United States ESR1 Mutated Metastatic Breast Cancer Diagnostics Market to hit US$ 93.21 Million by 2033 | Top Companies - 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." As per DataM intelligence research report

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United States: Recent Industry Developments

✅ In September 2025, Guardant Health received FDA clearance for its Guardant360 CDx test as a companion diagnostic to identify ESR1-mutated metastatic breast cancer patients eligible for targeted therapies. The approval enables blood-based precision testing for mutation detection and treatment selection. It marks a major step toward routine liquid biopsy use in breast cancer management.

✅ In June 2025, AstraZeneca reported strong clinical data demonstrating that liquid biopsy-guided use of its oral SERD, camizestrant, reduced disease progression risk in patients with emerging ESR1 mutations. The trial emphasized early ctDNA monitoring to detect resistance before visible progression. It highlighted precision-guided treatment adaptation as a key future model for advanced breast cancer care.

✅ In May 2025, Guardant Health showcased multiple studies at ASCO confirming the accuracy of its liquid biopsy platform for detecting ESR1 mutations in real time. The results reinforced the role of blood-based testing in identifying endocrine resistance early. This advancement supports more dynamic monitoring and treatment personalization for hormone receptor-positive breast cancer.

✅ In May 2025, Foundation Medicine introduced enhanced genomic profiling solutions that detect ESR1 mutations alongside co-occurring genetic alterations in metastatic breast cancer. The expanded platform combines tissue and liquid biopsy insights for comprehensive genomic mapping. It empowers clinicians to select optimal therapies for patients with ESR1-driven resistance.

Japan: Recent Industry Developments

✅ In October 2025, Sysmex Corporation announced new collaborations to accelerate genetic and liquid biopsy testing for breast cancer diagnostics across Japan. The partnerships expand national access to high-sensitivity ctDNA analysis, including ESR1 mutation detection. This effort strengthens Japan's precision oncology infrastructure and diagnostic readiness.

✅ In June 2025, Sysmex advanced its R&D programs focused on oncology liquid biopsy platforms and genetic panel development. These initiatives aim to improve test accuracy and streamline ESR1 mutation identification in clinical workflows. They reflect Japan's commitment to expanding early detection and molecular diagnostics in metastatic cancer care.

✅ In August 2024, Guardant Health Japan gained regulatory approval for its Guardant360 CDx liquid biopsy platform, paving the way for broader blood-based mutation testing. The technology supports identification of actionable biomarkers such as ESR1 in advanced breast cancer. It also strengthened the country's foundation for precision diagnostics adoption.

✅ In July 2023, Guardant Health achieved national reimbursement for its Guardant360 CDx test in Japan, making liquid biopsy accessible for routine oncology use. The coverage improved real-world ESR1 mutation testing during and after endocrine therapy. It marked a critical milestone in integrating precision diagnostics into Japan's standard cancer care.

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market: Drivers

The ESR1 mutated metastatic breast cancer diagnostics market is gaining significant traction as precision oncology advances enable earlier and more targeted detection of hormone-resistant tumors. ESR1 mutations, which drive resistance to endocrine therapy, are increasingly recognized as critical biomarkers in managing estrogen receptor-positive (ER+) metastatic breast cancer. The growing adoption of liquid biopsy and next-generation sequencing (NGS) technologies is revolutionizing mutation detection with higher sensitivity and non-invasive testing. Rising clinical emphasis on molecular profiling to guide therapy selection is further accelerating diagnostic uptake. Pharmaceutical companies and diagnostic developers are collaborating to integrate ESR1 mutation testing into personalized treatment workflows, enhancing therapeutic outcomes.

The market is also benefitting from regulatory support for companion diagnostics and expanding use of circulating tumor DNA (ctDNA) analysis in monitoring disease progression. Increasing awareness among oncologists regarding the role of ESR1 mutations in endocrine resistance is driving routine testing in advanced breast cancer cases. Technological advancements in real-time PCR and digital droplet PCR platforms are improving accuracy, turnaround time, and affordability. Moreover, growing clinical trial activity evaluating novel SERDs and targeted therapies is reinforcing the need for precise diagnostic tools. As personalized medicine continues to reshape cancer care, the ESR1 mutated metastatic breast cancer diagnostics market is poised for strong growth, driven by innovation and expanding clinical relevance.

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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
The market is categorized into NGS-Based and PCR-Based tests. NGS-Based testing dominates due to its high accuracy, multiplexing capability, and ability to detect multiple mutations simultaneously, while PCR-Based testing remains widely used for its cost-effectiveness and quick turnaround time.

By Sample Type
Based on sample type, the market includes Tissue and Plasma samples. Tissue samples hold a major share owing to their reliability in detecting tumor-specific genetic alterations, whereas plasma-based liquid biopsies are gaining traction for being minimally invasive and suitable for real-time disease monitoring.

By End User
End users comprise Oncology Centers, Diagnostic Centers, and Cancer Research Institutes. Oncology centers lead the market as primary users for personalized cancer treatment, while diagnostic centers and research institutes are expanding their adoption for early detection and clinical research applications.

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
✅ Live Market & Pricing Trends

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