Global ESR1 Mutated Metastatic Breast Cancer Diagnostics Market to hit US$ 93.21 Million by 2033, North America led 42% of global market share | Key Players:- Guardant Health, Inc., Illumina, Inc., APIS Assay Technologies.

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 the forecast period 2025-2033.

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Overview
The ESR1-mutated metastatic breast cancer diagnostics market is an emerging and rapidly evolving segment within the broader oncology diagnostics landscape. ESR1 gene mutations, which primarily drive resistance to endocrine therapies in hormone receptor-positive (HR+) metastatic breast cancer, have become crucial biomarkers guiding treatment decisions, particularly for therapy switching to selective estrogen receptor degraders (SERDs). Companies that address current technical, reimbursement, and infrastructure barriers, while leveraging unique opportunities in serial monitoring, companion diagnostics, and emerging markets, will capture the highest value share in this niche but strategically critical segment.

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Key Industry Development-
✅ November 2025: Roche reported positive Phase III evERA trial results for giredestrant, an oral SERD targeting ESR1-mutated breast cancer, advancing diagnostic integration for precision therapy selection in metastatic cases.

✅ October 2025: Sysmex Corporation expanded collaborations for liquid biopsy and genetic testing, enhancing ctDNA-based ESR1 mutation detection to improve access and precision oncology nationwide.

✅ September 2025: Guardant Health and Illumina advanced NGS-based ESR1 assays, supporting non-invasive monitoring and companion diagnostics for HR+ metastatic breast cancer resistance profiling.

✅ October 2025: Sysmex Corporation launched nationwide partnerships for high-sensitivity ctDNA analysis, focusing on ESR1 mutations to bolster liquid biopsy infrastructure in precision breast cancer care.

✅ September 2025: Sysmex Corporation introduced liquid biopsy diagnostics tailored for ESR1-mutated metastatic breast cancer, enabling early detection and personalized treatment monitoring.

✅ August 2025: FALCO Biosystems rolled out expanded genomic testing for ESR1 mutations, aiding oncologists in data-driven decisions for metastatic breast cancer therapies

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market: 2025 FDA Approvals:-
→ Key 2025 Approval: FDA approved imlunestrant (Inluriyo, Eli Lilly) on September 25, 2025, for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer post-endocrine therapy.

→ Companion Diagnostic: Guardant360 CDx assay approved concurrently to detect ESR1 mutations via ctDNA, enabling patient selection for imlunestrant.

→ Trial Basis: EMBER-3 phase 3 trial showed median PFS of 5.5 months with imlunestrant vs. 3.8 months standard care (HR 0.62) in 256 ESR1-mutated patients.

Report Objectives:-
The global ESR1 mutated metastatic breast cancer diagnostics market report delivers a detailed analysis with 56 key tables, more than 49 visually impactful figures, and 146 pages of expert insights, providing a complete view of the market landscape.

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Market Segmentation Analysis:-
→ By Test Type
The ESR1 mutated metastatic breast cancer diagnostics market by test type is segmented into NGS-based and PCR-based tests. NGS-based tests dominate with a market size of approximately USD 40.2 million in 2025, capturing about 62% market share due to their high sensitivity in detecting multiple mutations simultaneously. PCR-based tests follow with USD 24.4 million in 2025, holding 38% share, favored for their speed and cost-effectiveness in routine screening.

→ By Sample Type
Segmentation by sample type includes tissue and plasma samples. Tissue-based diagnostics lead with USD 38.8 million in 2025, representing 60% market share, as they provide direct tumor profiling essential for initial diagnosis. Plasma-based tests, leveraging liquid biopsies, account for USD 25.8 million or 40% share in 2025, gaining traction for non-invasive monitoring and real-time mutation detection.

→ By End User
The market by end user comprises oncology centers, diagnostic centers, and cancer research institutes. Oncology centers hold the largest portion at USD 27.5 million in 2025, with 42.6% share, driven by high patient volumes and integration with treatment planning. Diagnostic centers follow at USD 30.4 million or 47% share, benefiting from specialized testing infrastructure, while cancer research institutes represent USD 6.8 million or 10.5% share, focused on advanced R&D applications

Market Drivers:
→ The rising prevalence of metastatic breast cancer is significantly driving the ESR1-mutated metastatic breast cancer diagnostics market growth.

→ Advancements in ESR1-mutated metastatic breast cancer diagnostics are also driving the market growth

→ Low sensitivity of some ESR1 assays is hampering the growth of the ESR1-mutated metastatic breast cancer diagnostics market

Regional insights:-
• North America -42% share: North America is the dominant region, holding roughly 42% of the global ESR1 diagnostics market . Leadership is driven by early clinical adoption of liquid-biopsy and NGS platforms, strong reimbursement frameworks (improving payer recognition of ctDNA tests), deep clinical-trial activity for SERDs and other ER-targeted therapies, and the presence of major diagnostics players and reference labs that scale testing across oncology networks. The U.S. accounts for the bulk of the region's revenues thanks to high testing volumes, routine molecular profiling in advanced breast cancer, and greater access to advanced assays. MarketIntelo+1

• Asia-Pacific - 32% share: Asia-Pacific represents the fastest-growing regional opportunity (high-single to low-double digit CAGRs in many reports). Growth is propelled by rising incidence of hormone-receptor-positive metastatic breast cancer, rapid adoption of molecular diagnostics (NGS and PCR), expansion of centralized and private oncology labs in China, India, Japan and South Korea, and increasing use of ctDNA for therapy monitoring where tissue re-biopsy is impractical. China in particular is a focal point for growth (higher forecasted regional CAGR noted in market studies). Adoption is also supported by increasing local assay development and partnerships between global vendors and regional labs.

• Europe - 17.5% share: Europe is a mature market with mid-teens share (often reported in the high-teens range). Growth is steady and driven by strong regulatory emphasis on evidence and cost-effectiveness, widespread hospital-lab networks performing molecular profiling, and national precision-oncology initiatives in Western Europe. Key drivers are routine integration of molecular panels in metastatic breast cancer care pathways, research activity around ESR1 resistance mechanisms, and demand for validated NGS and liquid-biopsy workflows although pricing/reimbursement heterogeneity across countries moderates uptake.

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ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Competitive Landscape:-
→ Top companies in the ESR1 mutated metastatic breast cancer diagnostics market include Guardant Health, Inc., Illumina, Inc., APIS Assay Technologies, GENCURIX, Sysmex Corporation, ASURAGEN, INC., CUSABIO TECHNOLOGY LLC, and NeoGenomics Laboratories, among others.

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