Breast Cancer Liquid Biopsy Market Size Analysis:

The Breast Cancer Liquid Biopsy Market was valued at USD 1.13 billion in 2023 and is expected to reach USD 2.37 billion by 2032, growing at a CAGR of 8.61% over the forecast period of 2024-2032. This report emphasizes liquid biopsy adoption and usage patterns driven by a growing interest in non-invasive diagnostic procedures and early detection of cancer. The research investigates reimbursement and coverage patterns geographically, with differences in healthcare policy affecting patient access to these tests. It also discusses pricing patterns of liquid biopsy tests, with technological improvements and economies of scale driving costs lower and expanding market reach. The report discusses ongoing research pipeline trends, which highlight innovations in circulating tumor DNA (ctDNA) testing and biomarker discovery that improve test precision. In addition, regulatory patterns and policy effects are defining market growth, as governments and health authorities collaborate to standardize guidelines and affirm the clinical validity of liquid biopsy uses.

The U.S. Breast Cancer Liquid Biopsy Market was valued at USD 0.33 billion in 2023 and is expected to reach USD 0.63 billion by 2032, growing at a CAGR of 7.4% over the forecast period of 2024-2032. In the United States, the breast cancer liquid biopsy market is gaining pace because of greater FDA approvals, expanding insurance coverage, and increased investments in precision oncology, thus making the tests more accessible for early-stage and metastatic breast cancer surveillance.

Breast Cancer Liquid Biopsy Market Dynamics

Drivers

• The growing shift toward precision oncology has significantly driven the adoption of liquid biopsy in breast cancer management.

Liquid biopsy provides non-invasive, real-time monitoring of tumors, diminishing the necessity for invasive tissue biopsies. According to research, more than 70% of oncologists now include liquid biopsy as an important tool to guide targeted therapy. The elevated specificity and sensitivity of liquid biopsy, especially cfDNA-based testing, have made it a necessary element in choosing treatment and tracking minimal residual disease (MRD). Also, improved NGS technology and artificial intelligence (AI) in diagnostics have improved the tests' accuracy and dependability. Growth in companion diagnostics for precision medicines like HER2 and BRCA mutation tests has further accelerated demand. Research promotion by governments for liquid biopsies and enhanced FDA approvals for liquid biopsy-based tests are further fueling adoption. For instance, FDA-approved Guardant360 and FoundationOne Liquid CDx have widened the clinical use of the market. The patient demand for non-invasive methods, combined with an increase in late-stage breast cancer, is further driving demand. Moreover, the cost-effectiveness of a liquid biopsy over surgical biopsies makes it more accessible, even in resource-constrained and high-income environments.

Restraints

• The breast cancer liquid biopsy market faces regulatory and standardization challenges, which hinder widespread adoption.

The absence of globally harmonized standards for liquid biopsy testing generates inconsistencies in clinical use. Regulatory agencies such as the FDA and EMA place strict validation requirements, hindering approvals of novel liquid biopsy technologies. In contrast to the conventional tissue biopsies that possess established diagnostic criteria, liquid biopsy tests do not have standardized reference values, resulting in differences in test outcomes across laboratories and platforms. Moreover, anxiety about false positives and false negatives causes oncologists to doubt, which restricts its application in clinical decision-making. Reimbursement issues also limit market expansion since most insurance providers do not cover liquid biopsy tests, making them unavailable to a lot of patients. For example, Medicare only covers particular indications of liquid biopsy, restricting its extensive clinical value. Highly expensive advanced sequencing technologies also limit adoption among the poor. In addition, technical difficulties in isolating and analyzing circulating biomarkers, particularly CTCs, create limitations in obtaining precise results. The integration of these regulatory and technical hurdles hinders the clinical adoption of liquid biopsy, making it unable to completely replace conventional diagnostic techniques in breast cancer treatment.

Opportunities

• The expanding applications of liquid biopsy beyond late-stage diagnosis present a major growth opportunity for the market.

Conventionally employed for disease tracking and directing aimed therapies, liquid biopsy is increasingly being explored in early detection and screening schemes. The rise of multi-cancer early detection (MCED), led by key players such as Grail's Galleri test, underscores the prospects of liquid biopsy in the pre-symptomatic detection of breast cancer. Studies indicate that detection of early-stage breast cancer with the help of cfDNA has attained a sensitivity of more than 85% and thus offers a significant substitute to mammography. Additionally, the combination of AI and machine learning within liquid biopsy is improving the precision in detecting biomarkers, further enhancing clinical results. The increased partnerships among biotech firms and pharmaceutical companies for companion diagnostic development also offer a rich opportunity. For instance, the collaboration between Illumina and Roche is focused on driving NGS-based liquid biopsy solutions forward. Besides, the growth of home-based liquid biopsy test kits, spurred on by convenience demands from consumers, is an unexploited market potential. As continued research into extracellular vesicles (EVs) and epigenetic markers continues to develop, new biomarkers will further expand the applications of liquid biopsy, such that it becomes a cornerstone in personalized breast cancer management.

Challenges

• One of the biggest challenges facing the breast cancer liquid biopsy market is the technological and data interpretation limitations that impact clinical reliability.

Although a liquid biopsy is a non-invasive method, its performance can be hampered by the presence of low biomarker levels in blood. According to studies, tumor-derived cfDNA comprises less than 1% of the total circulating DNA, rendering it extremely difficult to detect. Further, tumor-derived cfDNA discrimination from cell-free DNA is also a cumbersome task, causing false negatives. Another major concern is the absence of standardization in bioinformatics pipelines since different sequencing platforms and algorithms yield different interpretations of genetic changes. This variability is a cause of concern for oncologists regarding the reproducibility of test results. Additionally, liquid biopsy is not able to differentiate between active and latent tumors, and hence, it is challenging to ascertain real-time disease progression. Data privacy and ethical issues around genomic sequencing also present challenges, with regulatory bodies enforcing stringent data protection regulations. The expense of incorporating AI-powered analytics into liquid biopsy platforms is also prohibitively high, limiting its scalability. Finally, the lack of awareness and training among oncologists and healthcare professionals in interpreting liquid biopsy data slows down widespread clinical uptake, presenting a bottleneck for market expansion.

Breast Cancer Liquid Biopsy Market Segmentation Analysis

By Biomarkers

The circulating cell-free DNA (cfDNA) segment dominated the Breast Cancer Liquid Biopsy Market in 2023 with a 50.7% revenue share. This is powered by the increasing clinical adoption of cfDNA-based liquid biopsies for the detection of genetic mutations and minimal residual disease (MRD) monitoring. The high specificity and sensitivity of cfDNA in detecting tumor-specific changes have made it a biomarker of choice in the diagnosis and treatment planning of breast cancer. Moreover, improvements in next-generation sequencing (NGS) technology have further cemented its position in informing targeted therapies.

The circulating tumor cells (CTCs) space is anticipated to see the highest growth in the future. Growing interest in real-time monitoring of cancer and the role that CTCs play in evaluating tumor heterogeneity are the key drivers of this growth. In contrast to cfDNA, whose contribution is fragmented genetic material, CTCs can present information related to tumor biology and thus enable improved monitoring of treatment response. The increasing investment in research for the improvement of CTC detection and analysis techniques is also anticipated to fuel its adoption.

By Application 

The treatment selection segment was the top application in 2023, with 48.4% of the entire market revenue. Liquid biopsy has a significant function in detecting mutations that inform customized treatment plans and, thus, is needed for choosing targeted treatments like hormone therapy or HER2 inhibitors. The growing appeal for precision medicine and companion diagnostics, particularly for metastatic breast cancers, has backed up the trend toward using liquid biopsy in determining the best care treatment. Secondarily, due to its minimally invasive quality, it poses less inconvenience when used compared to classical tissue biopsy procedures, augmenting its marketplace supremacy.

The early detection/screening segment is anticipated to develop at a high rate because of the increasing focus on the diagnosis of cancer at the early stages. Liquid biopsy provides a promising option to mammography and tissue biopsies through the identification of cancer-associated genetic mutations before the onset of clinical symptoms. The increase in awareness campaigns, along with continued research into multi-cancer early detection (MCED) technologies, is projected to propel the growth of liquid biopsy in screening applications. In addition, the growing use of liquid biopsy in standard cancer risk assessment programs is likely to drive its uptake.

Breast Cancer Liquid Biopsy Market Regional Insights

North America led the breast cancer liquid biopsy market in 2023, fueled by sophisticated healthcare infrastructure, high-precision oncology adoption rates, and robust regulatory encouragement. The region holds a significant portion of liquid biopsy tests globally, with the U.S. taking the lead due to the concentration of dominant market players such as Guardant Health, Exact Sciences, and Bio-Rad Laboratories. FDA approvals of liquid biopsy-based companion diagnostics have spurred clinical adoption, propelling the U.S. as a global market leader in breast cancer liquid biopsy applications. Further, the growing incidence of breast cancer, with more than 297,000 new cases reported in the U.S. in 2023, has boosted demand for non-invasive diagnostic tests.

Nonetheless, the Asia-Pacific is the highest-growing region projected to see faster growth with accelerating cancer incidence, developing healthcare infrastructure, and augmenting awareness related to early detection of cancer. Investment in research related to liquid biopsy is burgeoning in the Asia-Pacific region, with China, Japan, and India being leaders. Liquid biopsy uptake has amplified notably in China, with enterprises such as Burning Rock Biotech and BGI Genomics catalyzing market expansion in local areas. The escalating government backing for precision medicine projects, combined with rising healthcare expenditures, is likely to drive Asia-Pacific's market at the fastest growth rate in the forecast period.

List of Players and Their Respective Products Related to Breast Cancer Liquid Biopsy:

• The Menarini Group: DEPArray system

• NeoGenomics Laboratories: Liquid biopsy assays for breast cancer diagnostics

• F. Hoffmann-La Roche Ltd.: Cobas EGFR Mutation Test v2

• Myriad Genetics, Inc.: MyChoice HRD test

• Thermo Fisher Scientific, Inc.: Ion Torrent Oncomine Pan-Cancer Cell-Free Assay

• QIAGEN: QIAamp Circulating Nucleic Acid Kit

• Biocept, Inc.: Target Selector liquid biopsy assays

• Sysmex Corporation: OncoBEAM tests

• Fluxion Biosciences, Inc.: IsoFlux Liquid Biopsy System

• Epic Sciences, Inc.: Oncotype DX AR-V7 Nucleus Detect test

Recent Developments in the Breast Cancer Liquid Biopsy Market

In Oct 2024, Foundation Medicine, Inc. received FDA approval for FoundationOne Liquid CDx as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant. This approval supports the treatment of HR-positive, HER2-negative, PIK3CA-mutated metastatic breast cancer, developed by Genentech (Roche Group), for patients with endocrine-resistant disease following recurrence after adjuvant endocrine therapy.

In April 2024, Bio-Rad Laboratories launched the ddPLEX ESR1 Mutation Detection Kit, its first ultrasensitive multiplexed digital PCR assay for breast cancer mutation detection. This expands its Droplet Digital PCR (ddPCR) portfolio, enhancing mutation detection, therapy selection, and disease monitoring in oncology research.