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市場調查報告書

ESR1變異型轉移性乳癌:市場洞察、流行病學、市場預測(2030年)

ESR1 Mutated Metastatic Breast Cancer- Market Insight, Epidemiology and Market Forecast -2030

出版商 DelveInsight Business Research LLP 商品編碼 1023351
出版日期 按訂單生產 內容資訊 英文 167 Pages
商品交期: 2-10個工作天內
價格
ESR1變異型轉移性乳癌:市場洞察、流行病學、市場預測(2030年) ESR1 Mutated Metastatic Breast Cancer- Market Insight, Epidemiology and Market Forecast -2030
出版日期: 按訂單生產內容資訊: 英文 167 Pages
簡介

主要7個國家(美國,英國,德國,法國,義大利,西班牙,日本)的ESR1變異型轉移性乳癌的2020年的罹患數估計為115萬8,467人。ESR1變異型轉移性乳癌的市場規模,在美國,歐洲5個國家,日本各估計為9億1,900萬美元、4億1,500萬美元、1億2,000萬美元。

本報告提供主要7個國家的ESR1變異型轉移性乳癌市場相關調查,市場概要,疾病概要,各國的罹患數,已上市產品及新興治療藥詳細內容,市場規模的變化與預測,市場成長要素及障礙分析,未滿足需求,市場潛在性等相關資訊。

目錄

第1章 重要洞察

第2章 簡介

第3章 市場概要

  • ESR1變異型轉移性乳癌的市場佔有率:各治療法(一線)(2018年)
  • ESR1變異型轉移性乳癌的市場佔有率:各治療法(二線+)(2018年)
  • ESR1變異型轉移性乳癌的市場佔有率:各治療法(一線)(2030年)
  • ESR1變異型轉移性乳癌的市場佔有率:各治療法(二線+)(2030年)

第4章 ESR1變異型轉移性乳癌市場:未來展望

第5章 摘要整理

第6章 主要活動

第7章 疾病背景和概要

  • 簡介
  • ESR1變異
  • 內分泌療法
  • 診斷
  • 治療和管理

第8章 流行病學和患者人口

  • 主要調查結果
  • 流行病學的調查手法
  • 流行病學的假設和理論性根據
  • 主要7個國家的HR陽性乳癌的診斷罹患數
  • 主要7個國家的ESR1變異型轉移性乳癌的總診斷罹患數
  • 美國
    • HR陽性乳癌的診斷罹患數:各階段
    • 轉移性乳癌的診斷罹患數
    • ESR1變異型轉移性乳癌的診斷罹患數
  • 歐洲5個國家
  • 日本

第9章 病患歷程

第10章 推動ESR1變異型轉移性乳癌治療的組織

第11章 新藥

  • 關鍵交叉競爭
  • Elacestrant(RAD1901):Radius Pharmaceuticals/Berlin-Chemie(Menarini Group)
    • 產品說明
    • 其他開發趨勢
    • 臨床開發
    • 臨床實驗資訊
    • 安全性和有效性
    • 產品簡介
    • 分析師的見解
  • Ibrance (Palbociclib):Pfizer
  • Amcenestrant(SAR439859):Sanofi
  • Rintodestrant (G1T48):G1 Therapeutics, Inc.
  • SCO-120:Sun Pharma Advanced Research Company
  • ZB716:Zenopharm
  • ARV-471:Arvinas
  • Lasofoxifene:Sermonix Pharmaceuticals
  • H3B-6545:H3 Biomedicine/Eisai
  • Giredestrant (RG6171, GDC-9545):Roche
  • Camizestrant (AZD9833):AstraZeneca
  • LSZ102:Novartis
  • ZN-c5:Zentalis Pharmaceuticals
  • OP1250:Olema Pharmaceuticals

第12章 市場分析ESR1變異型轉移性乳癌:主要7個國家

  • 主要調查結果
  • 市場調查手法
  • 主要7個國家的ESR1變異型轉移性乳癌的市場規模
  • 主要7個國家的ESR1變異型轉移性乳癌的市場規模:各治療法
  • 新的治療方法和目前治療方法的可能性
  • 主要的市場預測的前提條件
  • 屬性分析
  • 市場預測
  • 美國
  • 歐洲5個國家
  • 日本

第13章 關鍵意見領袖的意見

第14章 市場推動因素

第15章 市場障礙

第16章 SWOT分析

第17章 未滿足需求

第18章 償付和市場進入

第19章 附錄

第20章 DelveInsight的服務內容

第21章 免責聲明

第22章 關於DelveInsight

目錄
Product Code: DIMI1505

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). ERα 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 (ERα), 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 ERα 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.

Continued in the report…..

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 α-(ERα) 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. 

Table of Contents

1 Key Insights

2 Report Introduction

3 ESR1 Mutated Metastatic Breast Cancer Market Overview at a Glance

  • 3.1 Market Share (%) Distribution of ESR1 Mutated metastatic breast cancer by Therapies (First-line) in 2018
  • 3.2 Market Share (%) Distribution of ESR1 Mutated metastatic breast cancer by Therapies (Second-line Plus) in 2018
  • 3.3 Market Share (%) Distribution of ESR1 Mutated metastatic breast cancer by Therapies (First-line) in 2030
  • 3.4 Market Share (%) Distribution of ESR1 Mutated metastatic breast cancer by Therapies (Second-line Plus) in 2030

4 ESR1 Mutated Metastatic Breast Cancer Market: Future Perspective

5 Executive Summary of ESR1 Mutated Metastatic Breast Cancer

6 Key Events

7 Disease Background and Overview

  • 7.1 Introduction
  • 7.2 ESR1 Mutations
    • 7.2.1 The Spectrum of ESR1 Alterations is found in Metastatic ER+ Breast Cancer
    • 7.2.2 Subgroups at Increased Risk of Developing ESR1 Mutations
  • 7.3 Endocrine therapy
    • 7.3.1 Mechanisms of Endocrine Therapy Resistance
  • 7.4 Diagnosis
  • 7.5 Treatment and Management

8 Epidemiology and Patient Population

  • 8.1 Key Findings
  • 8.2 Methodology of Epidemiology
  • 8.3 Epidemiology Assumptions and Rationale
  • 8.4 Total Diagnosed Prevalent Cases of HR Positive Breast Cancer in the 7MM
  • 8.5 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the 7MM
    • 8.5.1 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the First Line in the 7MM
    • 8.5.2 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the Second Line plus in the 7MM
  • 8.6 United States
    • 8.6.1 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in the United States
    • 8.6.2 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in the United States
    • 8.6.3 Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer in the United States
  • 8.7 EU-5
    • 8.7.1 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in the EU-5
    • 8.7.2 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in the EU-5
    • 8.7.3 Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer in the EU-5
  • 8.8 Japan
    • 8.8.1 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in Japan
    • 8.8.2 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in Japan
    • 8.8.3 Diagnosed Prevalent Cases of ESR1 Mutation Metastatic Breast Cancer in Japan

9 Patient Journey

10 Organizations contributing towards ESR1 Mutated Metastatic Breast Cancer

11 Emerging Drugs

  • 11.1 Key Cross Competition
  • 11.2 Elacestrant (RAD1901): Radius Pharmaceuticals/Berlin-Chemie (Menarini Group)
    • 11.2.1 Product Description
    • 11.2.2 Other Developmental Activities
    • 11.2.3 Clinical Development
    • 11.2.4 Clinical Trials Information
    • 11.2.5 Safety and Efficacy
    • 11.2.6 Product Profile
    • 11.2.7 Analysts' Views
  • 11.3 Ibrance (Palbociclib): Pfizer
    • 11.3.1 Drug Description
    • 11.3.2 Other Developmental Activities
    • 11.3.3 Clinical Development
    • 11.3.4 Clinical Trials Information
    • 11.3.5 Safety and Efficacy
    • 11.3.6 Product Profile
  • 11.4 Amcenestrant (SAR439859): Sanofi
    • 11.4.1 Product Description
    • 11.4.2 Other Developmental Activities
    • 11.4.3 Clinical Development
    • 11.4.4 Clinical Trials Information
    • 11.4.5 Safety and Efficacy
    • 11.4.6 Product Profile
    • 11.4.7 Analysts' Views
  • 11.5 Rintodestrant (G1T48): G1 Therapeutics, Inc.
    • 11.5.1 Product Description
    • 11.5.2 Other Developmental Activities
    • 11.5.3 Clinical Development
    • 11.5.4 Clinical Trials Information
    • 11.5.5 Safety and Efficacy
    • 11.5.6 Product Profile
    • 11.5.7 Analysts' Views
  • 11.6 SCO-120: Sun Pharma Advanced Research Company
    • 11.6.1 Drug Description
    • 11.6.2 Clinical Development
    • 11.6.3 Clinical Trials Information
    • 11.6.4 Product Profile
  • 11.7 ZB716: Zenopharm
    • 11.7.1 Drug Description
    • 11.7.2 Clinical Development
    • 11.7.3 Clinical Trials Information
    • 11.7.4 Product Profile
  • 11.8 ARV-471: Arvinas
    • 11.8.1 Drug Description
    • 11.8.2 Other Developmental Activities
    • 11.8.3 Clinical Development
    • 11.8.4 Clinical Trials Information
    • 11.8.5 Safety and Efficacy
    • 11.8.6 Product Profile
  • 11.9 Lasofoxifene: Sermonix Pharmaceuticals
    • 11.9.1 Product Description
    • 11.9.2 Other Developmental Activities
    • 11.9.3 Clinical Development
    • 11.9.4 Clinical Trials Information
    • 11.9.5 Product Profile
    • 11.9.6 Analysts' Views
  • 11.10 H3B-6545: H3 Biomedicine/ Eisai
    • 11.10.1 Product Description
    • 11.10.2 Other Developmental Activities
    • 11.10.3 Clinical Development
    • 11.10.4 Clinical Trials Information
    • 11.10.5 Safety and Efficacy
    • 11.10.6 Product Profile
  • 11.11 Giredestrant (RG6171, GDC-9545): Roche
    • 11.11.1 Product Description
    • 11.11.2 Clinical Development
    • 11.11.3 Clinical Trials Information
    • 11.11.4 Safety and Efficacy
    • 11.11.5 Product Profile
    • 11.11.6 Analysts' Views
  • 11.12 Camizestrant (AZD9833): AstraZeneca
    • 11.12.1 Product Description
    • 11.12.2 Other Developmental Activities
    • 11.12.3 Clinical Development
    • 11.12.4 Clinical Trials Information
    • 11.12.5 Safety and Efficacy
    • 11.12.6 Product Profile
  • 11.13 LSZ102: Novartis
    • 11.13.1 Product Description
    • 11.13.2 Other Developmental Activities
    • 11.13.3 Clinical Development
    • 11.13.4 Clinical Trials Information
    • 11.13.5 Safety and Efficacy
    • 11.13.6 Product Profile
  • 11.14 ZN-c5: Zentalis Pharmaceuticals
    • 11.14.1 Product Description
    • 11.14.2 Other Developmental Activities
    • 11.14.3 Clinical Development
    • 11.14.4 Clinical Trials Information
    • 11.14.5 Safety and Efficacy
    • 11.14.6 Product Profile
  • 11.15 OP1250: Olema Pharmaceuticals
    • 11.15.1 Product Description
    • 11.15.2 Other Developmental Activities
    • 11.15.3 Clinical Development
    • 11.15.4 Clinical Trials Information
    • 11.15.5 Product Profile

12 ESR1 Mutated Metastatic Breast Cancer: Seven Major Market Analysis

  • 12.1 Key Findings
  • 12.2 Market Methodology
  • 12.3 Market Size of ESR1 Mutated Metastatic Breast Cancer in the 7MM
  • 12.4 Market Size by Therapies of ESR1 Mutated Metastatic Breast Cancer in the 7MM
      • 12.4.1.1 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies
      • 12.4.1.2 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line plus of Therapies
  • 12.5 Potential of Emerging and Current Therapies
  • 12.6 Key Market Forecast Assumptions
  • 12.7 Attribute Analysis
  • 12.8 Market Outlook
  • 12.9 Market Size of ESR1 Mutated Metastatic Breast Cancer in the United States
    • 12.9.1 Total Market Size of ESR1 Mutated Metastatic Breast Cancer
    • 12.9.2 Market Size by Therapies of ESR1 Mutated Metastatic Breast Cancer
      • 12.9.2.1 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies
      • 12.9.2.2 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line plus of Therapies
  • 12.10 Market Size of ESR1 Mutated Metastatic Breast Cancer in the EU5
    • 12.10.1 Total Market Size of ESR1 Mutated Metastatic Breast Cancer
    • 12.10.2 Market Size by Therapies of ESR1 Mutated Metastatic Breast Cancer
      • 12.10.2.1 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies
      • 12.10.2.2 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies
  • 12.11 Market Size of ESR1 Mutated Metastatic Breast Cancer in Japan
    • 12.11.1 Total Market Size of ESR1-Mutated Metastatic Breast Cancer
    • 12.11.2 Market Size by Therapies of ESR1 Mutated Metastatic Breast Cancer
      • 12.11.2.1 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies
      • 12.11.2.2 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies

13 KOL Views

14 Market Drivers

15 Market Barriers

16 SWOT Analysis

17 Unmet Needs

18 Reimbursement and Market Access

19 Appendix

  • 19.1 Bibliography
  • 19.2 Report Methodology

20 DelveInsight Capabilities

21 Disclaimer

22 About DelveInsight

List of Tables

  • Table 1 Summary of ESR1 Mutated Metastatic Breast Cancer, Market and Epidemiology (2018-2030)
  • Table 2 Key Events
  • Table 3 Total Diagnosed Prevalent Cases of HR Positive Breast Cancer in the 7MM, in Thousand (2018-2030)
  • Table 4 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the 7MM, in Thousand (2018-2030)
  • Table 5 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the First Line in the 7MM, in Thousand (2018-2030)
  • Table 6 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the Second Line Plus in the 7MM, in Thousand (2018-2030)
  • Table 7 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in the United States, in Thousand (2018-2030)
  • Table 8 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in the United States, in Thousand (2018-2030)
  • Table 9 Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer in the United States, in Thousand (2018-2030)
  • Table 10 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in the EU-5, in Thousand (2018-2030)
  • Table 11 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in the EU-5, in Thousand (2018-2030)
  • Table 12 Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer in the EU-5, in Thousand (2018-2030)
  • Table 13 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in Japan, in Thousand (2018-2030)
  • Table 14 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in Japan, in Thousand (2018-2030)
  • Table 15 Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer in Japan, in Thousand (2018-2030)
  • Table 16 Organizations Contributing Toward the Fight Against ESR1 Mutated Metastatic Breast Cancer
  • Table 17 Comparison of emerging drugs under development
  • Table 18 Elacestrant, Clinical Trial Description, 2021
  • Table 19 Palbociclib, Clinical Trial Description, 2021
  • Table 20 Amcenestrant, Clinical Trial Description, 2021
  • Table 21 Rintodestrant (G1T48), Clinical Trial Description, 2021
  • Table 22 SCO-120, Clinical Trial Description, 2021
  • Table 23 ZB716, Clinical Trial Description, 2021
  • Table 24 ARV-471, Clinical Trial Description, 2021
  • Table 25 Lasofoxifene, Clinical Trial Description, 2021
  • Table 26 H3B-6545, Clinical Trial Description, 2021
  • Table 27 Giredestrant, Clinical Trial Description, 2021
  • Table 28 Camizestrant (AZD9833), Clinical Trial Description, 2021
  • Table 29 LSZ102, Clinical Trial Description, 2021
  • Table 30 ZN-c5, Clinical Trial Description, 2021
  • Table 31 OP1250, Clinical Trial Description, 2021
  • Table 32 Market Size of ESR1 Mutated Metastatic Breast Cancer in the 7MM in USD Million (2018-2030)
  • Table 33 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies in the 7MM, in USD Million (2018-2030)
  • Table 34 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies in the 7MM, in USD Million (2018-2030)
  • Table 35 Key Market Forecast Assumptions for Elacestrant
  • Table 36 Key Market Forecast Assumptions for Lasofoxifene in combination with abemaciclib
  • Table 37 Key Market Forecast Assumptions for Amcenestrant alone and in combination with Palbociclib
  • Table 38 Key Market Forecast Assumptions for Camizestrant (AZD9833) in combination with Palbociclib
  • Table 39 Key Market Forecast Assumptions for Giredestrant in combination with Palbociclib
  • Table 40 Market Size of ESR1 Mutated Metastatic Breast Cancer in the US, in USD Million (2018-2030)
  • Table 41 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies in the United States, in USD Million (2018-2030)
  • Table 42 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies in the United States, in USD Million (2018-2030)
  • Table 43 Market Size of ESR1 Mutated Metastatic Breast Cancer in the EU5, USD Million (2018-2030)
  • Table 44 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies in EU-5, in USD Million (2018-2030)
  • Table 45 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies in EU-5, in USD Million (2018-2030)
  • Table 46 Market Size of ESR1 Mutated Metastatic Breast Cancer in Japan, in USD Million (2018-2030)
  • Table 47 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies in Japan, in USD Million (2018-2030)
  • Table 48 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies in Japan, in USD Million (2018-2030)

List of Figures

  • Figure 1 Location of ESR1 Missense Mutations Found in Clinical Samples
  • Figure 2 The Spectrum of ESR1 Alterations is found in Metastatic ER+ Breast Cancer
  • Figure 3 Schematic Representation of Identification of ESR1 Mutations in Metastatic Breast Cancer
  • Figure 4 Diagrammatic Representation of Known Mechanisms of Resistance to Endocrine Therapy
  • Figure 5 Endocrine Resistance Mechanisms and Altered ER Functions In Breast Cancer and Novel Therapeutic Strategies
  • Figure 6 Diagnosis of ESR1 Mutation
  • Figure 7 Targetable Pathways in ESR1-mutant Cells Identified in Preclinical Studies
  • Figure 8 Total Diagnosed Prevalent Cases of HR Positive Breast Cancer in the 7MM, in Thousand (2018-2030)
  • Figure 9 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the 7MM, in Thousand (2018-2030)
  • Figure 10 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the First Line in the 7MM, in Thousand (2018-2030)
  • Figure 11 Total Diagnosed Prevalent Population of ESR1 Mutated Metastatic Breast Cancer in the Second Line plus in the 7MM, in Thousand (2018-2030)
  • Figure 12 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in the United States, in Thousand (2018-2030)
  • Figure 13 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in the United States, in Thousand (2018-2030)
  • Figure 14 Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer in the US, in Thousand (2018-2030)
  • Figure 15 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in the EU-5, in Thousand (2018-2030)
  • Figure 16 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in the EU-5, in Thousand (2018-2030)
  • Figure 17 Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer in the EU-5, in Thousand (2018-2030)
  • Figure 18 Stage-specific Diagnosed Prevalent Cases of HR+ Breast Cancer in Japan, in Thousand (2018-2030)
  • Figure 19 Total Diagnosed Prevalent Cases of Metastatic Breast Cancer in Japan, in Thousand (2018-2030)
  • Figure 20 Diagnosed Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer in Japan, in Thousand (2018-2030)
  • Figure 21 Patient Journey
  • Figure 22 Market Size of ESR1 Mutated Metastatic Breast Cancer in the 7MM in USD Million (2018-2030)
  • Figure 23 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies in the 7MM, in USD Million (2018-2030)
  • Figure 24 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies in the 7MM, in USD Million (2018-2030)
  • Figure 25 Market Size of ESR1 Mutated Metastatic Breast Cancer in the United States, in USD Millions (2018-2030)
  • Figure 26 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies in the US, in USD Million (2018-2030)
  • Figure 27 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies in the US, in USD Million (2018-2030)
  • Figure 28 Market Size of ESR1 Mutated Metastatic Breast Cancer in the EU5, USD Millions (2018-2030)
  • Figure 29 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies in the EU5, in USD Million (2018-2030)
  • Figure 30 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies in the EU5, in USD Million (2018-2030)
  • Figure 31 Market Size of ESR1 Mutated Metastatic Breast Cancer in Japan, in USD Millions (2018-2030)
  • Figure 32 Market Size of ESR1 Mutated Metastatic Breast Cancer by First-line of Therapies in Japan, in USD Million (2018-2030)
  • Figure 33 Market Size of ESR1 Mutated Metastatic Breast Cancer by Second-line Plus of Therapies in Japan, in USD Million (2018-2030)
  • Figure 34 Market Drivers
  • Figure 35 Market Barriers
  • Figure 36 SWOT Analysis
  • Figure 37 Unmet Needs