The breast cancer liquid biopsy market size was exhibited at USD 1.34 billion in 2024 and is projected to hit around USD 2.89 billion by 2034, growing at a CAGR of 8.0% during the forecast period 2024 to 2034.
The U.S. breast cancer liquid biopsy market size was exhibited at USD 106.25 million in 2024 and is projected to hit around USD 842.13 million by 2034, growing at a CAGR of 23.0% during the forecast period 2024 to 2034.
North America dominated the breast cancer liquid biopsy market with the largest revenue share of 45.0% in 2024. Driven by high cancer prevalence, well-established healthcare infrastructure, early adoption of precision diagnostics, and strong regulatory support. The U.S. is home to several pioneering companies, including Guardant Health, Biocept, and Exact Sciences, which are actively developing and commercializing liquid biopsy solutions. Moreover, regulatory bodies like the U.S. Food and Drug Administration (FDA) have fast-tracked approvals for liquid biopsy tests under breakthrough device designations, accelerating market availability. Clinical adoption is further reinforced by the presence of advanced oncology centers and wide physician awareness about the benefits of non-invasive testing.
On the other hand, Asia Pacific is the fastest-growing region, owing to rising breast cancer incidence, expanding healthcare access, and increasing awareness of molecular diagnostics. Countries like China, India, and Japan are investing heavily in precision oncology, supported by government initiatives and private sector partnerships. For instance, Chinese companies such as Burning Rock Dx are gaining traction with NGS-based liquid biopsy offerings tailored for breast cancer. Meanwhile, emerging markets in Southeast Asia are witnessing a surge in demand for affordable and non-invasive diagnostic tools, making Asia Pacific a lucrative growth frontier for global and local players alike.
The Breast Cancer Liquid Biopsy Market represents a pivotal advancement in oncology diagnostics and personalized medicine. Liquid biopsy—a minimally invasive alternative to traditional tissue biopsy—enables the detection and analysis of tumor-derived components such as circulating tumor cells (CTCs), cell-free DNA (cfDNA), and extracellular vesicles (EVs) from blood or other body fluids. In the context of breast cancer, this technology offers unprecedented potential for early detection, real-time monitoring, treatment stratification, and relapse prediction.
Breast cancer remains one of the most prevalent cancers among women globally. According to the World Health Organization, over 2.3 million women were diagnosed with breast cancer in 2020 alone. Traditional diagnostic methods like mammography and tissue biopsy, while effective, face limitations such as invasiveness, sampling errors, and delays in detection of metastasis or recurrence. Liquid biopsy addresses these gaps by offering dynamic, repeatable testing that reflects the tumor’s current genetic landscape.
The growth of this market is fueled by several factors: rising global incidence of breast cancer, increasing preference for non-invasive diagnostics, expanding clinical validation of liquid biopsy biomarkers, and supportive regulatory developments. Furthermore, advancements in next-generation sequencing (NGS) and digital PCR technologies have significantly enhanced the sensitivity and specificity of liquid biopsy platforms. As a result, the market is experiencing heightened interest from both diagnostics developers and biopharmaceutical companies, with several products receiving regulatory approval or entering clinical practice.
In essence, the breast cancer liquid biopsy market is not only transforming cancer detection and treatment but also redefining patient-centric care in oncology.
Expansion of companion diagnostics: Liquid biopsy tests are increasingly being paired with targeted breast cancer therapies to optimize treatment selection.
Integration of AI and machine learning for data interpretation: Advanced algorithms are enhancing the accuracy of mutation detection and resistance profiling.
Adoption in early-stage breast cancer: Liquid biopsy is being tested for screening and early diagnosis, especially in high-risk populations with genetic predispositions.
Emergence of multi-analyte panels: Companies are developing tests that assess multiple circulating biomarkers (e.g., CTCs + cfDNA) to improve diagnostic confidence.
Increased clinical validation: Numerous clinical trials are underway to validate liquid biopsy for monitoring therapeutic response and detecting minimal residual disease (MRD).
Rise in decentralized testing models: Liquid biopsy kits are being adapted for use in point-of-care or satellite laboratory settings to widen access.
Collaborations between diagnostics and pharma firms: Strategic partnerships are on the rise to co-develop liquid biopsy-based solutions for drug development and post-marketing surveillance.
Cost reduction through technological innovation: The decreasing cost of NGS and PCR platforms is helping make liquid biopsy more affordable.
Regulatory acceleration for breakthrough tests: Agencies such as the FDA are granting fast-track designations for promising liquid biopsy tests in oncology.
Personalized monitoring protocols: Real-time tracking of mutations enables personalized adjustments in treatment, particularly in HER2-positive and triple-negative breast cancer subtypes.
| Report Coverage | Details |
| Market Size in 2025 | USD 1.45 Billion |
| Market Size by 2034 | USD 2.89 Billion |
| Growth Rate From 2024 to 2034 | CAGR of 8.0% |
| Base Year | 2024 |
| Forecast Period | 2024-2034 |
| Segments Covered | Circulating Biomarkers, Application, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Regional scope | North America, Europe, Asia Pacific, Latin America, MEA |
| Key Companies Profiled | The Menarini Group; NeoGenomics Laboratories.; F. Hoffmann-La Roche Ltd.; Myriad Genetics, Inc.; QIAGEN; Biocept, Inc.; Sysmex Corporation; Fluxion Biosciences, Inc.; Epic Sciences, Inc.; Thermo Fisher Scientific, Inc. |
The primary driver of the breast cancer liquid biopsy market is the growing global preference for non-invasive, patient-friendly diagnostic technologies. Traditional tissue biopsies, while accurate, are associated with several limitations: they are invasive, carry procedural risks, may not always capture tumor heterogeneity, and cannot be repeated frequently for disease monitoring. In contrast, liquid biopsies offer a convenient, safer, and faster alternative that allows clinicians to assess a patient’s tumor profile in real-time through a simple blood draw.
For breast cancer patients undergoing treatment, this means dynamic disease monitoring without the need for repeated tissue excisions. For example, in metastatic breast cancer cases, where obtaining tissue from secondary tumor sites is often challenging, liquid biopsy provides a vital means to assess disease progression and treatment resistance. Furthermore, liquid biopsies can detect mutations such as PIK3CA, ESR1, and HER2, guiding clinicians in therapy selection. This shift towards patient-centric diagnostics is rapidly driving clinical and commercial interest in liquid biopsy.
Despite its promising clinical value, the lack of standardization across liquid biopsy platforms and the absence of universally accepted clinical guidelines remain significant restraints. Currently, different tests utilize varied methodologies for biomarker isolation, amplification, and analysis—ranging from PCR-based assays to NGS and digital droplet PCR—leading to inconsistencies in results and interpretation. Furthermore, while some assays are well-validated for certain breast cancer subtypes, others lack sufficient clinical evidence to support routine use.
The absence of harmonized protocols and thresholds also affects physician adoption. For instance, the interpretation of low variant allele frequency in cfDNA can vary based on the platform and the laboratory. Additionally, reimbursement frameworks in many regions do not yet cover liquid biopsy for all use cases, further limiting accessibility. Until standardized diagnostic algorithms and robust regulatory frameworks are established, the market’s full potential may remain constrained.
A major growth opportunity in this market lies in the application of liquid biopsy for early breast cancer detection and population screening, especially among individuals at high genetic risk (e.g., BRCA1/2 mutation carriers). While mammography remains the frontline screening tool, its limitations—such as reduced sensitivity in dense breast tissue—necessitate adjunctive diagnostic tools.
Liquid biopsy offers the potential to detect tumor-derived mutations or epigenetic markers even before radiological changes appear. For example, studies have shown promising results in using cfDNA methylation patterns to detect early-stage breast tumors. Additionally, emerging research into extracellular vesicle cargoes, such as microRNAs, may further enhance screening sensitivity. Developing cost-effective, high-throughput liquid biopsy assays for asymptomatic individuals could revolutionize early cancer detection and significantly improve survival outcomes. Companies that successfully commercialize validated early detection panels will have a competitive edge in preventive oncology.
Based on circulating biomarkets, the circulating cell-free DNA (cfDNA) segment led the market with the largest revenue share of 53.6% in 2024. Owing to its wide applicability in mutation detection, treatment monitoring, and minimal residual disease (MRD) assessment. cfDNA-based tests are well-suited for identifying actionable mutations such as ESR1, PIK3CA, and TP53, which guide targeted therapy decisions in breast cancer patients. Moreover, technological advancements in digital PCR and NGS have improved the sensitivity and precision of cfDNA detection. The ability of cfDNA assays to offer insights into tumor heterogeneity and emerging resistance mechanisms has made them indispensable in metastatic breast cancer management.
In contrast, Extracellular Vesicles (EVs) are emerging as the fastest-growing segment within circulating biomarkers. EVs—including exosomes—carry diverse molecular information such as DNA, RNA, and proteins, reflecting the tumor’s dynamic state. Their superior stability in biofluids and capacity to convey early-stage disease signals have caught the attention of researchers and companies alike. For example, EV-derived microRNA signatures are being explored as biomarkers for triple-negative breast cancer—a subtype that lacks clear molecular targets. As EV research matures and transitions into clinical applications, this segment is expected to witness rapid growth.
Based on application, the treatment selection segments led the market with the largest revenue share of 52.0% in 2024, 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 allows oncologists to tailor therapies based on evolving tumor genetics, avoiding unnecessary side effects and improving patient outcomes. Furthermore, the ability to conduct frequent, minimally invasive tests offers a major advantage in long-term surveillance of breast cancer survivors.
The early detection/screening segment is expected to grow at a significant CAGR of 9.7% 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. As mentioned earlier, 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. Once regulatory approvals and cost-effectiveness thresholds are achieved, early detection via liquid biopsy could become a game-changer in breast cancer control.
March 2025: Guardant Health announced positive clinical trial results for its Guardant360 CDx test in monitoring metastatic breast cancer, showing high concordance with tissue biopsies.
January 2025: Biocept Inc. launched a new proprietary assay panel for breast cancer, targeting ESR1 and PIK3CA mutations using digital PCR to guide therapy decisions.
October 2024: Lucence Diagnostics entered into a strategic partnership with a Japanese hospital group to deploy cfDNA-based early detection liquid biopsy tests in East Asia.
August 2024: Exact Sciences expanded its clinical trial network to include breast cancer liquid biopsy applications for treatment response prediction, aiming for a 2026 market launch.
June 2024: Burning Rock Dx (China) secured regulatory approval for its NGS liquid biopsy panel for HER2-positive breast cancer monitoring.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the breast cancer liquid biopsy market
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