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United States ESR1 Mutated Metastatic Breast Cancer Diagnostics Market valuation $93.21 million by 2033 - Exclusive Report by DatamIntelligence

10-14-2025 02:53 PM CET | Health & Medicine

Press release from: DataM intelligence 4 Market Research LLP

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market

"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." As per DataM intelligence research report

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United States: Recent Industry Developments

✅ In September 2025, Guardant Health launched an advanced liquid biopsy diagnostic for ESR1-mutated metastatic breast cancer, enabling non-invasive mutation detection and personalized treatment planning. The technology improves patient monitoring and therapy selection.

✅ In August 2025, Foundation Medicine expanded its genomic testing portfolio to include ESR1 mutation assays for metastatic breast cancer, supporting precision oncology and targeted therapy decisions.

✅ In July 2025, Thermo Fisher Scientific introduced next-generation sequencing-based diagnostics for ESR1 mutations, enhancing sensitivity and turnaround time for metastatic breast cancer patients.

✅ In June 2025, Roche Diagnostics invested in R&D for integrated ESR1 mutation detection platforms combining liquid biopsy and AI-driven analytics to improve treatment outcomes and disease monitoring.

Japan: Recent Industry Developments

✅ In September 2025, Sysmex Corporation launched liquid biopsy diagnostics for ESR1-mutated metastatic breast cancer, supporting early detection, treatment personalization, and non-invasive patient monitoring.

✅ In August 2025, FALCO Biosystems expanded genomic testing solutions for ESR1 mutations, enabling Japanese oncologists to make data-driven therapy decisions for metastatic breast cancer patients.

✅ In July 2025, Takara Bio introduced next-generation sequencing diagnostics for ESR1 mutation detection with improved accuracy and workflow efficiency for clinical laboratories.

✅ In June 2025, Chugai Pharmaceutical invested in R&D for advanced ESR1 mutation diagnostics, integrating AI-based analytics to support personalized treatment strategies and patient outcomes.

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market: Drivers

The ESR1 mutated metastatic breast cancer (MBC) diagnostics market is witnessing growth, driven by rising incidence of breast cancer, growing adoption of precision medicine, and increasing focus on personalized oncology. ESR1 mutations, which affect estrogen receptor signaling, are associated with resistance to endocrine therapy, making accurate and timely detection critical for optimizing treatment strategies and improving patient outcomes. Advances in molecular diagnostics, including next-generation sequencing (NGS), digital PCR, and liquid biopsy technologies, are enabling highly sensitive and non-invasive detection of ESR1 mutations. Growing awareness among oncologists and patients about targeted therapies and biomarker-driven treatment decisions is further boosting market adoption. Expansion of oncology testing facilities, research programs, and clinical trials is enhancing accessibility and utilization of ESR1 diagnostic tools.

Leading diagnostic companies and laboratories, including Guardant Health, Foundation Medicine, and Roche, are developing innovative ESR1 mutation assays and companion diagnostics to support treatment planning in metastatic breast cancer. Integration of liquid biopsy testing and minimally invasive approaches is improving turnaround time, patient compliance, and monitoring of disease progression. Strategic collaborations between diagnostic developers, pharmaceutical companies, and academic institutions are accelerating research, clinical validation, and regulatory approval of ESR1 testing solutions. Increasing emphasis on personalized medicine, regulatory support for companion diagnostics, and rising awareness of endocrine therapy resistance are further driving growth. With ongoing technological advancements, growing adoption of precision oncology, and increasing focus on biomarker-driven treatment, the ESR1 mutated metastatic breast cancer diagnostics market is poised for sustained global expansion.

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ESR1 Mutated Metastatic Breast Cancer Diagnostics Market: Major Players

Guardant Health, Inc., Illumina, Inc., APIS Assay Technologies, GENCURIX, Sysmex Corporation, ASURAGEN, INC., CUSABIO TECHNOLOGY LLC, and NeoGenomics Laboratories, among others.

Segment Covered in the ESR1 Mutated Metastatic Breast Cancer Diagnostics Market:

➥ By Test Type: NGS Based, PCR Based

➥ By Sample Type: Tissue, Plasma

➥ By End User: Oncology Centers, Diagnostic Centers, Cancer Research Institutes

Research Process:

Both primary and secondary data sources have been used in the ESR1 Mutated Metastatic Breast Cancer Diagnostics Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

Most Frequently Asked Questions in the ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Research Industry:

➠ Who leads the ESR1 Mutated Metastatic Breast Cancer Diagnostics industry and what's their competitive positioning regarding capacity, performance, and profitability?
➠ What growth opportunities and market challenges do ESR1 Mutated Metastatic Breast Cancer Diagnostics market vendors face?
➠ Which segments show the highest growth potential and market share distribution?
➠ What factors are driving or limiting ESR1 Mutated Metastatic Breast Cancer Diagnostics market growth?
➠ What are the dominant sales and distribution strategies in the ESR1 Mutated Metastatic Breast Cancer Diagnostics industry?

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Regional Analysis:

⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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✅ Import-Export Data Monitoring
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