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

List of Tables

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

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

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

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

Description

Table of Contents

List of Tables

Table of Contents

1. RESEARCH METHODOLOGY

2. Introduction to Selective Estrogen Receptor Degraders (SERDs)

3. Application Of Selective Estrogen Receptor Degraders By Indication

4. Selective Estrogen Receptor Degrader Market Analysis

5. Selective Estrogen Receptor Degrader Clinical Trials Overview

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

7. Marketed Selective Estrogen Receptor Degrader (SERD) Insight

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

9. Generic Fulvestrant - Availability & Price Analysis

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

11. Competitive Landscape

List of Figures

List of Tables