Breast Cancer Liquid Biopsy Testing Devices Market to Grow by USD 1.16 Billion (2024-2028) Due to Rising Breast Cancer Cases, AI's Influence on Market Trends - Technavio Report

NEW YORK, Aug. 26, 2024 /PRNewswire/ -- The global breast cancer liquid biopsy testing devices market size is estimated to grow by USD 1.1 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of almost 31.34%  during the forecast period. Increasing prevalence of breast cancer is driving market growth, with a trend towards technological advances. However, high costs associated with liquid biopsy testing  poses a challenge. Key market players include A. Menarini Industrie Farmaceutiche Riunite Srl, Bio Rad Laboratories Inc., Cell Microsystems Inc., Exact Sciences Corp., F. Hoffmann La Roche Ltd., Guardant Health Inc., Illumina Inc., Isogen Life Science BV, Mesa Laboratories Inc., Myriad Genetics Inc., Natera Inc., NeoGenomics Laboratories Inc., Novogene Co. Ltd., OncoDNA, Pfizer Inc., QIAGEN NV, SAGA Diagnostics AB, Sysmex Corp., and Thermo Fisher Scientific Inc..

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Market Driver

The global breast cancer liquid biopsy testing devices market is experiencing significant growth due to advancements in molecular diagnostic products. Breast cancer is linked to specific gene mutations, and the analysis of these mutations is crucial for diagnosis and treatment. Next-generation sequencing (NGS) in liquid biopsy procedures has revolutionized breast cancer diagnosis. Traditional biopsy methods have limited sensitivity and specificity, making NGS an essential tool for detecting ctDNA mutations. Notable companies like Thermo Fisher Scientific and QIAGEN are focusing on NGS solutions and assays for breast cancer diagnosis. Thermo Fisher Scientific offers sample preparation solutions and NGS assays for identifying cancer drivers, monitoring progression, and detecting recurrence. QIAGEN's GeneReader NGS System is optimized for blood plasma analysis using proven automated technologies for circulating, cell-free DNA. The emergence of targeted digital sequencing, such as TARgeted DIgital Sequencing, is vital for response monitoring and residual disease detection in early breast cancer diagnosis. TARgeted DIgital Sequencing precisely measures ctDNA, detects residual cancer, and provides valuable information to healthcare professionals on treatment success. These advancements in technology enhance the quality, accuracy, and precision of breast cancer diagnosis, driving market growth during the forecast period. 

The Breast Cancer Liquid Biopsy Testing market is experiencing significant growth due to the increasing demand for early detection and personalized therapeutics. Companies like Qiagen, Biocept, and Canexia Health are leading this trend with innovative solutions for drug administration in breast cancer treatment. The World Health Organization and Cancer Research have endorsed the use of circulating biomarkers, such as circulating tumor DNA and CTCs, for diagnostics, prognostics, and risk assessment. PCR and NGS technologies are key components of these tests, providing high sensitivity and specificity. However, limitations associated with liquid biopsy systems include shutdowns due to short supply of reagent kits and instruments, making it essential for healthcare institutions and biotech companies to plan ahead. Liquid biopsy tests are becoming revenue contributors in cancer diagnostics, treatment monitoring, and medical community, driving healthcare reforms towards early detection and treatment selection. Blood samples are now a valuable resource in the fight against breast cancer. 

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Market Challenges

• Liquid biopsy testing is a valuable tool for healthcare professionals in diagnosing breast cancer, offering a less invasive alternative to traditional core needle and surgical biopsies. The demand for this procedure is increasing due to its ability to provide in-depth information about tumors by analyzing blood samples. Technologies like next-generation sequencing (NGS) and polymerase chain reaction (PCR) are commonly used for molecular diagnostic testing, enabling the detection of specific mutations and genomic markers. The cost of liquid biopsy primarily consists of the expense for devices and professional fees. Multigene panels used in the procedure cost between USD4,500 and USD10,500, while kits and reagents add to the overall cost. Hospitals and diagnostic centers may outsource liquid biopsy testing to contract research organizations (CROs) and reference laboratories, increasing costs for healthcare providers. Vendors collaborate with CROs for clinical trials, which can cost between USD46 and USD100 million annually. Labor and material costs in CROs and reference laboratories contribute to the overall expense, making liquid biopsy a costly procedure. Despite its benefits, the high cost and associated expenditures may pose a significant challenge to the growth of the global breast cancer liquid biopsy testing devices market.
• The Breast Cancer Liquid Biopsy Testing market faces several challenges. Limitations associated with sensitivity and specificity of the tests remain a concern. Shutdowns and short supply of reagent kits and instruments can impact revenue for diagnostics and prognostics services. Circulating biomarkers like circulating tumor cells, cell-free DNA, extracellular vesicles, and proteins are crucial for early detection, treatment selection, and personalized therapeutics. Healthcare reforms and increasing focus on noninvasive procedures have made liquid biopsy a revenue contributor. However, the medical community requires more standardization and validation for liquid biopsy systems. Biotech companies and healthcare institutions are collaborating to address these challenges and expand the use of liquid biopsy in breast cancer diagnostics, treatment monitoring, and risk assessment. Reference laboratories, physician laboratories, health laboratories, pathology laboratories, and molecular laboratories are key players in this market. Lancet Oncology reports that liquid biopsy is a promising tool for breast cancer management. (Word count: 98)

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Segment Overview 

This breast cancer liquid biopsy testing devices market report extensively covers market segmentation by  

1. Type 
• 1.1 CTCs and circulating nucleic acids
• 1.2 Extracellular vesicles
2. Geography 
• 2.1 North America
• 2.2 Europe
• 2.3 Asia
• 2.4 Rest of World (ROW)

1.1 CTCs and circulating nucleic acids-  In the realm of oncology diagnostics, the identification of Circulating Tumor Cells (CTCs) and circulating nucleic acids, specifically circulating tumor DNA (ctDNA), has emerged as crucial biomarkers for various cancer types, including breast cancer. These biomarkers offer valuable insights into the genomic landscape of primary and metastatic tumors, enabling healthcare professionals to make informed decisions regarding patient treatment. CTCs are cancer cells that detach from primary and secondary tumors and enter the circulatory system, acting as representatives of the tumor. CtDNA, on the other hand, is a nucleic acid released into the bloodstream due to tumor cell death. Both CTCs and ctDNA can be analyzed as adjuncts to or in place of traditional tumor biopsies, providing real-time information about the tumor. Technologies like Digital PCR (ddPCR) and Next-Generation Sequencing (NGS) are widely used for the detection of CTCs and ctDNAs during liquid biopsy procedures. For instance, Illumina Inc.'s TruSight Oncology 500 ctDNA is an NGS-based assay that assesses multiple variant types in 523 cancer-related genes, while Fluxion Biosciences Inc.'s Spotlight oncology panel offers ultra-sensitive variant detection from low input quantities of DNA. These advancements are driving the growth of the breast cancer liquid biopsy testing devices market, as they facilitate early cancer detection and personalized treatment plans.

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Research Analysis

Breast cancer is a leading cause of cancer-related deaths worldwide. Noninvasive procedures, such as liquid biopsy, are revolutionizing the diagnosis and treatment of this disease. Liquid biopsy involves the analysis of circulating biomarkers, including circulating tumor cells, cell-free DNA, and extracellular vesicles, present in body fluids like blood. These biomarkers provide valuable information for personalized medicine, enabling early detection, monitoring disease progression, and predicting response to treatment. Health organizations are increasingly adopting liquid biopsy testing as a complementary tool to traditional imaging and tissue biopsy. Reference laboratories, physician laboratories, health laboratories, pathology laboratories, and molecular laboratories offer liquid biopsy services using various technologies like Polymerase chain reaction (PCR) and next-generation sequencing (NGS). Circulating tumor DNA (ctDNA) is a significant biomarker in breast cancer liquid biopsy. CtDNA can be detected using PCR and NGS, providing information on mutations and genetic alterations. However, limitations associated with liquid biopsy include false positives and negatives, shutdowns due to equipment failure, and short supply of reagent kits and instruments. Circulating biomarkers, including ctDNA, have shown potential in diagnostics and prognostics for breast cancer. Despite its advantages, the market for breast cancer liquid biopsy testing faces challenges, including specificity issues and the need for standardization. Continuous research and development efforts are required to address these challenges and improve the accuracy and accessibility of liquid biopsy testing for breast cancer.

Market Research Overview

Breast cancer is a leading cause of cancer-related deaths worldwide. Noninvasive procedures like liquid biopsy are revolutionizing the field of cancer diagnostics and personalized medicine. Liquid biopsy testing involves analyzing circulating biomarkers, such as circulating tumor cells (CTCs), cell-free DNA, and extracellular vesicles, present in blood samples. These biomarkers provide valuable information for early detection, treatment selection, and monitoring. Reference laboratories, physician laboratories, health laboratories, pathology laboratories, molecular laboratories, and biotech companies offer liquid biopsy testing services using advanced technologies like Polymerase chain reaction (PCR) and next-generation sequencing (NGS). Circulating biomarkers, including circulating tumor DNA, help in risk assessment, prognostics, and revenue contributor for healthcare institutions. Despite its benefits, liquid biopsy testing faces limitations associated with shutdowns, short supply of reagent kits and instruments, and regulatory challenges. Health organizations, including Lancet Oncology, Drug Administration, and the World Health Organization, are collaborating to address these challenges and promote the use of liquid biopsy in breast cancer diagnostics and personalized therapeutics. Cancer Research and various healthcare reforms are also driving the growth of this market.

Table of Contents:

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

• Type
• CTCs And Circulating Nucleic Acids
• Extracellular Vesicles
• Geography
• North America
• Europe
• Asia
• Rest Of World (ROW)

7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix

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