Breast Cancer Liquid Biopsy Market Size & Outlook, 2026-2034

Breast Cancer Liquid Biopsy Market Overview

The global breast cancer liquid biopsy market size is valued at USD 1.26 billion in 2025 and is estimated to reach USD 2.73 billion by 2034, growing at a CAGR of 8.4% during the forecast period. This growth is driven by factors such as the rising incidence of breast cancer, advancements in liquid biopsy technology, and the growing demand for early cancer detection and personalized medicine.

Key Market Trends & Insights

• North America dominated the global market, accounting for the largest revenue share of 44% in 2025.
• Asia Pacific is expected to register the fastest CAGR of 10.2% during the forecast period.
• By circulating biomarkers, the circulating cell-free DNA (cfDNA) segment led the market, accounting for the largest revenue share of 53.6% in 2025.
• By the Application, the early detection segment is expected to grow at a significant CAGR of 9.6% during the forecast period.
• The U.S. led the North American market, holding the largest revenue share of 38% in 2025.

Market Size & Forecast

• 2025 Market Size: USD 1.26 billion
• 2034 Projected Market Size: USD 2.73 billion
• CAGR (2026-2034): 8.4%
• Dominating Region: North America
• Fastest-Growing Region: Asia Pacific

A breast cancer liquid biopsy is a minimally invasive diagnostic test that detects biomarkers, such as cell-free DNA (cfDNA), circulating tumor cells (CTCs), and extracellular vesicles (EVs), in blood (and sometimes urine). It enables oncologists to screen, diagnose, select therapies, monitor disease progression, and detect minimal residual disease (MRD) in breast cancer patients without tissue biopsy. The growth of the liquid biopsy market is driven by several factors, including the rising burden of cancer, increasing research publications, and expanding clinical trials in liquid biopsy, which are leading to an increased demand for liquid biopsy tests and products. Additionally, growing adoption and demand for minimally invasive cancer detection methods have led to the development of more effective and innovative tests and kits.

Latest Market Trends

Supportive Government Initiatives for Cancer Screening

Government-led cancer screening initiatives are increasingly supporting the adoption of advanced diagnostic technologies, including liquid biopsy. National and regional health authorities are prioritizing early detection through population-level screening programs, public awareness campaigns, and subsidized testing. In India, large-scale state and national initiatives focused on breast and cervical cancer screening are improving diagnostic coverage, particularly in underserved populations. Liquid biopsy supports this shift by enabling broader access to screening without the infrastructure burden of surgical biopsies. As governments continue to invest in preventive oncology and early intervention strategies, demand for innovative, scalable diagnostic tools is expected to rise steadily.

Increased Focus on Early Detection

Early cancer detection remains a central trend driving growth in the breast cancer liquid biopsy market. Healthcare providers and patients are increasingly recognizing the clinical and economic benefits of diagnosing cancer at earlier stages, when treatment outcomes are significantly improved. A liquid biopsy enables the detection of circulating tumor DNA (ctDNA) and other biomarkers before clinical symptoms emerge, offering a non-invasive alternative to traditional tissue biopsies. This approach enhances patient compliance and enables repeated testing over time.

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Market Driver

Regulatory Support for Liquid Biopsy Approvals

Supportive regulatory frameworks are a major driver of the breast cancer liquid biopsy market. Regulatory agencies are increasingly acknowledging the clinical value of liquid biopsy technologies in cancer detection, prognosis, and treatment monitoring. Streamlined approval pathways and accelerated review processes are enabling faster market entry for validated assays. This regulatory clarity encourages diagnostic companies to invest in research, clinical trials, and product commercialization. As more liquid biopsy tests receive regulatory clearance, their availability and clinical adoption continue to expand. Increased regulatory support also intensifies competition, prompting innovation in assay sensitivity, biomarker panels, and testing platforms, ultimately strengthening the overall diagnostic ecosystem.

Market Restraints

Lack of Standardization and Clinical Guidelines

Despite strong clinical potential, the breast cancer liquid biopsy market faces challenges related to the lack of standardized methodologies and uniform clinical guidelines. Diagnostic platforms vary significantly in biomarker selection, sample processing, sequencing techniques, and data interpretation, resulting in inconsistent results across laboratories. Differences in assay sensitivity, especially in detecting low variant allele frequencies, complicate clinical decision-making. Limited consensus on clinical utility across breast cancer subtypes further slows adoption. Additionally, reimbursement uncertainty in several regions restricts access.

Market Opportunities

Application in Early Detection and Screening

The application of liquid biopsy in early detection and population screening represents a significant growth opportunity, particularly for high-risk groups such as individuals with genetic predispositions. While mammography remains the standard screening tool, its limitations in detecting breast cancer in dense breast tissue highlight the need for complementary diagnostics. Liquid biopsy can identify tumor-derived genetic and epigenetic alterations before radiographic changes become visible.

Advancements in cfDNA methylation analysis, microRNA profiling, and extracellular vesicle research are enhancing the accuracy of early-stage detection. The development of cost-effective, high-throughput screening assays could enable large-scale preventive screening programs, improve survival rates, and create strong commercial opportunities in preventive oncology.

Regional Analysis

North America accounted for the largest share, 44%, of the global breast cancer liquid biopsy market in 2025, due to the region's advanced healthcare infrastructure and high adoption rates of innovative diagnostic technologies, which have facilitated the widespread use of liquid biopsy methods. Additionally, increasing awareness among healthcare providers and patients about the benefits of early cancer detection and personalized treatment options has driven demand for noninvasive diagnostic tools. The presence of major pharmaceutical and biotechnology companies, along with robust research and development activities in North America, further supports market growth.

The U.S. market is the largest in North America. Growth is supported by the high prevalence of breast cancer, strong adoption of precision medicine, and increasing use of liquid biopsy for diagnosis, treatment selection, and disease monitoring. Favorable reimbursement policies for advanced diagnostics, robust clinical research activity, and the presence of leading biotechnology and diagnostics companies further strengthen the U.S. market.

Asia Pacific Market Insights

The Asia Pacific breast cancer liquid biopsy market is expected to register the fastest CAGR of 10.2% during the forecast period, driven by the expansion of healthcare infrastructure and increasing access to advanced diagnostic services. The rising incidence of breast cancer, raising awareness of early detection, and growing investments in oncology care are key drivers of growth. The region is witnessing the rapid adoption of minimally invasive diagnostic technologies due to their scalability and cost-effectiveness. Ongoing advancements in molecular diagnostics and growing integration of precision medicine into healthcare systems are expected to support sustained market expansion across the Asia Pacific.

The Chinese market is expanding due to the rising prevalence of breast cancer and growing demand for accurate diagnostic solutions. Increasing urbanization and environmental changes are contributing to higher cancer incidence, prompting more women to seek reliable testing methods. As healthcare providers strive to address the growing patient population, the adoption of liquid biopsy solutions is accelerating, driving strong market growth in China.

Europe Market Insights

Europe is anticipated to grow significantly during the forecast period, driven by rising demand for effective diagnostic solutions amid the increasing prevalence of cancer. Several market players in the region are focusing on receiving funding from various government or non-governmental organizations to develop advanced liquid biopsy platforms. Moreover, the European government's increasing strategic initiatives to boost cancer screening tests will further strengthen regional growth over the forecast period.

Germany leads the European breast cancer liquid biopsy market, supported by its well-established healthcare system and strong adoption of advanced diagnostic technologies. The country benefits from active clinical research, early integration of precision oncology, and supportive reimbursement policies. Additionally, the presence of major biotechnology and diagnostics companies enhances innovation and market penetration.

Latin America Market Insights

The Latin American breast cancer liquid biopsy market is expanding due to rising cancer incidence rates and improving healthcare access in key countries such as Brazil and Mexico. Brazil dominates as the leading contributor, supported by government initiatives and collaborations advancing next-generation sequencing technologies. Growth is further propelled by demand for non-invasive early detection methods, ongoing R&D efforts, and efforts to address challenges such as limited rural awareness, positioning the region for sustained potential in personalized oncology diagnostics.

Brazil spearheads the Latin American breast cancer liquid biopsy market, driven by rising cancer rates, advanced medical facilities, and supportive public health policies in oncology. Expansion arises from strategic alliances merging next-generation sequencing with domestic healthcare networks, coupled with heightened public education on non-invasive testing for timely diagnosis and therapy tracking.

Middle East and Africa Market Insights

The Middle East and Africa breast cancer liquid biopsy market is emerging, supported by rising cancer incidence and increasing focus on early diagnosis. Government initiatives aimed at strengthening oncology services and expanding diagnostic capacity are driving adoption. Growing investments in healthcare infrastructure and precision medicine are improving access to advanced diagnostics. Despite challenges such as limited resources and workforce shortages, increasing awareness and regulatory support are creating favorable conditions for market expansion across the region.

South Africa dominates the MEA breast cancer liquid biopsy market, propelled by cutting-edge diagnostic innovations and robust oncology networks. A high disease burden, state-supported screening efforts, and the integration of non-invasive assays from leaders like Roche and Guardant Health drive its momentum. International partnerships enhance capabilities, outpacing growth in the UAE and Saudi Arabia, despite rural disparities, and cement South Africa's frontrunner status in regional precision oncology.

Circulating Biomarkers Insights

The circulating cell-free DNA (cfDNA) segment led the market, accounting for the largest revenue share of 53.6% in 2025. Growth is driven by cfDNA’s non-invasive approach, enabling easier prognosis and detection of recurrence or disease progression. It offers advantages over tissue biopsies, including the ability to monitor drug response, resistance, and tumor status in real-time. Numerous companies provide cfDNA-based products for research, and ongoing studies and product launches aim to expand its use as a reliable tool for early cancer detection and clinical monitoring.

The circulating tumor cells (CTCs) segment is expected to grow at the fastest CAGR of 9.5% during the forecast period, driven by research on their role in early-stage breast cancer. CTCs provide intact cellular information, enabling phenotypic and functional analysis that complements genomic data. Technological advancements in enrichment, isolation, and detection methods have improved analytical reliability, making CTC-based assays more feasible for clinical use.

Application Insights

The treatment selection segments led the market with the largest revenue share of 52.2% in 2025, primarily because of the growing adoption of liquid biopsy to track treatment response, detect recurrence, and assess MRD. In clinical settings, serial liquid biopsy testing is increasingly being used to determine the efficacy of endocrine therapy or to detect emerging resistance mutations. Such real-time monitoring enables oncologists to tailor treatments based on the evolving genetics of tumors, thereby avoiding unnecessary side effects and improving patient outcomes.

The early detection/screening segment is expected to grow at a significant CAGR of 9.6% during the forecast period, fueled by ongoing R&D efforts and clinical trials aimed at validating liquid biopsy for asymptomatic individuals or those with genetic predispositions. Methylation-based cfDNA assays and EV-based diagnostics are showing potential for early-stage detection. Additionally, public health agencies and private companies are exploring the integration of liquid biopsy into breast cancer screening programs.

Competitive Landscape 

The breast cancer liquid biopsy market is moderately fragmented, characterized by a diverse array of key players, including established biotechnology companies, emerging startups, and academic institutions, all of which strive to innovate and capture market share. Major companies such as Guardant Health, GRAIL, Freenome, and Foundation Medicine are at the forefront, developing advanced liquid biopsy assays that utilize circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) for early cancer detection and monitoring. The competitive landscape is also marked by significant investments in research and development, with companies striving to obtain regulatory approvals for their assays. Collaborative efforts between industry players and academic institutions are common, aimed at advancing the science of liquid biopsy and improving test reliability. 

Thermo Fisher Scientific Inc- A Market Leader

Thermo Fisher Scientific Inc. is a biotechnology research company engaged in life science research and various diagnostic and laboratory solutions. The company specializes in analytical and diagnostic instruments, laboratory supply chain programs, e-commerce, laboratory equipment, lab services, life sciences, specialty diagnostics, and pharmaceutical services. The company delivers pharmaceutical services under various brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fischer Scientific, Unity Lab Services, Patheon, and PPD. The company’s products and solutions are utilized by various end-use industries, including biotechnology, pharmaceuticals, healthcare, industrial & applied sciences, food & beverage, and forensics. 

Latest News

• In July 2025, Thermo Fisher Scientific Inc. announced an expansion of its strategic partnership with Sanofi to enable additional U.S. drug product manufacturing.
• In April 2025, Thermo Fisher Scientific Inc. announced the grand opening of its Advanced Therapies Collaboration Center (ATxCC) in Carlsbad, Calif. This advanced facility is designed to accelerate the development and commercialization of cell therapies, specifically by supporting biotech, biopharma, and translational customers developing cell-based immunotherapies.

List of key players in Breast Cancer Liquid Biopsy Market

1. QIAGEN
2. NeoGenomics Laboratories
3. The Menarini Group
4. Biocept Inc.
5. Hoffmann-La Roche Ltd.
6. Sysmex Corporation
7. Epic Sciences Inc.
8. Myriad Genetics Inc.
9. Fluxion Biosciences Inc.
10. Illumina
11. Bio-Rad Laboratories
12. Myriad Genetics
13. Cynvenio
14. Biosystems Inc.
15. Genomic Health Inc.
16. Thermo Fisher Scientific Inc.
17. Fluxion Biosciences Inc.
18. Biodesix Inc.
19. Guardant Health Inc.
20. Isogen Life Science B.V.

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Strategic Initiatives

• June 2025 - The Florida Cancer Specialists and Research Institute, LLC (FCS), introduced a liquid biopsy test for the diagnosis and treatment of the most common cancers, including lung, breast, colorectal, prostate cancer, and cancers of the blood.
• May 2025 - England’s National Health Service (NHS) rolled out a new national scheme, which will offer liquid biopsy testing for patients with lung and breast cancer, further paving the way for tailored cancer care and improved patient survival outcomes.