A quick peek into the report
Table of Contents
1.1 Product Definition
1.2 Inclusion and Exclusion
2.1 Key Questions Answered in the Report
3.1 Data Sources
3.1.1 Primary Data Source
3.1.2 Secondary Data Sources
3.1.2.1 Open Sources
3.2 Market Estimation Model
3.3 Criteria for Company Profiling
4.1 Introduction
4.2 Clinical Biomarkers Approaches in Precision Medicine
4.3 Market Size Potential for Clinical Biomarkers, 2022-2033
4.4 COVID-19 Impact on Global Clinical Biomarkers Market
4.4.1 COVID-19 Impact on Market Size
4.5 Market Trends
4.5.1 Integration of Artificial Intelligence in Biomarker Discovery
4.5.2 Increasing Biomarkers Usage in Precision Medicine
4.5.3 Technologies Being Used in Clinical Biomarker Testing
4.5.4 Clinical Biomarker Discovery Making Early Disease Diagnosis Possible
5.1 Regulatory Framework
5.1.1 Regulatory Framework in the U.S.
5.1.2 FDA Regulations
5.1.3 Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff
5.1.4 Regulatory Framework in the U.S. for Medical Devices
5.1.5 Legal Requirements and Framework in Europe
5.1.5.1 U.K.
5.1.5.2 Germany
5.1.6 Legal Requirements and Framework in Asia-Pacific
5.1.6.1 China
5.1.6.2 Japan
5.1.6.2.1 Pharmaceuticals and Medical Devices Agency (PMDA)
5.2 Patent Analysis
5.3 Competitive Index (Unmet Needs and Innovations)
5.4 Pain Points of Manufacturers
6.1 Corporate Strategies
6.1.1 Acquisitions
6.1.2 Synergistic Activities
6.1.3 Funding and Business Expansions
6.2 Business Strategies
6.2.1 Service/Product Launches
6.3 Supply Chain Analysis
6.4 Pricing Analysis
6.4.1 Pricing Analysis (by Product)
6.4.2 Pricing Analysis (by Testing Service)
6.5 Market Share Analysis (by Product Manufacturer)
6.6 Market Share Analysis (by Service Provider)
7.1 Overview
7.2 Impact Analysis
7.3 Market Drivers
7.3.1 Growing Demand for Clinical Biomarker Products
7.3.2 Increase in Industrial Activity in Clinical Biomarker Landscape
7.3.3 Environment Changes Provoking Swift Care and Diagnosis
7.4 Market Challenges
7.4.1 High Price of Products/Services Limiting Adoption of Clinical Biomarkers in Low-Income Countries
7.4.2 Complex Regulatory Frameworks Delaying Approval of New Clinical Biomarkers Tests
7.4.3 Difficulty in Identifying New Biomarkers
7.5 Market Opportunities
7.5.1 Technological Advancement in Biomarker Testing
7.5.2 Increased Research Funding for Executing Research and Development Exercise
7.5.3 Discovery of Novel Biomarkers Expanding Precision Medicine Horizons
8.1 Overview
8.2 Product
8.2.1 Efficacy Biomarker
8.2.1.1 Diagnostic Biomarker
8.2.1.2 Predictive Biomarker
8.2.1.3 Prognostic Biomarker
8.2.2 Safety Biomarker
8.2.3 Validation Biomarker
8.3 Service
8.3.1 Genomic Biomarker Service
8.3.2 Tissue Biomarker Service
8.3.3 Cell Service
8.3.4 Proteomics Service
9.1 Overview
9.2 Next-Generation Sequencing (NGS)
9.3 Polymerase Chain Reaction (PCR)
9.4 Immunohistochemistry (IHC)
9.5 Enzyme-Linked Immunosorbent Assay (ELISA)
9.6 Other Technologies
10.1 Overview
10.2 Cancer Biomarker
10.2.1 Breast Cancer Biomarker
10.2.2 Lung Cancer Biomarker
10.2.3 Colorectal Cancer Biomarker
10.2.4 Prostate Cancer Biomarker
10.2.5 Other
10.3 Cardiac Biomarker
10.4 Neurological Biomarker
10.5 Infectious Disease Biomarker
10.6 Non-Invasive Prenatal Testing
10.7 Immunological Biomarker
10.8 Other Clinical Areas
11.1 Overview
11.1.1 Contract Research Organizations (CROs)
11.1.2 Research and Academic Laboratories
11.1.3 Diagnostic Centers
11.1.4 Biopharmaceutical and Biotech Companies
11.1.5 Other End Users
12.1 Overview
12.2 North America
12.2.1 U.S.
12.2.2 Canada
12.3 Europe
12.3.1 Germany
12.3.2 France
12.3.3 U.K.
12.3.4 Italy
12.3.5 Spain
12.3.6 Rest-of-Europe
12.4 Asia-Pacific
12.4.1 China
12.4.2 India
12.4.3 Japan
12.4.4 South Korea
12.4.5 Australia
12.4.6 Rest-of-Asia-Pacific
12.5 Latin America
12.5.1 Brazil
12.5.2 Mexico
12.5.3 Rest-of-Latin America
12.6 Rest-of-the-World
13.1 Overview
13.2 Abbott Laboratories
13.2.1 Company Overview
13.2.2 Role of Abbott Laboratories in the Global Clinical Biomarkers Market
13.2.3 Corporate Strategies
13.2.3.1 Product Launches
13.2.4 Business Strategies
13.2.4.1 Synergistic Activities
13.2.5 Financials
13.2.6 Analyst’s Perspective
13.3 Agilent Technologies, Inc.
13.3.1 Company Overview
13.3.2 Role of Agilent Technologies, Inc. in the Global Clinical Biomarkers Market
13.3.3 Corporate Strategies
13.3.3.1 Product Launches
13.3.4 Financials
13.3.5 Analyst’s Perspective
13.4 ALCEN
13.4.1 Company Overview
13.4.2 Role of ALCEN in the Global Clinical Biomarkers Market
13.4.3 Analyst’s Perspective
13.5 Arsenal Capital Partners
13.5.1 Company Overview
13.5.2 Role of Arsenal Capital Partners in the Global Clinical Biomarkers Market
13.5.3 Business Strategies
13.5.3.1 Funding and Expansion
13.5.4 Corporate Strategies
13.5.4.1 Synergistic Activities
13.5.5 Analyst’s Perspective
13.6 Azenta Life Sciences
13.6.1 Company Overview
13.6.2 Role of Azenta Life Sciences in the Global Clinical Biomarkers Market
13.6.3 Business Strategies
13.6.3.1 Acquisition
13.6.1 Financials
13.6.2 Analyst’s Perspectives
13.7 Becton, Dickinson and Company
13.7.1 Company Overview
13.7.2 Role of Becton, Dickinson and Company in the Global Clinical Biomarkers Market
13.7.3 Financials
13.7.4 Analyst’s Perspective
13.8 Bio-Rad Laboratories, Inc.
13.8.1 Company Overview
13.8.2 Role of Bio-Rad Laboratories, Inc. in the Global Clinical Biomarkers Market
13.8.3 Financials
13.8.4 Analyst’s Perspective
13.9 bioMérieux S.A.
13.9.1 Company Overview
13.9.2 Role of bioMérieux S.A. in the Global Clinical Biomarkers Market
13.9.3 Corporate Strategies
13.9.3.1 Funding and Expansion
13.9.3.2 Product Launches
13.9.4 Financials
13.9.5 Analyst’s Perspective
13.1 BGI
13.10.1 Company Overview
13.10.2 Role of BGI in the Global Clinical Biomarkers Market
13.10.3 Corporate Strategies
13.10.3.1 Product Launch
13.10.4 Analyst’s Perspective
13.11 Broad Institute
13.11.1 Company Overview
13.11.2 Role of Broad Institute in the Global Clinical Biomarkers Market
13.11.3 Analyst’s Perspective
13.12 Charles River Laboratories
13.12.1 Company Overview
13.12.2 Role of Charles River Laboratories in the Global Clinical Biomarkers Market
13.12.3 Financials
13.12.4 Analyst’s Perspective
13.13 Caris Life Sciences
13.13.1 Company Overview
13.13.2 Role of Caris Life Sciences in the Global Clinical Biomarkers Market
13.13.3 Analyst’s Perspective
13.14 CENTOGENE N.V.
13.14.1 Company Overview
13.14.2 Role of CENTOGENE N.V. in the Global Clinical Biomarkers Market
13.14.3 Business Strategies
13.14.3.1 Funding
13.14.4 Corporate Strategies
13.14.4.1 Synergistic Activities
13.14.5 Financials
13.14.6 Analyst’s Perspective
13.15 Discovery Life Sciences (DLS)
13.15.1 Company Overview
13.15.2 Role of Discovery Life Sciences in the Global Clinical Biomarkers Market
13.15.3 Business Strategies
13.15.3.1 Acquisition
13.15.4 Analyst’s Perspective
13.16 Enzo Biochem Inc.
13.16.1 Company Overview
13.16.2 Role of Enzo Biochem Inc. in the Global Clinical Biomarkers Market
13.16.3 Financials
13.16.4 Analyst’s Perspective
13.17 Eurofins Scientific
13.17.1 Company Overview
13.17.2 Role of Eurofins Scientific in the Global Clinical Biomarkers Market
13.17.3 Corporate Strategies
13.17.3.1 Product Launches
13.17.4 Financials
13.17.5 Analyst’s Perspective
13.18 F. Hoffmann-La Roche Ltd
13.18.1 Company Overview
13.18.2 Role of F. Hoffmann-La Roche Ltd in the Global Clinical Biomarkers Market
13.18.3 Business Strategies
13.18.3.1 Product Launches
13.18.4 Corporate Strategies
13.18.4.1 Synergistic Activities
13.18.5 Financials
13.18.6 Analyst’s Perspective
13.19 Illumina, Inc.
13.19.1 Company Overview
13.19.2 Role of Illumina, Inc. in the Global Clinical Biomarkers Market
13.19.3 Corporate Strategies
13.19.3.1 Product Launches
13.19.4 Financials
13.19.5 Analyst’s Perspective
13.2 Myriad Genetics, Inc.
13.20.1 Company Overview
13.20.2 Role of Myriad Genetics, Inc. in the Global Clinical Biomarkers Market
13.20.3 Business Strategies
13.20.3.1 Product Launches
13.20.4 Financials
13.20.5 Analyst’s Perspective
13.21 NeoGenomics Laboratories
13.21.1 Company Overview
13.21.2 Role of NeoGenomics Laboratories in the Global Clinical Biomarkers Market
13.21.3 Business Strategies
13.21.3.1 Funding and Expansion
13.21.3.2 Product Launches
13.21.4 Corporate Strategies
13.21.4.1 Synergistic Activities
13.21.5 Financials
13.21.6 Analyst’s Perspective
13.22 Novogene Co., Ltd.
13.22.1 Company Overview
13.22.2 Role of Novogene Co., Ltd. in the Global Clinical Biomarkers Market
13.22.3 Analyst’s Perspective
13.23 Personalis Inc.
13.23.1 Company Overview
13.23.2 Role of Personalis Inc. in the Global Clinical Biomarkers Market
13.23.3 Business Strategies
13.23.3.1 Funding and Expansion
13.23.3.2 Product Launches
13.23.4 Corporate Strategies
13.23.4.1 Synergistic Activities
13.23.5 Financials
13.23.6 Analyst’s Perspective
13.24 QIAGEN N.V.
13.24.1 Company Overview
13.24.2 Role of QIAGEN N.V. in the Global Clinical Biomarkers Market
13.24.3 Corporate Strategies
13.24.3.1 Product Launches
13.24.4 Business Strategies
13.24.4.1 Synergistic Activities
13.24.5 Financials
13.24.6 Analyst’s Perspective
13.25 Quest Diagnostics Incorporated
13.25.1 Company Overview
13.25.2 Role of Quest Diagnostics Incorporated in the Global Clinical Biomarkers Market
13.25.3 Financials
13.25.4 Analyst Perspective
13.26 Q2 Solutions
13.26.1 Company Overview
13.26.2 Role of Q2 Solutions in the Global Clinical Biomarkers Market
13.26.3 Business Strategies
13.26.3.1 Funding and Expansion
13.26.4 Corporate Strategies
13.26.4.1 Synergistic Activities
13.26.5 Analyst’s Perspective
13.27 Thermo Fisher Scientific Inc.
13.27.1 Company Overview
13.27.2 Role of Thermo Fisher Scientific Inc. in the Global Clinical Biomarkers Market
13.27.3 Business Strategies
13.27.3.1 Expansion and Funding
13.27.3.2 Product Launches
13.27.4 Corporate Strategies
13.27.4.1 Synergistic Activities
13.27.5 Financials
13.27.6 Analyst’s Perspective
Table 1: COVID-19 Impact on Global Clinical Biomarkers Market, 2020-2033
Table 2: List of Product/Service Offered and its Technology
Table 3: Global Clinical Biomarkers Market: Key Players Patent Portfolio
Table 4: Key Player Initiatives and Their Impact
Table 5: Pricing List of Product/Service
Table 6: List of Biomarker Qualification Submissions for FDA Approval
Table 7: Example of Efficacy Biomarker
Table 8: Examples of Diagnostic Biomarker
Table 9: Examples of Prognostic Biomarker
Table 10: Examples of Safety Biomarker
Table 11: Example of Clinical Biomarker Service
Table 12: Next-Generation Sequencing-Based Clinical Biomarker Products
Table 13: Polymerase Chain Reaction-Based Clinical Biomarker Products
Table 14: Immunohistochemistry (IHC)-Based Clinical Biomarker Products
Table 15: ELISA-Based Clinical Biomarker Products
Table 16: Companies Offering Other Technologies-Based Products
Table 17: Example of Cancer Biomarker
Table 18: Example of Cardiac Biomarker
Table 19: Example of Neurological Biomarker
Table 20: Examples of Infectious Disease Biomarker
Table 21: Estimated Cancer Deaths in California, 2022
Figure 1: Global Clinical Biomarkers Market Dynamics
Figure 2: Global Clinical Biomarkers Market (by Offering), $Billion, 2022 and 2033
Figure 3: Global Clinical Biomarkers Market (by Technology), $Billion, 2022 and 2033
Figure 4: Global Clinical Biomarkers Market (by Clinical Area), $Billion, 2022 and 2033
Figure 5: Global Clinical Biomarkers Market (by End User), $Billion, 2022 and 2033
Figure 6: Global Clinical Biomarkers Market (by Region), $Billion, 2022 and 2033
Figure 7: Global Clinical Biomarkers Market Research Methodology
Figure 8: Primary Research Methodology
Figure 9: Bottom-Up Approach (Segment-Wise Analysis)
Figure 10: Top-Down Approach (Segment-Wise Analysis)
Figure 11: Biomarkers Used in Various Clinical Areas
Figure 12: Leading Segments of the Global Clinical Biomarkers Market, 2022 and 2033
Figure 13: Global Clinical Biomarkers Market, $Billion, 2022-2033
Figure 14: Impact of COVID-19 on Clinical Biomarkers Market
Figure 15: Usage of Artificial Intelligence (AI) in Biomarker Discovery
Figure 16: Use of Clinical Biomarkers in Personalized Medicine
Figure 17: Prevalence vs. Age-Standardized Death Rate of Cancer Globally, % Share, 2010-2019
Figure 18: Responsibilities of the National Medical Products Administration (NMPA)
Figure 19: Unmet Needs and Innovations of Top Players
Figure 20: Pain Point, Impact, and Future Strategies for Manufacturers
Figure 21: Share of Synergistic Activities (by Company), January 2019-December 2023
Figure 22: Funding and Business Expansions (by Company), January 2019-December 2023
Figure 23: Service/Product Launches (by Key Companies), January 2019-December 2023
Figure 24: Clinical Biomarkers Supply Chain Analysis
Figure 25: Global Clinical Biomarkers Market (by Product Manufacturer), % Share, 2022
Figure 26: Global Clinical Biomarkers Market (by Service Provider), % Share, 2022
Figure 27: Role of Biomarkers in Cancer Care
Figure 28: History of Known Pandemics (100 AD to 2020)
Figure 29: Increasing Cancer Cases in U.S. with Percentage Increase, 2019 and 2022
Figure 30: Evidentiary Framework
Figure 31: Latest Technologies Seen in the Clinical Biomarkers Market and its Relevance
Figure 32: National Institute of Health (NIH) Funding, 2019-2022
Figure 33: Global Clinical Biomarkers Market (by Offering)
Figure 34: Share of Global Clinical Biomarkers Market (by Offering), $Billion, 2022 and 2033
Figure 35: Share of Global Clinical Biomarkers Market (by Product), $Billion, 2022 and 2033
Figure 36: Global Clinical Biomarkers Market (Product), $Billion, 2022-2033
Figure 37: Global Clinical Biomarkers Market (Efficacy Biomarker), $Billion, 2022-2033
Figure 38: Global Clinical Biomarkers Market (Diagnostic Biomarker), $Billion, 2022-2033
Figure 39: Role and Example of Predictive Biomarker
Figure 40: Global Clinical Biomarkers Market (Predictive Biomarker), $Billion, 2022-2033
Figure 41: Global Clinical Biomarkers Market (Prognostic Biomarker), $Billion, 2022-2033
Figure 42: Global Clinical Biomarkers Market (Safety Biomarker), $Billion, 2022-2033
Figure 43: Global Clinical Biomarkers Market (Validation Biomarker), $Billion, 2022-2033
Figure 44: Share of Global Clinical Biomarkers Market (by Service), $Billion, 2022 and 2033
Figure 45: Global Clinical Biomarkers Market (Service), $Billion, 2022-2033
Figure 46: Global Clinical Biomarkers Market (Genomic Biomarker Service), $Billion, 2022-2033
Figure 47: Global Clinical Biomarkers Market (Tissue Biomarker Service), $Billion, 2022-2033
Figure 48: Global Clinical Biomarkers Market (Cell Service), $Billion, 2022-2033
Figure 49: Global Clinical Biomarkers Market (Proteomics Service), $Billion, 2022-2033
Figure 50: Global Clinical Biomarkers Market (by Technology)
Figure 51: Global Clinical Biomarkers Market (by Technology), $Billion, 2022 and 2033
Figure 52: Benefits of NGS for Clinical Diagnostics and Biomarker Testing in Oncology
Figure 53: Global Clinical Biomarkers Market (Next-Generation Sequencing), $Billion, 2022-2033
Figure 54: Application of PCR
Figure 55: Global Clinical Biomarkers Market (Polymerase Chain Reaction), $Billion, 2022-2033
Figure 56: Global Clinical Biomarkers Market (Immunohistochemistry (IHC)), $Billion, 2022-2033
Figure 57: Global Clinical Biomarkers Market Enzyme-Linked Immunosorbent Assay (ELISA)), $Billion, 2022-2033
Figure 58: Global Clinical Biomarkers Market (Other Technologies), $Billion, 2022-2033
Figure 59: Cancers and their Biomarkers
Figure 60: Global Clinical Biomarkers Market (by Clinical Area)
Figure 61: Global Clinical Biomarkers Market (by Clinical Area), $Billion, 2022 and 2033
Figure 62: Global Clinical Biomarkers Market (Cancer Biomarker), $Billion, 2022-2033
Figure 63: Global Clinical Biomarkers Market (Breast Cancer Biomarker), $Billion, 2022-2033
Figure 64: Percentage of Non-Small Cell Lung Cancer (NSCLC) and its Biomarkers
Figure 65: Global Clinical Biomarkers Market (Lung Cancer Biomarker), $Billion, 2022-2033
Figure 66: Global Clinical Biomarkers Market (Colorectal Cancer Biomarker), $Billion, 2022-2033
Figure 67: Global Clinical Biomarkers Market (Prostate Cancer Biomarker), $Billion, 2022-2033
Figure 68: Global Clinical Biomarkers Market (Other), $Billion, 2022-2033
Figure 69: Global Clinical Biomarkers Market (Cardiac Biomarker), $Billion, 2022-2033
Figure 70: Global Clinical Biomarkers Market (Neurological Biomarker), $Billion, 2022-2033
Figure 71: Global Clinical Biomarkers Market (Infectious Disease Biomarker), $Billion, 2022-2033
Figure 72: Global Clinical Biomarkers Market Non-Invasive Prenatal Testing (NIPT)), $Billion, 2022-2033
Figure 73: Global Clinical Biomarkers Market (Immunological Biomarker), $Billion, 2022-2033
Figure 74: Global Clinical Biomarkers market (Other Clinical Areas), $Billion, 2022-2033
Figure 75: Global Clinical Biomarkers Market (by End User), $Billion, 2022 and 2033
Figure 76: Global Clinical Biomarkers Market (Contract Research Organizations (CROs)), $Billion, 2022-2033
Figure 77: Global Clinical Biomarkers Market (Research and Academic Laboratories), $Billion, 2022-2033
Figure 78: Global Clinical Biomarkers Market (Diagnostic Centers), $Billion, 2022-2033
Figure 79: Global Clinical Biomarkers Market (Biopharmaceutical and Biotech Companies), $Billion, 2022-2033
Figure 80: Global Clinical Biomarkers Market (Other End Users), $Billion, 2022-2033
Figure 81: Global Clinical Biomarkers Market Snapshot (by Region), $Billion, 2022-2033
Figure 82: Global Clinical Biomarkers Market (by Region), $Billion, 2022-2033
Figure 83: Global Clinical Biomarkers Market (by Region), $Billion, 2022 and 2033
Figure 84: North America Clinical Biomarkers Market, $Billion, 2022-2033
Figure 85: North America: Market Dynamics
Figure 86: North America Clinical Biomarkers Market (by Country), $Billion, 2022-2033
Figure 87: U.S. Clinical Biomarkers Market, $Billion, 2022-2033
Figure 88: Canada Clinical Biomarkers Market, $Billion, 2022-2033
Figure 89: Europe Clinical Biomarkers Market, $Billion, 2022-2033
Figure 90: Europe: Market Dynamics
Figure 91: Europe Clinical Biomarkers Market (by Country), $Billion, 2022-2033
Figure 92: Germany Clinical Biomarkers Market, $Billion, 2022-2033
Figure 93: Share of Cancer Cases in Germany, 2020
Figure 94: France Clinical Biomarkers Market, $Billion, 2022-2033
Figure 95: U.K. Clinical Biomarkers Market, $Billion, 2022-2033
Figure 96: Italy Clinical Biomarkers Market, $Billion, 2022-2033
Figure 97: Spain Clinical Biomarkers Market, $Billion, 2022-2033
Figure 98: Rest-of-Europe Clinical Biomarkers Market, $Billion, 2022-2033
Figure 99: Asia-Pacific Clinical Biomarkers Market, $Billion, 2022-2033
Figure 100: Asia-Pacific Clinical Biomarkers Market (by Country), $Billion, 2022-2033
Figure 101: Asia-Pacific: Market Dynamics
Figure 102: China Clinical Biomarkers Market, $Billion, 2022-2033
Figure 103: India Clinical Biomarkers Market, $Billion, 2022-2033
Figure 104: Japan Clinical Biomarkers Market, $Billion, 2022-2033
Figure 105: South Korea Clinical Biomarkers Market, $Billion, 2022-2033
Figure 106: Australia Clinical Biomarkers Market, $Billion, 2022-2033
Figure 107: Rest-of-Asia-Pacific Clinical Biomarkers Market, $Billion, 2022-2033
Figure 108: Latin America Clinical Biomarkers Market, $Billion, 2022-2033
Figure 109: Latin America: Market Dynamics
Figure 110: Latin America Clinical Biomarkers Market (by Country), $Billion, 2022-2033
Figure 111: Brazil Clinical Biomarkers Market, $Billion, 2022-2033
Figure 112: Mexico Clinical Biomarkers Market, $Billion, 2022-2033
Figure 113: Rest-of-Latin America Clinical Biomarkers Market, $Billion, 2022-2033
Figure 114: Rest-of-the-World Clinical Biomarkers Market, $Billion, 2022-2033
Figure 115: Total Number of Companies Profiled
Figure 116: Abbott Laboratories: Product Portfolio
Figure 117: Abbott Laboratories: Overall Financials, $Million, 2020-2022
Figure 118: Abbott Laboratories: Revenue (by Segment), $Million, 2020-2022
Figure 119: Abbott Laboratories: R&D Expenditure, $Million, 2020-2022
Figure 120: Agilent Technologies, Inc.: Product Portfolio
Figure 121: Agilent Technologies, Inc.: Overall Financials, $Million, 2021-2023
Figure 122: Agilent Technologies, Inc.: R&D Expenditure, $Million, 2021-2023
Figure 123: ALCEN: Service Portfolio
Figure 124: Arsenal Capital Partners: Services Portfolio
Figure 125: Azenta Life Sciences: Service Portfolio
Figure 126: Azenta Life Sciences: Overall Financials, $Million, 2021-2023
Figure 127: Becton, Dickinson and Company: Product Portfolio
Figure 128: Becton, Dickinson and Company: Overall Financials, $Million, 2021-2023
Figure 129: Becton, Dickinson and Company: Revenue (by Segment), $Million, 2021-2023
Figure 130: Becton, Dickinson and Company: Revenue (by Region), $Million, 2021-2023
Figure 131: Becton, Dickinson and Company: R&D Expenditure, $Million, 2021-2023
Figure 132: Bio-Rad Laboratories, Inc.: Product Portfolio
Figure 133: Bio-Rad Laboratories, Inc.: Overall Financials, $Million, 2020-2022
Figure 134: Bio-Rad Laboratories, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 135: Bio-Rad Laboratories, Inc.: Revenue (by Region), $Million, 2020-2022
Figure 136: Bio-Rad Laboratories, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 137: bioMérieux S.A.: Product Portfolio
Figure 138: bioMérieux S.A.: Overall Financials, $Million, 2020-2022
Figure 139: bioMérieux S.A.: Revenue (by Segment), $Million, 2020-2022
Figure 140: BGI: Service Portfolio
Figure 141: Broad Institute: Service Portfolio
Figure 142: Charles River Laboratories: Service Portfolio
Figure 143: Charles River Laboratories: Overall Financials, $Million, 2020-2022
Figure 144: Charles River Laboratories: Revenue (by Segment), $Million, 2020-2022
Figure 145: Charles River Laboratories.: Revenue (by Region), $Million, 2020-2022
Figure 146: Caris Life Sciences: Service Portfolio
Figure 147: CENTOGENE N.V.: Service Portfolio
Figure 148: CENTOGENE N.V.: Overall Financials, $Million, 2020-2022
Figure 149: Discovery Life Sciences: Service Portfolio
Figure 150: Enzo Biochem Inc.: Product Portfolio
Figure 151: Enzo Biochem Inc.: Overall Financials, $Million, 2020-2022
Figure 152: Enzo Biochem Inc.: R&D Expenditure, 2020-2022
Figure 153: Eurofins Scientific: Service Portfolio
Figure 154: Eurofins Scientific: Overall Financials, $Million, 2020-2022
Figure 155: F. Hoffmann-La Roche Ltd: Product Portfolio
Figure 156: F. Hoffmann-La Roche Ltd: Overall Financials, $Million, 2020-2022
Figure 157: F. Hoffmann-La Roche Ltd: Revenue (by Segment), $Million, 2020-2022
Figure 158: F. Hoffmann-La Roche Ltd: R&D Expenditure, $Million, 2020-2022
Figure 159: Illumina, Inc.: Product Portfolio
Figure 160: Illumina, Inc.: Overall Financials, $Million, 2020-2022
Figure 161: Illumina, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 162: Illumina, Inc.: Revenue (by Region), $Million, 2020-2022
Figure 163: Illumina, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 164: Myriad Genetics, Inc.: Service Portfolio
Figure 165: Myriad Genetics, Inc.: Overall Financials, $Million, 2020-2022
Figure 166: Myriad Genetics, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 167: NeoGenomics Laboratories: Service Portfolio
Figure 168: NeoGenomics Laboratories: Overall Financials, $Million 2020-2022
Figure 169: NeoGenomics Laboratories: Revenue (by Segment), 2020-2022
Figure 170: NeoGenomics Laboratories: R&D Expenditure, 2020-2022
Figure 171: Novogene Co., Ltd.: Service Portfolio
Figure 172: Personalis Inc.: Service Portfolio
Figure 173: Personalis Inc.: Overall Financials, $Million, 2020-2022
Figure 174: Personalis Inc.: R&D Expenditure, $Million, 2020-2022
Figure 175: QIAGEN N.V.: Product Portfolio
Figure 176: QIAGEN N.V.: Overall Financials, $Million, 2020-2022
Figure 177: QIAGEN N.V.: Revenue (by Segment), $Million, 2020-2022
Figure 178: QIAGEN N.V.: Revenue (by Region), $Million, 2020-2022
Figure 179: QIAGEN N.V.: R&D Expenditure, $Million, 20202022
Figure 180: Quest Diagnostics Incorporated, Inc.: Service Portfolio
Figure 181: Quest Diagnostics Incorporated: Overall Financials, $Million, 2020-2022
Figure 182: Quest Diagnostics Incorporated.: Revenue (by Segment), $Million, 2020-2022
Figure 183: Q2 Solutions: Service Portfolio
Figure 184: Thermo Fisher Scientific Inc.: Product Portfolio
Figure 185: Thermo Fisher Scientific Inc.: Overall Financials, $Million, 2020-2022
Figure 186: Thermo Fisher Scientific Inc.: R&D Expenditure, $Million, 2020-2022
Global Clinical Biomarkers Market Report Coverage
Clinical Biomarkers Market |
|||
Base Year |
2022 |
Market Size in 2023 |
$24.80 Billion |
Forecast Period |
2023-2033 |
Value Projection and Estimation by 2033 |
$53.20 Billion |
CAGR During Forecast Period |
7.93% |
Number of Pages |
255 |
Number of Tables |
21 | Number of Figures | 186 |
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 product segment players leading the market captured around 76.59% of the market's presence as of 2022. Services, on the other hand, accounted for approximately 23.41% of the market presence in 2022.
Some prominent names established in this market are
• Abbott Laboratories
• Agilent Technologies, Inc.
• ALCEN
• Arsenal Capital Partners
• Azenta Life Sciences
• Becton, Dickinson and Company
• BGI
• bioMérieux S.A.
• Bio-Rad Laboratories, Inc.
• Broad Institute
• Caris Life Sciences
• CENTOGENE N.V.
• Charles River Laboratories
• Discovery Life Sciences (DLS)
• Enzo Biochem Inc.
• Eurofins Scientific
• F. Hoffmann-La Roche Ltd
• Illumina, Inc.
• Myriad Genetics, Inc.
• NeoGenomics Laboratories
• Novogene Co., Ltd.
• Personalis Inc.
• Q² Solutions
• QIAGEN N.V.
• Quest Diagnostics Incorporated
• Thermo Fisher Scientific Inc.
How Can This Report Add Value to an Organization?
Product/Innovation Strategy: The global clinical biomarkers market has been segmented on the basis of various categories, such as offering, technology, clinical area, end user, and region. Segments such as by offering and by clinical area are then further subsegmented to ensure the comprehensiveness and thoroughness of the report.
Growth/Marketing Strategy: Product launches and upgradations accounted for the maximum number of key developments, at nearly 59% of the total developments in the clinical biomarkers market between January 2019 and December 2023. Numerous synergistic activities, fundings, and acquisitions of the market have also been tracked during the same time period.
Competitive Strategy: The global clinical biomarkers market is a highly fragmented market, with many smaller and private companies constantly entering the market. Key players in the clinical biomarkers market analyzed and profiled in the study involve established players that offer various kinds of products and services.
Methodology
Key Considerations and Assumptions in Market Engineering and Validation
• The base year considered for the calculation of the market size is 2022. A historical year analysis has been done for the period FY2019-FY2021. The market size has been estimated for FY2022 and projected for the period FY2023-FY2033.
• The scope of this report has been carefully derived based on interactions with experts in different companies across the world. This report provides a market study of clinical biomarkers.
• The market contribution of clinical biomarkers anticipated to be launched in the future has been calculated based on the historical analysis of the solutions.
• Revenues of the companies have been referenced from their annual reports for FY2022 and FY2023. For private companies, revenues have been estimated based on factors such as inputs obtained from primary research, funding history, market collaborations, and operational history.
• The market has been mapped based on the available clinical biomarker solutions. All the key companies with significant offerings in this field have been considered and profiled in this report.
Primary Research:
The primary sources involve industry experts in clinical biomarkers, including the market players offering centrifugation products and services. Resources such as specialists, scientists, marketing heads, researchers, CXOs, and manufacturing managers have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.
The key data points taken from the primary sources include:
• validation and triangulation of all the numbers and graphs
• validation of the report’s segmentation and key qualitative findings
• understanding the competitive landscape and business model
• current and proposed production values of a product by market players
• validation of the numbers of the different segments of the market in focus
• percentage split of individual markets for regional analysis
Secondary Research
Open Sources
• World Health Organization (WHO), National Institute of Health, National Medical Product Administration (NMPA), Food and Drug Administration (FDA), National Institute of Health (NIH) and PubMed, among others.
• Annual reports, SEC filings, and investor presentations of the leading market players
• Company websites and detailed study of their product portfolio
• Gold standard magazines, journals, white papers, press releases, and news articles
• Databases such as MarkerDB, Global Online Biomarker Platform (GOBIOM) and Cancer Biomarkers database
• Paid databases
The key data points taken from the secondary sources include:
• segmentations and percentage shares
• data for market value
• key industry trends of the top players of the market
• qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
• quantitative data for mathematical and statistical calculations
Introduction of Clinical Biomarkers Market
The global clinical biomarkers market was valued at $24.80 billion in 2023 and is expected to reach $53.20 billion by 2033, growing at a CAGR of 7.93% between 2023 and 2033. 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 molecular biomarkers that provide new targets for disease characterization, drug discovery, and development. The report focuses on the manufacturers of different types of tests based on biomarkers, namely prognostic, predictive, and diagnostic biomarkers, as well as services.
Market Introduction
As per BIS Research, the global clinical biomarkers market includes manufacturers and service providers offering proprietary biomarkers testing products and services for clinical diagnostics and research purposes. The study considers tests based on various technologies for different underlying applications in oncology and non-oncology diseases to detect biomarkers. However, the report does not cover instruments and software.
Industrial Impact
The global clinical biomarkers market is expected to witness high growth, attributed to the growing usage of products and services, the increasing key player initiatives, and the rising government initiatives in clinical biomarkers. The continued significant investments by healthcare companies to meet industry demand and the growing adoption of drug discovery and development, disease risk assessment, and others among major end users are the major factors propelling the growth of the global clinical biomarkers market. Drug discovery encompasses a rapidly evolving range of assays and systems that facilitate cancer biomarkers, cardiac biomarkers, infectious diseases, and others. Infectious diseases also offer prognostic assessments for a wide range of diseases, as well as assistance with treatment selection and monitoring of drug treatment efficacy.
Market Segmentation:
Segmentation 1: by Offering
• Product
o Efficacy Biomarker
o Safety Biomarker
o Validation Biomarker
• Service
o Genomic Biomarker Service
o Tissue Biomarker Service
o Cell Service
o Proteomics Service
Product Segment to Dominate the Clinical Biomarkers Market (by Offering)
Based on product, the global clinical biomarkers market was led by the product segment, with a 76.59% share in 2022. The report focuses on the manufacturers of different types of biomarkers, namely, prognostic, predictive, and diagnostic biomarkers. Acknowledging the future potential for massive growth in demand for biomarker-based assays, several biotechnology and life science companies, such as Illumina, Inc., Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., and F. Hoffmann-La Roche Ltd, have invested substantially to aid further developments in clinical biomarkers market.
Segmentation 2: by Clinical Area
• Cancer Biomarkers
• Cardiac Biomarkers
• Neurological Biomarkers
• Infectious Disease
• Immunological Biomarkers
• Non-Invasive Prenatal Testing
• Other Clinical Areas
Cancer Biomarkers to Witness the Highest Growth between 2023 and 2033
Cancer biomarkers are the biomolecules or the processes observed during the presence of the tumor. These biomolecules could be found in blood, serum, or any other body fluid, indicating the presence of any abnormal process. These biomarkers could be in the form of genetic biomarkers, protein biomarkers, and glycoproteins that are used for the diagnosis or prognosis of a tumor. A few of the biomarkers that have been diagnosed for the development of any diagnostic assay are BRCA1/BRCA2 and EGFR for breast cancer, SSC and TPA for lung cancer, and PSA for prostate cancer.
Segmentation 3: by Technology
• Next-Generation Sequencing (NGS)
• Polymerase Chain Reaction (PCR)
• Immunohistochemistry (IHC)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Other Technologies
Next-Generation Sequencing (NGS) to Witness the Highest Growth between 2023 and 2033
Based on technology, the clinical biomarkers market was led by next-generation sequencing, with a 31.55% share in 2022. Next-generation sequencing (NGS) has been increasingly used in cancer genomics research over the last decade (from 2010 to the present) as new sequencing technology has been developed and improved. NGS is a modern and alternative technique that allows clinicians to evaluate several genes of malignancy at the same time. Material from a patient's tumor that has been biopsied or surgically excised can be used for next-generation sequencing.
Segmentation 4: by End User
• Contract Research Organizations (CROs)
• Research and Academic Laboratories
• Biopharmaceutical and Biotech Companies
• Diagnostic Centers
• Other End Users
Contract Research Organization (CRO) to Witness the Highest Growth between 2023 and 2033
Contract research organizations (CROs) primarily use biomarker testing services for purposes related to bioanalysis in support of the pharmaceutical and biotechnology industry as well as research and academic institutions. Also, research and academic institutions are outsourcing identification and sequencing projects to CROs in an attempt to cut down on research costs. As a result, CROs form a considerable part of the end users in the clinical biomarkers market.
Segmentation 5: by Region
• North America
o U.S.
o Canada
• Europe
o Germany
o U.K.
o France
o Italy
o Spain
o Rest-of-Europe
• Asia-Pacific
o Japan
o India
o China
o South Korea
o Australia
o Rest-of-Asia-Pacific
• Latin America
o Brazil
o Mexico
o Rest-of-Latin America
• Rest-of-the-World
Recent Developments in the Global Clinical Biomarkers Market
• In August 2023, Quest Diagnostics launched the AD-Detect test for Alzheimer’s disease in the U.S., offering consumers the first opportunity to acquire and evaluate a blood-based biomarker test for assessing the potential risks of developing AD.
• In September 2023, Becton, Dickinson and Company partnered with Navigate BioPharma Services, Inc. to develop and commercialize flow cytometry-based companion diagnostics and clinical decision tools. The collaboration combined Navigate BioPharma's expertise in biomarker assay design for clinical trials with BD's extensive portfolio of flow cytometry instruments, reagents, software, and in vitro diagnostics (IVD) development services.
• In November 2023, Abbott Laboratories's Alinity i Lab-Based Blood Test was cleared by the FDA. The product is used to assess mild traumatic brain injury (TBI) or concussion in individuals using two biomarkers.
• In November 2023, Illumina Inc., a leader in DNA sequencing and array-based technologies, launched the updated TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2), a research assay designed for noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood. It is tailored for situations where tissue testing is unavailable or as a complement to tissue-based testing.
• In May 2023, Thermo Fisher Scientific Inc. declared that its BRAHMS PlGF plus KRYPTOR and BRAHMS sFlt-1 KRYPTOR biomarker immunoassays had received FDA clearance for assessing and managing the risk of preeclampsia.
Demand – Drivers, Challenges, and Opportunities
Market Demand Drivers:
Growing Demand for Clinical Biomarker Products: Due to the ever-rising cancer cases, the need for better products is becoming more evident. Several key players are aligning their technologies as per the market requirements to provide technologically advanced products and services by adopting inorganic strategies such as product launches. Globally, there has been a significant increase in the number of people suffering from different types of cancer. Incidence rates of cancer continue to increase, primarily owing to high-fidelity diagnostic and screening measures. Cancer prevalence has also been a major factor of concern for the global healthcare industry.
Market Challenges:
High Price of Products/Services Limiting Adoption of Clinical Biomarkers in Low-Income Countries: Despite a high opportunity for expansion in different regions, the need for high investment and infrastructure is the only reason restraining the market players from making investments. Expensive instruments are the major contributing factor to the high capital requirement. Therefore, the scale of capital investment required varies depending on the scale and abilities of the laboratory established. Though the global clinical biomarkers market possesses immense potential, the high capital investment requirement is hampering the expansion of global reach and thereby challenging the growth of the market globally.
Market Opportunities:
Technological Advancement in Biomarker Testing: Significant advancements have been achieved in biomarker detection technologies, leading to the development of various methods based on highly specific recognition biomarkers. Biomarker detection techniques encompass a range of approaches, including enzyme-linked immunosorbent assay (ELISA), gel electrophoresis, surface plasmon resonance (SPR), Mass-sensing BioCD protein array, surface-enhanced Raman spectroscopy (SERS), colorimetric assay, electrochemical assay, and fluorescence methods.
Analyst’s Thoughts
According to Swati Sood, Principal Analyst – BIS Research, “Growing demand for precision medicine and targeted therapies is in turn growing the demand for the clinical biomarkers market. This trend is expected to continue in the coming years due to its increasing awareness all over the world, including emerging countries.”
Clinical Biomarkers Market - A Global and Regional Analysis
Focus on Offering, Clinical Area, Technology, End User, and Region - Analysis and Forecast, 2023-2033
Frequently Asked Questions
Clinical biomarkers are measurable and quantifiable biological indicators or substances that are used to assess various physiological or pathological processes within the body. These biomarkers play a crucial role in healthcare and medical research by providing valuable information about a person's health status, disease progression, response to treatments, or overall well-being. Clinical biomarkers can encompass a wide range of molecules, including proteins, nucleic acids (DNA and RNA), metabolites, hormones, and various cellular or tissue characteristics.
Existing clinical biomarkers players are continually exploring various strategies to enhance their market position in the industry. Some of the key strategies include the expansion of their integration of artificial intelligence into biomarker discovery, increasing biomarker usage in precision medicine, and advancements of technologies in clinical biomarkers diagnosis, among others.
The following are the USPs of this report:
• Market regulations and a list of key trends in the clinical biomarkers market
• Market share of top clinical biomarkers manufacturers and service providers
• A competitive index of the market specific to the unmet needs and innovations of the key players
• Key challenges faced by manufacturers
• Market dynamic analysis of the opportunities, trends, and challenges in the market
• Competitive benchmarking of key players for each product type
The global clinical biomarkers report gives a detailed analysis of all aspects of the market. This can be useful to manufacturers, service providers, and any of the end users to make informed decisions and enable targeted marketing, strategic planning, product benchmarking, and better resource allocation, among other things.