DelveInsight’s “Metastatic HR+/HER2- Breast Cancer Market Insights, Epidemiology, and Market Forecast-2034” report provides comprehensive insights into the historical and projected metastatic HR+/HER2 breast cancer epidemiology, treatment patterns, emerging therapies, and market trends across the 7MM. The HR+/HER2- breast cancer market size was nearly USD 10 billion across 7MM in 2023, which is expected to grow by 2034 with an increasing patient pool and the launch of potential emerging therapies.
Regionally, the US dominated the HR+/HER2- breast cancer market in 2023, with a market share of USD 7.5 billion, followed by the EU4, UK, and Japan. Furthermore, among the EU4 countries, Germany captured the largest market share.
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According to the metastatic HR+/HER2- breast cancer epidemiological analysis presented in the report, the total incident population of HR+/HER2- breast cancer was approximately 480K cases across 7MM in 2023, with the US accounting for the highest number at around 210K cases. The HR+/HER2- subtype represents approximately 70% of all breast cancer cases, making it the most prevalent form of breast cancer. Further, age-specific data shows that most HR+/HER2- breast cancer cases occur in people aged between 60 and 79 years, accounting for approximately 48% of all cases in the US in 2023.
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The report also contains the current and emerging metastatic HR+/HER2- breast cancer treatment landscape. For the past decade, endocrine therapy has been the standard treatment for HR+/HER2- breast cancer in both early and advanced stages. FASLODEX, manufactured by AstraZeneca, is one of the most efficient and well-tolerated medications available in single-agent endocrine therapy formulations.
However, the introduction of CDK4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib has recently revolutionized treatment approaches by providing extended progression-free survival when combined with endocrine therapy. IBRANCE, manufactured by Pfizer, led the market in 2023 with revenues reaching approximately USD 4.5 billion.
The metastatic HR+/HER2- breast cancer pipeline is robust, with numerous promising therapies in late-stage development. Key players, including Pfizer, Novartis, AstraZeneca, Roche, Arvinas, Olema Pharmaceuticals, Eli Lilly, and others, are advancing innovative candidates through clinical trials. Notable emerging therapies include ARV-471 (vepdegestrant), a PROTAC estrogen receptor protein degrader being developed by Arvinas and Pfizer; OP1250 (palazestrant), a complete estrogen receptor antagonist from Olema Pharmaceuticals; and Capivasertib, an AKT inhibitor from AstraZeneca.
The emerging pipeline is particularly rich in next-generation selective estrogen receptor degraders (SERDs), which aim to address the limitations of FASLODEX, including its poor bioavailability and inconvenient administration route. However, these novel SERDs will face strong competition from established CDK4/6 inhibitors, which currently hold significant market share, potentially limiting their initial growth.
Other promising drug classes in development include AKT inhibitors, mTOR inhibitors, PI3K inhibitors, and TROP-2 targeting antibody-drug conjugates, all of which are expected to expand the treatment armamentarium for patients with HR+/HER2- breast cancer.
Recent regulatory milestones have significantly impacted the treatment landscape. In January 2025, the FDA approved DATROWAY for unresectable or metastatic HR+/HER2- breast cancer in patients who have received prior endocrine-based therapy and chemotherapy. Simultaneously, ENHERTU received approval for unresectable or metastatic HR+/HER2-low or HER2-ultralow breast cancer that has progressed on one or more endocrine therapies in the metastatic setting.
Additionally, in January 2025, Roche announced positive topline results from the Phase III INAVO120 study investigating ITOVEBI in combination with IBRANCE and fulvestrant for patients with PIK3CA-mutated HR+/HER2-, endocrine-resistant, locally advanced or metastatic breast cancer.
In April 2024, the FDA accepted the Biologics License Application (BLA) for Dato-DXd, a TROP2 antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, for the treatment of metastatic HR+/HER2- breast cancer, with a Prescription Drug User Fee Act (PDUFA) date set in July 2025.
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According to DelveInsight’s analysis, the 5-year survival rate for HR+/HER2- breast cancer is approximately 96% for all stages combined, which is the highest among all breast cancer subtypes. However, this rate drops significantly to approximately 37% for patients with distant metastases, highlighting the continued need for more effective therapies for advanced disease. The introduction of novel targeted agents and combination approaches is expected to address this unmet need and further improve survival outcomes for patients with metastatic HR+/HER2- breast cancer.
As the HR+/HER2- breast cancer market continues to evolve, stakeholders across the healthcare ecosystem must stay informed about emerging therapies, changing treatment paradigms, and market dynamics. DelveInsight’s comprehensive report offers valuable insights for pharmaceutical companies, healthcare providers, and patients navigating this complex and rapidly changing landscape.
Table of Contents
1. Key Insights
2. Report Introduction
3. Executive Summary of Metastatic HR+/HER2- Breast Cancer
4. Epidemiology and Market Forecast Methodology
5. Metastatic HR+/HER2- Breast Cancer Key Events
6. Metastatic HR+/HER2- Breast Cancer Market Overview at a Glance
7. Disease Background and Overview
8. Metastatic HR+/HER2- Breast Cancer Treatment
9. Metastatic HR+/HER2- Breast Cancer Epidemiology and Patient Population
10. Assumptions and Rationale
11. Metastatic HR+/HER2- Breast Cancer Patient Journey
12. Metastatic HR+/HER2- Breast Cancer Marketed Drugs
13. Metastatic HR+/HER2- Breast Cancer Emerging Therapies
14. HR+/HER2- Breast Cancer: The 7MM Analysis
15. Metastatic HR+/HER2- Breast Cancer Unmet needs
16. SWOT Analysis
17. KOL Views
18. Metastatic HR+/HER2- Breast Cancer Market Access and Reimbursement
19. Appendix
20. DelveInsight Capabilities
21. Disclaimer
22. About DelveInsight
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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