Myelodysplastic Syndrome Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035

Market Overview:

The myelodysplastic syndrome market reached a value of USD 2.4 Billion across the top 7 markets (US, EU4, UK, and Japan) in 2024. Looking forward, IMARC Group expects the top 7 major markets to reach USD 4.8 Billion by 2035, exhibiting a growth rate (CAGR) of 6.29% during 2025-2035.

The myelodysplastic syndrome market has been comprehensively analyzed in IMARC's new report titled "Myelodysplastic Syndrome Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035". Myelodysplastic syndrome (MDS) refers to a type of blood cancer that occurs when immature blood cells in the bone marrow do not mature properly. Instead, they accumulate in the bone marrow, leading to a shortage of normal blood cells in the body. The common symptoms of the ailment include fatigue, weakness, shortness of breath, pale skin, dizziness, increased susceptibility to infections, etc. Some patients may also experience abnormal bruising or bleeding, such as frequent nosebleeds, bleeding gums, heavy menstrual bleeding, etc. The diagnosis of myelodysplastic syndrome typically begins with a physical exam and a review of the individual's medical history and symptoms. Blood tests are usually the first step in diagnosing MDS, as they can reveal abnormalities in the levels of blood cells present in the circulation. Various additional procedures are also ordered to confirm the diagnosis and determine the subtype of the disease. These tests include a bone marrow biopsy, in which a small sample of bone marrow is extracted and examined under a microscope to look for abnormal cells.

The rising cases of genetic mutations in the blood-forming cells of the bone marrow are primarily driving the myelodysplastic syndrome market. In addition to this, the widespread adoption of several growth factors, such as erythropoietin and granulocyte colony-stimulating factor (G-CSF), for increasing the production of blood cells in the bone marrow is acting as another significant growth-inducing factor. Furthermore, the escalating demand for hypomethylating agents, which block the activity of enzymes that inhibit the formation of blood cells in the bone marrow, thereby reducing the need for blood transfusions, is creating a positive outlook for the market. Moreover, the ongoing development of several targeted therapies, including drugs targeting the enzyme IDH1, which is mutated in a subset of MDS patients, is also augmenting the market growth. This approach allows for more precise and effective treatment with fewer side effects compared to traditional chemotherapy. Additionally, the emerging popularity of cytogenetic testing for identifying chromosome abnormalities, such as deletions, additions, or translocations, that further aid in determining the subtype of MDS, is expected to drive the myelodysplastic syndrome market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the myelodysplastic syndrome market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for myelodysplastic syndrome and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the myelodysplastic syndrome market in any manner.

Recent Developments:

• In August 2024, Akeso announced the completion of the first patient enrollment in the U.S. for the phase II clinical trial of its innovative CD47 monoclonal antibody, ligufalimab (AK117), in combination with azacitidine for patients with newly diagnosed higher-risk myelodysplastic syndrome.

Key Highlights:

• According to Orphanet, the global prevalence of MDS ranges from one to nine per 100,000.
• The annual incidence of MDS is around 4 per 100,000 people, based on the United States Surveillance.
• The typical age of presentation is 70 years, and the likelihood of developing MDS rises with age.
• This condition is particularly common among white men.

Drugs:

Revlimid (lenalidomide) is indicated for the treatment of patients with transfusion dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid's mechanism of action in MDS involves multiple pathways: it directly kills abnormal cells by inducing apoptosis and cell cycle arrest, reduces new blood vessel formation, and modulates the immune system to target and destroy cancer cells.

CTX-712 is an oral, selective inhibitor of CDC2-like kinase (CLK), which regulates RNA splicing and contributes to cell proliferation. CTX-712 suppresses human tumor cell proliferation in vitro and shows anticancer efficacy in xenograft mouse models in vivo.

AK117, developed by Akeso Biopharma, is a humanized IgG4 monoclonal antibody targeting CD47. It allows tumor cells to evade macrophage-mediated phagocytosis. By blocking CD47 interaction with SIRPα, AK117 enhances innate immune recognition and clearance of malignant cells. In myelodysplastic syndrome, this restores antitumor immunity, promoting effective elimination of abnormal hematopoietic cells.

Time Period of the Study

• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: 2025-2035

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the myelodysplastic syndrome market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the myelodysplastic syndrome market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current myelodysplastic syndrome marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the myelodysplastic syndrome market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the myelodysplastic syndrome across the seven major markets in 2024 and what will it look like in 2035?
• What is the growth rate of the myelodysplastic syndrome across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?

Epidemiology Insights

• What is the number of incident cases (2019-2035) of myelodysplastic syndrome across the seven major markets?
• What is the number of incident cases (2019-2035) of myelodysplastic syndrome by age across the seven major markets?
• What is the number of incident cases (2019-2035) of myelodysplastic syndrome by gender across the seven major markets?
• What is the number of incident cases (2019-2035) of myelodysplastic syndrome by type across the seven major markets?
• How many patients are diagnosed (2019-2035) with myelodysplastic syndrome across the seven major markets?
• What is the size of the myelodysplastic syndrome patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (2025-2035) across the seven major markets?
• What are the key factors driving the epidemiological trend myelodysplastic syndrome of?
• What will be the growth rate of patients across the seven major markets?

Myelodysplastic Syndrome: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for myelodysplastic syndrome drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the myelodysplastic syndrome market?
• What are the key regulatory events related to the myelodysplastic syndrome market?
• What is the structure of clinical trial landscape by status related to the myelodysplastic syndrome market?
• What is the structure of clinical trial landscape by phase related to the myelodysplastic syndrome market?
• What is the structure of clinical trial landscape by route of administration related to the myelodysplastic syndrome market?