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SALE HR+ HER2-VE Breast Cancer Market Report
HR+ HER2-VE Breast Cancer Market Report
Metastatic HR+/HER2− Breast Cancer - Market Insights, Epidemiology, and Market Forecast-2032
  • Published Date : Oct 2023

  • Pages : 200

  • Delivery Time : 24 Hours

  • Region : United States, EU5, Japan

Metastatic HR+/HER2− Breast Cancer Market

  • Breast cancer is a genetically and clinically heterogeneous disease with multiple subtypes. The HR+ HER2- subtype is the most common of all the breast cancer subtypes.
  • The total market size in the 7MM for HR+ HER2- breast cancer was estimated to be USD 9,200 million in 2022, which is expected to grow by 2032.
  • For the past decade, endocrine therapy has been the standard therapy for HR+ breast cancer in the early and advanced stages. Fulvestrant is one of the most efficient and well-tolerated medications available in single-agent ET formulations. FASLODEX’s poor bioavailability and inconvenient IV formulations creates opportunity for Oral Next generation SERDs to make a place in both 1L and 2L.
  • Among the approved classes, CDK4/6 inhibitors (palbociclib, ribociclib, and abemaciclib) have attracted the most attention.
  • 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 (AI).
  • IBRANCE (palbociclib) is the leading molecule in the first line of therapy, as it also has the first-mover advantage in the first-line and second-line setting, along with the highest revenue in terms of sales.
  • 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.
  • Recently, NICE poised to reject AstraZeneca, Daiichi’s ENHERTU in HER2-low breast cancer.
  • The treatment of patients who experience disease progression on CDK4/6 inhibitors and ET remains challenging. Multiple novel biological and endocrine therapies have shown promise in this setting.
  • 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).
  • Moreover, the upcoming SERDS could also muscle its 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 antibody-drug conjugate.
  • Roche’s Giredestrant, in combination with palbociclib, could be a first-line rival for Camizestrant. However, giredestrant Phase II acelERA (monotherapy) did not meet its primary endpoint of INV-PFS.
  • Capivasertib is a leading targeted inhibitor of the cancer-driving protein AKT, also known as PKB
  • Dato-DXd, another TROP2 ADC in the race, with the same cytotoxic payload as trastuzumab deruxtecan.
  • Upcoming pipeline of ER+, HER2- breast cancer comprises many next-generation SERD drug candidates. They will face a strong competition from the existing CDK4/6 inhibitors that have a strong hold over majority of the market share. This could lead to their slow growth.

Hormone Receptor (HR) positive/ Human Epidermal Receptor 2 (HER2) negative Breast Cancer Market

DelveInsight's "Metastatic HR+ HER2- Breast Cancer Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the HR+ HER2- Breast Cancer, historical and forecasted epidemiology as well as the HR+ HER2- breast cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The HR+ HER2- breast cancer market report provides current treatment practices, emerging drugs, HR+ HER2- breast cancer market share of the individual therapies, and current and forecasted HR+ HER2- breast cancer market size from 2019 to 2032 segmented by seven major markets. The report also covers current HR+ HER2- breast cancer treatment practices/algorithms, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Report Metrics

Details

Study Period

2019 to 2032

Forecast Period

2023 to 2032

Geographies Covered

The US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan

HR+ HER2-VE Breast Cancer Market Assessment

  • Total Market Size
  • Market Size by Therapies
  • Market Size by Class

Market CAGR

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HR+ HER2-VE Breast Cancer Market Size

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HR+ HER2-VE Breast Cancer Companies

Pfizer, Novartis, AstraZeneca Pharmaceuticals, Eli Lilly, Jiangsu HengRui Medicine, Odonate Therapeutics, Radius Pharmaceuticals, Immunomedics

Geography Covered

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

Metastatic HR+ HER2- Breast Cancer Treatment Market

HR+ HER2- Breast Cancer Overview

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.

Metastatic HR+ HER2- Breast Cancer Diagnosis

A patient's journey through HR+ HER2- breast cancer diagnosis typically begins with the recognition of concerning symptoms, leading to clinical evaluation and imaging tests. 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.

Further details related to diagnosis will be provided in the report…

Metastatic HR+ HER2- Breast Cancer Treatment

The treatment of HR+ HER2- breast cancer typically involves a multimodal approach. Hormone therapy is a cornerstone, blocking estrogen's effects on cancer cells. Surgery, such as lumpectomy or mastectomy, may be performed to remove the tumor. Radiation therapy targets any remaining cancer cells after surgery. In more advanced cases, chemotherapy or targeted therapies like CDK4/6 inhibitors can be considered. The specific treatment plan depends on factors like cancer stage, receptor status, and patient preferences. Regular follow-up and monitoring are essential to track progress and adjust treatment as needed, offering the best chance for successful management and long-term survival.

A number of classes of anti-estrogenic agents available for patients with early, advanced, or metastatic breast cancer which includes selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), and a selective estrogen receptor degrader. However, the clinical development of combinations of antiestrogenic therapy with targeted agents that inhibit the phosphatidylinositol 3 kinase (PI3K)/AKT murine thymoma viral oncogene (AKT)/mammalian target of rapamycin inhibitor (mTOR) signalling pathway or the cyclin-dependent kinase 4/6 (CDK4/6) pathway at the G1/S checkpoint of the cell cycle is currently a key focus of clinical research in patients with hormone-receptor positive breast cancer who have demonstrated disease recurrence or progression.

Further details related to treatment will be provided in the report…

Metastatic HR+ HER2- Breast Cancer Epidemiology

The HR+ HER2- Breast Cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incidence of breast cancer, incident cases of HR+ HER2- breast cancer, menopausal status of HR+ HER2- breast cancer, stage-specific cases of HR+ HER2- breast cancer, age-specific cases of HR+ HER2- breast cancer and treatment-eligible Pool for HR+ HER2- Breast Cancer in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2019 to 2032.

  • According to the estimates, the total incident population of HR+ HER2- Breast Cancer in the 7MM was nearly 468,000 cases in 2022. The cases in the 7MM are expected to increase during the study period, i.e., 2019–2032.
  • The HR+ HER2- breast cases were highest in the United States accounting for ~201,400 cases.
  • According to the estimates, most cases of HR+ HER2- Breast Cancer occur in people aged between 60 to 79 years in the United States, which were nearly 96,700 cases in 2022.
  • Among EU4 and the UK, Germany had the maximum total incident cases of HR+ HER2- Breast Cancer with ~50,000 cases in 2022 while Spain accounted for the least number of cases. Spain accounted for 24,000 cases of HR+ HER2- Breast Cancer in 2022.
  • In EU4 and the UK, the total cases of HR+/HER2– breast cancer by treatment line were around 52,000 cases for metastatic patients in 2022
  • In Japan, stage-specific cases of HR+ HER2- Breast Cancer were highest in localized, accounting for approximately 44,500 cases in 2022.

Get detailed insights into the historical as well as forecasted epidemiology trends in the 7MM, at: Hormone Receptor (HR) positive/ Human Epidermal Receptor 2 (HER2) negative Breast Cancer Epidemiology Forecast

Hormone Receptor (HR) positive/ Human Epidermal Receptor 2 (HER2) negative Breast Cancer Epidemiology

Metastatic HR+ HER2- Breast Cancer Drug Chapters

The drug chapter segment of the HR+ HER2- Breast Cancer report encloses a detailed analysis of the marketed and late-stage (Phase III) pipeline drug. The marketed drugs segment encloses drugs such as KISQALI (Novartis), PIQRAY (Daiichi Sankyo/AstraZeneca), IBRANCE (Pfizer), and others. Furthermore, the current key players for the upcoming emerging drugs and their respective drug candidates include ARV-471 (Arvinas), OP1250 (Olema Pharmaceuticals), Capivasertib (AstraZeneca) and others. The drug chapter also helps understand the HR+ HER2- Breast Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Metastatic HR+ HER2- Breast Cancer Marketed Drugs

KISQALI (Ribociclib; LEE011): 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

Novartis is committed to continuing to study KISQALI in breast cancer. NATALEE is a large Phase III clinical trial of KISQALI with endocrine therapy in the adjuvant treatment of HR+ HER2- early breast cancer being conducted in collaboration with Translational Research in Oncology (TRIO). Additionally, Novartis is collaborating with the Akershus University Hospital in Norway on the NEOLETRIB trial, a neoadjuvant Phase II trial studying the effects of KISQALI in HR+ HER2- early breast cancer and to discover the potentially unique underlying mechanism of action. Novartis also plans to build on the findings from ADJUVANT WIDER, an open-label Phase IIIb trial evaluating KISQALI plus ET in a population of HR+ HER2- patients with Stage II and III EBC (early breast cancer) that is closer to a real-world population.

PIQRAY (Alpelisib; BYL719): Novartis

PIQRAY is an orally bioavailable, alpha-specific PI3K inhibitor developed by Novartis. In breast cancer cell lines harboring PIK3CA mutations, BYL719 has been shown to inhibit the PI3K pathway potentially and have antiproliferative effects. In addition, cancer cell lines with PIK3CA mutations were also more sensitive to BYL719 than those without the mutation across a broad range of cancers.

In vivo, alpelisib inhibited the PI3K/AKT signaling pathway and reduced tumor growth in xenograft models, including models of breast cancer. PI3K inhibition by alpelisib treatment has increased estrogen receptor (ER) transcription in breast cancer cells. The combination of alpelisib and fulvestrant demonstrated increased antitumor activity compared to either treatment alone in xenograft models derived from ER+ and PIK3CA mutated breast cancer cell lines.

Comparison of Marketed Drugs

Drugs and Company

MoA

US

EU4 and the UK

Patient Segment

Line of Therapy

KISQALI (Ribociclib) (Novartis)

CDK4/6 Inhibitor

2017, 2018

2017, 2018

women who have gone through menopause with HR+/HER2- advanced or metastatic breast cancer

1L and 2L

PIQRAY (Alpelisib; BYL719) (Novartis)

PI3K-alpha inhibitor

2019

2020

PIK3CA-mutated, advanced or metastatic breast cancer

2L

Detailed current therapies assessment will be provided in the report...

HR+ HER2- Breast Cancer Emerging Drugs

Comparison of Emerging Drugs

Drug Name and Company

Patient Segment

MoA

RoA

Molecule Type

ARV-471 (Arvinas)

ER+/HER2- Breast Cancer

SERD

Oral

Small molecule

OP1250 (Olema Pharmaceuticals)

ER+, HER2- Advanced or mBC

Complete estrogen receptor antagonist and SERD

Oral

Small molecule

ARV-471 (vepdegestrant): Arvinas

ARV-471 is an investigational, oral PROTAC estrogen receptor protein degrader for the treatment of patients with estrogen receptor (ER) positive/human epidermal growth factor receptor 2 (HER2) negative (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.

In the first quarter of 2023, Arvinas and Pfizer requested a meeting with the US Food and Drug Administration, or the FDA, to review the proposed update to the trial protocol for the VERITAC-3 first-line, metastatic ER+/HER2- breast cancer Phase III trial of ARV-471 in combination with IBRANCE (palbociclib) to determine the optimal dose of palbociclib as part of the trial design.

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.

The company is advancing OP-1250 toward pivotal Phase III studies. In addition to that, the pivotal Phase III study in 2/3L is planned to be initiated in mid-2023. The pivotal Phase III combination study with CDK 4/6i is expected to be initiated by 2024.

Detailed emerging therapies assessment will be provided in the final report...

Hormone Receptor (HR) positive/ Human Epidermal Receptor 2 (HER2) negative Breast Cancer Market Outlook

HR+ HER2- Breast Cancer Drug Class

The emergence of several novel CDK4/6 inhibitors in the ER+/HER2–breast cancer space has demonstrated widespread potential for this patient population in combination and as monotherapy. Moreover, the upcoming SERDS could also muscle its way into this treatment space for this patient pool. The other therapies include AKT inhibitors, mTOR inhibitors, SERMS, PI3K inhibitors, and TROP-2 targeting antibody–drug conjugate.

CDK4/6 inhibitors

Cyclin-dependent kinase (CDK) inhibitors, the newest class of interest for advanced breast cancer, work by specifically inhibiting CDK4/6 proteins and blocking the transition from the G1 to the S phase of the cell cycle. This drug class inhibits kinase activity, which phosphorylates the retinoblastoma protein pathway. By blocking this path, CDK4/6 inhibitors are able to block cell-cycle progression in the middle of the G1 phase and prevent cancer cell progression. The approved CDK4/6 inhibitors have already gained a higher revenue than mTOR protein inhibitors, followed by SERDS and other therapies. Three CDK4/6 inhibitors (palbociclib, ribociclib, and abemaciclib) have been approved as combination therapies for HR+, human epidermal growth factor receptor 2–negative (HER2–), advanced or metastatic breast cancers.

SERD and SERM

The benefit of SERD over SOC ET appears to be more pronounced in patients with endocrine-sensitive tumors harboring ESR1 mutations without significant activation of other pathways. Recently, in January 2023, the FDA approved an oral SERD elacestrant (ORSERDU) for postmenopausal women or adult men with ER + /HER2-, ESR1-mutated ABC after progression on at least one line of ET. Ocular or cardiac toxicities reported with other SERDs, SERMs, or SERCAs, such as giredestrant, camizestrant, and tamoxifen, were not observed with elacestrant. Compared with the other SERDS, Giredestrant (SERD) has witnessed disappointment in its Phase II acelERA study but showed some promise in ESR1 mutation. Roche is conducting another Phase III trial for evaluating giredestrant + everolimus for ER+ HER2- mBC.

PIK3 and AKT inhibitors

Approximately 40% of HR+ and HER2– breast cancers harbor an activating mutation in PIK3CA.The gene product of PIK3CA is phosphatidylinositol 3-kinase (PI3K), a tyrosine kinase and key component of the PI3K and protein kinase B (AKT) pathway that regulates cell growth. Dysregulation of the PI3K and AKT pathway occurs in several subtypes of breast cancer, and although degree of pathway activation may be highest in triple-negative breast cancers, the incidence of these mutations is most common in HR+ and HER2– breast cancers. Alpelisib, in combination with fulvestrant, is approved by the US FDA for PIK3CA-mutated advanced HR+ and HER2-breast cancer based on SOLAR-1.

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 first AI introduced in 1999 was AROMASIN (Exemestane), which proved effective as a second-line therapy for postmenopausal women with HR-positive MBC following tamoxifen 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).

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 HER2 Low segment. The emerging pipeline for HR/HER2- includes several potential drugs in late-stage (Phase III, II/III, 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 include Datopotamab deruxtecan, DB1303, Eftilagimod alpha, being administered in various combinations. The focus of this research is mostly on new oral SERDs.

Detailed market assessment will be provided in the final report.

Key Findings

  • The total market size in the United States for HR+ HER2- Breast Cancer was estimated to be nearly USD 6,400 million in 2022, which is expected to show growth by 2032.
  • Among the EU4 countries, Germany captured the maximum market share in 2022, whereas Spain was at the bottom of the ladder in the same year in HR+ HER2- Breast Cancer.
  • The current US market for HR+ HER2- Breast Cancer holds therapies like KISQALI, VERZENIO, IBRANCE, PIQRAY, TRODELVY, and others.
  • The market size of HR+ HER2- Breast Cancer in EU4 and the UK in 2022 was around USD 2,100 million, which is expected to increase during the study period (2019–2032).
  • The total market size of HR+ HER2- Breast Cancer in Japan was nearly USD 600 million in 2022.
  • Potential Therapies expected to launch are Lasofoxifene, Camizestrant, Capivasertib, ARV-471, and others. The launch of these therapies is expected to increase the market size in the coming years, assisted by an increase in the HR+ HER2- breast cancer patient pool.

Metastatic HR+ HER2- Breast Cancer Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019–2032. The landscape of HR+ HER2- breast cancer treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Detailed emerging therapies assessment will be provided in the final report...

Metastatic HR+ HER2- Breast Cancer Pipeline Development Activities

The Metastatic HR+ HER2- Breast Cancer report provides insights into Metastatic HR+ HER2- Breast Cancer Cliniccal Trials within Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for HR+ HER2- breast cancer emerging Metastatic HR+ HER2- Breast Cancer therapy.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the HR+ HER2- breast cancer evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including oncologists, radiation oncologists, surgical oncologists, and others.

DelveInsight’s analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as Institute for Personalized Cancer Therapy, Anderson Cancer Center, Aichi Cancer Center, University Hospital Ulm, International Breast Cancer Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or HR+ HER2- breast cancer market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

KOL Views

“The approval of ENHERTU in the HER2-low metastatic breast cancer population marks the first time we will have the opportunity to treat patients with lower levels of HER2 expression with a HER2-directed therapy. ENHERTU has shown a significant improvement in outcomes compared to chemotherapy for these patients, reinforcing its potential to become a new standard of care”

“With a significant number of ER+ HER2- patients ultimately developing ESR1 mutations at some point in their metastatic journey, it is important to test for ESR1 each time an mBC patient experiences disease progression, to understand what is fueling their breast cancer. ORSERDU approval gives the first-ever treatment option that directly acts against the very mutations that make this form of breast cancer more difficult to treat, and provides hope to our patients and their families."

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, 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. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Metastatic HR+ HER2- Breast Cancer Market Access and Reimbursement

The Patient Assistance Now Oncology (PANO) program assists with accessing Novartis medicine(s), from insurance verification to financial assistance. 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 supports the patients in accessing AFINITOR through its Oncology Universal Copay Program, through which 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. AfiniTRAC is another support program for eligible patients taking AFINITOR (everolimus) tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension). The program provides one-to-one telephone support directly to patients through AfiniTRAC Care Champions, who provide comprehensive educational support, including help with a treatment routine and reminders to patients to take medication as prescribed.

Detailed market access and reimbursement assessment will be provided in the final report...

Scope of the Metastatic HR+ HER2- Breast Cancer Report

  • The report covers a segment of key events, an executive summary, and a descriptive overview of HR+ HER2- breast cancer, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
  • Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
  • Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
  • A detailed review of the 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 shape and drive the 7MM HR+ HER2- breast cancer market.

Metastatic HR+ HER2- positive Breast Cancer Report Insights

  • HR+ HER2- Breast Cancer Patient Population
  • HR+ HER2- Breast Cancer Therapeutic Approaches
  • HR+ HER2- Breast Cancer Pipeline Analysis
  • HR+ HER2- Breast Cancer Market Size and Trends
  • Existing and Future Market Opportunity

Metastatic HR+ HER2- Breast Cancer Report Key Strengths

  • 10 Years Forecast
  • The 7MM Coverage
  • HR+ HER2- Breast Cancer Epidemiology Segmentation
  • Key Cross Competition
  • HR+ HER2- Breast Cancer Drugs Uptake
  • Key HR+ HER2- Breast Cancer Market Forecast Assumptions

Metastatic HR+ HER2- Breast Cancer Report Assessment

  • Current HR+ HER2- Breast Cancer Treatment Practices
  • HR+ HER2- Breast Cancer Unmet Needs
  • HR+ HER2- Breast Cancer Pipeline Product Profiles
  • HR+ HER2- Breast Cancer Market Attractiveness
  • Qualitative Analysis (SWOT and Analyst Views)
  • HR+ HER2- Breast Cancer Market Drivers
  • HR+ HER2- Breast Cancer Market Barriers

FAQs

  • What was the HR+ HER2- breast cancer market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2032? What are the contributing factors for this growth?
  • What are the pricing variations among different geographies for approved therapies?
  • What can be the future treatment paradigm of HR+ HER2- breast cancer?
  • What are the disease risks, burdens, and unmet needs of HR+ HER2- breast cancer? What will be the growth opportunities across the 7MM concerning the patient population with HR+ HER2- breast cancer?
  • What is the impact of biosimilar on the sales of FASLODEX?
  • Who is the major competitor of ENHERTU in the market?
  • How much market share antibody–drug conjugate (ADC) will capture by 2032?
  • What are the current options for the treatment of HR+ HER2- breast cancer? What are the current guidelines for treating HR+ HER2- breast cancer in the US, Europe, and Japan?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
  • What is the patient share in HR+ HER2- breast cancer?

Reasons to Buy Metastatic HR+ HER2- Breast Cancer Market Report

  • The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the HR+ HER2- breast cancer market.
  • 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.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis, ranking of class-wise potential current, and emerging therapies under the analyst view section to provide visibility around leading classes.
  • Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

1. Key Insights

2. Report Introduction

3. Executive Summary of Metastatic HR+/HER2-negative

4. Epidemiology and Market Forecast Methodology

5. Key Events

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

6.1. Total Market Size Distribution by Class in 2022

6.2. Total Market Size Distribution by Class in 2032

7. Disease Background and Overview

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. HR+/HER2– Breast Cancer Treatment

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. HR+/HER2– Breast Cancer Epidemiology and Patient Population

9.1. Key Findings

10. Assumptions and Rationale

10.1. Total Incident Cases of Breast Cancer in the 7MM

10.2. Total Incident Cases of HR+/HER2– Breast Cancer in the 7MM

10.3. The United States

10.3.1. Total Incident Cases of Breast Cancer in the United States

10.3.2. Incidence of HR+/HER2– Breast Cancer in the United States

10.3.3. Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in the United States

10.3.4. Stage-specific Incidence of HR+/HER2– Breast Cancer in the United States

10.3.5. Age-specific Incidence of HR+/HER2– Breast Cancer in the United States

10.3.6. Treatment-eligible Pool for HR+/HER2– Breast Cancer in the United States

10.4. EU4 and the UK

10.4.1. Total Incidence of Breast Cancer in EU4 and the UK

10.4.2. Incidence of HR+/HER2– Breast Cancer in EU4 and the UK

10.4.3. Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in EU4 and the UK

10.4.4. Stage-specific Incidence of HR+/HER2– Breast Cancer in EU4 and the UK

10.4.5. Age-specific Incidence of HR+/HER2– Breast Cancer in EU4 and the UK

10.4.6. Treatment-eligible Pool for HR+/HER2– Breast Cancer in EU4 and the UK

10.5. Japan

10.5.1. Total Incidence of Breast Cancer in Japan

10.5.2. Incidence of HR+/HER2– Breast Cancer in Japan

10.5.3. Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in Japan

10.5.4. Stage-specific Incidence of HR+/HER2– Breast Cancer in Japan

10.5.5. Age-specific Incidence of HR+/HER2– Breast Cancer in Japan

10.5.6. Treatment-eligible Pool for HR+/HER2– Breast Cancer in Japan

11. Patient Journey

12. HR+/HER2– Breast Cancer Marketed Drugs

12.1. Key cross Competition

12.2. KISQALI (Ribociclib; LEE011): Novartis

12.2.1. Product Description

12.2.2. Regulatory Milestones

12.2.3. Other Developmental Activity

12.2.4. Clinical Development

12.2.5. Safety and Efficacy

12.2.6. Product Profile

12.3. PIQRAY (Alpelisib; BYL719): Novartis

12.3.1. Product Description

12.3.2. Regulatory Milestones

12.3.3. Other Developmental Activities

12.3.4. Clinical Development

12.3.5. Safety and Efficacy

12.3.6. Product Profile

12.4. VERZENIO (Abemaciclib): Eli Lilly

12.4.1. Product Description

12.4.2. Regulatory Milestones

12.4.3. Other Development Activities

12.4.4. Clinical Development

12.4.5. Safety and Efficacy

12.4.6. Product Profile

12.5. IBRANCE (Palbociclib): Pfizer

12.5.1. Product Description

12.5.2. Regulatory Milestones

12.5.3. Other Development Activities

12.5.4. Clinical Development

12.5.5. Safety and Efficacy

12.5.6. Product Profile

12.6. LYNPARZA (Olaparib): AstraZeneca

12.6.1. Product Description

12.6.2. Regulatory Milestones

12.6.3. Other Developmental Activities

12.6.4. Clinical Development

12.6.5. Safety and efficacy

12.6.6. Product Profile

12.7. TRODELVY (sacitzumab govitecan-hziy): Gilead Sciences

12.7.1. Product Description

12.7.2. Regulatory Milestones

12.7.3. Clinical Development

12.7.4. Safety and Efficacy

12.7.5. Product Profiling

12.8. ORSERDU (elacestrant): Stemline Therapeutics (Menarini Group)

12.8.1. Product Description

12.8.2. Regulatory Milestones

12.8.3. Other Developmental Activities

12.8.4. Clinical Development

12.8.5. Safety and Efficacy

12.8.6. Product Profiling

12.9. ENHERTU (fam-trastuzumab deruxtecan-nxki): Daiichi Sankyo/AstraZeneca

12.9.1. Product Description

12.9.2. Regulatory Milestones

12.9.3. Other Developmental Activities

12.9.4. Clinical Development

12.9.5. Safety and Efficacy

12.9.6. Product Profiling

12.10. AFINITOR (Everolimus): Novartis

12.10.1. Product Description

12.10.2. Regulatory Milestones

12.10.3. Other Development Activities

12.10.4. Safety and Efficacy

12.10.5. Product Profile

12.11. FASLODEX (Fulvestrant) Injection: AstraZeneca

12.11.1. Product Description

12.11.2. Regulatory Milestones

12.11.3. Other Development Activities

12.11.4. Safety and Efficacy

12.11.5. Product Profile

13. HR+/HER2– Breast Cancer Emerging Therapies

13.1. Key Cross Competition

13.2. KEYTRUDA (perbrolizumab): Merck

13.2.1. Product Description

13.2.2. Other Developmental Activities

13.2.3. Clinical Development

13.2.4. Safety and Efficacy

13.3. ARV-471 (vepdegestrant): Arvinas

13.3.1. Product Description

13.3.2. Other Developmental Activities

13.3.3. Clinical Development

13.3.4. Safety and Efficacy

13.4. OP1250 (palazestrant): Olema Pharmaceuticals

13.4.1. Product Description

13.4.2. Other developmental Activities

13.4.3. Clinical development

13.4.4. Safety and Efficacy

13.5. Gedatolisib: Celcuity

13.5.1. Product Description

13.5.2. Other Developmental Activities

13.5.3. Clinical Development

13.5.4. Safety and Efficacy

13.6. Giredestrant (RG6171, GDC-9545): Roche

13.6.1. Product Description

13.6.2. Other Developmental Activity

13.6.3. Clinical Development

13.6.4. Safety and Efficacy

13.7. Datopotamab Deruxtecan (Dato-DXd): AstraZeneca and Daiichi Sankyo

13.7.1. Product Description

13.7.2. Other Development Activity

13.7.3. Clinical Development

13.7.4. Safety and Efficacy

13.8. Camizestrant (AZD9833): AstraZeneca

13.8.1. Product Description

13.8.2. Other Developmental Activities

13.8.3. Clinical Development

13.8.4. Safety and Efficacy

13.9. LY3484356/Imlunestrant: Eli Lilly

13.9.1. Product Description

13.9.2. Clinical Development

13.9.3. Safety and Efficacy

13.10. Lasofoxifene: Sermonix Pharmaceuticals

13.10.1. Product Description

13.10.2. Other Developmental Activities

13.10.3. Clinical Development

13.10.4. Safety and Efficacy

13.11. Capivasertib: AstraZeneca

13.11.1. Product Description

13.11.2. Other Developmental Activity

13.11.3. Clinical Development

13.11.4. Safety and Efficacy

13.12. Inavolisib: Roche/Genentech

13.12.1. Product Description

13.12.2. Clinical Development

13.12.3. Safety and Efficacy

13.13. Enobosarm: Veru Pharma

13.13.1. Product Description

13.13.2. Other Development Activities

13.13.3. Clinical Development

13.13.4. Safety and Efficacy

13.14. DB-1303: DualityBio/BioNtech

13.14.1. Product Description

13.14.2. Other Developmental Activity

13.14.3. Clinical Development

13.14.4. Safety and Efficacy

13.15. SFX-01: Evgen Pharma

13.15.1. Product Description

13.15.2. Other Developmental Activities

13.15.3. Clinical Development

13.15.4. Safety and Efficacy

13.16. Samuraciclib (CT-7001): Carrick Therapeutics

13.16.1. Product Description

13.16.2. Other Developmental Activities

13.16.3. Clinical Development

13.16.4. Safety and Efficacy

13.17. Lerociclib: EQRx/G1 Therapeutics

13.17.1. Product Description

13.17.2. Other Developmental Activities

13.17.3. Clinical Development

13.17.4. Safety and Efficacy

13.18. Eftilagimod Alpha (LAG-3lg/IMP321): Immutep

13.18.1. Product Description

13.18.2. Other Developmental Activities

13.18.3. Clinical Development

13.18.4. Safety and Efficacy

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

14.1. Key Findings

14.2. Conjoint Analysis

14.3. Key Market Forecast Assumptions

14.4. Market Outlook

14.5. Total Market Size of HR+/HER2- Breast Cancer in the 7MM

14.6. The United States Market Size

14.6.1. Total Market Size of HR+/HER2- Breast Cancer in the United States

14.6.2. Market Size of HR+/HER2- Breast Cancer by Current and Emerging Therapies in the United States

14.7. EU4 and the UK Market Size

14.7.1. Total Market Size of HR+/HER2- Breast Cancer in EU4 and the UK

14.7.2. Market Size of HR+/HER2- Breast Cancer by Current and Emerging Therapies in EU4 and the UK

14.8. Japan Market Size

14.8.1. Total Market Size of HR+/HER2- Breast Cancer in Japan

14.8.2. Market Size of HR+/HER2- Breast Cancer by Current and Emerging Therapies in Japan

15. HR+/HER2– Breast Cancer Market Unmet needs

16. SWOT Analysis

17. KOL Views

18. HR+/HER2– Breast Cancer Market Access and Reimbursement

18.1. United States

18.1.1. Centre for Medicare and Medicaid Services (CMS)

18.2. EU4 and the UK

18.2.1. Germany

18.2.2. France

18.2.3. Italy

18.2.4. Spain

18.2.5. United Kingdom

18.3. Japan

18.3.1. MHLW

18.4. HR+/HER2-: Market Access and Reimbursement

18.4.1. The United States

18.4.2. The United Kingdom

18.4.3. France

18.4.4. Germany

18.4.5. Spanish Agency of Medicines and Medical Products (AEMPS)

18.4.6. Italy

19. Appendix

19.1. Bibliography

19.2. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

List of Tables:

    Table 1: Summary of HR+/HER2- Breast Cancer Market, and Epidemiology (2019–2032)

    Table 2: The ASCO 2021 Focused Guideline Update

    Table 3: Systemic Therapy for ER- and/or PR-positive Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease

    Table 4: Systemic Therapy for Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease

    Table 5: Recommendation 3 for HR-positive, HER2-negative Breast Cancer

    Table 6: The Japanese Breast Cancer Society Clinical Practice Guidelines for Systemic Treatment of Breast Cancer, Edition 2018

    Table 7: Total Incident Cases of Breast Cancer in the 7MM (2019–2032)

    Table 8: Total Incident Cases of HR+/HER2– Breast Cancer in the 7MM (2019–2032)

    Table 9: Total Incident Cases of Breast Cancer in the United States (2019–2032)

    Table 10: Incidence of HR+/HER2– Breast Cancer in the United States (2019–2032)

    Table 11: Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in the United States (2019–2032)

    Table 12: Stage-specific Incidence of HR+/HER2– Breast Cancer in the United States (2019–2032)

    Table 13: Age-specific Incidence of HR+/HER2– Breast Cancer in the United States (2019–2032)

    Table 14: Treatment-eligible Cases of HR+/HER2– Breast Cancer in the United States (2019–2032)

    Table 15: Total Incidence of Breast Cancer in EU4 and the UK (2019–2032)

    Table 16: Incidence of HR+/HER2– Breast Cancer in EU4 and the UK (2019–2032)

    Table 17: Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in EU4 and the UK (2019–2032)

    Table 18: Stage-specific Incidence of HR+/HER2– Breast Cancer in EU4 and the UK (2019–2032)

    Table 19: Age-specific Incidence of HR+/HER2– Breast Cancer in EU4 and the UK (2019–2032)

    Table 20: Treatment-eligible cases of HR+/HER2– Breast Cancer in EU4 and the UK (2019–2032)

    Table 21: Total Incidence of Breast Cancer in Japan (2019–2032)

    Table 22: Incidence of HR+/HER2– Breast Cancer in Japan (2019–2032)

    Table 23: Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in Japan (2019–2032)

    Table 24: Stage-specific Incidence of HR+/HER2– Breast Cancer in Japan (2019–2032)

    Table 25: Age-specific Incidence of HR+/HER2– Breast Cancer in Japan (2019–2032)

    Table 26: Treatment-eligible Cases of HR+/HER2– Breast Cancer in Japan (2019–2032)

    Table 27: Marketed Drug Key Cross

    Table 28: KISQALI, Clinical Trial Description, 2023

    Table 29: PIQRAY, Clinical Trial Description, 2023

    Table 30: VERZENIO, Clinical Trial Description, 2023

    Table 31: IBRANCE (Palbociclib), Clinical Trial Description, 2023

    Table 32: LYNPARZA (Olaparib), Clinical Trial Description, 2023

    Table 33: TRODELVY, Clinical Trial Description, 2023

    Table 34: ORSERDU (Elacestrant), Clinical Trial Description, 2023

    Table 35: ENHERTU, Clinical Trial Description, 2023

    Table 36: Emerging Key Cross

    Table 37: KEYTRUDA (pembrolizumab), Clinical Trial Description, 2023

    Table 38: ARV-471, Clinical Trial Description, 2023

    Table 39: OP1250, Clinical Trial Description, 2023

    Table 40: Gedatolisib, Clinical Trial Description, 2023

    Table 41: Giredestrant, Clinical Trial Description, 2023

    Table 42: Datopotamab Deruxtecan (Dato-DXd), Clinical Trial Description, 2023

    Table 43: Camizestrant (AZD9833), Clinical Trial Description, 2023

    Table 44: LY3484356 (Imlunestrant), Clinical Trial Description, 2023

    Table 45: Lasofoxifene, Clinical Trial Description, 2023

    Table 46: Capivasertib, Clinical Trial Description, 2023

    Table 47: Inavolisib, Clinical Trial Description, 2023

    Table 48: Enobosarm, Clinical Trial Description, 2023

    Table 49: DB-1303, Clinical Trial Description, 2023

    Table 50: SFX-01, Clinical Trial Description, 2023

    Table 51: Samuraciclib, Clinical Trial Description, 2023

    Table 52: Lerociclib, Clinical Trial Description, 2023

    Table 53: Eftilagimod Alpha (LAG-3lg/IMP321), Clinical Trial Description, 2023

    Table 54: Key Market Forecast Assumptions for Elacestrant

    Table 55: Key Market Forecast Assumptions for Camizestrant

    Table 56: Key Market Forecast Assumptions for Imlunestrant /LY3484356

    Table 57: Key Market Forecast Assumptions for Enobosarm

    Table 58: Key Market Forecast Assumptions for Amcenestrant

    Table 59: Key Market Forecast Assumptions for Datopotamab Deruxtecan

    Table 60: Key Market Forecast Assumptions for Inavolisib

    Table 61: Key Market Forecast Assumptions for Lerociclib

    Table 62: Key Market Forecast Assumptions for Capivasertib

    Table 63: Key Market Forecast Assumptions for Giredestrant

    Table 64: Key Market Forecast Assumptions for Trodelvy

    Table 65: Key Market Forecast Assumptions for SM-88

    Table 66: Key Market Forecast Assumptions for SFX-01

    Table 67: Key Market Forecast Assumptions for Lasofoxifene

    Table 68: Market Size of HR+/HER2- Breast Cancer in the 7MM, in USD million (2019–2032)

    Table 69: Market Size of HR+/HER2- Breast Cancer in the US, in USD million (2019–2032)

    Table 70: Market Size of HR+/HER2- Breast Cancer by Current and Emerging in the US, in USD million (2019–2032)

    Table 71: Market Size of HR+/HER2- Breast Cancer in EU4 and the UK, in USD million (2019–2032)

    Table 72: Market Size of HR+/HER2- Breast Cancer by Current and Emerging Therapies in EU4 and the UK, in USD million (2019–2032)

    Table 73: Market Size of HR+/HER2- Breast Cancer in Japan, in USD million (2019–2032)

    Table 74: Market Size of HR+/HER2- Breast Cancer by Current and Emerging in Japan, in USD million (2019–2032)

    Table 75: NICE Decisions for HR+/HER2- Breast Cancer Therapies

    Table 76: Haute Autorité de santé (HAS) Decisions for HR+/HER2- Breast Cancer Therapies

    Table 77: IQWiG Assessment for HR+/HER2- Breast Cancer Therapies

    Table 78: AEMPS Assessment for HR+/HER2- Breast Cancer Therapies

    Table 79: AIFA Assessment for HR+/HER2- Breast Cancer Therapies

List of Figures:

    Figure 1: Molecular Subtypes of Breast Cancer

    Figure 2: Working of Estrogen Receptor

    Figure 3: Schematic Structure of the Estrogen Receptor (ER) Depicting Six Domains

    Figure 4: ER pathway and mechanisms of resistance

    Figure 5: Metabolism of Estrogen Receptor-Positive Breast Cancer

    Figure 6: Molecular pathways involved in the induction of hormone therapy resistance in Estrogen Receptor-Positive Breast Cancer Cells.

    Figure 7: Treatment Algorithm for Patients With HR+/HER2–Metastatic Breast Cancer

    Figure 8: Treatment Algorithm for Endocrine Therapy for Hormone-receptor-positive Metastatic Breast Cancer

    Figure 9: Systemic Treatment of Recurrent Unresectable (Local or Regional) or Stage IV (M1) Disease: ER- and/or PR-positive; HER2-negative

    Figure 10: Total Incident Cases of Breast Cancer in the 7MM (2019–2032)

    Figure 11: Total Incident Cases of HR+/HER2– Breast Cancer in the 7MM (2019–2032)

    Figure 12: Total Incident Cases of Breast Cancer in the United States (2019–2032)

    Figure 13: Incidence of HR+/HER2– Breast Cancer in the United States (2019–2032)

    Figure 14: Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in the United States (2019–2032)

    Figure 15: Stage-specific Incidence of HR+/HER2– Breast Cancer in the United States (2019–2032)

    Figure 16: Age-specific Incidence of HR+/HER2– Breast Cancer in the United States (2019–2032)

    Figure 17: Treatment-eligible Pool for HR+/HER2– Breast Cancer in the United States (2019–2032)

    Figure 18: Total Incidence of Breast Cancer in EU4 and the UK (2019–2032)

    Figure 19: Incidence of HR+/HER2– Breast Cancer in EU4 and the UK (2019–2032)

    Figure 20: Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in EU4 and the UK (2019–2032)

    Figure 21: Stage-specific Incidence of HR+/HER2– Breast Cancer in EU4 and the UK (2019–2032)

    Figure 22: Age-specific Incidence of HR+/HER2– Breast Cancer in EU4 and the UK (2019–2032)

    Figure 23: Treatment-eligible Pool for HR+/HER2– Breast Cancer in EU4 and the UK (2019–2032)

    Figure 24: Total Incidence of Breast Cancer in Japan (2019–2032)

    Figure 25: Incidence of HR+/HER2– Breast Cancer in Japan (2019–2032)

    Figure 26: Incidence of HR+/HER2– Breast Cancer Cases by Menopausal Status in Japan (2019–2032)

    Figure 27: Stage-specific Incidence of HR+/HER2– Breast Cancer in Japan (2019–2032)

    Figure 28: Age-specific Incidence of HR+/HER2– Breast Cancer in Japan (2019–2032)

    Figure 29: Treatment-eligible Pool for HR+/HER2– Breast Cancer in Japan (2019–2032)

    Figure 30: Market Size of HR+/HER2- Breast Cancer in the 7MM, in USD million (2019–2032)

    Figure 31: Market Size of HR+/HER2- Breast Cancer in the US, in USD million (2019–2032)

    Figure 32: Market Size of HR+/HER2- Breast Cancer in the US by Current and Emerging Therapies, in USD million (2019–2032)

    Figure 33: Market Size of HR+/HER2- Breast Cancer in EU4 and the UK, in USD million (2019–2032)

    Figure 34: Market Size of HR+/HER2- Breast Cancer by Current and Emerging Therapies in EU4 and the UK, in USD million (2019–2032)

    Figure 35: Market Size of HR+/HER2- Breast Cancer in Japan, in USD million (2019–2032)

    Figure 36: Market Size of HR+/HER2- Breast Cancer by Current and Emerging Therapies in Japan, in USD million (2019–2032)

    Figure 37: Unmet Needs

    Figure 38: Health Technology Assessment

    Figure 39: Reimbursement Process in Germany

    Figure 40: Reimbursement Process in France

    Figure 41: Reimbursement Process in Italy

    Figure 42: Reimbursement Process in Spain

    Figure 43: Reimbursement Process in the United Kingdom

    Figure 44: Reimbursement Process in Japan

List of Companies:

    • Merck
    • Arvinas
    • Olema Pharmaceuticals
    • Celcuity
    • Roche
    • AstraZeneca
    • Daiichi Sankyo
    • Eli Lilly
    • Sermonix Pharmaceuticals
    • Genentech
    • Veru Pharma
    • DualityBio
    • BioNtech
    • Evgen Pharma
    • Carrick Therapeutics
    • EQRx
    • G1 Therapeutics
    • Immutep, and others

Frequently Asked Questions

HR+ HER2-VE breast cancer is a subtype where cancer cells have hormone receptors (HR+), responding to estrogen and/or progesterone, but lack excess HER2 protein (HER2-). This type often grows at a slower rate and can be managed with hormone-targeted therapies, reducing hormone activity to slow cancer growth.

Yes, the HR+ HER2-VE Breast Cancer market is anticipated to transform in the upcoming years. Some of the key factors such as the ongoing research into HR+ HER2-VE breast cancer, improved understanding of the genetic and molecular characteristics of tumors, growth in the research efforts and clinical trials exploring novel treatment combinations and approaches, and regulatory support, will likely change the HR+ HER2-VE Breast Cancer market dynamics in the upcoming years.

Among the 7MM, the United States holds the largest HR+ HER2-VE Breast Cancer market share.

The HR+ HER2-VE Breast Cancer epidemiology scenario is expected to change in the 7MM owing to the rise in the number of cases of HR+ HER2-VE Breast Cancer and growing awareness among the public.

Some of the major pharma and biotech companies such as Pfizer, Novartis, AstraZeneca Pharmaceuticals, Eli Lilly, Jiangsu HengRui Medicine, Odonate Therapeutics, Radius Pharmaceuticals, Immunomedics, among others, are actively working to develop HR+ HER2-VE Breast Cancer drugs for better treatment outcomes.

DelveInsight’s “HR+ HER2-VE Breast Cancer Market Report” covers an in-depth market outlook, epidemiology trends, and therapeutic development for the study period.

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