메닌 억제제 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• Menin inhibitors represent a novel and promising treatment strategy for acute leukemias characterized by Lysine Methyltransferase 2A (KMT2A) rearrangements and nucleophosmin 1 (NPM1) mutations.
• The clinical development of menin inhibitors is reaching an advanced stage, poised to transform the treatment landscape for patients with KMT2A rearrangements, NPM1 mutations, and other rare genetic alterations as discussed earlier. Additionally, combining menin inhibitors with chemotherapy and other targeted therapies may offer new hope for selected acute myeloid leukemia (AML) patients.
• In November 2024, revumenib (REVUFORJ) became the first FDA-approved menin inhibitor for R/R acute leukemia with a KMT2A translocation. In October 2025, its label expanded to NPM1-mutated R/R AML in patients aged >=1 year with no satisfactory alternatives. In November 2025, ziftomenib (KOMZIFTI) became the first once-daily oral menin inhibitor approved for NPM1-mutated R/R AML.
• Menin inhibitors show synergistic potential when combined with agents like venetoclax and FLT3 inhibitors, amplifying the therapeutic impact of both classes. This combination approach holds promise for improving outcomes in KMT2Ar and NPM1-mutated AML, particularly among older patients and those with relapsed/refractory disease.
• Emerging players are also advancing their menin inhibitor candidates, Sumitomo Pharma is developing Enzomenib (DSP-5336) for acute leukemia; Johnson & Johnson Innovative Medicine is developing Bleximenib for newly diagnosed and R/R AML; Servier is developing S243249 for R/R AML and R/R acute lymphoblastic leukemia (ALL); and Biomea Fusion is developing Icovamenib (BMF-219) primarily for Type 2 diabetes mellitus, among other companies evaluating their own candidates.

DelveInsight's "Menin Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" report delivers an in-depth understanding of Menin Inhibitor, addressable patient pool, competitive landscape, and future market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan.

The Menin Inhibitor market report provides insights around existing treatment practices in patients with Menin Inhibitor, approved (if any) and emerging Menin Inhibitor, market share of individual therapies, patient pool eligible for treatment with Menin Inhibitor, along with current and forecasted 7MM Menin Inhibitor market size from 2022-2036 by therapies and by indication. The report also covers current unmet needs and challenges while incorporating new classes in treatment paradigm, variations in accessibility and acceptability of new Menin Inhibitor in different geographies, along with insights on Menin Inhibitor pricing reimbursements to curate the best opportunities and assess the market's potential.

Geography Covered:

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

Study Period: 2022-2036

Menin Inhibitor Overview

Menin inhibitors represent a novel and promising treatment strategy for acute leukemias characterized by Lysine Methyltransferase 2A (KMT2A) rearrangements and nucleophosmin 1 (NPM1) mutations.

The clinical development of menin inhibitors is reaching an advanced stage, poised to transform the treatment landscape for patients with KMT2A rearrangements, NPM1 mutations, and other rare genetic alterations as discussed earlier. Additionally, combining menin inhibitors with chemotherapy and other targeted therapies may offer new hope for selected acute myeloid leukemia (AML) patients.

Target Patient Pool Analysis

• GIST is one of the rare causes of gastrointestinal tumors, accounting for 1-3% of all Gastrointestinal malignancies.
• According Sulciner et al. (2024), the incidence of GISTs in the United States is approximately 0.70 per 100,000.
• According to Issa et al. (2024), rearrangements of the KMT2A gene, located at chromosome locus 11q23, occur in up to 10% of acute leukemias in children and adults, with higher incidence in certain types of infant and childhood acute leukemias.
• According to Vakiti et al. (2024), males exhibit a higher incidence of AML compared to females, with a ratio of 5:3.

Menin Inhibitor Drug Chapters

The drug chapter segment of the Menin Inhibitor report encloses a detailed analysis of marketed therapies and late-stage (Phase III and Phase II) therapies. It also helps understand the Menin Inhibitor clinical trial details, pharmacological action, agreements and collaborations related to Menin Inhibitor, their approval timelines, patent details, advantages and disadvantages, latest news and press releases.

Menin Inhibitor Marketed Drugs

Revumenib (REVUFORJ): Syndax Pharmaceuticals

Revumenib (REVUFORJ) developed by Syndax Pharmaceuticals, is an oral, first-in-class, selective menin inhibitor that received the US FDA approval in November 2024 for the treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older. In October 2025, the US FDA approved revumenib for the treatment of R/R AML with a susceptible NPM1 mutation in adult and pediatric patients aged one year and older who have no satisfactory alternative treatment options

Ziftomenib (KOMZIFTI): Kura Oncology/Kyowa Kirin

Ziftomenib (KOMZIFTI) is an investigational drug candidate and oral inhibitor of menin-KMT2A (MLL) for the treatment of AML, with the potential to combine with other targeted therapies. Ziftomenib is currently being evaluated as a monotherapy in the KOMET-001 trial and as a combination therapy with certain standards of care across multiple lines of therapy in the KOMET-007 and KOMET-008 trials. In November 2025, Kura Oncology announced that the FDA granted full approval to ziftomenib for adults with R/R NPM1-mutated AML who lack satisfactory treatment options, making it the first and only once-daily oral menin inhibitor approved for this indication

Menin Inhibitor Emerging Drugs

Bleximenib: Johnson & Johnson Innovative Medicine

Bleximenib is an investigational oral menin inhibitor being evaluated for the treatment of patients with newly diagnosed and relapsed or refractory AML.

In June 2025, the company presented Phase IB results of bleximenib in combination with venetoclax and azacitidine were featured in an oral presentation at the 2025 European Hematology Association (EHA) Congress. The result showed bleximenib in combination with venetoclax + azacitidine had an acceptable safety profile, with no QTc prolongation signal observed to date. A bleximenib 100 mg BID dose in combination with venetoclax + azacitidine resulted in optimal pharmacodynamic effects and improved depth of response, consistent with established monotherapy recommended Phase II dose.

Enzomenib (DSP-5336): Sumitomo Pharma

Enzomenib is an investigational small molecule inhibitor of the menin and MLL protein interaction. The FDA granted ODD for enzomenib for the indication of AML in June 2022. The FDA granted FTD for enzomenib for the indication of R/R AML with MLL or NPM1m in June 2024. The PMDA granted ODD for enzomenib for the indication of R/R AML with MLL or mutant NPM1 in September 2024.

In December 2024, preliminary clinical and translational data from the enzomenib Phase I/II study were presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition. The safety population included 84 total patients with acute leukemia, most of whom (94%, 79/84) had AML. The encouraging clinical activity results combined with an excellent safety profile suggested that enzomenib may play an important role in the treatment of patients with R/R acute leukemia with KMT2A rearrangement or NPM1 mutation.

Icovamenib (BMF0219): Biomea Fusion

Icovamenib (BMF-219) is an investigational, oral covalent menin inhibitor developed by Biomea Fusion, designed to restore and preserve pancreatic beta-cell function by targeting the menin protein, a key regulator of beta-cell proliferation. It is being studied as a potential disease-modifying therapy for Type-2 diabetes to improve insulin production and glycemic control. Early clinical and preclinical studies have shown durable improvements in markers like C-peptide and HbA1c, along with a favorable safety profile, supporting its potential as a novel treatment option across diabetes types. Biomea Fusion terminated its COVALENT-112 trial of icovamenib (BMF-219) for type 1 diabetes in late 2025 to focus its clinical resources exclusively on type 2 diabetes and other indications.

Recent Developments in the Menin Inhibitors Market

• In August 2026, Biomea Fusion announces completion of enrollment in COVALENT-211 phase II trial of icovamenib in insulin-deficient type 2 diabetes
• In July 2026, Sumitomo Pharma America announced that enzomenib (DSP-5336) received FDA Orphan Drug Designation for the treatment of ALL. The FDA had previously granted enzomenib Orphan Drug Designation for AML in June 2022.
• In June 2026, Biomea Fusion presents new clinical and translational data for icovamenib at the American Diabetes Association ("ADA") 86th Scientific Sessions

Drug Class Insights

The Drug Class Insights section will provide comprehensive information on Menin Inhibitor as a class. This will include a broad overview of the class and its role in treating specific conditions. Insights may cover the historical clinical development of Menin Inhibitor, their mechanism of action, their subtypes and future commercial prospects. Additionally, the section will provide detailed information about current trends, challenges, and future prospects for this class of drugs.

Menin Inhibitor Market Outlook

This section will include details on changing Menin Inhibitor market dynamics post initiation of clinical development activities of the inhibitor. It will also provide a detailed summary and comparison of all the therapies being developed by leading players in this space. This section will highlight the advantages of one therapy over the other after assessment based on parameters such as data availability in the form of safety and efficacy, number of patients enrolled in each trial, and trial's inclusion criteria. There will be a Key focus on the importance of development and need for the commercial success of these targeted therapies to achieve treatment goals that physicians and patients are looking for. It will also sum up all the early stage players active in this space.

Menin Inhibitor Drugs Uptake

This section focuses on the uptake rate of potential Menin Inhibitor already launched and expected to be launched in the market during 2022-2036, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Menin Inhibitor Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Menin Inhibitor Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Menin Inhibitor.

KOL Views

To keep up with current and future market trends, we incorporate Key physicians, Therapy Area Researcher's, and other Industry Experts' opinions working in the domain through primary research to fill in the data gaps and validate our secondary research. 25+ Key Opinion Leaders (KOLs) were contacted for insights on Menin Inhibitor' incorporation in the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.

Qualitative Analysis

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

Market Access and Reimbursement

This section will include insights around the standard HTA pricing, recent reformations in 2024 and modifications in reimbursement process in the 7MM. For example, In the United States, a multi payer model exists when it comes to drug pricing regime, which is currently undergoing significant changes, with recent federal legislation, such as the Prescription Drug Pricing Reform provisions of the Inflation Reduction Act, significantly altering the pricing regime under certain federal programs. Whereas in Germany, the market access differs from the systems followed in many other countries as no pricing and reimbursement approval is required during launch of a new therapy.

Moreover, this section will also provide details on reimbursement of approved therapy, if any.

Scope of the Report:

• The report covers a segment of key events, an executive summary, target patient pool, epidemiology and market forecasts, information around patient journey and varying biomarker testing rates
• Additionally, an all-inclusive account of the current and emerging therapies drug chapters, insights on Menin Inhibitor addressable patient pool
• A detailed review of the Menin Inhibitor market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, and treatment preferences that help in shaping and driving the 7MM Menin Inhibitor market.
• Market Size of Inhibitors by therapies and indication will be provided

Menin Inhibitor Report Key Strengths

• 11 Years Menin Inhibitor Market Forecast
• The 7MM Coverage
• Menin Inhibitor Competitive Landscape of current and emerging therapies
• Menin Inhibitor Total Addressable patient population
• Drugs Uptake and Key Market Forecast Assumptions
• Approved and Emerging therapy Profiles
• Physician's perspectives/KOL opinions
• Biomarker testing and Patient journey
• Qualitative Analysis (SWOT and Analyst Views)
• Menin Inhibitor Market Size by therapy and indication
• Existing and Future Market Opportunity
• Unmet Needs

FAQs:

• What was the Menin Inhibitor total market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2036? What are the contributing factors for Menin Inhibitor market growth?
• Which KRAS Inhibitor is going to be the largest contributor by 2036?
• What is the market access and reimbursement scenario of Menin Inhibitor?
• What are the pricing variations among different geographies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Menin Inhibitor Market.
• Understand the existing Menin Inhibitor market opportunities and future trends in varying geographies
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• 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 and acceptability of emerging treatment options along with unmet need of current therapies
• Details on report methodology, top indications covered, market assumptions, patient journey and KOLs to strengthen the pharmaceutical companies' development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Menin Inhibitor

4. Key Events

5. Menin Inhibitor Market Overview At A Glance

• 5.1. Market Share (%) Distribution of Menin Inhibitor By Therapy in 2025
• 5.2. Market Share (%) Distribution of Menin Inhibitor By Therapy in 2036

6. Background And Overview

7. Target Population

8. Menin Inhibitor Marketed Drugs

• 8.1. Key Competitors
  • 8.1.1. Product Description
  • 8.1.2. Regulatory Milestones
  • 8.1.3. Other Developmental Activities
  • 8.1.4. Ongoing Clinical Development
  • 8.1.5. Safety and Efficacy

9. Menin Inhibitor Emerging Drugs

• 9.1. Key Competitors
  • 9.1.1. Product Description
  • 9.1.2. Other Development Activities
  • 9.1.3. Clinical Development
    • 9.1.3.1. Clinical Trials Information
  • 9.1.4. Safety and Efficacy

10. Menin Inhibitor: The 7MM Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Key Market Forecast Assumptions
• 10.4. Total Market Size of Menin Inhibitor in the 7MM
  • 10.4.1. Market Size of Menin Inhibitor By Therapies In the 7MM
  • 10.4.2. Market Size of Menin Inhibitor By Indication In the 7MM
• 10.6. United States Market
  • 10.6.1. Total Market Size of Menin Inhibitor in the United States
  • 10.6.2. Market Size of Menin Inhibitor By Therapies in the United States
• 10.7. EU4 and the UK Market
  • 10.7.1. Total Market Size of Menin Inhibitor in EU4 and the UK
  • 10.7.2. Market Size of Menin Inhibitor By Therapies in EU4 and the UK
• 10.8. Japan Market
  • 10.8.1. Total Market Size of Menin Inhibitor in Japan
  • 10.8.2. Market Size of Menin Inhibitor By Therapies in Japan

11. Unmet Needs

12. SWOT Analysis

13. KOL Views

14. Market Access and Reimbursement

• 14.1. United States
  • 14.1.1. Centre for Medicare & Medicaid Services (CMS)
• 14.2. EU4 and the UK
  • 14.2.1. Germany
  • 14.2.2. France
  • 14.2.3. Italy
  • 14.2.4. Spain
  • 14.2.5. United Kingdom
• 14.3. Japan
  • 14.3.1. MHLW

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. Delveinsight Capabilities

17. Disclaimer

18. About DelveInsight