Breast Cancer Liquid Biopsy Market Size, Share & Trends Analysis Report By Circulating Biomarkers (Circulating Tumor Cells, Circulating Cell-free DNA, Extracellular Vesicles), By Application, By Region, And Segment- Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

The global breast cancer liquid biopsy market size was estimated at USD 492.17 million in 2023 and is projected to hit around USD 5,720.37 million by 2033, growing at a CAGR of 27.8% during the forecast period from 2024 to 2033.

Key Takeaways:

• North America dominated the breast cancer liquid biopsy industry in 2023.
• Asia Pacific is estimated to showcase lucrative growth over the forecast period.
• The circulating cell-free DNA (cfDNA) segment accounted for the largest revenue share in 2023
• The circulating tumor cells (CTCs) segment is expected to show the fastest growth during the forecast period.
• The treatment selection segment held the largest revenue share in 2023
• The diagnosis segment is expected to show lucrative growth over the forecast period.

Breast Cancer Liquid Biopsy Market Overview

The Breast Cancer Liquid Biopsy Market has witnessed significant growth and evolution in recent years, driven by advancements in diagnostic technologies and a growing emphasis on non-invasive cancer detection methods. This market overview aims to shed light on key aspects shaping the landscape, including market size, growth trends, and notable players contributing to the expansion of liquid biopsy applications in breast cancer diagnostics.

Breast Cancer Liquid Biopsy Market Growth

The growth can be attributed to factors such as the increasing prevalence of breast cancer among the population, and the need to provide diagnosis solutions at a faster time than other tissue biopsy techniques making treatment decisions easier for doctors. Moreover, a majority of liquid biopsies used today are for breast and colorectal cancer which further propels the demand. For instance, in 2020, according to World Cancer Research Fund Organization, breast cancer is one of the most commonly occurring among the population with 2.23 million new cases worldwide. raising screening rates is a priority for many hospitals and community health clinics. The COVID-19 pandemic has caused a dramatic reduction in pandemic-related rates of screening. In 2020, as the coronavirus epidemic spread, the number of screenings sharply decreased. While they dealt with acute manpower shortages, several screening facilities temporarily shut down. Furthermore, people were wary of using hospitals and other healthcare institutions for non-emergency treatments out of concern about getting COVID-19.

One of the major advantages associated with liquid biopsy is the less time consumption associated with the procedure. Tissue biopsy is derived from localized sources that limit the diagnostic information that the physicians may rely upon for determining and evaluating the patient’s response to treatment. Whereas, results from liquid biopsies tend to provide an easier way to understand the recurrence of cancer than tissue biopsies help in determining and providing faster therapy decisions to doctors.

Breast cancer is one of the most common applications of liquid biopsy, helping in identifying appropriate targeted therapy on basis of mutational analysis. For instance, determining the next course of treatment for patients with metastatic illness can be aided by testing for the PIK3CA mutation that exists in about 40% of all HR-positive breast tumors. Moreover, the evolving MRD detection through the circulating tumor DNA provides promising and transformative applications within oncology for liquid biopsy. However, the costs associated with the tests, and the lack of sensitivity and specificity associated with them are major restraining factors affecting the growth of the market. The cost of liquid biopsy tests varies from USD 299-5,000 and the tests are sometimes seen to produce false positives, which increases the risk of doctors over-treating patients. However, the cost in near future is expected to become a growth factor as it is likely to become less expensive than tissue sampling. Moreover, reimbursement is one of the biggest concerns in the market as the tests are only reimbursed on a case-by-case basis with Guardant 360 ranking among the few tests covered by health plans in the U.S.

Breast Cancer Liquid Biopsy Market Report Scope

Breast Cancer Liquid Biopsy Market Future Trends: 

The Breast Cancer Liquid Biopsy Market is on a trajectory of continuous evolution, with several key trends shaping its future landscape. As diagnostic technologies advance and healthcare paradigms shift towards personalized medicine, the following trends are anticipated to define the future of liquid biopsy in breast cancer diagnostics.

• Integration of Artificial Intelligence (AI): The incorporation of AI and machine learning algorithms is poised to enhance the accuracy and efficiency of liquid biopsy analysis. AI applications can aid in the interpretation of complex genomic data, enabling more precise identification of biomarkers associated with breast cancer. This integration holds the potential to streamline diagnostic processes and improve the overall reliability of liquid biopsy results.
• Expansion of Biomarker Panel: Future liquid biopsy protocols are likely to incorporate an expanded panel of biomarkers, providing a more comprehensive view of the genetic landscape associated with breast cancer. This expansion may include a diverse range of genetic alterations, allowing for a nuanced understanding of tumor heterogeneity and paving the way for more targeted and personalized treatment strategies.
• Increasing Clinical Validation and Standardization: Addressing current challenges related to standardization and validation, the future of the Breast Cancer Liquid Biopsy Market will witness concerted efforts towards establishing rigorous testing protocols. Collaborations between industry stakeholders, regulatory bodies, and research institutions will play a crucial role in defining standardized practices, ensuring the reliability and reproducibility of liquid biopsy results.
• Rise of Liquid Biopsy for Early Detection: Advancements in sensitivity and specificity are expected to position liquid biopsy as a formidable tool for early detection of breast cancer. The ability to detect minimal residual disease and identify actionable mutations at an earlier stage holds the potential to significantly improve patient outcomes, ushering in a new era of proactive and timely interventions.
• Emphasis on Cost-Effectiveness and Accessibility:Efforts to enhance the cost-effectiveness and accessibility of liquid biopsy procedures will be a prominent trend. As the technology matures and becomes more widespread, initiatives to reduce overall testing costs and improve accessibility, particularly in resource-limited settings, will play a pivotal role in expanding the reach of liquid biopsy diagnostics.
•  Integration with Multimodal Approaches: The future of breast cancer diagnostics will likely witness the integration of liquid biopsy with other diagnostic modalities, such as imaging and traditional biopsy. Combining multiple approaches can provide a more comprehensive understanding of the disease, enabling clinicians to make more informed decisions regarding treatment strategies.

Segments Insights:

Circulating Biomarkers Insights

The circulating cell-free DNA (cfDNA) segment accounted for the largest revenue share in 2023. The dominance of the market is attributed to the non-invasive way offered by cfDNA to simplify prognosis and diagnose recurrence or progression, detecting developing genomic abnormalities associated with medication resistance, and monitoring tumor molecular profiling in real-time at multiple time points.

Numerous businesses provide cfDNA-based products for use in scientific research. There are multiple tests under development that use cfDNA as the means of detecting cancer. For instance, in October 2021, Yemaachi Biotech and Lucence announced the launch of a study in Africa for the characterization of genomic alterations using Liquid HALLMARK assay in African Women to facilitate and expand access to liquid biopsy.

The circulating tumor cells (CTCs) segment is expected to show the fastest growth during the forecast period. The growth of the segment is associated with the ability of CTCs in providing higher sensitivity as biomarkers for the early detection of cancer, with higher CTCs counts being related to a very high risk of developing cancer.

CTCs monitoring over time indicates treatment effectiveness. There has been ongoing research to define the utility of CTCs in early-stage breast cancer. Moreover, researchers have concluded that the FDA-approved CellSearch system for CTCs detection concluded that CTCs numbers are low in the early stage of the disease. In the past few years, remarkable improvement has been made in increasing the efficiency and accuracy of the isolation of CTCs from peripheral blood samples.

Application Insights

The treatment selection segment held the largest revenue share in 2023, attributed to the need to provide early treatment. Liquid biopsies have emerged as an essential tool for enhancing the importance of early detection, characterization, and management of breast cancer in the early stages which makes this clinical setting the most appropriate to increase the chances for effective treatment selection and improved prognosis.

For instance, in August 2021, FoundationOne Liquid CDx received FDA approval for its ctDNA-based CGP assay intended to be used in conjunction with other diagnostic tests to help doctors decide which patients will benefit from receiving targeted medicines.

The diagnosis segment is expected to show lucrative growth over the forecast period. The growth is attributed to the increasing dominance of the use of liquid biopsy in the diagnosis of cancer. Liquid biopsy has drastically changed the field of clinical oncology, offering ease in monitoring and continuous sampling of tumors that gives a better way to provide early detection of cancer. The growth is also attributed to the increasing technological advancements in liquid biopsy technology aided by increasing awareness about non-invasive and safer testing procedures.

Regional Insights

North America dominated the breast cancer liquid biopsy industry in 2023. The dominance can be attributed to rapid technological advancements, the adoption of liquid biopsies for treatment selection, and growing government initiatives. The North American market is led by the U.S. owing to greater investments and the presence of several biotechnology companies developing the tests.

Organizations, such as the American Society of Clinical Oncology, are engaged in supporting the implementation of liquid biopsy, which is likely to boost revenue in this market. The increasing availability of liquid biopsy tests in the region is anticipated to enhance product adoption. For instance, in June 2022, GeneXpert system-compatible LBx-BCM test was made commercially available for research use by Johns Hopkins, which was developed in collaboration with Cepheid.

Asia Pacific is estimated to showcase lucrative growth over the forecast period. The growth is driven by the increasing healthcare reforms aided by improving healthcare infrastructure, a growing population, and a rising number of companies entering the market. Asia Pacific has a large population and a high prevalence of cancer. According to Global Cancer Statistics 2020, an estimated one-half of all cases and around 58.3% of cancer deaths occurred in Asia in 2020.

Thus, the usage of screening tests for cancer has increased in the past few years owing to growing government initiatives, such as free screening for breast cancer and increased collaborations for the distribution and supply of these tests. The companies in the region are focusing on product development and commercialization. For instance, in September 2021, AnchorDx a Chinese startup collaborated with a top-tier hospital in China and developed cfDNA based breast cancer early detection liquid biopsy test.

Key Companies & Market Share Insights

The key players are focusing on partnerships, strategic collaborations, and geographical expansion, in emerging and economically favorable regions. For Instance, in September 2022, a USC-led team of scientists found evidence of liquid biopsy to be able to use for the determination of breast cancer at its early stages, the team was a collaboration between USC, Epic Sciences, Billings Clinic, USC Norris Comprehensive Cancer Center, and Duke University. Some prominent players in the global breast cancer liquid biopsy market include:

• 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.

Segments Covered in the Report

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.

By Circulating Biomarkers 

• Circulating Tumor Cells (CTCs)
• Circulating Cell-free DNA (cfDNA)
• Extracellular Vesicles (EVs)
• Other Circulating Biomarkers

By Application 

• Early Detection/Screening
• Diagnosis
• Treatment Selection
• Monitoring

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)