

Biomarkers are biological molecules and include proteins, genes, and other molecules. These molecules are found in the blood, tissues, or body fluids that help in identifying biological processes or disease conditions. These biomarkers are utilized in early detection, diagnosis, monitoring treatment response, and designing personalized therapies to improve patient outcomes.
 

The global biomarkers market is experiencing significant growth, driven by the rising prevalence of chronic diseases. For instance, according to the World Health Organization (WHO), noncommunicable diseases (NCDs) are responsible for 41 million deaths annually, accounting for 74% of global mortality. Of these, 17 million premature deaths occur each year, with 86% affecting low- and middle-income countries. This rising burden of disease highlights the importance of reliable diagnostics. These trends create the need for advanced biomarkers to accelerate early detection, accurate diagnosis, personalized treatment, and improved monitoring of chronic disease progression and therapy outcomes.
 

Additionally, innovations in personalized medicine for biomarkers are revolutionizing detection, treatment, and monitoring, which helps in escalating the market growth. Advanced biomarkers detection methods, such as liquid biopsies, have emerged as a non-invasive method for identifying biomarkers in blood, which enables early disease diagnosis and real-time monitoring of treatment response. For example, the study published by the National Institute of Health (NIH) states that Guardant360 CDx has proven clinical validity in identifying patients with KRAS p.G12C–mutant non-small cell lung cancer (NSCLC).
 

Its effectiveness improves when used alongside tissue-based tests, as recommended in its approved product label, ensuring comprehensive and accurate mutation detection. Further, artificial intelligence in healthcare (AI) and multi-omics approaches improve the diagnosis rate and treatment precision by combining genomic, proteomic, and metabolomic data. Moreover, advancements in genomic and proteomic technologies and increasing research and development activities are propelling the market growth.
 

Biomarkers Market Trends

• Advancements in genomic and proteomic technologies have transformed biomarkers research, driving the market’s growth and enabling more precise and personalized diagnostic approaches. These innovations accelerate the identification of genetic and protein-based biomarkers that can guide disease detection, prognosis, and treatment strategies.
   
• Next-generation sequencing (NGS) has become a key tool in biomarker research, which helps to identify the genetic mutations, gene fusions, and alterations associated with various diseases. Thus, this supports selecting targeted therapies and predicting patient responses to specific drugs. NGS platforms can analyze multiple genes simultaneously, offering a comprehensive genetic profile of tumors.
   
• For instance, in August 2024, Illumina announced that the FDA had approved its TruSight Oncology Comprehensive test, a 500+ gene panel that rapidly matches patients to targeted therapies by identifying relevant genetic mutations and alterations.
   
• In addition, liquid biopsy is becoming popular because of its non-invasive way to detect biomarker-related genetic material (e.g., ctDNA, cfRNA) in blood samples. This is especially beneficial for monitoring disease progression, detecting minimal residual disease, and identifying molecular changes that can enable informed therapeutic decision making.
   
• Proteomic technologies allow the analysis of protein expression patterns at the single-cell level, which provides deeper insights into disease heterogeneity, biomarker identification, and drug resistance mechanisms. Thus, this supports the development of precision therapies based on specific biomarker profiles. For example, NanoString’s GeoMx Digital Spatial is the only spatial biology platform that non-destructively profiles the expression of RNA and protein from distinct tissue compartments and cell populations with an automated and scalable workflow that integrates with standard histology staining.
   
• Moreover, artificial intelligence in healthcare, which is estimated to reach USD 317.1 billion by 2032. (AI) and machine learning (ML) are being incorporated into genomic analysis to improve the interpretation of complex genetic data. Further, these technologies can identify novel biomarkers and also help in predicting treatment outcomes and support drug discovery, thereby enhancing the personalization of patient care.
   

Biomarkers Market Analysis

Based on product and services, the market is segmented into consumables, software, and services. The global market was estimated at USD 70.3 billion in 2023. The consumables segment held revenue of USD 37.8 billion in 2024 and the segment is poised for significant growth at a CAGR of 12.1% during the forecast period.
 

• Consumables, which include reagents, assay kits, and microplates, are manufactured under strict quality control measures, ensuring consistent performance across experiments. This reliability is necessary for generating reproducible results in biomarker studies, specifically in clinical diagnostics and drug discovery. For instance, Thermo Fisher Scientific’s ELISA kits provide high-sensitivity biomarker detection for disease research, confirming accurate and reproducible outcomes.
   
• Additionally, advanced consumables are designed to increase the sensitivity and specificity of biomarker assays. For example, Bio-Rad’s Droplet Digital PCR (ddPCR) reagents enable precise detection of low-abundance biomarkers in oncology and infectious disease diagnostics, minimizing false positives or negatives.
   
• Furthermore, consumables are optimized for use with advanced platforms such as mass spectrometry, next-generation sequencing (NGS), and liquid chromatography. This compatibility confirms seamless integration into workflows, which helps in improving the performance of these technologies in biomarker discovery and analysis, thereby driving market growth.
   

Based on biomarker type, the biomarkers market is bifurcated into safety biomarkers, efficacy biomarkers, predictive biomarkers, surrogate biomarkers, pharmacodynamic biomarkers, prognostics biomarkers, and validation biomarkers. The safety biomarkers segment accounted for a 25.2% market share in 2024 and is projected for significant growth to reach USD 63.2 billion by 2034.
 

• Safety biomarkers help in the early identification of potential adverse effects of drugs or treatments before significant clinical symptoms appear. They facilitate drug-induced toxicity across various organ systems, which include kidneys, heart, and nervous system. For instance, kidney injury molecule-1 (KIM-1) serves as a biomarker for detecting nephrotoxicity at an early stage, helping mitigate drug-induced renal damage.
   
• By detecting toxicity risks early in the drug development process, safety biomarkers help pharmaceutical companies avoid investing in candidates with high safety concerns. This minimizes the costs associated with late-stage clinical trial failures and accelerates the development of safer drugs.
   
• Additionally, safety biomarkers allow for continuous monitoring of organ function and overall health during the treatment. For example, cardiac troponins are used to monitor potential cardiac toxicity in patients receiving chemotherapy, ensuring timely intervention to prevent severe complications.
   
• Further, innovations in multi-omics approaches and high-throughput screening technologies have enhanced the identification and validation of novel safety biomarkers. Liquid biopsy-based safety biomarkers, such as circulating cell-free DNA (cfDNA) and extracellular vesicles (EVs), are gaining attention for their ability to detect toxicity-related molecular changes in real time. These advantages drive market growth.
   

Based on application, the biomarkers market is bifurcated into diagnostics, drug discovery and development, personalized medicine, disease risk assessment, and other applications. The diagnostics segment accounted for a 40.5% market share in 2024.
 

• Biomarkers enable the identification of diseases at an early stage, often before clinical symptoms manifest. Early detection helps in improving prognosis and allows for timely interventions. For example, prostate-specific antigen (PSA) is a widely used biomarker for early detection of prostate cancer, significantly improving treatment outcomes.
   
• Many biomarkers can be detected through non-invasive or minimally invasive methods such as blood, urine, or saliva tests. This improves patient compliance and minimizes the risks and discomfort associated with traditional diagnostic methods such as biopsies.
   
• Furthermore, biomarkers allow for continuous or periodic monitoring of disease progression and treatment efficacy.
   
• Moreover, innovations in diagnostic technologies have improved biomarker detection sensitivity and accuracy, helping in expanding their clinical utility. For instance, next-generation sequencing (NGS) allows comprehensive genetic profiling for precision diagnostics in oncology, whereas mass spectrometry improves the detection of low-abundance biomarkers in metabolic and infectious diseases. Thus, propelling market growth.
   

Based on disease type, the biomarkers market is bifurcated into cancer, cardiovascular diseases, neurological diseases, immunological diseases, and other disease types. The cancer segment accounted for a 38.5% market share in 2024.
 

• The rising prevalence of cancer is one of the key catalysts for the growth of the segment.
   
• For instance, according to the data from the World Health Organization (WHO), an estimated 20 million new cancer cases were reported in 2022, resulting in approximately 9.7 million deaths. It is estimated that 53.5 million people were living within five years of a cancer diagnosis. Globally, about 1 in 5 individuals will develop cancer during their lifetime, with around 1 in 9 men and 1 in 12 women succumbing to the disease.
   
• Biomarkers are important for identifying cancers at a very early stage, which helps in improving the chances of successful treatment. For example, the prostate-specific antigen (PSA) is used for early detection of prostate cancer, while CA-125 serves as an indicator for ovarian cancer.
   
• Additionally, biomarkers also provides molecular-level insights that help in distinguishing between benign and malignant tumors. For instance, cytokeratin fragments (CYFRA 21-1) are used to diagnose non-small cell lung cancer (NSCLC), which ensures accurate and timely intervention.
   
• Further, biomarkers help in post-treatment surveillance to identify cancer recurrence. For instance, elevated alpha-fetoprotein (AFP) levels in liver cancer patients may signal disease recurrence, prompting timely intervention, thereby escalating the market growth.
   

Based on end use, the biomarkers market is bifurcated into hospitals, diagnostic laboratories, academic and research institutions, and other end users. The hospitals segment accounted for a 38.4% market share in 2024.
 

• The growth of the segment can be attributed to the ability of the hospital to manage a large volume of patient pool, suffering from chronic diseases such as cancer, cardiovascular diseases, neurological disorders, among others, which includes both inpatient and outpatient. For instance, the Manipal Hospital of India, known as the second-largest hospital chain in the nation, annually observes a 400,000 cancer patient visit to their hospital.
   
• Hospitals use biomarkers to monitor the effectiveness of treatments in real-time, which allows doctors to adjust therapies quickly according to patients' needs for better outcomes and minimize side effects.
   
• Additionally, the growing demand for non-invasive biomarker test treatment such as liquid biopsy and companion diagnostics has stimulated the adoption of these technologies in the hospitals. Since these advanced technologies require highly skilled personnel which is readily available in the hospital setting, thereby the segment remains at the forefront in the rapidly evolving market of biomarkers.
   

The North America biomarkers market is accounted for USD 31.4 billion revenues in 2024, forecasted to reach USD 97.5 billion by 2034. The U.S. dominated the North America market with the largest revenue of USD 28.6 billion in 2024.
 

• The increasing prevalence of the chronic diseases such as cardiovascular diseases, neurological diseases, cancer in the U.S. are the key driver for the growth of the market in the U.S.
   
• For instance, as per the data from the American Cancer Society in 2025, around 2,041,910 new cases of cancer are expected to be diagnosed, and 618,120 cases of cancer related deaths is projected to occur in the U.S.
   
• Thus, this rising burden of the chronic diseases are propelling the market in the U.S. as many pharmaceutical and biotechnology companies, hospitals and research institutes are undertaking various research to develop advanced diagnostic solutions and therapies to the combat the disease in the country.
   

Europe: The biomarkers market in UK is expected to experience significant and promising growth from 2025 to 2034.
 

• Further, the growth of market in this region is anticipated to be bolstered by the rising cases of chronic condition such as cardiovascular diseases, cancer, neurological diseases, and immunological diseases in UK.
   
• For instance, according to the British Heart Foundation, over 7.6 million people in the UK are living with heart and circulatory diseases, including over 4 million men and 3.6 million women. With an aging population and improved survival rates following cardiovascular events, these numbers are expected to rise significantly. Projections indicate that by 2030, the number of individuals affected could increase by 1 million, reaching 2 million more than current figures by 2040.
   
• Further, the growth of the market in this region is anticipated to be bolstered by the UK government's commitment towards tackling chronic conditions via initiatives covering public health campaigns such as “Clear on Cancer,” and formulation of effective guidelines.
   

Asia Pacific: Japan biomarkers market is anticipated to witness lucrative growth between 2025 – 2034.
 

• The country as one of speediest aging population which needs frequent health monitoring. For instance, according to the World Health Organization, in 2021, Japan's elderly population, aged 65 and above, comprised 29.1% of the total population.
   
• This demographic shift has led to a rise in age-related diseases, with chronic diseases such as cancer being the leading cause of death, accounting for 27% of all fatalities in Japan, as reported by the National Cancer Center Japan in 2022. Thus, this rising disease burden has surged the demand for effective targeted therapies, escalating the growth of the biomarkers in Japan.
   

Middle East and Africa: The biomarkers market in Saudi Arabia is expected to experience significant and promising growth from 2025 to 2034.
 

• Saudi Arabia has experienced rise in early chronic disease detection due to growing awareness and improved screening programs. Thus, this trend encourages earlier treatment and heightens the demand for biomarkers.
   
• The rising need for diagnostics and care is further fueled by public health campaigns and national screening initiatives, resulting in significant market growth in the region.
   

Biomarkers Market Share

The top 4 players of the market accounted for approximately 45% of the market share which includes companies such as Abbott Laboratories, F. Hoffmann-La Roche, Illumina, Thermo Fisher Scientific, among others. With every firm introducing new products such as instruments, kits, assay and using advanced technologies, modernization is extremely important. Moreover, strategic partnerships with research institutes, and government agencies play a primary role in advancing the development of new products and getting the necessary permits. The enhancement of public awareness about chronic diseases and its health impact through the social media platform, will encourage more individuals to seek the treatment, assisting market players to strengthen their position in this growing sector.
 

Biomarkers Market Companies

Some of the eminent market participants operating in the biomarkers industry include:

• Abbott Laboratories
• Agilent Technologies
• Bio-Rad Laboratories
• Becton, Dickinson and Company
• Eurofins Scientific
• Epigenomics
• F. Hoffmann-La Roche
• GE Healthcare
• Illumina
• Johnson & Johnson
• Merck KGaA
• PerkinElmer
• QIAGEN
• Siemens Healthineers
• Thermo Fisher Scientific
   
• F. Hoffmann-La Roche Ltd has strong global workforce of approximately 100,000+ employees, which enables the company to drive innovation, and deliver high-quality solutions.
   
• Agilent Technologies has robust geographical presence which enables it to enhance its market reach. Agilent Technologies operates in more than 110 countries thus comprising of a strong distribution network.
   
• Abbott Laboratories offer wide array of diagnostic solutions such as advanced biomarker assays (including its innovative range of cardiac biomarkers), to enable early and accurate disease detection.
   

Biomarkers Industry News:

• In August 2024, Illumina, Inc. received FDA approval for its in vitro diagnostic test, TruSight Oncology Comprehensive, which analyzes over 500 genes in a patient's solid tumor. This test aims to enhance the identification of oncology biomarkers, marking a major advancement in personalized cancer treatment by enabling more precise and targeted therapies.
   
• In April 2021, Roche introduced the Elecsys Anti-p53 immunoassay, a cancer biomarker test designed to detect anti-p53 antibodies in serum and plasma. Available in CE mark-accepting markets, this diagnostic tool aids physicians in diagnosing various cancers, including throat, bowel, and breast cancer, when used in conjunction with other diagnostic methods.
   

The biomarkers market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Product and Services

• Consumables
• Software
• Services

Market, By Biomarker Type

• Safety biomarkers
• Efficacy biomarkers
• Predictive biomarkers
• Surrogate biomarkers
• Pharmacodynamic biomarkers
• Prognostics biomarkers
• Validation biomarkers

Market, By Application

• Diagnostics
• Drug discovery and development
• Personalized medicine
• Disease risk assessment
• Other applications

Market, By Disease Type

• Cancer
• Cardiovascular diseases
• Neurological diseases
• Immunological diseases
• Other disease types

Market, By End Use

• Hospitals
• Diagnostic laboratories
• Academic and research institutions
• Other end use

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE