A quick peek into the report
Table of Contents
1.1 Introduction
1.2 Clinical Biomarkers Approaches in Precision Medicine
1.3 Market Size Potential for Clinical Biomarkers, 2025-2035
1.4 Market Trends
1.5 Overview
1.6 Regulatory Framework
1.6.1 Regulatory Framework in the U.S.
1.6.2 FDA Regulations
1.6.3 Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff
1.6.4 Regulatory Framework in the U.S. for Medical Devices
1.6.5 Legal Requirements and Framework in Europe
1.6.5.1 U.K.
1.6.5.2 Germany
1.6.6 Legal Requirements and Framework in Asia-Pacific
1.6.6.1 China
1.6.6.2 Japan
1.7 Patent Analysis
1.8 Competitive Index (Unmet Needs and Innovations)
1.9 Pain Points of Manufacturers
1.10 Supply Cain Analysis
1.11 Pricing Analysis
2.1 Overview
2.1.1 Impact Analysis
2.2 Market Drivers
2.3 Market Challenges
2.4 Market Opportunities
3.1 Overview
3.2 Product
3.2.1 Efficacy Biomarker
3.2.1.1 Diagnostic Biomarker
3.2.1.2 Predictive Biomarker
3.2.1.3 Prognostic Biomarker
3.2.2 Safety Biomarker
3.2.3 Validation Biomarker
3.3 Service
3.3.1 Genomic Biomarker Service
3.3.2 Tissue Biomarker Service
3.3.3 Cell Service
3.3.4 Proteomics Service
4.1 Overview
4.2 Next-Generation Sequencing (NGS)
4.3 Polymerase Chain Reaction (PCR)
4.4 Immunohistochemistry (IHC)
4.5 Enzyme-Linked Immunosorbent Assay (ELISA)
4.6 Other Technologies
5.1 Overview
5.2 Cancer Biomarker
5.2.1 Breast Cancer Biomarker
5.2.2 Lung Cancer Biomarker
5.2.3 Colorectal Cancer Biomarker
5.2.4 Prostate Cancer Biomarker
5.2.5 Other
5.3 Cardiac Biomarker
5.4 Neurological Biomarker
5.5 Infectious Disease Biomarker
5.6 Non-Invasive Prenatal Testing
5.7 Immunological Biomarker
5.8 Other Clinical Areas
6.1 Overview
6.2 Contract Research Organizations (CROs)
6.3 Research and Academic Laboratories
6.4 Diagnostic Centers
6.5 Biopharmaceutical and Biotech Companies
6.6 Other End Users
7.1 Overview
7.2 North America
7.2.1 U.S.
7.2.2 Canada
7.3 Europe
7.3.1 Germany
7.3.2 U.K.
7.3.3 France
7.3.4 Italy
7.3.5 Spain
7.3.6 Rest-of-Europe
7.4 Asia Pacific
7.4.1 China
7.4.2 Japan
7.4.3 India
7.4.4 South Korea
7.4.5 Australia
7.4.6 Rest-of- Asia Pacific
7.5 Latin America
7.5.1 Brazil
7.5.2 Mexico
7.5.3 Rest-of-Latin America
7.6 Middle East and Africa
7.6.1 U.A.E.
7.6.2 South Africa
7.6.3 Rest-of-Middle East and Africa
8.1 Overview
8.2 Corporate Strategies
8.2.1 Mergers and Acquisitions
8.2.2 Synergistic Activities
8.2.3 Business Expansions and Funding
8.3 Business Strategies
8.3.1 Product Launches and Approvals
8.3.2 Publications
8.3.3 Licenses and Agreements
8.3.4 Other Activities
8.4 Market Share Analysis (By Product Manufacturer)
8.5 Market Share Analysis (by Service Provider)
8.6 Company Profiles
8.6.1 Abbott Laboratories
8.6.1.1 Overview
8.6.1.2 Top Products / Product Portfolio
8.6.1.3 Top Competitors
8.6.1.4 Target Customers/End-Users
8.6.1.5 Key Personnel
8.6.1.6 Analyst View
8.6.2 Agilent Technologies, Inc.
8.6.2.1 Overview
8.6.2.2 Top Products / Product Portfolio
8.6.2.3 Top Competitors
8.6.2.4 Target Customers/End-Users
8.6.2.5 Key Personnel
8.6.2.6 Analyst View
8.6.3 ALCEN
8.6.3.1 Overview
8.6.3.2 Top Products / Product Portfolio
8.6.3.3 Top Competitors
8.6.3.4 Target Customers/End-Users
8.6.3.5 Key Personnel
8.6.3.6 Analyst View
8.6.4 Arsenal Capital Partners
8.6.4.1 Overview
8.6.4.2 Top Products / Product Portfolio
8.6.4.3 Top Competitors
8.6.4.4 Target Customers/End-Users
8.6.4.5 Key Personnel
8.6.4.6 Analyst View
8.6.5 Azenta Life Sciences
8.6.5.1 Overview
8.6.5.2 Top Products / Product Portfolio
8.6.5.3 Top Competitors
8.6.5.4 Target Customers/End-Users
8.6.5.5 Key Personnel
8.6.5.6 Analyst View
8.6.6 Becton, Dickinson and Company
8.6.6.1 Overview
8.6.6.2 Top Products / Product Portfolio
8.6.6.3 Top Competitors
8.6.6.4 Target Customers/End-Users
8.6.6.5 Key Personnel
8.6.6.6 Analyst View
8.6.7 Bio-Rad Laboratories, Inc.
8.6.7.1 Overview
8.6.7.2 Top Products / Product Portfolio
8.6.7.3 Top Competitors
8.6.7.4 Target Customers/End-Users
8.6.7.5 Key Personnel
8.6.7.6 Analyst View
8.6.8 bioMérieux S.A.
8.6.8.1 Overview
8.6.8.2 Top Products / Product Portfolio
8.6.8.3 Top Competitors
8.6.8.4 Target Customers/End-Users
8.6.8.5 Key Personnel
8.6.8.6 Analyst View
8.6.9 BGI
8.6.9.1 Overview
8.6.9.2 Top Products / Product Portfolio
8.6.9.3 Top Competitors
8.6.9.4 Target Customers/End-Users
8.6.9.5 Key Personnel
8.6.9.6 Analyst View
8.6.10Broad Institute
8.6.10.1 Overview
8.6.10.2 Top Products / Product Portfolio
8.6.10.3 Top Competitors
8.6.10.4 Target Customers/End-Users
8.6.10.5 Key Personnel
8.6.10.6 Analyst View
8.6.11Charles River Laboratories
8.6.11.1 Overview
8.6.11.2 Top Products / Product Portfolio
8.6.11.3 Top Competitors
8.6.11.4 Target Customers/End-Users
8.6.11.5 Key Personnel
8.6.11.6 Analyst View
8.6.12Caris Life Sciences
8.6.12.1 Overview
8.6.12.2 Top Products / Product Portfolio
8.6.12.3 Top Competitors
8.6.12.4 Target Customers/End-Users
8.6.12.5 Key Personnel
8.6.12.6 Analyst View
8.6.13CENTOGENE N.V
8.6.13.1 Overview
8.6.13.2 Top Products / Product Portfolio
8.6.13.3 Top Competitors
8.6.13.4 Target Customers/End-Users
8.6.13.5 Key Personnel
8.6.13.6 Analyst View
8.6.14Discovery Life Sciences (DLS)
8.6.14.1 Overview
8.6.14.2 Top Products / Product Portfolio
8.6.14.3 Top Competitors
8.6.14.4 Target Customers/End-Users
8.6.14.5 Key Personnel
8.6.14.6 Analyst View
8.6.15Enzo Biochem Inc.
8.6.15.1 Overview
8.6.15.2 Top Products / Product Portfolio
8.6.15.3 Top Competitors
8.6.15.4 Target Customers/End-Users
8.6.15.5 Key Personnel
8.6.15.6 Analyst View
8.6.16Eurofins Scientific
8.6.16.1 Overview
8.6.16.2 Top Products / Product Portfolio
8.6.16.3 Top Competitors
8.6.16.4 Target Customers/End-Users
8.6.16.5 Key Personnel
8.6.16.6 Analyst View
8.6.17F. Hoffmann-La Roche Ltd
8.6.17.1 Overview
8.6.17.2 Top Products / Product Portfolio
8.6.17.3 Top Competitors
8.6.17.4 Target Customers/End-Users
8.6.17.5 Key Personnel
8.6.17.6 Analyst View
8.6.18Illumina, Inc.
8.6.18.1 Overview
8.6.18.2 Top Products / Product Portfolio
8.6.18.3 Top Competitors
8.6.18.4 Target Customers/End-Users
8.6.18.5 Key Personnel
8.6.18.6 Analyst View
8.6.19Myriad Genetics, Inc.
8.6.19.1 Overview
8.6.19.2 Top Products / Product Portfolio
8.6.19.3 Top Competitors
8.6.19.4 Target Customers/End-Users
8.6.19.5 Key Personnel
8.6.19.6 Analyst View
8.6.20NeoGenomics Laboratories
8.6.20.1 Overview
8.6.20.2 Top Products / Product Portfolio
8.6.20.3 Top Competitors
8.6.20.4 Target Customers/End-Users
8.6.20.5 Key Personnel
8.6.20.6 Analyst View
8.6.21Novogene Co., Ltd.
8.6.21.1 Overview
8.6.21.2 Top Products / Product Portfolio
8.6.21.3 Top Competitors
8.6.21.4 Target Customers/End-Users
8.6.21.5 Key Personnel
8.6.21.6 Analyst View
8.6.22Personalis Inc.
8.6.22.1 Overview
8.6.22.2Top Products / Product Portfolio
8.6.22.3Top Competitors
8.6.22.4Target Customers/End-Users
8.6.22.5Key Personnel
8.6.22.6Analyst View
8.6.23 QIAGEN N.V.
8.6.23.1Overview
8.6.23.2Top Products / Product Portfolio
8.6.23.3Top Competitors
8.6.23.4Target Customers/End-Users
8.6.23.5Key Personnel
8.6.23.6Analyst View
8.6.24 Quest Diagnostics Incorporated
8.6.24.1Overview
8.6.24.2Top Products / Product Portfolio
8.6.24.3Top Competitors
8.6.24.4Target Customers/End-Users
8.6.24.5Key Personnel
8.6.24.6Analyst View
8.6.25Q2 Solutions
8.6.25.1 Overview
8.6.25.2 Top Products / Product Portfolio
8.6.25.3 Top Competitors
8.6.25.4 Target Customers/End-Users
8.6.25.5 Key Personnel
8.6.25.6 Analyst View
8.6.26Thermo Fisher Scientific Inc.
8.6.26.1Overview
8.6.26.2 Top Products / Product Portfolio
8.6.26.3 Top Competitors
8.6.26.4 Target Customers/End-Users
8.6.26.5 Key Personnel
8.6.26.6 Analyst View
Table: Global Clinical Biomarkers Market Dynamics, Impact Analysis
Table: Global Clinical Biomarkers Market Dynamics, Regulatory Scenario
Table: Global Clinical Biomarkers Market (by Offering), $Million, 2023-2035
Table: Global Clinical Biomarkers Market (by Technology), $Million, 2023-2035
Table: Global Clinical Biomarkers Market (by Clinical Area), $Million, 2023-2035
Table: Global Clinical Biomarkers Market (by End User), $Million, 2023-2035
Table: Global Clinical Biomarkers Market (by Region), $Million, 2023-2035
Figure:Global Clinical Biomarkers Market, Dynamics Impact Analysis
Figure:Global Clinical Biomarkers Market Coverage
Figure:Global Clinical Biomarkers Market, Key Trends, Impact Analysis, 2023-2035
Figure:Global Clinical Biomarkers Market, Patent Analysis, January 2022-March 2025
Figure:Global Clinical Biomarkers Market, Competitive Landscape, January 2022-March 2025
Clinical Biomarker Market Report Coverage
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Clinical Biomarker Market |
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Base Year |
2024 |
Forecast Period |
2025-2035 |
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CAGR During Forecast Period |
10% |
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Key Market Players and Competition Synopsis
The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.
The top segment players of the global clinical biomarkers market include clinical biomarkers manufacturers and service providers that capture around 95% of the presence in the global clinical biomarkers market.
Some of the prominent names established in the global clinical biomarkers market are:
Company Type: Product and Service
• Abbott.
• F. Hoffmann-La Roche Ltd
• Thermo Fisher Scientific Inc.
• QIAGEN N.V.
• Bio-Rad Laboratories, Inc.
• Illumina, Inc.
• Eurofins Scientific
• NeoGenomics Laboratories
• Other Companies
How can this report add value to the Organization ?
Product/Innovation Strategy: Product launches and innovations in the Clinical Biomarkers Market are focused on advancing treatment options and diagnostic technologies to improve patient care. These innovations aim to enhance the efficacy of therapies and streamline the detection and management of HIV-1. Key players in the market, such as Gilead Sciences and Merck & Co., have been involved in the development of novel therapies, including long-acting injectable treatments and combination regimens, which provide improved adherence and enhanced patient outcomes. Additionally, innovations in HIV-1 diagnostics and prevention strategies such as pre-exposure prophylaxis (PrEP) are helping to reduce the spread of HIV-1 and improve disease management globally.
Competitive Strategy: Enterprises led by market leaders in the Clinical Biomarkers Market are continuously updating their product portfolios with innovative, application-specific treatments to maintain competitiveness. Companies are focusing on developing long-acting treatments, combination drugs, and novel prevention strategies to address the evolving needs of HIV-1 patients. A detailed competitive benchmarking of the key players in the global HIV-1 market has been conducted, providing insights into how these companies compare in terms of product offerings, market share, and innovation. This benchmarking provides readers with a clear understanding of the market landscape and the positions of the leading players. Additionally, comprehensive competitive strategies, such as partnerships, agreements, and collaborations, regulatory approvals, and product launches will help readers identify untapped revenue opportunities in the market.
Global Clinical Biomarkers Market Industry Overview
The global clinical biomarkers market was estimated to be at $XX million in 2024, which is expected to grow with a CAGR of approximately 10% and reach $XX million by 2035. The growth in the global clinical biomarkers market is expected to be driven by the increasing demand for clinical biomarker products, increasing key player initiatives, and increasing prevalence of infectious diseases and various types of cancer globally.
Market Lifecycle Stage
Clinical biomarkers have been extensively preferred in the field of clinical medicine to offer individualized treatment options to patients. Biomarkers are crucial to the rational development of medical therapeutics and are involved in their use in in-vitro diagnostics purposes, particularly in the fields of chronic disease and nutrition. Companies such as Illumina, Inc., F. Hoffmann-La Roche Ltd, Agilent Technologies, Inc., and Myriad Genetics, Inc., in the clinical biomarkers market, are launching products, majorly focusing on indications for infectious diseases and cancer types such as breast cancer, ovarian cancer, lung cancer, and cervical cancer. Several companies, such as Thermo Fisher Scientific Inc., QIAGEN N.V., NeoGenomics Laboratories, and CENTOGENE N.V., are collaborating and partnering with the stakeholders to develop and expand technological expertise to offer potential products in the global clinical biomarkers market. Breast cancer is the most frequent tumor growth in women, and its incidence experienced innovation in systematic screening. The increasing incidence of breast cancer has led to an increase in demand for its diagnosis and treatment.
Impact
• Increasing demand for clinical biomarkers products is anticipated to support the growth of the global clinical biomarkers market during the forecast period 2025-2035.
• The global clinical biomarkers market is expected to grow at a significant growth rate due to opportunities such as the expansion of biomarker discovery and increased research funding for executing research and development exercises.
Market Segmentation:
Segmentation 1: by Offering
• Product
• Service
Based on offering, with respect to the overall market share, the service segment of the clinical biomarkers market by offering segmentation held the largest share in 2024. The high share of the service segment is majorly due to the rising demand for clinical biomarkers services in oncology, the rising number of product launches and approvals in recent years, and the increasing emphasis on the adoption of clinical biomarkers technologies.
Segmentation 2: by Technology
• Next-Generation Sequencing (NGS)
• Polymerase Chain Reaction (PCR)
• Immunohistochemistry (IHC)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Other Technologies
Based on technology, in 2024, the global clinical biomarkers market was dominated by next-generation sequencing. This is primarily due to the growing cancer genomics research.
Segmentation 3: by Clinical Area
• Cancer Biomarker
• Cardiac Biomarker
• Neurological Biomarker
• Infectious Disease Biomarker
• Immunological Biomarker
• Non-Invasive Prenatal Testing
• Other Clinical Areas
Based on clinical area, the cancer biomarkers segment dominated the clinical biomarkers market in 2024. Increasing cancer cases across the globe will contribute significantly to the growth of the global clinical biomarkers market.
Segmentation 4: by End User
• Contract Research Organizations (CROs)
• Research and Academic Laboratories
• Biopharmaceutical and Biotech Companies
• Diagnostic Centers
• Other End Users
Based on end user, the contract research organizations (CROs) segment accounted for the largest share of the global clinical biomarkers market in 2024.
Segmentation 5: by Region
• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa
The North America region is expected to dominate the global clinical biomarkers market during the forecast period 2025-2035. North America has a high adoption rate of cancer genomics research. Backed by several healthcare companies working in the marketplace, the U.S. has the highest implementation of PCR, NGS, and other technologies in the global clinical biomarkers market. The existing dominance of North America in the global clinical biomarkers market is being stipulated based on the rise in infectious diseases and cancer cases.
Recent Developments in the Global Clinical Biomarkers Market
• Acquisition in 2021: NeoGenomics Laboratories acquired Inivata. With this acquisition, the company strengthened its market position and expanded its footprint in the clinical biomarkers market.
• Collaboration: In 2022, F. Hoffmann-La Roche Ltd collaborated with Nordic Bioscience to strengthen the development of biomarkers for chronic diseases.
• Product Approval: In 2020, F. Hoffmann-La Roche Ltd received FDA approval for an assay to detect the HER2 biomarker in breast cancer.
Demand – Drivers and Limitations
The following are the demand drivers for the clinical biomarkers market:
• Increasing Demand for Clinical Biomarker Products
• Increasing Key Player Initiatives
• Increasing Prevalence of Infectious Diseases and Various Types of Cancer Globally
The market is expected to face some limitations due to the following challenges:
• High Capital Requirement Hampering the Expansion of Global Reach
• Complex Regulatory Frameworks Delaying the Approval of New Clinical Biomarkers Tests
• Lack of Qualified Professionals
Clinical Biomarkers Market - A Global and Regional Analysis
Focus on Offering, Clinical Area, Technology, End User, and Region - Analysis and Forecast, 2025-2035
Frequently Asked Questions
The term clinical biomarkers refers to the quantifiable biological parameter that facilitates the understanding of the progression and early diagnosis of a disease. Clinical biomarkers specifically refer to the molecular biomarkers which are providing new targets for disease characterization, drug discovery, and development. The report focuses on the manufacturers of different types of biomarkers, namely, prognostic, predictive, and diagnostic biomarkers, along with their application in clinical and research areas.
A new entrant can focus on various technologies that are being offered by the established market players in the global clinical biomarkers market.
A new entrant can focus on various technologies that are being offered by the established market players in the global clinical biomarkers market.
The clinical biomarkers companies manufacturing clinical biomarkers products and services, contract research organizations (CROs), research institutions, and hospitals, among others, should buy this report.
