ESR1 Mutated Metastatic Breast Cancer Diagnostics Market to Reach US$ 93.21 Million by 2033, Driven by Endocrine-Resistant Breast Cancer and NGS Adoption

According to DataM Intelligence, the global ESR1 mutated metastatic breast cancer diagnostics market size reached US$ 63.51 million in 2024 (from US$ 61.05 million in 2023) and is expected to reach US$ 93.21 million by 2033, growing at a CAGR of 4.4% during 2025-2033, driven by increasing incidence of endocrine therapy resistance in metastatic breast cancer, growing adoption of NGS-based testing for ESR1 mutations, expanding use of liquid biopsy (plasma) for non-invasive monitoring, strong demand in oncology centers.

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ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Key Mergers and Acquisitions

✦ January 2026: Guardant Health, Inc. acquired a molecular diagnostics startup to enhance its liquid biopsy NGS capabilities for ESR1 mutation detection in metastatic breast cancer.
✦ December 2025: Illumina, Inc. completed a strategic acquisition of a targeted sequencing technology firm to strengthen its oncology NGS portfolio for plasma-based ESR1 testing.
✦ November 2025: NeoGenomics Laboratories secured a licensing agreement with an advanced genomics innovator to integrate high-sensitivity PCR and NGS assays for ESR1 mutation diagnostics.

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Key Industry Developments

☑️ January 2026: Guardant Health, Inc., Illumina, Inc., and NeoGenomics Laboratories launched upgraded NGS and PCR-based ESR1 mutation panels with improved sensitivity for plasma and tissue samples, gaining adoption in oncology centers and diagnostic labs.
☑️ December 2025: APIS Assay Technologies and GENCURIX expanded their PCR-based ESR1 diagnostic kits with faster turnaround times and higher specificity, targeting specialty clinics in North America and Europe.
☑️ November 2025: Sysmex Corporation and ASURAGEN, INC. introduced new tissue and plasma-based ESR1 mutation assays, focusing on early detection of endocrine resistance in metastatic breast cancer patients.

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ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Segmentation Analysis

By Test Type: NGS Based testing holds the largest share due to high sensitivity, comprehensive mutation profiling, and ability to detect low-frequency ESR1 variants in plasma and tissue; PCR Based testing grows steadily for cost-effective, rapid targeted detection in routine clinical settings.

By Sample Type: Tissue samples dominate with the highest share for gold-standard biopsy-based confirmation; Plasma (liquid biopsy) grows fastest due to non-invasive nature, real-time monitoring of resistance mutations, and increasing clinical acceptance for metastatic disease.

By End-User: Oncology Centers lead due to specialized expertise and high-volume testing for metastatic breast cancer patients; Diagnostic Centers follow for routine and reference lab services; Cancer Research Institutes expand for translational studies and companion diagnostics development; Others include academic hospitals and private labs.

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ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Key Players

✦ Guardant Health, Inc. - In January 2026, acquired a molecular diagnostics startup and launched enhanced NGS liquid biopsy panels with higher sensitivity for ESR1 mutation detection in plasma, expanding use in oncology centers.
✦ Illumina, Inc. - Completed acquisition of a targeted sequencing firm in December 2025 and introduced upgraded NGS assays for tissue and plasma ESR1 testing, targeting diagnostic labs and cancer research institutes.
✦ NeoGenomics Laboratories - Rolled out high-sensitivity PCR and NGS ESR1 mutation tests in late 2025, strengthening its position in oncology and specialty clinic markets for metastatic breast cancer monitoring.
✦ APIS Assay Technologies - Expanded PCR-based ESR1 diagnostic kits in December 2025 with improved specificity and faster results, focusing on clinical diagnostics in Europe and North America.
✦ Sysmex Corporation - Introduced new tissue and plasma ESR1 mutation assays in November 2025, emphasizing early resistance detection and integration with oncology workflows in hospitals.

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Regional Insights

North America dominates the ESR1 Mutated Metastatic Breast Cancer Diagnostics market with the largest revenue share, supported by high incidence of metastatic breast cancer, advanced molecular diagnostics infrastructure, rapid adoption of NGS and liquid biopsy for endocrine resistance monitoring, strong reimbursement for companion diagnostics, and presence of leading NGS and PCR providers.

Asia-Pacific is the fastest-growing region at 8.1% CAGR, fueled by rising breast cancer burden, increasing healthcare access and oncology centers, growing awareness of ESR1 mutation testing, expanding diagnostic labs and research institutes, government initiatives for precision oncology, and aggressive market entry by global players.

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