Metastatic HR+/HER2− Breast Cancer Market

Emerging therapies for Metastatic HR+/HER2− Breast Cancer, including KISQALI (ribociclib), PIQRAY (alpelisib), ARV-471 (vepdegestrant), OP1250 (palazestrant), and others, are anticipated to drive significant growth in the Metastatic HR+/HER2− Breast Cancer market in the coming years.

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

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

• The HR+/HER2- subtype remains the most common of all breast cancer types. In 2023, the market size for HR+/HER2- breast cancer across the 7MM reached nearly USD 10 billion and is projected to grow by 2034, driven by emerging therapies and a rising patient population.

• For the past decade, endocrine therapy has been the standard of care for HR+/HER2- breast cancer in both early and advanced stages. While FASLODEX (fulvestrant) is a widely used and effective single-agent endocrine therapy, its poor bioavailability and inconvenient IV administration highlight the need for next-generation oral selective estrogen receptor degraders (SERDs) in first- and second-line settings.

• CDK4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib have transformed treatment by improving progression-free survival in first- and second-line therapy. IBRANCE (palbociclib) leads the first-line setting, benefiting from a first-mover advantage and the highest sales. According to NCCN guidelines, KISQALI (ribociclib) is the preferred CDK4/6 inhibitor for first-line treatment when combined with an aromatase inhibitor (AI) in HR+/HER2- metastatic breast cancer (MBC). ORSERDU is another milestone therapy, becoming the first drug approved specifically for ER+, HER2- tumors with ESR1 mutations.

• The treatment landscape is expanding beyond CDK4/6 inhibitors. Late-stage therapies such as Antibody-Drug Conjugates (ADCs) and oral SERDs are anticipated to have a significant impact post-CDK4/6 inhibitor therapy. Other investigational classes include AKT inhibitors, mTOR inhibitors, SERMs, PI3K inhibitors, PARP inhibitors, and TROP2-targeting ADCs. Roche’s Giredestrant (with palbociclib) may compete with Camizestrant as a first-line option, though its Phase II trial failed to meet the primary endpoint. Capivasertib, an AKT inhibitor, and Dato-DXd, a TROP2 ADC with a BLA under FDA review (PDUFA Q1 2025), are among the most promising candidates.

• The patient burden is substantial, with around 476,000 HR+/HER2- breast cancer cases in the 7MM in 2023, a number expected to rise through 2034. The United States reported the highest prevalence with about 208,400 cases, primarily in patients aged 60–79 (48% of cases). In the EU4 and the UK, Germany recorded the most cases (50,200), while Spain reported the fewest. Japan had approximately 43,000 treatment-eligible cases in 2023.

• The emerging pipeline for HR+/HER2- therapies is highly competitive, with late-stage SERDs and other agents poised to meet unmet needs and drive market expansion. However, competition with established CDK4/6 inhibitors, which currently dominate the market, may temper their growth trajectory.

• Key companies such as Pfizer, Novartis, AstraZeneca, Eli Lilly, Jiangsu HengRui Medicine, Odonate Therapeutics, Radius Pharmaceuticals, and Immunomedics are actively developing novel therapies to enhance treatment outcomes. Promising pipeline therapies include KISQALI (ribociclib), PIQRAY (alpelisib), ARV-471 (vepdegestrant), OP1250 (palazestrant), and others.

Key benefits of the Metastatic HR+/HER2− Breast Cancer market report:

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

2. The Metastatic HR+/HER2− Breast Cancer market report provides insights on the current and emerging therapies.

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

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

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Metastatic HR+/HER2− Breast Cancer Overview

HR+/HER2- breast cancer is the most common subtype, characterized by the presence of estrogen and progesterone hormone receptors but the absence of HER2 overexpression. This form of breast cancer generally has a more favorable prognosis and is often treated with hormone therapies that block hormone-related tumor growth. In advanced stages, treatment may involve a combination of surgery, radiation, chemotherapy, and targeted drugs like CDK4/6 inhibitors. Early diagnosis plays a critical role in improving outcomes, and support from both healthcare providers and loved ones is essential throughout the treatment journey.

The patient journey typically starts when symptoms arise, leading to a clinical assessment and imaging. A biopsy confirms the diagnosis and provides detailed information about the tumor. Staging tests then determine how far the cancer has spread, enabling a multidisciplinary team to develop a tailored treatment strategy. This usually includes hormone therapy and may also involve surgery, radiation, chemotherapy, or targeted agents. Emotional support is crucial to help patients manage the psychological burden of the disease, and consistent follow-up care allows for ongoing monitoring and treatment adjustments, increasing the chances of long-term survival and improved quality of life.

Metastatic HR+/HER2− Breast Cancer Treatment Market

The management of HR+/HER2- breast cancer typically involves a multimodal treatment strategy. Hormone therapy is a cornerstone, aiming to block estrogen’s role in fueling cancer growth. Surgical interventions like lumpectomy or mastectomy are performed to remove tumors, often followed by radiation to eliminate any remaining cancer cells. In advanced or metastatic cases, chemotherapy or targeted therapies such as CDK4/6 inhibitors may be included. Treatment decisions are guided by factors like cancer stage, hormone receptor status, and patient preferences. Ongoing monitoring is essential to track progress and adapt the treatment plan for optimal outcomes and long-term survival.

A range of anti-estrogen therapies is available for early-stage, advanced, and metastatic breast cancer, including selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), and selective estrogen receptor degraders (SERDs). Current research is exploring the combination of these hormonal therapies with targeted agents that inhibit the PI3K/AKT/mTOR or CDK4/6 pathways—an approach particularly beneficial for patients who have experienced recurrence or disease progression despite initial hormone therapy.

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Metastatic HR+/HER2− Breast Cancer Market Outlook

Over the past decade, endocrine therapy has remained the primary treatment for HR-positive, HER2-negative metastatic breast cancer, thanks to its effectiveness and tolerability. Aromatase inhibitors (AIs) like anastrozole, letrozole, and exemestane are commonly used, with treatment sometimes enhanced by targeted agents such as CDK4/6 or mTOR inhibitors in more complex cases.

CDK4/6 inhibitors, when combined with endocrine therapy, have notably improved progression-free survival, as demonstrated in trials like MONALEESA and PALOMA. In Japan, palbociclib and abemaciclib are approved, while newer agents such as ENHERTU (approved in Aug 2022 for HER2-low cases) and TRODELVY (approved in Feb 2023 for previously treated HR+/HER2- cases) have broadened treatment options.

However, resistance to CDK4/6 inhibitors often leads to a shift toward chemotherapy due to limited success with fulvestrant alone. Emerging therapies like antibody–drug conjugates (ADCs) and oral selective estrogen receptor degraders (SERDs) offer new hope for patients in post-CDK4/6 settings.

The treatment pipeline includes promising candidates like Giredestrant, Camizestrant, LY3484356, and Datopotamab deruxtecan, especially targeting HER2-low subtypes. The future of HR+/HER2- breast cancer care lies in developing personalized treatments and understanding biomarkers and resistance mechanisms more deeply.

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

To explore more on the emerging therapies that are boosting the metastatic hr+/her2- breast cancer market, visit: https://www.delveinsight.com/sample-request/hr-positive-her2-negative-breast-cancer-market-insights?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Scope of the Metastatic HR+/HER2− 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− Breast Cancer Companies: Pfizer, Novartis, AstraZeneca Pharmaceuticals, Eli Lilly, Jiangsu HengRui Medicine, Odonate Therapeutics, Radius Pharmaceuticals, Immunomedics, and others

• Key Metastatic HR+/HER2− Breast Cancer Therapies: KISQALI (ribociclib), PIQRAY (alpelisib), ARV-471 (vepdegestrant), OP1250 (palazestrant), and others

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

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

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

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

Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

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

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

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

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

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

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

10. Unmet Needs

11. Metastatic HR+/HER2− Breast Cancer Emerging Therapies

12. Metastatic HR+/HER2− Breast Cancer Market Outlook

13. Country-Wise Metastatic HR+/HER2− 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− Breast Cancer Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Related Reports:

Metastatic HR+/HER2− Breast Cancer Pipeline Insights, DelveInsight

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