(Albany, US) On November 09, 2026, DelveInsight’s Acute Myeloid Leukemia market report provides comprehensive insights into the Acute Myeloid Leukemia market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including late-stage and mid-stage pipeline products. It also provides a therapeutics assessment by mechanism of action, molecule type, and clinical development stage, while examining the market drivers and barriers shaping the treatment landscape.
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Key Takeaways from the Acute Myeloid Leukemia Report
In January 2026, SELLAS Life Sciences Group announced an agreement with IMPACT-AML, a European collaborative initiative, to conduct a clinical study evaluating SLS009 in combination with azacitidine and venetoclax in newly diagnosed AML patients with high-risk features.
In January 2026, Ryvu Therapeutics announced that the US FDA raised no objections to opening an expansion cohort evaluating romaciclib in combination with venetoclax in the RIVER-81 study.
In September 2025, Akeso announced that its monoclonal antibody ligufalimab (AK117) received FDA Orphan Drug Designation for the treatment of acute myeloid leukemia.
In July 2025, ImCheck Therapeutics announced that ICT01 received FDA Orphan Drug Designation for AML.
In July 2025, the FDA accepted the supplemental new drug application for INQOVI (decitabine and cedazuridine) in combination with venetoclax for newly diagnosed AML patients who are ineligible for intensive chemotherapy.
Among the 7MM, the United States accounted for the largest Acute Myeloid Leukemia treatment market size in 2023.
According to DelveInsight’s estimates, the total number of Acute Myeloid Leukemia incident cases across the 7MM was approximately 44,000 in 2025.
Approximately 30–40% of newly diagnosed AML patients who achieve remission following frontline therapy experience disease relapse.
The current treatment landscape includes VYXEOS, REVUFORJ, REZLIDHIA, XOSPATA, RYDAPT, ONUREG, DAURISMO, TIBSOVO, IDHIFA, and VENCLEXTA, among others.
Leading Acute Myeloid Leukemia companies include Johnson & Johnson, SELLAS Life Sciences, Syndax Pharmaceuticals, Ryvu Therapeutics, Daiichi Sankyo, Bristol Myers Squibb, Jazz Pharmaceuticals, Astellas Pharma, and others.
Promising emerging therapies include bleximenib, SLS009, RVU120, L-Annamycin in combination with cytarabine, and ziftomenib, among others.
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Acute Myeloid Leukemia Overview
Acute myeloid leukemia (AML) is an aggressive hematological malignancy characterized by the abnormal proliferation and accumulation of immature myeloid cells in the bone marrow, peripheral blood, and other tissues. The disease interferes with the production of normal blood cells and can progress rapidly, making timely diagnosis and appropriate treatment essential.
AML primarily affects older adults, although it can also occur in children and younger individuals. The disease is associated with several genetic abnormalities and mutations, including FLT3, NPM1, IDH1/2, and KMT2A rearrangements, which play an important role in disease classification, prognosis, and treatment selection.
Common signs and symptoms include:
Persistent fatigue and weakness
Fever and recurrent infections
Frequent bruising and bleeding
Pale skin and shortness of breath
Bone and joint pain
Unexplained weight loss
Night sweats
Increased susceptibility to infections due to reduced normal blood cell production
Diagnosis generally involves a combination of complete blood count, peripheral blood smear examination, bone marrow aspiration and biopsy, flow cytometry, cytogenetic analysis, and molecular testing. These investigations help determine the AML subtype and identify genetic abnormalities that can guide treatment decisions.
Common features include:
Rapid proliferation of abnormal myeloid cells
Bone marrow dysfunction and impaired blood cell production
Association with genetic mutations and chromosomal abnormalities
Higher incidence among older adults
Risk of relapse following frontline treatment
Significant clinical heterogeneity
Need for personalized treatment approaches
Acute Myeloid Leukemia Emerging Drugs Profile
Bleximenib: Johnson & Johnson
Bleximenib is an investigational menin-KMT2A inhibitor being developed by Johnson & Johnson for the treatment of acute myeloid leukemia. The therapy is designed to disrupt the interaction between menin and KMT2A fusion proteins, which play an important role in the development and progression of genetically defined AML subtypes.
In June 2025, Johnson & Johnson announced Phase Ib clinical data demonstrating encouraging antileukemic activity and a promising safety profile for bleximenib in combination with venetoclax and azacitidine. The results were presented at the 2025 European Hematology Association Congress. The company has also indicated plans for a potential US submission for relapsed or refractory AML in 2026.
SLS009: SELLAS Life Sciences
SLS009 is a potential first- and best-in-class selective CDK9 inhibitor being developed by SELLAS Life Sciences for patients with AML, particularly those with relapsed or refractory disease.
The investigational therapy is designed to inhibit cyclin-dependent kinase 9 (CDK9), which plays an important role in regulating transcription and cancer cell survival. Clinical findings have demonstrated encouraging response rates, particularly among patients with unfavorable prognostic factors, including ASXL1 mutations.
In January 2024, the FDA granted Fast Track Designation to SLS009 for relapsed or refractory AML. The drug also received Orphan Drug Designation and Rare Pediatric Disease Designation for AML, highlighting its potential in addressing significant unmet medical needs.
L-Annamycin in Combination With Cytarabine: Moleculin Biotech
L-Annamycin is an investigational anthracycline being developed by Moleculin Biotech in combination with cytarabine for patients with relapsed or refractory acute myeloid leukemia.
The therapy is designed to inhibit topoisomerase II, interfering with DNA replication and promoting cancer cell death. The combination approach is being investigated as a potential treatment option for patients who have experienced disease relapse or have not responded adequately to previous induction therapy.
In February 2025, Moleculin Biotech announced that it received FDA feedback and guidance on an amendment to its investigational new drug application, allowing a reduction in the planned size of its Phase III pivotal trial protocol evaluating the AnnAraC combination in relapsed or refractory AML.
Ziftomenib: Kura Oncology
Ziftomenib is an investigational oral menin inhibitor being developed by Kura Oncology in collaboration with Kyowa Kirin for patients with NPM1-mutated relapsed or refractory AML.
The therapy targets the menin-KMT2A interaction, which plays a critical role in maintaining leukemic cell growth and differentiation abnormalities. By disrupting this interaction, ziftomenib aims to promote differentiation of leukemic cells and improve treatment outcomes.
In February 2025, Kura Oncology and Kyowa Kirin announced positive topline results from the KOMET-001 Phase II registration-directed trial evaluating ziftomenib in patients with relapsed or refractory NPM1-mutated AML. In June 2025, the FDA accepted the company’s NDA and granted Priority Review.
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Acute Myeloid Leukemia Market Drivers
Increasing disease incidence: The growing burden of AML, particularly among older adults, is expected to increase demand for effective treatment options across major markets.
Emerging pipeline therapies: The advancement of menin inhibitors, CDK9 inhibitors, immunotherapies, and other targeted candidates is expected to expand the AML treatment landscape.
Rising research and development activities: Increasing investments in oncology research and clinical trials are accelerating the development of innovative therapeutic approaches.
Advancements in precision medicine: Improved understanding of genetic mutations, including FLT3, NPM1, IDH1/2, and KMT2A, is facilitating the development of personalized treatment strategies.
Growing adoption of targeted therapies: Increasing utilization of FLT3 inhibitors, IDH inhibitors, and BCL-2 inhibitors is transforming the treatment landscape.
Innovative combination therapies: The development of novel combinations involving chemotherapy, targeted agents, and immunotherapies may improve clinical outcomes.
Unmet medical needs: High relapse rates and limited durable treatment responses are creating opportunities for therapies with improved efficacy and safety profiles.
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Acute Myeloid Leukemia Market Barriers
High treatment costs: The considerable cost of advanced targeted therapies and intensive treatment regimens may restrict patient access and market adoption.
Treatment-related toxicity: Intensive chemotherapy, transplantation, and certain targeted therapies can cause significant adverse events and complications.
Disease heterogeneity: Genetic diversity and clonal evolution can influence treatment response and contribute to resistance.
Clinical development challenges: Designing effective clinical trials for different AML subtypes and patient populations remains challenging.
High relapse rates: A considerable proportion of patients experience disease recurrence despite achieving remission following frontline therapy.
Limited treatment options: Patients with relapsed or refractory AML continue to face significant unmet medical needs, particularly those with unfavorable genetic and prognostic characteristics.
Low survival rates: The aggressive nature of AML and its association with poor outcomes in certain patient populations continue to create challenges for disease management.
Scope of the Acute Myeloid Leukemia Report
Coverage: 7MM (US, EU4, UK, and Japan).
Companies: Johnson & Johnson, SELLAS Life Sciences, Ryvu Therapeutics, Syndax Pharmaceuticals, Daiichi Sankyo, Bristol Myers Squibb, and others.
Therapies: Revumenib (REVUFORJ), quizartinib (VANFLYTA), azacitidine (ONUREG), bleximenib, SLS009, RVU120, L-Annamycin in combination with cytarabine, and others.
Study Period: 2022–2036.
Forecast Period: 2026–2036.
Epidemiology: Total incidence cases, gender-specific cases, age-specific cases, genetic mutations, and line-wise treated pool.
Analysis: Epidemiology segmentation, market size by therapy and class, drug uptake, KOL views, SWOT analysis, conjoint analysis, market access and reimbursement, and unmet needs.
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Table of Contents
Introduction
Executive Summary
Acute Myeloid Leukemia: Overview
Epidemiology
Diagnosis and Classification
Current Treatment and Management
Pipeline Therapeutics
Therapeutic Assessment
Marketed Products
Emerging Products
Drug Class Insights
Market Outlook
Drug Uptake
Pipeline Development Activities
Key Companies
Key Products
KOL Views
Qualitative Analysis
Market Access and Reimbursement
Market Drivers and Barriers
Future Perspectives and Conclusion
Appendix
About Us
About DelveInsight
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.
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