New York, USA, March 22, 2023 (GLOBE NEWSWIRE) -- ESR1-Mutated Metastatic Breast Cancer Market to Climb Swiftly at a Significant CAGR During the Study Period (2019–2032) | DelveInsight
The ESR1-mutated metastatic breast cancer market is expected to surge in the coming years due to the rising prevalence of metastatic breast cancer over the globe, which is increasing the probabilities of ESR1-mutated metastatic breast cancer and thus the surge in treatment options. Along with these, the expected launch of emerging therapies will boost the ESR1-mutated metastatic breast cancer market.
DelveInsight’s ESR1-Mutated Metastatic Breast Cancer Market Insights report includes a comprehensive understanding of current treatment practices, ESR1-mutated metastatic breast cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].
Key Takeaways from the ESR1-Mutated Metastatic Breast Cancer Market Report
- As per DelveInsight analysis, the ESR1-mutated metastatic breast cancer market size in the 7MM was approximately USD 1.5 billion in 2021.
- According to the assessment done by DelveInsight, the estimated total HR-positive breast cancer diagnosed prevalent cases in the 7MM was approximately 1.2 million in 2021.
- Leading ESR1-mutated metastatic breast cancer companies such as Radius Pharmaceuticals, Berlin-Chemie, Pfizer, G1 Therapeutics, Inc., Sun Pharma Advanced Research Company, Zenopharm, Arvinas, Sermonix Pharmaceuticals, H3 Biomedicine, Eisai, Roche, AstraZeneca, Zentalis Pharmaceuticals, Olema Pharmaceuticals, and others are developing novel ESR1-mutated metastatic breast cancer drugs that can be available in the ESR1-mutated metastatic breast cancer market in the coming years.
- The promising ESR1-mutated metastatic breast cancer therapies in the pipeline include 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.
- On October 21, 2022, Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers specifically, presented additional findings from its Phase II Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1) study today at the 4th Annual Congress of the International Society of Liquid Biopsy (ISLB) in Miami.
- On August 17, 2022, Sanofi discontinued the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD).
- In August 2022, Zentalis announced that they discontinued the clinical development of ZN-c5, its oral SERD, and ZN-e4, its EGFRinhibitor, following completion of its existing clinical trials, which are closed to accrual, in these two programs.
- In August 2022, the FDA granted priority review to NDA seeking the approval of elacestrant for use in patients with estrogen receptor (ER)–positive/HER2-negative advanced or metastatic breast cancer. Under the Prescription Drug User Fee Act, the regulatory agency is expected to decide on the application by February 17, 2023.
- In August 2022, FDA granted a fast-track designation to OP-1250 for the treatment of patients with ER-positive, HER2- metastatic breast cancer.
- In April 2022, Roche announced the first-quarter result and stated that giredestrant missed the mark in the Phase II acelERA trial in advanced breast cancer, the emerging oral selective estrogen receptor degrader (SERD) class.
Discover which therapies are expected to grab the major ESR1-mutated metastatic breast cancer market share @ ESR1-Mutated Metastatic Breast Cancer Market Report
ESR1-Mutated Metastatic Breast Cancer Overview
Metastatic breast cancer is essentially a Stage IV breast cancer in which cancer begins in the breast tissue and then spreads to other parts of the body. Estradiol, a steroid hormone, is important in the progression of breast cancer, and the majority of human breast cancers begin as estrogen-dependent and express the estrogen receptor (ER). ESR1 mutations are more commonly selected in cancers that progress after sensitivity to prior aromatase inhibitor therapy and are relatively rare in patients with intrinsic endocrine resistance.
ESR1 mutations rarely occur in primary breast cancer but are common in advanced breast cancers previously treated with aromatase inhibitors, implying evolution through selective treatment pressure. Most ESR1 mutations occur in hotspot regions of the ER’s ligand-binding domain, resulting in ligand-independent, constitutive ER activity.
Tumor tissue and baseline liquid biopsies could be used for mutation detection using sensitive next-generation sequencing (MPS) at the time of diagnosis. Following neoadjuvant therapy, Droplet Digital PCR ddPCR could be used to confirm ESR1 mutations.
ESR1-Mutated Metastatic Breast Cancer Epidemiology Segmentation
DelveInsight estimates that there were approximately 1.2 million HR-positive breast cancer diagnosed prevalent cases in the 7MM in 2021.
Among the EU-4 and the UK countries, Germany captured the highest diagnosed prevalent cases of ESR1 mutated metastatic breast cancer in 2021.
The ESR1-mutated metastatic breast cancer market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
- 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
Download the report to understand which factors are driving ESR1-mutated metastatic breast cancer epidemiology trends @ ESR1-Mutated Metastatic Breast Cancer Epidemiological Insights
ESR1-Mutated Metastatic Breast Cancer Treatment Market
Patients with ESR1 mutations benefit clinically from fulvestrant and CDK4/6 targeted therapies, but more potent selective estrogen receptor degraders (SERDs) and new targeted biotherapies are needed to overcome the endocrine-resistant phenotype of ESR1 mutant-bearing tumors. There are effective ETs for treating patients with ER-positive metastatic disease. Rather than sequencing single endocrine agents, ET and biotherapy combinations are now commonly used to treat ET-resistant MBC. For ER-positive breast cancer, two biological targets have been approved: mammalian target of rapamycin (mTOR) and cyclin-dependent kinases (CDK) 4/6.
According to ESR1-mutated metastatic breast cancer treatment guidelines, patients who develop MBC 12 months after adjuvant ET or who are newly metastatic should be treated in the first-line setting with an AI combined with a CDK4/6 inhibitor.
Although many preclinical studies have shown that ESR1 mutant cells respond to fulvestrant with less sensitivity, recent retrospective analyses of the PALOMA-2 clinical trial published by O’Leary et al. revealed that patients treated with fulvestrant monotherapy alone or in combination with palbociclib continued to acquire the Y537S ESR1 mutation during treatment.
Furthermore, a more recent retrospective correlative analysis of the PALMOA-3 trial investigated whether early changes in ESR1 or PIK3CA mutations measured using ddPCR of ctDNA were predictive of therapy response. Although total ESR1 mutant abundance decreased in both treatment arms, these changes were not predictive of fulvestrant response.
To know more about ESR1-mutated metastatic breast cancer treatment, visit @ ESR1-Mutated Metastatic Breast Cancer Treatment Drugs
ESR1-Mutated Metastatic Breast Cancer Pipeline 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
Learn more about the FDA-approved drugs for ESR1-mutated metastatic breast cancer @ Drugs for ESR1-Mutated Metastatic Breast Cancer Treatment
ESR1-Mutated Metastatic Breast Cancer Market Dynamics
The ESR1-mutated metastatic breast cancer is expected to boost in the coming years due to the rising global incidence of ER+ breast cancer, combined with an increase in the use of endocrine drugs, will contribute to an increase in the incidence of ESR1 mutant breast cancer and, as a result, a surge in treatment options. Moreover, the increase in clinical trial activity for emerging therapies will drive the ESR1-mutated metastatic breast cancer market forward.
In addition, a lack of approved and effective therapies may provide good ESR1-mutated metastatic breast cancer market space for emerging therapies. Furthermore, the rising disease awareness among researchers, clinicians, and patients will drive the ESR1-mutated metastatic breast cancer market size.
Moreover, the current unmet need of the ESR1 mutant breast cancer market is for medications with improved safety and effectiveness that provide the best cure. There is a need to concentrate on therapies with higher compliance in the ESR1 mutant breast cancer market.
However, a lack of comprehension of the occurrence and clinical significance may represent a missed ESR1 mutant breast cancer market opportunity to make the correct diagnosis. Current pharmacological therapies have limitations, such as limited activity. Furthermore, the drugs are sometimes the root cause of this specific mutation in patients.
The current treatments, such as CDK4/6 inhibitors, are prohibitively expensive. As this mutation was discovered only a decade ago, there is very little data available in studies, and thus very little work has been done to date. Furthermore, strict pricing and reimbursement policies will significantly challenge the ESR1 mutant breast cancer market growth. Another major cause of unsatisfactory current patient care is a lack of awareness, which may impede ESR1 mutated breast cancer market growth.
| Report Metrics | Details |
| Study Period | 2019–2032 |
| Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Base Year | 2019 |
| ESR1-Mutated Metastatic Breast Cancer Market Size in 2021 | USD 1.5 Billion |
| Key ESR1-Mutated Metastatic Breast Cancer Companies | Radius Pharmaceuticals, Berlin-Chemie, Pfizer, G1 Therapeutics, Inc., Sun Pharma Advanced Research Company, Zenopharm, Arvinas, Sermonix Pharmaceuticals, H3 Biomedicine, Eisai, Roche, AstraZeneca, Zentalis Pharmaceuticals, Olema Pharmaceuticals, and others |
| Key Pipeline 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 |
Scope of the ESR1-Mutated Metastatic Breast Cancer Market Report
- Therapeutic Assessment: ESR1-Mutated Metastatic Breast Cancer current marketed and emerging therapies
- ESR1-Mutated Metastatic Breast Cancer Market Dynamics: Attribute Analysis of Emerging ESR1-Mutated Metastatic Breast Cancer Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, ESR1-Mutated Metastatic Breast Cancer Market Access and Reimbursement
Discover more about ESR1-mutated metastatic breast cancer drugs in development @ ESR1-Mutated Metastatic Breast Cancer Clinical Trials
Table of Contents
| 1. | ESR1-Mutated Metastatic Breast Cancer Market Key Insights |
| 2. | ESR1-Mutated Metastatic Breast Cancer Market Report Introduction |
| 3. | ESR1-Mutated Metastatic Breast Cancer Market Overview at a Glance |
| 4. | ESR1-Mutated Metastatic Breast Cancer Market Executive Summary |
| 5. | Disease Background and Overview |
| 6. | ESR1-Mutated Metastatic Breast Cancer Treatment and Management |
| 7. | ESR1-Mutated Metastatic Breast Cancer Epidemiology and Patient Population |
| 8. | Patient Journey |
| 9. | ESR1-Mutated Metastatic Breast Cancer Marketed Drugs |
| 10. | ESR1-Mutated Metastatic Breast Cancer Emerging Drugs |
| 11. | Seven Major ESR1-Mutated Metastatic Breast Cancer Market Analysis |
| 12. | ESR1-Mutated Metastatic Breast Cancer Market Outlook |
| 13. | Potential of Current and Emerging Therapies |
| 14. | KOL Views |
| 15. | ESR1-Mutated Metastatic Breast Cancer Market Drivers |
| 16. | ESR1-Mutated Metastatic Breast Cancer Market Barriers |
| 17. | Unmet Needs |
| 18. | SWOT Analysis |
| 19. | Appendix |
| 20. | DelveInsight Capabilities |
| 21. | Disclaimer |
| 22. | About DelveInsight |
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