Japan ESR1 Mutated Metastatic Breast Cancer Diagnostics Market to Grow at 4.4% CAGR Driven by Liquid Biopsy & Precision Oncology

Leander, Texas and Tokyo, Japan - Dec.30.2025
As per DataM Intelligence research report "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% from 2025 to 2033." Rising prevalence of metastatic breast cancer, advancements in liquid biopsy and NGS technologies, and the need for companion diagnostics to guide targeted therapies are fueling demand for accurate ESR1 mutation detection.

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Japan: Recent Industry Developments
✅ In September 2025, Sysmex Corporation launched liquid biopsy diagnostics for ESR1-mutated metastatic breast cancer. The platform supports early detection, treatment personalization, and non-invasive monitoring for Japanese patients.
✅ In August 2025, FALCO Biosystems expanded genomic testing solutions for ESR1 mutations. This enables oncologists to make data-driven therapy decisions, addressing resistance in hormone receptor-positive cases.
✅ In July 2025, Takara Bio introduced next-generation sequencing diagnostics for ESR1 mutation detection. The solution offers improved accuracy and efficiency for clinical laboratories in Japan.

United States: Recent Industry Developments
✅ In September 2025, The FDA approved imlunestrant (Inluriyo) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The Guardant360 CDx assay was simultaneously approved as a companion diagnostic for ESR1 mutation identification.
✅ In September 2025, Guardant Health launched an advanced liquid biopsy diagnostic for ESR1-mutated metastatic breast cancer. It enables non-invasive detection and personalized treatment planning.
✅ In June 2025, Roche Diagnostics invested in R&D for integrated ESR1 mutation detection platforms. These combine liquid biopsy with AI-driven analytics to enhance monitoring and outcomes.

ESR1 Mutated Metastatic Breast Cancer Diagnostics Market: Drivers
The ESR1 mutated metastatic breast cancer diagnostics market is driven by increasing incidence of hormone receptor-positive metastatic breast cancer and acquired resistance to endocrine therapies. Advancements in non-invasive liquid biopsy, NGS, and digital PCR enable sensitive, accurate detection of ESR1 mutations for timely therapy switching to oral SERDs.
Another driver is regulatory approvals of companion diagnostics alongside novel therapies like elacestrant and imlunestrant. Growing demand for precision oncology, real-world evidence, and monitoring of treatment resistance in aging populations and high-burden regions sustain market growth.

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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, NeoGenomics Laboratories.
Segment Covered in the ESR1 Mutated Metastatic Breast

Cancer Diagnostics Market:
By Test Type
The market is segmented into NGS Based (67.39% share in 2024) and PCR Based. NGS Based dominates due to high sensitivity, multi-gene profiling, and suitability for liquid biopsy in detecting low-frequency ESR1 mutations.
By Sample Type
The market includes Tissue and Plasma. Plasma leads with the shift toward non-invasive liquid biopsy for serial monitoring and resistance detection.
By End-User
End-users comprise Hospitals, Diagnostic Centers, Oncology Centers, and Research & Academic Institutes. Oncology Centers and Diagnostic Centers drive adoption for clinical decision-making.

Regional Analysis
North America - Dominant Share (41.32% in 2024)
North America leads with advanced laboratories, high liquid biopsy adoption, FDA approvals of companion diagnostics, and strong pharmaceutical partnerships. The U.S. contributes significantly amid high disease burden.
Asia Pacific - Fastest-Growing (19.02% in 2024)
Asia Pacific is the fastest-growing region, driven by rising breast cancer incidence, improving diagnostic infrastructure, and collaborations in countries like Japan and China.
Europe - Significant Share
Europe grows with increasing precision oncology initiatives and regulatory support.
South America - Gradual Growth
South America shows steady progress with expanding access to advanced testing.
Middle East & Africa - Emerging Growth
Middle East & Africa expands with investments in oncology diagnostics.

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