Press release
California Breast Cancer Liquid Biopsy Market to grow at a CAGR of 23.2%, led by north America 44.6% global market share | key Players:- F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Abbott, Agilent Technologies Inc.
Breast Cancer Liquid Biopsy
The market is growing due to rising breast cancer prevalence, increasing adoption of minimally invasive diagnostics, advancements in liquid biopsy technologies, faster detection of recurrence, strong investment in precision oncology, and growing clinical validation supporting liquid biopsy as an effective alternative to tissue biopsies.
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United States: Key Industry Developments
✅ October 2025: Guardant Health expanded its Guardant360 platform with enhanced ctDNA detection for breast cancer monitoring, improving sensitivity for early relapse detection in clinical trials.
✅ September 2025: New regulatory approvals advanced liquid biopsy assays for HER2 and BRCA mutation profiling, enabling better targeted therapy selection in metastatic breast cancer patients.
✅ April 2025: Guardant Health launched Guardant360 Tissue, offering multi-omic profiling of 742 DNA and 367 RNA genes from minimal tissue samples to support breast cancer liquid biopsy integration
Japan: Key Industry Developments
✅ September 2025: A Japanese clinical diagnostics company announced the rollout of an improved ctDNA breast cancer liquid biopsy test optimized for local population genomic profiles, enhancing detection of region-specific variants in metastatic breast cancer.
✅ March 2025: Japan's medical technology regulator updated guidance encouraging the use of liquid biopsy assays (including breast cancer) in routine oncology practice, which is expected to accelerate test deployment across hospital systems.
Breast Cancer Liquid Biopsy Market: 2025 FDA Approvals
→ Guardant360 CDx Expansion: FDA approved Guardant360 CDx as companion diagnostic for Eli Lilly's imlunestrant (Inluriyo) on September 25, 2025, detecting ESR1 mutations in ER+/HER2- advanced/metastatic breast cancer post-endocrine therapy.
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Market Segmenatation-
→ By Product Type
Reagents & Kits - 60%
Largest share due to recurring test use and high demand for cfDNA/ctDNA and multi-analyte panels.
Instruments - 40%
Driven by NGS, digital PCR, and CTC platform adoption, though replacement cycles are slower.
→ By Circulating Biomarkers
cfDNA/ctDNA - 50%
Dominant segment used for mutation profiling, MRD monitoring, and companion diagnostics.
CTCs - 25%
Widely used in metastatic breast cancer for prognostic and monitoring purposes.
Extracellular Vesicles (Exosomes) - 15%
Growing in research and early clinical applications for miRNA and protein signatures.
Other Biomarkers - 10%
Includes circulating RNA, proteins, and multi-omic assays in early-stage development.
→ By Application
Clinical Diagnostics - 55%
Strong use in treatment selection, monitoring, and MRD assessment in breast cancer.
Research Applications - 30%
Driven by biomarker discovery, drug development, and translational oncology programs.
Early Detection & Screening - 15%
Emerging segment supported by advanced multi-omic early-screening technologies.
Regional Insights (2025)
→ North America: 44.6% of the global market the largest share due to advanced healthcare systems, high adoption of liquid biopsy technologies, and strong research & diagnostics infrastructure.
→ Europe: 26.8%% share significant growth driven by widespread cancer screening programs, strong regulatory support, and established diagnostic companies.
→ Asia Pacific: 15%% share rapidly expanding with rising breast cancer incidence, increasing healthcare investments, and growing adoption of precision diagnostics in countries like China, India, and Japan.
→ Latin America: 5%% share driven by expanding healthcare access and rising awareness in key markets such as Brazil and Mexico.
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Key Market Drivers -
Demand for minimally-invasive testing patients and clinicians prefer blood tests over tissue biopsies for safety and repeat monitoring.
Rising breast-cancer incidence and screening efforts increase testing volumes worldwide.
Precision medicine & targeted therapies: liquid biopsies guide therapy selection and track resistance mutations in real time.
Rapid technological advances (NGS, ctDNA/CTC assays, bioinformatics) improve sensitivity and clinical utility.
Growing use in treatment monitoring, minimal residual disease (MRD) detection and recurrence surveillance expands clinical applications.
Regulatory & reimbursement progress in some regions is making tests more accessible (pilot rollouts and guideline adoption)
Market Companies
F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Abbott, Agilent Technologies Inc., Merck KGaA, Cell Signaling Technology Inc., Medtronic, Bio-Rad Laboratories Inc., ExoDx, and Biocept Inc.
1. How big is the Breast Cancer Liquid Biopsy Market ?
Global Breast Cancer Liquid Biopsy Market reached US$ 1.6 billion in 2023 and is expected to reach US$ 7.98 billion by 2031
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