SMARCA 분해제 시장 - 표적 집단, 경쟁 구도, 시장 예측(2034년)

Key Highlights:

• The SMARCA gene subgroup, including SMARCA2 and SMARCA4, is part of the SWI/SNF chromatin remodeling complex that regulates gene expression and DNA accessibility.
• SMARCA2 functions through its ATPase activity, while SMARCA4 facilitates nucleosome repositioning; both are essential for proper chromatin remodeling and repair.
• Mutations or loss of SMARCA4 have been linked to multiple cancers, such as NSCLC, colorectal, bladder, uterine, pancreatic cancers, and others, highlighting its key role in tumor suppression.
• SMARCA4-deficient tumors often develop a dependency on SMARCA2, presenting a synthetic lethal vulnerability that can be therapeutically targeted.
• Historically, the high structural similarity between SMARCA2 and SMARCA4, especially their conserved ATPase domains, has hindered the development of selective inhibitors.
• Targeted protein degradation (TPD) leverages the ubiquitin-proteasome system to eliminate disease-driving proteins and has shown selective degradation of SMARCA2 over SMARCA4.
• This selectivity makes TPD a promising strategy in SMARCA4-deficient cancers, avoiding the off-target effects associated with ATPase inhibitors.
• Several biotech firms, including Foghorn Therapeutics and Prelude Therapeutics, are advancing SMARCA2-selective degrader candidates for oncology indications.
• As the field evolves, SMARCA degraders are expected to become a key part of targeted therapies, especially for tumors resistant to conventional treatments.
• Continued clinical and translational research is likely to expand the utility of SMARCA degraders across a broader range of epigenetically driven malignancies.

DelveInsight's "SMARCA Degrader-Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the SMARCA degrader, historical and competitive landscape as well as its market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The SMARCA degrader market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM SMARCA degrader market size from 2020 to 2034. The report also covers current SMARCA degrader treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

SMARCA degrader Understanding and Treatment Algorithm

SMARCA degrader Overview

The SMARCA genes (SMARCA2 and SMARCA4) are part of the SWI/SNF family, which plays an important role in chromatin remodeling-a process that controls how DNA is packed and accessed in the cell nucleus, ultimately influencing gene expression and DNA repair.

SMARCA4 produces a protein called BRG1, and SMARCA2 produces a similar protein to the brahma protein found in fruit flies (Drosophila). Both proteins are key components of the SWI/SNF complex, which helps regulate gene activity by using energy (ATP) to rearrange the structure of chromatin, making certain genes easier or harder to access for transcription.

When either SMARCA2 or SMARCA4 is inactivated by mutations, the proteins they encode are lost from the cell nucleus. This disrupts chromatin remodeling and gene regulation, which can lead to the development of certain cancers. These cancers are referred to as "SMARCA-deficient" and tend to be aggressive and hard to treat.

SMARCA4/2 deficiencies have been observed in rare and aggressive tumors, including small-cell carcinoma of the ovary, as well as cancers originating in the lung, gastrointestinal (GI) tract, and endometrium.

SMARCA Degrader Epidemiology

The epidemiology chapter of SMARCA degrader in the report provides historical as well as forecasted epidemiology segmented as total cases in selected indications for SMARCA degrader, total eligible patient pool in selected indications for SMARCA degrader, and total treated cases in selected indications for SMARCA degrader in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• In 2024, the incident cases of non-small cell lung cancer (NSCLC) in the United States are estimated to be approximately 204,800 cases.
• In 2024, the EU4 countries (France, Germany, Italy, and Spain), along with the UK, accounted for approximately 211,000 incident cases of NSCLC.
• In 2024, colorectal cancer (CRC) incidence in the United States is higher among men, with approximately 156,200 cases.
• In Japan, CRC affects more males than females, with approximately 85,000 cases in males and 67,000 in females.
• Bladder cancer is more common in men than women about 84,900 new cases of bladder cancer (about 65,000 in men and 19,800 in women).

SMARCA Degrader Drug Chapters

The drug chapter segment of the SMARCA degrader report encloses a detailed analysis of emerging drugs (Phase I) of SMARCA degraders. It also helps understand the clinical trial details of SMARCA degrader, expressive pharmacological action, agreements and collaborations, approval, and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging SMARCA Degrader

PRT3789: Prelude Therapeutics

PRT3789 is a potent, once-weekly intravenous degrader of SMARCA2, exhibiting over 1,000-fold selectivity for SMARCA2 over SMARCA4 in cell-based assays. It selectively inhibits the growth of SMARCA4-deficient human non-small cell lung cancer cell lines both in vitro and in vivo at well-tolerated doses.

PRT3789 is currently being evaluated in a Phase I clinical trial for patients with SMARCA4-deficient solid tumors, both as a monotherapy and in combination with docetaxel. This investigational therapy represents the first clinical data in the industry targeting this novel mechanism. Interim results presented at a recent medical meeting provide initial proof of concept that selective degradation of SMARCA2 may produce anti-tumor activity in select cancers harboring SMARCA4 mutations.

PRT7732: Prelude Therapeutics

PRT7732 is a potent, orally administered degrader of SMARCA2 that demonstrates >3000-fold selectivity for SMARCA2 relative to SMARCA4 in cell-based assays. PRT7732 specifically inhibits SMARCA4-deficient human NSCLC cell lines in vitro and in vivo at well-tolerated doses.

PRT7732 is currently being evaluated in a Phase I clinical trial for patients with SMARCA4-mutated NSCLC & other cancers.

FHD-909: Foghorn Therapeutics/Eli Lilly

FHD-909 (also known as LY4050784) is a first-in-class, orally available, allosteric small molecule that selectively inhibits SMARCA2 (BRM), a key ATPase subunit of the SWI/SNF (BAF) chromatin remodeling complex. It is being developed by Foghorn Therapeutics in collaboration with Eli Lilly, primarily for the treatment of cancers with SMARCA4 (BRG1) mutations, particularly non-small cell lung cancer.

FHD-909 is currently being evaluated in a Phase I clinical trial.

SMARCA Degrader Market Outlook

The SMARCA degrader targeted therapy space is rapidly advancing, led by investigational agents such as PRT3789, PRT7732, and FHD-909, all in early-phase clinical trials. Although no therapies in this class have been approved to date, these candidates offer a novel approach to treating SMARCA4-mutant cancers and are well-positioned for broader clinical adoption and commercial growth. Preclinical data for PRT3789 and PRT7732 have demonstrated encouraging activity, supporting their continued development and fueling optimism for success in this high-need, first-in-class therapeutic space.

SMARCA Degrader Drugs Uptake

This section focuses on the uptake rate of potential approved and emerging SMARCA Degrader expected to be launched in the market during 2025-2034.

SMARCA Degrader Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase I. It also analyzes key players involved in developing targeted therapeutics. The presence of numerous drugs at different stages is expected to generate immense opportunities for the SMARCA Degrader market growth over the forecast period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for SMARCA Degrader.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on SMARCA Degrader ' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Washington University and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or SMARCA Degrader market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health Technology Assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Continuing Medical Education (CME) program, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates on SMARCA Degrader

• In July 2024, Prelude Therapeutics announced a clinical trial collaboration and supply agreement with Merck to evaluate PRT3789, a selective SMARCA2 degrader, in combination with KEYTRUDA (pembrolizumab) in a Phase 2 study for patients with SMARCA4-mutated cancers.
• In October 2024, Prelude Therapeutics presented new findings at the 36th EORTC-NCI-AACR Symposium, showcasing enhanced clinical activity of its SMARCA2 degrader PRT3789 at higher doses in patients with NSCLC, initial safety data from its combination with docetaxel, and preclinical proof-of-concept for a novel antibody-drug conjugate (ADC) program featuring a dual SMARCA2/4 degrader payload.
• In December 2021, Foghorn announced a strategic collaboration with Lilly to create novel oncology medicines. The collaboration includes a U.S. 50/50 co-development and co-commercialization agreement for Foghorn's Selective SMARCA2 oncology program and an additional undisclosed oncology target. The collaboration also includes three discovery programs using Foghorn's proprietary Gene Traffic Control(R) platform.

The abstract list is not exhaustive and will be provided in the final report...

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the SMARCA Degrader, explaining its mechanism and therapies (current and emerging).
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborate profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the SMARCA Degrader market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM SMARCA Degrader market.

SMARCA Degrader Report Insights

• SMARCA Degrader Targeted Patient Pool
• Therapeutic Approaches
• SMARCA Degrader Pipeline Analysis
• SMARCA Degrader Market Size and Trends
• Existing and future Market Opportunities

SMARCA Degrader Report Key Strengths

• 10 years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

SMARCA Degrader Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions:

• What was the total market size of SMARCA Degrader, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for SMARCA Degrader?
• What are the pricing variations among different geographies for approved therapies?
• How has the reimbursement landscape for SMARCA Degrader evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with SMARCA Degrader? What will be the growth opportunities across the 7MM for the patient population of SMARCA Degrader?
• What are the key factors hampering the growth of the market for SMARCA Degrader?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for SMARCA Degrader?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the SMARCA Degrader market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Key Highlights from the Report

4. Executive Summary of SMARCA Degraders

5. Key Events

6. Epidemiology and Market Forecast Methodology

7. SMARCA Degrader Market Overview at a Glance in the 7MM

• 7.1. Market Share (%) Distribution by Therapies in 2024
• 7.2. Market Share (%) Distribution by Therapies in 2034
• 7.3. Market Share (%) Distribution by Indications in 2024
• 7.4. Market Share (%) Distribution by Indications in 2034

8. Background and Overview

• 8.1. Introduction
• 8.2. Treatment

9. Target Patient Pool

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: 7MM
• 9.3. Epidemiology Scenario in the 7MM
  • 9.3.1. Total Incident Cases in Selected Indications for SMARCA Degrader in the 7MM
  • 9.3.2. Total Eligible Patient Pool for SMARCA Degrader in Selected Indications in the 7MM
  • 9.3.3. Total Treated Cases in Selected Indications for SMARCA Degrader in the 7MM

10. Emerging Drugs

• 10.1. Key Competitors
• 10.2. PRT7732: Prelude Therapeutics
  • 10.2.1. Product description
  • 10.2.2. Other developmental activity
  • 10.2.3. Clinical developmental activities
    • 10.2.3.1. Clinical trial information
• 10.3. FHD-909: Foghorn Therapeutics/Eli Lilly
  • 10.3.1. Product description
  • 10.3.2. Other developmental activity
  • 10.3.3. Clinical developmental activities
    • 10.3.3.1. Clinical trial information
  • 10.3.4. Safety and efficacy

11. SMARCA Degrader: 7MM analysis

• 11.1. Key Findings
• 11.2. Market Outlook
• 11.3. Conjoint Analysis
• 11.4. Key Market Forecast Assumptions
  • 11.4.1. Cost Assumptions and Rebates
  • 11.4.2. Pricing Trends
  • 11.4.3. Analogue Assessment
  • 11.4.4. Launch Year and Therapy Uptakes
• 11.5. Market Size by Indications in the 7MM
• 11.6. Market Size by Therapies in the 7MM
• 11.7. United States Market Size
  • 11.7.1. Market Size by Indications in the US
  • 11.7.2. Market Size by Therapies in the US
• 11.8. EU4 and the UK Market Size
  • 11.8.1. Market Size by Indications in EU4 and the UK
  • 11.8.2. Market Size by Therapies in EU4 and the UK
• 11.9. Japan Market Size
  • 11.9.1. Market Size by Indications in Japan
  • 11.9.2. Market Size by Therapies in Japan

12. Unmet Needs

13. SWOT Analysis

14. KOL Views

15. Market Access and Reimbursement

16. Appendix

• 16.1. Bibliography
• 16.2. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight