U.S. Liquid Biopsy Market

Market Definition

The liquid biopsy market comprises products, technologies, and services that are used to detect and analyze tumor-derived biomarkers from minimally invasive body fluid samples, primarily blood, for disease diagnosis, monitoring, and treatment guidance. The market includes biomarker detection platforms, consumables, instruments, and associated software and services utilized across oncology, infectious disease, reproductive health, and other clinical applications, supporting precision medicine and improving patient management.

Liquid Biopsy Market Overview

The U.S. liquid biopsy market was valued at USD 1,261.1 million in 2025 and is estimated to grow from USD 1,419.6 million in 2026 to reach USD 3,545.3 million by 2033, registering a CAGR of 13.79% over the forecast period (2026-2033). The market growth is attributed to the growing demand for non-invasive biopsy procedures that provide insights into a complex genomic landscape and intratumoral heterogeneity of cancer tumors. Tissue biopsy remains the standard for cancer diagnosis and treatment strategy formulation. However, increasing demand for minimally invasive and early detection solutions is expanding the clinical adoption of liquid biopsy technologies in the U.S.

Major companies, including Abbott, Caris Life Sciences, Exact Sciences Corporation, F. Hoffmann-La Roche Ltd, GRAIL, Inc., Guardant Health, Inc., Illumina, Inc., Myriad Genetics, Inc., NeoGenomics, Inc., and Thermo Fisher Scientific, are emphasizing portfolio expansion through product launches, technological advancements, and investments in precision oncology solutions to strengthen their market presence.

• In April 2025, Labcorp introduced the Labcorp Plasma Detect blood test to assess the risk of disease recurrence in stage III colon cancer patients. The company also launched PGDx elio plasma focus Dx, a pan-solid tumor liquid biopsy test authorized by the U.S. Food and Drug Administration (FDA) to identify patients for targeted therapies. 

Key Market Highlights:

• The U.S. liquid biopsy market size was USD 1,261.1 million in 2025.
• The market is projected to grow at a CAGR of 13.79% from 2026 to 2033.
• The ctDNA segment captured the largest share of 43.45% in 2025 and garnered USD 547.7 million in revenue in 2025.
• The NGS segment was valued at USD 608.0 million in 2025.
• The kits & reagents (consumables) segment held the largest share of 61.43% in 2025, with a valuation of USD 774.7 million.
• The infectious disease segment is estimated to register the fastest growth rate of 15.53% over the forecast period.
• The hospital segment garnered the highest share of 40.13%, generating USD 506.1 million in 2025.

How do advancements in cancer diagnosis and precision oncology drive market growth?

Cancer is the second-leading cause of casualties in the U.S., with more than 1.8 million new cancer diagnoses and more than 0.6 million deaths annually. Conventional tissue biopsies require invasive procedures, such as surgery or needle extraction, posing risks of complications, particularly for tumors in hard-to-reach areas. Liquid biopsy offers a non-invasive method, involving the analysis of body fluids, typically blood, to detect tumor-derived biomarkers. This approach enables healthcare professionals to detect cancer, guide therapy selection, and monitor treatment response over time. Furthermore, the expanding applications of liquid biopsy align with precision oncology objectives, supporting targeted research through tumor DNA analysis. This facilitates data-driven therapy selection, continuous monitoring, and advancements in oncology research.

• In May 2026, the U.S. FDA approved Guardant360 Liquid CDx, an advanced liquid biopsy panel that expands its genomic footprint by 100 times compared to its previous version. The test integrates genomic and epigenomic data from a single blood draw, enhancing detection sensitivity and supporting more informed treatment decisions for advanced cancer patients.

How do technical and operational limitations restrain the growth of the U.S. liquid biopsy market?

Liquid biopsy is a nascent technology, limiting its widespread integration into standard clinical practice. The procedure may miss critical genetic alterations in early disease states owing to low concentrations of circulating tumor DNA (ctDNA). This can delay diagnosis and the timely administration of life-saving therapeutics. Additionally, high costs, limited insurance coverage, and unclear reimbursement pathways restrict adoption. Liquid biopsy tests require rapid sample transport, specialized processing, and advanced sequencing infrastructure, which are generally unavailable in community or under-resourced settings, thereby limiting availability. Moreover, limited clinician familiarity, along with patient and regulatory hesitation, further slows adoption. To address this challenge, market players are focusing on developing advanced liquid biopsy technologies that enhance sensitivity, improve diagnostic accuracy, and enable earlier cancer detection.

• In March 2026, Volition launched a liquid biopsy technology capable of achieving over 99% purity in isolating ctDNA from blood samples using its proprietary Capture-Seq platform. The technology combines physical enrichment and bioinformatic analysis to separate cancer-derived DNA from healthy cell-free DNA, thereby improving detection accuracy.  

• In February 2025, Researchers at Oregon Health & Science University developed the PAC-MANN test to enable earlier detection of pancreatic disease. The test uses a small blood sample to identify changes in protease activity, a key indicator of pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. 

How is the adoption of AI-guided liquid biopsy emerging as a notable trend in the market?

AI is broadening the scope of liquid biopsy by improving diagnostic performance and enabling rapid analysis of hundreds of proteomic signatures of cancer-related circulating proteins and nucleic acids. Its adoption supports the interpretation of complex, multi-parametric, and non-homogeneous oncology datasets, generating predictive signatures for clinical decision-making. The process utilizes machine learning models to analyze circulating tumor DNA (ctDNA) from blood-based DNA sequencing data, enhancing signal-to-noise ratios and enabling earlier detection of cancer recurrence compared to conventional clinical methods.

The integration of AI algorithms and deep learning models to leverage high-dimensional fragmentomic features is improving cancer detection accuracy and enabling analysis of fragment size profiles for early tumor microenvironment identification, emerging as a key market trend. In January 2026, researchers at Memorial Sloan Kettering Cancer Center, New York, developed an AI-powered liquid biopsy that integrates carbon nanotube nanosensors with machine learning, achieving 98% accuracy in detecting and classifying brain tumors from blood samples.

• In June 2025, Dxcover entered the U.S. liquid biopsy sector to accelerate the commercialization of its AI-powered PANAROMIC multiomic cancer detection platform. The non-invasive blood test combines infrared spectroscopy with AI-driven analysis to enable early detection of multiple cancers, including brain, colorectal, lung, and pancreatic cancer.

Liquid Biopsy Market Report Snapshot

 Market Segmentation

• By Biomarker (ctDNA, CTC, cfDNA (non-tumor), Extracellular Vesicles & Exosomes, and Others): The ctDNA segment accounted for the largest share of 43.45% in 2025, generating USD 547.7 million in revenue. The dominance is attributed to its technical reliability and stability in analyzing tumor genetics compared to other biomarkers. 

• By Technology Platform (NGS, PCR Based (PCR, qPCR, Digital PCR), Microarray, and Others): The NGS segment was valued at USD 608.0 million in 2025 and is anticipated to reach USD 1783.6 million in 2033. This growth is driven by its ability to detect multiple mutations simultaneously and identify emerging biomarkers. 

• By Product Type (Kits & Reagents (Consumables), Instruments, and Software & Services): The kits & reagents (consumables) segment held the largest share of 61.43% in 2025, valued at USD 774.7 million. This is primarily due to their recurring usage requirement across all tests. 

• By Application (Oncology (Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer, Others), Infectious Disease, Reproductive Health, and Others): The oncology segment accounted for the largest share of 89.45% in 2025, reaching USD 1,128.1 million. This growth is fueled by its ability to capture systematic tumor heterogeneity and identify resistance mutations with minimally invasive procedures compared to tissue biopsies. 

• By End User (Hospitals, Diagnostic & Clinical Laboratories, Reference Laboratories, and Others): The hospital segment held the largest share of 40.13%, generating USD 506.1 million in 2025. This expansion is supported by high patient volumes, availability of specialized oncology expertise, and advanced diagnostic infrastructure.

What is the market scenario in the U.S. in the liquid biopsy market?

The presence of a well-established healthcare ecosystem in the U.S., comprising research laboratories and medical facilities, along with per capita healthcare spending that is nearly twice the global average, presents significant growth opportunities for the adoption of liquid biopsy solutions. Cancer screening plays a vital role in reducing mortality by enabling early detection of tumors before metastasis and facilitating the removal of precancerous lesions. Early detection further enables timely and less intensive treatment interventions, improving the likelihood of cure and survival rates. According to the U.S. National Institutes of Health (NIH), nearly 4.75 million deaths have been prevented through screening over the last 45 years, supporting the adoption of non-invasive cancer detection methods in the country.

Moreover, according to the American Cancer Society (ACS), approximately 2.1 million new cancer cases are anticipated to be diagnosed in the U.S. in 2026, with deaths projected to reach nearly 626,000. Key risk factors, including excessive UV exposure and behavioral factors such as tobacco use, high body mass index, physical inactivity, and poor dietary habits, continue to drive cancer incidence and mortality. This drives the demand for early diagnosis and treatment approaches, creating growth opportunities for liquid biopsy technologies.

• In February 2026, the U.S. government enacted the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act, allowing Medicare coverage for FDA-approved MCED tests upon CMS determination. This initiative expands access to advanced cancer screening technologies and supports early-stage detection, improving patient outcomes.

Regulatory Frameworks

• The U.S. Food and Drug Administration (FDA), through the Center for Devices and Radiological Health (CDRH) and in collaboration with the Oncology Center of Excellence (OCE), regulates oncology diagnostic devices to ensure safety, effectiveness, and clinical reliability. The agency also supports innovation by approving advanced technologies, including companion diagnostics, AI-based diagnostic tools, and molecular testing platforms, while maintaining rigorous safety standards.

• The U.S. FDA Pre-Market Approval PMA (Class III) regulatory framework provides guidelines for scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. The devices support or sustain human life and are critical in preventing impairment of human health, thereby requiring a PMA application under section 515 of the FD&C Act prior to commercialization.

Competitive Landscape

The U.S. liquid biopsy market has rapidly transitioned from a niche concept to a mainstream clinical tool in diagnostics. Market growth is driven by evolving federal policies aimed at improving patient outcomes and reducing cancer mortality through accurate detection of ctDNA and biomarkers. This advancement enables companies to evaluate safety, efficacy and monitor emerging therapeutics, supporting disease diagnosis and market expansion.

Companies are prioritizing strategic acquisitions and technical collaborations to strengthen their market presence across the U.S. Additionally, investments from government agencies, including those from the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services, aimed at combating cancer research and treatment are creating new growth opportunities for market development.

• In November 2025, Inspira Technologies signed a term sheet to acquire advanced liquid biopsy cancer diagnostics technology and secured an investment of USD 15 million at a valuation of USD 180 million. 

• In November 2025, Abbott acquired Exact Sciences for approximately USD 21 billion to expand its presence in cancer screening and precision oncology diagnostics. The acquisition adds key diagnostic products, including Cologuard, Oncotype DX, Cancerguard, and Oncodetect to Abbott's portfolio, strengthening its capabilities in cancer detection, treatment guidance, and monitoring. 

Key Companies In The U.S. Liquid Biopsy Market:

• Abbott
• Adaptive Biotechnologies
• Caris Life Sciences
• Exact Sciences Corporation
• Hoffmann-La Roche Ltd
• GRAIL, Inc.
• Guardant Health, Inc.
• Illumina, Inc.
• Myriad Genetics, Inc.
• Natera, Inc.
• Naveris
• NeoGenomics, Inc.
• Northstar Liquid Biopsy
• Thermo Fisher Scientific
• Veracyte, Inc.

 Recent Developments 

• In December 2025, Vortex Liquid Biopsy Solutions initiated a clinical study with The Doctors Laboratory (TDL) to evaluate its live-cell liquid biopsy technology. The study focuses on real-time cancer treatment monitoring, integrating AI-driven analysis via AxonDx to identify biomarkers and detect emerging therapeutic resistance. 

• In September 2025, Myriad Genetics and SOPHiA GENETICS collaborated to develop a global liquid biopsy companion diagnostic (CDx) test. The partnership will initially focus on developing MSK-ACCESS powered by SOPHiA DDM, a liquid biopsy test that detects actionable genomic alterations from a single blood draw.