Breast Cancer Liquid Biopsy Market By Circulating Biomarker (Circulating Tumor Cells (CTCs), Cell-free DNA (cfDNA), Extracellular Vesicles (EVs), Others) By End User (Reference Laboratories, Hospitals & Physician Laboratories, Others)-Growth, Future Prospects & Competitive Analysis, 2016 – 2030

Key Highlights of the Report

The global breast cancer liquid biopsy market is segmented by circulating biomarker, end user, and region. Circulating tumor cells (CTCs) dominate the biomarker segment, while hospitals & physician laboratories are the leading end users. North America and Europe are the largest markets, driven by advanced healthcare infrastructure and stringent regulatory standards.

The breast cancer liquid biopsy market is driven by factors such as the increasing incidence of breast cancer worldwide, the need for early and accurate detection methods, advancements in liquid biopsy technologies, and the growing focus on precision medicine in cancer treatment. However, the market faces challenges such as the high cost of liquid biopsy tests, regulatory complexities surrounding liquid biopsy approval and reimbursement, and the need for further validation and standardization of liquid biopsy techniques.

Nonetheless, the global breast cancer liquid biopsy market presents opportunities for growth due to the rising demand for non-invasive diagnostic tools, the development of targeted therapies based on liquid biopsy results, the integration of artificial intelligence & machine learning in liquid biopsy analysis, and the expansion of the market in emerging economies with improving healthcare infrastructure.

Market Overview

The global breast cancer liquid biopsy market has witnessed steady growth in recent years and is expected to grow at a CAGR of 22.7% between 2023 and 2030. The market was valued at USD 0.3 billion in 2022 and is expected to reach USD 1.25 billion in 2030.

What Are The Main Drivers Of The Global Breast Cancer Liquid Biopsy Market?

The major drivers of the global breast cancer liquid biopsy market growth are the increasing incidence of breast cancer, growing demand for non-invasive and early detection methods, advancements in liquid biopsy technologies, and the potential to provide real-time monitoring of treatment response and disease progression. Besides, the rising emphasis on personalized medicine and the need for improved patient outcomes drive the adoption of liquid biopsy techniques in breast cancer management, further fueling market expansion.

What Are The Major Challenges Faced By The Global Breast Cancer Liquid Biopsy Market?

The major challenges faced by the global breast cancer liquid biopsy market are the complexity of biomarker analysis and interpretation, variability in assay performance and sensitivity, limited standardization and regulatory guidelines, and the need for robust validation studies to establish clinical utility and reliability. Also, the high cost of liquid biopsy tests and the reimbursement landscape poses challenges for widespread adoption, along with the need for larger-scale clinical studies to demonstrate liquid biopsy's clinical utility and validity in breast cancer management.

What Are The Growth Opportunities In The Global Breast Cancer Liquid Biopsy Market?

The growth opportunities in the global breast cancer liquid biopsy market include the development of more sensitive and specific liquid biopsy technologies, integration of multi-omics analysis for comprehensive profiling, exploration of novel biomarkers for early detection and treatment monitoring, expanding applications beyond diagnosis, and increasing awareness and education among healthcare professionals and patients.

Executive Summary

Overview of the Global Breast Cancer Liquid Biopsy Market

The breast cancer liquid biopsy market is a rapidly evolving field in diagnosing and monitoring breast cancer. Liquid biopsy is the non-invasive detection and analysis of tumor-specific biomarkers, such as circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and extracellular vesicles in blood or other body fluids. This approach offers a less invasive alternative to traditional tissue biopsies and provides valuable insights into tumor characteristics, treatment response, and disease progression. The market is driven by factors such as the rising incidence of breast cancer, emerging demands for early detection methods, advancements in liquid biopsy technologies, and the potential for real-time monitoring of treatment efficacy.

Market Definition

The breast cancer liquid biopsy market encompasses developing and commercializing diagnostic tools and technologies for detecting, analyzing, and monitoring breast cancer using liquid biopsy techniques. This includes collecting and analyzing circulating tumor biomarkers, such as ctDNA and CTCs, from blood samples or other body fluids. The market includes various liquid biopsy assays, platforms, and kits designed to detect and quantify these biomarkers and associated software and data analysis tools. The goal is to provide clinicians with valuable information for accurate diagnosis, treatment decision-making, and monitoring of breast cancer patients.

Market Insights

• The global demand for breast cancer liquid biopsy was valued at USD 0.3 Billion in 2022 and is expected to reach USD 1.25 Billion in 2030, growing at a CAGR of 22.7% between 2023 and 2030.
• Circulating tumor cells (CTCs) are the leading segment by circulating biomarker and held over 35% share in terms of value in 2022, while the cell-free DNA (cfDNA) segment is likely to exhibit the fastest CAGR in the forecast period.
• The hospitals & physician laboratories end-user segment dominates the global demand for breast cancer liquid biopsy, holding a significant share of over 40% in 2022, and is expected to grow at a rapid CAGR.
• North America dominated the industry in 2022, accounting for more than 44% of global market revenue owing to the well-established healthcare infrastructure, strong R&D activities, and increasing awareness among healthcare professionals and patients.
• The Asia-Pacific region is projected to witness substantial growth in the coming years, fueled by the growing prevalence of breast cancer, rising healthcare expenditure, and emerging adoption of advanced diagnostic technologies.
• Liquid biopsy offers several advantages over traditional tissue biopsies, such as its non-invasive nature, ability to monitor treatment response, and potential for early detection of tumor recurrence.

Segmentation by Circulating Biomarker

• Circulating tumor cells (CTCs) dominate the segment, contributing to over 35% of the market share in terms of value in 2022.
• The cell-free DNA (cfDNA) segment is expected to exhibit the fastest CAGR in the projected period, driven by technological advancements and its potential for non-invasive cancer detection.

Segmentation by End User

• The reference laboratories segment is projected to post the highest CAGR over the estimated period, owing to the growing demand for accurate and specialized diagnostic services.
• The hospitals & physician laboratories segment led the global market in 2022, holding over 40% share in terms of value. These facilities play a critical role in breast cancer diagnosis and management.

Segmentation by Region

• North America dominated the global breast cancer liquid biopsy market in 2022, accounting for over 44% of revenue share.
• Europe is another prominent global breast cancer liquid biopsy market, contributing substantially to the overall market share.
• The Asia-Pacific region is experiencing rapid growth, with a high CAGR in the breast cancer liquid biopsy industry.
• The rest of the World, including regions like the Middle East, Latin America, and Africa, is witnessing the rapid adoption of breast cancer liquid biopsy solutions.

The global breast cancer liquid biopsy market is driven by factors such as the emerging incidence of breast cancer, increasing demand for non-invasive diagnostic methods, and advancements in liquid biopsy technologies. However, the market faces restraints in the form of high costs associated with liquid biopsy tests, regulatory challenges, and the need for skilled healthcare professionals.

The United States is a major country in the global breast cancer liquid biopsy market. The country has a well-established healthcare infrastructure, advanced research facilities, and a higher incidence of breast cancer. The United States is at the forefront of technological advancements and innovation in the healthcare sector. The presence of key market players, research institutions, and regulatory bodies further contributes to the growth of the country's breast cancer liquid biopsy market. The U.S. also strongly focuses on personalized medicine and precision oncology, driving the adoption of liquid biopsy technologies for better patient outcomes.

China represents a significant opportunity in the breast cancer liquid biopsy industry. The country has a large population, a rising incidence of breast cancer, and a growing healthcare infrastructure. The Chinese government has invested in developing precision medicine and encouraging R&D in liquid biopsy. With an increasing emphasis on early detection and personalized treatment, there is a growing demand for non-invasive diagnostic methods like liquid biopsy in China. A robust biotechnology industry, academic collaborations, and a large patient pool make China a key breast cancer liquid biopsy technology market.

Increasing Demand for Non-Invasive Diagnostic Methods

The growing demand for non-invasive diagnostic methods drives the adoption of breast cancer liquid biopsy. Liquid biopsy offers a less invasive alternative to traditional tissue biopsies, reducing patient discomfort and potential complications. The need for early detection and personalized treatment strategies further fuels the demand for non-invasive techniques.

Advancements in Liquid Biopsy Technologies

Technological advancements in liquid biopsy techniques and platforms have significantly enhanced their sensitivity, specificity, and reliability. Improvements in the detection and analysis of circulating tumor biomarkers, such as ctDNA and CTCs, have enabled more accurate diagnosis, treatment monitoring, and disease prognosis. These advancements drive the market by providing healthcare professionals with valuable insights for clinical decision-making.

Regulatory Challenges and Standardization

The breast cancer liquid biopsy market faces regulatory challenges and the need for standardization. Ensuring the accuracy, reliability, and consistency of liquid biopsy tests and results across different platforms and laboratories is a significant challenge. Regulatory guidelines and approval processes may vary across regions, leading to market entry and commercialization complexities.

High Cost and Limited Reimbursement

The cost of liquid biopsy tests can be relatively high, making it a limiting factor for widespread adoption. Additionally, the reimbursement landscape for liquid biopsy procedures may be limited, impacting the accessibility and affordability of these tests for patients. The high cost and reimbursement challenges can impede market growth, particularly in regions with resource constraints.

Integration of Multi-Omics Analysis

Integrating multi-omics analysis, such as genomics, transcriptomics, and proteomics, in liquid biopsy can comprehensively profile breast cancer tumors. This integration allows for a deeper understanding of tumor heterogeneity, treatment resistance, and disease progression. The ability to analyze multiple biomarkers simultaneously presents an opportunity for market growth and improved patient management.

Competitive Landscape

Key Players

The global breast cancer liquid biopsy market is highly competitive and characterized by the presence of several key players, research institutions, and diagnostic laboratories. Some of the major players in the market and their market share are as follows:

• 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

These players strive to develop innovative products, enhance the sensitivity and specificity of assays, and expand their geographical presence. The market is witnessing collaborations and partnerships between industry participants and research institutions to leverage their expertise and accelerate technological advancements. Companies are also investing in research and development activities to develop novel biomarkers and improve the performance of liquid biopsy tests.

For instance, Gene Solutions, a Vietnam-based firm, developed the Screening for the Presence of Tumour by Methylation and Size (SPOT-MAS) - a multimodal liquid biopsy-based assay - on March 1, 2023, to identify the five most common cancer types (liver, breast, colorectal, stomach, and lung cancer). The circulating tumor DNA (ctDNA) assay seeks to detect the presence of ctDNA in blood. This method, colloquially as a 'liquid biopsy,' requires only blood samples, not tumor material.

Likewise, REVEAL GENOMICS S.L., a biotechnology start-up in Barcelona that aims to revolutionize precision oncology through biomarker innovation, revealed a new addition to its pipeline in March 2023, consisting of a revolutionary biomarker approach in liquid biopsy for patients with advanced cancer. GENOMICS REVEAL Machine learning-based technology applied to ctDNA predicted treatment response and survival outcomes in patients with metastatic breast cancer treated with endocrine therapy and CDK4/6 inhibitors.

Summary of Key Findings

• The increasing prevalence of breast cancer in the population and the necessity to deliver detection solutions faster than other tissue biopsy procedures are driving market expansion.
• Market segmented by circulating biomarker, end user, and region.
• Circulating tumor cells (CTCs) are the dominant biomarker segment, playing a key role in detecting and monitoring breast cancer.
• North America and Europe have emerged as major breast cancer liquid biopsy markets, benefiting from advanced healthcare infrastructure and stringent regulatory standards.
• The high cost of liquid biopsy tests presents a challenge to market growth, particularly for healthcare facilities with limited budgets.
• Technological advancements, including developing more sensitive and specific liquid biopsy assays, contribute to innovations in breast cancer liquid biopsy biomarkers.

Future Outlook

• Growing emphasis on personalized medicine and targeted therapies drives the demand for liquid biopsy tests, offering valuable molecular information for treatment decisions and improved patient outcomes.
• Expansion of R&D operations focused on identifying novel liquid biopsy biomarkers, such as circulating nucleic acids and exosomes, which hold the potential for enhancing breast cancer detection with improved sensitivity and specificity.
• Rising investments in healthcare infrastructure, particularly in emerging economies, are expected to boost the adoption of liquid biopsy technologies, expanding access to advanced diagnostic tools for breast cancer management.

Segmentation

• By Circulating Biomarker
  • Circulating Tumor Cells (CTCs)
  • Cell-free DNA (cfDNA)
  • Extracellular Vesicles (EVs)
  • Others
• By End User
  • Reference Laboratories
  • Hospitals & Physician Laboratories
  • Others
• By Region
• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • France
  • The U.K.
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • South-east Asia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • GCC Countries
  • South Africa
  • Rest of the Middle East and Africa