Acute Myeloid Leukemia - Market Insight, Epidemiology, and Market Forecast - 2036

Acute Myeloid Leukemia (AML) Insights and Trends

• AML, a highly aggressive form of leukemia originating in the bone marrow, is treated through intensive or nonintensive approaches centered around chemotherapy, often combined with stem cell transplant, targeted therapies, radiotherapy, or leukapheresis.
• Treatment options depend on patient-specific factors. While multiagent induction chemotherapy can induce complete remission, allogeneic hematopoietic stem cell transplantation remains the only established curative therapy.
• While the majority of newly diagnosed patients with AML, receiving frontline therapy achieve remission, 30-40% will experience a relapse.
• The KMT2A rearrangement is present in up to 15% of children and adults with acute leukemias and around 80% of infants with acute lymphoblastic leukemia. The NPM1 mutation is more common, occurring in up to 30% of patients with AML.
• Menin inhibitors represent a novel and promising treatment strategy for acute leukemias characterized by KMT2A rearrangements (KMT2Ar) and NPM1 mutations (NPM1m). REVUFORJ (revumenib) has become the first menin inhibitor to receive approval from the US FDA for use in relapsed or refractory KMT2Ar acute leukemias. In addition, multiple other menin inhibitors with unique safety and efficacy profiles are currently undergoing development for the treatment of AML.
• The FDA-approved treatment landscape for AML includes a variety of targeted therapies such as revumenib (REVUFORJ), olutasidenib (REZLIDHIA), and gilteritinib (XOSPATA). These agents work by disrupting specific pathways critical to cancer cell growth and survival.
• In January 2026, the FDA granted BTD to ICT01 (IPN60340), an investigational anti-BTN3A antibody, in combination with venetoclax (Venclexta) and azacitidine for first-line treatment of AML.
• Key Companies involved in the emerging treatment landscape of AML are SELLAS Life Sciences, Johnson & Johnson, Ryvu Therapeutics SA, Ipsen, and others
• AML market growth is expected to be mainly driven by the entry of novel therapies with better clinical profiles, an increase in market penetration of targeted/advanced therapies, an upsurge in research and development, an enriched understanding of the disease, and increased AML incidence, and imminent drug launches.

The ‘Acute Myeloid Leukemia (AML) - Market Insights, Epidemiology and Market Forecast - 2036’ report delivers an in-depth understanding of the AML, historical and forecasted epidemiology, as well as the AML market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Acute Myeloid Leukemia (AML) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, AML patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in AML and maps the competitive and clinical landscape to uncover high‑value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Acute Myeloid Leukemia (AML) Market

Rising AML Incidence

The increasing incidence of AML, particularly among older adults is creating a larger and more consistent patient pool for treatment. In the US, in 2025, there were ~22,000 incident cases of AML, which will further increase by 2036.

Advancements in Targeted & Personalized Medicine

The development and approval of inhibitors targeting specific genetic mutations (such as IDH1 and IDH2 inhibitors) allow for highly effective, tailored treatment regimens, especially for patients who cannot tolerate intensive chemotherapy. Ivosidenib, an IDH1 inhibitor. It is approved for patients with relapsed or refractory acute myeloid leukemia (AML) who carry the IDH1 mutation.

Emerging AML Competitive Landscape

Some of the AML drugs in clinical trials include Bleximenib, SLS009, Gemtuzumab ozogamicine, Iomab-B, L-Annamycin, and others.

Acute Myeloid Leukemia (AML) Understanding and Treatment Algorithm

Acute Myeloid Leukemia (AML) Overview and Diagnosis

AML is a heterogeneous hematologic malignancy characterized by the clonal expansion of myeloid blasts in the peripheral blood, bone marrow, and/or other tissues. AML can involve tissues outside the bone marrow and blood, including lymph nodes, the brain, skin, and other body parts. The classification of AML depends on the etiology, genetics, immunophenotype, and morphology.

For many years the diagnosis of AML was based solely on pathologic and cytological examination of bone marrow and peripheral blood smears. A way to recognize and classify different subgroups of AML through clinical, morphological, and genetic correlation was proposed by the WHO, which made a new classification that was updated in 2008. This classification has important differences from the classification of the (French-American-British) FAB. Over the time, Various tests and examinations are involved in the accurate diagnosis and classification of AML into different subtypes, including, complete blood count (CBC), flow cytometry, bone marrow aspiration and biopsy, cytogenetic analysis, molecular testing, and immunophenotyping. Various imaging tests such as PET/CT scan or CT-guided needle biopsy are also required to make accurate diagnosis.

Current Acute Myeloid Leukemia (AML) Treatment Landscape

Remission is the treatment target for AML. and the current standard of care for AML relies on intense chemotherapy-based induction, consolidation therapy, and hematopoietic stem cell transplantation. Despite induction therapy, there is still minimal residual disease for which consolidation therapy is initiated to prevent any relapse risk by eliminating the residual disease. Stem cell transplants are intensive treatments with real risks of serious complications, including death, and their exact role in treating AML is not always clear. If further treatment or a clinical trial is not an option, the focus of treatment may shift to controlling symptoms caused by leukemia rather than trying to cure it.

Acute Myeloid Leukemia (AML) Unmet Needs

The section “unmet needs of Acute Myeloid Leukemia (AML)” outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

• Genetic heterogeneity and clonal evolution lead to resistance to targeted therapies
• Need for better minimal residual disease (MRD) monitoring and eradication
• Access to curative therapies
• Precision medicine expansion, and others…..

Acute Myeloid Leukemia (AML) Epidemiology

Key Findings from AML Epidemiological Analysis and Forecast

• According to the publisher’s estimates, in 2025, the total number of incident cases of AML in the 7MM were ~44,000.
• As per DelveInsight’s estimates, it has been observed that AML is slightly more common in males (~55%) than females.
• AML can occur in children, but it is uncommon in people under the age of 45. The average age of people when they are first diagnosed with AML is about 69.
• Among all the genetic mutations in AML, NPM1 gene mutation accounted for the majority of the cases.

Acute Myeloid Leukemia (AML) Drug Analysis & Competitive Landscape

The AML drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase IIII-I clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the AML treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the AML therapeutics market.

Approved Therapies for Acute Myeloid Leukemia (AML)

Quizartinib (VANFLYTA): Daiichi Sankyo

Quizartinib (VANFLYTA), developed by Daiichi Sankyo, is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML. In July 2023, the US FDA approved VANFLYTA (quizartinib), with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3 internal tandem duplication (ITD)-positive. Later in September, the drug got approval in Europe for the same patient segment. Quizartinib also is approved in Japan for FLT3-ITD mutation positive AML, and as a monotherapy for relapsed/refractory AML that is FLT3-ITD positive.

Revumenib (REVUFORJ): Syndax Pharmaceuticals

Revumenib (REVUFORJ), developed by Syndax Pharmaceuticals, is an oral, selective menin inhibitor designed to disrupt the interaction between menin and KMT2A (MLL) fusion proteins, a key driver in certain genetically defined subsets of AML. The approval of the drug was primarily supported by results from the AUGMENT-101 clinical trial, which demonstrated clinically meaningful response rates, including complete remissions, along with a manageable safety profile. Beyond its approved indication, revumenib continues to be evaluated in multiple ongoing studies across earlier lines of therapy and in combination regimens.

Acute Myeloid Leukemia (AML) Pipeline Analysis

Bleximenib: Johnson & Johnson

Bleximenib is a MENIN-KMT2A inhibitor in Phase III clinical study by Janssen Research & Development. In june 2025, Johnson & Johnson announced new Phase Ib data showing encouraging antileukemic activity and a promising safety profile for bleximenib in combination with venetoclax and azacitidine for the treatment of AML. The results were featured in an oral presentation at the 2025 European Hematology Association (EHA) Congress (S137). According to the company’s earnings presentation, it is indicated that the organization has planned bleximenib for US submission for r/r AML (cAMeLot-1) in 2026

SLS009: SELLAS Life Sciences

SLS009 is a potential first- and best-in-class, highly selective, differentiated small molecule CDK9 inhibitor. Compared with other CDK9 inhibitors, SLS009 has reduced toxicity and increased potency. In patients with AML, data has shown SLS009 to demonstrate a high response rate, specifically among those with unfavorable prognostic factors like an ASXL1 mutation. Recently, in July 2024, the FDA granted SLS009 a rare pediatric disease designation (RPDD) for the treatment of pediatric patients AML. Previously, the drug has also been granted an orphan drug designation for the treatment of relapsed/refractory AML, and in January 2024, a fast track designation was granted by the FDA to SLS009 for this same indication.

Acute Myeloid Leukemia (AML) Key Players, Market Leaders and Emerging Companies

• Johnson & Johnson
• SELLAS Life Sciences
• Syndax Pharmaceuticals
• Ryvu Therapeutics
• Daiichi Sankyo
• Celgene
• Bristol Myers Squibb, and others

Acute Myeloid Leukemia (AML) Drug Updates

• In January 2026, SELLAS Life Sciences Group announced an agreement with IMPACT-AML, a European collaborative initiative to conduct a clinical study evaluating SLS009. The study in Europe is planned to enroll approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax in patients with newly diagnosed AML with high-risk features.
• In May 2025, Syndax Pharmaceuticals announced data from the pivotal Phase II portion of the AUGMENT-101 trial of revumenib have been published in Blood. The study met the primary efficacy endpoint with a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 23%. The median time to first response was 2.8 months, with a median duration of 4.7 months.
• In October 2025, US FDA approved Revumenib (REVUFORJ) for label expansion to include NPM1-mutated AML. The aproval was based on the Phase II (AUGMENT-101) trial, demonstrating CR/CRh rates of ~23-26% and ORR ~48%.

Acute Myeloid Leukemia (AML) Market Outlook

The goal of treatment is remission and current conventional therapeutic options for AML rely on intensive chemotherapy-based induction and consolidation therapy, together with hematopoietic stem cell transplantation. However, not all patients are eligible for this intensive therapy, which can be both physically and mentally demanding, and this approach is more frequently used in healthy, younger patients. The standard treatment for AML involves cytarabine combined with an anthracycline (e.g., daunorubicin). This regimen has been the backbone of AML treatment for decades, particularly for younger, fit patients.

NPM1-mutant AML represents approximately 30% of new AML cases annually. Ziftomenib became the first investigational treatment to be granted breakthrough therapy designation in NPM1-mutant AML in April 2024. The pipeline therpaies includes SLS009, SNDX-5613/ Chemotherapy Regimen/HiDAC, Bleximenib, and others.

Overall, accelerated drug approvals for targeted therapies and immunotherapies, and expanding precision medicine capabilities are expected to drive steady growth in the 7MM AML market from 2022-2036, with strong commercial implications for both marketed products and emerging pipelines.

• Among the 7MM, the US accounted for the largest market size of revumenib (REVUFORJ) in AML. i.e., USD ~90 million in 2025.
• AML market is expected to be distributed across multiple therapeutic classes, with significant contributions from targeted therapies (e.g., FLT3 and IDH inhibitors), while emerging agents such as menin inhibitors are anticipated to rise.
• The entry of mid- to late-stage pipeline candidates, particularly menin inhibitor and CDK9 inhibitor such as Bleximenib and SLS009, are expected to intensify competition in the AML treatment landscape during the latter half of the forecast period.

Drug Class/Insights into Leading Emerging and Marketed Therapies in AML (2022-2036 Forecast)

The AML market comprises FLT3 inhibitors, and small molecules, each targeting different aspects of AML.

• FLT3 inhibitors: In some people with AML, the leukemia cells have a change (mutation) in the FLT3 gene. Drugs called FLT3 inhibitors target AML cells with this gene change. FLT3 inhibitors such as midostaurin (RYDAPT), quizartinib (VANFLYTA), and gilteritinib (XOSPATA) are now approved to treat people whose AML cells have an FLT3 mutation. Research has shown that these inhibitors enhance BCL-2 dependence while reducing BCL-xL and MCL-1 expression.
• MENIN-KMT2A inhibitor: Menin inhibitors represent a promising targeted treatment approach for patients with r/r AML harboring KMT2A rearrangements or NPM1 mutations. These agents disrupt the interaction between menin and KMT2A, a key driver of leukemogenesis, thereby suppressing oncogenic gene expression. Revumenib, has received regulatory approval for relapsed/refractory KMT2A-rearranged acute leukemia, while several next-generation agents such as ziftomenib, bleximenib, and others are currently under investigation.

Small molecules defines the core innovation landscape in AML, due to oral bioavailability, target specificity, and flexibility in combination regimens, positions them as a backbone of modern AML treatment strategies.

Acute Myeloid Leukemia (AML) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the AML drug’s uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

The uptake of therapies in AML is expected to vary based on clinical positioning, mechanism of action, and stage of development. Approved therapy such as REVUFORJ (Revumenib) is projected to demonstrate relatively faster uptake, due to its MENIN-KMT2A inhibition and oral administration.

In contrast, pipeline candidate Bleximenib is expected to follow a moderate uptake trajectory, supported by encouraging early-phase efficacy and tolerability data in genetically defined AML populations. Phase Ib results have demonstrated high response rates (ORR up to ~82-90% and composite CR rates up to ~59-75%), positioning the regimen as a potentially transformative option, particularly in newly diagnosed patients ineligible for intensive chemotherapy. Meanwhile, broader adoption will depend on outcomes from the ongoing Phase III (cAMeLot-2) trial.

Market Access and Reimbursement of Approved therapies in Acute Myeloid Leukemia (AML)

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.

Reimbursement is a crucial factor that affects the drug’s access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

Acute Myeloid Leukemia (AML) Therapies Price Scenario & Trends

Pricing and analogue assessment of AML therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Acute Myeloid Leukemia (AML)

To keep up with AML market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) 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 the AML emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in AML, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

The analysts connected with 15+ KOLs to gather insights at country level. Centers such as the MD Anderson Cancer Center, Dana-Farber Cancer Institute, and Josep Carreras Leukaemia Research Institute, etc. were contacted.Their opinion helps understand and validate current and emerging AML therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in AML.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of AML, 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.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial’s primary and secondary outcome measures are evaluated, whereas the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report

• The report covers a segment of key events, an executive summary, a descriptive overview of AML, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the AML 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 and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM AML market.

Report Insights

• Acute Myeloid Leukemia (AML) Patient Population Forecast
• Acute Myeloid Leukemia (AML) Therapeutics Market Size
• Acute Myeloid Leukemia (AML) Pipeline Analysis
• Acute Myeloid Leukemia (AML) Market Size and Trends
• Acute Myeloid Leukemia (AML) Market Opportunity (Current and forecasted)

Report Key Strengths

• Epidemiology‑based (Epi‑based) Bottom‑up Forecasting
• Artificial Intelligence (AI)-Enabled Market Research Report
• 11-Year Forecast
• Acute Myeloid Leukemia (AML) Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (By Geography)
• Acute Myeloid Leukemia (AML) Treatment Addressable Market (TAM)
• Acute Myeloid Leukemia (AML) Competitve Landscape
• Acute Myeloid Leukemia (AML)) Major Companies Insights
• Acute Myeloid Leukemia (AML) Price Trends and Analogue Assessment
• Acute Myeloid Leukemia (AML) Therapies Drug Adoption/Uptake
• Acute Myeloid Leukemia (AML) Therapies Peak Patient Share Analysis

Report Assessment

• Acute Myeloid Leukemia (AML) Current Treatment Practices
• Acute Myeloid Leukemia (AML) Unmet Needs
• Acute Myeloid Leukemia (AML) Clinical Development Analysis
• Acute Myeloid Leukemia (AML) Emerging Drugs Product Profiles
• Acute Myeloid Leukemia (AML) Market attractiveness
• Acute Myeloid Leukemia (AML) Qualitative Analysis (SWOT and conjoint analysis)

FAQs

Market Insights

• What was the AML market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of AML?
• What are the disease risks, burdens, and unmet needs of AML? What will be the growth opportunities across the 7MM concerning the patient population with AML?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of AML? What are the current guidelines for treating AML in the US, Europe, and Japan?

Reasons to Buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the AML market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs’ perspectives on 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.
• This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

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