Acute Myeloid Leukemia Market Expected to Transform with Next-Generation Therapies and Strong Growth Through 2036 - DelveInsight

The Acute Myeloid Leukemia market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Acute Myeloid Leukemia pipeline products will significantly revolutionize the Acute Myeloid Leukemia market dynamics.

DelveInsight's "Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast-2036′′ report offers an in-depth understanding of the Acute Myeloid Leukemia, historical and forecasted epidemiology as well as the Acute Myeloid Leukemia market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Acute Myeloid Leukemia market report covers emerging drugs, current treatment practices, market share of the individual therapies, and current & forecasted market size from 2022 to 2036. It also evaluates the current treatment practice/algorithm, market drivers & barriers, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

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Some of the key facts of the Acute Myeloid Leukemia Market Report:
• The Acute Myeloid Leukemia market size is anticipated to grow with a significant CAGR during the study period (2022-2036).
• In March 2026, SELLAS Life Sciences Group, Inc. is recruiting patients newly diagnosed with acute myeloid leukemia for a clinical study evaluating its investigational therapy SLS009 (tambiciclib). The Phase 2 trial, NCT04588922, aims to enroll approximately 80 participants. While the overall study is assessing SLS009 across multiple hematologic malignancies, the latest update focuses on two cohorts of AML patients. The company also confirmed that the first patient with newly diagnosed AML has already been enrolled in this segment of the trial.
• In November 2025, Senti Biosciences, Inc. (Nasdaq: SNTI) ("Senti Bio"), a clinical-stage biotech firm advancing next-generation cell and gene therapies through its proprietary Gene Circuit platform, today announced its financial results for Q3 2025 along with updates on its pipeline and corporate progress. "The team remains fully committed to advancing SENTI-202 clinical development. Following key milestones reached in the third quarter, we are progressing with the dose expansion phase and continuing to enroll additional patients with relapsed/refractory AML at the Recommended Phase 2 Dose," the company stated.
• In September 2025, Akeso Inc. (9926.HK) announced that its monoclonal antibody ligufalimab (AK117) has been granted FDA Orphan Drug Designation for the treatment of acute myeloid leukemia (AML). This designation provides development incentives, tax benefits, and up to seven years of market exclusivity upon approval.
• In July 2025, ImCheck Therapeutics announced that the FDA has granted Orphan Drug Designation to ICT01, their humanized anti-BTN3A monoclonal antibody targeting γ9δ2 T cells, for the treatment of acute myeloid leukemia (AML). AML remains particularly difficult to manage in older or unfit patients who are ineligible for intensive chemotherapy.
• In July 2025, The FDA has accepted the supplemental New Drug Application (sNDA) for INQOVI (decitabine and cedazuridine) in combination with venetoclax for treating adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The FDA has assigned a standard review, with a decision anticipated by February 25, 2026, based on results from the Phase 2b ASCERTAIN-V study.
• In July 2025, Syndax Pharmaceuticals announced that the FDA has granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj (revumenib), aimed at treating relapsed or refractory mutant NPM1 acute myeloid leukemia (AML). The review is being accelerated under the FDA's Real-Time Oncology Review program, with a PDUFA action date of October 25. Revuforj, an oral menin inhibitor, was first approved in 2024 for acute leukemia with KMT2A translocation. Additionally, in June 2025, Senti Biosciences announced that the FDA granted orphan drug designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies, including AML.
• In June 2025, Moleculin Biotech has received FDA approval to proceed with a single pediatric study evaluating Annamycin in combination with Cytarabine as a second-line treatment for children with relapsed or refractory acute myeloid leukemia (R/R AML).
• In June 2025, Moleculin Biotech has received FDA approval to proceed with a single pediatric study evaluating Annamycin in combination with Cytarabine as a second-line treatment for children with relapsed or refractory acute myeloid leukemia (R/R AML).
• In April 2025, CERo Therapeutics has announced that the Colorado Blood Cancer Institute (CBCI) at the Sarah Cannon Research Institute (SCRI), US, will serve as the lead site for its Phase I clinical trial of CER-1236 for the treatment of acute myeloid leukemia (AML). Patient enrollment is currently underway for this first-in-human study, with initial cohort dosing expected to begin by June. This open-label, multi-centre Phase I/Ib trial is designed to evaluate the early safety and efficacy of CER-1236 in patients with relapsed or refractory AML, measurable residual disease, or those carrying a tumor protein p53 (TP53) gene mutation.
• In February 2025, U.S.-based Moleculin Biotech received approval from Ukraine's Ministry of Health to initiate patient enrollment for its Phase III MIRACLE trial, evaluating annamycin with cytarabine for the treatment of acute myeloid leukemia (AML). The study will be conducted across multiple sites in Europe, the Middle East, and the U.S., enrolling AML patients who are refractory to or have relapsed after induction therapy.
• In January 2025, The FDA granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for its potential in treating patients with acute myeloid leukemia (AML). Luba Greenwood, JD, entrepreneur-in-residence at PureTech and leader of the Gallop Oncology program, stated in a press release that this designation supports their confidence in LYT-200's potential to meet the urgent needs of AML patients. This achievement adds to previous FDA recognitions, including orphan drug status for AML and another Fast Track designation awarded last year for head and neck cancers.
• In October 2024, Qurient Co. Ltd. (KRX: 115180) has initiated a clinical trial for adrixetinib (formerly Q702) following the U.S. FDA's approval of its investigational new drug (IND) application. This Phase 1 dose-escalation and expansion study aims to evaluate the safety and preliminary efficacy of adrixetinib as a monotherapy and in a triplet combination with venetoclax and azacitidine for patients with relapsed or refractory acute myeloid leukemia (AML) (ClinicalTrials.gov Identifier: NCT06445907). Adrixetinib, an oral selective inhibitor targeting AXL/MER/CSF1R kinases, has shown strong anti-tumor activity, enhancing chemo-sensitivity and immune response in various tumor models. The novel combination therapy holds promise for synergistically improving outcomes in AML treatment.
• In 2023, there were an estimated 43,500 incidence cases of Acute Myeloid Leukemia (AML) across the 7MM, with the United States reporting the highest number of cases.
• Leading companies developing therapies for Acute Myeloid Leukemia (AML) include Arog Pharmaceuticals (Crenolanib), Actinium Pharmaceutical (Iomab-B), Astex Pharmaceutical (ASTX030), Syndax (Revumenib), SELLAS Life Sciences (SLS009), Johnson & Johnson Innovative Medicine (JNJ-75276617), among others.
• Currently, there are no approved targeted therapies for KMT2A-related disease. However, menin inhibitors in clinical development have demonstrated promising CR + CRh response rates in patients with KMT2A rearrangements (KMT2Ar) or NPM1-mutated (NPM1m) acute leukemia. Reported outcomes include Syndax's Revumenib (23% in KMT2Ar), Kura's Ziftomenib (35% in NPM1m), and Janssen's JNJ-75276617 (21% in KMT2Ar/NPM1m populations).
• In the 7MM, the United States reported the highest number of new AML cases, with approximately 21,300 cases in 2023.
• Within the EU4 and the UK, Germany recorded the highest number of AML cases, while Spain reported the fewest.
• According to DelveInsight's estimates, AML is marginally more prevalent in males (~52%) compared to females (~48%).
• Among the various genetic mutations in AML, the NPM1 gene mutation was responsible for the majority of the cases.
• Key Acute Myeloid Leukemia Companies: SystImmune, Jasper Therapeutics, Chimerix, Akeso Biopharma Co., Ltd., Syros Pharmaceuticals, TC Biopharm, Stemline Therapeutics, Orca Bio, Gilead Sciences, GlycoMimetics, and others
• Key Acute Myeloid Leukemia Therapies: GNC 035, JSP 191, ONC201, AK117, Tamibarotene, TCB008, Elzonris, Orca T, Magrolimab+ azacitidine, Uproleselan, and others
• The Acute Myeloid Leukemia epidemiology based on gender analyzed that acute myeloid leukemia (AML) is more prominent in males in comparison to females

Acute Myeloid Leukemia Overview
Acute Myeloid Leukemia (AML) is a fast-progressing cancer of the blood and bone marrow characterized by the rapid proliferation of abnormal myeloid cells. These cells interfere with normal blood cell production, leading to symptoms like fatigue, infections, bruising, and anemia. AML primarily affects adults and requires prompt treatment, including chemotherapy, targeted therapy, or stem cell transplantation.

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Acute Myeloid Leukemia Market
The dynamics of the Acute Myeloid Leukemia market are anticipated to change in the coming years owing to the expected launch of emerging therapies and others during the forecast period 2022-2036.

Acute Myeloid Leukemia Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Acute Myeloid Leukemia Epidemiology Segmentation:
The Acute Myeloid Leukemia market report proffers epidemiological analysis for the study period 2022-2036 in the 7MM segmented into:
• Total Prevalence of Acute Myeloid Leukemia
• Prevalent Cases of Acute Myeloid Leukemia by severity
• Gender-specific Prevalence of Acute Myeloid Leukemia
• Diagnosed Cases of Episodic and Chronic Acute Myeloid Leukemia

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Acute Myeloid Leukemia Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Acute Myeloid Leukemia market or expected to get launched during the study period. The analysis covers Acute Myeloid Leukemia market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Acute Myeloid Leukemia Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Acute Myeloid Leukemia Therapies and Key Companies
• GNC 035: SystImmune
• JSP 191: Jasper Therapeutics
• ONC201: Chimerix
• AK117: Akeso Biopharma Co., Ltd.
• Tamibarotene: Syros Pharmaceuticals
• TCB008: TC Biopharm
• Elzonris: Stemline Therapeutics
• Orca T: Orca Bio
• Magrolimab+ azacitidine: Gilead Sciences
• Uproleselan: GlycoMimetics

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Acute Myeloid Leukemia Market Drivers
• Rising incidence and aging population: AML is more prevalent in older adults, and the global aging population is increasing the patient pool.
• Strong R&D pipeline and innovation: Growing investment in novel therapies such as targeted therapies, immunotherapies, and bispecific antibodies is accelerating market growth.
• Advancements in precision medicine: Increasing focus on genetic profiling and personalized treatment approaches improves treatment outcomes and adoption rates.
• Improved diagnostic capabilities: Enhanced molecular diagnostics and early detection are identifying more AML cases and enabling targeted interventions.
• Development of targeted and oral therapies: Availability of oral and less intensive therapies supports outpatient care and expands treatment accessibility.

Acute Myeloid Leukemia Market Barriers
• High cost of treatment: Novel AML therapies can exceed thousands of dollars monthly, limiting affordability and access, especially in low- and middle-income regions.
• Limited access to advanced therapies: A significant proportion of patients globally do not receive targeted treatments due to economic and infrastructure constraints.
• Disease heterogeneity and complexity: AML consists of multiple genetic subtypes, making it difficult to develop universally effective treatments.
• Drug resistance and relapse: High relapse rates and resistance mechanisms reduce long-term treatment success and require continuous innovation.
• Shortage of stem cell donors: Limited availability of matched donors restricts access to potentially curative stem cell transplantation.

Scope of the Acute Myeloid Leukemia Market Report
• Study Period: 2022-2036
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Acute Myeloid Leukemia Companies: SystImmune, Jasper Therapeutics, Chimerix, Akeso Biopharma Co., Ltd., Syros Pharmaceuticals, TC Biopharm, Stemline Therapeutics, Orca Bio, Gilead Sciences, GlycoMimetics, and others
• Key Acute Myeloid Leukemia Therapies: GNC 035, JSP 191, ONC201, AK117, Tamibarotene, TCB008, Elzonris, Orca T, Magrolimab+ azacitidine, Uproleselan, and others
• Acute Myeloid Leukemia Therapeutic Assessment: Acute Myeloid Leukemia current marketed and Acute Myeloid Leukemia emerging therapies
• Acute Myeloid Leukemia Market Dynamics: Acute Myeloid Leukemia market drivers and Acute Myeloid Leukemia market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Acute Myeloid Leukemia Unmet Needs, KOL's views, Analyst's views, Acute Myeloid Leukemia Market Access and Reimbursement

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About DelveInsight
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It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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