Acute Myeloid Leukemia Market Forecast to 2034: 7MM Opportunity, Strong CAGR, 43,500 Annual Cases, and Pipeline-Driven Growth | DelveInsight

Robust R&D activity, breakthrough regulatory designations, and precision oncology approaches are driving meaningful change in AML care and commercial dynamics.
The Acute Myeloid Leukemia (AML) market is expected to grow at a strong CAGR through 2034 across the US, EU4, UK, and Japan, driven by innovation in targeted therapies and rising disease incidence. In 2023, the US dominated the AML treatment market, with total 7MM incidence reaching ~43,500 cases, the highest share occurring in the US. Despite high remission rates with frontline therapy, 30-40% of patients relapse, highlighting persistent unmet needs.

The treatment landscape has seen limited change over the past five decades, though several approved therapies are available across frontline and relapsed/refractory settings, including VENCLEXTA, VYXEOS, RYDAPT, XOSPATA, TIBSOVO, ONUREG, and VANFLYTA. Major companies such as Daiichi Sankyo, Novartis, AbbVie, BMS, Pfizer, Jazz Pharmaceuticals, Agios, Astellas, and others are active in the market, alongside emerging players developing novel agents.

Genetically defined AML subtypes, particularly KMT2A rearrangements and NPM1 mutations, are gaining attention. While no targeted therapies are yet approved for KMT2A-rearranged AML, menin inhibitors notably Revumenib (Syndax) have shown promising remission rates. Revumenib is the only therapy with Phase II data in KMT2A AML, with an FDA decision expected by December 2024.

Acute Myeloid Leukemia Market growth will be fueled by imminent drug launches, deeper disease understanding, and expanding use of targeted therapies, though challenges such as high treatment costs, toxicity, trial complexity, and low survival rates may restrain overall expansion.

DelveInsight's Acute Myeloid Leukemia Market Insights report includes a comprehensive understanding of current treatment practices, acute myeloid leukemia emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

The Acute Myeloid Leukemia market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Acute Myeloid Leukemia market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Acute Myeloid Leukemia treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Acute Myeloid Leukemia market.

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Key Takeaways from the Acute Myeloid Leukemia Market Report

* As per DelveInsight's analysis, the acute myeloid leukemia market is anticipated to grow at a significant CAGR by 2034.
* The total 7MM Acute Myeloid Leukemia Incidence Cases in 2023 were 43,500, out of which the highest cases of this disease were seen in the United States.
* Leading acute myeloid leukemia companies such as CicloMed LLC, Jazz Pharmaceuticals (NASDAQ: JAZZ), Minneamrita Therapeutics LLC, Syndax Pharmaceuticals (NASDAQ: SNDX), Astex Pharmaceuticals, Inc., Karyopharm Therapeutics Inc (NASDAQ: KPTI), Sanofi (NASDAQ: SNY), Polaris Group, Bio-Path Holdings, Inc. (NASDAQ: BPTH), Chordia Therapeutics, Inc., Theradex, BioTheryX, Inc., Precigen, Inc (NASDAQ: PGEN), Eli Lilly and Company (NYSE: LLY), Bayer (OTC: BAYRY), Takeda (NYSE: TAK), Meryx, Inc., 2seventy bio (NASDAQ: TSVT), JW Pharmaceutical (KRX: 001060), Telios Pharma, Inc., Kartos Therapeutics, Inc., Celyad Oncology SA (NASDAQ: CYAD), Merck Sharp & Dohme LLC (NYSE: MRK), Celgene (NYSE: BMY), AbbVie (NYSE: ABBV), Genentech, Wugen, Inc., Arcellx, Inc (NASDAQ: ACLX), NextCure, Inc. (NASDAQ: NXTC), Bellicum Pharmaceuticals (NASDAQ: BLCM), ImmunoGen, Inc. (NASDAQ: IMGN), Astellas Pharma Inc (OTC: ALPMY), Aptose Biosciences Inc (NASDAQ: APTO), Ascentage Pharma Group Inc. (HKEX: 6855), BioSight Ltd. (TASE: BOLT), GlycoMimetics Incorporated (NASDAQ: GLYC), Gilead Sciences (NASDAQ: GILD), Chimerix (NASDAQ: CMRX), Daiichi Sankyo (OTC: DSNKY), Ryvu Therapeutics SA (WSE: RVU), Syros Pharmaceuticals (NASDAQ: SYRS), PrECOG, LLC, Cleave Therapeutics, Inc., Kronos Bio (NASDAQ: KRON), Cullinan Oncology, LLC (NASDAQ: CGEM), Actinium Pharmaceuticals (NYSE American: ATNM), Amgen (NASDAQ: AMGN), In8bio Inc (NASDAQ: INAB), SELLAS Life Sciences Group (NASDAQ: SLS), Kura Oncology, Inc. (NASDAQ: KURA), Arog Pharmaceuticals, Inc., Novo Nordisk A/S (NYSE: NVO), Marker Therapeutics, Inc. (NASDAQ: MRKR), Shattuck Labs, Inc. (NASDAQ: STTK), Oncoceutics, Inc., and others are developing novel acute myeloid leukemia drugs that can be available in the acute myeloid leukemia market in the coming years.
* Some of the key therapies for acute myeloid leukemia treatment include Fosciclopirox + Cytarabine, CPX-351, Minnelide, SNDX-5613, ASTX727, KPT-9274, SAR445419, ADI-PEG 20, BP1002, CTX-712, BTX-A51, PRGN-3006 T Cells, LY3214996, Regorafenib, GDX012, MRX-2843, SC-DARIC33, CWP232291, TL-895, KRT-232, CYAD-02, MK-0482, and others.
* On Dec. 1 2025, Cullinan Therapeutics Inc. (NASDAQ: CGEM) announced that the FDA granted fast track designation to CLN-049, a FLT3xCD3 bispecific T-cell engager, for the treatment of patients with relapsed/refractory acute myeloid leukemia.
* In September 2025, Akeso Inc. (9926.HK) announced that its monoclonal antibody ligufalimab (AK117) received FDA Orphan Drug Designation for treating acute myeloid leukemia (AML). This status offers development support, tax benefits, and up to seven years of market exclusivity upon approval.
* In July 2025, ImCheck Therapeutics announced that the FDA granted Orphan Drug Designation to ICT01, their humanized anti-BTN3A monoclonal antibody targeting 92 T cells, for treating acute myeloid leukemia (AML). AML is especially challenging to treat in older or unfit patients ineligible for intensive chemotherapy.
* In July 2025, the FDA accepted the supplemental new drug application for INQOVI (decitabine and cedazuridine) plus venetoclax to treat adults with newly diagnosed acute myeloid leukemia (AML) who cannot undergo intensive chemotherapy. The FDA set a standard review with a decision expected by February 25, 2026. This is based on Phase 2b study results from ASCERTAIN-V.
* In July 2025, Syndax Pharmaceuticals announced that the FDA granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj (revumenib), targeting relapsed or refractory mutant NPM1 acute myeloid leukemia (AML). The FDA's Real-Time Oncology Review program is expediting the process, with a PDUFA action date set for October 25. Revuforj is an oral menin inhibitor initially approved in 2024 for acute leukemia with KMT2A translocation.
* In June 2025, Senti Biosciences announced FDA orphan drug designation for SENTI-202 to treat relapsed/refractory hematologic malignancies, including AML.
* In June 2025, Kura Oncology and Kyowa Kirin announced the FDA has accepted Kura's NDA for ziftomenib to treat adult relapsed or refractory AML with NPM1 mutation. The application received Priority Review, with a PDUFA date of November 30, 2025.
* In June 2025, Moleculin Biotech., (Nasdaq: MBRX) received FDA agreement on a single pediatric approval study to evaluate Annamycin combined with Cytarabine as a second-line treatment for pediatric relapsed/refractory acute myeloid leukemia (R/R AML).
* In February 2025, Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has received first country regulatory approval in Europe to begin recruiting for its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108). In Ukraine the final necessary regulatory approvals from the Ministry of Health were received last week. This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US, Europe and the Middle East.
* In February 2025, Kura Oncology and Kyowa Kirin announced positive topline results from KOMET-001, a Phase 2 registration-directed trial of ziftomenib, a once-daily oral menin inhibitor, in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML).
* In February 2025, Auron Therapeutics, a clinical-stage biotechnology company focused on cell-state plasticity to improve outcomes in oncology and inflammatory diseases, announced progress in its lead KAT2A/B program and clinical candidate, AUTX-703. The company also completed a $27 million Series B financing.
* On January 21, 2025, the Food and Drug Administration approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
* In November 2024, Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting acute leukemia that have significant unmet medical needs, today announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia. Lin BioScience is currently conducting a phase 1/2 trial in patients with relapsed or resistant acute leukemias in the US, Australia, and Taiwan, and has been granted for orphan drug designation (ODD) for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA.
* On March 2024, Syndax Pharmaceuticals announced a study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.
* On March 2024, Hikma Pharmaceuticals announced a Randomized, Single Oral Dose, Open Label, Two Sequence, Two Treatment, Four Periods, Full Replicate Crossover Study to Determine the Bioequivalence of Azacitidine 300 mg Film- Coated Tablets Versus Onureg Registered 300 mg Film-Coated Tablets for Adult Patients With Acute Myeloid Leukaemia (AML) Under Fasting Conditions
* On April 2024, AbbVie announced a Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-787 in Adult Subjects with Acute Myeloid Leukemia (AML).

Discover which therapies are expected to grab the major acute myeloid leukemia market share @ https://www.delveinsight.com/sample-request/acute-myeloid-leukemia-aml-market [https://www.delveinsight.com/sample-request/acute-myeloid-leukemia-aml-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Acute Myeloid Leukemia Overview

Acute Myeloid Leukemia (AML) is an aggressive and heterogeneous blood cancer characterized by the rapid proliferation of immature myeloid cells in the bone marrow and blood, leading to impaired normal blood cell production. It primarily affects older adults but can occur at any age. AML presents with symptoms such as fatigue, infections, anemia, and bleeding. Despite high initial remission rates with frontline chemotherapy, relapse is common, particularly in high-risk and genetically defined subtypes. Advances in molecular profiling have improved risk stratification and enabled the development of targeted and combination therapies, although significant unmet clinical needs remain.

Acute Myeloid Leukemia Epidemiology

In the seven major markets (7MM), the United States reported the highest incidence of Acute Myeloid Leukemia, with approximately 21,300 new cases in 2023. Within the EU4 and the UK, Germany recorded the highest number of AML cases, while Spain had the lowest incidence. Overall, AML shows a slight male predominance, with around 52% of cases occurring in men compared to 48% in women.

Acute Myeloid Leukemia Epidemiology Segmentation

The acute myeloid leukemia market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

* Total Acute Myeloid Leukemia Incident Cases
* Acute Myeloid Leukemia Gender-specific Cases
* Acute Myeloid Leukemia Age-specific Cases
* Acute Myeloid Leukemia Mutation-specific Cases
* Treated Cases of Acute Myeloid Leukemia by Line of Therapies

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Acute Myeloid Leukemia Treatment Market

The treatment for AML typically involves a combination of therapies, tailored to each patient's specific condition and health status. The primary goal of AML treatment is to achieve remission, where no cancer cells are detectable in the bone marrow. The main acute myeloid leukemia treatment approaches include chemotherapy, targeted therapy, and stem cell transplantation. Chemotherapy utilizes powerful drugs to destroy cancer cells, but it can also damage healthy cells, leading to side effects. Targeted therapy, on the other hand, aims to attack specific molecules or proteins involved in the growth of leukemia cells, reducing damage to normal cells. In some cases, stem cell transplantation may be recommended, particularly for patients with high-risk or relapsed AML. This procedure involves replacing damaged bone marrow with healthy stem cells from a compatible donor, either from a family member or an unrelated donor.

Advancements in research and personalized medicine have led to the development of novel treatments and therapies for AML. Clinical trials play a crucial role in evaluating new approaches and improving outcomes for patients. Multidisciplinary teams, including hematologists, oncologists, and other specialists, work closely together to provide comprehensive care, manage side effects, and support patients throughout their AML treatment journey. Early diagnosis and timely intervention remain essential factors in achieving successful outcomes for individuals facing this challenging disease.

Key Acute Myeloid Leukemia Therapies and Companies

* Fosciclopirox + Cytarabine: CicloMed LLC
* CPX-351: Jazz Pharmaceuticals
* Minnelide: Minneamrita Therapeutics LLC
* SNDX-5613: Syndax Pharmaceuticals
* ASTX727: Astex Pharmaceuticals, Inc.
* KPT-9274: Karyopharm Therapeutics Inc
* SAR445419: Sanofi
* ADI-PEG 20: Polaris Group
* BP1002: Bio-Path Holdings, Inc.
* CTX-712: Chordia Therapeutics, Inc./Theradex
* BTX-A51: BioTheryX, Inc.
* PRGN-3006 T Cells: Precigen, Inc
* LY3214996: Eli Lilly and Company
* Regorafenib: Bayer
* GDX012: Takeda
* MRX-2843: Meryx, Inc.
* SC-DARIC33: 2seventy bio
* CWP232291: JW Pharmaceutical
* TL-895: Telios Pharma, Inc.
* KRT-232: Kartos Therapeutics, Inc.
* CYAD-02: Celyad Oncology SA
* MK-0482: Merck Sharp & Dohme LLC

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Acute Myeloid Leukemia Market Dynamics

Acute myeloid leukemia was a rapidly evolving segment within the oncology market, and its dynamics were shaped by various factors. One key driver of the AML market was the rising global incidence of the disease, prompting increased demand for effective treatments. Pharmaceutical companies were heavily invested in research and development, focusing on novel therapies and targeted agents. The emergence of precision medicine and personalized treatment approaches allowed for more tailored and effective treatment options, leading to a shift from traditional chemotherapy to more innovative and potentially curative therapies.

In addition, the regulatory landscape played a crucial role in shaping the AML market dynamics. Expedited approval pathways, such as Breakthrough Therapy Designation and Fast Track designation, facilitated the accelerated introduction of promising drugs to the acute myeloid leukemia market, benefiting patients by providing quicker access to new treatments.

However, challenges persisted in the AML market, particularly related to the high cost of innovative therapies and the limited accessibility to these treatments in certain regions. Efforts were being made to address these issues, such as healthcare reforms and collaborations between governments, healthcare providers, and pharmaceutical companies. Furthermore, ongoing research and clinical trials continued to shed light on the underlying biology of AML, leading to a better understanding of disease mechanisms and potential therapeutic targets. This knowledge expansion fueled the development of more precise and effective treatments, promising better outcomes for patients in the future.

Scope of the Acute Myeloid Leukemia Market Report

* Study Period: 2020-2034
* Acute Myeloid Leukemia Report Coverage: 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
* Key Acute Myeloid Leukemia Companies: Jazz Pharmaceuticals (JAZZ: NASDAQ), Syndax Pharmaceuticals (SNDX: NASDAQ), Karyopharm Therapeutics Inc (KPTI: NASDAQ), Sanofi (SNY: NASDAQ), Bio-Path Holdings, Inc. (BPTH: NASDAQ), Precigen, Inc. (PGEN: NASDAQ), Eli Lilly and Company (LLY: NYSE), Bayer (BAYN: XETRA), 2seventy bio (TSVT: NASDAQ), Celyad Oncology SA (CYAD: NASDAQ), Merck Sharp & Dohme LLC (MRK: NYSE), AbbVie (ABBV: NYSE), Gilead Sciences (GILD: NASDAQ), Daiichi Sankyo (4568: TYO), Syros Pharmaceuticals (SYRS: NASDAQ), Kronos Bio (KRON: NASDAQ), Cullinan Oncology, LLC (CGEM: NASDAQ), Actinium Pharmaceuticals (ATNM: NYSE American), Amgen (AMGN: NASDAQ), In8bio Inc (INAB: NASDAQ), Sellas Life Sciences Group (SLS: NASDAQ), Kura Oncology, Inc. (KURA: NASDAQ), Novo Nordisk A/S (NVO: NYSE), Marker Therapeutics, Inc. (MRKR: NASDAQ), Shattuck Labs, Inc. (STTK: NASDAQ)., and others
* Key Acute Myeloid Leukemia Therapies: Fosciclopirox + Cytarabine, CPX-351, Minnelide, SNDX-5613, ASTX727, KPT-9274, SAR445419, ADI-PEG 20, BP1002, CTX-712, BTX-A51, PRGN-3006 T Cells, LY3214996, Regorafenib, GDX012, MRX-2843, SC-DARIC33, CWP232291, TL-895, KRT-232, CYAD-02, MK-0482, and others
* Therapeutic Assessment: Acute Myeloid Leukemia current marketed and emerging therapies
* Acute Myeloid Leukemia Market Dynamics: Attribute Analysis of Emerging Acute Myeloid Leukemia Drugs
* Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
* Unmet Needs, KOL's views, Analyst's views, Acute Myeloid Leukemia Market Access and Reimbursement

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Table of Contents

1. Acute Myeloid Leukemia Market Key Insights

2. Acute Myeloid Leukemia Market Report Introduction

3. Acute Myeloid Leukemia Market Overview at a Glance

4. Acute Myeloid Leukemia Market Executive Summary

5. Disease Background and Overview

6. Acute Myeloid Leukemia Treatment and Management

7. Acute Myeloid Leukemia Epidemiology and Patient Population

8. Patient Journey

9. Acute Myeloid Leukemia Marketed Drugs

10. Acute Myeloid Leukemia Emerging Drugs

11. Seven Major Acute Myeloid Leukemia Market Analysis

12. Acute Myeloid Leukemia Market Outlook

13. Potential of Current and Emerging Therapies

14. KOL Views

15. Unmet Needs

16. SWOT Analysis

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end to end comprehensive solutions to improve their performance.

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