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March 2025
Principal Consultant
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The global acute myeloid leukemia treatment market size is calculated at USD 3.5 billion in 2024, grew to USD 3.87 billion in 2025, and is projected to reach around USD 9.62 billion by 2034. The market is expanding at a CAGR of 10.64% between 2025 and 2034.
The rising incidence of acute myeloid leukemia (AML) can be attributed to factors such as an aging population, increased exposure to environmental toxins, and changing lifestyles. As a result, there is a growing demand for more effective treatment options, which is contributing to the expansion of the global market.
Acute myeloid leukemia (AML) is a type of cancer that affects the blood and begins in the bone marrow, the soft tissue inside certain bones where blood cells are produced. Typically, AML rapidly spreads from the bone marrow into the bloodstream and can sometimes extend to other areas of the body, such as the lymph nodes, liver, spleen, brain, spinal cord, and testicles. In some cases, leukemia cells may also form a tumor known as myeloid sarcoma. The increasing prevalence of AML, fueled by factors like genetic mutations, poor lifestyle choices, and environmental risks, highlights the critical demand for new and effective treatments.
The American Cancer Society estimates that in 2025, 22,010 people in the U.S. will be diagnosed with acute myeloid leukemia (AML), with most cases occurring in adults. Approximately 11,090 people are expected to die from the disease. AML accounts for about 1 in 3 leukemias in adults and around 1% of all cancers in the U.S., emphasizing the need for better treatment and research.
The growth of the market is expected to be driven by the advancement of novel therapies for high-risk patients, coupled with significant global investments in research and development. Additionally, collaborations between pharmaceutical companies and research institutions are accelerating the development of new treatments for AML.
For instance,
Artificial Intelligence (AI) and Machine Learning (ML) possess the ability to greatly influence the acute myeloid leukemia (AML) market by improving early detection, customized treatment strategies, and pharmaceutical advancement. AI and ML algorithms have the capability to analyze large datasets, uncovering patterns and genetic mutations linked to AML, potentially resulting in faster, more precise diagnoses. These technologies can assist in forecasting patient reactions to various therapies, allowing for more personalized and efficient treatments.
In drug discovery, AI and ML can speed up the identification of new drug candidates by examining molecular structures and forecasting their interactions with AML cells. This might facilitate the creation of new treatments, shorten time-to-market, and enhance patient outcomes. Moreover, AI and ML have the potential to enhance clinical trial designs, facilitating more effective recruitment, oversight, and evaluation, which in turn aids in the quicker approval of novel AML therapies.
Rising incidence of acute myeloid leukemia
The rising incidence of acute myeloid leukemia (AML) can be attributed to several key factors. An aging population is one of the primary drivers, as the risk of AML increases with age, particularly in older adults. Genetic mutations and conditions like Down syndrome also contribute to the higher occurrence of AML. Environmental exposures to toxins such as benzene, pesticides, and industrial chemicals further elevate the risk. Additionally, individuals who have undergone chemotherapy or radiation therapy for other cancers are at an increased risk of developing AML later in life. Unhealthy lifestyle choices, including smoking and poor diet, may also play a role, although their impact is less well-established. Finally, advancements in diagnostic techniques and greater awareness of the disease have led to earlier detection, contributing to the overall rise in incidence. These combined factors are driving the growing demand for effective treatments and further research into AML therapies.
For instance,
High-cost treatments
The high cost of treatment for acute myeloid leukemia acts as a significant restraint in the market. AML therapies often involve complex and prolonged treatments, such as chemotherapy, stem cell transplants, and targeted therapies, all of which can be expensive. Additionally, newer treatments like gene therapies and personalized medicine, though promising, can further increase the financial burden on patients and healthcare systems. The costs of hospitalization, frequent monitoring, and the need for specialized care also add to the overall treatment expenses. For many patients, these high costs can limit access to necessary treatments, particularly in low-income or uninsured populations, creating challenges in the widespread adoption of effective therapies. This financial barrier not only affects patients but also impacts the growth and accessibility of the acute myeloid leukemia treatment market globally.
The growing number of clinical trials
The growing number of clinical trials presents a significant opportunity for acute myeloid leukemia by fostering the development of new, more effective treatments. These trials allow researchers to explore innovative therapies, including targeted treatments, immunotherapies, and gene therapies, which can potentially offer better outcomes for patients. Increased participation in clinical trials also helps gather valuable data on the efficacy and safety of emerging therapies, accelerating the approval process for new drugs. Furthermore, as the number of trials increases, there is greater collaboration between pharmaceutical companies, research institutions, and healthcare providers, leading to faster innovation and expanded treatment options for AML patients.
For instance,
By disease, the myeloblastic leukemia segment held the largest acute myeloid leukemia treatment market share in 2024 due to its higher prevalence compared to other types of AML. Myeloblastic leukemia, which involves the rapid growth of abnormal white blood cells in the bone marrow, is more commonly diagnosed, leading to a greater demand for treatment options. As a result, this segment drives a significant portion of the market, as more patients require therapies such as chemotherapy, targeted treatments, and stem cell transplants. Additionally, ongoing research into more effective therapies for myeloblastic leukemia further contributes to the growth of this segment.
The National Institutes of Health (NIH) initiated clinical trials in the United States in October 2024, which are focused on precision medicine. The purpose of the experiment is to evaluate tailored therapy combinations for acute myeloid leukemia and myelodysplastic syndromes based on the patient's genetic profiles.
By disease, the promyelocytic leukemia segment is anticipated to grow at the fastest CAGR in the acute myeloid leukemia treatment market between 2025 and 2034 due to significant advancements in targeted therapies and improved treatment outcomes. Recent breakthroughs, such as the development of targeted treatments like all-trans retinoic acid (ATRA) and arsenic trioxide, have dramatically improved survival rates for patients with promyelocytic leukemia. These therapies have revolutionized the treatment landscape, driving higher demand for effective treatments. Additionally, ongoing research and clinical trials aimed at further enhancing therapeutic options are likely to contribute to the segment's rapid growth. As awareness increases and treatment options improve, more patients will benefit from these advancements, fueling market expansion.
By treatment, the chemotherapy segment held a dominant presence in the acute myeloid leukemia treatment market in 2024 because of its long-established role as the primary treatment option for AML. Chemotherapy, particularly regimens like "7+3" cytarabine combined with anthracycline, remains the standard of care for many AML patients, especially those with newly diagnosed or relapsed disease. It is widely used in both the induction and consolidation phases of treatment, making it the most common and accessible option. Despite the development of newer therapies, chemotherapy continues to be essential in managing AML, contributing to its dominant market share. Furthermore, chemotherapy's proven effectiveness, availability, and established clinical protocols make it the cornerstone of AML treatment, supporting its leading position in the market.
By treatment, the immunotherapy segment is predicted to witness the fastest growth in the acute myeloid leukemia treatment market over the forecast period, driven by the rising emphasis on targeted and personalized therapies. Immunotherapies, including checkpoint inhibitors, monoclonal antibodies, and CAR T-cell therapies are becoming more popular for their ability to leverage the immune system to specifically attack and eliminate cancer cells with reduced side effects compared to conventional treatments like chemotherapy. With numerous potentially effective immunotherapy choices presently in clinical trials, progress in this area is anticipated to result in novel, more efficient treatments for AML. Since these therapies demonstrate favorable outcomes in enhancing survival rates and quality of life, they are expected to achieve broad acceptance, fueling the segment's swift expansion in the years ahead.
By route of administration, the parenteral segment held the largest share of the acute myeloid leukemia treatment market in 2024 due to the nature of the therapies commonly used for AML, which are often administered through injections or infusions. Chemotherapy agents, immunotherapies, and targeted treatments for AML are typically delivered via intravenous (IV) or subcutaneous routes to ensure rapid and effective absorption, as well as to maintain the required drug concentrations in the bloodstream. Parenteral administration also offers better control over dosing and is more effective for drugs that cannot be absorbed efficiently through the digestive system. As a result, the parenteral route continues to dominate the AML treatment market, especially for critical therapies like chemotherapy and biological treatments.
By route of administration, the oral segment is anticipated to grow with the fastest CAGR in the acute myeloid leukemia treatment market during the studied years. Increasing development of oral therapies that offer greater convenience and improved patient adherence. Oral treatments, such as targeted therapies and some new-generation chemotherapies, provide a less invasive alternative to traditional intravenous (IV) or subcutaneous administration. These therapies can be taken at home, reducing the need for frequent hospital visits, which is particularly beneficial for patients who require long-term treatment or those in remission. As oral medications for AML are developed, they are expected to gain popularity because of their ease of use, lower healthcare costs, and improved quality of life for patients. The growing focus on oral therapies, combined with positive clinical outcomes, is expected to drive rapid growth in this segment.
By end-use, the hospital and clinics segment registered its dominance over the global acute myeloid leukemia treatment market in 2024 because of the extensive care and specialized therapies needed for AML patients. Hospitals and clinics have advanced diagnostic equipment, chemotherapy delivery capabilities, and skilled medical professionals, positioning them as the main environment for AML treatment. Due to the aggressive characteristics of AML, patients frequently need intensive treatments like chemotherapy, stem cell transplants, and other specialized care that is most effectively administered in a clinical environment. Moreover, hospitals and clinics provide the essential infrastructure for handling complications, tracking side effects, and delivering emergency care, which further enhances the acute myeloid leukemia treatment market.
By end-use, the homecare setting segment is expected to witness the fastest growth in the acute myeloid leukemia treatment market over the coming years, as increased availability of oral therapies like venetoclax (Venclexta) and the rise of remote monitoring technologies. These advancements allow patients to manage treatment at home, reducing hospital visits and improving convenience, cost-effectiveness, and quality of life, driving growth in this segment.
North America dominated the global acute myeloid leukemia treatment market share by 38% in 2024, attributed to some key factors such as advanced healthcare infrastructure, high healthcare spending, and the presence of leading pharmaceutical companies. The region benefits from robust research and development activities, leading to the rapid availability of innovative therapies. Additionally, increased awareness, early diagnosis, and access to cutting-edge treatments like targeted therapies and immunotherapies contribute to the market's dominance. Furthermore, North America has a high prevalence of AML, particularly among older populations, driving demand for effective treatment options.
In February 2024, researchers at City of Hope developed CD38-BIONIC, a T cell engager antibody that targets and eliminates leukemia stem cells. This new approach could provide a safer, more effective treatment for older AML patients ineligible for stem cell transplants, addressing drug resistance and relapse, which is expected to boost regional market growth.
The U.S. dominated the North American market due to its advanced healthcare infrastructure, high healthcare expenditure, and leading position in medical research and innovation. The country is home to numerous top pharmaceutical companies and research institutions, driving the development and availability of new AML treatments. Each year, AML claims the lives of approximately 11,400 people in the U.S., highlighting the need for new treatments. As a result, regulatory agencies have increasingly approved innovative therapies for AML treatment. Additionally, the U.S. has a high prevalence of AML, especially among the aging population, which contributes to the growing demand for effective therapies.
Canada is the fastest-growing AML treatment market in North America due to increased investment in cancer research, an aging population, and a focus on precision medicine. Collaborations between pharma companies and research institutions are accelerating the development of innovative therapies, driving market growth.
In December 2023, researchers at the University of Montreal received a USD 6 million grant from Genome Canada to develop a new Cyclin K degrader for high-risk AML patients to improve treatment outcomes and foster economic growth in Canada.
Asia-Pacific is anticipated to grow at the fastest rate in the market during the forecast period due to increasing healthcare investments, rising awareness about AML, and improvements in medical infrastructure. The region is witnessing rapid advancements in oncology research, along with a growing aging population and higher incidence rates of leukemia. Additionally, governments and healthcare organizations in countries like China, India, and Japan are prioritizing cancer treatments, further accelerating market growth. The increasing availability of innovative therapies and improving access to healthcare are key factors contributing to the region’s rapid expansion.
China dominated the market due to its large patient population, significant healthcare investments, and rapid advancements in medical research. The country has made substantial progress in cancer research and treatment infrastructure, enabling faster access to innovative therapies. Additionally, China's growing healthcare spending, increasing prevalence of leukemia, and aging population contribute to the demand for advanced treatment options. The government's focus on improving cancer care and expanding access to new treatments further strengthens China's position as the market leader in the region.
Japan is the quickest expanding market for myeloid leukemia treatment in the Asia-Pacific area, attributable to its advanced healthcare system, emphasis on medical research, and widespread use of innovative therapies. The nation experiences a significant rate of leukemia, especially in its older demographic, fueling the need for advanced therapies. Moreover, partnerships between pharmaceutical firms and research organizations are speeding up the innovation and accessibility of new leukemia therapies. The Ministry of Health, Labour, and Welfare approved Vyxeos The integration for I.V. Injection in Japan in May 2024, allowing Nippon Shinyaku to treat high-risk AML.
Europe is expected to experience significant growth in the AML treatment market due to increasing research and development activities, a high prevalence of AML, and advancements in healthcare infrastructure. The region's strong regulatory framework and government support for innovative treatments, coupled with a growing aging population, contribute to the rising demand for effective therapies. Additionally, Europe is home to several leading pharmaceutical companies focused on developing novel AML treatments, further driving market expansion in the coming years.
Germany leads the European market due to its advanced healthcare system, strong pharmaceutical industry, and significant investment in cancer research. The country's large patient population and access to innovative therapies contribute to its market dominance.
In March 2023, researchers from the German Cancer Research Center (DKFZ), Heidelberg University Hospital, and HI-STEM discovered a marker to predict therapy response in acute myeloid leukemia. This discovery optimizes transplantation procedures and allows for a cost-effective test to evaluate the effectiveness of the Venetoclax and 5-Azacitidine combo.
France is the fastest-growing market in Europe, driven by strong cancer research, increased healthcare investments, and an aging population. The country's advanced medical infrastructure and supportive regulatory environment further boost its growth in the AML market. Additionally, France’s aging population and government initiatives to improve cancer care are driving demand for new treatments, positioning it as a key player in the European AML market.
The National Institutes of Health (NIH) has initiated a proof-of-concept clinical trial focused on precision medicine for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The trial, funded by the NIH's National Cancer Institute (NCI), aims to test treatment combinations targeting specific genetic changes in cancer cells. Dr. W. Kimryn Rathmell, NCI Director, emphasized the trial's significance, stating, "By conducting these precision medicine studies, we are bringing cutting-edge science directly to patients across the nation. Our goal is to ensure that the findings benefit future patients facing similar challenges."
By Disease
By Treatment
By Route of Administration
By End Use
By Region
March 2025
February 2025
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January 2025