세계의 선택적 에스트로겐 수용체 분해제(SERD) 시장 - 시장 기회, 제네릭 의약품 가용성, 약물 용량, 가격, 임상시험 동향(2030년)

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.

Table of Contents

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