Clinical Biomarkers Market Size, Share & Trends Analysis Report 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, By Technology, By End User, By Region, And By Segment Forecasts, 2024-2031

Report Id: 2324 Pages: 179 Last Updated: 06 February 2025 Format: PDF / PPT / Excel / Power BI
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Clinical Biomarkers Market Size is valued at USD 25.02 Bn in 2023 and is predicted to reach USD 47.25 Bn by the year 2031 at a 8.54% CAGR during the forecast period for 2024-2031.

Clinical Biomarkers Market

Clinical biomarkers are molecular biomarkers that offer novel avenues for studying diseases and identifying potential new therapeutic targets. Clinical biomarkers are finding more and more applications in drug development, disease risk assessment, and other areas, and healthcare companies are investing heavily to keep up with industry demand, fueling market growth. Many different assays and methods are utilized in drug discovery to help develop biomarkers for various diseases. Furthermore, infectious diseases can aid in disease prognostic evaluations, treatment decision-making, and pharmaceutical efficacy tracking. 

However, the market growth is hampered by the high-cost criteria for the safety and health of the clinical biomarkers market and the product's inability to prevent fog in environments with dramatic temperature fluctuations or high clinical biomarkers market because the lack of investment and infrastructure is the main thing stopping market companies from investing, one of the main reasons for the high capital demand is the expensive instruments. Thus, the desired level of capital investment differs according to the capabilities and size of the newly constructed laboratory. Despite the enormous untapped potential in the global clinical biomarkers market, the prohibitive entry cost limits the industry's ability to reach new audiences and accelerate its progress. 

Competitive Landscape

Some Major Key Players In The Clinical Biomarkers Market:

  • Abbott Laboratories
  • Agilent Technologies, Inc.
  • ALCEN
  • Arsenal Capital Partners
  • Azenta Life Sciences
  • Becton, Dickinson and Company
  • Bio-Rad Laboratories, Inc.
  • bioMérieux S.A.
  • BGI
  • Broad Institute
  • Charles River Laboratories
  • Caris Life Sciences
  • CENTOGENE N.V.
  • Discovery Life Sciences (DLS)
  • Enzo Biochem Inc.
  • Eurofins Scientific
  • Hoffmann-La Roche Ltd
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • NeoGenomics Laboratories
  • Novogene Co., Ltd.
  • Personalis Inc.
  • QIAGEN N.V.
  • Quest Diagnostics Incorporated
  • Q2 Solutions
  • Thermo Fisher Scientific Inc.

Market Segmentation:

The clinical biomarkers market is segmented based on offering, clinical area, technology, and end user. According to offerings, the market is segmented into products and services. Product segment comprises Efficacy Biomarker (Diagnostic Biomarker, Predictive Biomarker, Prognostic Biomarker), Safety Biomarker, and Validation Biomarker. The Service segment includes Genomic Biomarker Service, Tissue Biomarker Service, Cell Service, Proteomics Service. By clinical area, the market is segmented into cancer biomarkers, cardiac biomarkers, neurological biomarkers, infectious disease, immunological biomarkers, non-invasive prenatal testing, and other clinical areas. By technology, the market is segmented into next-generation sequencing (NGS), polymerase chain reaction (PCR), immunohistochemistry (IHC), enzyme-linked immunosorbent assay (ELISA), and other technologies. By end user, the market is segmented into contract research organizations (CROs), research and academic laboratories, biopharmaceutical and biotech companies, diagnostic centers, and other end users.

Based On The Offering, The Service Segment Is Accounted As A Major Contributor To The Clinical Biomarkers Market 

The service clinical biomarkers market is expected to lead with a major global market share. biomarker services help with trial design, execution, and analysis. Diseases can be diagnosed using biomarker testing, which clinical laboratories and diagnostic service providers offer. These services aid in the monitoring and early identification of diseases by facilitating the accurate and dependable detection of biomarkers.

Next-Generation Sequencing (NGS) Segment To Witness Growth At A Rapid Rate

The Next-generation sequencing (NGS) industry makes up the bulk of acrylic acid ester usage because of the advancements in sequencing technology. Nucleotide sequencing (NGS) is a novel and complementary method that enables oncologists to study many cancer genes simultaneously. A patient's tumor tissue that has been surgically removed or biopsied can be utilized for next-generation sequencing, especially in countries like the US, Germany, the UK, China, and India.

In The Region, The North American Clinical Biomarkers Market Holds A Significant Revenue Share

The North American clinical biomarkers market is expected to record the maximum market revenue share in the near future. It can be attributed to the increasing disease burden, new technologies, more informed consumers, encouraging government programs, and better healthcare facilities. In addition, Asia Pacific is projected to grow rapidly in the global clinical biomarkers market due to the increasing need for top-notch healthcare, the growth of regional research initiatives, and the worldwide burden of cancer.

Recent Developments:

  • 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.

Clinical Biomarkers Market Report Scope

Report Attribute Specifications
Market Size Value In 2023 USD 25.02 Bn
Revenue Forecast In 2031 USD 47.25 Bn
Growth Rate CAGR CAGR of 8.54% from 2024 to 2031
Quantitative Units Representation of revenue in US$ Bn and CAGR from 2024 to 2031
Historic Year 2019 to 2023
Forecast Year 2024-2031
Report Coverage The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends
Segments Covered By Offering, Clinical Area, Technology, End User
Regional Scope North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Country Scope U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; Southeast Asia; South Korea
Competitive Landscape F. Hoffmann-La Roche AG, Epigenomics AG, Abbott, Thermo Fisher Scientific Inc, General Electric, Eurofins Scientific, Johnson & Johnson Services, Inc., QIAGEN, Bio-Rad Laboratories, Inc., Siemens Healthineers AG, Merck KGaA, PerkinElmer Inc., Agilent Technologies, Inc., DiaMetra, Others
Customization Scope Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape.
Pricing And Available Payment Methods Explore pricing alternatives that are customized to your particular study requirements.

Segmentation of Clinical Biomarkers Market-

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

Clinical Biomarkers Market Seg

Clinical Biomarkers Market 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

Clinical Biomarkers Market By Technology

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

Clinical Biomarkers Market By End User

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

Clinical Biomarkers Market By Region-

North America-

  • The US
  • Canada
  • Mexico

Europe-

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

Asia-Pacific-

  • China
  • Japan
  • India
  • South Korea
  • South East 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

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Chapter 1. Methodology and Scope

1.1. Research Methodology

1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Clinical Biomarker Market Snapshot

Chapter 4. Global Clinical Biomarkers Market Variables, Trends & Scope

4.1. Market Segmentation & Scope

4.2. Drivers

4.3. Challenges

4.4. Trends

4.5. Investment and Funding Analysis

4.6. Industry Analysis – Porter’s Five Forces Analysis

4.7. Competitive Landscape & Market Share Analysis

4.8. Impact of Covid-19 Analysis

Chapter 5. Market Segmentation 1: by Offering Estimates & Trend Analysis

5.1. by Offering & Market Share, 2019 & 2031

5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Offering:

5.2.1. Product

5.2.1.1. Efficacy Biomarker

5.2.1.1.1. Diagnostic Biomarker

5.2.1.1.2. Predictive Biomarker

5.2.1.1.3. Prognostic Biomarker

5.2.1.2. Safety Biomarker

5.2.1.3. Validation Biomarker

5.2.2. Service

5.2.2.1. Genomic Biomarker Service

5.2.2.2. Tissue Biomarker Service

5.2.2.3. Cell Service

5.2.2.4. Proteomics Service

Chapter 6. Market Segmentation 2: by Clinical Area Estimates & Trend Analysis

6.1. by Clinical Area & Market Share, 2019 & 2031

6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Clinical Area:

6.2.1. Cancer Biomarkers

6.2.1.1. Breast Cancer Biomarker

6.2.1.2. Lung Cancer Biomarker

6.2.1.3. Colorectal Cancer Biomarker

6.2.1.4. Prostate Cancer Biomarker

6.2.1.5. Other

6.2.2. Cardiac Biomarkers

6.2.3. Neurological Biomarkers

6.2.4. Infectious Disease

6.2.5. Immunological Biomarkers

6.2.6. Non-Invasive Prenatal Testing

6.2.7. Other Clinical Areas

Chapter 7. Market Segmentation 3: by Technology Estimates & Trend Analysis

7.1. by Technology & Market Share, 2019 & 2031

7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Technology:

7.2.1. Next-Generation Sequencing (NGS)

7.2.2. Polymerase Chain Reaction (PCR)

7.2.3. Immunohistochemistry (IHC)

7.2.4. Enzyme-Linked Immunosorbent Assay (ELISA)

7.2.5. Other Technologies

Chapter 8. Market Segmentation 4: by End User Estimates & Trend Analysis

8.1. by End User & Market Share, 2019 & 2031

8.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by End User:

8.2.1. Contract Research Organizations (CROs)

8.2.2. Research and Academic Laboratories

8.2.3. Biopharmaceutical and Biotech Companies

8.2.4. Diagnostic Centers

8.2.5. Other End Users

Chapter 9. Clinical Biomarkers Market Segmentation 5: Regional Estimates & Trend Analysis

9.1. North America

9.1.1. North America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2019-2031

9.1.2. North America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2019-2031

9.1.3. North America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2019-2031

9.1.4. North America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by End User, 2019-2031

9.1.5. North America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by country, 2019-2031

9.2. Europe

9.2.1. Europe Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2019-2031

9.2.2. Europe Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2019-2031

9.2.3. Europe Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2019-2031

9.2.4. Europe Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by End User, 2019-2031

9.2.5. Europe Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by country, 2019-2031

9.3. Asia Pacific

9.3.1. Asia Pacific Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2019-2031

9.3.2. Asia Pacific Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2019-2031

9.3.3. Asia-Pacific Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2019-2031

9.3.4. Asia Pacific Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by End User, 2019-2031

9.3.5. Asia Pacific Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by country, 2019-2031

9.4. Latin America

9.4.1. Latin America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2019-2031

9.4.2. Latin America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2019-2031

9.4.3. Latin America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2019-2031

9.4.4. Latin America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by End User, 2019-2031

9.4.5. Latin America Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by country, 2019-2031

9.5. Middle East & Africa

9.5.1. Middle East & Africa Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2019-2031

9.5.2. Middle East & Africa Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2019-2031

9.5.3. Middle East & Africa Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2019-2031

9.5.4. Middle East & Africa Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by End User, 2019-2031

9.5.5. Middle East & Africa Clinical Biomarkers Market Revenue (US$ Million) Estimates and Forecasts by country, 2019-2031

Chapter 10. Competitive Landscape

10.1. Major Mergers and Acquisitions/Strategic Alliances

10.2. Company Profiles

10.2.1. Abbott Laboratories

10.2.2. Agilent Technologies, Inc.

10.2.3. ALCEN

10.2.4. Arsenal Capital Partners

10.2.5. Azenta Life Sciences

10.2.6. Becton, Dickinson and Company

10.2.7. Bio-Rad Laboratories, Inc.

10.2.8. Bio Mérieux S.A.

10.2.9. BGI

10.2.10. Broad Institute

10.2.11. Charles River Laboratories

10.2.12. Caris Life Sciences

10.2.13. CENTOGENE N.V.

10.2.14. Discovery Life Sciences (DLS)

10.2.15. Enzo Biochem Inc.

10.2.16. Eurofins Scientific

10.2.17. F. Hoffmann-La Roche Ltd

10.2.18. Illumina, Inc.

10.2.19. Myriad Genetics, Inc.

10.2.20. NeoGenomics Laboratories

10.2.21. Novogene Co., Ltd.

10.2.22. Personalis Inc.

10.2.23. QIAGEN N.V.

10.2.24. Quest Diagnostics Incorporated

10.2.25. Q2 Solutions

10.2.26. Thermo Fisher Scientific Inc.

10.2.27. Other Prominent Players

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Frequently Asked Questions

Clinical Biomarkers Market Size is valued at USD 25.02 Bn in 2023 and is predicted to reach USD 47.25 Bn by the year 2031

Clinical Biomarkers Market is expected to grow at a 8.54% CAGR during the forecast period for 2024-2031.

QIAGEN, Bio-Rad Laboratories, Inc., Siemens Healthineers AG, Merck KGaA, PerkinElmer Inc., Agilent Technologies, Inc., DiaMetra, Others
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