Circulating Biomarkers Market Size to Hit USD 12.41 Billion by 2033

Circulating Biomarkers Market Size, Share, Growth, Segmental Analysis, By Biomarker Type (Circulating Tumor DNA — ctDNA, Circulating Tumor Cells — CTCs, Exosomes and Extracellular Vesicles, Cell-Free DNA — cfDNA, MicroRNA — miRNA, Proteins and Peptides, Metabolites, Others), By Technology (Next-Generation Sequencing, Polymerase Chain Reaction — PCR, Immunoassay, Microarray, Mass Spectrometry, Others), By Application (Oncology, Cardiovascular Disease, Neurological Disorders, Infectious Diseases, Autoimmune Diseases, Others), By End User (Hospitals and Diagnostic Laboratories, Academic and Research Institutes, Pharmaceutical and Biotechnology Companies, Contract Research Organizations), By Region (North America — U.S., Canada; Europe — Germany, UK, France, Italy, Rest of Europe; Asia Pacific — China, Japan, India, South Korea, Rest of Asia Pacific; Latin America; Middle East & Africa), and Market Forecast, 2026 – 2033

  • Published: Apr, 2026
  • Report ID: 411
  • Pages: 160+
  • Format: PDF / Excel.

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Circulating Biomarkers Market Size to Hit USD 12.41 Billion by 2033

(An Updated Version is Available)

1. Preface

  • 1.1 Report Description and Scope

  • 1.2 Research Objectives

  • 1.3 Key Assumptions and Limitations

  • 1.4 Target Audience

2. Executive Summary

  • 2.1 Market Overview and Snapshot

  • 2.2 Key Market Findings and Highlights

  • 2.3 Market Size Estimation and Forecast Summary

  • 2.4 Key Trends at a Glance

  • 2.5 Recommendations for Market Participants

3. Research Methodology

  • 3.1 Research Design and Approach

  • 3.2 Primary Research (Molecular Oncologists, Clinical Laboratory Directors, Liquid Biopsy Platform Developers, Biopharmaceutical R&D Heads, Precision Medicine KOLs, Hospital Procurement Managers)

  • 3.3 Secondary Research (Annual Reports, FDA 510(k)/PMA/Breakthrough Device Designation Databases, EMA Scientific Guidelines on Companion Diagnostics, NIH/NCI Cancer Genomics Atlas, ClinicalTrials.gov, AACR/ASCO/ESMO Publication Databases, MolDX Program Coverage Decisions, Horizon Europe Biomarker Funding Databases, Japan Precision Medicine Initiative Publications)

  • 3.4 Top-Down and Bottom-Up Estimation Approach

  • 3.5 Data Triangulation and Validation

  • 3.6 Market Forecast Assumptions and Key Parameters

4. Market Overview

  • 4.1 Introduction to Circulating Biomarkers and Their Transformative Role in Non-Invasive Early Disease Detection, Real-Time Monitoring, and Precision Therapeutics

  • 4.2 Historical Market Background and Evolution (Serum Protein Markers → CTC Enumeration → ctDNA PCR Detection → Next-Generation Liquid Biopsy → Multi-Omics AI-Integrated Panels → Multi-Cancer Early Detection [MCED] Blood Tests)

  • 4.3 Market Scope and Definition

    • 4.3.1 Circulating Tumor DNA (ctDNA) and Cell-Free DNA (cfDNA)

    • 4.3.2 Circulating Tumor Cells (CTCs)

    • 4.3.3 Cell-Free RNA (cfRNA) and Circulating MicroRNAs (miRNAs)

    • 4.3.4 Exosomes and Extracellular Vesicles (EVs)

    • 4.3.5 Circulating Proteins, Metabolites, and Epigenetic Biomarkers

  • 4.4 Parent Market and Adjacent Market Analysis (Liquid Biopsy, Molecular Diagnostics, In-Vitro Diagnostics, Companion Diagnostics, Precision Oncology, Genomics and Proteomics Research Tools)

  • 4.5 Regulatory Overview

    • 4.5.1 U.S. FDA Breakthrough Device Designation for Liquid Biopsy (Mercy BioAnalytics Ovarian Cancer FDA Breakthrough, May 2024; Guardant Shield CRC FDA Approval, July 2024)

    • 4.5.2 MolDX Program Medicare Coverage Decisions (Guardant Reveal MRD Coverage, January 2025; Lucence LiquidHALLMARK ctDNA/ctRNA Coverage, January 2025)

    • 4.5.3 EU IVD Regulation (IVDR) 2017/746 and Class C/D Performance Evaluation for Companion Diagnostic Biomarker Assays

    • 4.5.4 ISO 15189 Molecular Laboratory Accreditation and CLSI Liquid Biopsy Analytical Validation Guidelines

    • 4.5.5 Japan PMDA Precision Medicine Initiative, India CDSCO Molecular Diagnostic Rules, China NMPA Genomic Diagnostics Framework

    • 4.5.6 HIPAA/GDPR Compliance for Genomic and Biomarker Data Protection

  • 4.6 Technology and Innovation Timeline

    • 4.6.1 First-Generation: ELISA-Based Protein Biomarker Detection (PSA, CA125, CEA)

    • 4.6.2 Second-Generation: PCR-Based ctDNA and CTC Enumeration

    • 4.6.3 Third-Generation: NGS-Based Comprehensive Genomic Profiling (Foundation One Liquid CDx, Guardant360 CDx)

    • 4.6.4 Fourth-Generation: Digital PCR (ddPCR) for Ultrasensitive MRD and ctDNA Quantification

    • 4.6.5 Fifth-Generation: Multi-Omics AI-Integrated Platforms — Proteomics + Genomics + Epigenomics (MCED: GRAIL Galleri, Exact Sciences Cologuard Plus, DELFI FirstLook Lung)

    • 4.6.6 Emerging: CRISPR-Based Biomarker Detection, Portable Microfluidic Devices, AI-Powered Liquid Biopsy Signal Classification

  • 4.7 Liquid Biopsy vs. Tissue Biopsy vs. Imaging: Clinical Sensitivity, Turnaround Time, Patient Burden, Real-Time Monitoring, and Cost Comparison

  • 4.8 Circulating Biomarker Types Comparison: ctDNA vs. CTCs vs. miRNA vs. Exosomes vs. Proteins — Application Suitability, Detection Sensitivity, and Clinical Validation Status

5. Market Dynamics

  • 5.1 Market Drivers

    • 5.1.1 Rising Global Cancer Burden — WHO 2024 Reports 20 Million New Cancer Cases Annually; Urgent Need for Non-Invasive Early Detection and Real-Time Treatment Monitoring

    • 5.1.2 Expanding FDA Approvals and MolDX Medicare Coverage — Guardant Shield CRC Approval (July 2024), Guardant Reveal MRD Coverage (January 2025), Lucence LiquidHALLMARK ctDNA/ctRNA Coverage (January 2025)

    • 5.1.3 Rapid Technological Advancement in NGS, Digital PCR, and Multi-Omics Platforms Enabling Ultrasensitive, Comprehensive Circulating Biomarker Detection

    • 5.1.4 Surge in Companion Diagnostics (CDx) Co-Development — Pharma-Diagnostics Partnerships Mandating Circulating Biomarker Assays for Targeted Therapy Approvals (EGFR, KRAS, BRCA, ALK, PD-L1)

    • 5.1.5 Multi-Cancer Early Detection (MCED) Platform Commercialization — GRAIL Galleri (2024 NHS-ENGLAND Pilot: 140,000 Participants), Exact Sciences Cologuard Plus, DELFI FirstLook Lung

    • 5.1.6 Growing Demand for Minimal Residual Disease (MRD) Monitoring in Hematologic and Solid Tumor Oncology — ctDNA MRD as Surrogate Endpoint in Clinical Trials

    • 5.1.7 Increasing Government and Private Funding for Liquid Biopsy R&D — NIH/NCI Cancer Moonshot Initiative, EU Horizon Europe Biomarker Funding, Japan Precision Medicine Initiative

  • 5.2 Market Restraints

    • 5.2.1 High Cost of NGS-Based and Multi-Omics Liquid Biopsy Tests (USD 1,000–USD 5,000+ per Panel) Limiting Adoption in Resource-Constrained Settings

    • 5.2.2 Limited Standardization in ctDNA/CTC Pre-Analytical Variables — Sample Collection, Processing, and Storage Protocol Variability Affecting Reproducibility

    • 5.2.3 Reimbursement Uncertainty for Novel MCED and MRD Assays Beyond Currently Covered Indications — CMS Coverage With Evidence Development (CED) Constraints

    • 5.2.4 Fragmented Regulatory Pathway for Multi-Analyte Circulating Biomarker Panels — Differing FDA, EMA, NMPA, and CDSCO Classification and Validation Requirements

    • 5.2.5 Technical Challenges in Low ctDNA Shedding Tumors — Early-Stage, Low-Burden Cancers and Brain Tumors With Limited Blood-Barrier Penetration

  • 5.3 Market Opportunities

    • 5.3.1 MCED Platforms Entering Routine Screening — GRAIL Galleri NHS Pilot Expansion, DELFI Technologies FirstLook Lung, Exact Sciences Multi-Cancer Blood Test Scale-Up

    • 5.3.2 AI and Machine Learning Integration — Deep Learning Signal Classification for Low-Fraction ctDNA, cfRNA Methylation Pattern Analysis, and Digital Pathology Convergence

    • 5.3.3 Exosome and Extracellular Vesicle (EV) Biomarkers — Emerging Platform for Non-Cancer Disease Biomarker Discovery (CNS, Cardiovascular, Neurodegenerative)

    • 5.3.4 Circulating Biomarkers in Neurodegenerative Diseases — Plasma Phospho-Tau 217, Amyloid-Beta 42/40 Ratio for Blood-Based Alzheimer's Diagnosis (FDA Breakthrough Device — ALZpath pTau217 Assay)

    • 5.3.5 Expanding Cardiovascular Biomarker Applications — High-Sensitivity Troponin (hs-TnI, hs-TnT), NT-proBNP, and Novel Circulating Protein Panels for Acute MI and Heart Failure Risk

    • 5.3.6 Point-of-Care Liquid Biopsy — Portable Microfluidic and Biosensor Platforms for ctDNA/miRNA Detection in Decentralized and Low-Resource Settings

    • 5.3.7 Pharmacogenomics and Treatment Response Monitoring — Real-Time ctDNA Kinetics as Predictive Biomarker for Immunotherapy and Targeted Therapy Efficacy

  • 5.4 Market Challenges

    • 5.4.1 Clinical Utility Validation — Demonstrating That Circulating Biomarker-Guided Treatment Changes Improve Patient Outcomes vs. Standard-of-Care Monitoring

    • 5.4.2 Interoperability of Multi-Omics Biomarker Data Across Clinical LIS, EHR, and Regional Health Information Platforms

    • 5.4.3 Managing False-Positive Rates in MCED Screening — Preventing Unnecessary Invasive Follow-Up Procedures in Cancer-Free Patients

    • 5.4.4 Building Clinician Confidence and Education Around Interpretation of Novel Circulating Biomarker Reports in Routine Clinical Practice

6. Market Trends and Key Insights

  • 6.1 Oncology Segment Dominates Circulating Biomarker Applications (56.2% Share in 2026) — ctDNA and Liquid Biopsy Becoming Standard-of-Care for Advanced NSCLC, CRC, Breast, and Prostate Cancer Management

  • 6.2 Blood-Based Sample Type Retaining Largest Market Share — Venipuncture ctDNA/CTC/cfRNA Panels Preferred for Repeat Real-Time Monitoring; Urine and CSF Gaining Clinical Niche

  • 6.3 NGS Technology Segment Recording Fastest CAGR — Comprehensive Genomic Profiling (Foundation One Liquid CDx, Guardant360 CDx) Expanding Companion Diagnostic Co-Approval Footprint

  • 6.4 Multi-Cancer Early Detection (MCED) Entering Mainstream — GRAIL Galleri 140,000-Patient NHS England Pilot Generating Landmark Clinical Evidence for Population Screening Models

  • 6.5 MRD Monitoring Transforming Oncology Treatment Paradigms — ctDNA MRD as Regulatory-Accepted Surrogate Endpoint Driving Clinical Trial Design Across Hematology and Solid Tumors

  • 6.6 Blood-Based Alzheimer's Diagnosis Advancing Rapidly — ALZpath pTau217 Plasma Assay (FDA Breakthrough Device Designation), Plasma Amyloid-Beta 42/40 Enabling Pre-Symptomatic Neurology Biomarker Testing

  • 6.7 Strategic M&A and Partnerships Reshaping Competitive Landscape — Illumina–GRAIL Reacquisition (USD 8B), Exact Sciences–Ashion Analytics, Guardant Health–Novartis ctDNA CDx Partnership, Foundation Medicine–Roche Expanded Integration

  • 6.8 Decentralized and POC Liquid Biopsy Emerging — Microfluidic ctDNA Chips, CRISPR-Based Biosensor Panels, and AI-Powered Portable NGS Platforms Targeting Point-of-Care and LMIC Markets

7. Impact Assessment

  • 7.1 Impact of COVID-19 on the Circulating Biomarkers Market

    • 7.1.1 Pre-COVID Market Scenario

    • 7.1.2 Pandemic Impact: Disrupted Clinical Trial Enrollment, Lab Workflow Disruptions, but Accelerated At-Home Sample Collection and Remote Biomarker Monitoring Interest

    • 7.1.3 Post-COVID Realignment: Renewed NIH/NCI Investment in Cancer Early Detection, Telehealth-Linked Biomarker Testing, and MRD Monitoring Expansion

  • 7.2 Macroeconomic Indicators and Their Influence on Market Growth

  • 7.3 Impact of FDA Breakthrough Device Designations, MolDX Medicare Coverage Expansions (2024–2026), EU IVDR 2017/746 Transition, and CMS CED Policies on Market Access

  • 7.4 Geopolitical Factors — U.S.-China BIOSECURE Act Implications for BGI/MGI Genomic Platform Supply Chains, EU-U.S. Genomic Data Transfer Under Schrems II Framework, and Asia Pacific Precision Medicine Infrastructure Investment

8. Strategic Framework Analysis

  • 8.1 Value Chain Analysis

    • 8.1.1 Raw Material and Reagent Suppliers (cfDNA Extraction Kits, Sequencing Reagents, PCR Master Mixes, Reference Standards — Roche, QIAGEN, Thermo Fisher, IDT)

    • 8.1.2 Biomarker Discovery and Assay Development Organizations (Academic Research, CROs, Biomarker Platform Developers)

    • 8.1.3 Instrument and Platform Manufacturers (NGS: Illumina, Oxford Nanopore; ddPCR: Bio-Rad, Stilla Technologies; CTC: Menarini Silicon Biosystems, RareCyte)

    • 8.1.4 Diagnostic Kit and Companion Diagnostic Assay Manufacturers (Guardant Health, Foundation Medicine, Exact Sciences, Biocept)

    • 8.1.5 Clinical and Reference Laboratory Operators (Quest Diagnostics, LabCorp, NeoGenomics, Caris Life Sciences)

    • 8.1.6 Bioinformatics, AI, and Digital Pathology Platform Providers (Tempus AI, Sophia Genetics, Fabric Genomics)

    • 8.1.7 End Users — Hospitals, Academic Medical Centers, Oncology Research Institutes, Biopharmaceutical R&D, CROs

  • 8.2 Supply Chain Analysis and Risk Assessment (Sequencing Reagent Availability, BIOSECURE Act Impact on Chinese Genomic Platform Components, cfDNA Pre-Analytical Variable Standardization)

  • 8.3 Porter's Five Forces Analysis

    • 8.3.1 Threat of New Entrants (AI-Native Liquid Biopsy Startups, CRISPR Biosensor Platform Companies, MCED New Entrants)

    • 8.3.2 Bargaining Power of Buyers (Hospital Laboratory Networks, Biopharma CDx Co-Development Partners, CMS/Payer Systems)

    • 8.3.3 Bargaining Power of Suppliers (Illumina NGS Reagents, cfDNA Extraction Kit Suppliers, Reference Standard Providers)

    • 8.3.4 Threat of Substitute Diagnostic Approaches (Tissue Biopsy, Traditional Imaging, Protein Immunoassays, Proteomic Mass Spectrometry)

    • 8.3.5 Competitive Rivalry Among Existing Players

  • 8.4 SWOT Analysis of the Overall Market

  • 8.5 Pricing Analysis and Trends by Biomarker Type, Technology, and Clinical Application (USD 500–USD 5,000+ per Panel Range)

  • 8.6 Technology Landscape and Innovation Matrix

    • 8.6.1 Next-Generation Sequencing (NGS) — Targeted Panel, Whole-Exome, and Whole-Genome Liquid Biopsy Applications

    • 8.6.2 Digital PCR (ddPCR / cdPCR) — Ultrasensitive ctDNA Quantification and MRD Monitoring

    • 8.6.3 Polymerase Chain Reaction (PCR) and qRT-PCR — Established ctDNA, miRNA, and cfRNA Detection

    • 8.6.4 Immunoassay and ELISA-Based Circulating Protein and Metabolite Detection

    • 8.6.5 CTC Isolation and Characterization Platforms — DEPArray NxT, CellSearch, RareCyte, OncoDiscover

    • 8.6.6 Exosome and Extracellular Vesicle Capture and Profiling Technologies

    • 8.6.7 AI and Machine Learning for Multi-Omics Liquid Biopsy Signal Classification and Clinical Decision Support

    • 8.6.8 Microfluidics and Point-of-Care Biosensor Platforms for Decentralized ctDNA/miRNA Detection

  • 8.7 IP and Patent Landscape (ctDNA Detection, MCED Algorithm, CTC Microfluidic Isolation, Exosome Cargo Analysis Patent Clusters — Guardant, Illumina/GRAIL, Foundation Medicine, Exact Sciences)

  • 8.8 M&A Activity, Strategic Partnerships, and Funding Landscape (2022–2026)

  • 8.9 Regulatory and Standards Landscape by Region (FDA Breakthrough Device/510(k)/PMA, MolDX Coverage, EU IVDR 2017/746, ISO 15189, CLSI Liquid Biopsy Guidelines, NMPA, CDSCO, PMDA)

  • 8.10 Drivers Impact Analysis on CAGR

9. Global Circulating Biomarkers Market — By Biomarker Type

  • 9.1 Overview and Market Size, 2026–2033

  • 9.2 Circulating Tumor DNA (ctDNA) and Cell-Free DNA (cfDNA)

    • 9.2.1 Somatic Mutation Detection (EGFR, KRAS, BRCA1/2, ALK, ROS1 — Companion Diagnostic Applications)

    • 9.2.2 Copy Number Variation and Chromosomal Instability (CNA/CIN) Analysis

    • 9.2.3 DNA Methylation and Epigenetic Profiling for Multi-Cancer Early Detection (GRAIL Galleri Methylation Panel)

    • 9.2.4 MRD Detection via ctDNA Kinetics (Guardant Reveal, Signatera MRD, FoundationOne Tracker)

    • 9.2.5 Market Size, Share, and Forecast (Dominant Biomarker Type: Highest Clinical Validation, FDA-Approved CDx Applications, Expanding MCED Adoption)

  • 9.3 Circulating Tumor Cells (CTCs)

    • 9.3.1 CTC Enumeration and Prognostic Monitoring (CellSearch — FDA-Cleared for Breast, Colorectal, Prostate)

    • 9.3.2 CTC Single-Cell Genomic and Proteomic Characterization

    • 9.3.3 CTC-Derived Xenograft (CDX) Models for Drug Sensitivity Testing

    • 9.3.4 Market Size, Share, and Forecast (Established Clinical Utility in Metastatic Setting; Innovation in Single-Cell Analysis Driving Platform Upgrades)

  • 9.4 Circulating RNA (cfRNA) and MicroRNA (miRNA)

    • 9.4.1 cfRNA-Based Tissue-of-Origin Cancer Classification

    • 9.4.2 miRNA Panels for Hepatocellular Carcinoma, Lung Cancer, and Cardiovascular Risk

    • 9.4.3 Lucence LiquidHALLMARK ctDNA + ctRNA Combined Panel (MolDX Coverage January 2025)

    • 9.4.4 Market Size, Share, and Forecast (Fastest Growing Biomarker Type: Multi-Analyte Multi-Omics Panels Demonstrating Superior Clinical Sensitivity)

  • 9.5 Exosomes and Extracellular Vesicles (EVs)

    • 9.5.1 Exosome-Derived Protein and Nucleic Acid Cargo Analysis

    • 9.5.2 EV-Based CNS Biomarker Detection (Neurodegenerative, Psychiatric Applications)

    • 9.5.3 Market Size, Share, and Forecast (High-Growth Research Platform: Clinical Validation Advancing Toward Diagnostic-Grade Applications)

  • 9.6 Circulating Proteins and Peptides

    • 9.6.1 High-Sensitivity Troponin (hs-TnI, hs-TnT) and NT-proBNP for Cardiovascular Disease

    • 9.6.2 Plasma Phospho-Tau 217 and Amyloid-Beta 42/40 Ratio for Alzheimer's Disease (ALZpath pTau217 — FDA Breakthrough Device)

    • 9.6.3 Tumor-Associated Protein Markers (PSA, CA-125, CEA, AFP, CA 19-9)

    • 9.6.4 Market Size, Share, and Forecast (Widest Established Clinical Adoption Across Multiple Therapeutic Areas — Oncology, Cardiology, Neurology)

  • 9.7 Circulating Metabolites and Epigenetic Markers

    • 9.7.1 Metabolomic Liquid Biopsy for Colorectal, Pancreatic, and Ovarian Cancer

    • 9.7.2 DNA Methylation and Hydroxymethylation Patterns for Multi-Cancer Detection

    • 9.7.3 Market Size, Share, and Forecast

10. Global Circulating Biomarkers Market — By Technology

  • 10.1 Overview and Market Size, 2026–2033

  • 10.2 Next-Generation Sequencing (NGS)

    • 10.2.1 Targeted Gene Panel Sequencing (Guardant360 CDx, Foundation One Liquid CDx, Tempus xF+)

    • 10.2.2 Whole-Exome Sequencing (WES) Liquid Biopsy

    • 10.2.3 Whole-Genome Sequencing (WGS) and Low-Pass WGS for CNA/Methylation Analysis

    • 10.2.4 Long-Read Liquid Biopsy Sequencing (Oxford Nanopore, PacBio)

    • 10.2.5 Market Size, Share, and Forecast (Fastest Growing Technology: Comprehensive Genomic Profiling, CDx Co-Approval, MCED Platform Backbone)

  • 10.3 Polymerase Chain Reaction (PCR) and qRT-PCR

    • 10.3.1 Real-Time qPCR for ctDNA Hotspot Mutation Detection

    • 10.3.2 Multiplex PCR for cfRNA and miRNA Panels

    • 10.3.3 Market Size, Share, and Forecast (Dominant Technology by Volume: Cost-Effective, Widely Validated, Broad Laboratory Infrastructure Availability)

  • 10.4 Digital PCR (ddPCR / cdPCR)

    • 10.4.1 Droplet Digital PCR (ddPCR) — Bio-Rad QX200/QX600 for MRD and Low-Allele-Fraction ctDNA Detection

    • 10.4.2 Crystal Digital PCR — Stilla Technologies naica System for Ultrasensitive Liquid Biopsy

    • 10.4.3 Market Size, Share, and Forecast (High CAGR: Superior Sensitivity for Early-Stage and MRD Applications vs. qPCR)

  • 10.5 Immunoassays

    • 10.5.1 ELISA and Chemiluminescent Immunoassay (CLIA) for Circulating Protein Biomarkers

    • 10.5.2 Multiplexed Immunoassay Platforms (Luminex xMAP, MSD Electrochemiluminescence, Olink Proximity Extension Assay)

    • 10.5.3 Market Size, Share, and Forecast (Established Clinical Standard for Cardiovascular, Neurological, and Tumor Protein Biomarkers)

  • 10.6 Flow Cytometry

    • 10.6.1 CTC Identification, Phenotyping, and Functional Characterization

    • 10.6.2 Immune Cell Subtype Enumeration for Immunotherapy Biomarker Monitoring

    • 10.6.3 Market Size, Share, and Forecast

  • 10.7 Microfluidics and Biosensor Platforms

    • 10.7.1 Lab-on-Chip ctDNA and CTC Isolation Devices

    • 10.7.2 Electrochemical Biosensors for Point-of-Care miRNA and Protein Detection

    • 10.7.3 Market Size, Share, and Forecast (Emerging Technology: POC Liquid Biopsy in Decentralized and LMIC Settings)

  • 10.8 Others (Mass Spectrometry for Metabolomics and Proteomics, CRISPR-Based Nucleic Acid Detection, Surface Plasmon Resonance)

11. Global Circulating Biomarkers Market — By Application

  • 11.1 Overview and Market Size, 2026–2033

  • 11.2 Oncology

    • 11.2.1 Early Cancer Detection and Multi-Cancer Early Detection (MCED)

      • 11.2.1.1 GRAIL Galleri Methylation-Based MCED (NHS England 140,000-Patient Pilot)

      • 11.2.1.2 DELFI Technologies FirstLook Lung cfDNA Fragmentation-Based NSCLC Screening

      • 11.2.1.3 Exact Sciences Cologuard Plus and Multi-Cancer Blood Test

    • 11.2.2 Treatment Selection and Companion Diagnostics

      • 11.2.2.1 NSCLC — EGFR Exon 19/21 Deletion, ALK/ROS1 Fusion ctDNA (Roche Cobas EGFR, Guardant360 CDx)

      • 11.2.2.2 Colorectal Cancer — KRAS/NRAS/BRAF Liquid Biopsy (Therascreen, Guardant Shield CRC FDA Approval July 2024)

      • 11.2.2.3 Breast Cancer — ESR1 Mutation, PIK3CA, HER2 Amplification ctDNA Monitoring

      • 11.2.2.4 Prostate Cancer — AR-V7 CTC and ctDNA for Enzalutamide/Abiraterone Resistance

      • 11.2.2.5 Hematologic Malignancies — BCR-ABL MRD, FLT3/NPM1 ctDNA, CAR-T Response Monitoring

    • 11.2.3 Minimal Residual Disease (MRD) Monitoring

      • 11.2.3.1 Guardant Reveal MRD ctDNA Panel (MolDX Medicare Coverage January 2025)

      • 11.2.3.2 Signatera Tumor-Informed MRD (Natera — NSCLC, CRC, Urothelial, Breast)

      • 11.2.3.3 FoundationOne Tracker Personalized MRD Panel

    • 11.2.4 Recurrence Surveillance and Treatment Response Monitoring

    • 11.2.5 Market Size, Share, and Forecast (56.2% Dominant Share in 2026: Largest Cancer Burden, CDx-Driven Regulatory Coverage, MRD Standard-of-Care Integration)

  • 11.3 Cardiovascular Diseases

    • 11.3.1 Acute Myocardial Infarction (AMI) Diagnosis — High-Sensitivity Troponin I/T (hs-TnI/hs-TnT) as Gold Standard

    • 11.3.2 Heart Failure Risk Stratification — NT-proBNP, BNP, ST2, Galectin-3

    • 11.3.3 Atherosclerosis and Plaque Vulnerability — Lipoprotein(a), Oxidized LDL, Inflammatory Cytokine Panels

    • 11.3.4 Atrial Fibrillation, Stroke, and Thromboembolism Circulating Biomarker Panels

    • 11.3.5 Market Size, Share, and Forecast (Significant Share: Broad Established Reimbursement, WHO CVD Burden — 17.9 Million Deaths Annually)

  • WHO CVD Burden — 17.9 Million De1.4.1 Alzheimer's Disease — Plasma Phospho-Tau 217, Amyloid-Beta 42/40, NfL (ALZpath pTau217 FDA Breakthrough Device Designation)

    • 11.4.2 Parkinson's Disease — Alpha-Synuclein and NfL Plasma Biomarkers

    • 11.4.3 Multiple Sclerosis — Serum NfL as Treatment Response and Disease Activity Biomarker

    • 11.4.4 Traumatic Brain Injury (TBI) — GFAP and UCH-L1 Blood Biomarkers (FDA-Cleared Banyan BTI)

    • 11.4.5 Market Size, Share, and Forecast (Fastest Growing Application: FDA Breakthrough Designations for Blood-Based Alzheimer's Diagnosis Driving Investment and Clinical Validation)

  • 11.5 Infectious Diseases

    • 11.5.1 Pathogen-Derived cfDNA for Sepsis Source Identification and Antimicrobial Stewardship (Karius Test — MolDX Covered)

    • 11.5.2 HIV/HBV/HCV Circulating Nucleic Acid Load Monito WHO CVD Burden — 17.9 Million Denfectious Disease Monitoring via dd-cfDNA

    • 11.5.4 Market Size, Share, and Forecast

  • 11.6 Transplant Medicine

    • 11.6.1 Donor-Derived Cell-Free DNA (dd-cfDNA) for Solid Organ Rejection Monitoring (Allosure — dd-cfDNA Heart/Lung/Kidney — MolDX Covered)

    • 11.6.2 Market Size, Share, and Forecast (Growing: Non-Invasive Rejection Monitoring Reducing Surveillance Biopsy Burden)

  • 11.7 Other Applications

    • 11.7.1 Prenatal Testing — Cell-Free Fetal DNA (cffDNA) for NIPT (Natera Panorama, Illumina VeriSeq NIPS)

    • 11.7.2 Autoimmune Disease Biomarker Panels

    • 11.7.3 Metabolic Disease and Diabetes Monitoring

    • 11.7.4 Market Size, Share, and Forecast

12. Global Circulating Biomarkers Market — By End User

  • 12.1 Overview and Market Size, 2026–2033

  • 12.2 Hospitals and Clinical Laboratories

    • 12.2.1 Hospital-Based Molecular Oncology Laboratories

    • 12.2.2 Clinical and Reference Laboratories (Quest Diagnostics, LabCorp, NeoGenomics, Caris Life Sciences)

    • 12.2.3 Market Size, Share, and Forecast (Dominant End User: Highest Volume Turnover, CDx Testing at Point-of-Treatment, EHR-Integrated Biomarker Reporting)

  • 12.3 Pharmaceutical and Biotechnology Companies

    • 12.3.1 ctDNA-Based Patient Stratification for Clinical Trial Enrollment and Companion Diagnostic Co-Development

    • 12.3.2 Pharmacodynamic Biomarker Monitoring for Drug Development Programs

    • 12.3.3 Market Size, Share, and Forecast (Significant CAGR: Growing Pharma-Diagnostics CDx Co-Development Agreements, FDA Accelerated Approval Biomarker Surrogate Endpoint Requirements)

  • 12.4 Research and Academic Institutes

    • 12.4.1 University-Based Translational Oncology and Liquid Biopsy Research Laboratories

    • 12.4.2 Government Research Programs (NCI, NIH, NIHR, DBT-India, CNRS France)

    • 12.4.3 Market Size, Share, and Forecast

  • 12.5 Contract Research Organizations (CROs)

    • 12.5.1 Biomarker-Enabled Clinical Trial Support Services (Circulating Biomarker Central Laboratory, Reference Standard Supply)

    • 12.5.2 Market Size, Share, and Forecast

  • 12.6 Others

    • 12.6.1 Blood Banks and Transfusion Medicine Centers (dd-cfDNA Post-Transplant)

    • 12.6.2 Public Health Surveillance and Epidemiological Research Programs

    • 12.6.3 Market Size, Share, and Forecast

13. Global Circulating Biomarkers Market — By Region

  • 13.1 Market Overview by Geography

  • 13.2 North America

    • 13.2.1 Market Size and Forecast (Dominant Region: FDA Regulatory Leadership, MolDX Coverage Expansion, NCI Cancer Moonshot Investment, Largest CDx Market Globally)

    • 13.2.2 United States (GRAIL Guardant Health, Foundation Medicine, Exact Sciences, Natera — All Headquartered in U.S.; Guardant Shield FDA Approval July 2024; ALZpath pTau217 Breakthrough Device)

    • 13.2.3 Canada

    • 13.2.4 Key Drivers, Trends, and Market Dynamics

  • 13.3 Europe

    • 13.3.1 Market Size and Forecast (EU IVDR 2017/746 Driving Platform Re-Validation; NHS England GRAIL Galleri 140,000-Patient Pilot; Horizon Europe Biomarker Funding)

    • 13.3.2 Germany (Leading Liquid Biopsy Research Hub, GMP Molecular Diagnostics Manufacturing)

    • 13.3.3 United Kingdom (NHS GRAIL Galleri Pilot Expansion, NIHR Clinical Biomarker Research Integration)

    • 13.3.4 France (CNRS/INSERM Exosome and ctDNA Research, INCa Cancer Research Biomarker Programs)

    • 13.3.5 Italy

    • 13.3.6 Spain

    • 13.3.7 Rest of Europe

    • 13.3.8 Key Drivers, Trends, and Market Dynamics

  • 13.4 Asia Pacific

    • 13.4.1 Market Size and Forecast (Fastest Growing Region: Japan Precision Medicine Initiative, China NMPA Genomic Diagnostics, India DBT Biomarker Research Funding)

    • 13.4.2 China (BGI Genomics Liquid Biopsy, GenomiCare ctDNA Platform; BIOSECURE Act Implications for U.S. Market Access; NMPA Expanding CDx Approvals)

    • 13.4.3 Japan (PMDA Precision Medicine Framework, Toray miRNA Panel for Gastric and Colorectal Cancer; Japan Biomarker Initiative JBA)

    • 13.4.4 India (Lucence LiquidHALLMARK India Launch, Cambrian Bioworks NGS Expansion, CDSCO Molecular Diagnostic Rules)

    • 13.4.5 South Korea (K-BIO Precision Genomics Initiative, Samsung Medical Center Liquid Biopsy Programs)

    • 13.4.6 Australia (Genomics Health Australia, Unique CRC/Prostate Cancer ctDNA Clinical Validation Studies)

    • 13.4.7 Southeast Asia

    • 13.4.8 Rest of Asia Pacific

    • 13.4.9 Key Drivers, Trends, and Market Dynamics

  • 13.5 Latin America

    • 13.5.1 Market Size and Forecast

    • 13.5.2 Brazil (Growing Oncology Infrastructure, ctDNA Testing Reimbursement Pilots)

    • 13.5.3 Mexico

    • 13.5.4 Rest of Latin America

    • 13.5.5 Key Drivers, Trends, and Market Dynamics

  • 13.6 Middle East and Africa

    • 13.6.1 Market Size and Forecast

    • 13.6.2 GCC Countries (Saudi Arabia, UAE — National Oncology Programs, Government Precision Medicine Investment)

    • 13.6.3 South Africa

    • 13.6.4 Rest of Middle East and Africa

    • 13.6.5 Key Drivers, Trends, and Market Dynamics

14. Competitive Landscape

  • 14.1 Market Structure and Competitiveness Overview (Moderately Concentrated: Guardant Health, Foundation Medicine/Roche, and Exact Sciences as Dominant Players; Active Innovation Pipeline From Natera, GRAIL, and Emerging Startups)

  • 14.2 Market Share Analysis of Key Players

  • 14.3 Competitive Positioning Matrix

  • 14.4 Key Strategies Adopted by Market Leaders

    • 14.4.1 FDA Approval and MolDX Coverage Acceleration — Guardant Shield CRC Approval (July 2024), Guardant Reveal MRD (January 2025), Lucence LiquidHALLMARK (January 2025)

    • 14.4.2 Population-Scale MCED Commercialization — GRAIL Galleri NHS England 140,000-Patient Pilot, DELFI FirstLook Lung Screening Rollout

    • 14.4.3 Strategic Pharma-Diagnostics CDx Partnerships — Guardant Health–Novartis, Foundation Medicine–Roche Expanded Integration, Exact Sciences–Ashion Analytics

    • 14.4.4 AI and Bioinformatics Platform Differentiation — Tempus AI Multi-Omics Platform, Sophia Genetics AI-Powered Variant Classification, GRAIL Galleri Deep Learning Methylation Algorithm

    • 14.4.5 International Market Expansion and Regulatory Filings — Lucence Diagnostics APAC Expansion, Biocept EMEA Partnerships, Natera Signatera Multi-Country MRD Launch

  • 14.5 Recent Developments and Industry News (2024–2026)

  • 14.6 Technology and Product Pipeline Analysis

15. Company Profiles
(The final report includes a complete list of companies)

  • 15.1 Guardant Health, Inc.

    • 15.1.1 Company Overview

    • 15.1.2 Financial Performance

    • 15.1.3 Product Portfolio

    • 15.1.4 Strategic Initiatives

    • 15.1.5 SWOT Analysis

  • 15.2 Foundation Medicine, Inc. (Roche Group)

  • 15.3 Exact Sciences Corporation

  • 15.4 Natera, Inc.

  • 15.5 GRAIL, Inc. (Illumina)

  • 15.6 Roche Diagnostics

  • 15.7 Qiagen N.V.

  • 15.8 Thermo Fisher Scientific, Inc.

  • 15.9 Bio-Rad Laboratories, Inc.

  • 15.10 Biocept, Inc.

  • 15.11 Tempus AI, Inc.

  • 15.12 NeoGenomics Laboratories, Inc.

  • 15.13 Caris Life Sciences

  • 15.14 Lucence Diagnostics Pte. Ltd.

  • 15.15 DELFI Diagnostics, Inc.

16. Appendix

  • 16.1 Abbreviations and Acronyms

  • 16.2 List of Tables

  • 16.3 List of Figures

  • 16.4 About the Publisher

  • 16.5 Research Process and Data Sources

17. Disclaimer

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