Acute Myeloid Leukemia Treatment Market Size, Share & Trends Analysis Report By Disease, By Treatment (Chemotherapy, Targeted Therapy, Immunotherapy), By Route of Administration, By End Use, By Region, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The global acute myeloid leukemia treatment market size was estimated at USD 3.47 billion in 2024 and is projected to grow at a CAGR of 10.6% from 2025 to 2030. Rising incidences of acute myeloid leukemia and increasing need for advanced therapeutics are attributed to factors such as genetic mutations, unhealthy lifestyles, continued exposure to hazardous chemicals such as benzene, and radiation exposure. Moreover, the increasing geriatric population base and growing unmet healthcare needs are expected to boost market growth further. 

Advancements in targeted therapies have been at the forefront of the progress in Acute Myeloid Leukemia (AML) treatment so far. In recent years, there has been substantial development in therapies such as BCL2 inhibitors, IDH inhibitors, and FLT3 inhibitors. These therapies provide personalized treatment options tailored to specific genetic mutations, resulting in improved outcomes for patients. For instance, in July 2023, the FDA approved quizartinib (Vanflyta) for newly diagnosed FLT3-ITD positive acute myeloid leukemia in the U.S., enhancing treatment options alongside standard chemotherapy.

Combinations such as venetoclax with azacitidine or other hypomethylating agents have shown promising results in enhancing survival rates for AML patients. Additional research interest focuses on incorporating venetoclax into the traditional 7+3 chemotherapy regimen, which aims to maximize treatment efficacy. Such innovative approaches indicate a growing commitment to developing multifaceted treatment strategies that promise to improve patient outcomes.

Moreover, the exploration of immunotherapies, including CAR-T cell therapies, represents a transformative trend in AML treatment. These therapies are designed to bolster the immune system’s response to cancer cells, thus providing new hope for patients who have limited options. The advancements in the understanding of genetic mutations associated with AML have further contributed to personalized treatment strategies, such as targeting specific mutations such as KMT2A and NPM1 with menin inhibitors.

The growing incidence of AML, driven by factors such as genetic mutations, unhealthy lifestyles, and environmental hazards, underscores the urgent need for innovative therapies. According to the American Cancer Society, approximately 22,010 individuals are estimated to be diagnosed with AML in 2025, further highlighting the rising demand for effective treatment options. In December 2023, scientists at the University of Montreal secured a USD 6 million grant from Genome Canada to develop a novel Cyclin K degrader for high-risk acute myeloid leukemia patients, aiming to enhance treatment outcomes and stimulate economic growth in Canada. The development of innovative therapies for high-risk patients, along with substantial global investments in research and development, is expected to drive market growth. Furthermore, partnerships between pharmaceutical companies and research institutions are enhancing the pace of new AML treatment development.

Disease Insights

The myeloblastic leukemia segment accounted for the largest market share of 43.0% in 2024, fueled by this disease type’s high incidence and prevalence, which drives significant demand for effective treatments. The robust size of this market segment is also supported by the continuous development of new therapies and the improvement of existing treatments. For instance, in October 2024, the National Institute of Health launched a precision medicine clinical trial in the U.S. to evaluate targeted treatment combinations for acute myeloid leukemia and myelodysplastic syndromes based on patients’ genetic profiles. Further investment in research is evident with significant fundings. For instance, in February 2025, Auron Therapeutics announced that the FDA granted Fast Track designation to AUTX-703 for relapsed or refractory acute myelogenous leukemia, highlighting the urgent need for innovative treatments for patients facing poor outcomes in the U.S.

Promyelocytic leukemia is expected to grow at the fastest CAGR of 11.7% over the forecast period, driven by advancements in targeted therapies and a deeper understanding of the disease’s molecular basis, leading to more effective, tailored approaches. Innovations such as arsenic trioxide and all-trans retinoic acid (ATRA) revolutionized the treatment paradigm, significantly improving survival rates and reducing long-term side effects associated with traditional chemotherapy. Furthermore, focused research on molecular and genetic therapies further stimulated the rapid development and adoption of new treatments in this market segment.

Treatment Insights

The chemotherapy segment accounted for the largest market share of 48.0% in 2024. Chemotherapy has maintained its status as a primary treatment modality for AML due to its broad application across various subtypes and proven efficacy in achieving remission, especially during induction therapy. For instance, in December 2024, the 66th American Society of Hematology Annual Meeting witnessed 3 studies that offered new insights into acute myelogenous leukemia treatment, enhancing understanding of CPX-351 efficacy, oral maintenance therapy outcomes, and long-term data on midostaurin for high-risk patients. Moreover, the strategic integration of chemotherapy with newer agents, such as low-dose cytarabine and glasdegib, has further improved outcomes for older patients and those with significant comorbidities, ensuring chemotherapy’s continued relevance and substantial market share in AML treatment strategies.

The immunotherapy segment is expected to grow at the fastest CAGR of 12.8% over the forecast period, fueled by breakthroughs in targeted therapies and monoclonal antibodies that enhance the immune system’s capacity to fight leukemia cells. Segment growth has been fueled by clinical successes and accelerated FDA approvals of treatments that specifically target pathways crucial for cancer cell survival. For instance, in July 2024, new findings from Therapeutic Advances in Hematology highlighted advances in CAR therapy for AML in China, focusing on targeting specific surface markers to enhance treatment efficacy. Immunotherapy’s potential for providing durable remissions with fewer side effects compared to conventional chemotherapy, along with ongoing clinical trials combining it with other therapies, underscores its emerging importance in AML treatment strategies. Significant investments in research from major pharmaceutical companies further support its anticipated accelerated growth.

Route of Administration Insights

The parenteral route segment dominated the market with a revenue share of 66.0% in 2024, primarily due to the intravenous administration of the most effective chemotherapies, including cytarabine and anthracycline-based drugs. This method enables rapid absorption into the bloodstream, allowing for controlled dosing that effectively targets cancer cells. Given the urgent nature of AML, parenteral administration is vital for initial treatment phases aimed at achieving remission. The FDA’s approval of new drug combinations in 2023 further emphasized this segment’s critical role in effective AML management.

The oral segment is expected to grow at the fastest CAGR of 12.7% over the forecast period. The approval of new oral medications, such as IDH inhibitors (e.g., ivosidenib) and BCL-2 inhibitors (e.g., venetoclax), marked a significant advancement in AML treatment, offering ease of administration and the potential for outpatient care. For instance, in December 2024, findings from the ASH Annual Meeting indicated that the revumenib-based combination therapy showed significant remission rates in patients with relapsed/refractory acute myeloid leukemia. Oral therapies have effectively targeted specific AML subtypes, reflecting a shift towards less invasive treatments that improve patient convenience, reduce hospital stays, lower costs, and enhance compliance and satisfaction.

End Use Insights

The hospitals and clinics segment accounted for the largest market share of 52.5% in 2024. This is primarily due to the complex nature of AML, which requires sophisticated diagnostic tools, specialized healthcare professionals, and advanced facilities for effective treatment management. Hospitals and clinics are equipped to provide comprehensive care, including high-dose chemotherapy and stem cell transplants, which are often necessary in AML treatment protocols.

The infrastructure of hospitals allows for the integration of multi-disciplinary teams needed for AML management, including hematologists, oncologists, nurses, and support staff, ensuring a coordinated treatment approach. In 2023, the reliance on hospitals for AML treatment was further emphasized with the introduction of newer, advanced therapies requiring controlled administration and monitoring, highlighting their critical role in delivering intensive care.

Homecare setting is expected to grow at the fastest CAGR of 13.5% over the forecast period. This growth is driven by the increasing availability of oral chemotherapeutics and targeted therapies, which can be safely administered at home. The shift towards home care is facilitated by advancements in telehealth and remote monitoring technologies, allowing healthcare providers to offer continuous support and management of AML patients from a distance.

In 2024, the expansion of homecare services was influenced by healthcare policies aiming to reduce hospital readmissions and the burden on healthcare facilities, while also improving patient quality of life by allowing them to receive treatment in the comfort of their homes. The adoption of homecare settings is further supported by the development of patient education programs and home health services, ensuring that patients receive safe and effective treatment outside of hospital settings.

Regional Insights

North America acute myeloid leukemia treatment market dominated the global market with a revenue share of 37.6% in 2024. Targeted therapies and immunotherapies have shown promising results in clinical trials, transforming AML treatment in North America. A significant emphasis on precision medicine aims to tailor therapies to individual genetic profiles, with emerging treatments such as BiTE antibodies and CAR-T cell therapy offering hope for refractory cases. A 2024 study by the Alliance for Leukemias in Mexico revealed considerable disparities in leukemia care access. Only 29.5% of the physicians surveyed reported having a dedicated leukemia clinic, while 64.2% identified access to diagnostic tests as a major treatment barrier. For instance, the PRONAII Childhood Leukemia Project advanced leukemia care in Mexico by enhancing diagnostic capabilities, fostering collaboration, standardizing processes, and addressing disparities in the states of Oaxaca, Puebla, and Tlaxcala, ultimately seeking to reduce early mortality rates among children with leukemia. Recent initiatives to improve leukemia care in Mexico have significantly contributed to market growth.

U.S. Acute Myeloid Leukemia Treatment Market Trends

The acute myeloid leukemia treatment market in the U.S. dominated the North America acute myeloid leukemia treatment market with a revenue share of 90.9% in 2024. Market growth in the country is influenced by the stringent regulatory environment governing drug approvals and clinical trials in the country. The FDA is crucial in evaluating and approving new AML therapies, ensuring patient safety and efficacy standards are met. Furthermore, the high healthcare expenditure in the U.S. enables patients to access advanced treatments, contributing to the rapid adoption of novel therapies in the market. For instance, in September 2024, ImCheck Therapeutics received FDA Fast Track designation in the U.S. for ICT01, combined with azacitidine and venetoclax, to treat AML patients unfit for intensive chemotherapy.

Europe Acute Myeloid Leukemia Treatment Market Trends

Europe acute myeloid leukemia treatment market is characterized by evolving trends shaped by regulatory frameworks and cultural factors unique to the region. One trend is the emphasis on cost-effectiveness and value-based healthcare systems across European countries. Health technology assessment agencies evaluate new therapies based on their clinical benefits and economic impact, influencing market access for AML treatments.

The acute myeloid leukemia treatment market in Germany has made significant strides in AML treatment, highlighted by a clinical trial challenging traditional stem cell transplantation methods. For instance, in March 2023, Researchers from the German Cancer Research Center (DKFZ), Heidelberg University Hospital, and HI-STEM identified a marker for therapy response in acute myeloid leukemia, allowing a cost-effective test to predict the efficacy of the Venetoclax and 5-Azacitidine combination while optimizing transplantation approaches. Moreover, the 2025 EHA-SWG Scientific Meeting in Berlin addressed advances in secondary AML. Rising incidence and improved diagnostics further drive demand for innovative therapies in the country.

Asia Pacific Acute Myeloid Leukemia Treatment Market Trends

Asia Pacific acute myeloid leukemia treatment market is expected to register the fastest CAGR of 11.7% in the forecast period. The region presents distinct trends in AML treatment driven by economic factors, regulatory landscapes, and cultural nuances. In countries such as China and Japan, there is a growing demand for innovative therapies due to the increasing prevalence of AML cases, coupled with improved healthcare infrastructure. Regulatory bodies in the Asia Pacific region are working towards streamlining approval processes for new drugs to expedite patient access to advanced treatments.

The acute myeloid leukemia treatment market in Japan is projected to grow at the fastest rate of 12.9% in the Asia Pacific market over the forecast period. The aging population has led to a higher incidence of AML among older adults. Moreover, advancements in diagnostic techniques enabled earlier detection of the disease. Recent regulatory approvals of targeted therapies, such as quizartinib, further expanded treatment options, while global collaboration continues to advance AML management research and practices. For instance, in May 2024, Nippon Shinyaku launched Vyxeos Combination for I.V. Injection in Japan, following marketing approval for the treatment of high-risk AML granted by the Ministry of Health, Labour and Welfare.

Key Acute Myeloid Leukemia Treatment Company Insights

Some key companies operating in the market include Astellas Pharma Inc.; Bristol-Myers Squibb Company; DAIICHI SANKYO COMPANY, LIMITED; among others. The market is characterized by a dynamic competitive landscape, with pharmaceutical giants, biotechnology innovators, diagnostics companies, and healthcare institutions vying for market share-pharmaceuticals who are launching innovative targeted therapies, immunotherapies, and personalized treatments.

• Bristol-Myers Squibb Company provides Onureg (azacitidine), an oral maintenance therapy approved for adult patients in complete remission. It enhances overall and relapse-free survival, serving as an important option for those ineligible for stem cell transplantation.

• Jazz Pharmaceuticals plc offers Vyxeos (daunorubicin and cytarabine), a liposomal formulation approved for newly diagnosed therapy-related AML or AML with myelodysplasia-related changes. Vyxeos demonstrates improved overall survival compared to standard treatments, making it vital for high-risk AML patients.

Recent Developments

• In December 2024, the QuANTUM-Wild Phase 3 trial began in Japan and the U.S., assessing VANFLYTA’s efficacy combined with chemotherapy for patients with newly diagnosed FLT3-ITD negative acute myeloid leukemia.

• In October 2024, MilliporeSigma announced a USD 76 million expansion of its ADC manufacturing capabilities in St. Louis, Missouri, tripling capacity to meet global demand and creating 170 new jobs.

• In September 2024, Rigel expanded its partnership with Kissei, granting them exclusive rights to develop and commercialize REZLIDHIA in Japan, Korea, and Taiwan, receiving an upfront payment of USD 10 million.

• In April 2024, Actinium revealed the results of the Phase 3 SIERRA trial for Iomab-B, showing a survival advantage in patients with high-risk relapsed or refractory acute myeloid leukemia who have TP53 mutations. These findings were accepted for oral presentation at the 50th European Bone Marrow Transplant Annual Meeting.

• In December 2023, Venetoclax combined with Azacitidine and novel targeted therapies resulting from research advancements. The combination of venetoclax and Azacitidine emerged as a significant advancement in the treatment of acute myeloid leukemia (AML), particularly for older patients or those ineligible for intensive chemotherapy.

Acute Myeloid Leukemia Treatment Market Report Scope

Global Acute Myeloid Leukemia Treatment Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global acute myeloid leukemia treatment market report based on disease, treatment, route of administration, end use, and region:

• Disease Outlook (Revenue, USD Million, 2018 - 2030)

  • Myeloblastic Leukemia

  • Myelomonocytic Leukemia

  • Promyelocytic Leukemia

  • Monocytic Leukemia

  • Other Diseases

• Treatment Outlook (Revenue, USD Million, 2018 - 2030)

  • Chemotherapy

    • Anti-metabolites

    • Alkylating Agents

    • Anthracycline Drugs

    • Others

  • Targeted Therapy

    • FLT3 Inhibitors

      • Rydapt

      • Vanflyta

      • Xospata

    • IDH Inhibitors

      • Tibsovo

      • Rezlidhia

      • Idhifa

    • Mylotarg

    • BCL-2 Inhibitor

    • Hedgehog Pathway Inhibitor

  • Immunotherapy

    • Bispecific Antibodies

    • Antibody-drug Conjugates

    • Immune Checkpoint Inhibitors

    • Chimeric Antigen Receptor (CAR) T-cell Therapy

  • Other Treatments

• Route of Administration Outlook (Revenue, USD Million, 2018 - 2030)

  • Parenteral

  • Oral

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals and Clinics

  • Specialty Centers

  • Homecare Setting

  • Ambulatory Care Centers

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait