U.S. Liquid Biopsy Market Growth Fueled by Precision Medicine

Revenue, 2025

USD 2.44 Billion

Forecast, 2035

USD 8.90 Billion

CAGR, 2026-2035

13.82%

Report Coverage

United States

U.S. Liquid Biopsy Market Size, Key Players with Growth and Trends

The U.S. liquid biopsy market size was estimated at USD 2.44 billion in 2025 and is predicted to increase from USD 2.78 billion in 2026 to approximately USD 8.90 billion by 2035, expanding at a CAGR of 13.82% from 2026 to 2035.

The U.S. liquid biopsy market is rapidly evolving, driven by rising demand for non-invasive cancer diagnostics and advancements in genomic technologies. Increasing adoption of precision medicine, coupled with growing awareness of early cancer detection benefits, is fueling market growth. Continuous innovations in circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) assays, along with strong research collaborations, are shaping the competitive landscape.

Key Takeaways

• The U.S. liquid biopsy market will likely exceed USD 2.78 billion by 2026.
• Valuation is projected to hit USD 8.90 billion by 2035.
• Estimated to grow at a CAGR of 13.82% starting from 2026 to 2035.
• The global liquid biopsy market is expected to grow from USD 7.08 billion in 2025 to USD 27.42 billion by 2035, at a CAGR of 14.5%.
• By biomarker type, the circulating tumor DNA (ctDNA) segment registered its dominance over the U.S. market in 2025.
• By biomarker type, the RNA (microRNA, mRNA) segment is expected to grow with the highest CAGR in the market during the studied years.
• By technology/platform, the next-generation sequencing (NGS) segment held the largest revenue in the market in 2025.
• By technology/platform, the epigenetic analysis segment is expected to show the fastest growth over the forecast period.
• By test type/application stage, the therapy selection/companion diagnostics segment held a dominant presence in the U.S. liquid biopsy market in 2025.
• By test type/application stage, the minimal residual disease (MRD) detection segment is expected to witness the fastest growth in the market over the forecast period.
• By cancer type (indication area), the lung cancer segment registered its dominance over the U.S. market in 2025.
• By cancer type (indication area), the pancreatic cancer segment is expected to grow with the highest CAGR in the market during the studied years.
• By product & service type, the services segment contributed the biggest revenue in the market in 2025.
• By product & service type, the software & bioinformatics tools segment is expected to grow at the fastest CAGR in the market during the forecast period.
• By clinical setting/end user, the reference laboratories segment registered its dominance over the U.S. market in 2025.
• By clinical setting/end user, the biopharmaceutical & biotechnology companies segment is expected to grow with the highest CAGR in the market during the studied years.
• By sample type, the blood (plasma/serum) segment registered its dominance over the U.S. liquid biopsy market by 2025.
• By sample type, the cerebrospinal fluid (CSF) segment is expected to grow with the highest CAGR in the market during the studied years.

Key Indicators and Highlights

Is Liquid Biopsy the Future of Cancer Detection in the U.S.?

Liquid biopsy is a non-invasive diagnostic technique that detects cancer-related biomarkers, such as circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), from blood or other body fluids. The U.S. liquid biopsy market is driven by factors including rising cancer prevalence, increasing demand for early detection, advancements in genomic and molecular technologies, growing adoption of precision medicine, and supportive government initiatives promoting cancer research and diagnostic innovation, which collectively fuel market growth and enhance patient outcomes through timely and accurate diagnostics.

Can AI Revolutionize the U.S. Liquid Biopsy Market?

AI integration can significantly enhance the U.S. liquid biopsy industry by improving the accuracy, speed, and efficiency of cancer detection. Machine learning algorithms can analyze complex genomic and molecular data from circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), identifying patterns that might be missed by traditional methods. AI-powered tools enable predictive analytics for disease progression, personalized treatment planning, and early detection of relapse. Additionally, automation of data interpretation reduces human error, accelerates clinical decision-making, and optimizes research and development. Overall, AI fosters more precise, cost-effective, and scalable liquid biopsy solutions, advancing patient care and outcomes.

Trends & Future Outlook of the U.S. Liquid Biopsy Market

• Early Cancer Detection: Liquid biopsies are increasingly used for early-stage cancer diagnosis, enabling timely treatment interventions and improved survival rates.
• Expansion Beyond Oncology: Research is exploring liquid biopsies for other diseases, such as cardiovascular and infectious conditions, broadening clinical applications.
• Partnerships and Collaborations: Companies are collaborating with academic institutions and biotech firms to accelerate innovation and regulatory approvals.
• Non-Invasive Monitoring: Liquid biopsies are increasingly preferred for monitoring treatment response and detecting cancer relapse, reducing the need for invasive tissue biopsies.

Estimated New Cancer Cases in the U.S. in 2025

Rising cases of cancer have driven the growth of the liquid biopsy market in the U.S.

Major Government Initiatives in the U.S. Liquid Biopsy Market

U.S. Boosts Liquid Biopsy Research and Precision Oncology Investments in 2025

In 2025, the U.S. government continued supporting the advancement of liquid biopsy technologies, especially through federally backed research consortia and funding programs. The Liquid Biopsy Consortium, backed by the National Cancer Institute, funds academic-industry collaboration to validate early cancer detection methods using circulating tumor DNA, RNA, and exosomes.

U.S. Government, Federal Agencies Back Liquid Biopsy Innovation

•  In 2025, the U.S. National Institutes of Health (NIH) launched a precompetitive collaboration to accelerate liquid biopsy research and early cancer detection tools, bringing together academic, industry, and regulatory stakeholders to expand precision oncology diagnostics.  
• In October 2024, the Quad Cancer Moonshot Initiative, a multinational effort including the United States, prioritizes the development and deployment of next‑generation liquid biopsy technologies to reduce cancer burden through enhanced early detection. 

Segmental Insights

Biomarker Type Insights

Which Biomarker Type Segment Dominated the U.S. Liquid Biopsy Market?

The circulating tumor DNA (ctDNA) segment dominates the U.S. market due to its high sensitivity for early cancer detection, ability to monitor minimal residual disease, and suitability for guiding personalized therapy. Technological advancements in next-generation sequencing, non-invasive sample collection, and increasing clinical adoption further accelerate its growth and widespread application.

Circulating Tumor DNA (ctDNA)

The RNA (microRNA, mRNA) segment is estimated to be the fastest-growing in the U.S. liquid biopsy market due to its high stability in blood, ability to reflect real-time gene expression changes, and strong potential for early cancer detection and prognosis. Advances in RNA sequencing technologies, growing research on RNA-based biomarkers, and their utility in personalized medicine further drive adoption and clinical relevance.

Technology/Platform Insights

Why Did the Next-Generation Sequencing (NGS) Segment Dominate the U.S. Liquid Biopsy Market?

The next-generation sequencing (NGS) segment dominates the U.S. market due to its high accuracy, ability to analyze multiple genetic mutations simultaneously, and suitability for comprehensive genomic profiling. Growing adoption in precision medicine, technological advancements reducing costs, and increasing use in early cancer detection, treatment monitoring, and research applications further strengthen its leading position.

Epigenetic Analysis

The epigenetic analysis segment is anticipated to be the fastest-growing in the U.S. market due to its ability to detect cancer-specific DNA methylation patterns and other epigenetic modifications with high sensitivity. Advancements in sequencing technologies, growing research on epigenetic biomarkers, and their potential for early cancer detection and personalized therapy are driving rapid adoption in clinical and research settings.

Test Type/Application Stage Insights

Why Did Therapy Selection/Companion Diagnostics Segment Dominate the U.S. Liquid Biopsy Market?

The therapy selection/companion diagnostics segment dominates the U.S. market due to its critical role in guiding personalized cancer treatment. By identifying specific genetic mutations and biomarkers, it enables targeted therapy decisions, improves treatment outcomes, and is increasingly integrated into precision medicine, driving widespread clinical adoption.

Minimal Residual Disease (MRD) Detection

The minimal residual disease (MRD) detection segment is estimated to be the fastest-growing in the U.S. market due to its ability to detect tiny amounts of cancer cells remaining post-treatment. High sensitivity, early relapse detection, and guidance for therapy adjustments drive adoption, making it a critical tool in precision oncology and patient monitoring.

Cancer Type (Indication Area) Insights

Which Technology/Mode of Action Segment Led the U.S. Liquid Biopsy Market?

The lung cancer segment dominates the U.S. market due to the high prevalence of lung cancer, the critical need for early detection, and the availability of targeted therapies. Liquid biopsies enable non-invasive mutation profiling, treatment monitoring, and personalized therapy selection, driving widespread adoption in clinical oncology for lung cancer patients.

Pancreatic Cancer

The pancreatic cancer segment is anticipated to be the fastest-growing in the U.S. liquid biopsy market due to the disease’s typically late diagnosis and poor prognosis. Liquid biopsies enable early detection, monitoring of treatment response, and identification of actionable biomarkers, driving increasing adoption in research and clinical settings for improved patient outcomes.

Product & Service Type

Why Did the Services Segment Dominate the U.S. Liquid Biopsy Market?

The services segment dominates the U.S. market due to the high demand for specialized testing, clinical support, and diagnostic interpretation. Outsourced laboratory services, customized analysis, and growing adoption of precision medicine contribute to its prominence, as healthcare providers increasingly rely on service-based solutions for accurate and efficient liquid biopsy testing.

Software & Bioinformatics Tools

The software & bioinformatics tools segment is estimated to be the fastest-growing in the U.S. liquid biopsy market due to increasing data complexity from genomic analyses, the need for accurate interpretation of ctDNA and CTC results, and integration with AI-driven analytics. These tools enhance diagnostic precision, enable personalized therapy decisions, and accelerate research applications.

Clinical Setting/End-User Insights

Which Reference Laboratories Segment Led the U.S. Liquid Biopsy Market?

The reference laboratories segment dominates the market due to their advanced infrastructure, specialized expertise, and ability to process high volumes of complex tests. Strong partnerships with healthcare providers, extensive quality control measures, and the growing demand for outsourced, reliable diagnostic services further reinforce their leading position in the market.

Biopharmaceutical & Biotechnology Companies

The biopharmaceutical & biotechnology companies segment is anticipated to be the fastest-growing in the U.S. liquid biopsy market due to increased investment in R&D, focus on developing targeted therapies, and partnerships for diagnostic innovation. Rising demand for precision medicine and advanced biomarker-driven drug development further drives the rapid adoption of liquid biopsy solutions in this segment.

Sample Type Insights

Why Did the Blood (Plasma/Serum) Segment Dominate the U.S. Liquid Biopsy Market?

The blood (plasma/serum) segment dominates the U.S. market due to its non-invasive collection, high concentration of circulating tumor DNA (ctDNA) and cell-free nucleic acids, and compatibility with advanced molecular and genomic assays. Its reliability, widespread clinical adoption, and ability to provide accurate, real-time cancer monitoring make it the preferred sample type.

Cerebrospinal Fluid (CSF)

The cerebrospinal fluid (CSF) segment is estimated to be the fastest-growing in the U.S. liquid biopsy market due to its ability to detect central nervous system (CNS) tumors and metastases with high sensitivity. CSF provides direct access to tumor-derived biomarkers, enabling early diagnosis, monitoring of disease progression, and personalized therapy, driving increasing adoption in neuro-oncology.

Business Model Insights

Which Treatment Line / Usage Segment Led the U.S. Liquid Biopsy Market?

The centralized testing lab segment dominates the U.S. market due to its advanced infrastructure, high-throughput capabilities, and specialized expertise in processing complex genomic and molecular tests. Strong quality control, regulatory compliance, and established partnerships with healthcare providers make centralized labs the preferred choice for accurate and reliable liquid biopsy testing.

Direct-To-Consumer (DTC) Testing Model

The direct-to-consumer (DTC) testing model segment is anticipated to be the fastest-growing in the U.S. liquid biopsy market due to increasing consumer awareness, demand for convenient and non-invasive testing, and the rise of personalized health monitoring. Easy access, rapid results, and growing adoption of at-home diagnostic solutions drive its rapid market growth.

Percentage Share of Total New Cancer Cases

Global Liquid Biopsy Market Growth

The global liquid biopsy market size is projected to reach USD 27.42 billion by 2035, growing from USD 7.08 billion in 2025, at a CAGR of 14.5% during the forecast period from 2026 to 2035, as a result of technological advancements in cancer diagnostics, and rising preference for minimally invasive cancer diagnostics.

U.S. Liquid Biopsy Market Value Chain Analysis

Research and Development (R&D):

• The R&D phase involves the discovery and validation of novel biomarkers such as circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and RNA fragments. Biotechnology and biopharmaceutical companies, along with academic institutions, focus on developing highly sensitive assays and optimizing detection technologies. Government-funded programs and research consortia support innovation and early-stage validation studies.
• Organizations: Guardant Health, Grail, Illumina, Foundation Medicine, NIH-funded research programs, and academic institutions.

Clinical Trials & Regulatory Approval:

• In this phase, liquid biopsy assays undergo rigorous multi-phase clinical trials to establish their safety, efficacy, and diagnostic accuracy. Clinical research organizations (CROs), hospitals, and specialized laboratories collaborate to recruit patients, monitor outcomes, and collect critical data required for regulatory evaluation. These trials ensure that the technology meets clinical performance standards. Regulatory authorities, primarily the U.S. Food and Drug Administration (FDA), review trial data to ensure compliance with diagnostic and therapeutic regulations. Additional guidance and support may come from initiatives like the National Cancer Institute (NCI) and ARPA-H. Approval is granted only after rigorous evaluation, enabling the assays to enter the U.S. healthcare market.
• Organizations: Clinical research organizations (CROs), NCI-supported trials, hospital networks, specialized laboratories, U.S. FDA, ARPA-H, and other federal oversight agencies.

Patient Support and Services:

• Once approved, patient support and services encompass sample collection, testing, result interpretation, and counseling. Centralized testing labs, reference laboratories, and direct-to-consumer service providers play key roles in delivering reliable, timely, and personalized diagnostic solutions, supporting clinical decision-making and ongoing patient monitoring.
• Organizations:  Labcorp, Quest Diagnostics, centralized testing labs, DTC liquid biopsy providers.

Top Vendors in the U.S. Liquid Biopsy Market & Their Offerings

SWOT Analysis

Strengths:

• Non-invasive diagnostic approach, reducing the need for tissue biopsies.
• Ability to detect cancer early and monitor minimal residual disease (MRD).
• High adoption of precision medicine and integration with next-generation sequencing (NGS) technologies.
• Strong presence of innovative companies and advanced R&D infrastructure.

Weaknesses:

• High cost of tests limits accessibility in some healthcare settings.
• Limited standardization of assays and variability across laboratories.
• Low awareness among certain patient populations and physicians.

Opportunities:

• Growing applications beyond oncology, including cardiovascular and infectious disease diagnostics.
• Increasing integration of AI and bioinformatics for enhanced data interpretation.
• Expansion of direct-to-consumer (DTC) testing and patient-centric services.
• Supportive government initiatives and funding for biomarker research.

Threats:

• Regulatory challenges and complex FDA approval processes.
• Competition from conventional tissue biopsies and alternative diagnostic methods.
• Reimbursement constraints and insurance coverage limitations.
• Potential privacy and ethical concerns with genomic data handling.

Recent Developments in the U.S. Liquid Biopsy Market

• In December 2025, at the 2025 San Antonio Breast Cancer Symposium (Dec 9–12), Guardant Health highlighted 14 abstracts demonstrating the clinical utility of its liquid biopsy tests, including Guardant Reveal and Guardant360 Liquid, for predicting outcomes and tailoring treatment in early and metastatic breast cancer.
• In September 2025, Exact Sciences, a company providing tests for cancer prevention, revealed the debut of Cancerguard, a blood‑based multi‑cancer early detection (MCED) test, the first commercially available MCED in the U.S., analyzing multiple biomarker classes to detect more than 50 cancer types. The test is offered as a laboratory‑developed test and is accessible through Quest Diagnostics’ nationwide collection network.
• In April 2025, Labcorp broadened its precision oncology offerings by introducing Labcorp Plasma Detect to help assess recurrence risk in stage III colon cancer patients. Additionally, the PGDx elio plasma focus Dx test, FDA‑authorized as the first kitted, pan‑solid tumor liquid biopsy, became available to identify patients who may benefit from targeted treatments.
• On April 22, 2025, Guardant Health announced it would present 18 research abstracts at the AACR 2025 Annual Meeting, highlighting advances in multi‑cancer detection and liquid/tissue molecular profiling using its Guardant Infinity smart liquid biopsy platform. This underscores ongoing innovation in using multiomic data to inform oncology care.

Segments Covered in the Report

By Biomarker Type

• Circulating Tumor Cells (CTCs)
• Circulating Tumor DNA (ctDNA)
• Extracellular Vesicles (Exosomes & Microvesicles)
• Cell-free DNA (cfDNA)
• RNA (microRNA, mRNA)
• Proteins
• Others (e.g., metabolites)

By Technology/Platform

• Next-Generation Sequencing (NGS)
• PCR-based Methods 
  • Digital PCR (dPCR)
  • Real-time PCR (qPCR)
• Microarrays
• Beads, Emulsions, Amplification, and Magnetics (BEAMing)
• Epigenetic Analysis
• Immunoassays (for protein biomarkers)

By Test Type / Application Stage

• Screening / Early Detection
• Diagnosis
• Prognosis
• Therapy Selection / Companion Diagnostics
• Minimal Residual Disease (MRD) Detection
• Recurrence Monitoring / Surveillance
• Treatment Response Monitoring

By Cancer Type (Indication Area)

• Lung Cancer (NSCLC, SCLC)
• Breast Cancer
• Colorectal Cancer
• Prostate Cancer
• Pancreatic Cancer
• Ovarian Cancer
• Melanoma
• Bladder Cancer
• Liver Cancer
• Others (e.g., hematological malignancies)

By Product & Service Type

• Kits & Reagents
• Instruments/Devices
• Software & Bioinformatics Tools
• Services
  
  • Laboratory Testing Services
  • Sample Collection & Analysis
  • Data Interpretation Services

By Clinical Setting / End-User

• Hospitals & Clinics
• Reference Laboratories
• Academic & Research Institutes
• Biopharmaceutical & Biotechnology Companies
• Contract Research Organizations (CROs)
• Government & Public Health Agencies

By Sample Type

• Blood (Plasma/Serum)
• Urine
• Saliva
• Cerebrospinal Fluid (CSF)
• Other Biofluids (e.g., pleural effusion, ascites)

By Business Model

• Test Kit Manufacturers
• Centralized Testing Labs (e.g., Guardant Health, Foundation Medicine)
• Decentralized Platforms
• Direct-to-Consumer (DTC) Testing Models
• Partnership-based Companion Diagnostics (CDx)