DelveInsight’s “ER+/HER2- Breast Cancer – Market Insights, Epidemiology and Market Forecast – 2032” report provides an in-depth understanding of ER+/HER2- breast cancer, historical and forecasted epidemiology, and market trends across the 7MM (United States, EU4, United Kingdom, and Japan). The ER+/HER2- breast cancer therapeutic market is projected to experience significant growth through 2032, with the current US market size of USD 7.4 billion, expected to expand considerably during the forecast period (2023-2032).
Download the ER+/HER2- Breast Cancer Market Report to understand which factors are driving the ER+/HER2- breast cancer therapeutic market @ ER+/HER2- Breast Cancer Market Trends.
The report highlights that ER+/HER2 breast cancer represents the most prevalent breast cancer subtype, accounting for approximately 70% of all breast cancer cases. This hormonal subtype occurs when breast cancer cells contain estrogen receptors that can promote tumor growth when stimulated by estrogen, but lack high levels of human epidermal growth factor receptor 2 (HER2) protein on their surface.
Epidemiological analysis reveals that in 2021, the US reported 260K new cases of breast cancer, with the majority occurring in postmenopausal women. Furthermore, most cases were diagnosed at a localized stage, followed by regional and distant stages. These trends are expected to continue in the coming years.
Discover evolving trends in the ER+/HER2- breast cancer patient pool forecasts @ ER+/HER2- Breast Cancer Epidemiology Analysis.
The current treatment landscape for ER+/HER2 breast cancer is dominated by several key therapies. IBRANCE (palbociclib) by Pfizer (NYSE: PFE) maintains a strong position in first-line and second-line treatments, while KISQALI (ribociclib) by Novartis (SWX: NOVN) continues to demonstrate substantial efficacy in combination with aromatase inhibitors or fulvestrant. VERZENIO, the only CDK4/6 inhibitor approved in the adjuvant setting, is expected to benefit from its first-mover advantage. Other significant marketed treatments include AFINITOR (everolimus) by Novartis, Elacestrant by Radius Pharmaceuticals (NASDAQ: RDUS), and LYNPARZA (olaparib) by AstraZeneca, which is indicated for patients with deleterious or suspected deleterious gBRCAm HR+/HER2- metastatic breast cancer.
The ER+/HER2- breast cancer therapeutic pipeline shows remarkable promise, with several emerging treatments poised to transform the treatment paradigm. Next-generation Selective Estrogen Receptor Degraders (SERDs) represent a significant portion of the development pipeline, including Giredestrant (Roche), Camizestrant (AstraZeneca), and Imlunestrant (Eli Lilly). Lerociclib (EQRx) is a novel, oral, potent, and selective small-molecule cyclin-dependent kinase (CDK) 4/6 inhibitor, which is also currently in the pipeline for ER+/HER2- breast cancer treatment.
Notably, Giredestrant has received Fast Track Designation from the FDA for ER+, HER2-, second and third-line metastatic breast cancer. In January 2022, Veru (NASDAQ: VERU) announced that enobosarm, an oral selective androgen receptor targeting agonist, also received Fast Track Designation for AR+ ER+ HER2- metastatic breast cancer treatment.
In January 2025, the FDA approved ENHERTU, developed by Daiichi Sankyo (TYO: 4568), for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer. This approval represents a significant expansion of ENHERTU’s usage, as it becomes the first HER2-directed therapy available for patients with HER2-ultralow disease, a group that previously lacked targeted treatment options.
Additionally, in October 2024, the FDA approved ITOVEBI from Genentech (NYSE: DNA), an oral PI3Kα inhibitor, for use in combination with palbociclib and fulvestrant. This combination is intended for treating adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer. This approval was based on the pivotal phase III trial, which demonstrated that the inavolisib-based triplet regimen more than doubled median progression-free survival compared to palbociclib and fulvestrant alone.
Furthermore, results from a double-blind, placebo-controlled Phase III study (KEYNOTE-756), published in January 2025, found that KEYTRUDA combined with chemotherapy significantly improved pathological complete response rates in high-risk, early-stage ER+/HER2- breast cancer compared to chemotherapy alone. This finding supports the integration of immunotherapy for selected patients.
As of April 2025, several novel KAT6A/6B inhibitors such as HW321005, IST-477, and PF-07248144 are in early-phase clinical development. These inhibitors are showing promising preclinical and early clinical activity in ER+/HER2 breast cancer, particularly in patients resistant to endocrine therapy and CDK4/6 inhibitors.
Meanwhile, the phase II EVANGELINE trial is the combination of Z-endoxifen plus goserelin versus exemestane plus goserelin as neoadjuvant therapy in premenopausal women with ER+/HER2- breast cancer, aiming to enhance endocrine sensitivity and improve treatment outcomes.
Discover recent advancements in the ER+/HER2- breast cancer treatment landscape @ ER+/HER2- Breast Cancer Recent Developments.
Despite the strong pipeline, emerging drugs will face intense competition from established CDK4/6 inhibitors, which currently dominate market share. DelveInsight’s analysis suggests that while next-generation SERDs offer novel mechanisms of action and potential benefits for patients resistant to current therapies, their market uptake may be gradual as they compete with entrenched treatment options.
Looking ahead, the ER+/HER2 breast cancer treatment market is expected to undergo significant evolution as novel targeted therapies and combination approaches address current unmet needs. The continued focus on developing treatments for specific patient subgroups, particularly those with ESR1 mutations or resistance to endocrine therapy, suggests a shifting landscape toward more personalized treatment approaches.
Table of Contents
1. Key Insights
2. Report Introduction
3. Executive Summary of ER+/HER2− Breast Cancer
4. Key Events
5. SWOT Analysis
6. ER+/HER2− Breast Cancer Market Overview at a Glance in the 7MM
7. ER+/HER2− Breast Cancer Background and Overview
8. Treatment of Estrogen-Receptor (ER)-Positive Breast Cancer
9. ER+/HER2− Breast Cancer Epidemiology and Patient Population of 7MM
10. ER+/HER2− Breast Cancer Patient Journey
11. ER+/HER2− Breast Cancer Marketed Products
12. ER+/HER2− Breast Cancer Emerging Therapies
13. ER+/HER2− Breast Cancer: 7MM Market Analysis
14. ER+/HER2− Breast Cancer Unmet Needs
15. Market Access and Reimbursement
16. Appendix
17. DelveInsight Capabilities
18. Disclaimer
19. About DelveInsight
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ER+/ HER2 -ve Breast Cancer Pipeline Insight
ER+/ HER2 -ve breast cancer pipeline insight provides comprehensive insights about the ER+/ HER2 -ve breast cancer pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the ER+/ HER2 -ve breast cancer companies, including AstraZeneca (NASDAQ: AZN), Atossa Therapeutics (NASDAQ: ATOS), Accutar Biotechnology Inc, VelosBio Inc, Merus N.V. (NASDAQ: MRUS), Pfizer (NYSE: PFE), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Eli Lilly and Company (NYSE: LLY), Novartis Pharmaceuticals (SWX: NOVN), Hoffmann-La Roche (SWX: ROG), Ellipses Pharma, and BeiGene (SHA: 688235), among others.
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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