DelveInsight analyzes that the HR-positive HER2-negative Breast Cancer pipeline includes over 50 leading companies actively developing more than 53 therapies for the treatment of this breast cancer subtype.
HR-positive HER2-negative Breast Cancer Overview:
Breast cancer is considered hormone receptor-positive (HR-positive) when the cancer cells have receptors for estrogen and progesterone, indicating that these hormones promote tumor growth. Additionally, breast tissue is tested for the presence of HER2 proteins, which play a role in cell growth and repair. In HER2-negative breast cancer, the cells produce little or no HER2 protein, resulting in slower tumor growth and generally a better prognosis compared to HER2-positive cases. The HR-positive/HER2-negative (HR+/HER2-) subtype is the most common, with an age-adjusted incidence rate of 87.4 new cases per 100,000 women based on data from 2015 to 2019. The HER2 or ERBB2 gene encodes the HER2/ERBB2 proteins, which act as receptors on breast cells. A diagnosis of HER2-negative indicates that the cancer is unlikely to respond to therapies targeting the HER2 protein. Nearly half of metastatic breast cancers fall into the HR-positive and HER2-negative category.
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“HR-positive HER2-negative Breast Cancer Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the HR-positive HER2-negative Breast Cancer Therapeutics Market.
Key Takeaways from the HR-positive HER2-negative Breast Cancer Pipeline Report
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DelveInsight’s HR-positive HER2-negative Breast Cancer pipeline report highlights a vibrant landscape, featuring over 50 active companies developing more than 53 therapies for the treatment of HR-positive HER2-negative Breast Cancer.
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Key players in this space include Regor Therapeutics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others, all working on innovative drugs to enhance treatment options.
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Noteworthy therapies in development at various stages include Camizestrant, Dato-DXd, CX-2009, RGT-419B, and more.
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On October 10, 2025, the FDA approved inavolisib in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive/HER2-negative advanced breast cancer. This approval was based on a randomized, double-blind, placebo-controlled, multicenter trial that showed a median progression-free survival of 15.0 months for the inavolisib combination group versus 7.3 months for the placebo group.
HR-positive HER2-negative Breast Cancer Pipeline Analysis
The report provides insights into:
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The report provides detailed insights into the key companies that are developing therapies in the HR-positive HER2-negative Breast Cancer Market.
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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for HR-positive HER2-negative Breast Cancer treatment.
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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the HR-positive HER2-negative Breast Cancer market.
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HR-positive HER2-negative Breast Cancer Emerging Drugs
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Camizestrant: AstraZeneca
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Dato-DXd: Daiichi Sankyo, Inc.
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CX-2009: CytomX Therapeutics
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RGT-419B: Regor Therapeutics
HR-positive HER2-negative Breast Cancer Companies
More than 50 leading companies are actively engaged in developing therapies for HR-positive/HER2-negative breast cancer, with AstraZeneca and several others having drug candidates in the advanced Phase III clinical trial stage.
DelveInsight’s report covers around 53+ products under different phases of clinical development like
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Late stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I) along with the details of
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
HR-positive HER2-negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
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Intravenous
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Subcutaneous
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Oral
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Intramuscular
HR-positive HER2-negative Breast Cancer Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
Download Sample Pages to Get an in-depth Assessment of the Emerging HR-positive HER2-negative Breast Cancer Therapies and Key Companies: HR-positive HER2-negative Breast Cancer Clinical Trials and advancements
HR-positive HER2-negative Breast Cancer Pipeline Therapeutic Assessment
• HR-positive HER2-negative Breast Cancer Assessment by Product Type
• HR-positive HER2-negative Breast Cancer By Stage
• HR-positive HER2-negative Breast Cancer Assessment by Route of Administration
• HR-positive HER2-negative Breast Cancer Assessment by Molecule Type
Download HR-positive HER2-negative Breast Cancer Sample report to know in detail about the HR-positive HER2-negative Breast Cancer treatment market @ HR-positive HER2-negative Breast Cancer Therapeutic Assessment
Table of Content
1. Report Introduction
2. Executive Summary
3. HR-positive HER2-negative Breast Cancer Current Treatment Patterns
4. HR-positive HER2-negative Breast Cancer – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. HR-positive HER2-negative Breast Cancer Late-Stage Products (Phase-III)
7. HR-positive HER2-negative Breast Cancer Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. HR-positive HER2-negative Breast Cancer Discontinued Products
13. HR-positive HER2-negative Breast Cancer Product Profiles
14. HR-positive HER2-negative Breast Cancer Key Companies
15. HR-positive HER2-negative Breast Cancer Key Products
16. Dormant and Discontinued Products
17. HR-positive HER2-negative Breast Cancer Unmet Needs
18. HR-positive HER2-negative Breast Cancer Future Perspectives
19. HR-positive HER2-negative Breast Cancer Analyst Review
20. Appendix
21. Report Methodology
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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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