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(Albany, New York) – November 05, 2026: DelveInsight’s “Myelodysplastic Syndrome Market Insights, Epidemiology, and Market Forecast-2036″ report offers an in-depth understanding of the Myelodysplastic Syndrome, historical and forecasted epidemiology as well as the Myelodysplastic Syndrome market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

Additionally, it examines Myelodysplastic Syndrome market dynamics, offering a thorough assessment of current and emerging market trends, treatment patterns, and therapeutic developments. The analysis spans major markets, including the United States, EU4 (Germany, Spain, Italy, France, and the United Kingdom), and Japan, equipping decision-makers with actionable intelligence for strategic planning, investment, and research initiatives.

To Know in detail about the Myelodysplastic Syndrome market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Myelodysplastic Syndrome Market Forecast

Some of the key facts of the Myelodysplastic Syndrome Market Report:

• The Myelodysplastic Syndrome Market size across the major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 4.3 billion in 2025.

• In November 2026, Bristol Myers Squibb initiated patient recruitment for the LUNIS clinical trial (NCT07752121), evaluating luspatercept as a first-line treatment in patients with transfusion-dependent, lower-risk myelodysplastic neoplasms. The study is designed to assess the therapy’s potential to improve anemia management and reduce the need for regular blood transfusions.

• In October 2026, PureTech Health, along with its subsidiary Gallop Oncology, presented Phase Ib clinical findings for LYT-200, an investigational monoclonal antibody targeting galectin-9, at the ESMO 2026 Congress. The study assessed LYT-200 as a monotherapy and in combination with hypomethylating agents (HMAs), with or without venetoclax, in heavily pretreated patients with relapsed/refractory high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The company reported promising clinical activity, including two minimal residual disease (MRD)-negative complete responses that allowed patients to proceed to stem cell transplantation. Following the FDA’s Fast Track designation and completion of an End-of-Phase I meeting, Gallop Oncology plans to advance LYT-200 into the Phase II STRIDE-MDS trial.

• In October 2026, A Phase I dose-escalation and expansion study investigating SL-172154, a bispecific CD47 inhibitor and CD40 agonist, in combination with azacitidine in patients with higher-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), was published in October 2026. The results demonstrated an acceptable safety profile and promising complete remission activity in selected patient subgroups, particularly those with TP53 mutations. However, the combination failed to show a meaningful improvement in overall survival among patients with TP53-mutated higher-risk MDS, prompting the sponsor to discontinue further clinical development of SL-172154.

• In September 2026, Findings from the Phase III ENHANCE trial (NCT04313881), which investigated magrolimab in combination with azacitidine versus placebo plus azacitidine in previously untreated patients with higher-risk myelodysplastic syndromes (MDS), were published in the Journal of Clinical Oncology on September 10, 2026. The combination failed to demonstrate improvements in the primary endpoints of complete remission and overall survival. Median overall survival was 15.9 months in the magrolimab treatment arm compared with 18.6 months in the control group. Additionally, the combination was associated with a higher incidence of serious and severe adverse events.

• Geron in its 2026 corporate presentation mentions that a PTE application is filed in the US and EU for RYTELO patents and the RYTELO MOU (MDS) patent, respectively.

• In May 2026, Halia Therapeutics announced final Phase II results for ofirnoflast (HT-6184) in patients with LR-MDS. The data will be presented in an oral session at the European Hematology Association (EHA) 2026 Hybrid Congress.

• In May 2026, Geron Corporation announced that the first real-world evidence study of imetelstat in patients with LR-MDS will be presented at the European Hematology Association (EHA) 2026 Congress.

• In May 2026, Faron Pharmaceuticals announces that an abstract for its bexmarilimab Phase I/II study has been accepted as a poster presentation at the European Hematology Association (EHA) 2026 Congress. The BEXMAB study investigates bexmarilimab in combination with standard of care (SoC) in MDS.

• In March 2026, Faron Pharmaceuticals announcesd that investigators at City of Hope are in the process of developing a Phase II investigator-initiated clinical trial (IIT) in collaboration with Faron to evaluate bexmarilimab in participants with relapsed or refractory MDS.

• In Feburary 2026, Orca Bio announced new clinical data presented at the 2026 Tandem Meetings of ASTCT and CIBMTR. In Phase III Precision-T study, Orca-T demonstrated superior OS and RFS with reduced non-relapse mortality in patients with myelodysplastic syndromes compared to PTCy-based transplants.

• In September 2025, The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MNV-201, an investigational therapy for treating myelodysplastic syndrome (MDS), as announced by Minovia Therapeutics Ltd., a clinical-stage biotechnology company. This recognition underscores the potential of MNV-201 as a first-in-class mitochondrial cell therapy for patients with this serious age-associated blood disorder. Previously, the FDA had also awarded MNV-201 Fast Track and Rare Pediatric Disease designations for Pearson Syndrome, an ultra-rare mitochondrial disorder in children, which is currently under evaluation in an ongoing Phase 2 clinical trial.

• The total incident population of Myelodysplastic Syndrome in the 7MM was ~43,000 in 2025. These numbers are expected to increase by 2036.

• Patients classified as LR-MDS frequently present with symptomatic anemia, occurring in approximately 89% of cases.

• Among the EU4 and the UK, Germany had the highest incidence of Myelodysplastic Syndrome, followed by France. On the other hand, Spain had the lowest incidence of Myelodysplastic Syndrome in 2025.

• In the US, the majority of Myelodysplastic Syndrome cases were of the RAEB/MDS-EB subtype, accounting for nearly 7,000 cases in 2025.

• As per the analysis, mutation-specific cases of SF3B1 mutation accounted for the highest number of cases in MDS, i.e., ~900 cases, in Germany in 2025.

• Key Myelodysplastic Syndrome Companies: Geron, Servier, AbbVie, OrcaBio, Rigel Pharmaceuticals, University Hospital, Grenoble, Kind Pharmaceuticals LLC, Otsuka Beijing Research Institute, Agios Pharmaceuticals, Bristol-Myers Squibb, Syros Pharmaceuticals, H. Lee Moffitt Cancer Center, Novartis, Acceleron Pharma, Celgene, Eli Lilly and Company, Geron Corporation, Amgen, Astex Pharmaceuticals, Hoffmann-La Roche, Janssen Research & Development, and others

• Key Myelodysplastic Syndrome Therapies: Imetelstat (RYTELO), Ivosidenib (TIBSOVO), Venetoclax (VENCLEXTA), Orca-T, R289, Deferasirox, AND017, Decitabine, AG-946, Luspatercept, Tamibarotene, INCB024360, MBG453, ACE-536, Durvalumab, Galunisertib, Imetelstat, Darbepoetin Alfa, ASTX727 LD, Epoetin beta, Talacotuzumab, and others

• The Myelodysplastic Syndrome epidemiology based on gender analyzed that Myelodysplastic Syndrome is more common in men as compared to women

• The Myelodysplastic Syndrome market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Myelodysplastic Syndrome pipeline products will significantly revolutionize the Myelodysplastic Syndrome market dynamics.

Myelodysplastic Syndrome Overview

Myelodysplastic syndromes (MDS) are a group of disorders characterized by abnormal development and function of blood cells in the bone marrow. In MDS, the bone marrow fails to produce enough healthy blood cells, including red blood cells, white blood cells, and platelets. This results in cytopenias (low blood cell counts) and can lead to symptoms such as fatigue, weakness, shortness of breath, frequent infections, and easy bruising or bleeding.

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Myelodysplastic Syndrome Epidemiology

The Myelodysplastic Syndrome epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Myelodysplastic Syndrome Epidemiology Segmentation:

The Myelodysplastic Syndrome market report proffers epidemiological analysis for the study period 2022–2036 in the 7MM segmented into:

• Total Myelodysplastic Syndrome Incident Cases

• Myelodysplastic Syndrome Age-specific Incident Cases

• Myelodysplastic Syndrome Subtype-specific Incident Cases

• Myelodysplastic Syndrome Risk-specific Incident Cases

• Myelodysplastic Syndrome Mutation-specific Incident Cases

Download the report to understand which factors are driving Myelodysplastic Syndrome epidemiology trends @ Myelodysplastic Syndrome Epidemiology Forecast

Myelodysplastic Syndrome Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Myelodysplastic Syndrome market or expected to get launched during the study period. The analysis covers Myelodysplastic Syndrome market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Myelodysplastic Syndrome Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Myelodysplastic Syndrome Therapies and Key Companies

• Imetelstat (RYTELO): Geron

• Ivosidenib (TIBSOVO): Servier

• Venetoclax (VENCLEXTA): AbbVie

• Orca-T: OrcaBio

• R289: Rigel Pharmaceuticals

• Deferasirox: University Hospital, Grenoble

• AND017: Kind Pharmaceuticals LLC

• Decitabine: Otsuka Beijing Research Institute

• AG-946: Agios Pharmaceuticals

• Luspatercept: Bristol-Myers Squibb

• Tamibarotene: Syros Pharmaceuticals

• Luspatercept: Bristol-Myers Squibb

• INCB024360: H. Lee Moffitt Cancer Center

• MBG453: Novartis

• ACE-536: Acceleron Pharma

• Durvalumab: Celgene

• Galunisertib: Eli Lilly and Company

• Imetelstat: Geron Corporation

• Darbepoetin Alfa: Amgen

• ASTX727 LD: Astex Pharmaceuticals

• Epoetin beta: Hoffmann-La Roche

• Talacotuzumab: Janssen Research & Development

Discover more about therapies set to grab major Myelodysplastic Syndrome market share @ Myelodysplastic Syndrome Treatment Market

Myelodysplastic Syndrome Market Drivers

• Rising prevalence of hematologic malignancies and aging populations globally

• Increasing awareness and early diagnosis through advanced genetic and molecular testing

• Growing adoption of targeted therapies, hypomethylating agents, and precision medicine approaches

• Expanding clinical trials focused on novel biologics, immunotherapies, and combination therapies

• Advancements in stem cell transplantation and supportive care improving patient outcomes

• Rising investments in oncology and rare blood cancer research by pharmaceutical companies

Myelodysplastic Syndrome Market Barriers

• High treatment costs associated with long-term therapy, hospitalization, and stem cell transplantation

• Limited curative options for many MDS patients, especially elderly populations

• Risk of disease progression to acute myeloid leukemia (AML) complicating treatment outcomes

• Adverse effects and toxicity associated with chemotherapy and immunomodulatory treatments

• Challenges in identifying suitable stem cell transplant donors for eligible patients

• Limited awareness and delayed diagnosis in early-stage or low-risk MDS cases

Scope of the Myelodysplastic Syndrome Market Report

• Study Period: 2022–2036

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Myelodysplastic Syndrome Companies: Geron, Servier, AbbVie, OrcaBio, Rigel Pharmaceuticals, University Hospital, Grenoble, Kind Pharmaceuticals LLC, Otsuka Beijing Research Institute, Agios Pharmaceuticals, Bristol-Myers Squibb, Syros Pharmaceuticals, H. Lee Moffitt Cancer Center, Novartis, Acceleron Pharma, Celgene, Eli Lilly and Company, Geron Corporation, Amgen, Astex Pharmaceuticals, Hoffmann-La Roche, Janssen Research & Development, and others

• Key Myelodysplastic Syndrome Therapies: Imetelstat (RYTELO), Ivosidenib (TIBSOVO), Venetoclax (VENCLEXTA), Orca-T, R289, Deferasirox, AND017, Decitabine, AG-946, Luspatercept, Tamibarotene, INCB024360, MBG453, ACE-536, Durvalumab, Galunisertib, Imetelstat, Darbepoetin Alfa, ASTX727 LD, Epoetin beta, Talacotuzumab, and others

• Myelodysplastic Syndrome Therapeutic Assessment: Myelodysplastic Syndrome current marketed and Myelodysplastic Syndrome emerging therapies

• Myelodysplastic Syndrome Market Dynamics: Myelodysplastic Syndrome market drivers and Myelodysplastic Syndrome market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Myelodysplastic Syndrome Unmet Needs, KOL’s views, Analyst’s views, Myelodysplastic Syndrome Market Access and Reimbursement

To know more about Myelodysplastic Syndrome companies working in the treatment market, visit @ Myelodysplastic Syndrome Clinical Trials and Therapeutic Assessment

Table of Contents

1. Myelodysplastic Syndrome Market Report Introduction

2. Executive Summary for Myelodysplastic Syndrome

3. SWOT analysis of Myelodysplastic Syndrome

4. Myelodysplastic Syndrome Patient Share (%) Overview at a Glance

5. Myelodysplastic Syndrome Market Overview at a Glance

6. Myelodysplastic Syndrome Disease Background and Overview

7. Myelodysplastic Syndrome Epidemiology and Patient Population

8. Country-Specific Patient Population of Myelodysplastic Syndrome

9. Myelodysplastic Syndrome Current Treatment and Medical Practices

10. Myelodysplastic Syndrome Unmet Needs

11. Myelodysplastic Syndrome Emerging Therapies

12. Myelodysplastic Syndrome Market Outlook

13. Country-Wise Myelodysplastic Syndrome Market Analysis (2022–2036)

14. Myelodysplastic Syndrome Market Access and Reimbursement of Therapies

15. Myelodysplastic Syndrome Market Drivers

16. Myelodysplastic Syndrome Market Barriers

17. Myelodysplastic Syndrome Appendix

18. Myelodysplastic Syndrome Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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