HR 양성/HER2 음성 전이성 유방암 : 시장 인사이트, 역학 및 시장 예측(2036년)

Metastatic HR+/HER2- Breast Cancer Insights and Trends

• For the past decade, endocrine therapy has been the standard therapy for HR+/HER2- breast cancer in the early and advanced stages. FASLODEX (fulvestrant) is one of the most efficient and well-tolerated medications available in single-agent endocrine therapy formulations. FASLODEX's poor bioavailability and inconvenient IV formulations create an opportunity for oral next-generation selective estrogen receptor degraders (SERDs) to make a place in both first and second-line settings.
• Among the approved classes, CDK4/6 inhibitors (palbociclib, ribociclib, and abemaciclib) have attracted the most attention in first and second-line settings by providing an extended period of progression-free survival (PFS).
• IBRANCE (palbociclib) is the leading molecule in the first line of therapy, as it also has the first-mover advantage in the first and second lines, along with the highest revenue in terms of sales.
• The NCCN Clinical Practice Guidelines in Oncology for breast cancer recommend KISQALI (ribociclib) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an aromatase inhibitor (AIs).
• ORSERDU is the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations. This approval represents the first innovation in endocrine therapy in nearly two decades.
• Recent developments suggest that the post-CDK4/6 inhibitor treatment landscape could benefit from adopting Antibody-Drug Conjugates (ADCs) and oral SERDs that can muscle their way into this treatment space for this patient pool. The other class of therapies includes AKT inhibitors, mTOR inhibitors, SERMS, PI3K inhibitors, PARP inhibitors, and TROP-2 targeting ADCs.
• The pipeline for HR+/HER2- therapies is robust, with several late-stage candidates (Phase III, II/III, and II) expected to address unmet needs and support market growth. However, many next-generation SERDs may face strong competition from established CDK4/6 inhibitors, potentially limiting their uptake and slowing growth.

Metastatic HR+/HER2- Breast Cancer Market size and Forecast in the 7MM

• 2025 Metastatic HR+/HER2- Breast Cancer Market Size: ~USD 14,000 million
• Metastatic HR+/HER2- Breast Cancer Growth Rate (2026-2036): ~8% CAGR

DelveInsight's 'Metastatic HR+/HER2- Breast Cancer - Market Insights, Epidemiology and Market Forecast - 2036' report 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, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The metastatic HR+/HER2- breast cancer market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates metastatic HR+/HER2- breast cancer patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in metastatic HR+/HER2- breast cancer and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Metastatic HR+/HER2- Breast Cancer Market

Rising prevalence of HR+/HER2- breast cancer

HR+/HER2- is the most common breast cancer subtype, representing a substantial share of cases, with a significant proportion progressing to metastatic disease and requiring prolonged treatment.

Strong reliance on endocrine and targeted therapies

The widespread use of endocrine therapies in combination with targeted agents such as CDK4/6 inhibitors continues to drive market growth by improving PFS and becoming the standard of care in first-line settings.

Expansion of targeted treatment options

The introduction of newer agents targeting pathways such as PI3K/AKT/mTOR and next-generation SERDs is broadening treatment choices and supporting continued market expansion.

Metastatic HR+/HER2- Breast Cancer Understanding and Treatment Algorithm

Metastatic HR+/HER2- Breast Cancer Overview and Diagnosis

HR+/HER2- breast cancer is the most common subtype of breast cancer, characterized by cancer cells with hormone receptors for estrogen and progesterone but lacking the overexpression of HER2. This subtype generally has a better prognosis and is often treated with hormone therapy to block hormone-driven growth. Surgery and radiation may be used to remove or target tumors, while chemotherapy and targeted therapies like CDK4/6 inhibitors may be considered for more advanced cases. Early detection is crucial, and support from healthcare providers and loved ones is vital for coping with the diagnosis and treatment of HR+/HER2- breast cancer. A biopsy confirms the diagnosis and determines the cancer's characteristics. Staging tests assess the cancer's extent, guiding a multidisciplinary team in devising a personalized treatment plan, often involving hormone therapy, surgery, radiation, and possibly chemotherapy or targeted therapies. Emotional support plays a crucial role in managing the emotional toll of the diagnosis, and follow-up care ensures ongoing monitoring and adjustment of treatment as needed, fostering hope for successful recovery and survivorship.

Metastatic HR+/HER2- Breast Cancer Treatment

Treatment of HR+/HER2- breast cancer generally follows a multimodal strategy. Hormone therapy remains the backbone, targeting estrogen-driven tumor growth. Surgery (lumpectomy or mastectomy) is often used to remove the tumor, followed by radiation to eliminate residual disease. In advanced settings, chemotherapy or targeted therapies such as CDK4/6 inhibitors may be added. Treatment decisions are guided by disease stage, receptor profile, and patient preferences, with ongoing monitoring to optimize outcomes. Several classes of endocrine therapies are available, including selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), and selective estrogen receptor degraders (SERDs). Current research is increasingly focused on combining these therapies with targeted agents, particularly those inhibiting the PI3K/AKT/mTOR and CDK4/6 pathways.

Metastatic HR+/HER2- Breast Cancer Unmet Needs

The section "unmet needs of metastatic HR+/HER2- breast cancer" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Endocrine resistance and disease progression

2. Limited durability of treatment response

3. Lack of clear treatment sequencing strategies

4. Limited options post-CDK4/6 inhibitor progression and others.....

Metastatic HR+/HER2- Breast Cancer Epidemiology

Key Findings from Metastatic HR+/HER2- Breast Cancer Epidemiological Analysis and Forecast

• According to the estimates, the total incident population of HR+/HER2- breast cancer in the 7MM was nearly 486,000 cases in 2025. The cases in the 7MM are expected to increase during the forecast period, i.e., 2026-2036.
• The metastatic HR+/HER2- breast cancer cases were highest in the United States, accounting for ~57,000 cases in 2025.
• According to the estimates, most cases of HR+/HER2- breast cancer occur in people aged between 60 and 79 years in the United States, accounting for ~48% of cases in 2025.
• Among EU4 and the UK, Germany had the maximum total incident cases of HR+/HER2- breast cancer, with ~50,500 cases in 2025, while Spain accounted for the least number of incident cases.

Metastatic HR+/HER2- Breast Cancer Drug & Competitive Landscape

The metastatic HR+/HER2- breast cancer drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships, upcoming key catalysts for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the metastatic HR+/HER2- breast cancer treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the metastatic HR+/HER2- breast cancer market.

Approved Therapies for Metastatic HR+/HER2- Breast Cancer

KISQALI (ribociclib): Novartis

KISQALI is a kinase inhibitor indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic cancer in combination with:

• An aromatase inhibitor as initial endocrine-based therapy
• Fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or men.

In October 2025, Novartis announced results from the five-year analysis of the pivotal Phase III NATALEE trial of KISQALI that demonstrated a sustained benefit at a median of two years after a three-year treatment with KISQALI. Results showed a 28.4% reduction in risk of recurrence in the broadest population of patients with high-risk stage II and III HR+/HER2- early breast cancer (EBC) treated with KISQALI plus endocrine therapy compared to endocrine therapy alone.

VERZENIO (abemaciclib): Eli Lilly

VERZENIO is a targeted treatment known as a CDK4/6 inhibitor. VERZENIO is a non-chemotherapy oral tablet. It works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells so that they may eventually die (based on preclinical studies). The National Comprehensive Cancer Network (NCCN) recommends consideration of 2 years of VERZENIO added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.

In February 2018, the US FDA approved VERZENIO in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer.

Metastatic HR+/HER2- Breast Cancer Pipeline Analysis

ARV-471 (vepdegestrant): Arvinas

Vepdegestrant is an investigational, oral PROTAC estrogen receptor protein degrader for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer. Arvinas and Pfizer are collaborating to develop and commercialize vepdegestrant. This program is currently in Phase III clinical studies. The US FDA is reviewing the filed New Drug Application (NDA) for vepdegestrant. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026. Vepdegestrant has also been granted Fast Track designation by the FDA.

In November 2025, Arvinas announced that multiple abstracts on vepdegestrant have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS).

In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the commercialization and potential further development of vepdegestrant.

OP1250 (palazestrant): Olema Pharmaceuticals

OP-1250 is a small molecule complete estrogen receptor antagonist (CERAN). OP-1250 competes with the endogenous activating estrogenic ligand 17-beta estradiol for binding in the ligand-binding pocket. OP-1250 blocks estrogen-driven transcriptional activity, inhibits estrogen-driven breast cancer cell growth, and induces degradation of the estrogen receptor.

In October 2025, Olema Pharmaceuticals announced updated data from the Phase Ib/II study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer. These findings were presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2025.

In October 2025, Olema Pharmaceuticals announced that they presented a trial-in-progress poster for the Phase III OPERA-02 trial at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025). The trial is evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer.

Metastatic HR+/HER2- Breast Cancer Key Players, Market Leaders and Emerging Companies

• Roche
• AstraZeneca / Daiichi Sankyo
• Eli Lilly
• Sermonix Pharmaceuticals
• Veru Pharma
• Arvinas
• Olema Pharmaceuticals
• Celcuity
• DualityBio/ BioNtech
• Merck
• Immutep
• Atossa Therapeutics
• Velos Bio/ Merck
• Evgen Pharma, and others

Metastatic HR+/HER2- Breast Cancer Drug Updates

• In October 2025, Novartis announced results from the five-year analysis of the pivotal Phase III NATALEE trial of KISQALI (ribociclib) that demonstrated a sustained benefit at a median of two years after a three-year treatment with KISQALI.
• In November 2025, Arvinas announced that multiple abstracts on vepdegestrant have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS).
• In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the commercialization and potential further development of vepdegestrant.
• In October 2025, Olema Pharmaceuticals announced that they presented a trial-in-progress poster for the Phase III OPERA-02 trial at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025). The trial is evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer.

Metastatic HR+/HER2- Breast Cancer Market Outlook

For the past decade, endocrine therapy has been the preferred treatment for HR-positive and HER2- metastatic breast cancer, including cases with visceral involvement. This therapy, encompassing antiestrogens and aromatase inhibitors (AIs), remains the primary systemic approach for HR+/HER2- metastatic breast cancer due to its favorable treatment profile. Currently, there are three AIs available: anastrozole and letrozole are nonsteroidal AIs, while exemestane is a steroidal AI. Combining endocrine therapy with targeted agents, such as CDK 4/6 inhibitors or mTOR inhibitors, is an option for patients who do not meet the criteria for chemotherapy or sole endocrine treatment.

The addition of the three registered CDK4/6 inhibitors (CDK4/6i) to an endocrine drug in the first line of treatment, like in MONALEESA 2, 3, and 7 (ribociclib), PALOMA-2 (palbociclib), and MONARCH-3 (abemaciclib), showed a significant increase in the median progression-free survival (PFS). CDK4 and 6 inhibitors are relatively new drugs in Japan, and two of them, palbociclib and abemaciclib, have received regulatory approval for clinical use. In August 2022, AstraZeneca and Daiichi's ENHERTU received expedited approval for widespread HER2-low breast cancer. ENHERTU has emerged as the first therapeutic intended for treating HER2-low, metastatic, or unresectable breast cancer, a newly created subgroup previously associated with HR+/HER2- breast cancer. Later, the FDA authorized TRODELVY in February 2023 for previously treated HR-positive, HER2-negative breast cancer.

There is promising potential for expanding CDK4/6 inhibitor applications beyond HR+, HER2- advanced breast cancer. Patients who develop resistance to combined CDK4/6 inhibitor and endocrine treatments often switch to conventional chemotherapy due to disappointing outcomes with single-agent fulvestrant. Recent developments suggest that the post-CDK4/6 inhibitor treatment landscape could benefit from adopting Antibody-Drug Conjugates (ADCs) and oral selective estrogen receptor degraders (SERDs).

The emerging pipeline is crowded by HR+/HER2- potential therapies, whereas few of them have shifted their focus to evaluate the therapies targeting the HER2 Low segment. The emerging pipeline for HR/HER2- includes several potential drugs in late-stage (Phase III, II/III, and II) that include Giredestrant, Camizestrant (AZD9833), LY3484356 (Imlunestrant), Lasofoxifene, ARV-471, Capivasertib, Inavolisib, KEYTRUDA (pembrolizumab), Enobosarm, OP1250, Samuraciclib, Lerociclib, SFX-01, Endoxifen, whereas HER2 Low includes Datopotamab deruxtecan, DB1303, Eftilagimod alpha, being administered in various combinations. The focus of this research is mostly on new oral SERDs. Overall, the evolving landscape holds the potential for more tailored and effective treatments, providing renewed hope for patients facing this form of breast cancer.

While research advances have significantly improved the management of ER+, HER2- breast cancer, there remains substantial room for enhancement in this field. Dedicated research efforts are necessary to better comprehend factors such as mutations, the discovery of biomarkers, and the development of improved therapeutic approaches.

• The United States accounted for the largest market size of HR+/HER2- Breast Cancer in the 7MM, at approximately USD 10,000 million in 2025, and is expected to grow at a significant CAGR through 2036.
• Among all the therapies in 2025, IBRANCE had the largest market size with a revenue of USD 3,900 million. By 2036, VERZENIO is expected to capture the largest market share, followed by IBRANCE.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Metastatic HR+/HER2- Breast Cancer (2022-2036 Forecast)

The HR+/HER2- MBC treatment landscape comprises CDK4/6 inhibitors, SERD and SERM, and PIK3 and AKT inhibitors, each designed to target distinct mechanisms involved in tumor growth, HER2 signaling, and treatment resistance.

CDK4/6 inhibitors: CDK4/6 inhibitors block cell cycle progression at the G1 phase and are widely used in HR+/HER2- metastatic breast cancer. Approved agents palbociclib, ribociclib, and abemaciclib are standard combination therapies and have generated higher revenues than mTOR inhibitors, SERDs, and other classes.

SERDs: SERDs show greater benefit in endocrine-sensitive tumors, particularly those with ESR1 mutations. In January 2023, the FDA approved elacestrant (ORSERDU) for ER+/HER2-, ESR1-mutated advanced breast cancer after prior endocrine therapy. It has demonstrated a favorable safety profile compared to other agents. While some SERDs like giredestrant have shown mixed results, ongoing Phase III trials are evaluating combination strategies.

PI3K and AKT inhibitors: Around 40% of HR+/HER2- breast cancers harbor PIK3CA mutations, leading to activation of the PI3K/AKT pathway involved in tumor growth. Alpelisib, combined with fulvestrant, is FDA-approved for patients with PIK3CA-mutated advanced disease based on the SOLAR-1 trial.

Metastatic HR+/HER2- Breast Cancer Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the HR+/HER2- MBC drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

Among the first-line therapies, Camizestrant + CDK4/6 Inhibitor and Lasofoxifene + abemaciclib are expected to have a medium-fast uptake.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved Therapies in Metastatic HR+/HER2- Breast Cancer

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

The United States

• The Patient Assistance Now Oncology (PANO) program assists with accessing Novartis medicine(s), from insurance verification to financial assistance. The Free Trial and Access Program can help patients receive a free PIQRAY supply for a US FDA-approved indication. Patients may be eligible for immediate copay savings with a PIQRAY copay card; eligible patients with private insurance may pay USD 0 per month, and Novartis will pay the remaining copay, up to USD 15,000 per calendar year, per product. The program is unavailable for patients enrolled in Medicare, Medicaid, or any other federal or state healthcare program.
• Novartis is committed to helping patients who have been prescribed KISQALI. For eligible patients, there is more than one way to save on KISQALI (ribociclib). KISQALI Care offers programs such as one free treatment cycle of KISQALI and/or FEMARA, KISQALI 5-Treatment Cycle Access Program, and KISQALI and/or FEMARA USD 0 copay offer. Patients may be eligible for immediate copay savings on their next prescription of KISQALI tablets, FEMARA (letrozole) tablets, the KISQALI FEMARA (letrozole) Copack tablets, and/or generic letrozole. Eligible patients with private insurance may pay USD 0 per month. Novartis will pay the remaining copay, up to USD 15,000 per calendar year, per product. This offer is only available to patients with private insurance. The program is unavailable for patients enrolled in Medicare, Medicaid, or any other federal or state healthcare program. Use of this offer for FEMARA (or generic letrozole) does not require a KISQALI prescription.

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report....

Metastatic HR+/HER2- Breast Cancer therapies Price Scenario & Trends

Pricing and analogue assessment of metastatic HR+/HER2- breast cancer therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

• Pricing of Metastatic HR+/HER2- Breast Cancer Approved Drugs

ORSERDU is administered orally, 345 mg, taken orally with food once daily. The estimated annual treatment cost is approximately USD 183,773.

Industry Experts and Physician Views for Metastatic HR+/HER2- Breast Cancer

To keep up with metastatic HR+/HER2- breast cancer market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the metastatic HR+/HER2- breast cancer emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in metastatic HR+/HER2- breast cancer, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights at the country level. Centers such as the National Breast Cancer Foundation (NBCF), University of Texas MD Anderson Cancer Center, and Iwate Medical University, etc. were contacted. Their opinion helps understand and validate current and emerging metastatic HR+/HER2- breast cancer therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in metastatic HR+/HER2- breast cancer.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of metastatic HR+/HER2- breast cancer, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed.

In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of metastatic HR+/HER2- breast cancer, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the metastatic HR+/HER2- breast cancer market, historical and forecasted market size, and market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM metastatic HR+/HER2- breast cancer market.

Report Insights

• Metastatic HR+/HER2- Breast Cancer Patient Population Forecast
• Metastatic HR+/HER2- Breast Cancer Market Opportunity (Current and Forecasted)
• Metastatic HR+/HER2- Breast Cancer Pipeline Analysis
• Metastatic HR+/HER2- Breast Cancer Market Size and Trends
• Metastatic HR+/HER2- Breast Cancer Market Opportunity (Current and Forecasted)

Report Key Strengths

• Epidemiology-based (Epi-based) Bottom-up Forecasting
• Artificial Intelligence (AI)-enabled Market Research Report
• 11-year forecast
• Metastatic HR+/HER2- Breast Cancer Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (by geography)
• Metastatic HR+/HER2- breast cancer Treatment Addressable Market (TAM)
• Metastatic HR+/HER2- Breast Cancer Competitive Landscape
• Metastatic HR+/HER2- Breast Cancer Major Companies Insights
• Metastatic HR+/HER2- Breast Cancer Price Trends and Analogue Assessment
• Metastatic HR+/HER2- Breast Cancer Therapies and Drug Adoption/Uptake
• Metastatic HR+/HER2- Breast Cancer Therapies Peak Patient Share Analysis

Report Assessment

• Metastatic HR+/HER2- Breast Cancer Current Treatment Practices
• Metastatic HR+/HER2- Breast Cancer Unmet Needs
• Metastatic HR+/HER2- Breast Cancer Clinical Development Analysis
• Metastatic HR+/HER2- Breast Cancer Emerging Drugs Product Profiles
• Metastatic HR+/HER2- Breast Cancer Market Attractiveness
• Metastatic HR+/HER2- Breast Cancer Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

• What was the metastatic HR+/HER2- breast cancer market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of metastatic HR+/HER2- breast cancer?
• What are the disease risks, burdens, and unmet needs of metastatic HR+/HER2- breast cancer? What will be the growth opportunities across the 7MM concerning the patient population with metastatic HR+/HER2- breast cancer?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of metastatic HR+/HER2- breast cancer? What are the current guidelines for treating metastatic HR+/HER2- breast cancer in the US, Europe, and Japan?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the metastatic HR+/HER2- breast cancer market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
• This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Metastatic HR+/HER2- Breast Cancer

4. Key Events

• 4.1. Upcoming Key Catalysts
• 4.2. Key Conferences and Meetings
• 4.3. Key Transactions and Collaborations
• 4.4. News Flow

5. Epidemiology and Market Forecast Methodology

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

• 6.1. Emerging Landscape Analysis in 7MM (by Phase)
• 6.2. Market Size of Metastatic HR+/HER2- Breast Cancer by Line of Therapies in 7MM (2025)
• 6.3. Market Size of Metastatic HR+/HER2- Breast Cancer by Line of Therapies in 7MM (2036)

7. Disease Background and Overview of Metastatic HR+/HER2- Breast Cancer

• 7.1. Introduction
• 7.2. Types of Breast Cancer
  • 7.2.1. Subtypes of Breast Cancer
  • 7.2.2. Molecular Subtypes of Breast Cancer
• 7.3. Estrogen Receptor (ER)-Positive Breast Cancer
  • 7.3.1. Estrogen Receptor
  • 7.3.2. Estrogen Receptor 1 Mutations
• 7.4. Metabolic Pathway of Estrogen Receptor (ER)-Positive Breast Cancer
  • 7.4.1. Role of Estrogen Receptor Alpha (ERa) in Regulating Breast Cancer Metabolism
• 7.5. Symptoms of HR-Positive Breast Cancer
• 7.6. Risk Factors of Estrogen Receptor (ER)-Positive Breast Cancer
• 7.7. Characterization of HER2-low Breast Cancers
  • 7.7.1. Biology of HER2-low Breast Cancer
• 7.8. Diagnosis of Estrogen Receptor (ER)-Positive Breast Cancer
• 7.9. Diagnostic Guidelines
  • 7.9.1. Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update 2020
  • 7.9.2. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update

8. Treatment of Metastatic HR+/HER2- Breast Cancer

• 8.1. Treatment Algorithm of Estrogen Receptor (ER)-Positive Breast Cancer
• 8.2. Treatment Guidelines
  • 8.2.1. ASCO: American Society of Clinical Oncology
  • 8.2.2. NCCN Guidelines
  • 8.2.3. Pan-Asian Adapted ESMO Clinical Practice Guidelines for the Diagnosis, Staging, and Treatment of Patients With Metastatic Breast Cancer
  • 8.2.4. The Japanese Breast Cancer Society Clinical Practice Guidelines for Systemic Treatment of Breast Cancer

9. Epidemiology and Patient Population of Metastatic HR+/HER2- Breast Cancer

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Total Incident Cases of Breast Cancer in the 7MM
• 9.4. Total Incident Cases of HR+/HER2- Breast Cancer in the 7MM
• 9.5. The United States
  • 9.5.1. Total Incident Cases of Breast Cancer in the United States
  • 9.5.2. Incidence of HR+/HER2- Breast Cancer in the United States
  • 9.5.3. Incidence of HR+/HER2- Breast Cancer Cases by Menopausal Status in the United States
  • 9.5.4. Stage-specific Incidence of HR+/HER2- Breast Cancer in the United States
  • 9.5.5. Age-specific Incidence of HR+/HER2- Breast Cancer in the United States
  • 9.5.6. Line-wise Metastatic Cases of HR+/HER2- Breast Cancer in the United States
• 9.6. EU4 and the UK
  • 9.6.1. Total Incidence of Breast Cancer in EU4 and the UK
  • 9.6.2. Incidence of HR+/HER2- Breast Cancer in EU4 and the UK
  • 9.6.3. Incidence of HR+/HER2- Breast Cancer Cases by Menopausal Status in EU4 and the UK
  • 9.6.4. Stage-specific Incidence of HR+/HER2- Breast Cancer in EU4 and the UK
  • 9.6.5. Age-specific Incidence of HR+/HER2- Breast Cancer in EU4 and the UK
  • 9.6.6. Line-wise Metastatic Cases of HR+/HER2- Breast Cancer in EU4 and the UK
• 9.7. Japan
  • 9.7.1. Total Incidence of Breast Cancer in Japan
  • 9.7.2. Incidence of HR+/HER2- Breast Cancer in Japan
  • 9.7.3. Incidence of HR+/HER2- Breast Cancer Cases by Menopausal Status in Japan
  • 9.7.4. Stage-specific Incidence of HR+/HER2- Breast Cancer in Japan
  • 9.7.5. Age-specific Incidence of HR+/HER2- Breast Cancer in Japan
  • 9.7.6. Line-wise Metastatic Cases of HR+/HER2- Breast Cancer in Japan

10. Patient Journey of Metastatic HR+/HER2- Breast Cancer

11. Marketed Drugs

• 11.1. Marketed Competitive Landscape of Metastatic HR+/HER2- Breast Cancer
• 11.2. KISQALI (ribociclib; LEE011): Novartis
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Other Developmental Activity
  • 11.2.4. Clinical Development
  • 11.2.5. Safety and Efficacy
  • 11.2.6. Product Profile
• 11.3. PIQRAY (alpelisib; BYL719): Novartis
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Developmental Activities
  • 11.3.4. Clinical Development
  • 11.3.5. Safety and Efficacy
  • 11.3.6. Product Profile
• 11.4. VERZENIO (abemaciclib): Eli Lilly
  • 11.4.1. Product Description
  • 11.4.2. Regulatory Milestones
  • 11.4.3. Other Development Activities
  • 11.4.4. Clinical Development
  • 11.4.5. Safety and Efficacy
  • 11.4.6. Product Profile
• 11.5. IBRANCE (palbociclib): Pfizer
  • 11.5.1. Product Description
  • 11.5.2. Regulatory Milestones
  • 11.5.3. Other Development Activities
  • 11.5.4. Clinical Development
  • 11.5.5. Safety and Efficacy
  • 11.5.6. Product Profile
• 11.6. LYNPARZA (olaparib): AstraZeneca
  • 11.6.1. Product Description
  • 11.6.2. Regulatory Milestones
  • 11.6.3. Other Developmental Activities
  • 11.6.4. Clinical Development
  • 11.6.5. Safety and efficacy
  • 11.6.6. Product Profile
• 11.7. TRODELVY (sacitzumab govitecan-hziy): Gilead Sciences
  • 11.7.1. Product Description
  • 11.7.2. Regulatory Milestones
  • 11.7.3. Clinical Development
  • 11.7.4. Safety and Efficacy
  • 11.7.5. Product Profile
• 11.8. ORSERDU (elacestrant): Stemline Therapeutics (Menarini Group)
  • 11.8.1. Product Description
  • 11.8.2. Regulatory Milestones
  • 11.8.3. Other Developmental Activities
  • 11.8.4. Clinical Development
  • 11.8.5. Safety and Efficacy
  • 11.8.6. Product Profile
• 11.9. ENHERTU (fam-trastuzumab deruxtecan-nxki): Daiichi Sankyo/AstraZeneca
  • 11.9.1. Product Description
  • 11.9.2. Regulatory Milestones
  • 11.9.3. Other Developmental Activities
  • 11.9.4. Clinical Development
  • 11.9.5. Safety and Efficacy
  • 11.9.6. Product Profile
• 11.10. AFINITOR (everolimus): Novartis
  • 11.10.1. Product Description
  • 11.10.2. Regulatory Milestones
  • 11.10.3. Other Development Activities
  • 11.10.4. Safety and Efficacy
  • 11.10.5. Product Profile
• 11.11. FASLODEX (fulvestrant) Injection: AstraZeneca
  • 11.11.1. Product Description
  • 11.11.2. Regulatory Milestones
  • 11.11.3. Other Development Activities
  • 11.11.4. Safety and Efficacy
  • 11.11.5. Product Profile

12. Emerging Therapies

• 12.1. Emerging Competitive Landscape of Metastatic HR+/HER2- Breast Cancer
• 12.2. KEYTRUDA (pembrolizumab): Merck
  • 12.2.1. Product Description
  • 12.2.2. Other Developmental Activity
  • 12.2.3. Clinical Development
  • 12.2.4. Safety and Efficacy
• 12.3. ARV-471 (vepdegestrant): Arvinas
  • 12.3.1. Product Description
  • 12.3.2. Other Developmental Activities
  • 12.3.3. Clinical Development
  • 12.3.4. Safety and Efficacy
• 12.4. OP1250 (palazestrant): Olema Pharmaceuticals
  • 12.4.1. Product Description
  • 12.4.2. Other developmental Activities
  • 12.4.3. Clinical development
  • 12.4.4. Safety and Efficacy
• 12.5. Gedatolisib: Celcuity
  • 12.5.1. Product Description
  • 12.5.2. Other Developmental Activities
  • 12.5.3. Clinical Development
  • 12.5.4. Safety and Efficacy
• 12.6. Giredestrant (RG6171, GDC-9545): Roche
  • 12.6.1. Product Description
  • 12.6.2. Other Developmental Activity
  • 12.6.3. Clinical Development
  • 12.6.4. Safety and Efficacy
• 12.7. Datopotamab Deruxtecan (Dato-DXd): AstraZeneca and Daiichi Sankyo
  • 12.7.1. Product Description
  • 12.7.2. Other Development Activity
  • 12.7.3. Clinical Development
  • 12.7.4. Safety and Efficacy
• 12.8. Camizestrant (AZD9833): AstraZeneca
  • 12.8.1. Product Description
  • 12.8.2. Other Developmental Activities
  • 12.8.3. Clinical Development
  • 12.8.4. Safety and Efficacy
• 12.9. LY3484356/Imlunestrant: Eli Lilly
  • 12.9.1. Product Description
  • 12.9.2. Clinical Development
  • 12.9.3. Safety and Efficacy
• 12.1. Lasofoxifene: Sermonix Pharmaceuticals
  • 12.10.1. Product Description
  • 12.10.2. Other Developmental Activities
  • 12.10.3. Clinical Development
  • 12.10.4. Safety and Efficacy
• 12.11. Capivasertib: AstraZeneca
  • 12.11.1. Product Description
  • 12.11.2. Other Developmental Activity
  • 12.11.3. Clinical Development
  • 12.11.4. Safety and Efficacy
• 12.12. Inavolisib: Roche/Genentech
  • 12.12.1. Product Description
  • 12.12.2. Clinical Development
  • 12.12.3. Safety and Efficacy
• 12.13. Enobosarm: Veru Pharma
  • 12.13.1. Product Description
  • 12.13.2. Other Development Activities
  • 12.13.3. Clinical Development
  • 12.13.4. Safety and Efficacy
• 12.14. DB-1303: DualityBio/BioNtech
  • 12.14.1. Product Description
  • 12.14.2. Other Developmental Activity
  • 12.14.3. Clinical Development
  • 12.14.4. Safety and Efficacy
• 12.15. SFX-01: Evgen Pharma
  • 12.15.1. Product Description
  • 12.15.2. Other Developmental Activity
  • 12.15.3. Clinical Development
  • 12.15.4. Safety and Efficacy
• 12.16. Samuraciclib (CT-7001): Carrick Therapeutics
  • 12.16.1. Product Description
  • 12.16.2. Other Developmental Activities
  • 12.16.3. Clinical Development
  • 12.16.4. Safety and Efficacy
• 12.17. Lerociclib: EQRx/G1 Therapeutics
  • 12.17.1. Product Description
  • 12.17.2. Other Developmental Activities
  • 12.17.3. Clinical Development
  • 12.17.4. Safety and Efficacy
• 12.18. Eftilagimod Alpha (LAG-3lg/IMP321): Immutep
  • 12.18.1. Product Description
  • 12.18.2. Other Developmental Activities
  • 12.18.3. Clinical Development
  • 12.18.4. Safety and Efficacy

13. Metastatic HR+/HER2- Breast Cancer: The 7MM Analysis

• 13.1. Key Findings
• 13.2. Market Outlook
• 13.3. Key Market Forecast Assumptions
• 13.4. Conjoint Analysis
• 13.5. Total Market Size of Metastatic HR+/HER2- Breast Cancer in the 7MM
• 13.6. The United States Market Size
  • 13.6.1. Total Market Size of Metastatic HR+/HER2- Breast Cancer in the United States
  • 13.6.2. Market Size of Metastatic HR+/HER2- Breast Cancer by Therapies in the United States
• 13.7. EU4 and the UK Market Size
  • 13.7.1. Total Market Size of Metastatic HR+/HER2- Breast Cancer in EU4 and the UK
  • 13.7.2. Market Size of Metastatic HR+/HER2- Breast Cancer by Therapies in EU4 and the UK
• 13.8. Japan Market Size
  • 13.8.1. Total Market Size of Metastatic HR+/HER2- Breast Cancer in Japan
  • 13.8.2. Market Size of Metastatic HR+/HER2- Breast Cancer by Therapies in Japan

14. SWOT Analysis of Metastatic HR+/HER2- Breast Cancer

15. KOL Views of Metastatic HR+/HER2- Breast Cancer

16. Market Access and Reimbursement of Metastatic HR+/HER2- Breast Cancer

• 16.1. United States
  • 16.1.1. Centre for Medicare and Medicaid Services (CMS)
• 16.2. EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW
• 16.4. HR+/HER2-: Market Access and Reimbursement
  • 16.4.1. The United States
  • 16.4.2. The United Kingdom
  • 16.4.3. France
  • 16.4.4. Germany
  • 16.4.5. Spanish Agency of Medicines and Medical Products (AEMPS)
  • 16.4.6. Italy

17. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight