Breast Cancer Liquid Biopsy Testing Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Breast Cancer Liquid Biopsy Testing Devices Market is projected to expand significantly, rising from USD 895.36 Million in 2025 to USD 2.34 billion by 2031, reflecting a CAGR of 17.41%. These devices, which include diagnostic platforms and assay kits, are engineered to isolate and analyze circulating tumor cells or circulating tumor DNA from blood samples for oncological evaluation.

This growth trajectory is chiefly propelled by the rising incidence of breast carcinomas combined with the clinical necessity for frequent, non-invasive monitoring to detect treatment resistance. Additionally, the industry is buoyed by the transition toward precision medicine, which demands detailed genomic profiling without the inherent risks of repeated tissue biopsies. Highlighting the urgency for scalable diagnostic solutions, the American Cancer Society estimates that approximately 316,950 women in the United States will be diagnosed with invasive breast cancer in 2025.

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.

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.

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.

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.

Key Players Profiled in the Breast Cancer Liquid Biopsy Testing Devices Market

• 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.

Report Scope

In this report, the Global Breast Cancer Liquid Biopsy Testing Devices Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Breast Cancer Liquid Biopsy Testing Devices Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.