Metastatic HR+/HER2- Breast Cancer Market—The Road Ahead for Targeted Therapies and Personalized Medicine | DelveInsight

In recent years, the treatment landscape of HR+/HER2−ve breast cancer has completely changed with the introduction of particularly active targeted drugs, from CDK4/6 inhibitors, mTOR inhibitors, and PARP inhibitors to new oral SERDs and PI3K inhibitors, which have expanded the treatment armamentarium and improved survival outcomes for this patient population. The market size of metastatic HR+/HER2−breast cancer in the 7MM is expected to increase during the forecast period (2025–2034) due to the launch of several novel emerging classes in the market.

/EIN News/ -- New York, USA, April 30, 2025 (GLOBE NEWSWIRE) -- Metastatic HR+/HER2- Breast Cancer Market—The Road Ahead for Targeted Therapies and Personalized Medicine | DelveInsight 

In recent years, the treatment landscape of HR+/HER2−ve breast cancer has completely changed with the introduction of particularly active targeted drugs, from CDK4/6 inhibitors, mTOR inhibitors, and PARP inhibitors to new oral SERDs and PI3K inhibitors, which have expanded the treatment armamentarium and improved survival outcomes for this patient population. The market size of metastatic HR+/HER2−breast cancer in the 7MM is expected to increase during the forecast period (2025–2034) due to the launch of several novel emerging classes in the market.

DelveInsight’s Metastatic HR+/HER2- Breast Cancer Market Insights report includes a comprehensive understanding of current treatment practices, emerging metastatic HR+/HER2- breast cancer drugs, market share of individual therapies, and current and forecasted metastatic HR+/HER2- breast cancer market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Takeaways from the Metastatic HR+/HER2- Breast Cancer Market Report

• The total market size in the 7MM for HR+/HER2- breast cancer was nearly USD 10 billion in 2023, which is expected to grow by 2034 with the launch of potential emerging therapies, assisted by an increase in the HR+/HER2- breast cancer patient pool.
• According to DelveInsight’s estimates, the US accounted for around 211,000 incident cases of HR+/HER2– breast cancer in 2024. 
• Prominent companies working in the domain of HR+/HER2- breast cancer, including Pfizer, Novartis, Stemline Therapeutics, Olema Pharmaceuticals, Arvinas, Immutep, AstraZeneca, Roche, Genentech, Evexta Bio, EQRx, Sermonix Pharmaceuticals, Celcuity, Veru Pharma, Evgen Pharma, Eli Lilly, Biotheryx, and others, are actively working on innovative metastatic HR+/HER2- breast cancer drugs. These novel metastatic HR+/HER2- breast cancer therapies are anticipated to enter the metastatic HR+/HER2- breast cancer market in the forecast period and are expected to change the market.
• Some of the key metastatic HR+/HER2- breast cancer treatments include Gedatolisib, ARV-471, OP-1250, KEYTRUDA, Rupitasertib, and others. 
• In January 2025, the US FDA approved DATROWAY (for unresectable or metastatic HR+, HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease) and ENHERTU (unresectable or metastatic HR+, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer that has progressed on one or more endocrine therapies in the metastatic setting.
• In January 2025, Roche announced positive topline results from the Phase III INAVO120 study investigating ITOVEBI in combination with IBRANCE and fulvestrant for people with PIK3CA-mutated HR+/HER2-, endocrine-resistant, locally advanced or metastatic breast cancer. 

Discover which therapies are expected to grab the metastatic HR+/HER2- breast cancer market share @ Metastatic HR+/HER2- Breast Cancer Market Report

Metastatic HR+/HER2- Breast Cancer Overview

HR+/HER2- breast cancer is the most prevalent form of breast cancer. It is defined by the presence of hormone receptors for estrogen and progesterone on the cancer cells, without an overexpression of the HER2 protein. This subtype usually has a more favorable outlook and is commonly managed with hormone therapies that inhibit hormone-driven tumor growth. 

The patient journey often begins with the appearance of worrisome symptoms, prompting clinical evaluation and imaging. A biopsy is then performed to confirm the diagnosis and identify the cancer’s specific features. Further staging tests help determine how far the cancer has progressed, enabling a multidisciplinary team to create a customized treatment plan. This plan typically includes hormone therapy, surgery, radiation, and, in some cases, chemotherapy or targeted treatments.

Metastatic HR+/HER2- Breast Cancer Epidemiology Segmentation

The metastatic HR+/HER2- breast cancer epidemiology section provides insights into the historical and current metastatic HR+/HER2- breast cancer patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

The metastatic HR+/HER2- breast cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Incident Cases of Breast Cancer 
• Incident Cases of HR+/HER2– Breast Cancer
• Incident Cases of HR+/HER2– Breast Cancer by Menopausal Status 
• Stage-specific Incident Cases of HR+/HER2– Breast Cancer 
• Age-specific Incident Cases of HR+/HER2– Breast Cancer 
• Line-wise Treatment-eligible Pool of HR+/HER2– Breast Cancer

Download the report to understand which factors are driving metastatic HR+/HER2- breast cancer epidemiology trends @ Metastatic HR+/HER2- Breast Cancer Epidemiological Insights

Metastatic HR+/HER2- Breast Cancer Treatment Market 

Endocrine therapy targeting estrogen receptor (ER) signaling remains the primary treatment for HR+/HER2− advanced or metastatic breast cancer. This includes strategies such as suppressing estrogen production and blocking the ER pathway directly using Selective Estrogen Receptor Modulators (SERMs) or Selective Estrogen Receptor Degraders (SERDs). Despite these treatments, the challenge of both de novo and acquired endocrine resistance persists, complicating oncologists' efforts. However, the combination of novel endocrine therapies with targeted therapies, such as Cyclin-dependent Kinase 4 and 6 (CDK4/6) inhibitors, has led to significant improvements in long-term patient outcomes, revolutionizing the treatment approach for metastatic HR+/HER2− breast cancer.

The approval of CDK4/6 inhibitors has dramatically changed the treatment landscape for HR+/HER2− breast cancer. Currently, three selective CDK4/6 inhibitors—ENHERTU, DATROWAY, IBRANCE, KISQALI, and VERZENIO—are used in combination with endocrine therapy. In November 2023, the FDA approved TRUQAP (capivasertib) combined with FASLODEX for patients with HR+/HER2− advanced breast cancer exhibiting one or more biomarker alterations (PIK3CA, AKT1, or PTEN).

The NCCN Guidelines' recommendation of KISQALI as the preferred CDK4/6 inhibitor for first-line treatment with an aromatase inhibitor has strengthened KISQALI's position in the U.S. market. As a result, KISQALI regained market share, with its U.S. revenue contribution returning to 50%, recovering from a decline in previous years when its share fell from 46% in 2020 to 36% in 2021 and 38% in 2022.

Learn more about the market of metastatic HR+/HER2- breast cancer @ Metastatic HR+/HER2- Breast Cancer Treatment 

Metastatic HR+/HER2- Breast Cancer Emerging Drugs and Companies

Some of the drugs in the pipeline include Gedatolisib (Celcuity), ARV-471 (Arvinas and Pfizer), OP-1250 (Olema Pharmaceuticals), KEYTRUDA (Merck), Rupitasertib (Evexta Bio), among others.

Gedatolisib is an investigational, intravenously delivered dual inhibitor targeting both PI3K (pan-Class I isoforms: p110α, p110β, p110γ, p110δ) and mTOR complexes (mTORC1 and mTORC2) with high potency in the low nanomolar range. It is currently being tested in the Phase III VIKTORIA-1 trial in combination with fulvestrant, with or without IBRANCE, for advanced HR+/HER2− breast cancer. The drug has been granted Breakthrough Therapy Designation (BTD) for second-line HR+/HER2− advanced breast cancer. In April 2021, Celcuity entered into an exclusive global licensing agreement with Pfizer for the development and commercialization of gedatolisib. Celcuity plans to begin the Phase III VIKTORIA-2 trial in the second half of 2025, targeting first-line treatment of endocrine therapy-resistant (ETR) HR+/HER2− advanced or metastatic breast cancer.

ARV-471 (vepdegestrant) is an orally administered PROTAC estrogen receptor (ER) degrader being co-developed by Arvinas and Pfizer for HR+/HER2− locally advanced or metastatic breast cancer. It is under evaluation as a monotherapy in the ongoing Phase III VERITAC-2 study (second-line setting) and in combination with palbociclib in the Phase III VERITAC-3 study (first-line setting, lead-in cohort). In February 2024, the FDA granted Fast Track Designation (FTD) for vepdegestrant in HR+/HER2− metastatic breast cancer. Preliminary results from the Phase 1b segment of the TACTIVE-U sub-study, evaluating the combination of vepdegestrant with abemaciclib, were presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), involving patients with ER+/HER2− locally advanced or metastatic disease.

OP-1250 is a small-molecule complete estrogen receptor antagonist (CERAN) being studied both as a standalone therapy in the ongoing Phase III OPERA-01 trial and in combination trials with CDK4/6 inhibitors (palbociclib, ribociclib) and the PI3Kα inhibitor alpelisib in Phase II studies. The drug has been awarded FTD by the FDA for treating ER+/HER2− metastatic breast cancer that has progressed after one or more lines of endocrine therapy. In December 2024, Olema Pharmaceuticals shared clinical data from the Phase Ib/II study of OP-1250 (palazestrant) with ribociclib in patients with ER+/HER2− advanced or metastatic breast cancer at SABCS 2024.

The anticipated launch of these emerging therapies are poised to transform the metastatic HR+/HER2- breast cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the metastatic HR+/HER2- breast cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

To know more about metastatic HR+/HER2- breast cancer clinical trials, visit @ Metastatic HR+/HER2- Breast Cancer Treatment Drugs 

Metastatic HR+/HER2- Breast Cancer Market Dynamics

The metastatic HR+/HER2- breast cancer market dynamics are anticipated to change in the coming years. Breast cancer treatment is rapidly evolving with innovations targeting specific mutations and pathways—ORSERDU offers a groundbreaking option for patients with ESR1-mutated metastatic breast cancer, while dual PI3K/mTOR inhibitors like gedatolisib demonstrate strong potential with a median progression-free survival of around 12 months; immunotherapies, including immune checkpoint inhibitors, are opening new avenues, particularly for HER2-negative subtypes, and the growing market of mutation-specific therapies—featuring agents like ENHERTU, DATROWAY, LYNPARZA, PIQRAY, and ORSERDU—presents opportunities for emerging treatments such as Roche’s inavolisib.

Furthermore, many potential therapies are being investigated for the treatment of metastatic HR+/HER2- breast cancer, and it is safe to predict that the treatment space will significantly impact the metastatic HR+/HER2- breast cancer market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the metastatic HR+/HER2- breast cancer market in the 7MM.

However, several factors may impede the growth of the metastatic HR+/HER2- breast cancer market. The failure of Roche’s giredestrant and Sanofi’s amcenestrant in clinical trials underscores the ongoing challenges in developing effective treatments for breast cancer, compounded by insufficient data on older protocols like everolimus with exemestane post-CDK4/6 inhibition, the looming threat to market growth from the loss of patent protection for drugs such as IBRANCE in 2027 and the resulting entry of generics, and the deterrent effect of treatment resistance and high costs, which reduce efficacy and accessibility, ultimately limiting growth in the HR+/HER2− breast cancer segment.

Moreover, metastatic HR+/HER2- breast cancer treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, the metastatic HR+/HER2- breast cancer market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the metastatic HR+/HER2- breast cancer market growth.

Metastatic HR+/HER2- Breast Cancer Report Metrics	Details
Study Period	2020–2034
Metastatic HR+/HER2- Breast Cancer Report Coverage	7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
HR+/HER2- Breast Cancer Market Size in 2023	USD 10 Billion
Key HR+/HER2- Breast Cancer Companies	Pfizer, Novartis, Stemline Therapeutics, Olema Pharmaceuticals, Arvinas, Immutep, AstraZeneca, Roche, Genentech, Evexta Bio, EQRx, Sermonix Pharmaceuticals, Celcuity, Veru Pharma, Evgen Pharma, Eli Lilly, Biotheryx, and others
Key Metastatic HR+/HER2- Breast Cancer Therapies	Gedatolisib, ARV-471, OP-1250, KEYTRUDA, Rupitasertib, and others

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

• Metastatic HR+/HER2- Breast Cancer Therapeutic Assessment: Metastatic HR+/HER2- Breast Cancer current marketed and emerging therapies
• Metastatic HR+/HER2- Breast Cancer Market Dynamics: Conjoint Analysis of Emerging Metastatic HR+/HER2- Breast Cancer Drugs
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL’s views, Analyst’s views, Metastatic HR+/HER2- Breast Cancer Market Access and Reimbursement

Discover more about metastatic HR+/HER2- breast cancer drugs in development @ Metastatic HR+/HER2- Breast Cancer Clinical Trials

Table of Contents

1	Key Insights
2	Report Introduction
3	MPM Market Overview at a Glance
4	Executive Summary
5	Key Events
6	Disease Background and Overview
7	Epidemiology and Market Methodology
8	Epidemiology and Patient Population
9	Patient Journey
10	Marketed Therapies
11	Emerging Drug Profiles
13	Key Opinion Leaders’ Views
14	Unmet Needs
15	SWOT Analysis
16	Market Access and Reimbursement
17	Appendix
18	DelveInsight Capabilities
19	Disclaimer
20	About DelveInsight

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