Metastatic HR+/HER2- Breast Cancer Market: Analysis of Epidemiology, Pipeline Products, and Key Companies Working, DelveInsight | Pfizer, Novartis, AstraZeneca Pharmaceuticals, Eli Lilly, Jiangsu HengRui Medicine, Odonate Therapeutics, Radius Pharmaceutic

Metastatic HR+/HER2- Breast Cancer emerging therapies such as KISQALI (ribociclib), PIQRAY (alpelisib), ARV-471 (vepdegestrant), OP1250 (palazestrant), and others are expected to boost the Metastatic HR+/HER2- Breast Cancer Market in the upcoming 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 is the most prevalent among all breast cancer subtypes. In 2023, the market size for HR+/HER2- breast cancer in the 7MM was nearly USD 10 billion, with expectations for growth by 2034 due to the introduction of emerging therapies and a rising patient pool.
Endocrine therapy has been the standard treatment for HR+/HER2- breast cancer, both in early and advanced stages, for the past decade. FASLODEX (fulvestrant) is a well-tolerated, effective treatment in single-agent endocrine therapy but has limitations due to poor bioavailability and inconvenient IV formulations. This opens up opportunities for next-generation oral selective estrogen receptor degraders (SERDs) to be used in both first- and second-line treatments.
Among approved therapies, CDK4/6 inhibitors like palbociclib, ribociclib, and abemaciclib have gained significant attention for extending progression-free survival in first- and second-line settings. IBRANCE (palbociclib) leads the market in first-line therapy, having both a first-mover advantage and the highest sales.
The NCCN guidelines recommend KISQALI (ribociclib) as the preferred CDK4/6 inhibitor for first-line treatment in HR+/HER2- metastatic breast cancer (MBC) when combined with an aromatase inhibitor (AI). ORSERDU is the first therapy specifically approved for ER+, HER2- tumors with ESR1 mutations, marking a significant advancement in endocrine therapy.
Recent developments suggest that treatments beyond CDK4/6 inhibitors, including Antibody-Drug Conjugates (ADCs) and oral SERDs, could make a significant impact in the post-CDK4/6 inhibitor landscape. Other therapeutic classes being explored include AKT inhibitors, mTOR inhibitors, SERMs, PI3K inhibitors, PARP inhibitors, and TROP-2 targeting ADCs.
Roche's Giredestrant, in combination with palbociclib, could rival Camizestrant as a first-line option, but Giredestrant's Phase II trial did not meet its primary endpoint. Capivasertib, an AKT inhibitor, is another promising drug targeting cancer-driving proteins. Dato-DXd, a TROP2 ADC, recently had its Biologics License Application accepted in the US for metastatic HR+/HER2- breast cancer, with a PDUFA date in Q1 2025.
Estimates show that the total number of HR+/HER2- breast cancer cases in the 7MM was approximately 476,000 in 2023, with cases expected to rise throughout the forecast period from 2024 to 2034. The United States had the highest number of HR+/HER2- breast cancer cases, accounting for about 208,400 cases in 2023. Most cases of HR+/HER2- breast cancer in the United States occurred in individuals aged 60 to 79, representing approximately 48% of cases in 2023. Among the EU4 countries and the UK, Germany had the highest number of HR+/HER2- breast cancer cases, with around 50,200 cases in 2023, while Spain had the fewest. In Japan, there were around 43,000 treatment-eligible HR+/HER2- breast cancer cases in 2023.
The emerging pipeline for HR+/HER2- therapies is highly competitive, with several late-stage drug candidates expected to address current unmet medical needs and drive market growth. However, these new SERD candidates will face stiff competition from existing CDK4/6 inhibitors, which currently dominate the market, potentially slowing their growth.
Key Metastatic HR+/HER2- Breast Cancer companies such as Pfizer, Novartis, AstraZeneca Pharmaceuticals, Eli Lilly, Jiangsu HengRui Medicine, Odonate Therapeutics, Radius Pharmaceuticals, Immunomedics, and others are evaluating new drugs for Metastatic HR+/HER2- Breast Cancer to improve the treatment landscape.
Promising Metastatic HR+/HER2- Breast Cancer pipeline therapies in various stages of development include KISQALI (ribociclib), PIQRAY (alpelisib), ARV-471 (vepdegestrant), OP1250 (palazestrant), and others.
Key benefits of the Metastatic HR+/HER2- Breast Cancer market report:
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.)
The Metastatic HR+/HER2- Breast Cancer market report provides insights on the current and emerging therapies.
Metastatic HR+/HER2- Breast Cancer market report provides a global historical and forecasted market covering drug outreach in 7MM.
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 prevalent subtype, where cancer cells have hormone receptors for estrogen and progesterone but do not overexpress HER2. This subtype typically has a better outlook and is often managed with hormone therapy to block hormone-driven growth. For more advanced cases, treatments like surgery, radiation, chemotherapy, and targeted therapies, such as CDK4/6 inhibitors, may be used. Early detection is essential, and having support from healthcare professionals and loved ones is key to coping with the diagnosis and treatment of HR+/HER2- breast cancer.

The patient's journey usually begins with noticing concerning symptoms, followed by a clinical evaluation and imaging tests. A biopsy is performed to confirm the diagnosis and identify the cancer's characteristics. Staging tests help determine the extent of the cancer, allowing a multidisciplinary team to create a personalized treatment plan. This plan typically includes hormone therapy, surgery, radiation, and possibly chemotherapy or targeted treatments. Emotional support is vital in managing the emotional impact of the diagnosis, and regular follow-up care ensures continued monitoring and adjustments to the treatment plan, offering hope for recovery and long-term survival.

Metastatic HR+/HER2- Breast Cancer Treatment Market

The treatment of HR+/HER2- breast cancer generally involves a comprehensive approach. Hormone therapy plays a key role by blocking estrogen's effects on cancer cells. Surgical options, such as lumpectomy or mastectomy, may be performed to remove the tumor, while radiation therapy targets any remaining cancer cells after surgery. In more advanced stages, chemotherapy or targeted therapies like CDK4/6 inhibitors may be considered. The treatment plan is tailored based on factors such as the cancer's stage, receptor status, and patient preferences. Ongoing follow-up and monitoring are crucial for assessing progress and adjusting the treatment plan as necessary, providing the best chance for successful treatment and long-term survival.

Various anti-estrogenic agents are available for patients with early, advanced, or metastatic breast cancer, including selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), and selective estrogen receptor degraders. Currently, clinical research is focused on combining antiestrogenic therapies with targeted agents that inhibit the PI3K/AKT/mTOR signaling pathway or the CDK4/6 pathway. This approach is particularly important for patients with hormone-receptor-positive breast cancer who have experienced disease recurrence or progression.

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Metastatic HR+/HER2- Breast Cancer Market Outlook

For the past decade, endocrine therapy has been the preferred treatment for HR-positive, HER2-negative metastatic breast cancer, including those with visceral involvement. This therapy, which includes antiestrogens and aromatase inhibitors (AIs), is the primary systemic approach due to its favorable profile. There are three available AIs: anastrozole and letrozole (nonsteroidal) and exemestane (steroidal). In cases where chemotherapy or sole endocrine treatment isn't suitable, combining endocrine therapy with targeted agents like CDK4/6 inhibitors or mTOR inhibitors may be considered.

The use of CDK4/6 inhibitors with endocrine therapy has significantly improved progression-free survival (PFS) in the first line of treatment, as shown in trials like MONALEESA 2, 3, and 7, PALOMA-2, and MONARCH-3. In Japan, two CDK4/6 inhibitors (palbociclib and abemaciclib) have been approved for clinical use. ENHERTU received expedited approval for HER2-low metastatic breast cancer in August 2022, and in February 2023, TRODELVY was approved for previously treated HR-positive, HER2-negative breast cancer.

There is potential to extend the use of CDK4/6 inhibitors beyond HR+/HER2- advanced breast cancer. However, patients who develop resistance to this combination often switch to chemotherapy due to poor outcomes with single-agent fulvestrant. Emerging strategies like Antibody-Drug Conjugates (ADCs) and oral selective estrogen receptor degraders (SERDs) show promise in improving treatment options after CDK4/6 inhibitors.

The HR+/HER2- pipeline includes several late-stage therapies, such as Giredestrant, Camizestrant, and LY3484356, among others. Additionally, therapies targeting the HER2-low segment, like Datopotamab deruxtecan, are being explored in combination treatments. The focus of research is shifting toward new oral SERDs. The evolving landscape of therapies offers hope for more personalized and effective treatments, though further research is needed to improve understanding of mutations, biomarkers, and therapeutic approaches in HR+/HER2- breast cancer.

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/report-store/hr-positive-her2-negative-breast-cancer-market-insights?utm_source=openpr&utm_medium=pressrelease&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.

Contact Info:

Kritika Rehani, Team Leader Marketing & Branding
krehani@delveinsight.com
info@delveinsight.com
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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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