Breast Cancer Liquid Biopsy Market Size, Share & Trends Analysis Report By Product and Service (Reagent Kits, Instruments, Services), By Circulating Biomarker (Circulating Tumor Cells, Extracellular Vesicles, Circulating Tumor DNA), By Applications (Diagnostics, Prognostics, Risk assessment ) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global breast cancer liquid biopsy market size was valued at USD 103.03 million in 2022. It is projected to reach USD 474.62 million by 2031, growing at a CAGR of 18.50% during the forecast period (2023-2031). 

A non-invasive blood test called a breast cancer liquid biopsy can find tumor DNA fragments and circulating tumor cells, which are discharged into the blood from primary tumors and metastatic sites. Breast cancer liquid biopsy is a quick and accurate substitute for surgical biopsy techniques that enables doctors and surgeons to identify and treat breast cancer at an early stage and collect tumor data using blood samples. Breast cancer liquid biopsy is essential since it aids doctors in comprehending molecular dynamics and breast cancer dynamics. Furthermore, timely breast cancer liquid biopsy procedures are anticipated to aid in understanding breast cancer recurrence.

Market Dynamics

Market Drivers

Increased Desire for Non-Invasive, Safe Techniques

Breast cancer liquid biopsy testing has become more prevalent in industrialized nations, encouraging interventions in various cancer therapy domains. Both doctors and patients prefer a diagnosis that includes a liquid biopsy analysis of breast cancer. Breast cancer liquid biopsy tests are becoming increasingly popular because they are straightforward, minimally invasive, and offer more benefits than traditional imaging and cancer detection modalities like radiographic and tomographic tests, computerized tomography (CT) scans, positron emission tomography (PET) scans, and others.

Breast cancer liquid biopsies do not expose patients to radiation hazards, as with traditional testing techniques. Breast cancer liquid biopsy is much less invasive than other tissue biopsy techniques, such as solid conventional tissue biopsy, because it only needs a tiny bit of blood. The benefits of breast cancer liquid biopsy testing help to raise demand for it in medical settings, which in turn spurs market expansion.

Increasing Frequency of Breast Cancer Worldwide

The rise in breast cancer cases has compelled medical professionals to use thorough diagnostic and testing procedures that aid in understanding tumor dynamics and molecular characterization of breast cancer to make accurate prognoses. Breast cancer liquid biopsy tests are intended to provide a comprehensive diagnosis of the patient's breast cancer profile by detecting many circulating biomarkers, such as tumor DNA, exosomes, and tumor cells in the blood. As a result, the breast liquid biopsy testing market is anticipated to grow along with the number of breast cancer patients.

Market Restraint

Lack of Access and Awareness in Less Developed Nations

Breast cancer liquid biopsy market growth is hindered in developing nations like Asia and Africa due to a lack of financial resources, low income, a shortage of diagnostic firms, and a lack of cutting-edge manufacturing techniques. The lack of healthcare professionals' and patients' education and the scarcity of liquid biopsy facilities for breast cancer in this area severely limit market expansion. Global market growth is hampered in developing nations like Ethiopia, Afghanistan, and Guinea by ineffective assistance from government organizations to adopt these technologies.

Market Opportunities

Advantages of Breast Cancer Liquid Biopsy Methods over Conventional Diagnostics

Due to its significant benefits over conventional diagnostic techniques, liquid biopsy testing for breast cancer has transformed the field of cancer diagnosis. Breast cancer liquid biopsy tests are a minimally invasive, safe, and cost-effective way to diagnose malignancy. Comparatively speaking, radiographic and tomographic tests cost more than breast cancer liquid biopsy. Therefore, unlike computed tomography (CT), positron emission tomography (PET), and other conventional tomographic and radiographic cancer testing methods, breast cancer liquid biopsy allows for continuous breast cancer disease monitoring at frequent time intervals, such as once per week.

Traditional testing can only be performed again three to six months later. Breast cancer liquid biopsy can continuously monitor a sick condition and evaluate functions, including patient response to therapy, treatment resistance assessment, and fast adjustment of prognosis course (if needed). The market is expanding due to the additional benefits liquid biopsy testing for breast cancer has over conventional tests.

Potential for Rapid Growth in Emerging Markets

Due to better healthcare industry infrastructure, a rise in the number of medical device companies, and a rise in demand for breast cancer liquid biopsy products, it is anticipated that unexplored, emerging markets will fuel the growth of the breast cancer liquid biopsy industry size. Due to the increased demand for improved sophisticated manufacturing systems and significant government investments to upgrade healthcare infrastructure, the healthcare business is multiplying in emerging nations.

Regional Analysis

North America Dominates the Global Market

The global breast cancer liquid biopsy industry is bifurcated into four regions: North America, Europe, Asia-Pacific, and LAMEA. 

North America is the major revenue contributor and is expected to grow at a CAGR of 18.80% during the forecast period. The United States, a mature market, contributed the most revenue to North America in 2019. The growth of the breast cancer liquid biopsy industry in North America is fueled by the presence of significant key players in the area, including Biocept Inc., Fluxion Biosciences, Inc., Myriad Genetics, Inc., NeoGenomics Laboratories, Inc., and Thermo Fisher Scientific Inc. Additionally, the primary element that significantly contributes to the market's growth is the increase in breast cancer prevalence. For example, Globocon 2018 reports that in North America, there were approximately 262,347 new breast cancer cases in 2018. As a result, the demand for liquid biopsy for breast cancer has increased in the area due to the increase in prevalence.

Europe is expected to grow at a CAGR of 19.40% during the forecast period. The demand for breast cancer liquid biopsy products and the dominance of key players like F. Hoffmann-La Roche Ltd. (Foundation Medicine, Inc.), Menarini Group (Menarini Silicon Biosystems, Inc.), and Qiagen N.V. is expected to drive the market for breast cancer liquid biopsy in European nations to grow steadily during the forecast period. Additionally, patients in these nations are increasingly utilizing breast cancer liquid biopsy tests, and the European Code Against Cancer (ECAC) continues to raise awareness of the disease among the general public, all of which have a favorable impact on the market's expansion.

Asia-Pacific is a significant market. Due to the rising demand for non-invasive procedures, technological advancements to detect breast cancer at an early stage increased government initiatives to raise public awareness of genome-based diagnostic procedures. Widespread use of polymerase chain reaction (PCR) and next-generation sequencing (NGS) among medical professionals, Asia-Pacific is anticipated to experience the fastest market growth during the forecast period. A sharp increase in leading manufacturers' attention to regional expansion in developing Asia-Pacific nations to seize significant development possibilities spurs market expansion.

LAMEA is an expanding market that is anticipated to offer lucrative growth possibilities for significant players due to the expansion of the target population, the demand for breast cancer liquid biopsy procedures, and improvements in the healthcare infrastructure. Additionally, the rising number of breast cancer patients in LAMEA fuels the use of breast cancer liquid biopsy, which in turn propels market expansion.

Segmental Analysis

The global breast cancer liquid biopsy industry size is segmented by product and service, circulating biomarker, and 

Based on product and service, the global market is bifurcated into reagent kits, instruments, and services.

The reagent kits segment is the highest contributor to the market and is estimated to boost at a CAGR of 19.50% during the forecast period. Liquid biopsy procedures primarily use reagents to recover nucleic acids from the tumor fragments detected in blood, mainly circulating tumor DNA, extracellular vesicles, micro RNAs, and other genetic material. Reagents are essential for amplifying the gene targets being studied and measuring the amplified genetic material to identify the molecular dynamics of the tumor in breast cancer liquid biopsy procedures. The main applications of kit-based reagents are sample collection, stabilization, preparation, and detection. Reagents are an essential part of liquid biopsy kits for breast cancer.

Breast cancer liquid biopsy is a diagnostic procedure that uses various tools and platforms designed specifically for liquid biopsy. Automated procedures include loading blood samples, priming flow cells, marking captured cells with immunofluorescence, and isolating target cells using instruments. This equipment has dramatically decreased the cost of liquid biopsy procedures for breast cancer. PCR and real-time genetic characterization of liquid biopsy samples are combined in liquid biopsy equipment. Hospitals, laboratories, and research institutions use various fluid biopsy tools and platforms designed to automate the testing procedure.

Breast cancer liquid biopsy services offer a wide range of unique options, such as early cancer recurrence prediction, tumor profiling, tumor surveillance, targeted therapy assessment, minimal residual disease (MRD) testing, and more. Customized assay development is another service provided by various molecular diagnostic businesses, including NeoGenomics Laboratories, Inc. Currently, complementing items that work with chemically fixed samples are included in the market for liquid biopsy services. It is now possible to conduct comparative studies of DNA from matched tumor tissues and plasma samples because of the adoption of liquid biopsy services. These combined data significantly aid the clinical validation of liquid biopsies.

Based on circulating biomarkers, the global market is bifurcated into circulating tumor cells, extracellular vesicles, and circulating tumor DNA.

The circulating tumor cells segment owns the highest market and is estimated to go up at a CAGR of 19.40% during the forecast period. Circulating tumor cells (CTCs) are essential diagnostic tools for analyzing breast cancer progression and the metastatic phase. CTCs are associated with lower breast cancer survival rates. The main benefit of using CTCs is that each CTC may have its genetic makeup, which is essential for understanding tumor biology and the metastatic process of a specific patient's tumor. Without the potential health concerns associated with some radiographic imaging techniques, such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and ultrasound, CTCs offer comparable or better predictive information. CTCs are currently used as biomarkers to indicate the state of metastatic cancer.

Extracellular vesicles (EVs), which range in size from 30-2,000 nm, are secreted by cells. Exosomes, apoptotic bodies, micro-vesicles, retroviral particles, and other entities are several agents covered in this section. Numerous essential physiological processes are carried out by EVs, including immune function regulation, mediating the spread of cancer, regulating the metastatic niche, intracellular communication, cellular remodeling, and modulating the tumor microenvironment. Since cancer cells exude EVs, which have proteomic and genomic contents that represent the origin of a given cell, it is conceivable to find tumor-specific material there. To better understand disease diagnosis and therapeutic monitoring in cancer patients, there is an increase in interest in EV analysis from biofluids of cancer patients.

Circulating tumor DNA (ctDNA) is single-stranded or double-stranded DNA secreted into the bloodstream by tumor cells and kept the original tumor's mutations alive. Liquid biopsy based on ctDNA analysis has recently opened new pathways for cancer molecular diagnosis and monitoring. In addition to being non-invasive, scientists have discovered that ctDNA screening of genetic lesions is very sensitive and specific. This shows that using ctDNA as a liquid biopsy circulating biomarker may enhance existing tumor diagnosis techniques, enabling the early detection of malignancy. Additionally, ctDNA analysis helps select treatments, track cancer evolution, and accurately determine prognosis and tumor progression.

Based on application, the global market is bifurcated into diagnostics, prognostics, and risk assessment.

The diagnostics segment is the highest contributor to the market and is estimated to grow at a CAGR of 19.70% during the forecast period. Breast cancer liquid biopsy diagnostic techniques are practical, low-risk, and economical molecular diagnostics methods that can provide specific details on the molecular landscapes of breast cancer. These tests also indicate strategies for overcoming tumor heterogeneity and real-time tumor monitoring. Additionally, CTC-based breast cancer liquid biopsy testing allows doctors to assess the burden of metastatic disease and instructive biomarkers to support clinical decision-making in breast cancer patients. 

Breast cancer liquid biopsy prognostic test examines gene activity that may impact how breast cancer will react or behave in response to medical or surgical treatment. Among the liquid biopsy prognostics for breast cancer on the market is FoundationACT, which is sold by F. Hoffmann-La Roche AG (Foundation Medicine, Inc.). FoundationACT is a central send-out service that makes use of a laboratory-developed test (LDT), circulating tumor DNA (ctDNA) assay for solid tumors based on liquid biopsy that finds >60 clinically associated genetic changes that cause breast cancer in individuals. A patient's molecular basis for breast cancer can be tracked throughout time thanks to prognostics.

Medical experts can calculate a woman's probability of acquiring breast cancer during the following five years and up to the age of 90 using a breast cancer risk assessment tool. The risk score and BRACAnalysis are liquid biopsy risk assessment tools for breast cancer and are sold by Myriad Genetics, Inc. By assessing several unique parameters, RiskScore provides complete and individualized risk assessment for a 5-year window and remaining lifetime risk of developing breast cancer for particular women. Additionally, it clarifies the individual risk of breast cancer for a woman who carries a pathogenic CHEK2 (Checkpoint Kinase 2) mutation.

Recent Developments

• March 2023- REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, announced a new addition to its pipeline consisting of a novel biomarker approach in liquid biopsy for patients with advanced cancer.
• March 2023- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, and Guardant Health, Inc., a leading precision oncology company, announced the initiation of a registrational Phase 3 clinical study comparing targeted lasofoxifene in combination with the CDK 4/6 inhibitor abemaciclib versus fulvestrant plus abemaciclib in pre and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.