Metastatic HR+/HER2 - Breast Cancer - Market Insights, Epidemiology, and Market Forecast-2032

Key Highlights

• 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.

This "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.

Geography Covered

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

Study Period: 2019-2032

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

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.

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.

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.

Emerging Drugs

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.

Comparison of Emerging Drugs

Drug Name Company Patient Segment MoA RoA Molecule Type Designation
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 FTD
Detailed emerging therapies assessment will be provided in the final report.

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.

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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 report provides insights into therapeutic candidates in 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 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.

The 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.

Qualitative Analysis

The publisher performed 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.

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 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

• Patient Population
• 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

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

Metastatic HR+/HER2- Breast Cancer Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Analyst Views)

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

• 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