Acute Myeloid Leukemia Treatment Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Therapies, Statistics, Revenue, Patient Pool, Prevalence and Companies DelveInsight

(Albany, USA) 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, Minneamrita Therapeutics LLC, Syndax Pharmaceuticals, Astex Pharmaceuticals, Inc., Karyopharm Therapeutics Inc, Sanofi, Polaris Group, Bio-Path Holdings, Inc., Chordia Therapeutics, Inc., Theradex, BioTheryX, Inc., Precigen, Inc, Eli Lilly and Company, Bayer, Takeda, Meryx, Inc., 2seventy bio, JW Pharmaceutical, Telios Pharma, Inc., Kartos Therapeutics, Inc., Celyad Oncology SA, Merck Sharp & Dohme LLC, Celgene, AbbVie, Genentech, Wugen, Inc., Arcellx, Inc, NextCure, Inc., Bellicum Pharmaceuticals, ImmunoGen, Inc., Astellas Pharma Inc, Aptose Biosciences Inc, Ascentage Pharma Group Inc., BioSight Ltd., GlycoMimetics Incorporated, Gilead Sciences, Chimerix, Daiichi Sankyo, Ryvu Therapeutics SA, Syros Pharmaceuticals, PrECOG, LLC, Cleave Therapeutics, Inc., Kronos Bio, Cullinan Oncology, LLC, Actinium Pharmaceuticals, Amgen, In8bio Inc, Sellas Life Sciences Group, Kura Oncology, Inc., Arog Pharmaceuticals, Inc., Novo Nordisk A/S, Marker Therapeutics, Inc., Shattuck Labs, Inc., 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.
• 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® 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).

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Acute Myeloid Leukemia Overview
Acute Myeloid Leukemia (AML) is a type of aggressive cancer that affects the bone marrow and blood. It primarily affects myeloid cells, which are responsible for producing red blood cells, platelets, and certain white blood cells. AML is characterized by the rapid proliferation of immature and abnormal myeloid cells, interfering with the production of healthy blood cells. The exact causes of AML are not always clear, but certain risk factors have been identified.
The symptoms of AML often appear suddenly and can be quite severe. Common symptoms include unexplained fatigue, recurrent infections, easy bruising or bleeding, frequent nosebleeds, shortness of breath, and pale skin. AML can also lead to an enlarged spleen or liver, leading to discomfort in the abdomen. Diagnosing AML typically involves a series of tests, starting with a complete blood count to check for abnormal blood cell counts. Further tests, such as bone marrow aspiration and biopsy, are conducted to examine the bone marrow for abnormal cells and confirm the AML diagnosis.

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Acute Myeloid Leukemia Epidemiology Segmentation
The acute myeloid leukemia epidemiology section provides insights into the historical and current acute myeloid leukemia patient pool and forecasted trends for the seven individual major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders.
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

Learn more about the FDA-approved drugs for acute myeloid leukemia @ Acute Myeloid Leukemia clinical trials - https://www.delveinsight.com/sample-request/acute-myeloid-leukemia-aml-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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

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