Breast Cancer Liquid Biopsy Testing Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Offerings (Assay & Reagents Kits, Instruments), By Circulating Biomarker (Circulating Tumor DNA, Circulating Tumor Cell, Extracellular Vesicles), By Application (Cancer Applications, Non-Cancer Applications), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 895.36 Million
CAGR (2026-2031)	17.41%
Fastest Growing Segment	Circulating Tumor DNA
Largest Market	North America
Market Size (2031)	USD 2345.46 Million

Market Overview

The Global Breast Cancer Liquid Biopsy Testing Devices Market will grow from USD 895.36 Million in 2025 to USD 2345.46 Million by 2031 at a 17.41% CAGR. Breast Cancer Liquid Biopsy Testing Devices encompass diagnostic platforms and assay kits designed to isolate and analyze circulating tumor DNA or circulating tumor cells from blood samples for oncological assessment. The market growth is primarily driven by the increasing incidence of breast carcinomas and the clinical imperative for frequent and non-invasive monitoring of treatment resistance. This demand is further supported by the shift toward precision medicine which requires granular genomic profiling without the risks associated with repeated tissue biopsies. According to the American Cancer Society, in 2025, approximately 316,950 women will be diagnosed with invasive breast cancer in the United States, underscoring the critical need for scalable diagnostic solutions to manage this expanding patient population.

One significant challenge hampering the widespread expansion of this market is the lack of standardized reimbursement policies and the high cost associated with next-generation sequencing assays. Inconsistent coverage across different healthcare systems creates financial barriers that limit patient access to these molecular diagnostic tools. Furthermore, the variability in assay sensitivity and the requirement for substantial clinical validation data to secure regulatory approval continue to delay market entry for new entrants, thereby impeding rapid commercial adoption.

Key Market Drivers

The Rising Global Incidence and Prevalence of Breast Cancer constitutes the foundational driver propelling the demand for scalable liquid biopsy solutions. As the burden of disease intensifies worldwide, healthcare systems are increasingly prioritizing non-invasive tools that can provide frequent genomic profiling without the logistical and clinical complications of tissue extraction. This escalating patient population necessitates high-throughput screening and monitoring capabilities that only molecular diagnostics can efficiently sustain on a global scale. According to the World Health Organization, August 2025, in the 'Breast cancer' key facts, there were an estimated 2.3 million women diagnosed with breast cancer globally in 2022, highlighting the massive addressable market for advanced diagnostic interventions.

Simultaneously, Advancements in Next-Generation Sequencing (NGS) and Digital PCR Technologies are removing technical barriers to entry and accelerating commercial adoption. These technological innovations have significantly enhanced the sensitivity of assays, allowing for the precise detection of low-frequency circulating tumor DNA mutations that were previously undetectable, thereby validating the clinical utility of liquid biopsies for treatment selection and recurrence monitoring. This technical maturation is directly reflected in the surging volume of clinical testing. According to Natera, Inc., February 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', the company processed approximately 151,000 oncology tests in the fourth quarter alone, representing a 55% increase year-over-year. This rapid uptake is indicative of a broader market trend where financial viability is improving alongside clinical efficacy; According to Guardant Health, in 2025, the company reported that its oncology revenue grew to $184.4 million in the third quarter, underscoring the lucrative expansion of blood-based cancer diagnostics.

Download Free Sample Report

Key Market Challenges

The lack of standardized reimbursement policies and the high costs associated with next-generation sequencing assays present a formidable barrier to the expansion of the Global Breast Cancer Liquid Biopsy Testing Devices Market. Insurers frequently classify these advanced molecular tests as investigational rather than medically necessary, resulting in fragmented coverage and unpredictable payment models across different healthcare regions. This financial ambiguity discourages clinicians from prescribing liquid biopsies, as they cannot ensure that patients will be insulated from significant expenses. Consequently, clinical laboratories face difficulties in justifying the capital investment required for these diagnostic platforms, effectively slowing the operational momentum needed for market expansion.

These economic hurdles directly restrict patient access to precision medicine, narrowing the addressable market for device manufacturers. When third-party payers deny claims or impose high deductibles, patients often decline testing despite its potential to guide therapy or monitor recurrence. According to the American Cancer Society Cancer Action Network, in 2025, a report indicated that over 70% of commercially-insured patients encountered out-of-pocket expenses for follow-up breast cancer diagnostic tests. This financial toxicity forces patients to opt for less expensive, invasive alternatives or delay testing entirely, thereby reducing the testing volume necessary to drive commercial growth and technological innovation in the sector.

Key Market Trends

The Rising Adoption of Minimal Residual Disease (MRD) Monitoring is transforming clinical protocols by enabling the detection of microscopic tumor fragments long before radiological recurrence. This trend addresses the critical gap in post-surgical surveillance, where traditional imaging often fails to identify occult metastases until they are clinically advanced. By utilizing tumor-informed assays, clinicians can now stratify patients based on their real-time recurrence risk, allowing for timely therapeutic intervention. According to Exact Sciences, December 2025, in the 'Exact Sciences, the NSABP Foundation, and the German Breast Group Present Results for the Oncodetect® MRD Test' press release, results from the NSABP B-59 substudy demonstrated that post-surgery MRD-positive status in early triple-negative breast cancer patients was associated with an approximate 30-fold higher risk of distant recurrence compared to MRD-negative patients.

Concurrently, the Integration of Artificial Intelligence for Enhanced Biomarker Discovery is reshaping the competitive landscape by decoding complex genomic datasets to identify novel therapeutic targets. Market players are increasingly leveraging machine learning algorithms to analyze vast amounts of clinical and molecular data, thereby improving the sensitivity of liquid biopsy panels and operationalizing precision oncology at scale. This technological convergence is driving substantial commercial growth as providers adopt these AI-enhanced platforms for more accurate profiling. According to Tempus AI, August 2025, in the 'Tempus AI: Q2 2025 Earnings' report, the company’s oncology testing revenue reached $133.2 million in the second quarter, marking a 32.9% increase year-over-year, which validates the accelerating market demand for AI-driven diagnostic solutions.

Segmental Insights

The Circulating Tumor DNA segment constitutes the fastest-growing category in the Global Breast Cancer Liquid Biopsy Testing Devices Market, primarily due to its high sensitivity in detecting residual disease and monitoring treatment response. This biomarker enables physicians to identify specific genetic alterations required for prescribing targeted breast cancer therapies without relying on invasive tissue samples. The expansion of this segment is significantly bolstered by recent approvals from the U.S. Food and Drug Administration for ctDNA-based companion diagnostics, which have established regulatory confidence and accelerated the adoption of these devices in clinical oncology settings.

Regional Insights

North America dominates the Global Breast Cancer Liquid Biopsy Testing Devices Market primarily due to established healthcare infrastructure and the presence of key industry players. The region benefits from supportive regulatory frameworks, specifically the approval of comprehensive genomic profiling assays by the U.S. Food and Drug Administration (FDA), which fosters product commercialization. Furthermore, substantial investment in oncology research by institutions such as the National Cancer Institute drives the development of circulating tumor DNA technologies. High adoption rates of non-invasive diagnostic procedures by medical professionals in the United States and Canada further solidify the region's leading market position.

Recent Developments

• In November 2025, Exact Sciences unveiled new data at the San Antonio Breast Cancer Symposium supporting the predictive validity of its Oncodetect molecular residual disease test. Conducted in partnership with the National Surgical Adjuvant Breast and Bowel Project, the research focused on a sub-study of patients with triple-negative breast cancer. The results showed that the tumor-informed liquid biopsy assay effectively identified residual disease using prospectively collected samples from a randomized trial. This development reinforced the company's commitment to advancing non-invasive testing solutions that assist clinicians in personalizing surveillance and treatment planning for high-risk breast cancer subtypes.
• In May 2025, Guardant Health and its collaborators highlighted the clinical utility of the Guardant360 CDx liquid biopsy test during a plenary session at the American Society of Clinical Oncology Annual Meeting. The presentation featured data from the Phase 3 SERENA-6 trial, which utilized the blood-based test to detect emerging ESR1 mutations in patients with hormone receptor-positive, HER2-negative advanced breast cancer receiving first-line endocrine therapy. The study demonstrated that liquid biopsy could identify these resistance mutations before disease progression occurred on scans, providing a critical window for oncologists to switch therapies and potentially improve patient outcomes through precision medicine strategies.
• In June 2024, Personalis presented new data at the American Society of Clinical Oncology Annual Meeting regarding the performance of its NeXT Personal liquid biopsy assay. The findings indicated that this ultra-sensitive test could predict breast cancer recurrence with a median lead time of approximately 15 months compared to conventional imaging methods. By utilizing a whole-genome sequencing approach to track up to 1,800 unique mutations, the assay demonstrated exceptional sensitivity in detecting minute traces of circulating tumor DNA. These results suggested that the device could play a crucial role in monitoring molecular residual disease and guiding treatment decisions for patients with early-stage breast cancer.
• In May 2024, Natera announced the publication of a significant study in JCO Precision Oncology demonstrating the capability of its molecular residual disease test, Signatera, in early-stage breast cancer surveillance. The research, which analyzed plasma samples from patients enrolled in a multi-site interval study, revealed that the liquid biopsy test could detect disease relapse up to 38 months earlier than standard imaging, with a median lead time of 10.5 months. The study highlighted that patients who tested positive for circulating tumor DNA had significantly worse relapse-free and overall survival outcomes, underscoring the test's potential to identify high-risk patients who might benefit from earlier therapeutic intervention.

Key Market Players

• A Menarini AG
• NeoGenomics Laboratories Inc
• F Hoffmann-La Roche AG
• Myriad Genetics Inc
• QIAGEN NV
• Biocept Inc
• Sysmex Corp
• Fluxion Biosciences Inc
• Thermo Fisher Scientific Inc
• Epic Sciences Inc

By Offerings	By Circulating Biomarker	By Application	By Region
Assay & Reagents Kits Instruments	Circulating Tumor DNA Circulating Tumor Cell Extracellular Vesicles	Cancer Applications Non-Cancer Applications	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Breast Cancer Liquid Biopsy Testing Devices Market, By Offerings:

• Assay & Reagents Kits
• Instruments

• Breast Cancer Liquid Biopsy Testing Devices Market, By Circulating Biomarker:

• Circulating Tumor DNA
• Circulating Tumor Cell
• Extracellular Vesicles

• Breast Cancer Liquid Biopsy Testing Devices Market, By Application:

• Cancer Applications
• Non-Cancer Applications

• Breast Cancer Liquid Biopsy Testing Devices 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