ESR1-Mutated Metastatic Breast Cancer Market to Rise by 2034 | Arvinas, Sermonix Pharmaceuticals, Roche, Eli Lilly and Company, H3 Biomedicine, Eisai, Pfizer, Sun Pharma Advanced Research Company, Zenopharm, and others

DelveInsight's "ESR1-Mutated Metastatic Breast Cancer Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of ESR1-Mutated Metastatic Breast Cancer, historical and forecasted epidemiology as well as the ESR1-Mutated Metastatic Breast Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The ESR1-Mutated Metastatic Breast Cancer market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted ESR1-Mutated Metastatic Breast Cancer market size from 2020 to 2034, segmented by seven major markets. The Report also covers current ESR1-Mutated Metastatic Breast Cancer treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the ESR1-Mutated Metastatic Breast Cancer market.

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Key highlights from the ESR1-Mutated Metastatic Breast Cancer Market Report:

ESR1 mutations are rare in primary tumors, occurring in about 1% of cases, but are more common in metastatic, endocrine therapy-resistant cancers, with prevalence rates ranging from 10% to 50%. These mutations are associated with shorter progression-free survival.

In 2023, the market for ESR1-mutated metastatic breast cancer in the US was the largest among the 7MM, reaching approximately USD 820 million, with expectations for further growth by 2034. Within the EU4 and the UK, Germany held the largest market share, accounting for around 26% of the total market, followed by France at approximately 21%.

ORSERDU (elacestrant) represents the first significant advancement in endocrine therapy in 20 years, specifically targeting ESR1 mutations in ER+, HER2-, advanced, or metastatic breast cancer patients who have experienced disease progression after at least one line of endocrine therapy.

The introduction of several novel selective estrogen receptor degraders (SERDs) in the ESR1 market has shown considerable potential for treating this patient population, both as monotherapies and in combination with other therapies. There is a critical need for new endocrine therapy agents that demonstrate strong and lasting efficacy in heavily treated patients, particularly those who have undergone standard first-line therapy with CDK4/6 inhibitors and possess ESR1 mutations.

Despite recent advancements in understanding disease biology and detection, patients with ESR1-mutant ER+ breast cancer still face a lack of effective treatment options, highlighting a significant unmet need in this area.

Key players, including AstraZeneca (Camizestrant), Eli Lilly and Company (Imlunestrant), H3 Biomedicine (H3B-6545), Roche (Giredestrant), Arvinas (ARV-471), Sermonix Pharmaceuticals (Lasofoxifene), and Olema Pharmaceuticals (OP-1250), are actively evaluating their lead candidates across various lines of therapy and stages of clinical development. These companies have the potential to significantly impact the ESR1 market size during the forecast period from 2024 to 2034.

ESR1-Mutated Metastatic Breast Cancer Overview

ESR1-mutated metastatic breast cancer refers to breast cancer that has spread beyond the breast and nearby lymph nodes and is characterized by mutations in the estrogen receptor 1 (ESR1) gene. These mutations can lead to changes in how breast cancer cells respond to hormone therapies, making treatment more challenging. ESR1 mutations are more common in estrogen receptor-positive (ER+) breast cancers, particularly in postmenopausal women.

Causes
The exact causes of ESR1 mutations are not fully understood, but several factors may contribute:

Hormonal Influence: Prolonged exposure to estrogen may play a role in the development of ER+ breast cancer and subsequent ESR1 mutations.
Previous Hormonal Therapy: Patients who have received hormone therapy for earlier-stage breast cancer may develop ESR1 mutations as the cancer evolves and adapts.
Genetic Factors: Some individuals may have a genetic predisposition that increases the likelihood of developing breast cancer and associated mutations.
Signs and Symptoms
The signs and symptoms of ESR1-mutated metastatic breast cancer are similar to those of other types of metastatic breast cancer and may include:

Breast Changes: New lumps or changes in the breast or surrounding tissues.
Pain: Pain in the breast, chest, or back, especially if the cancer has spread to the bones.
Swelling: Swelling in the breast or lymph nodes under the arms.
Weight Loss: Unexplained weight loss and fatigue.
Other Symptoms: Symptoms may also vary depending on where the cancer has spread (e.g., difficulty breathing if it has spread to the lungs).
Diagnosis
Diagnosing ESR1-mutated metastatic breast cancer involves several steps:

Medical History and Physical Examination: The doctor will review the patient's history and perform a physical exam.
Imaging Studies: Mammograms, ultrasounds, CT scans, or MRIs may be used to assess the extent of the disease.
Biopsy: A biopsy is often performed to obtain tissue samples for histological examination and to check for ESR1 mutations through genetic testing.
Hormone Receptor Testing: Tests are conducted to determine if the cancer cells are estrogen receptor-positive (ER+) and to identify any mutations in the ESR1 gene.
Treatment Options
Treatment for ESR1-mutated metastatic breast cancer typically involves a combination of therapies tailored to the individual's condition. Options may include:

Hormonal Therapy: Although ESR1 mutations can lead to resistance to standard hormonal treatments like tamoxifen, other options such as aromatase inhibitors or selective estrogen receptor degraders (SERDs) may be considered.
Targeted Therapy: Newer drugs that specifically target ESR1 mutations, such as specific SERDs or other investigational agents, are being explored in clinical trials.
Chemotherapy: Chemotherapy may be used, especially if the cancer is aggressive or if hormonal therapies are ineffective.
Radiation Therapy: This may be used to relieve symptoms or treat specific areas of metastasis.
Clinical Trials: Participation in clinical trials may provide access to new and emerging therapies.
Managing ESR1-mutated metastatic breast cancer requires a multidisciplinary approach, and ongoing monitoring is essential to adjust treatment plans as needed.

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ESR1-Mutated Metastatic Breast Cancer Market

ESR1 mutations have become more prevalent even with aromatase inhibitor (AI) therapy, demonstrating the adaptability of these mutations to AI treatment conditions. Additionally, the presence of ESR1 mutations is linked to a shorter time to treatment failure, as metastatic breast cancer (MBC) patients with these mutations show inadequate responses and reduced durations of effective endocrine control. If AI treatment exerts selection pressure for mutant clonal outgrowth, the next therapeutic options are likely to be more effective selective estrogen receptor modulators (SERMs) and/or selective estrogen receptor downregulators (SERDs).

Studies suggest that ESR1 mutations may still respond to SERMs or SERDs, although with potentially decreased sensitivity, as indicated by in vitro, xenograft, and PDX preclinical models. In the last five years, CDK4/6 inhibitors have emerged as new agents in this space.

Fulvestrant at a dose of 500 mg has shown greater effectiveness in preventing progression in ER mutant-bearing tumors, suggesting that high-dose fulvestrant could be a promising therapeutic option. This also underscores the need for the development of novel, more potent SERMs and SERDs.

While combinations of fulvestrant with other endocrine treatments have not demonstrated a clear advantage over single-agent therapies, fulvestrant may provide benefits as part of combination therapy, particularly in overcoming ESR1 mutations in patients who have relapsed after adjuvant aromatase inhibitors. Many patients prefer oral therapies over injectables, but long-term adherence to oral endocrine therapy can be a challenge.

The current market is segmented into various therapeutic classes based on prevalent treatment patterns across the 7MM, revealing minor variations in overall prescription habits. The forecast model includes combinations such as aromatase inhibitors with CDK4/6 inhibitors, as well as CDK4/6 inhibitors with fulvestrant.

The anticipated launch of new therapies, along with improved early patient screening, better integration of medications in secondary care, research into optimal implementation methods, and increased awareness, will ultimately facilitate the development of effective treatment options. However, an ideal endocrine therapy that is effective regardless of the presence of an ESR1 mutation would be highly beneficial.

According to DelveInsight, the ESR1-Mutated Metastatic Breast Cancer market in 7MM is expected to witness a major change in the study period 2020-2034.

ESR1-Mutated Metastatic Breast Cancer Market Insights:

The total market size for ESR1-mutated metastatic breast cancer in the 7MM was approximately USD 1,300 million in 2023, with projections for growth during the forecast period from 2024 to 2034.

According to DelveInsight estimates, the US held the largest share of the total market, accounting for around 63%, while the combined EU4 and UK captured nearly 29% of the market in 2023. Among the EU4 countries, Germany had the highest market size, estimated at approximately USD 90 million.

In the United States, the combination of aromatase inhibitors and CDK4/6 inhibitors is expected to achieve the highest market share in the first-line setting, generating approximately USD 500 million in revenue in 2023.

Key therapies with Fast Track Designation (FTD) for ESR1 mutations include Camizestrant, Lasofoxifene, and OP-1250.

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ESR1-Mutated Metastatic Breast Cancer Epidemiology

In 2023, there were approximately 18,800 diagnosed cases of ESR1-mutated metastatic breast cancer in the United States. Among these, about 18,400 cases involved ESR1-mutated HR+ metastatic breast cancer receiving first-line treatment.

Within the EU4 countries, Germany reported the highest number of ESR1 mutations in metastatic breast cancer, followed by France, while Spain had the lowest number of cases in 2023.

According to DelveInsight estimates, Japan had around 45,000 cases of metastatic breast cancer, representing approximately 13% of the total cases across the 7MM.

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ESR1-Mutated Metastatic Breast Cancer Drugs Uptake

This section focuses on the uptake rate of the potential ESR1-Mutated Metastatic Breast Cancer drugs recently launched in the ESR1-Mutated Metastatic Breast Cancer market or expected to be launched in 2020-2034. The analysis covers the ESR1-Mutated Metastatic Breast Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug.

ESR1-Mutated Metastatic Breast Cancer Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on ESR1-Mutated Metastatic Breast Cancer market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

ESR1-Mutated Metastatic Breast Cancer Pipeline Development Activities

The ESR1-Mutated Metastatic Breast Cancer report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses ESR1-Mutated Metastatic Breast Cancer key players involved in developing targeted therapeutics.

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ESR1-Mutated Metastatic Breast Cancer Therapeutics Assessment

Major pharma companies such as Arvinas, Sermonix Pharmaceuticals, Roche, Eli Lilly and Company, H3 Biomedicine, Eisai, Pfizer, Sun Pharma Advanced Research Company, Zenopharm, and others are working proactively in the ESR1-Mutated Metastatic Breast Cancer Therapeutics market to develop novel therapies which will drive the ESR1-Mutated Metastatic Breast Cancer treatment markets in the upcoming years.

Learn more about the emerging therapies & key companies at: https://www.delveinsight.com/report-store/esr1-mutated-metastatic-breast-cancer-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

ESR1-Mutated Metastatic Breast Cancer Report Key Insights

1. ESR1-Mutated Metastatic Breast Cancer Patient Population
2. ESR1-Mutated Metastatic Breast Cancer Market Size and Trends
3. Key Cross Competition in the ESR1-Mutated Metastatic Breast Cancer Market
4. ESR1-Mutated Metastatic Breast Cancer Market Dynamics (Key Drivers and Barriers)
5. ESR1-Mutated Metastatic Breast Cancer Market Opportunities
6. ESR1-Mutated Metastatic Breast Cancer Therapeutic Approaches
7. ESR1-Mutated Metastatic Breast Cancer Pipeline Analysis
8. ESR1-Mutated Metastatic Breast Cancer Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the ESR1-Mutated Metastatic Breast Cancer Market

Table of Contents

1. Key Insights
2. Executive Summary
3. ESR1-Mutated Metastatic Breast Cancer Competitive Intelligence Analysis
4. ESR1-Mutated Metastatic Breast Cancer Market Overview at a Glance
5. ESR1-Mutated Metastatic Breast Cancer Disease Background and Overview
6. ESR1-Mutated Metastatic Breast Cancer Patient Journey
7. ESR1-Mutated Metastatic Breast Cancer Epidemiology and Patient Population
8. ESR1-Mutated Metastatic Breast Cancer Treatment Algorithm, Current Treatment, and Medical Practices
9. ESR1-Mutated Metastatic Breast Cancer Unmet Needs
10. Key Endpoints of ESR1-Mutated Metastatic Breast Cancer Treatment
11. ESR1-Mutated Metastatic Breast Cancer Marketed Products
12. ESR1-Mutated Metastatic Breast Cancer Emerging Therapies
13. ESR1-Mutated Metastatic Breast Cancer Seven Major Market Analysis
14. Attribute Analysis
15. ESR1-Mutated Metastatic Breast Cancer Market Outlook (7 major markets)
16. ESR1-Mutated Metastatic Breast Cancer Access and Reimbursement Overview
17. KOL Views on the ESR1-Mutated Metastatic Breast Cancer Market
18. ESR1-Mutated Metastatic Breast Cancer Market Drivers
19. ESR1-Mutated Metastatic Breast Cancer Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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