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选择性雌激素受体分解药(SERD)的全球市场 - 市场机会，学名药的可得性，药物用量，价格，临床试验趋势(2030年)

Global Selective Estrogen Receptor Degrader (SERDs) Market Opportunity, Generic Availability, Drug Dosage, Price & Clinical Trials Insight 2030

出版日期: 2025年07月01日 | 出版商:

KuicK Research | 英文 110 Pages | 商品交期: 最快1-2个工作天内

价格

简介目录图表

全球选择性雌激素受体降解药物 (SERD) 市场 - 市场机会、仿製药供应、药物剂量、定价、临床试验趋势（2030 年）报告结果和要点

研究方法
全球选择性雌激素受体降解药物市场分析与趋势洞察
已批准药物剂量、专利摘要、批准时间表、定价和报销方案
已核准药物数量：2 种
氟维司群的仿製药供应和定价分析：25 种以上仿製药
公司、国家、适应症和阶段划分的选择性雌激素受体降解药物 (SERD) 临床试验洞察
选择性雌激素受体降解药物的应用适应症

自21世纪初以来，选择性雌激素受体降解药物 (SERD) 的市场环境发生了显着变化，这始于氟维司群的问世。与以往仅抑制雌激素讯号传导的内分泌疗法相比，SERD 拥有主动降解雌激素受体的新优势。这不仅抑制了受体的主动式，也限制了荷尔蒙受体阳性、HER2阴性乳癌细胞的后续增生。随着患者对芳香化酶抑制剂和选择性雌激素受体调节剂产生抗药性，SERD 迅速成为更有效、更持久的治疗方法。

阿斯特捷利康以商品名 Faslodex 销售的氟维司群是首个获得美国 FDA 等监管机构批准的 SERD。氟维司群最初作为对抗药性患者的单药疗法，迅速普及，目前正与其他药物（如CDK4/6抑制剂）合併使用。随着临床证据的增加和全球广泛的应用，氟维司群已成为HR+停经后乳癌的主流疗法。然而，氟维司群专利到期带来了重大变化。 2019年仿製药的上市显着改变了市场格局，价格实惠的产品层出不穷。全球已有超过25种仿製药上市，在Faslodex市占率下降的同时，氟维司群的仿製药使用量却大幅成长，目前已占总使用量的一半以上。

这项转变为Auseldu（elacestrant）创造了创新缺口，该药物于2023年获得FDA批准。 Auseldu的独特之处在于它是一种口服药物，是同类SERD中的第一种药物。它是肌肉注射氟维司群的一种便捷替代方案，仅获批用于治疗对标准内分泌疗法抗药性的ESR1基因突变患者。 Auseldu的核准不仅填补了明显的临床空白，也重新激发了药物开发者和临床医师对SERD的兴趣。

像Auseldu这样的口服SERD备受关注，引发了研发管线的蓬勃发展，多种下一代化合物已进入中后期临床试验。礼来、罗氏、阿斯特捷利康和Olema Oncology都在研发各自的候选药物，以克服氟维司群的局限性，例如生物利用度低和在ESR1突变患者中的主动式降低。这些候选药物中最有前景的是伊莫司群、齐瑞德司群、卡米司群、帕拉兹司群和塔拉加司群，这些药物目前均处于后期试验阶段。其中几种药物不仅正在接受单药治疗测试，还正在与标靶疗法联合测试，以克服晚期疾病中的多种抗药性途径。

或许技术上最具创新性的药物是vepdegestrant，这是一种由Arvinas和辉瑞共同开发的蛋白水解靶向嵌合体(PROTAC)药物。 vepdegestrant并非采用经典的受体拮抗剂，而是利用细胞固有的蛋白水解机制来降解雌激素受体。在成功完成VERITAC-2 III期临床试验后，辉瑞和Arvinas将于2025年6月向FDA提交新药申请，以期获得批准。 Bepdegesulant预计将成为首个上市的基于PROTAC的SERD，标誌着标靶降解疗法的新前沿。

SERD平台除了单一药物使用外，还在探索与其他类别药物的合併用药，包括CDK4/6抑制剂、PI3K抑制剂和新型分子标靶。这些策略旨在延长疗效持续时间，并防止抗药性途径抑制治疗效果。

儘管SERD的开发目前主要集中在乳癌领域，但它们在其他雌激素受体介导的恶性肿瘤（例如卵巢癌和子宫内膜癌）中的应用也越来越受到关注。此外，临床前研究正在探索非肿瘤学应用，包括神经精神疾病、代谢性疾病和慢性疼痛。儘管这些应用尚处于早期阶段，但它们有可能成为新的前沿领域。

儘管核准的药物数量不多，但SERD市场是一个快速发展、充满活力且竞争激烈的市场。凭藉丰富的研发管线、先进的临床试验计画以及PROTAC等新技术，SERD已准备好彻底改变荷尔蒙受体驱动型癌症的治疗格局。

本报告提供全球选择性雌激素受体分解药(SERD)市场相关调查，提供市场概要，以及各适应症，各地区的趋势，及加入此市场的主要企业简介等资讯。

Research Methodology
Global Selective Estrogen Receptor Degrader Market Analysis & Trends Insight
Approved Drugs Dosage, Patent Overview, Approval Timeline, Pricing & Reimbursement Scenario
Number Of Approved Drugs: 2 Drugs
Generic Fulvestrant Availability & Price Analysis: > 25 Generics
Selective Estrogen Receptor Degrader (SERD) Clinical Trials Insight By Company, Country, Indication & Phase
Selective Estrogen Receptor Degraders Application By Indication

Since the early 2000s, the landscape for Selective Estrogen Receptor Degraders (SERDs) has significantly changed, starting with the introduction of fulvestrant as the first in class drug. In contrast to previous endocrine therapies that only inhibited estrogen signaling, SERDs had a new edge by actively degrading the estrogen receptor. This not only stopped receptor activity but also limited the subsequent proliferation of hormone receptor-positive, HER2-negative breast cancer cells. As patients developed resistance to aromatase inhibitors and selective estrogen receptor modulators, SERDs soon became popular as a more effective and long-lasting therapeutic agent.

Fulvestrant, marketed under the brand name Faslodex by AstraZeneca, was the first SERD to be approved by regulatory authorities like US FDA. Initially used as a monotherapy for tamoxifen resistant patients, it soon gained popularity and was used in combination with other agents like CDK4/6 inhibitors. It grew over the years to become a mainstay therapy in HR+ postmenopausal breast cancer, owing to increasing clinical evidence and global uptake. The patent expiration of fulvestrant, however, brought about a significant change. The launch of generics in 2019 triggered a tide of affordable versions, significantly changing its market dynamics. With over 25 generics on the market worldwide, Faslodex market share has declined while generic fulvestrant use has skyrocketed, now representing over half of total usage.

This transition left an innovation gap that was addressed in 2023 with FDA approval of Orserdu (elacestrant), which was originally developed by Radius Health and then acquired by Menarini Group. What set Orserdu apart was its oral form, i.e., the first in the SERD class. It provided a convenient alternative to fulvestrant's intramuscular injection and was approved solely for a subpopulation of ESR1-mutation patients, who commonly become resistant to standard endocrine treatments. Orserdu's approval not only filled an evident clinical void but also reinvigorated interest in SERDs among pharmaceutical developers and clinicians.

The spotlight on oral SERDs such as Orserdu has set off a pipeline boom, as several next generation compounds find their way into mid to late stage clinical trials. Eli Lilly, Roche, AstraZeneca, and Olema Oncology are all pushing their own candidates, each trying to build on fulvestrant's limitations, such as poor bioavailability and short activity in patients with ESR1 mutations. Among the most promising of these candidates are imlunestrant, giredestrant, camizestrant, palazestrant, and taragarestrant, which all currently reside in late-phase testing. Several of these are not only being tested as monotherapies but also in combination with targeted therapies in an attempt to overcome multiple resistance pathways in advanced disease.

Perhaps the most technologically novel entries to this scene is vepdegestrant, a PROteolysis Targeting Chimera (PROTAC) drug co-developed by Arvinas and Pfizer. Instead of acting via classical receptor antagonism, vepdegestrant enlists the cell's native protein degradation machinery to degrade the estrogen receptor. With the completion of the successful Phase 3 VERITAC-2 trial, in June 2025 Pfizer and Arvinas filed an NDA seeking FDA approval. Vepdegestrant is set to be the first PROTAC-based SERD to hit the market, signaling a new frontier in targeted degradation therapy.

Beyond monotherapy use, the SERD platform is investigating combinations with other classes of agents including CDK4/6 inhibitors, PI3K inhibitors, and novel molecularly targeted agents. These strategies are designed to sustain the duration of response and prevent resistance pathways from outpacing treatment.

Although SERD development is presently centered on breast cancer, they are now gaining attention in other malignancies of the estrogen receptor-mediated nature, such as ovarian and endometrial cancers. Further, preclinical studies are investigating their use in non-oncologic applications like neuropsychiatric disorders, metabolic disorders, and chronic pain. Although these are in the initial stages, they are potential new frontiers.

The SERD market, while narrow in terms of approved medicines, has developed with rapid evolving into a dynamic and competitive landscape. With deep pipelines, sophisticated trial programs, and new technologies such as PROTACs, SERDs are already set to revolutionize the treatment landscape for hormone receptor-driven cancers and quite possibly much more.

1. RESEARCH METHODOLOGY

2. Introduction to Selective Estrogen Receptor Degraders (SERDs)

2.1 Overview & Evolution of SERDs
2.2 Selective Estrogen Receptor Degraders - Mechanism of Action
2.3 Selective Estrogen Receptor Degraders in Combination Therapies

3. Application Of Selective Estrogen Receptor Degraders By Indication

3.1 Breast Cancer
3.2 Other Cancers
3.3 Other Applications

4. Selective Estrogen Receptor Degrader Market Analysis

4.1 Commercially Approved Selective Estrogen Receptor Degraders
4.2 Current Market Scenario
4.3 Future Commercialization Opportunity

5. Selective Estrogen Receptor Degrader Clinical Trials Overview

5.1 By Company
5.2 By Country
5.3 By Indication
5.4 By Patient Segment
5.5 By Phase

6. Selective Estrogen Receptor Degrader (SERD) Clinical Trials Insight

6.1 Phase I
6.2 Phase-I/II
6.3 Phase-II
6.4 Phase-III

7. Marketed Selective Estrogen Receptor Degrader (SERD) Insight

8. Faslodex - 1st Commercially Available Selective Estrogen Receptor Degrader

8.1 Approval & Patent Overview
8.2 Pricing & Dosage Analysis
8.3 Sales Analysis
8.4 Faslodex - Reimbursement Scenario

9. Generic Fulvestrant - Availability & Price Analysis

10. Orserdu - 2nd Commercially Available Selective Estrogen Receptor Degrader

10.1 Approval & Patent Overview
10.2 Pricing & Dosage Analysis
10.3 Orserdu - Reimbursement Scenario

11. Competitive Landscape

11.1 AstraZeneca
11.2 Eli Lilly
11.3 EnhancedBio
11.4 Olema Oncology
11.5 Radius Therapeutics
11.6 Roche

简介目录图表

List of Figures

Figure 2-1: Evolution of Selective Estrogen Receptor Degraders
Figure 2-2: Role of Estrogen Receptor in Tumor Development
Figure 2-3: Mechanism of Selective Estrogen Receptor Degraders
Figure 2-4: Mechanism of SERDs in Combination with other Cancer Therapeutics
Figure 2-5: CDK 4/6 Inhibitors Used in Combination with Selective Estrogen Receptor Degraders
Figure 2-6: PI3K Inhibitors Used in Combination with Selective Estrogen Receptor Degraders
Figure 2-7: Aromatase Inhibitors Used in Combination with Selective Estrogen Receptor Degraders
Figure 2-8: mTOR Inhibitors Used in Combination with Selective Estrogen Receptor Degraders
Figure 3-1: Breast Cancer - Estimated Incidence & Mortality (Millions), 2045
Figure 3-2: Selective Estrogen Receptor Degraders in Development
Figure 3-3: VERITAC-2 Phase 3 (NCT05654623) Trial - Study Initiation & Completion Year
Figure 3-4: VERITAC-3 Phase 3 (NCT05909397) Trial - Study Initiation & Completion Year
Figure 3-5: EvoPAR-BR01 Phase 3 (NCT06380751) Trial - Study Initiation & Completion Year
Figure 3-6: CAMBRIA-1 Phase 3 (NCT05909397) Trial - Study Initiation & Completion Year
Figure 3-7: CAMBRIA-2 Phase 3 (NCT05952557) Trial - Study Initiation & Completion Year
Figure 3-8: SERENA-4 Phase 3 (NCT04711252) Trial - Study Initiation & Completion Year
Figure 3-9: SERENA-6 Phase 3 (NCT04964934) Trial - Study Initiation & Completion Year
Figure 3-10: OPERA-01/OP-1250-301 Phase 3 (NCT06016738) Trial - Study Initiation & Completion Years
Figure 3-11: OP-1250-001 Phase 1/2 (NCT04505826) Trial - Study Initiation & Completion Years
Figure 3-12: OP-1250-003 Phase 1 (NCT04964934) Trial - Study Initiation & Completion Year
Figure 3-13: EMBER-3 Phase 3 (NCT04975308) Trial - Study Initiation & Completion Year
Figure 3-14: EMBER-4 Phase 3 (NCT05514054) Trial - Study Initiation & Expected Completion Year
Figure 3-15: persevERA Phase 3 (NCT04546009) Trial - Study Initiation & Expected Completion Year
Figure 3-16: lidERA Phase 3 (NCT04961996) Trial - Study Initiation & Expected Completion Year
Figure 3-17: heredERA Phase 3 (NCT05296798) Trial - Study Initiation & Expected Completion Year
Figure 3-18: evERA Phase 3 (NCT05306340) Trial - Study Initiation & Expected Completion Year
Figure 3-19: pionERA Phase 3 (NCT06065748) Trial - Study Initiation & Expected Completion Year
Figure 3-20: 2017-0405 Phase 2 (NCT03531645) Trial - Study Initiation & Expected Completion Year
Figure 3-21: 18-107 Phase 2 (NCT03643510) Trial - Study Initiation & Expected Completion Year
Figure 3-22: CASE2820 Phase 2 (NCT05113368) Trial - Study Initiation & Expected Completion Year
Figure 4-1: Fulvestrant & Elacestrant - Mechanism of Action
Figure 4-2: Selective Estrogen Receptor Degraders Market - Future Opportunities
Figure 5-1: SERD - Clinical Trials by Company (Number of Drugs), 2025 Till 2030
Figure 5-2: SERD - Clinical Trials by Country (Number of Drugs), 2025 Till 2030
Figure 5-3: SERD - Clinical Trials by Indication (Number of Drugs), 2025 Till 2030
Figure 5-4: SERD - Clinical Trials by Patient Segment (Number of Drugs), 2025 Till 2030
Figure 5-5: SERD - Clinical Trials by Phase (Number of Drugs), 2025 Till 2030
Figure 8-1: Faslodex - FDA Approval Years by Breast Cancer Type
Figure 8-2: Faslodex - FDA Approval Year & First Generic Approval Year
Figure 8-3: Faslodex - Price per Unit & Supply of Intramuscular Injection (US$), July'2025
Figure 8-4: Faslodex - Recommended & Reduced Dose (mg)
Figure 8-5: Faslodex - Number of Doses by Treatment Phase
Figure 8-6: Faslodex - Cost For First & Subsequent Treatment Cycles (US$)
Figure 8-7: Global - Faslodex Annual Sales (US$ Million), 2019-2023
Figure 8-8: US - Faslodex Annual Sales (US$ Million), 2019-2023
Figure 8-9: EU - Faslodex Annual Sales (US$ Million), 2019-2023
Figure 8-10: ROW - Faslodex Annual Sales (US$ Million), 2019-2023
Figure 8-11: Global - Faslodex Quarterly Sales (US$ Million), 2023
Figure 8-12: Global - Faslodex Annual Sales by Region (US$ Million), 2023
Figure 8-13: Global - Faslodex Annual Sales by Region (%), 2023
Figure 8-14: US - Faslodex Quarterly Sales (US$ Million), 2023
Figure 8-15: EU - Faslodex Quarterly Sales (US$ Million), 2023
Figure 8-16: ROW - Faslodex Quarterly Sales (US$ Million), 2023
Figure 9-1: Fulviglen - Price per Unit & Supply of 3 Intramuscular Injections (US$), July'2025
Figure 9-2: Fulviglen - Price per Unit & Supply of 6 Intramuscular Injections (US$), July'2025
Figure 9-3: Fulviglen - Price per Unit & Supply of 9 Intramuscular Injections (US$), July'2025
Figure 9-4: Fulvenat - Price per Unit & Supply of 120 mg Intramuscular Injection (US$), July'2025
Figure 9-5: Fulvenat - Price per Unit & Supply of 250 mg Intramuscular Injection (US$), July'2025
Figure 9-6: Fulvetraz - Price per Unit & Supply of 50 mg Intramuscular Injection (US$), July'2025
Figure 9-7: Fulvetraz - Price per Unit & Supply of 250 mg Intramuscular Injection (US$), July'2025
Figure 9-8: Fuvestrol - Price per Unit & Supply of 250 mg Intramuscular Injection (US$), July'2025
Figure 9-9: Strantas - Price per Unit & Supply of 250 mg Intramuscular Injection (US$), July'2025
Figure 9-10: Celvestrant - Price per Unit & Supply of 250 mg Intramuscular Injection (US$), July'2025
Figure 9-11: Faslomax - Price per Unit & Supply of 250 mg Intramuscular Injection (US$), July'2025
Figure 9-12: Fasnorm - Price per Unit & Supply of 250 mg Intramuscular Injection (US$), July'2025
Figure 9-13: India - Price per Unit & Supply of Fulveryze Intramuscular Injections (INR/US$), July'2025
Figure 9-14: India - Price per Unit & Supply of Vestrant Intramuscular Injections (INR/US$), July'2025
Figure 9-15: India - Price per Unit & Supply of Fulvether Intramuscular Injections (INR/US$), July'2025
Figure 9-16: India - Price per Unit & Supply of Fulveser Intramuscular Injections (INR/US$), July'2025
Figure 9-17: India - Price per Unit & Supply of Fulzos Intramuscular Injection (INR/US$), July'2025
Figure 9-18: India - Price per Unit & Supply of Fistent Intramuscular Injection (INR/US$), July'2025
Figure 9-19: India - Price per Unit & Supply of Fulpost Intramuscular Injection (INR/US$), July'2025
Figure 9-20: India - Price per Unit & Supply of Fulvested Intramuscular Injection (INR/US$), July'2025
Figure 9-21: India - Price per Unit & Supply of Fulvaa Intramuscular Injection (INR/US$), July'2025
Figure 9-22: India - Price per Unit & Supply of Fulbreca Intramuscular Injection (INR/US$), July'2025
Figure 9-23: India - Price per Unit & Supply of Fulvekast Intramuscular Injection (INR/US$), July'2025
Figure 9-24: Europe - Price for Supply of Teva Fulvestrant Intramuscular Injection (GBP/US$), July'2025
Figure 9-25: Europe - Price for Supply of Zentiva Fulvestrant Intramuscular Injection (GBP/US$), July'2025
Figure 9-26: Europe - Price for Supply of Sandoz Fulvestrant Intramuscular Injection (GBP/US$), July'2025
Figure 9-27: Europe - Price for Supply of AAH Fulvestrant Intramuscular Injection (GBP/US$), July'2025
Figure 9-28: Europe - Price for Supply of Thornton & Ross Fulvestrant Intramuscular Injection (GBP/US$), July'2025
Figure 9-29: Europe - Price for Supply of Dr. Reddy's Fulvestrant Intramuscular Injection (GBP/US$), July'2025
Figure 9-30: Europe - Price for Supply of Kent Fulvestrant Intramuscular Injection (GBP/US$), July'2025
Figure 9-31: Europe - Price for Supply of Amneal Pharmaceuticals Fulvestrant Intramuscular Injection (GBP/US$), July'2025
Figure 10-1: Orserdu - US Patent Grant & Expiration years
Figure 10-2: Orserdu - Price per Unit & Supply of Oral Tablets (US$), July'2025
Figure 10-3: EU - Price per Unit & Supply of (US$), July'2025

List of Tables

Table 3-1: Breast Cancer - Selective Estrogen Receptor Degraders In Clinical Trials
Table 4-1: Globally Approved Branded SERDs
Table 10-1: Orserdu - Dose Reduction Levels for Adverse Reactions
Table 10-2: Orserdu - Dosage Modification Guidelines for Adverse Reaction

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选择性雌激素受体分解药(SERD)的全球市场 - 市场机会，学名药的可得性，药物用量，价格，临床试验趋势(2030年)

Global Selective Estrogen Receptor Degrader (SERDs) Market Opportunity, Generic Availability, Drug Dosage, Price & Clinical Trials Insight 2030

目录

第1章调查手法

第2章选择性雌激素受体分解药(SERD)的简介

第3章选择性雌激素受体分解药的各适应症应用

第4章选择性雌激素受体分解酵素抑制剂市场分析

第5章选择性雌激素受体分解酵素抑制剂的临床试验概要

第6章选择性雌激素受体分解药(SERD)的临床试验的洞察

第7章市售的选择性雌激素受体分解药(SERD)相关考察

第8章 Faslodex- 第一次市售被做了的选择性雌激素受体分解药

第九章：氟维司群仿製药 - 供应及定价分析

第十章 Orserdu - 第二个上市的选择性雌激素受体降解剂

第11章竞争情形