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    Biomarker Test Market

    ID: MRFR/LS/2428-CR
    200 Pages
    Rahul Gotadki
    April 2025

    Biomarker Tests Market Research Report By Application (Oncology, Cardiovascular, Neurology, Infectious Diseases, Metabolic Diseases), By Type of Test (Genetic Tests, Proteomic Tests, Metabolomic Tests, Microbiomic Tests), By Technology (Polymerase Chain Reaction, Mass Spectrometry, Immunoassays, Next-Generation Sequencing), By End Use (Hospitals, Clinical Laboratories, Research Institutions, Pharmaceutical Companies) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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    Biomarker Tests Market Research Report - Global Forecast till 2035 Infographic
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    Biomarker Test Market Summary

    The Global Biomarker Tests Market is projected to grow from 31.3 USD Billion in 2024 to 50.1 USD Billion by 2035.

    Key Market Trends & Highlights

    Biomarker Tests Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate of 4.36 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 50.1 USD Billion, indicating robust growth.
    • In 2024, the market is valued at 31.3 USD Billion, reflecting its current significance in the healthcare sector.
    • Growing adoption of biomarker tests due to increasing demand for personalized medicine is a major market driver.

    Market Size & Forecast

    2024 Market Size 31.3 (USD Billion)
    2035 Market Size 50.1 (USD Billion)
    CAGR (2025-2035) 4.36%

    Major Players

    Abbott Laboratories, Thermo Fisher Scientific, QIAGEN, Merck KGaA, Illumina, Genomic Health, Guardant Health, Bristol-Myers Squibb, Roche Diagnostics, Agilent Technologies, BioRad Laboratories, HoffmannLa Roche, PerkinElmer, Siemens Healthineers

    Biomarker Test Market Trends

    The rising incidence of chronic diseases, including diabetes, cancer, and cardiovascular disorders, is one of the major factors propelling the global biomarker test market. This increases the need for cutting-edge diagnostic tools that enable early identification and individualized care.

    In addition, technological developments, especially in the fields of proteomics and genomics, make it possible to create biomarker tests that are more accurate and effective. As healthcare systems seek to customize therapies to specific patient profiles based on biomarker results, the increased emphasis on personalized medicine is another important market driver.The emergence of liquid biopsy methods, which provide a less invasive option for identifying biomarkers and so pique the interest of both patients and medical professionals, presents opportunities to be investigated.

    Furthermore, the use of AI in data analysis opens up new possibilities for improving the precision and speed of biomarker testing, which could result in better patient satisfaction and health outcomes. Recent trends indicate a move toward regulatory approval of additional biomarker tests and a focus on cooperation between academic institutions and biotech companies.

    This spirit of cooperation improves the study and creation of new biomarkers, which eventually results in a wider variety of tests on the market. To demonstrate their dedication to enhancing healthcare outcomes globally, governments from all over the world are also backing programs that advance biomarker research and precision medicine.The global biomarker tests market is well-positioned for future expansion and innovation thanks to this confluence of factors, including trends, opportunities, and drivers.

    The increasing integration of biomarker tests into clinical practice appears to enhance diagnostic accuracy and personalize treatment strategies, thereby potentially transforming patient care across various medical disciplines.

    U.S. National Institutes of Health (NIH)

    Biomarker Test Market Drivers

    Market Growth Projections

    Regulatory Support and Guidelines

    Regulatory bodies worldwide are increasingly establishing frameworks and guidelines that support the development and commercialization of biomarker tests. This regulatory support is crucial for ensuring the safety and efficacy of these tests, which in turn fosters confidence among healthcare providers and patients. The Global Biomarker Tests Market Industry benefits from initiatives aimed at expediting the approval processes for innovative diagnostic tools. As these regulatory pathways become more streamlined, the market is likely to witness accelerated growth, contributing to the overall enhancement of patient care and treatment outcomes.

    Advancements in Genomic Technologies

    Technological advancements in genomics and proteomics are significantly influencing the Global Biomarker Tests Market Industry. Innovations such as next-generation sequencing and high-throughput screening have enhanced the ability to identify and validate biomarkers with greater accuracy and efficiency. These advancements enable researchers and clinicians to develop more precise diagnostic tools, which are crucial for personalized medicine. As a result, the market is expected to grow, with projections indicating a value of 50.1 USD Billion by 2035. This growth underscores the importance of integrating cutting-edge technologies into biomarker testing processes.

    Rising Prevalence of Chronic Diseases

    The increasing incidence of chronic diseases such as cancer, diabetes, and cardiovascular disorders is a primary driver of the Global Biomarker Tests Market Industry. As healthcare systems globally strive to enhance patient outcomes, the demand for biomarker tests that facilitate early diagnosis and personalized treatment options is on the rise. For instance, cancer biomarkers are pivotal in identifying specific tumor types, which can lead to tailored therapies. The market is projected to reach 31.3 USD Billion in 2024, reflecting the urgent need for innovative diagnostic solutions to combat these prevalent health issues.

    Growing Demand for Personalized Medicine

    The shift towards personalized medicine is a significant driver of the Global Biomarker Tests Market Industry. Patients and healthcare providers are increasingly seeking tailored treatment options that consider individual genetic and molecular profiles. Biomarker tests play a vital role in this paradigm shift by enabling the identification of specific patient subgroups that may respond better to particular therapies. This trend is reflected in the market's projected growth, with an expected value of 31.3 USD Billion in 2024. The emphasis on personalized approaches is likely to continue shaping the future of healthcare.

    Increased Investment in Research and Development

    The Global Biomarker Tests Market Industry is experiencing a surge in investment directed towards research and development. Governments and private entities are recognizing the potential of biomarker tests in transforming healthcare delivery. This influx of funding is facilitating the exploration of novel biomarkers and their applications in various diseases. For example, initiatives aimed at discovering new cancer biomarkers are gaining momentum, which could lead to breakthroughs in treatment strategies. The anticipated compound annual growth rate of 4.36% from 2025 to 2035 further highlights the growing commitment to advancing biomarker research.

    Market Segment Insights

    Biomarker Tests Market Application Insights

    The Global Biomarker Tests Market in the Application segment showcased a diverse landscape. This segment reflected the increasing reliance on biomarker tests in various disciplines of medicine, proving essential for early disease detection and tailored therapies.The Oncology application held a leading position in this market, with a valuation of 9.9 USD Billion in 2024, which rises to 15.77 USD Billion by 2035, indicating its dominance due to the continuous advancements in cancer diagnostics and therapeutics.

    The growth was supported by ongoing research in oncology that emphasizes precision medicine, allowing for individualized treatment regimens that led to improved patient outcomes.The Cardiovascular segment was also significant, valued at 7.08 USD Billion in 2024, expanding to 10.67 USD Billion in 2035. This area benefited from growing awareness of cardiovascular diseases and the importance of early detection, reinforcing the necessity for biomarker testing in risk assessment and management strategies.

    Neurology, with a market value of 6.0 USD Billion in 2024 rising to 9.45 USD Billion in 2035, reflected advancements in understanding neurological disorders and highlights the need for biomarkers that enhanced diagnostics and therapeutic approaches, leading to better management of conditions such as Alzheimer's and multiple sclerosis.The Infectious Diseases application segment, valued at 5.5 USD Billion in 2024, is expected to grow to 8.5 USD Billion by 2035, largely driven by the global demand for rapid and accurate testing, especially highlighted by the COVID-19 pandemic.

    This area utilized biomarkers for the identification of pathogens, disease progression, and treatment efficacy, which is critical for public health responses.

    Lastly, the Metabolic Diseases segment was sized at 2.84 USD Billion in 2024, forecasted to reach 5.11 USD Billion by 2035, driven by the increasing prevalence of conditions like diabetes and obesity, and the push for diagnostic tools that enable early intervention.

    Biomarker Tests Market Type of Test Insights

    Within this market, the Type of Test segment plays a vital role, contributing to various applications in disease diagnosis and treatment. Genetic Tests are increasingly important as they enable personalized healthcare solutions, identifying genetic predispositions to specific conditions and guiding therapeutic decisions.

    Proteomic Tests, on the other hand, provide insights into protein expressions, facilitating the understanding of disease mechanisms and biomarker discovery. Metabolomic Tests are significant for their ability to analyze metabolic profiles, which can reveal changes indicative of disease states.

    Additionally, Microbiomic Tests offer a unique perspective by analyzing microbial communities in the body, helping to understand their role in health and disease. The growing demand for precision medicine, alongside advancements in technology, drives the expansion of these testing methods.

    Market trends demonstrate a heightened focus on early diagnosis and preventive healthcare, while challenges include the complexity of test interpretation and the need for standardized protocols. Overall, this segment showcases a diverse range of methodologies that cater to the evolving needs of the Global Biomarker Tests Market, tapping into the potential for improved patient outcomes.

    Biomarker Tests Market Technology Insights

    The market is characterized by various innovative technologies, including Polymerase Chain Reaction, Mass Spectrometry, Immunoassays, and Next-Generation Sequencing, all contributing to diverse applications in diagnostics and personalized medicine.

    Polymerase Chain Reaction is essential for amplifying DNA sequences, while Mass Spectrometry provides precise molecular characterization, thus enhancing the accuracy of biomarker detection.Immunoassays are widely used due to their specificity in identifying biomarkers and facilitating early disease detection, whereas Next-Generation Sequencing offers comprehensive genomic analysis, paving the way for targeted therapies.

    The demand for these technologies is driven by a growing focus on precision medicine, increased funding for Research and Development, and advancements in laboratory capabilities globally. Additionally, regulatory support and collaboration among healthcare entities are likely to boost the growth of the Global Biomarker Tests Market.This collective wave of technological innovation is poised to significantly transform the landscape of healthcare, supporting not only diagnostics but also the development of tailored treatment strategies.

    Biomarker Tests Market End-Use Insights

    The growth is driven by the increasing demand for early diagnostic tests and personalized medicine. The end-user segmentation, comprising Hospitals, Clinical Laboratories, Research Institutions, and Pharmaceutical Companies, plays a crucial role in this market.Hospitals are key users of biomarker tests, utilizing them for improved patient management and treatment strategies, while Clinical Laboratories significantly contribute to the analysis and verification of test results.

    Research Institutions are important for advancing biomarker research and facilitating innovative developments that translate into clinical applications. Additionally, Pharmaceutical Companies leverage biomarker tests for drug development and patient stratification, aiming to enhance therapeutic efficacy.As biomarker tests continue to gain importance in disease prevention and management, the dynamics within this segment reflect a robust and evolving landscape in the Global Biomarker Tests Market, influencing market growth and opportunities ahead.

    Such developments are also supported by governmental health initiatives and investment in healthcare infrastructure, further augmenting the relevance of these end-use sectors in driving advancements within the industry.

    Get more detailed insights about Biomarker Tests Market Research Report - Global Forecast till 2035

    Regional Insights

    North America was the leading region, holding a considerable market value of 12.5 USD Billion in 2024, driven by advanced healthcare infrastructure and robust Research and Development initiatives. Europe followed closely, valued at 9.0 USD Billion in the same year, benefiting from strong regulatory frameworks that promote innovation in biomarker technologies.

    The Asia Pacific (APAC) region, valued at 6.5 USD Billion, emerged as a vital market due to increasing investments in healthcare and growing patient awareness, providing substantial opportunities for expansion. South America, with a market valuation of 2.0 USD Billion, presented a growing landscape as governments focus on improving healthcare accessibility and biomarker applications.

    The Middle East and Africa (MEA) represented a smaller but significant market at 1.32 USD Billion, highlighting the region's evolving healthcare needs and increasing recognition of precision medicine. Each region contributes uniquely to the Global Biomarker Tests Market revenue, indicating a diverse landscape driven by distinct growth factors and market demand.

    Biomarker Tests Market Regional Insights

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Key Players and Competitive Insights

    The Global Biomarker Tests Market has gained substantial traction in recent years, driven by advancements in diagnostic technologies and an increasing focus on personalized medicine. This competitive landscape is characterized by the presence of numerous key players who are continuously innovating and evolving their product offerings to cater to the growing demand for biomarker tests.

    The market is shaped by various strategic initiatives including partnerships, collaborations, mergers, and acquisitions, which help companies expand their market reach and enhance their technological capabilities.Additionally, regulatory approvals and the introduction of novel biomarkers are influencing market dynamics, providing companies with opportunities to strengthen their foothold in this rapidly expanding sector.

    Abbott Laboratories stands as a formidable player in the Global Biomarker Tests Market, leveraging its extensive portfolio of diagnostic products. The company is recognized for its commitment to developing innovative solutions that facilitate disease detection and management through biomarker identification.Abbott Laboratories has successfully established a significant presence in the market, underscored by its strong research and development capabilities which enable the introduction of advanced testing technologies.

    The company’s strengths lie not only in its comprehensive range of diagnostic tests but also in its proven track record of collaborations with healthcare professionals and organizations that pave the way for novel biomarker development. Abbott’s focus on integrating cutting-edge technology into its testing systems provides a competitive advantage, enhancing its position within the biomarker testing landscape.

    Thermo Fisher Scientific is another key contender in the Global Biomarker Tests Market, offering a wide array of products and services that cater to diverse diagnostic needs. The company specializes in instruments, reagents, and software used in the development and implementation of biomarker assays.

    Thermo Fisher's robust market presence is bolstered by its strategic partnerships and acquisitions, which have expanded its capabilities and product lines within the biomarker testing domain. The company's strengths lie in its commitment to innovation and its comprehensive understanding of the regulatory landscape, ensuring compliance while advancing its testing technologies.

    Key products from Thermo Fisher, including advanced genomic and proteomic assays, position the company well to meet the needs of researchers and clinicians globally. Through continued investment in research and development, Thermo Fisher Scientific aims to enhance its offerings and maintain its leadership position within the biomarker testing market on a global scale.

    Key Companies in the Biomarker Test Market market include

    Industry Developments

    The Global Biomarker Tests Market has seen significant developments, particularly with companies such as Abbott Laboratories, Thermo Fisher Scientific, and Roche Diagnostics leading the charge in innovative advancements.In October 2023, Guardant Health announced a strategic partnership with Bristol-Myers Squibb aimed at enhancing precision oncology through liquid biopsy technology. In September 2023, Merck KGaA launched a new biomarker test tailored for early detection of certain types of cancer, enhancing diagnostic capabilities.

    Additionally, in August 2023, Illumina acquired GRAIL, Inc., a move expected to strengthen its foothold in multi-cancer early detection tests. The market valuation of major companies has shown notable growth, driven by the increased focus on personalized medicine, leading to improved patient outcomes and healthcare efficiencies.In recent years, the sector has witnessed rapid changes, including advances in genetic testing technologies and the rising demand for companion diagnostics, particularly from 2021 to 2023. Global initiatives to regulate and support diagnostic innovation have also benefited companies such as QIAGEN and Agilent Technologies, facilitating broader access to biomarker testing in healthcare systems worldwide.

    Future Outlook

    Biomarker Test Market Future Outlook

    The Biomarker Tests Market is poised for growth at a 4.36% CAGR from 2024 to 2035, driven by advancements in precision medicine, increasing prevalence of chronic diseases, and technological innovations.

    New opportunities lie in:

    • Develop personalized biomarker panels for targeted therapies in oncology.
    • Invest in AI-driven analytics for enhanced biomarker discovery and validation.
    • Expand partnerships with diagnostic companies to integrate biomarker tests into routine clinical practice.

    By 2035, the Biomarker Tests Market is expected to achieve substantial growth, reflecting its critical role in healthcare advancements.

    Market Segmentation

    Biomarker Tests Market End-Use Outlook

    • Hospitals
    • Clinical Laboratories
    • Research Institutions
    • Pharmaceutical Companies

    Biomarker Tests Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa
    • Q2 2024: Bio-Techne Launches ExoDx Prostate Test at American Urological Association 2024 Annual Meeting Bio-Techne announced the commercial launch of its ExoDx Prostate Test, a non-invasive urine-based biomarker test for prostate cancer risk assessment, at the AUA 2024 meeting. The test aims to improve early detection and reduce unnecessary biopsies.
    • Q2 2024: Quanterix Announces FDA Breakthrough Device Designation for Simoa p-Tau 217 Plasma Biomarker Test Quanterix received FDA Breakthrough Device Designation for its Simoa p-Tau 217 plasma biomarker test, designed to aid in the diagnosis of Alzheimer’s disease, marking a significant regulatory milestone for blood-based neurodegenerative diagnostics.
    • Q2 2024: Roche Receives CE Mark for Elecsys Amyloid Plasma Panel for Early Alzheimer’s Detection Roche announced it has received CE Mark for its Elecsys Amyloid Plasma Panel, a blood-based biomarker test to aid in the early detection of Alzheimer’s disease, enabling broader access to early diagnostic tools in Europe.
    • Q3 2024: Freenome Raises $254 Million in Series H Funding to Advance Multiomics Blood Test for Early Cancer Detection Freenome secured $254 million in Series H funding to accelerate the development and commercialization of its multiomics blood-based biomarker test for early cancer detection, with participation from new and existing investors.
    • Q3 2024: Guardant Health Launches Shield™ Multi-Cancer Early Detection Blood Test in the U.S. Guardant Health announced the commercial launch of Shield™, a blood-based multi-cancer early detection test, expanding its portfolio of liquid biopsy biomarker tests for early cancer screening in the U.S. market.
    • Q3 2024: Exact Sciences Receives FDA Approval for Cologuard 2.0, Next-Generation Stool DNA Biomarker Test Exact Sciences received FDA approval for Cologuard 2.0, an updated version of its non-invasive stool DNA biomarker test for colorectal cancer screening, featuring improved sensitivity and specificity.
    • Q4 2024: Abbott Opens New Biomarker R&D Facility in Massachusetts to Accelerate Diagnostic Innovation Abbott inaugurated a new research and development facility focused on biomarker discovery and diagnostic test development, aiming to expand its pipeline of blood-based and molecular biomarker tests.
    • Q4 2024: Siemens Healthineers Acquires FastBio, Expanding Point-of-Care Biomarker Testing Portfolio Siemens Healthineers completed the acquisition of FastBio, a company specializing in rapid point-of-care biomarker tests, to strengthen its diagnostics business and accelerate the rollout of new biomarker-based assays.
    • Q1 2025: Grail Partners with NHS England to Pilot Galleri Multi-Cancer Blood Test in National Screening Program Grail announced a partnership with NHS England to pilot its Galleri multi-cancer early detection blood test in a large-scale national screening program, aiming to evaluate the test’s impact on early cancer diagnosis.
    • Q1 2025: Myriad Genetics Appoints New CEO to Drive Growth in Biomarker Testing Business Myriad Genetics announced the appointment of a new Chief Executive Officer, signaling a strategic focus on expanding its portfolio of biomarker-based diagnostic tests and accelerating commercial growth.
    • Q2 2025: Biodesix Receives FDA Clearance for Nodify Lung Nodule Risk Assessment Biomarker Test Biodesix received FDA clearance for its Nodify biomarker test, designed to assess the risk of malignancy in lung nodules, supporting clinicians in early lung cancer diagnosis and management.
    • Q2 2025: Thermo Fisher Scientific Launches Oncomine Precision Assay GX for Comprehensive Genomic and Biomarker Profiling Thermo Fisher Scientific launched the Oncomine Precision Assay GX, a next-generation sequencing-based test for comprehensive genomic and biomarker profiling in oncology, enabling more precise and personalized cancer treatment decisions.

    Biomarker Tests Market Technology Outlook

    • Polymerase Chain Reaction
    • Mass Spectrometry
    • Immunoassays
    • Next-Generation Sequencing

    Biomarker Tests Market Application Outlook

    • Oncology
    • Cardiovascular
    • Neurology
    • Infectious Diseases
    • Metabolic Diseases

    Biomarker Tests Market Type of Test Outlook

    • Genetic Tests
    • Proteomic Tests
    • Metabolomic Tests
    • Microbiome Tests

    Report Scope

    Report Attribute/Metric Details
    Market Size 2023 30.01(USD Billion)
    Market Size 2024 31.32(USD Billion)
    Market Size 2035 50.1(USD Billion)
    Compound Annual Growth Rate (CAGR) 4.36% (2025 - 2035)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2019 - 2024
    Market Forecast Units USD Billion
    Key Companies Profiled Abbott Laboratories, Thermo Fisher Scientific, QIAGEN, Merck KGaA, Illumina, Genomic Health, Guardant Health, Bristol-Myers Squibb, Roche Diagnostics, Agilent Technologies, Biomarker Discovery, BioRad Laboratories, F. HoffmannLa Roche, PerkinElmer, Siemens Healthineers
    Segments Covered Application, Type of Test, Technology, End Use, Regional
    Key Market Opportunities Personalized medicine advancements, Rising prevalence of chronic diseases, Increased funding for biomarker research, Growth in companion diagnostics, Expansion of non-invasive testing methods
    Key Market Dynamics Technological advancements, Increasing prevalence of diseases, Rising healthcare expenditure, Growing personalized medicine demand, Government initiatives and funding
    Countries Covered North America, Europe, APAC, South America, MEA

    Market Highlights

    Author
    Rahul Gotadki
    Assistant Manager

    He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

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    FAQs

    What was the market size of the Global Biomarker Tests Market in 2024?

    The Global Biomarker Tests Market was valued at 31.32 USD Billion in 2024.

    What is the projected market size for the Global Biomarker Tests Market by 2035?

    By 2035, the Global Biomarker Tests Market is anticipated to reach approximately 50.1 USD Billion.

    What is the expected compound annual growth rate (CAGR) for the Global Biomarker Tests Market from 2025 to 2035?

    The Global Biomarker Tests Market is expected to grow at a CAGR of 4.36% from 2025 to 2035.

    Which region held the largest market share in the Global Biomarker Tests Market in 2024?

    North America held the largest market share, valued at 12.5 USD Billion in 2024.

    What are the expected market values for the Oncology application within the Global Biomarker Tests Market in 2024 and 2035?

    The Oncology application was valued at 9.9 USD Billion in 2024 and is expected to reach 15.77 USD Billion by 2035.

    What market size is expected for the Cardiovascular application in the Global Biomarker Tests Market by 2035?

    The Cardiovascular application is projected to reach a market size of 10.67 USD Billion by 2035.

    Who are the key players in the Global Biomarker Tests Market?

    Key players in the Global Biomarker Tests Market include Abbott Laboratories, Thermo Fisher Scientific, QIAGEN, and Roche Diagnostics.

    What was the market value for the Asia-Pacific (APAC) region in 2024 within the Global Biomarker Tests Market?

    The Asia-Pacific region held a market value of 6.5 USD Billion in 2024.

    What is the anticipated growth for the Infectious Diseases application segment in the Global Biomarker Tests Market by 2035?

    The Infectious Diseases application segment is expected to grow to a market value of 8.5 USD Billion by 2035.

    What challenges are facing the Global Biomarker Tests Market?

    The Global Biomarker Tests Market faces challenges such as regulatory hurdles and the need for technological advancements.

    Biomarker Tests Market Research Report - Global Forecast till 2035 Infographic
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