InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the “Global Clinical Biomarkers Market – (By Offering (Product (Efficacy Biomarker (Diagnostic Biomarker, Predictive Biomarker, Prognostic Biomarker), Safety Biomarker, Validation Biomarker), Service (Genomic Biomarker Service, Tissue Biomarker Service, Cell Service, Proteomics Service), By Clinical Area (Cancer Biomarkers (Breast Cancer Biomarker, Lung Cancer Biomarker, Colorectal Cancer Biomarker, Prostate Cancer Biomarker, Other), Cardiac Biomarkers, Neurological Biomarkers, Infectious Disease, Immunological Biomarkers, Non-Invasive Prenatal Testing, Other Clinical Areas), By Technology (Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC), Enzyme-Linked Immunosorbent Assay (ELISA), Other Technologies), By End User (Contract Research Organizations (CROs), Research and Academic Laboratories, Biopharmaceutical and Biotech Companies, Diagnostic Centers, Other End Users)), Trends, Industry Competition Analysis, Revenue and Forecast To 2031.”

According to the latest research by InsightAce Analytic, the Global Clinical Biomarkers Market is valued at US$ 25.02 Billion in 2023, and it is expected to reach US$ 47.25 Billion by 2031, with a CAGR of 8.54% during the forecast period of 2024-2031.


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Clinical biomarkers are measurable biological parameters that help understand a disease’s development and make an early diagnosis. Manufacturers and service providers in the worldwide clinical biomarkers market offer proprietary biomarkers testing products and services for research and clinical diagnostics. The research considers tests that rely on diverse technologies for varied underlying uses in cancer and non-cancer disorders to identify biomarkers.

Healthcare providers are pouring resources into clinical biomarkers to meet industry demand, and the rising number of applications in sectors such as medication development and disease risk assessment is driving market expansion—many different kinds of testing and methodologies to aid in creating biomarkers for diverse diseases. However, the absence of payment regulations in both developing and developed nations is one contributor to the global limitation of the market for these biomarkers. This is adding to the growing cancer epidemic and the number of patients needing diagnostic tests.


List of Prominent Players in the Clinical Biomarkers Market:

  • F. Hoffmann-La Roche AG
  • Epigenomics AG
  • Abbott
  • Thermo Fisher Scientific Inc
  • General Electric
  • Eurofins Scientific
  • Johnson & Johnson Services, Inc.
  • Bio-Rad Laboratories, Inc.
  • Siemens Healthineers AG
  • Merck KGaA
  • PerkinElmer Inc.
  • Agilent Technologies, Inc
  • DiaMetra
  • Others


Market Dynamics:


The growing demand for the clinical biomarkers market is fueled by the need for improved products in response to the continuously increasing number of cancer cases. Using inorganic techniques like product releases, several major firms are adjusting their technology to meet the market’s needs for technologically sophisticated goods and services. An increasing number of people are afflicted with various forms of cancer on a global scale. Cancer incidence rates are on the rise, mostly because of more accurate diagnostic tools and screening programs.


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The prime challenges are high cost, a shortage of competent individuals, and a lack of norms and protocol because of lockdowns and isolation in emerging countries, which are predicted to slow the growth of the clinical biomarkers market. The clinical utility and cost-effectiveness of the biomarker testing must be proven for reimbursement decisions. Evidence for this comes from statistics on test accuracy, clinical outcomes, effects on patient treatment, and potential cost savings. Building the required proof can be an arduous and time-consuming task, particularly when it concerns novel biomarkers. The market availability and penetration of biomarker testing could be hindered by limited reimbursement coverage or delays in reimbursement determinations, particularly for novel or innovative biomarkers. 


Regional Trends:

The North American clinical biomarkers market is anticipated to register a large market share in revenue. It is projected to grow at a high CAGR in the near future because of the increased use of cutting-edge technology, such as next-generation sequencing, and a proliferation of studies demonstrating the efficacy of biomarkers in cancer diagnosis, drug development, and efficiency. Besides, Europe had a considerable share in the market because laboratories in the area are increasingly using biomarker-based testing for cancer detection and because they are also adopting more modern technological tools.


Recent Developments:


  • In Feb 2024, Johnson & Johnson released the primary findings from two important studies involving the use of nipocalimab: the VIVACITY research, which is currently underway in adults with gMG, and the DAHLIAS study, which is currently underway in people with Sjögren’s disease (SjD).
  • In Feb 2024, Abbott and Fujirebio teamed up to provide a research-use-only test for neurofilament-light chain (NfL). The neurology biomarker assay will be accessible on Abbott’s Alinity I instrument and will be provided to researchers doing studies showcasing the usefulness of the NfL biomarker, as stated by the firms. The companies plan to release the test by 2025, making it the initial RUO assay for the Alinity I system. The businesses mentioned that NfL is being investigated as a biomarker for many neurological illnesses such as multiple sclerosis, Alzheimer’s disease, and traumatic brain injury. 
  • In June 2023, Roche declared that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Total-Tau CSF tests (tTau) had obtained clearance from the U.S. Food & Drug Administration (FDA) under the 510(k) process. The Elecsys AD CSF Abeta42 and tTau assays quantify beta-amyloid and tau proteins, two indicators of Alzheimer’s pathology, in persons aged 55 and above undergoing evaluation for the illness.


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Segmentation of Clinical Biomarkers Market-

By Offering

  • Product
    • Efficacy Biomarker
      • Diagnostic Biomarker
      • Predictive Biomarker
      • Prognostic Biomarker
    • Safety Biomarker
    • Validation Biomarker
  • Service
    • Genomic Biomarker Service
    • Tissue Biomarker Service
    • Cell Service
    • Proteomics Service

By Clinical Area

  • Cancer Biomarkers
    • Breast Cancer Biomarker
    • Lung Cancer Biomarker
    • Colorectal Cancer Biomarker
    • Prostate Cancer Biomarker
    • Other
  • Cardiac Biomarkers
  • Neurological Biomarkers
  • Infectious Disease
  • Immunological Biomarkers
  • Non-Invasive Prenatal Testing
  • Other Clinical Areas

By Technology

  • Next-Generation Sequencing (NGS)
  • Polymerase Chain Reaction (PCR)
  • Immunohistochemistry (IHC)
  • Enzyme-Linked Immunosorbent Assay (ELISA)
  • Other Technologies

By End User

  • Contract Research Organizations (CROs)
  • Research and Academic Laboratories
  • Biopharmaceutical and Biotech Companies
  • Diagnostic Centers
  • Other End Users

By Region-

North America-

  • The US
  • Canada
  • Mexico


  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe


  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South Africa
  • Rest of the Middle East and Africa


Details insights on this market:


Why should buy this report:

  • To receive a comprehensive analysis of the prospects for global Clinical Biomarkers market
  • To receive industry overview and future trends of global Clinical Biomarkers market
  • To analyze the Clinical Biomarkers market drivers and challenges
  • To get information on the Clinical Biomarkers market size value (US$ Mn) forecast till 2031
  • Major Investments, Mergers & Acquisition in global Clinical Biomarkers market industry


Other Related Reports Published by InsightAce Analytic:

Predictive Biomarkers Market

Blood-Based Biomarker Market

Digital Biomarkers Market

Biomarker Discovery Outsourcing Services Market


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