Fluid Biopsy Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Other) By Type (Circulating Tumor Cells, Circulating Tumor DNA, Cell-free DNA), By Region, & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 11.92 Billion
CAGR (2026-2031)	12.23%
Fastest Growing Segment	Breast Cancer
Largest Market	North America
Market Size (2031)	USD 23.82 Billion

Market Overview

The Global Fluid Biopsy Market will grow from USD 11.92 Billion in 2025 to USD 23.82 Billion by 2031 at a 12.23% CAGR. The Global Fluid Biopsy Market, technically referred to as liquid biopsy, comprises diagnostic technologies that analyze biological fluids such as blood or urine to detect tumor-derived markers including circulating tumor cells and DNA. The primary drivers propelling this market are the clinical requirement for minimally invasive alternatives to surgical tissue extraction and the critical need for repeated sampling to monitor disease progression. These factors allow clinicians to obtain real-time genomic information and adjust therapeutic regimens without subjecting patients to the risks and recovery times associated with conventional solid tissue biopsies.

The continued expansion of this sector is further necessitated by the rising incidence of oncological conditions which demands scalable and efficient diagnostic capability. According to the American Cancer Society, in 2025, it is projected that the United States will witness approximately 2,041,910 new cancer cases. Despite this clear demand, a significant challenge impeding market growth is the inconsistency in reimbursement coverage and payer policies, which creates financial barriers for healthcare providers and restricts widespread patient access to these diagnostic tests.

Key Market Drivers

The growing adoption of precision medicine and companion diagnostics is significantly advancing the Global Fluid Biopsy Market, as healthcare providers increasingly rely on blood-based tests to guide targeted therapy selection. This shift is characterized by the integration of circulating tumor DNA analysis into routine clinical workflows, allowing for precise patient stratification without the invasiveness of tissue biopsies. The escalating demand for these diagnostics is reflected in the operational metrics of leading industry players, indicating a robust shift toward non-invasive monitoring. According to Natera, January 2025, the company processed approximately 528,200 oncology tests in the full year 2024, representing a substantial increase of 54.9% compared to the prior year. This rapid uptake demonstrates the critical role liquid biopsy now plays in detecting minimal residual disease and optimizing treatment regimens, thereby reinforcing the market's upward trajectory.

Simultaneously, a surge in public and private funding is fueling the research and development necessary to enhance assay sensitivity and commercialize new screening modalities. Robust financial support allows diagnostic companies to conduct pivotal clinical trials and scale operations to meet global demand. According to Geneoscopy, Inc., January 2025, the organization secured $105 million in a Series C funding round to advance the commercial launch of its non-invasive colorectal cancer screening test. This influx of capital validates the commercial potential of emerging technologies and supports broader market penetration. Highlighting the sector's overall financial health, according to Guardant Health, February 2025, the company reported a total revenue of $739 million for the full year 2024, marking a 31% increase driven by expanding clinical test volumes.

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Key Market Challenges

The inconsistency in reimbursement coverage and payer policies directly hampers the growth of the Global Fluid Biopsy Market by creating significant financial uncertainty for healthcare providers and commercial laboratories. Although liquid biopsy offers distinct clinical advantages, the high costs associated with next-generation sequencing and genomic analysis necessitate robust insurance support. When commercial payers classify these diagnostic tests as investigational or restrict coverage to narrow clinical indications, healthcare facilities face the risk of claim denials and non-payment. This financial liability discourages the widespread adoption of fluid biopsy protocols in routine clinical practice, forcing clinicians to rely on traditional, invasive tissue sampling methods that are more reliably reimbursed by standard codes.

Furthermore, this disparity in payer policies restricts market expansion by limiting patient access based on geography and insurance type rather than clinical need. Without uniform coverage mandates, patients often encounter prohibitive out-of-pocket expenses, leading to refused testing and lost market volume. The extent of this barrier is highlighted by recent policy data regarding access. According to the American Cancer Society Cancer Action Network, as of June 2025, only 18 states had enacted legislation requiring state-regulated health plans to provide coverage for comprehensive biomarker testing. This fragmented reimbursement landscape limits the scalability of diagnostic services and stalls broader market penetration.

Key Market Trends

The emergence of Multi-Cancer Early Detection (MCED) tests is fundamentally reshaping the market by transitioning diagnostics from single-organ screening to simultaneous pan-cancer analysis. Unlike traditional methods that investigate symptomatic patients, these assays utilize methylation patterns and circulating cell-free DNA to screen asymptomatic populations for dozens of malignancies with a single blood draw. This capability addresses the clinical gap for cancers lacking standard screening protocols, thereby significantly expanding the addressable patient population. The commercial traction of this segment is evident in recent financial performance. According to GRAIL, Inc., November 2024, the company reported that revenue for its Galleri test reached $25.4 million in the third quarter of 2024, marking a 52% increase compared to the prior year period.

Simultaneously, the market is witnessing a critical expansion into non-oncology applications, particularly within neurology and organ transplant monitoring. Developers are increasingly validating blood-based biomarkers to detect neurodegenerative conditions such as Alzheimer’s disease and to assess allograft health, moving liquid biopsy beyond its traditional oncology boundaries. This diversification allows manufacturers to mitigate the cyclical risks of the cancer diagnostics sector and tap into rising demand for non-invasive neurological assessments. Highlighting this sector's growth, according to Quanterix Corporation, November 2024, the organization achieved a total revenue of $35.7 million for the third quarter of 2024, a 13% increase driven largely by the acceleration of its neurology-focused diagnostic services.

Segmental Insights

The breast cancer segment currently registers as the fastest-growing category within the Global Fluid Biopsy Market due to the rising prevalence of the disease and a heightened demand for non-invasive diagnostic solutions. This expansion is significantly driven by regulatory milestones, including approvals from the U.S. Food and Drug Administration for blood-based companion diagnostics that detect specific genetic mutations. These approvals allow clinicians to monitor treatment response and identify recurrence risks more frequently than traditional methods permit, thereby accelerating the clinical adoption of fluid biopsy for breast cancer management.

Regional Insights

North America holds the largest share of the Global Fluid Biopsy Market due to significant investment in medical research and established healthcare infrastructure. The region benefits from the high concentration of major diagnostic companies and reimbursement structures that support clinical testing. Furthermore, initiatives funded by the National Cancer Institute accelerate the development of non-invasive detection methods. The US Food and Drug Administration further drives market growth by approving new diagnostic tests for clinical use. These factors collectively establish North America as the dominant region for fluid biopsy adoption and revenue generation.

Recent Developments

• In October 2025, AccuGenomics, Inc. and 1Cell.Ai announced a strategic collaboration to deliver ultra-sensitive liquid biopsy testing services. This partnership focused on integrating AccuGenomics' internal standards technology into 1Cell.Ai's multi-omic precision oncology platform to enhance the accuracy and sensitivity of cancer diagnostics. The collaboration aimed to provide clinically actionable liquid biopsy testing through a clinical laboratory in India, serving cancer patients across the Asian market. By embedding specific quality controls within every patient sample, the companies sought to improve reproducibility and reduce false negatives in next-generation sequencing tests for colorectal and lung cancers.
• In June 2025, Tempus AI, Inc. introduced a new liquid biopsy assay known as xM for treatment response monitoring. This innovative diagnostic tool was developed to detect molecular responses to immune-checkpoint inhibitor therapies in patients suffering from advanced solid tumors. The assay functioned by quantifying changes in circulating tumor DNA from blood samples over time, enabling early assessment of how well a patient was responding to immunotherapy. Although initially available for research use, the company planned for the assay to become clinically available later in the year to help physicians refine treatment strategies.
• In July 2024, Guardant Health, Inc. launched a significant upgrade to its widely used Guardant360 liquid biopsy test, which was designed to run on the company's Guardant Infinity smart liquid biopsy platform. This enhanced test provided the capability to evaluate biomarkers in 739 genes, representing a ten-fold increase in cancer biomarkers compared to the previous version. The upgraded diagnostic tool allowed oncologists to identify a more extensive array of actionable and emerging biomarkers to precisely characterize cancers and quantify disease burden with much higher sensitivity, ultimately aiming to improve treatment planning for patients with advanced solid tumors.
• In March 2024, Bayer AG and Thermo Fisher Scientific Inc. announced a strategic collaboration to develop next-generation sequencing-based companion diagnostic assays. The partnership aimed to identify patients who would benefit from Bayer's precision cancer therapies by offering decentralized genomic testing with rapid turnaround times. These diagnostic tests were designed to be developed using Thermo Fisher's Oncomine Dx Express Test on the Ion Torrent Genexus Dx System, a fully integrated platform capable of delivering results on a patient's tumor or liquid biopsy sample in as little as 24 hours, thereby improving patient access to targeted treatments.

Key Market Players

• Bio-Rad Laboratories
• Guardant Health Inc.
• Illumina, Inc.
• Qiagen NV
• Laboratory Corporation of America Holdings
• F. Hoffmann-La Roche AG
• Thermo Fisher Scientific Inc.
• Johnson & Johnso
• Biocept Inc.
• Bio-Rad Laboratories, Inc.

By Indication	By Type	By Region
Lung Cancer Breast Cancer Colorectal Cancer Other	Circulating Tumor Cells Circulating Tumor DNA Cell-free DNA	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Fluid Biopsy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Fluid Biopsy Market, By Indication:

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Other

• Fluid Biopsy Market, By Type:

• Circulating Tumor Cells
• Circulating Tumor DNA
• Cell-free DNA

• Fluid Biopsy Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE