Report

Global acute myeloid leukemia market is projected to witness a CAGR of 10.10% during the forecast period 2024-2031, growing from USD 2.32 billion in 2023 to USD 5.01 billion in 2031. The market demand for acute myeloid leukemia (AML) is anticipated to thrive drastically in the forecast years due to the rising prevalence and the growing interest of investors and market players.
The progression rate of AML is quite fast, affecting the circulatory system of patients. Treatment options for AML include chemotherapy, radiotherapy, stem cell transplant, and novel targeted therapies. Currently, there are around 40 drugs approved by the United States Food and Drug Administration (USFDA) for the treatment of AML. Several promising studies focused on AML have been the subject of interest in recent years and may provide concrete clinical outcomes. The recent trend observed in AML research includes combination therapy in which a combination of drugs or different therapies is administered to reduce toxic effects, improve patient compliance, and enhance clinical outcomes. For instance, as per the research findings reported in the Oncogenesis journal in March 2024, the combination of JAK1/2 inhibitor (ruxolitinib) with either ERK or CSNK2A1 inhibitor had the highest efficacy and lowest toxicity, demonstrating the important role of these targets in AML. The research findings claim that this combination has the lowest toxicity and seems to be promising for AML treatment. Additionally, regulatory approvals of drugs for AML treatment boost market growth, adding another treatment option for the target population. In July 2023, Daiichi Sankyo, Inc. announced that it received USFDA approval for its VANFLYTA (quizartinib) in combination 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 acute myeloid leukemia (AML).
Rising Prevalence of Acute Myeloid Leukemia to Expand Market Size
AML is the most common type of leukemia, prevalent mainly in adults, and despite being characterized as a rare disease, its prevalence is reported to be increasing. The main reasons for the growing burden of AML include genetic mutations in isocitrate dehydrogenase (IDH) and age-associated factors. The rising prevalence of AML boosts the demand for more therapies and drugs to be used for treatment purposes and drives market demand. The exploration of its subtypes and efforts to improve clinical outcomes through the reduction of side effects of drugs are further contributing to the growth in demand for AML treatments, expanding the market further. According to the estimates by the American Cancer Society, about 20,800 people will be diagnosed with AML in 2024 within the United States, and 11,220 deaths are expected. AML is more common in men than women and accounts for 1 out of 3 leukemia cases.
Fundings for AML Research to Drive Market Growth
Monetary funding is a crucial driver for research in the global AML market. In recent years, several grants, funding, and government support have been promoting the research of AML treatments and diagnosis. These funding initiatives accelerate the market growth as research usually translates to promising market products. Besides government bodies, university grants and fellowships from various associations like the Leukemia & Lymphoma Society are reportedly driving market growth. For instance, in November 2023, the Leukemia & Lymphoma Society, the largest private funder of blood cancer research, announced new grants to 78 research groups across seven countries worth USD 65 million for blood cancer research. This announcement expands the Leukemia and Lymphoma Society's academic research portfolio over USD 240 million across multi-year grants. The major beneficiaries of these grants include researchers from prestigious cancer institutions, including Dana-Farber Cancer Center, MD Anderson Cancer Center, St. Jude Children's Research Hospital, and others.
Chemotherapy to Dominate the Acute Myeloid Leukemia Market Share
The chemotherapy segment is anticipated to possess a significant market share in the AML market owing to its widespread usage, high adoption rates, and comparative affordability compared to targeted therapies. Chemotherapies are usually the first line of treatment provided to AML patients by medical professionals, followed by other approved conjugated therapies or drugs. Despite all these factors, chemotherapy has several side effects, which may hinder future market share growth. The chemotherapy segment is expected to retain the lead position in the AML market during the forecast period. However, targeted therapy and immunotherapy segments are anticipated to register a robust growth rate due to high efficacy. New regulatory approvals further strengthen the market share of the chemotherapy segment. For instance, in April 2024, the USFDA granted breakthrough therapy designation to ziftomenib for the treatment of heavily pretreated patients with relapsed/refractory NPM1-mutant AML. It marks the first investigational treatment granted to breakthrough therapy designation for NPM1-mutant AML. Ziftomenib is a once-daily oral drug that targets the Menin-KMT2A/MLL protein-protein interaction to treat AML in genetically defined patients with high unmet needs.
North America to Dominate the Global Acute Myeloid Leukemia Market Share
North America is anticipated to dominate the share of the AML market, driven by several key factors. The rising prevalence of AML, particularly in the United States, is a significant contributor. In 2024, approximately 20,800 new cases are expected to be diagnosed in the United States, highlighting the impact of the disease and the urgent need for effective treatments. Moreover, advancements in research and development have led to the introduction of innovative therapies, such as the FDA's approval of ivosidenib in combination with azacitidine for newly diagnosed AML patients. This trend is expected to continue under the influence of investments in healthcare infrastructure and increased awareness of AML. The aging population further exacerbates the incidence of AML, as the median age of diagnosis is around 65 years. Consequently, North America is poised to maintain its dominance in the AML market due to these interrelated factors.
Future Market Scenario (2024 - 2031F)
Innovations in measurable residual disease (MRD) diagnosis, which assesses response to treatment and for early detection of imminent relapse, are notable drivers that may translate into futuristic growth of the AML market. A better prognosis and disease diagnosis are key to discovering its prevalence. Thus, AML diagnosis advancements may bring a significant expansion of the market growth rate. The contribution of several market players in the same line is anticipated to drive future market growth. For instance, in June 2024, SOPHiA GENETICS SA, a cloud-native healthcare technology company and a global leader in data-driven medicine, announced its new Residual Acute Myeloid Application. This new offering expands the company's comprehensive oncology portfolio to support MRD capabilities and will be available to customers worldwide. The SOPHiA DDM RAM Solution provides users the confidence that MRD will detect even one cancer cell among 10,000 cells.
Key Players Landscape and Outlook
The AML treatment market is mainly dominated by pharmaceutical and biotechnology giants such as Celgene Corporation, Novartis AG, and Daiichi Sankyo, Inc. Due to the rare disease designation of AML, the market is quite consolidated with a limited number of players. Several startups and small players are working in pre-clinical stages, usually collaborating or getting acquired by larger players. The recent market activities include strategic product launches, regulatory approvals, collaborations for geographic expansion, and acquisition.
In December 2023, VERAXA Biotech AG, a leading company in the development of advanced antibody-based cancer treatments and a portfolio company of Xlife Sciences AG, announced the acquisition of Synimmune GmbH and its innovative Phase I antibody (FLYSYN) for the treatment of Acute Myeloid Leukemia. It represents a significant milestone in the company's history and signifies the expansion of VERAXA's cancer pipeline. The FLYSYN antibody was obtained by VERAXA Biotech AG from Xlife Sciences AG portfolio company Synimmune GmbH through a share deal. The deal involved an initial payment as well as various milestones and is expected to have a total value of approximately USD 35.33 million.
In September 2023, Rigel Pharmaceuticals, Inc. announced that it has entered into an exclusive license and supply agreement with Kissei Pharmaceutical Co., Ltd. to develop and commercialize REZLIDHIA (olutasidenib) in all current and potential indications in Japan, the Republic of Korea and Taiwan. REZLIDHIA is commercially available to patients in the United States for the treatment of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML).