Breast Cancer Liquid Biopsy Market, estimated at around USD 330.8 million in 2024, is projected to expand at a robust compound annual growth rate (CAGR) of over 21%, driven by the rising incidence of breast cancer globally and increasing adoption of non-invasive diagnostics using circulating tumor DNA (ctDNA) and other biomarkers.

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Market Growth Drivers & Opportunities

A convergence of clinical, technological, and systemic factors is accelerating the uptake of liquid biopsy in breast cancer management. First, the prevalence of breast cancer continues to climb, heightening the need for sensitive diagnostic tools that minimize patient discomfort and risk. Liquid biopsies, which analyze ctDNA or circulating tumor cells (CTCs) in blood, offer a less invasive alternative to tissue biopsies, making them attractive for repeated monitoring and early detection.

Second, advancements in molecular diagnostics are making liquid biopsy more powerful and practical. Next-generation sequencing (NGS), digital PCR, and emerging multi-analyte panels are enabling highly sensitive detection of low-frequency mutations, resistance mechanisms, and minimal residual disease (MRD). These technologies allow oncologists to tailor treatment, detect relapse early, and make dynamic therapy decisions — a cornerstone of precision oncology.

Third, regulatory support and reimbursement momentum are improving access. With growing clinical evidence and better payer frameworks, liquid biopsy is increasingly being integrated into standard care pathways for breast cancer, particularly for companion diagnostics and MRD monitoring.

Fourth, real-world clinical application opportunities are expanding. Liquid biopsy is not just used for detecting mutations at diagnosis; it is now playing a role in treatment selection, treatment monitoring, relapse prediction, and minimal residual disease (MRD) detection. As more patients and physicians adopt these applications, the commercial potential of the market deepens.

Finally, geographical expansion offers major upside. Emerging markets, especially in Asia-Pacific, are investing in diagnostic infrastructure, while established markets such as North America and Europe continue to scale adoption and reimbursement for advanced tests.

Segmentation Analysis

The breast cancer liquid biopsy market is segmented primarily by circulating biomarkers, technology, application, and end user.

When it comes to circulating biomarkers, the landscape includes cfDNA/ctDNA, circulating tumor cells (CTCs), extracellular vesicles (EVs), and others. The cfDNA/ctDNA segment remains dominant due to its strong clinical traction and utility in mutation detection, monitoring, and MRD. CTCs continue to be used for prognosis and therapy guidance, while EVs are gaining attention for their cargo of proteins, RNA, and other molecules, enabling a richer picture of tumor biology.

On the technology front, the market is primarily divided between next-generation sequencing (NGS) and digital PCR (dPCR), among other emerging methods. NGS holds a significant share because it allows broad genomic profiling, whereas dPCR is valued for its ultra-high sensitivity, particularly in monitoring known mutations over time.

In terms of application, the use cases for breast cancer liquid biopsy span diagnostic profiling, treatment selection, MRD monitoring, relapse detection, and prognostics. Diagnostic profiling and companion diagnostics still drive major revenue, while MRD monitoring is emerging as one of the fastest-growing areas, as serial ctDNA tests help detect residual disease months before clinical or imaging relapse.

As for the end user, the market encompasses hospitals and physician laboratories, reference laboratories, and academic and research institutions. Hospital labs dominate volume, but reference labs are scaling rapidly due to their specialized infrastructure and bioinformatics capabilities.

From a geographical perspective, regions include North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa. North America remains the largest market due to advanced healthcare infrastructure, but Asia-Pacific is gaining ground, backed by rising cancer incidence, improved healthcare access, and increased diagnostic spending.

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Country-Level Analysis

United States (USA):
The U.S. is a clear leader in the breast cancer liquid biopsy market. Its advanced oncology ecosystem, robust regulatory environment, and high reimbursement support make it a fertile ground for both early detection and MRD monitoring. Liquid biopsies are increasingly woven into clinical workflows for mutation profiling, treatment adaptation, and relapse surveillance, helping oncologists offer more personalized care.

Germany:
In Germany, liquid biopsy is gaining strong traction due to the country’s emphasis on precision diagnostics and strong biotech sector. Laboratories and hospitals in Germany are adopting ctDNA-based assays for treatment decision-making, supported by advanced infrastructure and clinical research programs. The integration of liquid biopsy in German cancer centers is helping to drive broader adoption across Europe.

China:
China’s market for breast cancer liquid biopsy is growing fast. Rising cancer burden, increasing diagnostic capacity, and government support for precision medicine all contribute. Local and international companies are investing heavily to expand ctDNA and CTC testing. As Chinese hospitals and diagnostic networks modernize, demand for non-invasive tests that can be deployed at scale is rising.

United Kingdom (UK):
In the UK, liquid biopsy is being embraced by national health services and research institutions. Recent pilot programs aim to use ctDNA assays to monitor relapse in breast cancer survivors and guide therapy. The NHS is evaluating large-scale incorporation of blood-based testing, which could accelerate adoption and reimbursement under public health programs.

Japan:
Japan’s aging population and well-developed healthcare system make it an attractive market for liquid biopsy. Oncologists are increasingly using ctDNA tests to guide the treatment of metastatic and recurrent breast cancer. Moreover, Japanese diagnostic labs and hospitals are investing in both NGS and dPCR platforms to support longitudinal monitoring.

Competitive Landscape

The breast cancer liquid biopsy sector is highly innovative, with key players pushing forward with assay development, platform expansion, and clinical validation. Some of the top competitors include Guardant Health, Roche Diagnostics, Illumina, Thermo Fisher Scientific, Myriad Genetics, QIAGEN, Biocept, Menarini Silicon Biosystems, Bio-Rad Laboratories, and Exact Sciences.

Here are five major players and their recent developments:

1. Guardant Health: A pioneer in ctDNA NGS panels, Guardant Health holds a leading market position in liquid biopsy. It has been expanding its assays to include more genes and improve sensitivity, particularly for minimal residual disease. Guardant continues to make inroads into both the US and international markets.

2. Roche Diagnostics: Roche is active with digital PCR-based liquid biopsy tests and has a strong presence in companion diagnostics. They leverage their broad diagnostics portfolio to integrate ctDNA testing into clinical pathways, particularly in Europe and other regulated markets.

3. Illumina: Known for its sequencing technology, Illumina’s NGS platforms are widely used for ctDNA testing. Its high-throughput sequencing capabilities support broad genomic panels that help oncologists detect mutations and resistance mechanisms in breast cancer.

4. Thermo Fisher Scientific: Thermo Fisher supports liquid biopsy through its Ion Torrent sequencing platforms and targeted assays. It is developing and marketing specialized cfDNA/ctDNA panels for use in both research and clinical settings, contributing to personalized oncology workflows.

5. Myriad Genetics: Myriad has been active in the oncology diagnostics space and is developing liquid biopsy assays to complement its existing genetic testing services. Their focus includes profiling of clinically actionable breast cancer mutations and biomarkers for therapy selection.

Other players such as QIAGEN, Biocept, Menarini, Bio-Rad, and Exact Sciences are also aggressively innovating. QIAGEN offers sample-processing workflows and ctDNA panels; Biocept focuses on CTC-based monitoring; Bio-Rad leverages its droplet digital PCR expertise; and Exact Sciences is developing multi-cancer early detection applications using circulating biomarkers.

Strategically, these companies are not only competing on assay sensitivity and breadth, but also on data analysis, turnaround time, regulatory clearance, and reimbursement. Partnerships with academic institutions, oncology centers, and reference labs further strengthen their market positions.

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Conclusion

The global Breast Cancer Liquid Biopsy Market stands at the frontier of a paradigm shift in oncology diagnostics. With powerful drivers such as growing breast cancer prevalence, demand for minimally invasive testing, and technological advances in ctDNA and CTC detection, the market is poised for double-digit growth in the coming years.

Companies like Guardant Health, Roche, Illumina, Thermo Fisher, and Myriad are leading this transformation with next-gen assays, sequencing platforms, and clinical partnerships. Meanwhile, key regional markets — including the U.S., Germany, China, the UK, and Japan — are embracing liquid biopsy for early detection, therapy monitoring, and recurrence surveillance.

As liquid biopsy becomes more integrated into clinical practice, it promises to enable truly personalized, adaptive breast cancer care — accelerating response to disease dynamics, minimizing invasive procedures, and improving patient outcomes in ways that were previously impossible.