首頁 > 市場調查報告書 > 製藥

婦科治療

市場調查報告書

商品編碼

1759331

選擇性雌激素受體分解藥(SERD)的全球市場 - 市場機會，學名藥的可得性，藥物用量，價格，臨床試驗趨勢(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個工作天內

價格

簡介目錄圖表

全球選擇性雌激素受體降解藥物 (SERD) 市場 - 市場機會、仿製藥供應、藥物劑量、定價、臨床試驗趨勢（2030 年）報告結果和要點

研究方法
全球選擇性雌激素受體降解藥物市場分析與趨勢洞察
已批准藥物劑量、專利摘要、批准時間表、定價和報銷方案
已核准藥物數量：2 種
氟維司群的仿製藥供應和定價分析：25 種以上仿製藥
公司、國家、適應症和階段劃分的選擇性雌激素受體降解藥物 (SERD) 臨床試驗洞察
選擇性雌激素受體降解藥物的應用適應症

自21世紀初以來，選擇性雌激素受體降解藥物 (SERD) 的市場環境發生了顯著變化，這始於氟維司群的問世。與以往僅抑制雌激素訊號傳導的內分泌療法相比，SERD 擁有主動降解雌激素受體的新優勢。這不僅抑制了受體的主動式，也限制了荷爾蒙受體陽性、HER2陰性乳癌細胞的後續增生。隨著患者對芳香化酶抑制劑和選擇性雌激素受體調節劑產生抗藥性，SERD 迅速成為更有效、更持久的治療方法。

阿斯特捷利康以商品名 Faslodex 銷售的氟維司群是首個獲得美國 FDA 等監管機構批准的 SERD。氟維司群最初作為對抗藥性患者的單藥療法，迅速普及，目前正與其他藥物（如CDK4/6抑制劑）合併使用。隨著臨床證據的增加和全球廣泛的應用，氟維司群已成為HR+停經後乳癌的主流療法。然而，氟維司群專利到期帶來了重大變化。 2019年仿製藥的上市顯著改變了市場格局，價格實惠的產品層出不窮。全球已有超過25種仿製藥上市，在Faslodex市佔率下降的同時，氟維司群的仿製藥使用量卻大幅成長，目前已佔總使用量的一半以上。

這項轉變為Auseldu（elacestrant）創造了創新缺口，該藥物於2023年獲得FDA批准。 Auseldu的獨特之處在於它是一種口服藥物，是同類SERD中的第一種藥物。它是肌肉注射氟維司群的一種便捷替代方案，僅獲批用於治療對標準內分泌療法抗藥性的ESR1基因突變患者。 Auseldu的核准不僅填補了明顯的臨床空白，也重新激發了藥物開發者和臨床醫師對SERD的興趣。

像Auseldu這樣的口服SERD備受關注，引發了研發管線的蓬勃發展，多種下一代化合物已進入中後期臨床試驗。禮來、羅氏、阿斯特捷利康和Olema Oncology都在研發各自的候選藥物，以克服氟維司群的局限性，例如生物利用度低和在ESR1突變患者中的主動式降低。這些候選藥物中最有前景的是伊莫司群、齊瑞德司群、卡米司群、帕拉茲司群和塔拉加司群，這些藥物目前均處於後期試驗階段。其中幾種藥物不僅正在接受單藥治療測試，還正在與標靶療法聯合測試，以克服晚期疾病中的多種抗藥性途徑。

或許技術上最具創新性的藥物是vepdegestrant，這是一種由Arvinas和輝瑞共同開發的蛋白水解靶向嵌合體(PROTAC)藥物。 vepdegestrant並非採用經典的受體拮抗劑，而是利用細胞固有的蛋白水解機制來降解雌激素受體。在成功完成VERITAC-2 III期臨床試驗後，輝瑞和Arvinas將於2025年6月向FDA提交新藥申請，以期獲得批准。 Bepdegesulant預計將成為首個上市的基於PROTAC的SERD，標誌著標靶降解療法的新前沿。

SERD平台除了單一藥物使用外，還在探索與其他類別藥物的合併用藥，包括CDK4/6抑制劑、PI3K抑制劑和新型分子標靶。這些策略旨在延長療效持續時間，並防止抗藥性途徑抑制治療效果。

儘管SERD的開發目前主要集中在乳癌領域，但它們在其他雌激素受體介導的惡性腫瘤（例如卵巢癌和子宮內膜癌）中的應用也越來越受到關注。此外，臨床前研究正在探索非腫瘤學應用，包括神經精神疾病、代謝性疾病和慢性疼痛。儘管這些應用尚處於早期階段，但它們有可能成為新的前沿領域。

儘管核准的藥物數量不多，但SERD市場是一個快速發展、充滿活力且競爭激烈的市場。憑藉豐富的研發管線、先進的臨床試驗計畫以及PROTAC等新技術，SERD已準備好徹底改變荷爾蒙受體驅動型癌症的治療格局。

本報告提供全球選擇性雌激素受體分解藥(SERD)市場相關調查，提供市場概要，以及各適應症，各地區的趨勢，及加入此市場的主要企業簡介等資訊。

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

簡介目錄圖表

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

02-2729-4219

+886-2-2729-4219

License/價格

相關商品

雌激素阻斷劑市場：依產品類型、應用、通路和地區分類

Raloxifene雷洛昔芬市場：按劑型、分銷管道分類 - 全球預測 2025-2030

FAQ

選擇性雌激素受體分解藥(SERD)的全球市場 - 市場機會，學名藥的可得性，藥物用量，價格，臨床試驗趨勢(2030年)

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

目錄

第1章調查手法

第2章選擇性雌激素受體分解藥(SERD)的簡介

第3章選擇性雌激素受體分解藥的各適應症應用

第4章選擇性雌激素受體分解酵素抑制劑市場分析

第5章選擇性雌激素受體分解酵素抑制劑的臨床試驗概要

第6章選擇性雌激素受體分解藥(SERD)的臨床試驗的洞察

第7章市售的選擇性雌激素受體分解藥(SERD)相關考察

第8章 Faslodex- 第一次市售被做了的選擇性雌激素受體分解藥

第九章：氟維司群仿製藥 - 供應及定價分析

第十章 Orserdu - 第二個上市的選擇性雌激素受體降解劑

第11章競爭情形