ESR1 Mutated Metastatic Breast Cancer Treatment Market Size in 7MM is expected to grow at a decent CAGR by 2034, estimates DelveInsight | AstraZeneca, Olema Pharmaceuticals, Arvinas, Sermonix Pharmaceuticals, Roche, Eli Lilly and Company, H3 Biomedicine,

DelveInsight's "ESR1-mutated Metastatic Breast Cancer Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the ESR1 Mutated Metastatic Breast Cancer Market Report
• In March 2025, GBG Forschungs GmbH announced a phase II Study Evaluating the Addition of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD), to Standard-of-care Olaparib in Patients with Hormone Receptor (HR)-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer with GBRCA1/2 Mutations.
• In March 2025, Sermonix Pharmaceuticals Inc. announced a study Evaluating the Safety of Lasofoxifene in Combination With Abemaciclib for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and Have an ESR1 Mutation ( ELAINEII).
• The total diagnosed prevalent cases of ESR1-mutated Metastatic Breast Cancer in the United States was around 18,800 cases in 2023.
• The diagnosed prevalent cases of ESR1-mutated HR+ Metastatic Breast Cancer on first-line of treatment in the United States was estimated to be around 18,400 in 2023.
• Among the EU4 countries, Germany had the highest cases of ESR1 mutation in metastatic breast cancer, followed by France, whereas Spain accounted for the lowest number of cases in 2023.
• According to DelveInsight estimates, Japan reported approximately 45,000 cases of metastatic breast cancer, equivalent to around 13% of total cases in the 7MM.
• The leading Esr1-mutated Metastatic Breast Cancer Companies such as AstraZeneca, Olema Pharmaceuticals, Arvinas, Sermonix Pharmaceuticals, Roche, Eli Lilly and Company, H3 Biomedicine, Eisai, Pfizer, Sun Pharma Advanced Research Company, Zenopharm, and others
• Promising Esr1-mutated Metastatic Breast Cancer Therapies such as Elacestrant (RAD1901), Ibrance (Palbociclib), Rintodestrant (G1T48), SCO-120, ZB716, ARV-471, Lasofoxifene, H3B-6545, Giredestrant (RG6171, GDC-9545), Camizestrant (AZD9833), ZN-c5, OP1250, and others

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Esr1-mutated Metastatic Breast Cancer Epidemiology Segmentation
• Total Diagnosed Prevalent Cases of HR-Positive Breast Cancer
• Stage-specific Diagnosed Prevalent Cases of HR-positive Breast Cancer
• Total Diagnosed Prevalent Cases of Metastatic Breast Cancer
• Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer
• Line-wise treatable cases of ESR1 Mutated Metastatic Breast Cancer

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ESR1 Mutated Metastatic Breast Cancer Marketed Drugs

• ORSERDU (elacestrant): Stemline Therapeutics (a wholly owned subsidiary of the Menarini Group)
ORSERDU (elacestrant) is a selective estrogen receptor degrader (SERD) out-licensed to Menarini Group. In January 2023, the US FDA approved ORSERDU for treating postmenopausal women or adult men with ER+, HER2-, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Later in September 2023, the drug also got approved in Europe.

ESR1 Mutated Metastatic Breast Cancer Emerging Drugs

• Camizestrant (AZD9833): AstraZeneca
Camizestrant (AZD9833) is an oral SERD that has shown antitumor efficacy in a range of preclinical models of breast cancer. In June 2020, AstraZeneca initiated a Phase III clinical trial, SERENA-6, to evaluate the Safety and Efficacy of AZD9833 in combination with a CDK4/6 inhibitor (palbociclib or abemaciclib) for the treatment of patients with HR+ HER2- metastatic breast cancer with a detectable ESR1 mutation. As per Astrazeneca's pipeline, Camizestrant's + CDK4/6 inhibitor's estimated filing acceptance in 1st line HR+ HER2- ESR1m breast cancer is 2025. Apart from that, the indication for SERENA-6 has been granted Fast Track Designation (FTD) by the US FDA.

• Lasofoxifene: Sermonix Pharmaceuticals
Lasofoxifene is being investigated as a potent, bioavailable selective estrogen receptor modulator (SERM) with a differentiated safety profile that could prove useful in treating postmenopausal women and premenopausal women on ovarian suppression with locally advanced or metastatic ER+ breast cancer. Lasofoxifene's bioavailability and activity in estrogen receptor mutations could hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical needs need.

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ESR1 Mutated Metastatic Breast Cancer Drugs Market Insights
The existing ESR1 treatment is mainly dominated by classes such as aromatase inhibitors, aromatase inhibitors + CDK4/6 inhibitors, and CDK4/6 + SERDs. For postmenopausal women with HR-positive, HER2-positive recurrent/Stage IV breast cancer, the preferred options available include fulvestrant with a CDK 4/6 inhibitor (palbociclib, ribociclib, and abemaciclib; category 1) or for those with tumor PIK3CA mutations, fulvestrant with alpelisib; everolimus with either an AI, tamoxifen or fulvestrant; monotherapy with fulvestrant, nonsteroidal or steroidal AI, or SERM. Estrogen receptor 1 (ESR1) activating mutations are frequently detected in patients with prior exposure to AIs. Tumors with these mutations are generally resistant to both AIs and tamoxifen. Certain tumors with these mutations retain sensitivity to fulvestrant. All may benefit from adding a CDK 4/6 inhibitor, mTOR-inhibitor, or alpelisib in combination with fulvestrant if the tumor has PIK3CA mutation.

ESR1-mutated Metastatic Breast Cancer Market Outlook
ESR1 mutations have increased, even with aromatase inhibitor (AI) therapy, indicating their adaptability to AI therapeutic conditions. In addition, the presence of ESR1 mutations has been correlated with a shorter time to treatment failure, as metastatic breast cancer (MBC) patients with ESR1 mutations exhibit an inadequate response to and shorter duration of effective endocrine control. Suppose AI treatment provides selection pressure for mutant-bearing clonal outgrowth in patients. In that case, the next option for therapy is likely a more effective selective estrogen receptor modulator (SERMs) and/or selective estrogen receptor downregulators (SERDs). Various studies have predicted that ESR1 mutations will still respond to SERMs or SERDs, though perhaps at a decreased sensitivity based on in vitro, xenograft, and PDX preclinical models. In the past 5 years, agents that have become available are CDK4/6 inhibitors.

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Esr1-mutated Metastatic Breast Cancer Therapies and Key Companies
• Elacestrant (RAD1901): Radius Pharmaceuticals/Berlin-Chemie (Menarini Group)
• Ibrance (Palbociclib): Pfizer
• Rintodestrant (G1T48): G1 Therapeutics, Inc.
• SCO-120: Sun Pharma Advanced Research Company
• ZB716: Zenopharm
• ARV-471: Arvinas
• Lasofoxifene: Sermonix Pharmaceuticals
• H3B-6545: H3 Biomedicine/Eisai
• Giredestrant (RG6171, GDC-9545): Roche
• Camizestrant (AZD9833): AstraZeneca
• ZN-c5: Zentalis Pharmaceuticals
• OP1250: Olema Pharmaceuticals

Scope of the ESR1 Mutated Metastatic Breast Cancer Market Report
• Study Period: 2020-2034
• Coverage: 7MM
• Esr1-mutated Metastatic Breast Cancer Companies- AstraZeneca, Olema Pharmaceuticals, Arvinas, Sermonix Pharmaceuticals, Roche, Eli Lilly and Company, H3 Biomedicine, Eisai, Pfizer, Sun Pharma Advanced Research Company, Zenopharm, and others
• Esr1-mutated Metastatic Breast Cancer Therapies- Elacestrant (RAD1901), Ibrance (Palbociclib), Rintodestrant (G1T48), SCO-120, ZB716, ARV-471, Lasofoxifene, H3B-6545, Giredestrant (RG6171, GDC-9545), Camizestrant (AZD9833), ZN-c5, OP1250, and others
• Esr1-mutated Metastatic Breast Cancer Therapeutic Assessment: - Esr1-mutated Metastatic Breast Cancer current marketed and Esr1-mutated Metastatic Breast Cancer emerging therapies
• Esr1-mutated Metastatic Breast Cancer Market Dynamics: Esr1-mutated Metastatic Breast Cancer market drivers and Esr1-mutated Metastatic Breast Cancer market barriers
• Esr1-mutated Metastatic Breast Cancer Unmet Needs, KOL's views, Analyst's views, Esr1-mutated Metastatic Breast Cancer Market Access and Reimbursement

Table of Content
1 Key Insights
2 Report Introduction
3 Executive Summary
4 Key Events
5 Epidemiology and Market Forecast Methodology
6 ESR1-Mutated Metastatic Breast Cancer Market Overview at a Glance in the 7MM
7 Disease Background and Overview
8 Epidemiology and patient Population of the 7MM
9 Patient Journey
10 Key Endpoints in ESR1-mutated Metastatic Breast Cancer
11 Key Cross Competition of Drugs
12 Marketed Drug
13 Emerging Drugs
14 ESR1-mutated Metastatic Breast Cancer: The 7MM Market Analysis
15 Unmet Needs
16 SWOT Analysis
17 KOL Views
17.1 KOL Interviews
18 Market Access and Reimbursement
19 Appendix
20 DelveInsight Capabilities
21 Disclaimer
22 About DelveInsight

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