Acute Myeloid Leukemia Treatment Market

Market Overview

The global acute myeloid leukemia treatment market size was valued at USD 2.58 billion in 2023. It is estimated to reach USD 6.29 billion by 2032, growing at a CAGR of 10.25% during the forecast period (2024–2032). In recent years, there has been a rise in cases of acute myeloid leukemia owing to a surge in the aging population, exposure to environmental toxins, and lifestyle changes, thereby increasing the demand for efficient treatment options and subsequently driving global market growth. 

Moreover, over the past few years, the quantity of pipeline drugs approved by regulatory bodies and undergoing various phases of clinical trials to further assess their safety has increased, thereby creating lucrative opportunities for market players to launch novel drugs. 

Highlight

• Chemotherapy dominates the treatment type segment
• North America is estimated to be the largest shareholder in the market

Market Overview

Acute Myeloid Leukemia (AML) is a cancer that impacts the blood and bone marrow, leading to the production of atypical white blood cells. In acute myeloid leukemia (AML), there is uncontrolled and fast proliferation of immature myeloid cells, which are intended to differentiate into red blood cells, white blood cells, and platelets. This rapid growth interferes with normal blood cell production, leading to symptoms like fatigue, easy bruising, and increased susceptibility to infections. 

AML progresses rapidly and requires prompt treatment. Treatment typically involves chemotherapy, sometimes followed by stem cell transplantation. While some patients achieve remission with treatment, AML can exhibit a high level of aggressiveness and pose significant challenges in terms of treatment, particularly in the case of older persons. Ongoing research aims to develop more effective therapies to improve outcomes for individuals with AML. 

Market Dynamics

Global Acute Myeloid Leukemia Treatment Market Drivers

Increasing Disease Incidence

The increasing incidence of acute myeloid leukemia (AML) globally is a pivotal driver propelling market growth. According to the American Society of Clinical Oncology, Acute myeloid leukemia (AML) is the dominant form of acute leukemia in adults, contributing to almost 80% of all cases of acute leukemias. Over the past 30 years, there has been a 46% increase in the annual number of newly diagnosed individuals with all types of leukemias worldwide. The prevalence of AML has risen by 15%, while the relative representation of AML among all leukemia patients has increased by 27%.

It is among the most lethal forms of the disease, accounting for 60% of all casualties. The category of patients aged 65 years had the most unfavorable outcomes, with only a 30% survival rate at 1-year intervals. Factors such as aging populations, prolonged exposure to environmental toxins, and lifestyle changes contribute to the rising prevalence of AML. This growing disease burden underscores the urgent need for innovative therapies and interventions to address the rising demand for effective AML management strategies.

Global Acute Myeloid Leukemia Treatment Market Restraint

High Cost of AML Therapies

Despite significant advancements in treatment modalities, the high cost associated with AML therapies remains a formidable restraint limiting market accessibility. The exorbitant prices of targeted therapies, chemotherapy agents, and supportive care medications pose substantial financial burdens on patients, healthcare systems, and payers worldwide. The complex nature of AML treatment, involving multiple cycles of induction, consolidation, and maintenance therapies, escalates the overall treatment costs, exacerbating the economic strain on patients and caregivers.

Moreover, limited insurance coverage and reimbursement challenges further exacerbate the affordability barriers, particularly in resource-constrained settings and developing regions. The disparity in access to innovative therapies exacerbates healthcare inequities, impacting treatment outcomes and patient survival rates. Thus, such factors are estimated to restrain market growth.

Global Acute Myeloid Leukemia Treatment Market Opportunities

Rising Clinical Trials

In recent years, there has been a rise in the number of pipeline drugs that have received approvals from the regulatory bodies and are in different phases of clinical trials to further evaluate their safety. For instance, in February 2024, Treadwell Therapeutics announced that the FDA had given ocifisertib (CFI-400945 fumarate) orphan drug status for its possible usage as a treatment option for individuals with acute myeloid leukemia (AML). A phase 1 study (NCT03187288) is now investigating the safety and tolerability of the PLK4 inhibitor in patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

At the same time, Kurome Therapeutics Inc. announced that the U.S. FDA has approved the Investigational New Drug (IND) application for KME-0584. This clearance permits the business to move on with a Phase 1 clinical trial in patients with relapsed/refractory (R/R) AML and high-risk (HR) Myelodysplastic Syndrome (MDS). Kurome intends to commence the clinical trial in the latter portion of 2024. Such factors are estimated to create opportunities for market growth.

Regional Analysis

Based on region, the global acute myeloid leukemia treatment market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global acute myeloid leukemia treatment market shareholder and is expected to expand substantially during the forecast period. North America dominates the AML treatment market, attributed to factors such as high healthcare expenditure, robust research infrastructure, and favorable reimbursement policies. AML claims the lives of around 11,400 individuals annually in the United States, necessitating the development of novel therapies. Thus, there has been a rise in the approval of novel therapeutics used in the treatment of AML by the regulatory bodies. For instance, in July 2023, the FDA approved the use of quizartinib (Vanflyta) in conjunction with chemotherapy as an initial treatment for individuals diagnosed with AML who possess a specific genetic mutation known as FLT3. Moreover, the region is defined by the presence of leading pharmaceutical companies and academic institutions driving innovation in AML therapeutics.

For instance, in February 2024, researchers at the City of Hope, a prominent cancer research and treatment institution in the United States, developed a novel method to specifically target and eliminate resilient leukemia stem cells. The scientists developed a T cell engager antibody named CD38-BIONIC, which establishes a connection between the T cells and the leukemia stem cells that express CD38. This connection allows the immune system to eliminate the cancer cells. The therapeutic method has the potential to offer a safer and more effective treatment option for older and sicker patients with AML who are ineligible for stem cell transplantation by addressing issues such as medication resistance and treatment relapse. These factors are expected to boost the regional market growth.

Asia-Pacific is experiencing rapid expansion in the acute myeloid leukemia (AML) treatment market, driven by several factors. A burgeoning population coupled with increasing life expectancy has led to a rise in AML cases, particularly in countries like China, Japan, and India. Moreover, initiatives to improve access to healthcare services, raise disease awareness, and foster international collaborations contribute to developing robust AML treatment ecosystems in the Asia-Pacific region, presenting lucrative market expansion and investment opportunities.

For instance, in January 2024, Glenmark Pharma and its biotech business, Ichnos Sciences, announced the establishment of their partnership, Ichnos Glenmark Innovation (IGI), to expedite the development of novel cancer treatments. The recently established IGI possesses a strong and diverse portfolio of three cutting-edge oncology compounds that specifically target multiple myeloma, acute myeloid leukemia, and solid tumors. These compounds are now being evaluated in clinical trials. Such collaborations are estimated to drive regional market growth.

Segmental Analysis

The global acute myeloid leukemia treatment market is segmented by type, treatment type, route of administration, and distribution channel.

Based on type, the global acute myeloid leukemia treatment market is segmented into myeloblastic, promyelocytic, myelomonocytic, and others. 

Myeloblastic leukemia, also known as acute myeloblastic leukemia (AML), is a blood cancer described by the exponential proliferation of immature myeloid cells in the bone marrow. These abnormal cells, known as blasts or myeloblasts, fail to mature into normal white blood cells, red blood cells, or platelets. Therefore, they accumulate in the bone marrow, interfering with the production of healthy blood cells. Myeloblastic leukemia can lead to symptoms such as fatigue, weakness, easy bruising or bleeding, and increased susceptibility to infections.

If treatment is postponed, the condition may worsen quickly and with potentially fatal consequences. Treatment typically involves chemotherapy, targeted therapy, stem cell transplantation, or a combination of these approaches to eliminate leukemic cells and restore normal blood cell production. Improving the prognosis and outcomes for patients requires early diagnosis and action.

Based on treatment type, the global acute myeloid leukemia treatment market is divided into chemotherapy, targeted therapy, immunotherapy, stem cell transplantation, and others. 

The chemotherapy segment dominates the global market. Chemotherapy remains a cornerstone in treating acute myeloid leukemia (AML), comprising a significant segment of the AML treatment market. Chemotherapy involves the administration of cytotoxic drugs to eradicate rapidly dividing cancer cells, thereby inducing remission and prolonging survival in AML patients. The chemotherapy segment encompasses various agents, including anthracyclines, cytarabine, and hypomethylating agents, administered via various oral, intravenous, and subcutaneous routes.

Despite its associated side effects, such as myelosuppression and mucositis, chemotherapy remains a mainstay in induction, consolidation, and salvage therapies for AML. Ongoing research efforts focus on refining chemotherapy regimens, optimizing dosing strategies, and integrating novel agents to enhance treatment efficacy and minimize toxicity, underscoring the continued significance of chemotherapy in AML management.

Based on the route of administration, the global acute myeloid leukemia treatment market is bifurcated into oral, intravenous, and subcutaneous administrations. 

The oral administration segment of the AML treatment market encompasses a diverse array of medications delivered via the oral route, offering patients a convenient and flexible option for managing their condition. Oral chemotherapy agents, targeted therapies, and maintenance medications play a major role in the treatment, allowing patients to self-administer medications at home or in outpatient settings. This approach enhances patient autonomy and quality of life and reduces the burden on healthcare infrastructure and resources associated with hospital-based treatments.

With advancements in pharmaceutical formulations and drug delivery technologies, oral therapies continue to gain prominence in AML management, promising improved treatment adherence, better disease control, and enhanced therapeutic outcomes. However, challenges such as medication adherence, drug interactions, and patient education remain pertinent considerations in optimizing the efficacy and safety of oral AML treatments.

Based on the distribution channel, the global acute myeloid leukemia treatment market is bifurcated into retail pharmacies, hospital pharmacies, specialty clinics, and online pharmacies. 

Online pharmacies have emerged as a disruptive force in the distribution of AML treatments, leveraging digital platforms to provide convenient access to medications and healthcare products for patients battling leukemia. These virtual pharmacies offer a user-friendly interface where patients can browse, purchase, and refill prescriptions from the comfort of their homes, eliminating the need for physical visits to traditional brick-and-mortar pharmacies. Online pharmacies prioritize patient convenience, offering doorstep delivery services, medication reminders, and 24/7 customer support to enhance the overall treatment experience.

Moreover, they facilitate access to a wide range of AML medications, including specialty drugs and supportive care therapies, often at competitive prices. With stringent adherence to regulatory standards and patient privacy measures, online pharmacies ensure safe and reliable distribution of AML treatments, empowering patients to manage their health journey efficiently in collaboration with healthcare providers.

Recent Developments

• May 2024- GlycoMimetics reported the findings from a crucial Phase 3 trial investigating the effectiveness of Uproleselan in patients with relapsed/refractory (R/R) Acute Myeloid Leukemia (AML). The study found that the combination of uproleselan and chemotherapy did not result in a statistically significant improvement in overall survival compared to chemotherapy alone when considering the entire population of patients intended to receive treatment.
• April 2024- Ziftomenib was awarded breakthrough therapy designation by the FDA for the treatment of heavily pretreated patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). This makes it the first investigational treatment to receive breakthrough therapy designation for NPM1-mutant AML.