Metastatic HR+/HER2- Positive Breast Cancer Market

Metastatic HR+/HER2- Positive Breast Cancer emerging therapies, such as ARV-471 (vepdegestrant), OP1250 (palazestrant), and others, are expected to boost the Metastatic HR+/HER2- Positive Breast Cancer Market in the upcoming years.

DelveInsight has launched a new report on “Metastatic HR+/HER2- Positive Breast Cancer – Market Insights, Epidemiology, and Market Forecast-2034” that delivers an in-depth understanding of the Metastatic HR+/HER2- Positive Breast Cancer, historical and forecasted epidemiology as well as the Metastatic HR+/HER2- Positive Breast Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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Recent breakthroughs in market developments in the Metastatic HR+/HER2- Positive Breast Cancer Market:

• At the ESMO 2025 Congress, Celcuity Inc. revealed that its PI3K‐inhibitor candidate Gedatolisib achieved positive Phase 3 results in HR+/HER2- advanced breast cancer patients with wild-type PIK3CA, marking the first such outcome in this population.

• In August 2025, Celcuity Inc. announced that the FDA had accepted its New Drug Application (NDA) for gedatolisib for the treatment of HR+/HER2- advanced breast cancer (ABC) under the Real-Time Oncology Review (RTOR) program.

• Earlier, in April 2025, AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) received EU approval as a monotherapy for adults with unresectable or metastatic HR-positive, HER2-low/ultralow breast cancer who have undergone at least one prior endocrine therapy and are no longer suitable for further endocrine treatment.

Some of the key facts of the Metastatic HR+/HER2- Positive Breast Cancer Market Report:

• The total HR+/HER2- breast cancer market size across the 7MM was approximately USD 10 billion in 2023 and is projected to grow by 2034, driven by the introduction of emerging therapies and a rising HR+/HER2- breast cancer patient pool.

• This subtype remains the most prevalent among all breast cancer types.

• Over the past decade, endocrine therapy has been the mainstay for treating HR+/HER2– breast cancer in both early and advanced stages. Among available therapies, FASLODEX (fulvestrant) stands out for its efficacy and tolerability as a single-agent endocrine therapy. However, its low bioavailability and injectable form have paved the way for next-generation oral selective estrogen receptor degraders (SERDs) to enter both first- and second-line treatment settings.

• Within approved therapy classes, CDK4/6 inhibitors—including palbociclib, ribociclib, and abemaciclib—have garnered significant attention in first- and second-line use by providing prolonged progression-free survival. IBRANCE (palbociclib) leads the market due to its first-mover advantage and strong sales performance across both settings. Meanwhile, the NCCN Guidelines recommend KISQALI (ribociclib) as the only Category 1 preferred CDK4/6 inhibitor for first-line HR+/HER2- metastatic breast cancer when combined with an aromatase inhibitor (AI).

• Key industry players—such as Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNTech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, and Immutep—are actively advancing novel therapies for metastatic HR+/HER2− breast cancer.

• ORSERDU represents a major milestone as the first and only therapy specifically approved for ER+, HER2- tumors with ESR1 mutations, marking the first significant innovation in endocrine therapy in nearly 20 years.

• Emerging data suggest that the post-CDK4/6 inhibitor landscape could be reshaped by the introduction of antibody–drug conjugates (ADCs) and oral SERDs, which are poised to play a key role in future treatment strategies. Other therapeutic classes in development include AKT inhibitors, mTOR inhibitors, SERMs, PI3K inhibitors, PARP inhibitors, and TROP2-targeting ADCs.

• Roche’s giredestrant, when combined with palbociclib, is positioned as a potential first-line competitor to camizestrant, though its Phase II acelERA trial (monotherapy) failed to achieve its primary endpoint of investigator-assessed PFS. Capivasertib continues to lead among targeted AKT (PKB) inhibitors, while Dato-DXd, a TROP2 ADC sharing the same payload as trastuzumab deruxtecan, has gained traction following its BLA acceptance in April 2024 in the US for metastatic HR+/HER2– breast cancer previously treated with systemic therapy. The PDUFA decision is expected in Q1 2025.

• The late-stage pipeline is populated with numerous HR+/HER2- candidates in Phase II–III trials that aim to address current unmet needs and are expected to significantly expand the market in the coming years. However, as many of these are next-generation SERDs, they will face intense competition from established CDK4/6 inhibitors, potentially slowing their market uptake.

• In April 2025, AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) received EU approval as a monotherapy for adults with unresectable or metastatic HR-positive, HER2-low/ultralow breast cancer following prior endocrine therapy when further endocrine treatment is no longer appropriate.

Metastatic HR+/HER2- Positive Breast Cancer Overview

HR+/HER2- breast cancer represents the most prevalent subtype of breast cancer, defined by the presence of hormone receptors for estrogen and progesterone but the absence of HER2 overexpression. This form of breast cancer typically has a more favorable prognosis and is primarily managed through hormone (endocrine) therapy, which works by blocking hormone-driven tumor growth. In addition, surgery and radiation therapy are commonly employed to remove or target tumors, while chemotherapy and targeted treatments such as CDK4/6 inhibitors are often used in more advanced stages. Early diagnosis plays a critical role in improving outcomes, and emotional and medical support from healthcare professionals and loved ones is essential in navigating treatment and recovery.

Metastatic HR+/HER2- Positive Breast Cancer Market Outlook

Over the past decade, endocrine therapy has remained the standard of care for treating HR-positive, HER2-negative metastatic breast cancer, including cases involving visceral metastases. This treatment approach—comprising antiestrogens and aromatase inhibitors (AIs)—continues to be the main systemic therapy due to its proven efficacy and favorable safety profile. Currently, three AIs are available: anastrozole and letrozole (nonsteroidal AIs) and exemestane (steroidal AI). For patients who are not suitable for chemotherapy or monotherapy with endocrine agents, combination regimens pairing endocrine therapy with targeted drugs such as CDK4/6 inhibitors or mTOR inhibitors have become an effective option.

The addition of CDK4/6 inhibitors—including ribociclib (MONALEESA-2, -3, -7), palbociclib (PALOMA-2), and abemaciclib (MONARCH-3)—to endocrine therapy in first-line treatment has demonstrated a substantial improvement in median progression-free survival (PFS). While these inhibitors are relatively recent additions in Japan, palbociclib and abemaciclib have already received regulatory approval for clinical use.

In August 2022, AstraZeneca and Daiichi Sankyo’s ENHERTU gained accelerated approval for HER2-low breast cancer, marking it as the first therapy designed specifically for HER2-low, metastatic, or unresectable breast cancer—a newly defined subgroup closely associated with HR+/HER2− disease. Following this, in February 2023, the FDA approved TRODELVY for patients with previously treated HR-positive, HER2-negative breast cancer.

The therapeutic potential of CDK4/6 inhibitors may extend beyond HR+/HER2− advanced breast cancer. However, patients who develop resistance to CDK4/6 inhibitor plus endocrine therapy combinations often transition to chemotherapy, as single-agent fulvestrant has shown limited efficacy. Recent advances indicate that the post-CDK4/6 treatment landscape may be reshaped by antibody–drug conjugates (ADCs) and oral selective estrogen receptor degraders (SERDs), both showing promising activity in resistant settings.

The emerging drug pipeline for HR+/HER2− breast cancer includes several promising agents, with growing attention on therapies targeting the HER2-low segment. Late-stage (Phase II–III) candidates for HR+/HER2− disease include Giredestrant, Camizestrant (AZD9833), LY3484356 (Imlunestrant), Lasofoxifene, ARV-471, Capivasertib, Inavolisib, KEYTRUDA (pembrolizumab), Enobosarm, OP1250, Samuraciclib, Lerociclib, SFX-01, and Endoxifen. For HER2-low disease, agents such as Datopotamab deruxtecan, DB1303, and Eftilagimod alpha are being evaluated in various combination regimens. Much of the current research focuses on next-generation oral SERDs, reflecting the field’s shift toward more targeted and patient-specific approaches.

Despite these advances, significant unmet needs remain in ER+, HER2− breast cancer. Ongoing research aimed at understanding tumor biology, genetic mutations, and biomarker discovery will be essential to develop more precise and effective therapies, ultimately improving patient outcomes in this common subtype of breast cancer.

Discover how the Metastatic HR+/HER2- Positive Breast Cancer market is rising in the coming years

Metastatic HR+/HER2- Positive Breast Cancer Marketed Drugs:

• KISQALI (ribociclib): Novartis

• PIQRAY (alpelisib): Novartis

Metastatic HR+/HER2- Positive Breast Cancer Emerging Drugs

• ARV-471 (vepdegestrant): Arvinas

• OP1250 (palazestrant): Olema Pharmaceuticals

Scope of the Metastatic HR+/HER2- Positive Breast Cancer Market Report

• Study Period: 2020-2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Metastatic HR+/HER2- Positive Breast Cancer Companies: Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, and others

• Key Metastatic HR+/HER2- Positive Breast Cancer Therapies: ARV-471 (vepdegestrant), OP1250 (palazestrant), and others

• Metastatic HR+/HER2- Positive Breast Cancer Therapeutic Assessment: Metastatic HR+/HER2- Positive Breast Cancer current marketed and Metastatic HR+/HER2- Positive Breast Cancer emerging therapies

• Metastatic HR+/HER2- Positive Breast Cancer Market Dynamics: Metastatic HR+/HER2- Positive Breast Cancer market drivers and Metastatic HR+/HER2- Positive Breast Cancer market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Metastatic HR+/HER2- Positive Breast Cancer Unmet Needs, KOL’s views, Analyst’s views, Metastatic HR+/HER2- Positive Breast Cancer Market Access and Reimbursement

To know what’s more in our Metastatic HR+/HER2- Positive Breast Cancer report, visit https://www.delveinsight.com/report-store/hr-positive-her2-negative-breast-cancer-market-insights?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Key benefits of the Metastatic HR+/HER2- Positive Breast Cancer Market Report:

1. Metastatic HR+/HER2- Positive Breast Cancer market report covers a descriptive overview and comprehensive insight of the Metastatic HR+/HER2- Positive Breast Cancer Epidemiology and Metastatic HR+/HER2- Positive Breast Cancer market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

2. The Metastatic HR+/HER2- Positive Breast Cancer market report provides insights into the current and emerging therapies.

3. The Metastatic HR+/HER2- Positive Breast Cancer market report provides a global historical and forecasted market covering drug outreach in 7MM.

4. The Metastatic HR+/HER2- Positive Breast Cancer market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Metastatic HR+/HER2- Positive Breast Cancer market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Metastatic HR+/HER2- Positive Breast Cancer Patient Share (%) Overview at a Glance

5. Metastatic HR+/HER2- Positive Breast Cancer Market Overview at a Glance

6. Metastatic HR+/HER2- Positive Breast Cancer Disease Background and Overview

7. Metastatic HR+/HER2- Positive Breast Cancer Epidemiology and Patient Population

8. Country-Specific Patient Population of Metastatic HR+/HER2- Positive Breast Cancer

9. Metastatic HR+/HER2- Positive Breast Cancer Current Treatment and Medical Practices

10. Unmet Needs

11. Metastatic HR+/HER2- Positive Breast Cancer Emerging Therapies

12. Metastatic HR+/HER2- Positive Breast Cancer Market Outlook

13. Country-Wise Metastatic HR+/HER2- Positive Breast Cancer Market Analysis (2020–2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Metastatic HR+/HER2- Positive Breast Cancer Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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“Metastatic HR+/HER2- Positive Breast Cancer Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Metastatic HR+/HER2- Positive Breast Cancer market. A detailed picture of the Metastatic HR+/HER2- Positive Breast Cancer pipeline landscape is provided, which includes the disease overview and Metastatic HR+/HER2- Positive Breast Cancer treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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