The total metastatic HR+/HER2− breast cancer market size in the 7MM was estimated to be nearly USD 9.1 billion in 2022, which is expected to show positive growth by 2032. The emergence of several novel CDK4/6 inhibitors in the ER+/HER2– breast cancer market 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.
LAS VEGAS, Dec. 4, 2023 /PRNewswire/ -- DelveInsight's Metastatic HR+/HER2− Breast Cancer Market Insights report includes a comprehensive understanding of current treatment practices, metastatic HR+/HER2− breast cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Metastatic HR+/HER2− Breast Cancer Market Report Key Takeaways from the
- As per DelveInsight estimates, the total incident population of HR+/HER2- breast cancer in the 7MM was nearly 468K cases in 2022. The cases in the 7MM are expected to increase during the study period, i.e., 2019–2032.
- Leading metastatic HR+/HER2− breast cancer companies such as 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 are developing novel metastatic HR+/HER2− breast cancer drugs that can be available in the metastatic HR+/HER2− breast cancer market in the coming years.
- The promising metastatic HR+/HER2− breast cancer therapies in the pipeline include KEYTRUDA (perbrolizumab), ARV-471 (vepdegestrant), OP1250 (palazestrant), Gedatolisib, Giredestrant (RG6171, GDC-9545), Datopotamab Deruxtecan (Dato-DXd), Camizestrant (AZD9833), LY3484356/Imlunestrant, Lasofoxifene, Capivasertib, Inavolisib, Enobosarm, DB-1303, SFX-01, Samuraciclib (CT-7001), Lerociclib, Eftilagimod Alpha (LAG-3lg/IMP321), and others.
- The development and approval of CDK4/6 inhibitors has transformed the treatment landscape of HR+/HER2− metastatic breast cancer. Currently, three selective CDK4/6 inhibitor agents, including palbociclib (IBRANCE), ribociclib (KISQALI), abemaciclib (VERZENIO), combined with endocrine therapy are the preferred choice for front-line treatment. Now NCCN has recommended KISQALI in the first-line metastatic setting. Chemotherapy and ADCs are used once ET and targeted therapy options are exhausted.
- Approved next in the line is TRODELVY, an ADC, that could now provide new hope for people living with pre-treated HR+/HER2− metastatic breast cancer, building on the transformative role that TRODELVY is already playing for people with metastatic triple-negative breast cancer.
- ORSERDU is the first endocrine innovation in 20 years specifically targeting ESR1 mutations in ER+, HER2−, advanced, or metastatic breast cancer patients with disease progression following at least one line of endocrine therapy.
- The emerging pipeline is crowded by HR+/HER2- potential therapies whereas few of them have shifted their focus to evaluate the therapies targeting the newly discovered 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.
Discover which therapies are expected to grab the major metastatic HR+/HER2− breast cancer market share @ Metastatic HR+/HER2− Breast Cancer Market Report
Metastatic HR+/HER2− Breast Cancer Overview
The most frequently encountered type of breast cancer is HR+ HER2- subtype, characterized by cancer cells with estrogen and progesterone hormone receptors while lacking HER2 overexpression. The trajectory of a patient diagnosed with hormone receptor-positive, HER2-negative breast cancer typically commences with the identification of worrisome symptoms, prompting a thorough clinical examination and various imaging procedures. Subsequent confirmation and characterization of the cancer occur through a biopsy. Staging examinations then gauge the cancer's spread, facilitating a collaborative approach by a multidisciplinary team to develop an individualized treatment strategy. This often encompasses hormone therapy, surgical intervention, radiation, and potentially chemotherapy or targeted therapies. Recognizing the emotional impact, a vital component of care involves providing emotional support. Follow-up care ensures continuous monitoring and adaptation of treatment, fostering optimism for a successful recovery and ongoing survivorship.
Metastatic HR+/HER2− Breast Cancer Epidemiology Segmentation
As per DelveInsight analysis, the HR+ HER2- breast cases were highest in the United States accounting for ~201K 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 97K cases in 2022.
The metastatic HR+/HER2− breast cancer market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
- 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
- Treatment-Eligible Pool for HR+/HER2- Breast Cancer
Metastatic HR+/HER2− Breast Cancer Treatment Market
The management of HR+/HER2- breast cancer typically employs a comprehensive approach. Hormone therapy, a primary strategy, works by inhibiting estrogen's influence on cancer cells. Surgical procedures, such as lumpectomy or mastectomy, are utilized to excise the tumor. Post-surgery, radiation therapy is employed to target any residual cancer cells. In cases of advanced cancer, options may include chemotherapy or targeted therapies, such as CDK4/6 inhibitors. The treatment plan is tailored based on various factors including cancer stage, receptor status, and the individual's preferences. Regular monitoring and follow-up are crucial to monitor progress and make necessary adjustments in the treatment regimen, providing the best opportunity for effective management and long-term survival.
Various classes of anti-estrogenic drugs are accessible for patients with early, advanced, or metastatic breast cancer. These encompass Selective Estrogen Receptor Modulators (SERMs), Aromatase Inhibitors (AIs), and Selective Estrogen Receptor Degraders. Currently, there is a significant emphasis on clinical research for combinations of antiestrogenic therapy with targeted agents inhibiting the PI3K/AKT/mTOR signaling pathway or the cyclin-dependent kinase 4/6 (CDK4/6) pathway at the G1/S checkpoint of the cell cycle. This focus is particularly crucial for patients with hormone-receptor-positive breast cancer showing signs of disease recurrence or progression.
To know more about metastatic HR+/HER2− breast cancer treatment guidelines, visit @ Metastatic HR+/HER2− Breast Cancer Management
Metastatic HR+/HER2− Breast Cancer Pipeline Therapies and Key Companies
- KEYTRUDA (perbrolizumab): Merck
- ARV-471 (vepdegestrant): Arvinas
- OP1250 (palazestrant): Olema Pharmaceuticals
- Gedatolisib: Celcuity
- Giredestrant (RG6171, GDC-9545): Roche
- Datopotamab Deruxtecan (Dato-DXd): AstraZeneca and Daiichi Sankyo
- Camizestrant (AZD9833): AstraZeneca
- LY3484356/Imlunestrant: Eli Lilly
- Lasofoxifene: Sermonix Pharmaceuticals
- Capivasertib: AstraZeneca
- Inavolisib: Roche/Genentech
- Enobosarm: Veru Pharma
- DB-1303: DualityBio/BioNtech
- SFX-01: Evgen Pharma
- Samuraciclib (CT-7001): Carrick Therapeutics
- Lerociclib: EQRx/G1 Therapeutics
- Eftilagimod Alpha (LAG-3lg/IMP321): Immutep
Learn more about the FDA-approved drugs for metastatic HR+/HER2− breast cancer @ Drugs for Metastatic HR+/HER2− Breast Cancer Treatment
Metastatic HR+/HER2− Breast Cancer Market Dynamics
The metastatic HR+/HER2- breast cancer market landscape is expected to undergo significant changes in the coming years. Ongoing research in the field of molecular biology is likely to identify new biomarkers and molecular targets specific to HR+/HER2- breast cancer. This could lead to the development of novel targeted therapies that aim to address the specific pathways involved in the progression of this subtype. Moreover, the integration of immunotherapy into the treatment paradigm for metastatic breast cancer is an area of active investigation. Immunotherapeutic approaches, such as immune checkpoint inhibitors, may play a role in enhancing the immune response against cancer cells, providing a new avenue for treatment.
Furthermore, the metastatic HR+/HER2− breast cancer pipeline is very robust; many potential therapies including, KEYTRUDA (perbrolizumab) (Merck), ARV-471 (vepdegestrant) (Arvinas), Camizestrant (AZD9833) (AstraZeneca), LY3484356/Imlunestrant (Eli Lilly), andd others are being investigated for the treatment of metastatic HR+/HER2− breast cancer, and it is safe to predict that the treatment space will significantly impact the metastatic HR+/HER2− breast cancer market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the metastatic HR+/HER2− breast cancer market in the 7MM.
The metastatic HR+/HER2− breast cancer market faces several formidable barriers to evolution in the coming years. One significant challenge is the complexity of the disease itself, marked by heterogeneity in patient populations and treatment responses. The lack of a one-size-fits-all approach hampers the development of targeted therapies and personalized treatment regimens. Additionally, the high cost of innovative therapies and the financial burden on healthcare systems pose a substantial hurdle. Access to advanced treatments may be limited for some patients, exacerbating disparities in healthcare.
Metastatic HR+/HER2− Breast Cancer Market Report Metrics |
Details |
Study Period |
2019–2032 |
Coverage |
7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. |
Metastatic HR+/HER2− Breast Cancer Market Size in 2022 |
USD 9.1 Billion |
Key Metastatic HR+/HER2− Breast Cancer 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 |
Key Pipeline Metastatic HR+/HER2− Breast Cancer Therapies |
KEYTRUDA (perbrolizumab), ARV-471 (vepdegestrant), OP1250 (palazestrant), Gedatolisib, Giredestrant (RG6171, GDC-9545), Datopotamab Deruxtecan (Dato-DXd), Camizestrant (AZD9833), LY3484356/Imlunestrant, Lasofoxifene, Capivasertib, Inavolisib, Enobosarm, DB-1303, SFX-01, Samuraciclib (CT-7001), Lerociclib, Eftilagimod Alpha (LAG-3lg/IMP321), and others |
Scope of the Metastatic HR+/HER2− Breast Cancer Market Report
- Metastatic HR+/HER2− Breast Cancer Therapeutic Assessment: Metastatic HR+/HER2− Breast Cancer current marketed and emerging therapies
- Metastatic HR+/HER2− Breast Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Metastatic HR+/HER2− Breast Cancer Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Metastatic HR+/HER2− Breast Cancer Market Access and Reimbursement
Discover more about metastatic HR+/HER2− breast cancer drugs in development @ Metastatic HR+/HER2− Breast Cancer Clinical Trials
Table of Contents
1. |
Metastatic HR+/HER2− Breast Cancer Key Insights |
2. |
Metastatic HR+/HER2− Breast Cancer Report Introduction |
3. |
Metastatic HR+/HER2− Breast Cancer Overview at a Glance |
4. |
Metastatic HR+/HER2− Breast Cancer Executive Summary |
5 |
Metastatic HR+/HER2− Breast Cancer Key Events |
6 |
Epidemiology and Market Forecast Methodology |
6. |
Disease Background and Overview |
7. |
Metastatic HR+/HER2− Breast Cancer Treatment and Management |
8. |
Metastatic HR+/HER2− Breast Cancer Guidelines |
9. |
Metastatic HR+/HER2− Breast Cancer Epidemiology and Patient Population |
10. |
Patient Journey |
11. |
Key Endpoints in Metastatic HR+/HER2− Breast Cancer |
12. |
Metastatic HR+/HER2− Breast Cancer Marketed Drugs |
13. |
Metastatic HR+/HER2− Breast Cancer Emerging Drugs |
14. |
7MM Metastatic HR+/HER2− Breast Cancer Market Analysis |
15. |
Market Access and Reimbursement |
16. |
KOL Views |
17. |
Unmet Needs |
18. |
SWOT Analysis |
19. |
Appendix |
20. |
DelveInsight Capabilities |
21. |
Disclaimer |
22. |
About DelveInsight |
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