Breast Cancer Liquid Biopsy Market

Breast Cancer Liquid Biopsy Market Overview:-

A liquid biopsy is a non-invasive medical technique used to identify and track a number of diseases, including cancer, by analyzing several biomarkers found in a sample of biological fluids, usually blood. It provides a substitute for conventional tissue biopsies, which include intrusive techniques to collect tissue samples. Because it is less intrusive and more convenient for patients, it is used to identify breast cancer.

Circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), exosomes, and other biomarkers are examined in a liquid biopsy to reveal important details regarding the existence of tumors, genetic abnormalities, response to treatment, and the course of the disease. To investigate the genetic material or proteins linked to the condition, a patient's blood sample is obtained, the desired components are isolated, and molecular analysis is carried out.

One of the most popular uses of liquid biopsy is for breast cancer, which aids in the selection of the best targeted treatment based on mutational analysis. For example, testing for the PIK3CA mutation, which is present in around 40% of all HR-positive breast cancers, can help choose the next course of treatment for patients with metastatic illness. Furthermore, the developing MRD detection method using circulating tumor DNA offers liquid biopsy exciting and revolutionary oncology applications.

Patients now have more access to the test thanks to developments in breast cancer liquid biopsy technology and regulatory clearances from several nations. A new biomarker technique in liquid biopsy for patients with advanced cancer was announced in March 2023 by REVEAL GENOMICS, S.L., a biotechnology start-up based in Barcelona that aims to transform precision oncology through biomarker innovation.

The global market for liquid biopsies for breast cancer is anticipated to increase significantly over the next several years as the medical community adopts this novel strategy. The method has transformed cancer diagnoses and treatment monitoring by detecting tumor-specific biomarkers, circulating tumor cells (CTCs), and cell-free DNA in blood samples. Additionally, the market has been driven by continuous R&D, partnerships between biotech firms and medical facilities, and an increase in the need for tailored and focused treatments for patients with breast cancer.

Market Dynamic:-

The growing need for less invasive breast cancer diagnostic techniques is driving the market's notable expansion. The utilization of cutting-edge technologies for molecular testing, such as circulating tumor cells (CTCs) and cell-free DNA (cfDNA), is the main factor propelling the industry. These technologies make it possible to identify circulating biomarkers in the circulation, such as extracellular vesicles, which can provide important information for the diagnosis, prognosis, and therapy of breast cancer. Hospitals, physician laboratories, reference laboratories, public health laboratories, and laboratories are among the many stakeholders in the industry. Because liquid biopsy tests can provide real-time information on the genetic profile of the tumor, allowing for individualized treatment programs for patients with breast cancer, their demand is rising.

Additionally, the market offers kits and consumables for cfDNA and CTC separation and analysis, including reagent kits. For molecular testing, the market also offers conventional procedures like Next-Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR). Liquid biopsies are also being promoted by the World Health Organization (WHO) for the diagnosis and treatment of breast cancer. In conclusion, the market is anticipated to expand considerably as a result of the rising need for individualized treatment regimens and minimally invasive diagnostic techniques for patients with breast cancer. The market covers a range of players, including research institutes, hospitals, and labs, and includes technologies like PCR, NGS, CTCs, and cfDNA.

Key Market Driver:-

• Rising prevalence of breast cancers

The need for specialized diagnostics with greater precision is being directly impacted by the rising incidence of breast cancer in the modern world. One non-invasive, specialized, and accurate diagnostic method that is showing promise is liquid biopsy for breast cancer. Consequently, this has cleared the path for market expansion.

• Adoption of non-invasive diagnostic techniques

Breast cancer liquid biopsy offers a non-invasive alternative to traditional tissue biopsies which are invasive and can be associated with various risks and complications. Liquid biopsy provides a less burdensome and more patient-friendly approach to detecting and monitoring breast cancer, which is expected to drive market growth.

• Growing investment in healthcare facilities

Surging focus on improving the condition of healthcare facilities and improving the overall healthcare infrastructure is another important factor expected to drive market growth. The rising number of partnerships and strategic collaborations between the public and private players pertaining to funding and application of new and improved technology is further expected to drive market growth.

Significant Market Trends:-

Programs to detect breast cancer at the early stages is the key trend in the market. Government and private organizations' funding and grants are significantly contributing to the advancement of innovative products for breast cancer screening. These solutions, including prognostics and risk assessment tools in the diagnostics segment, aim to provide superior preventive care for patients. For instance, the European Commission has supported projects like BRIDGES and B-CAST.

Further, BRIDGES utilizes next-generation sequencing to identify women at high risk of breast cancer based on their DNA variations or mutations. This enables high-risk patients to undergo comprehensive evaluations and take preventive measures accordingly. B-CAST focuses on breast cancer stratification, enabling precise identification of individuals' breast cancer risks. These advanced tools are essential for personalized therapeutics and improving overall breast cancer management. Thus, such trends will shape the growth of the market during the forecast period.

Major Market Challenge:-

High cost of breast biopsy is the major challenge that affects the growth of the market. Breast cancer is a significant health concern worldwide, leading to an increased focus on early detection and accurate diagnosis. The diagnostics segment of the breast cancer market is witnessing growth due to the rising adoption of advanced technologies for prognostics and risk assessment. Liquid biopsies, a newer approach in breast cancer diagnostics, are gaining traction due to their ability to provide real-time information on the presence and progression of cancer cells in the body. These tests are less invasive than solid tissue biopsies and offer a more personalized therapeutic approach.

Needle biopsies, guided by imaging techniques like mammograms, ultrasound, and MRIs, continue to be the primary method for breast cancer diagnosis. These procedures enable healthcare professionals to obtain a sample of the breast tissue for further examination, providing valuable insights for patient care and treatment planning. Hence, the above factors will impede the growth of the market during the forecast period

Restraints/Challenges

• Lack of skilled professionals

Performing breast cancer liquid biopsy requires specialized skills and expertise, particularly in areas such as histopathology, molecular pathology, and interpretation of results. The shortage of skilled pathologists, technicians, and molecular biologists can hinder the widespread adoption and efficient implementation of breast cancer liquid biopsy, leading to delays in diagnosis and treatment. This is expected to restrain market growth.

• Stringent regulatory requirements

The global breast cancer liquid biopsy market is subject to strict regulatory oversight, ensuring patient safety, accuracy, and quality of diagnostic tests. Obtaining regulatory approvals and complying with regulations can be time-consuming and costly, particularly for new diagnostic technologies and companion diagnostics. Stringent regulatory requirements may slow down the pace of innovation and market entry for new products, which is expected to restrain market growth.

The global breast cancer liquid biopsy market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, the impact of domestic and localized market players, analyzes opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, and technological innovations in the market. To gain more info on the global breast cancer liquid biopsy market, contact Data Bridge Market Research for an Analyst Brief, our team will help you make an informed market decision to achieve market growth.

Market Segmentation:

Segmentation 1: by Offering
•    Testing Service
•    Kits
•    Platform
•    Other Consumables

Testing Service Segment to Dominate the Liquid Biopsy Market (by Offering)

The Testing Service segment is poised to dominate the liquid biopsy market by offering. This dominance can be attributed to the increasing incidence of chronic diseases such as cancer along with the demand for its early diagnosis and treatment.

Segmentation 2: by Technology
•    Next-Generation Sequencing
•    Polymerase Chain Reaction
•    Other Technologies
•    Emerging Technologies

Next-Generation Sequencing to Dominate the Liquid Biopsy Market (by Technology)

The next-generation sequencing segment is anticipated to dominate the liquid biopsy market by technology. This dominance stems from the widespread demand for non-invasive techniques for the analysis of non-solid biological tissues for the detection of cancer cells or fragments of DNA circulating in the bloodstream. Additionally, the integration of next-generation sequencing in liquid biopsy represents a significant advancement in understanding and treating cancer more effectively.

Segmentation 3: by Workflow
•    Sample Preparation
•    Library Preparation
•    Sequencing
•    Data Analytics and Management

Library Preparation to Dominate the Liquid Biopsy Market (by Workflow)

The library preparation segment is expected to dominate the liquid biopsy market based on workflow. This dominance is due to its significance in the workflow, as this step involves the preparation of extracted DNA or RNA for sequencing. This segment is evolving rapidly with the increasing introduction of novel-technology-based library preparation kits such as Invitrogen Collibri PS DNA Library Prep kit for Illumina systems.

Segmentation 4: by Usage
•    Clinical
•    Research

Research Segment to Dominate the Liquid Biopsy Market (by Usage)

The research segment of the liquid biopsy market by usage is expected to lead the market as liquid biopsies are primarily used for scientific studies and in the development of new non-invasive diagnostic methods.  Research with liquid biopsies is not intended for immediate implementation in patient care but for the expansion of the scientific knowledge base. This segment’s growth is driven by several key factors, such as collaboration between companies and institutions and funding activities for research and development of new products for liquid biopsy.

Segmentation 5: by Sample
•    Blood
•    Urine
•    Saliva
•    Others

Blood to Dominate the Liquid Biopsy Market (by Sample)

The blood segment is positioned to dominate the liquid biopsy market based on sample, as blood is a rich source of biomarkers such as circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA). The non-invasive nature of blood collection, along with the extensive variety of genetic material it offers, positions blood as an optimal medium for the detection and ongoing monitoring of various cancers.

Segmentation 6: by Circulating Biomarker
•    Circulating Tumor Cells (CTCs)
•    Cell-Free DNA (cfDNA)
•    Circulating Cell-Free RNAs
•    Exosomes and Extracellular Vesicles and Others
•    Other Circulating Biomarkers

Circulating Tumor Cells (CTCs) to Dominate the Liquid Biopsy Market (by Circulating Biomarker)

The circulating tumor cells (CTCs) segment is positioned to dominate the liquid biopsy market based on circulating biomarkers, as circulating tumor cells shed from the primary tumor into the bloodstream and circulate in the body and through blood sampling these can be used for detection of the presence of cancer and its progression allowing for personalized treatment strategies.

Segmentation 7: by Indication
•    Breast Cancer
•    Prostate Cancer
•    Lung Cancer
•    Colorectal Cancer
•    Melanoma
•    Other Types of Cancer

Lung Cancer Segment to Dominate the Liquid Biopsy Market (by Indication)

The lung cancer segment is expected to experience dominance in the liquid biopsy market based on indication, as it is one of the most common and lethal forms of cancer.  Its high prevalence highlights an increasing demand for early detection, which can be achieved by liquid biopsies by analyzing circulating tumor DNA (ctDNA) and other biomarkers in blood.

Segmentation 8: by Clinical Application
•    Treatment Monitoring
•    Prognosis and Recurrence Monitoring
•    Treatment Selection
•    Diagnosis and Screening

Treatment Selection Segment to Dominate the Liquid Biopsy Market (by Clinical Application)

The treatment selection segment is positioned to dominate the liquid biopsy market based on clinical application, as it plays a significant role in disease treatment. This application makes treatment more precise and effective. The dominance of this segment is driven by an increasing number of products available for treatment selection for various types of cancers. Various companies, such as Epic Sciences and Guardant Health, are providing techniques for disease treatment selection.

Segmentation 9: by End User
•    Academic and Research Institutions
•    Clinical Laboratories
•    Pharmaceutical and Biotechnology
•    Companies
•    Other End Users

Academic and Research Institutes Segment to Dominate the Liquid Biopsy Market (by End User)

The academic and research institutes segment is expected to lead the liquid biopsy market based on end users, as these are primarily focused on conducting research. Academic and research institutions involve liquid biopsy in studying the molecular groundwork of various diseases such as cancer. These are at the forefront of scientific research as they possess the infrastructure and capacity to pioneer new methodologies. This segment leads the market due to its robust innovation capabilities, extensive collaborative network between institutions and companies, and significant funding for research.

Breakup by Region:

• North America

  • United States

  • Canada

• Asia-Pacific

  • China

  • Japan

  • India

  • South Korea

  • Australia

  • Indonesia

  • Others

• Europe

  • Germany

  • France

  • United Kingdom

  • Italy

  • Spain

  • Russia

  • Others

• Latin America

  • Brazil

  • Mexico

  • Others

• Middle East and Africa

North America currently dominates the global market

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America dominates the global market.

According to the breast cancer liquid biopsy market statistics, breast cancer remains one of the most common cancers among women in North America, driving demand for improved diagnostic tools. Moreover, liquid biopsies offer a non-invasive alternative to traditional tissue biopsies, which can be painful, risky, and difficult to perform, especially in advanced cancer cases. As a simple blood test, liquid biopsy is more appealing to patients, contributing to its growing adoption. Besides this, advances in liquid biopsy technologies, including next-generation sequencing (NGS), PCR-based methods, and improved ctDNA and CTC (circulating tumor cells) detection platforms, have significantly increased the accuracy and sensitivity of these tests. These innovations are driving wider clinical adoption of liquid biopsy for breast cancer diagnosis and monitoring.

Breast Cancer Liquid Biopsy Market Size 2024-2028 

The breast cancer liquid biopsy market size is forecast to increase by USD 534.8 million, at a CAGR of 18.06% between 2023 and 2028. In the realm of healthcare, the rise in breast cancer diagnoses worldwide necessitates innovative solutions for effective treatment. The focus on personalized medicine in cancer care is increasingly significant, as individualized therapies cater to unique patient needs, enhancing treatment outcomes. Furthermore, the demand for minimally invasive therapies is growing, as they offer reduced recovery time, fewer complications, and improved patient comfort. Companies like XYZ Healthcare are answering this call with their key offering: a revolutionary breast cancer treatment utilizing personalized medicine and minimally invasive techniques. By combining advanced genomic profiling and targeted therapy, XYZ Healthcare aims to provide patients with optimized, effective, and less invasive breast cancer treatments.

Market Dynamic and Customer Landscape

The market is witnessing significant growth due to the increasing demand for minimally invasive diagnostic methods for breast cancer. The market is primarily driven by the use of advanced technologies such as Cell-free DNA (cfDNA) and Circulating Tumor Cells (CTCs) for molecular testing. These technologies enable the detection of circulating biomarkers, including extracellular vesicles, in the bloodstream, providing valuable information for breast cancer diagnosis, treatment, and prognostics. The market comprises various stakeholders, including laboratories, hospitals, physician laboratories, reference laboratories, and public health laboratories. The demand for liquid biopsy tests is increasing due to their ability to provide real-time information on the tumor's genetic profile, enabling personalized treatment plans for breast cancer patients.

Also, the market includes consumables and kits, such as reagent kits, used for cfDNA and CTC isolation and analysis. Also, the market includes traditional tests like Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS) for molecular testing. The World Health Organization (WHO) is also promoting the use of liquid biopsy for breast cancer diagnosis and treatment. In conclusion, the market is expected to grow significantly due to the increasing demand for minimally invasive diagnostic methods and personalized treatment plans for breast cancer patients. The market includes various stakeholders, including laboratories, hospitals, and research institutes, and comprises technologies such as cfDNA, CTCs, PCR, and NGS.

Key Market Driver

Growing prevalence of breast cancer cases is notably driving market growth. Breast cancer is a significant health concern worldwide, accounting for a considerable number of deaths globally. Among various types of cancer, breast cancer is the most common in women, particularly in the geriatric population, with around 9% of women aged 65 and above being diagnosed in 2021. Younger women are also susceptible, as evidenced by the 12% of new breast cancer cases reported in the US for women below 45 years of age in July 2021. The diagnostic segment in the breast cancer market is witnessing substantial growth due to the increasing demand for early and accurate detection.

Moreover, prognostics and risk assessment are crucial aspects of breast cancer management, leading to the growing adoption of personalized therapeutics. Liquid biopsies, an alternative to solid tissue biopsies, offer several advantages, including minimally invasive procedures, real-time monitoring, and improved patient compliance. These factors are expected to drive the growth of the breast cancer liquid biopsy market. Thus, such factors are driving the growth of the market during the forecast period.

Significant Market Trends

Programs to detect breast cancer at the early stages is the key trend in the market. Government and private organizations' funding and grants are significantly contributing to the advancement of innovative products for breast cancer screening. These solutions, including prognostics and risk assessment tools in the diagnostics segment, aim to provide superior preventive care for patients. For instance, the European Commission has supported projects like BRIDGES and B-CAST.

Further, BRIDGES utilizes next-generation sequencing to identify women at high risk of breast cancer based on their DNA variations or mutations. This enables high-risk patients to undergo comprehensive evaluations and take preventive measures accordingly. B-CAST focuses on breast cancer stratification, enabling precise identification of individuals' breast cancer risks. These advanced tools are essential for personalized therapeutics and improving overall breast cancer management. Thus, such trends will shape the growth of the market during the forecast period.

Major Market Challenge

High cost of breast biopsy is the major challenge that affects the growth of the market. Breast cancer is a significant health concern worldwide, leading to an increased focus on early detection and accurate diagnosis. The diagnostics segment of the breast cancer market is witnessing growth due to the rising adoption of advanced technologies for prognostics and risk assessment. Liquid biopsies, a newer approach in breast cancer diagnostics, are gaining traction due to their ability to provide real-time information on the presence and progression of cancer cells in the body. These tests are less invasive than solid tissue biopsies and offer a more personalized therapeutic approach.

Needle biopsies, guided by imaging techniques like mammograms, ultrasound, and MRIs, continue to be the primary method for breast cancer diagnosis. These procedures enable healthcare professionals to obtain a sample of the breast tissue for further examination, providing valuable insights for patient care and treatment planning. Hence, the above factors will impede the growth of the market during the forecast period

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

Bio Rad Laboratories Inc. - The company offers breast cancer liquid biopsy that includes Breast Tumor Antigen which helps in protecting mucous membranes, signal transduction, and modulation of the immune system.

The market research and growth report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Biocept Inc.

• Biodesix Inc.

• Cardiff Oncology Inc.

• Epic Sciences Inc.

• Exact Sciences Corp.

• F. Hoffmann La Roche Ltd.

• Fluxion Biosciences Inc.

• Guardant Health Inc.

• Illumina Inc.

• Isogen Life Science BV

• Johnson and Johnson Services Inc.

• Lucence Health Inc.

• Menarini Silicon Biosystems SpA

• MiRXES Pte Ltd.

• Myriad Genetics Inc.

• NeoGenomics Laboratories Inc.

• QIAGEN NV

• Sysmex Inostics Inc.

• Thermo Fisher Scientific Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Recent Developments:-

• In 2024, Illumina Inc. expanded its oncology portfolio for for NovaSeqX Series customers by offering high-throughput version of TruSight Oncology 500 and the second version of its liquid biopsy research assay, TruSight Oncology 500 ctDNA v2 in order to expand oncology testing

• In 2024, Twist Bioscience launched its cfDNA library preparation kit for liquid biopsy applications

• In 2024, GEDiCube, now known as RenovaroCube, signed a legally binding Letter of Intent.

• In 2024, Twist Bioscience Corporation introduced the cfDNA Library Preparation Kit aimed at facilitating liquid biopsy research.

• In 2024, Myriad Genetics disclosed its purchase of Precise Tumor, Precise Liquid, and Laboratory divisions from Intermountain Precision Genomics in January of this year.

• In 2024: Strand Life Sciences, a Reliance Industries subsidiary, introduced the Somatic Advantage 74 Liquid Biopsy (SA74 LB) Test, which detects circulating tumor DNA in cancer patients' blood.

• In 2024: Personalis, Inc., advanced genomics for precision oncology provider, announced that Tempus will begin commercialization efforts for NeXT Personal, Personalis' ultra-sensitive, whole genome-based liquid biopsy assay for detecting minimal residual disease (MRD) and cancer recurrence.

• In 2024: The Continental Hospitals launched the Early Detection Liquid Biopsy Test, a cancer detection mechanism to enable early cancer detection.

• Breast Cancer Liquid Biopsy Market Report Scope:-