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DelveInsight's ESR1 Mutated Metastatic Breast Cancer-Market Insights, Epidemiology, and Market Forecast-2030' report deliver an in-depth understanding of the ESR1 Mutated Metastatic Breast Cancer, historical and forecasted epidemiology as well as the ESR1 Mutated Metastatic Breast Cancer market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The ESR1 Mutated Metastatic Breast Cancer market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM ESR1 Mutated Metastatic Breast Cancer market size from 2018 to 2030. The Report also covers current ESR1 Mutated Metastatic Breast Cancer treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Study Period: 2018-2030
ESR1 Mutated Metastatic Breast Cancer Disease Understanding and Treatment Algorithm
ESR1 Mutated Metastatic Breast Cancer Overview
Metastatic breast cancer is essentially a Stage IV breast cancer wherein cancer originates in breast tissue and then spreads to other body parts. The steroid hormone, estradiol, plays a vital role in breast cancer progression, and a majority of human breast cancers start as estrogen-dependent and express the estrogen receptor (ER). ERa is the major ER subtype in the mammary epithelium and plays a critical role in mammary gland biology and breast cancer progression.
Estrogen receptor alpha (ERa), encoded by the ESR1 gene, is a member of the nuclear hormone receptor superfamily that is expressed in ~70% of newly diagnosed breast cancers. Most of the breast cancers are ERa positive and are, therefore, treated with endocrine therapies. ESR1 mutations are acquired most frequently when aromatase inhibitors are used to treat advanced breast cancer are more frequently selected in cancers that progress after sensitivity to prior aromatase inhibitor therapy and are relatively rare in patients with intrinsic endocrine resistance.
ESR1 Mutated Metastatic Breast Cancer Diagnosis
At the time of diagnosis, tumor tissue and baseline liquid biopsies could be used for mutation detection using sensitive next-generation sequencing or MPS. Following neoadjuvant therapy, ddPCR could be employed to confirm ESR1 mutations. ddPCR could also be used to monitor mutation status during hormone therapy via blood sampling during standard follow-up visits. These liquid biopsies could also be used to monitor emerging driver mutations and subclonal evolution during therapy which would affect hormone therapy sequencing and enable precision therapy on an individual basis. Plasma sample (ctDNA) and ddPCR technology are new and reliable for the determination of ESR1 mutation.
ESR1 Mutated Metastatic Breast Cancer Treatment
Current treatment guidelines for ER-positive MBC do not stratify patients based on ESR1 mutation status. Although many preclinical studies have demonstrated that ESR1 mutant cells respond to fulvestrant, with less sensitivity, however, patients treated with fulvestrant monotherapy alone or combined with palbociclib continued to acquire the Y537S ESR1 mutation during treatment.
For postmenopausal women with HR-positive, HER2-positive recurrent/stage IV breast cancer, the preferred options available include fulvestrant with a CDK 4/6 inhibitor (palbociclib, ribociclib, and abemaciclib; category1), or for those with tumor PIK3CA mutations, fulvestrant with alpelisib; everolimus with either an AI, tamoxifen or fulvestrant; monotherapy with fulvestrant, nonsteroidal or steroidal AI, or SERM.
Estrogen receptor 1 (ESR1) activating mutations are frequently detected in patients with prior exposure to AIs. Tumors with these mutations are generally resistant to both AIs and tamoxifen. Certain tumors with these mutations retain sensitivity to fulvestrant. All may benefit from the addition of a CDK 4/6-inhibitor, mTOR-inhibitor, or alpelisib in combination with fulvestrant if the tumor has PIK3CA mutation.
ESR1 Mutated Metastatic Breast Cancer Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of HR-positive breast cancer, stage-specific diagnosed prevalent cases of HR-positive breast cancer, total diagnosed prevalent cases of metastatic breast cancer, and diagnosed prevalent cases of ESR1 mutated metastatic breast cancer scenario of ESR1 Mutated Metastatic Breast Cancer in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.
Key Findings
- According to DelveInsight, in 2020, it is estimated that the total diagnosed prevalent cases of HR-positive breast cancer in the 7MM were 1,158,467. It was noted that among diagnosed prevalent cases of HR-positive breast cancer in the 7MM, the maximum number of cases were occupied by the United States (494,584), in 2020.
- Based on the different stages of the disease, diagnosed prevalent population of HR+ breast cancer varied as 464,909 and 29,675 for early-stage and distant/metastatic stage breast cancer cases, respectively in the United States for the year 2020.
- In the 7MM, the diagnosed prevalent cases of metastatic breast cancer were 341,748 in 2020. That also includes early-stage cases which progressed to metastatic stage.
- In 2020, the diagnosed prevalent cases of metastatic breast cancer in the US were 145,902, these cases also included early-stage cases which progressed to metastatic. The diagnosed prevalent metastatic breast cancer cases are likely to increase by 2030 at a CAGR of 2.17%.
- In the United States, the diagnosed prevalent cases of ESR1 mutated metastatic breast cancer was 24,575 in 2020 which included 17,654 cases from first-line and 6,920 cases from the second line.
- Among EU-5 countries, Germany captured the highest diagnosed prevalent cases of ESR1 mutated metastatic breast cancer with 6,585 cases, followed by France (5,534 cases) and Italy (5,278 cases) in 2020. Spain consistently showed to possess the least cases among other EU5 countries throughout the study period (2018-2030).
- In Japan, the diagnosed prevalent cases of ESR1 mutated metastatic breast cancer was 7,426 in 2020 which included 5,335 cases from first-line and 2,091 cases from the second line of treatment.
ESR1 Mutated Metastatic Breast Cancer Epidemiology
The epidemiology segment also provides the ESR1 Mutated Metastatic Breast Cancer epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
ESR1 Mutated Metastatic Breast Cancer Drug Chapters
The drug chapter segment of the ESR1 Mutated Metastatic Breast Cancer report encloses the detailed analysis of ESR1 Mutated Metastatic Breast Cancer marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the ESR1 Mutated Metastatic Breast Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.
ESR1 Mutated Metastatic Breast Cancer Emerging Drugs
Elacestrant (RAD1901): Radius Pharmaceuticals/Berlin-Chemie (Menarini Group)
Radius Pharmaceutical's elacestrant is a selective estrogen receptor degrader (SERD) out-licensed to Menarini Group, which is being evaluated for potential use as a once-daily oral treatment for HR+ breast cancer. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The Phase III trial EMERALD with Radius' partner Menarini Group is on track for topline results readout during the second half of 2021.
Products detail in the report
Amcenestrant (SAR439859): Sanofi
Sanofi's Amcenestrant (formerly known as SAR439859) is an investigational oral selective estrogen receptor degrader (SERD) dosed once daily. It antagonizes and degrades the estrogen receptor (ER), in turn blocking the ER signaling pathway. Amcenestrant is a potent, oral selective estrogen receptor a-(ERa) degrader, dosed once daily. The drugs have received FDA fast-track designation. In February 2020, Sanofi announced that it intends to submit a regulatory application for metastatic or locally advanced breast cancer, progressing after previous hormonal therapies in 2021.
Products detail in the report
Rintodestrant (G1T48): G1 Therapeutics, Inc.
G1 is advancing one novel therapy for people living with cancer. Rintodestrant is an oral selective estrogen receptor degrader (SERD), which is being developed as a monotherapy and combined with a CDK4/6 inhibitor, Ibrance (palbociclib), for the treatment of ER+ HER2- breast cancer. The company will evaluate partnering options for rintodestrant following data read-out from the combination study with palbociclib. The drug is currently being evaluated in phase I/IIa (dose escalation/dose expansion) clinical trial in ER+, HER2- breast cancer. The company recently announced Phase II results.
Products detail in the report
List to be continued in the report
ESR1 Mutated Metastatic Breast Cancer Market Outlook
United States contributes to the major share of the ESR1 Mutated Metastatic Breast Cancer market as compared to other countries, such as EU5 (Italy, Spain, United Kingdom, France, and Germany) and Japan.
Preclinical and clinical studies have demonstrated that ESR1 mutations can preexist in primary tumors and can be enriched during metastasis. Furthermore, ESR1 mutations express a unique transcriptional profile that favors tumor progression, suggesting that selected ESR1 mutations may influence metastasis
Patients with ESR1-mutant ER+ HER2- breast cancer still lack treatment options despite the latest advances in disease biology and detection, making this an area of unmet need. These ESR1 mutations are present in approximately 40% of patients, and currently, their presence is associated with predictive information.
ESR1 mutations have increased over time, even with AI therapy, indicating their adaptability to AI therapeutic conditions. In addition, the presence of ESR1 mutations has been correlated with a shorter time to treatment failure, as MBC patients with ESR1 mutations exhibit an inadequate response to and shorter duration of effective endocrine control. Suppose AI treatment provides selection pressure for mutant-bearing clonal outgrowth in patients. In that case, the next option for therapy is likely a more effective selective estrogen receptor modulators (SERMs) and/or selective estrogen receptor downregulators (SERDs). Various studies have predicted that ESR1 mutations will still respond to SERMs or SERDs, though perhaps at a decreased sensitivity based on in vitro, xenograft, and PDX preclinical models. In the past 5 years, agents that have become available are CDK4/6 inhibitors.
According to DelveInsight, ESR1 Mutated Metastatic Breast Cancer 7MM is expected to change in the study period 2018-2030.
Key Findings
- The market size for ESR1 Mutated Metastatic Breast Cancer was USD 919 million in 2020 in the United States.
- DelveInsight's analysts estimate that the market is expected to show positive growth, mainly attributed to the increase in cancer prevalence and also, the launch of upcoming therapies during the forecast period. Through this, the market size is set to show an extensive jump by end of 2030, at a CAGR of 4.48% from 2018-2030.
- The market size of ESR1 mutated metastatic breast cancer in the EU5 was USD 415 million in 2020. EU5 accounted for 29% of the total 7MM market size. Among the EU5 countries, Germany holds the highest market size of USD 107 million followed by France (USD 90 million) and Italy (USD 86 million). Spain holds the least market size of USD 51 million among the EU5 countries in 2020.
- The market size of ESR1 mutated metastatic breast cancer in the EU5 is expected to increase by the end of 2030, at a CAGR of 4.11% for the study period 2018-2030. The main growth factors for this surge will be the expected approval of emerging therapies such as Elacestrant, Lasofoxifene + abemaciclib, Amcenestrant + Palbociclib, Camizestrant (AZD9833) + Palbociclib, Giredestrant + Palbociclib, etc.
- The market size of ESR1 mutated metastatic breast cancer in Japan was USD 120 million in 2020. Japan accounted for 8.3% of the total 7MM market size.
The United States Market Outlook
This section provides the total ESR1 Mutated Metastatic Breast Cancer market size and market size by therapies in the United States.
EU-5 Market Outlook
The total ESR1 Mutated Metastatic Breast Cancer market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total ESR1 Mutated Metastatic Breast Cancer market size and market size by therapies in Japan are provided.
ESR1 Mutated Metastatic Breast Cancer Drugs Uptake
This section focuses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2018-2030. The analysis covers ESR1 Mutated Metastatic Breast Cancer market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
ESR1 Mutated Metastatic Breast Cancer Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for ESR1 Mutated Metastatic Breast Cancer emerging therapies.
Reimbursement Scenario in ESR1 Mutated Metastatic Breast Cancer
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the ESR1 Mutated Metastatic Breast Cancer market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of ESR1 Mutated Metastatic Breast Cancer, explaining various diagnostic approaches and treatments.
- Comprehensive insight has been provided into the ESR1 Mutated Metastatic Breast Cancer epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for ESR1 Mutated Metastatic Breast Cancer is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the ESR1 Mutated Metastatic Breast Cancer market; historical and forecasted is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM ESR1 Mutated Metastatic Breast Cancer market.
Report Highlights
- The robust pipeline with novel MOA and oral ROA and increasing prevalence will positively drive the ESR1 Mutated Metastatic Breast Cancer market.
- The companies and academics are working to assess challenges and seek opportunities that could influence ESR1 Mutated Metastatic Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
- Major players are involved in developing therapies for ESR1 Mutated Metastatic Breast Cancer. The launch of emerging therapies will significantly impact the ESR1 Mutated Metastatic Breast Cancer market.
- Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
ESR1 Mutated Metastatic Breast Cancer Report Insights
- Patient Population
- Therapeutic Approaches
- ESR1 Mutated Metastatic Breast Cancer Pipeline Analysis
- ESR1 Mutated Metastatic Breast Cancer Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
ESR1 Mutated Metastatic Breast Cancer Report Key Strengths
- 10-Years Forecast
- 7MM Coverage
- ESR1 Mutated Metastatic Breast Cancer Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
ESR1 Mutated Metastatic Breast Cancer Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- SWOT analysis
Key Questions
Market Insights:
- What was the ESR1 Mutated Metastatic Breast Cancer market share (%) distribution in 2018 and how it would look like in 2030?
- What would be the ESR1 Mutated Metastatic Breast Cancer total market size as well as market size by therapies across the 7MM during the forecast period (2021-2030)?
- What are the
Key Findings pertaining to the market across the 7MM and which country will have the largest ESR1 Mutated Metastatic Breast Cancer market size during the forecast period (2021-2030)?
- At what CAGR, the ESR1 Mutated Metastatic Breast Cancer market is expected to grow at the 7MM level during the forecast period (2021-2030)?
- What would be the ESR1 Mutated Metastatic Breast Cancer market outlook across the 7MM during the forecast period (2021-2030)?
- What would be the ESR1 Mutated Metastatic Breast Cancer market growth till 2030 and what will be the resultant market size in the year 2030?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
- What are the disease risk, burden, and unmet needs of ESR1 Mutated Metastatic Breast Cancer?
- What is the historical ESR1 Mutated Metastatic Breast Cancer patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
- What would be the forecasted patient pool of ESR1 Mutated Metastatic Breast Cancer at the 7MM level?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to ESR1 Mutated Metastatic Breast Cancer?
- Out of the above-mentioned countries, which country would have the highest prevalent population of ESR1 Mutated Metastatic Breast Cancer during the forecast period (2021-2030)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2021-2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the treatment of ESR1 Mutated Metastatic Breast Cancer?
- What are the ESR1 Mutated Metastatic Breast Cancer marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
- How many companies are developing therapies for the treatment of ESR1 Mutated Metastatic Breast Cancer?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of ESR1 Mutated Metastatic Breast Cancer?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the ESR1 Mutated Metastatic Breast Cancer therapies?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for ESR1 Mutated Metastatic Breast Cancer and their status?
- What are the key designations that have been granted for the emerging therapies for ESR1 Mutated Metastatic Breast Cancer?
- What are the 7MM historical and forecasted market of ESR1 Mutated Metastatic Breast Cancer?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving the ESR1 Mutated Metastatic Breast Cancer.
- To understand the future market competition in the ESR1 Mutated Metastatic Breast Cancer market and an insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for ESR1 Mutated Metastatic Breast Cancer in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for the ESR1 Mutated Metastatic Breast Cancer market.
- To understand the future market competition in the ESR1 Mutated Metastatic Breast Cancer market.