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Biomarkers Market Size Grows by 14.54% CAGR till 2034

Biomarkers Market 2025 Driven by Cancer Dominance and Rapid Rise in Neurological Disease Applications

Market insights predict the global biomarkers industry will increase from USD 108.04 billion in 2025 to USD 366.6 billion by 2034, achieving a CAGR of 14.54%. North America leads with a 46% market share in biomarker research due to strong support and FDA involvement. Biomarkers aid in disease diagnosis, monitoring, and drug development. AI and wearable tech are advancing biomarker discovery, with key companies like Abbott, Roche, and J&J driving innovation.

Category: Biotechnology Insight Code: 5322 Format: PDF / PPT / Excel

Biomarkers Market Size, Forecasts, Segmentation and Applications Insights

The biomarkers market size to grow from at US$ 94.32 billion in 2024 and is projected to grow to US$ 366.6 billion by 2034, rising at a double digit compound annual growth rate (CAGR) of 14.54% from 2024 to 2034. The rising incidences of chronic disorders, growing research and development, and increasing investments drive the market.

Biomarkers Market Revenue 2023 - 2034

Key Takeways

  • Asia Pacific is expected to be the fastest-growing during the forecast period.
  • By type, the safety biomarkers segment dominated the market in 2024.
  • By type, the efficacy biomarkers segment is expected to be the fastest growing at a notable CAGR during the forecast period.
  • By disease type, the cancer segment dominated the market in 2024.
  • By disease type, the neurological diseases segment is expected to grow significantly during the forecast period.
  • By application type, the drug discovery & development segment dominated the market in 2024.

Biomarkers Market: Tracing the Disease

Biomarkers or biological markers are molecules found in blood, body fluids, or tissues that explain what is happening in a cell or organism. They are used to perform clinical assessments and monitor and predict health states in individuals. For instance, high levels of lead in the bloodstream may indicate a need to test for nervous system and cognitive disorders, especially in children. Biomarkers play a crucial role in determining relationships between environmental exposures, human biology, and disease. A biomarker can also act as a diagnostic measure that examines the organ function or other aspects of health when introduced into an organism. Biomarkers can also aid in disease prognosis by providing information about the patient's overall outcome, regardless of any treatment or therapeutic intervention.

The rising incidence and prevalence of chronic disorders potentiates the demand for finding the root cause of the disease and aiding in novel drug discovery and development. The growing research and development boost biomarkers research. The market is also driven by increasing investments from both gove ment and private organizations, and collaborations augment the market.

  • In October 2024, SanboxAQ, an AI and quantum technology company, announced the collaboration with Sanofi to locate biomarkers using large quantitative models (LQMs) to gain a better understanding of human biology. The collaboration was made to support scientists’ ability to promote trust throughout investigational medicines and clinical development.
  • In October 2024, MEDiC Life Sciences announced the collaboration with Hanmi Pharmaceutical. The collaboration was made to use MEDiC’s MCAT platform to identify cancer biomarkers for one of Hanmi’s clinical assets.
  • In August 2024, the University of Nevada, Las Vegas, received a $3.2 million investment from the Alzheimer’s Drug Discovery Foundation (ADDF) to develop a biomarker observatory to diagnose and monitor Alzheimer’s disease.

Artificial Intelligence: Opportunity for the Biomarkers Market

Artificial intelligence (AI) revolutionizes research and development activities, streamlining the workflow. Biomarkers are an essential part of routine clinical practice, complementing clinical examination and physician expertise to provide accurate disease diagnosis, prediction of complications, personalized treatment guidance, and prognosis. The advent of advanced technologies simplifies the discovery of biomarkers using larger data sets, resulting in improved analysis. Additionally, digital biomarkers offer powerful interpretations of a patient’s digital measurements and correlated medical conditions. Sensors, wearables, and digital platforms are some examples of digital biomarkers that can capture and analyze an array of physiological, behavioral, and environmental data. These measurements are provided by a digital ecosystem that gives people and their healthcare professionals dynamic and individualized health insights. Hence, such advanced technologies can deeply transform healthcare by driving innovations in disease prevention, diagnostics, treatment, and monitoring.

Market Dynamics

Drivers

Increasing personalized medications

There is a rise in the demand for the use of personalized medications for various treatments. This, in tu , increases the use of individuals' biomarkers to identify the genetic profile of the patients for their development. At the same time, they are used for the development of targeted therapies. This helps in reducing the side effects and enhances the success rates of the treatment, as well as improves the patient outcomes. Thus, all these advancements drive the biomarkers market growth.

Opportunity

Rising demand for precise diagnostics

As the demand for precise diagnostics is increasing, biomarkers are being used to detect diseases. They also deliver molecular-level insights, which enhance the early diagnosis of diseases. They can also differentiate between the types of diseases effectively. At the same time, they are being used in the development of non-invasive diagnostics. Moreover, further complications can also be detected with the use of the biomarkers. Thus, their use in the development of point-of-care diagnostics for home testing is also increasing. Hence, this is promoting the biomarker market growth.

For instance,

  • In June 2025, a chemiluminescent enzyme immunoassay (CLEIA), that is Lumipulse G sTREM2 assay, was launched by H.U. Group Holdings Inc. and its subsidiary Fujirebio. To understand neuroinflammation or the mechanism of neurodegenerative conditions, the sTREM2 and other neurobiomarkers will be used by this tool

Restraints

Disease Heterogeneity and Complexity Hinder the Biomarkers Market

The major challenge of the market is disease heterogeneity. A biomarker may be specific to certain types of disease and even within the same type of disease, but it can vary between patients. This limits the clinical applications of biomarkers. Another major challenge is the disease complexity. Biomarkers may not give a complete understanding of the disease due to the full complexity of the disease.

Segmental Insights

How Safety Biomarkers Segment Dominated the Biomarkers Market in 2024?

By type, the safety biomarkers segment led the global biomarkers market in 2023. A safety biomarker indicates the possibility, existence, or degree of toxicity as an unfavorable impact that is tested either before or after exposure to a medicinal product or environmental contaminant. The demand is attributed to their implementation in early clinical trials, which plays a key role in decision-making and facilitates the progression of promising therapeutics from preclinical to clinical development.

The efficacy biomarkers segment is expected to grow at the fastest rate in the market during the forecast period. Efficacy biomarkers are indicators of a drug’s therapeutic effects. They refer to early events in disease progression, toxic changes, or pharmacological events.

What Made Cancer the Dominant Segment in the Biomarkers Market in 2024?

By disease, the cancer segment held a dominant presence in the biomarkers market in 2023. The rising incidences of cancer, cancer complexity, rapid mutations, and demand for personalized medicines augment the segment’s growth. Biomarkers can help in cancer diagnosis, prognosis, or likelihood of disease recurrence independent of treatment.

The neurological diseases segment is anticipated to grow at a significant CAGR in the market during the studied years. The rising geriatric population and increasing incidence and prevalence of neurological disorders like Alzheimer’s disease and Parkinson’s disease drive the segment growth.

Why Did the Drug Discovery & Development Segment Dominate in the Biomarkers Market in 2024?

By application, the drug discovery & development segment registered its dominance over the global biomarkers market in 2023. Since biomarkers give a deeper understanding of the disease pathway, they assist in novel drug discovery and development. The increasing awareness and investments & collaborations promote the segment’s growth.

Regional Insights

Biomarkers Market NA, EU, APAC, LA, MEA Share 2023 (%)

Favorable Gove ment Policies Dominated North America

North America held the largest share of the biomarkers market by 46% in 2023. State-of-the-art research and development, favorable gove ment policies, rising incidences of chronic disorders, and the presence of key players drive the market. The US FDA encourages the integration of biomarkers in medical product development and approval, thereby helping to speed the development of promising new therapeutics. The Canadian Health Measures Survey (CHMS) is an ongoing national human biomonitoring survey led by Statistics Canada in collaboration with Health Canada and the Public Health Agency of Canada. The market is also driven by novel drug discovery research in the region.

The U.S Market Trends

  • The U.S. biomarkers market is experiencing significant growth driven by rising chronic disease incidences and the increasing adoption of personalized medicine. Major players in the biomarkers market include companies like Abbott, Merck & Co., Johnson & Johnson Services, Thermo Fisher Scientific, and Bio-Rad Laboratories are present in the U.S., contributing to major expansion of the market.
  • In March 2024, Labcorp launched and made immediately available its test to identify the presence or absence of phosphorylated tau 217, a crucial blood biomarker designed to aid in the diagnosis of Alzheimer's disease and the subsequent monitoring of patients undergoing treatment with the latest Alzheimer's disease therapies

Rising Incidences of Chronic Disorders Promote Asia-Pacific

Asia-Pacific is projected to host the fastest-growing biomarkers market in the coming years. The rising incidence and prevalence of chronic disorders, growing research and development, and increasing investments & collaborations drive the market. The rising incidence of cancer and immunological and neurological disorders potentiates the demand for biomarkers in disease diagnosis and novel drug discovery. It is estimated that China has more than 15 million people over 60 years old living with dementia. India reported 8.8 million cases of dementia in people 60 years or older. At the same time, Japan accounted for approximately 3.9 million cases in 2023. The huge demand for biomarkers research is due to the increasing geriatric population, rapid urbanization, and changing demographics in the region.

Indian Market Trends

  • The Indian biomarkers market is experiencing significant growth because of the increasing prevalence of chronic diseases, advancements in technology, and a growing demand for personalized medicine. This growth is conspicuous in areas like cancer biomarkers, digital biomarkers, and precision oncology, where biomarkers play a crucial role in early detection, monitoring, and treatment.
  • In April 2024, Bio-Rad Laboratories launched the ddPLEX ESR1 Mutation Detection Kit, an ultrasensitive multiplexed digital PCR assay in the oncology segment, focusing on therapy selection, translational research, and disease monitoring.

Research Institutions and Companies Drive the Market in Europe

Europe is considered to be a significantly growing area in the biomarker market because of the increase in personalized medicine, the presence of major research institutions and companies such as Abbott, Thermo Fisher Scientific, F. Hoffmann-La Roche, and QIAGEN, and the development of innovative technologies like next-generation sequencing, leading to more accurate and less invasive detection methods. This region boasts numerous well-known research institutes and major players in the biomarker industry by encouraging collaborations and innovation.

Growing Disease Burden Drives Middle East and Africa

The Middle East and Africa are expected to grow significantly in the Biomarkers market during the forecast period. The Middle East and Africa are facing a growth in chronic diseases, which in tu is increasing the demand for effective diagnostic and treatment approaches. This increases the demand for biomarkers for their development. Moreover, the growing research and development for the development of personalized medications is also increasing their use. Additionally, the growing gove ment screening programs and campaigns are increasing the awareness among the population, increasing the demand for biomarker-based diagnostics and treatments. Thus, this is promoting the market growth.

Top Companies in the Biomarkers Market

Biomarkers Market Companies

Company Revenue

In January 2025, the fourth quarter (Q4) of 2024, reports were released by Sanofi. There was a rise in the net income, which was reported to be €880m ($916m). €1.06bn was noted to be the company's income before joint ventures, tax, and associates. €1.18bn was achieved as operating income, indicating growth, while €7.84bn was the reported gross profit. €2.25bn were the R&D expenses. Moreover, the net sale was noted to be €10.56bn, which indicated growth.

In October 2024, financial results for the third quarter of 2024 were announced by Regeneron Pharmaceuticals, Inc. The revenues showed a growth of 11% to $3.72 billion. The global net sale of Dupixent® was 23% to $3.82 billion, and for Libtayo® were 24% to $289 million, which reflected overall growth. Whereas, the U.S. net sales for EYLEA HD® and EYLEA® increased by 3%. Moreover, the GAAP diluted EPS and non-GAAP diluted EPS(a) increased by 30% to $11.54 and 8% to $12.46, respectively.

Latest Announcements by Industry Leaders

Rinol Alaj, Senior Director of Digital Health Technologies at Regeneron, commented that many companies are working independently on building digital biomarkers. Hence, the company organized the Digital Biomarkers Summit in May 2024, which could be a terrific opportunity to bring the industry together and create a mechanism of collaboration to help accelerate overall digital biomarker adoption. He also explained that researching digital biomarkers requires change management, innovative thinking/frameworks, and novel ways of problem-solving.

In January 2024, Angel Alberich-Bayarri, Co-Founder and CEO of Quibim, announced its collaboration with Merck KGaA, Darmstadt, Germany, to develop the next generation of precision medicine technology targeting a wide range of cancers. Also commented on the partnership that the partnership is poised to be a game-changer in the field of oncology by utilizing their innovative imaging-based methodologies.

Recent Developments in the Biomarkers Market

  • In October 2024, researchers from the Walter and Eliza Hall Institute investigated the role of extracellular vesicles as biomarkers in cancer treatment. They found that there were abnormally high levels of extracellular vesicles in the blood of mice with leukemia.
  • In October 2024, researchers from Nationwide Children’s identified a potential biomarker to examine the presence of single ventricle heart disease (SVHD) in a fetus based on a mate al blood test. They found elevated levels of cell-free miRNAs in the blood of mothers carrying a baby with an SVHD.

Segments Covered in the Report

By Type

  • Safety Biomarkers
  • Efficacy Biomarkers
  • Validation Biomarkers

By Disease

  • Cancer
  • Neurological Diseases
  • Immunological Diseases
  • Cardiovascular Diseases
  • Others

By Application

  • Drug Discovery & Development
  • Personalized Medicines
  • Diagnostics
  • Others

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
  • Last Updated: 14 August 2025
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2023
  • Base Year: 2024
  • Estimated Years: 2025-2034

Meet the Team

Shivani Zoting is a dedicated research analyst specializing in the healthcare industry. With a strong academic foundation, a B.Sc. in Biotechnology and an MBA in Pharmabiotechnology, she brings a unique blend of scientific understanding and strategy.

Learn more about Shivani Zoting

Aditi Shivarkar, with over 14 years of experience in consumer goods, leads research at Towards Consumer Goods, ensuring precise, actionable insights on trends, consumer preferences, and sustainable packaging for businesses.

Learn more about Aditi Shivarkar

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FAQ's

The seven types of biomarkers include susceptibility/risk, diagnostic, monitoring, prognostic, predictive, pharmacodynamics/response, and safety.

The most common biomarkers are blood pressure, pulse, body temperature, and body mass index (BMI).

Food and Drug Administration, Health Canada, National Institutes of Health, WHO.