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PUBLISHER: DelveInsight | PRODUCT CODE: 2082961

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PUBLISHER: DelveInsight | PRODUCT CODE: 2082961

Myelodysplastic Syndrome - Market Insight, Epidemiology, and Market Forecast - 2036

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Myelodysplastic Syndrome (MDS) Insights and Trends

  • According to DelveInsight's analysis, the MDS market size was found to be ~USD 4,300 million in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • As per Blood Cancer United, approximately 25-30% of MDS patients have high-risk disease. The disease can progress to high-risk MDS and secondary AML in approximately 30% of cases.
  • As per MDS UK, MDS is a rare disease. In the UK, there are about 4 cases per 100,000 population per year. The typical age at which patients develop MDS is around 70 years old. Fewer than 10% of MDS patients are younger than 50 years.
  • MDS primarily affects older adults, with a median age at diagnosis of approximately 71 years. The standardized net survival is estimated to be about 83% at 1 year and 51% at 5 years.
  • The pharmaceutical companies active in the MDS market include Bristol Myers Squibb (REBLOZYL), Geron (RYTELO), Servier Pharmaceuticals (TIBSOVO), and others.
  • Venetoclax is expected to be one of the most influential emerging therapies in HR-MDS. Backed by extensive clinical experience in AML and encouraging combination data with hypomethylating agents.
  • Luspatercept-aamt (REBLOZYL) is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naive) in adult patients with very low- to intermediate-risk MDS who may require RBC transfusions.
  • The pipeline of MDS is very robust, emerging therapies such as Venetoclax (VENCLEXTA) (AbbVie), bexmarilimab (Faron Pharmaceuticals), ASTX727 (Taiho Oncology), Orca-T (Orca Bio), R289 (Rigel Pharmaceuticals), lisaftoclax (APG-2575) (Ascentage Pharma), olutasidenib (Rigel Pharmaceuticals), ofirnoflast (HT-6184) (Halia Therapeutics), and others are being developed for safe and efficacious treatments.
  • Halia Therapeutics is scheduled to present final Phase II results for ofirnoflast in LR-MDS at EHA 2026. The accepted abstract indicated that the study achieved its primary endpoint of hematological improvement (HI) per IWG 2018 criteria, supporting the therapeutic potential of ofirnoflast in this patient population.
  • The introduction of risk-adapted treatment strategies has transformed the MDS treatment landscape. While hypomethylating agents long served as the cornerstone of therapy, up to 50% of patients derived little or no benefit from these treatments.

DelveInsight's 'Myelodysplastic Syndrome (MDS) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the MDS, historical and forecasted epidemiology, as well as the MDS market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The MDS market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates MDS patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in MDS and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Myelodysplastic Syndrome (MDS) Market

Increasing Aging Population and Disease Burden

MDS predominantly affects older adults, with incidence rising significantly in individuals aged 65 years and above. The growing elderly population across major markets is expected to increase the number of diagnosed and treated MDS cases, thereby expanding the market opportunity.

Expanding Use of Combination Therapies

Combination approaches involving hypomethylating agents, B-cell lymphoma-2 (Bcl-2) inhibitor, immune-modulating therapies, and novel targeted agents are being increasingly evaluated. Positive clinical outcomes from these strategies are expected to drive treatment adoption and market growth.

Growing Clinical Trial Activity and Pipeline Innovation

A robust pipeline featuring cell therapies, immunotherapies, and targeted agents reflects strong industry interest in MDS. Continued clinical development and potential approvals of novel therapies are expected to diversify treatment options and stimulate market expansion.

Myelodysplastic Syndrome (MDS) Understanding and Treatment Algorithm

Myelodysplastic Syndrome (MDS) Overview and Diagnosis

MDS is a group of rare, heterogeneous bone marrow disorders characterized by ineffective hematopoiesis, leading to insufficient production of healthy blood cells. The disease arises from genetic and epigenetic abnormalities in hematopoietic stem cells, resulting in persistent cytopenias, bone marrow dysplasia, and an increased risk of progression to acute myeloid leukemia (AML). MDS primarily affects older adults and presents a substantial clinical burden due to chronic anemia, recurrent infections, bleeding complications, reduced quality of life, and the need for ongoing medical management. The biological and clinical heterogeneity of MDS has led to the development of risk-adapted treatment approaches and continues to drive the need for novel disease-modifying therapies.

The diagnosis of MDS is based on a combination of clinical evaluation, laboratory testing, bone marrow examination, and cytogenetic or molecular analyses. Patients typically present with persistent unexplained cytopenias identified through complete blood counts (CBCs). Bone marrow aspiration and biopsy are essential for assessing dysplasia, blast percentage, and cellularity, while cytogenetic testing and next-generation sequencing (NGS) help identify chromosomal abnormalities and gene mutations that support diagnosis, risk stratification, and treatment selection. Prognosis is commonly assessed using scoring systems such as the IPSS-R and IPSS-M.

Current Myelodysplastic Syndrome (MDS) Treatment Landscape

Treatment strategies for MDS are guided by disease risk, symptom burden, age, and patient fitness. Lower-risk patients are often managed with supportive care, including red blood cell transfusions, erythropoiesis-stimulating agents (ESAs), and luspatercept for anemia. Higher-risk patients generally receive disease-modifying therapies such as hypomethylating agents, including azacitidine and decitabine, while eligible patients may undergo allogeneic hematopoietic stem cell transplantation, the only potentially curative treatment. Emerging therapies such as Bcl-2 inhibitors, immune-targeted agents, and novel cellular therapies are expected to further transform the MDS treatment landscape.

Myelodysplastic Syndrome (MDS) Unmet Needs

The section "unmet needs of MDS" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Poor understanding of bone marrow failure mechanisms independent of blast burden

2. Lack of effective therapies after hma failure

3. Limited therapies addressing disease progression

4. Persistent transfusion dependence, and others.....

Myelodysplastic Syndrome (MDS) Epidemiology

Key Findings from MDS Epidemiological Analysis and Forecast

  • The total incident population of MDS in the 7MM were ~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 highest incident cases of MDS, followed by France. On the other hand, Spain had the lowest incident population of MDS, in 2025.
  • In the US, the majority of MDS 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.

Myelodysplastic Syndrome (MDS) Drug Analysis & Competitive Landscape

The MDS drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase III/I clinical trials and preclinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the MDS treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the MDS therapeutics market.

Approved Therapies for Myelodysplastic Syndrome (MDS)

Imetelstat (RYTELO): Geron

Imetelstat is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Imetelstat is the first and only telomerase inhibitor approved by the US FDA and the European Commission. It has US market exclusivity till June 2029 and till March 2035 in EU. It also has orphan drug exclusivity till June 2031 in US and till March 2025 in EU. RYTELO is positioned to lead in second-line Lower-Risk Myelodysplastic Syndrome (LR-MDS).

Ivosidenib (TIBSOVO): Servier

Ivosidenib is a oral, targeted, first-in-class precision medicine developed by Servier that blocks the isocitrate dehydrogenase-1 (IDH1) mutation. It is primarily prescribed for adults with relapsed/refractory (r/r) or newly diagnosed MDS. The FDA approval of this indication is supported by a pivotal Phase I, open-label study in IDH1-mutated R/R MDS patients. The therapy has demonstrated clinical benefit in hematologic cancers and targeted oncology settings driven by IDH1 mutations.

Myelodysplastic Syndrome (MDS) Pipeline Analysis

Venetoclax (VENCLEXTA): AbbVie

Venetoclax is a selective Bcl-2 inhibitor. The US FDA granted a Breakthrough Therapy Designation (BTD) to venetoclax in combination with azacitidine for the treatment of adult patients with previously untreated intermediate-, high- and very high-risk MDS. Venetoclax is a prescription medicine used in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by Genentech in the US and by AbbVie outside of the US.

Orca-T: OrcaBio

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment MDS. Orca Bio is evaluating Orca-T across multiple clinical trials in MDS, including Phase III, Phase II, and Phase I/Ib studies assessing different donor settings, conditioning regimens, and transplant approaches. By improving transplant outcomes and lowering transplant-related complications, Orca-T has the potential to expand access to curative HSCT for patients with HR-MDS.

Myelodysplastic Syndrome (MDS) Key Players, Market Leaders and Emerging Companies

  • Geron
  • Servier
  • Bristol Myers Squibb
  • AbbVie
  • OrcaBio
  • Ascentage Pharma
  • Faron Pharmaceuticals
  • Taiho Oncology
  • Rigel Pharmaceuticals, and others

Myelodysplastic Syndrome (MDS) Drug Updates

  • Geron in its 2026 corporate presenation mentions PTE application is filed in the US and EU for RYTELO patents and 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 Feburary 2026, Orca Bio announced first patients dosed in the Phase II SERENE-T study evaluating Orca-T with RIC in MDS.
  • In December 2025, Faron Pharmaceuticals announced that two abstracts featuring data from the Phase I/II bexmarilimab study have been accepted for presentation at the American Society of Hematology (ASH) 2025 Annual Meeting. The Phase I/II BEXMAB study assessed impact of bexmarilimab plus azacitidine in patients with treatment-naive HR-MDS.
  • In December 2025, Rigel Pharmaceuticals announced updated data from its ongoing Phase Ib study evaluating R2891 in patients with R/R LR-MDS. R289 continued to be generally well tolerated and at doses of >=500 mg QD preliminary efficacy was observed in elderly.

Myelodysplastic Syndrome (MDS) Market Outlook

The treatment landscape for MDS is undergoing a significant transformation from traditional supportive care and hypomethylating agents (HMAs) toward targeted therapies, erythroid maturation agents, and combination regimens designed to address specific molecular abnormalities and disease biology. The market is currently anchored by approved therapies such as luspatercept-aamt, imetelstat, and ivosidenib, each occupying distinct patient segments. Luspatercept has established itself as a preferred option for lower-risk transfusion-dependent anemia, while imetelstat has strengthened competition by offering durable transfusion independence in ESA-refractory patients. ivosidenib, although limited to IDH1-mutated disease, exemplifies the growing role of biomarker-driven treatment approaches in MDS. Imetelstat generated net revenue of USD 51.8 million in Q1 2026, representing an 8% increase over Q4 2025, indicating strong early commercial uptake. While luspatercept continues to maintain a substantially larger market presence owing to its broader label and earlier market entry.

Among emerging therapies, venetoclax is expected to be one of the most influential pipeline assets in the HR-MDS setting. The drug has already established a strong clinical foundation in AML, and ongoing MDS studies have shown encouraging response rates when combined with azacitidine. If ongoing trials demonstrate a survival benefit and manageable safety profile. Bexmarilimab has attracted attention due to its encouraging activity in patients with r/r MDS. Early clinical data have demonstrated durable responses and a favorable tolerability profile, supporting its potential role in a patient population with limited therapeutic options. Another notable emerging asset is lisaftoclax, which has reported promising efficacy signals in combination regimens and is being positioned as a next-generation BCL-2 inhibitor. Its future competitiveness will depend on whether it can demonstrate advantages over venetoclax in terms of safety, dosing flexibility, or durability of response.

  • Rigel Pharmaceuticals is emerging as a strong competitor in the MDS market with olutasidenib and R289 in its pipeline. The company's presence across both targeted and immune-modulating therapies strengthens its competitive position and provides opportunities to address multiple MDS patient subgroups.
  • Bexmarilimab has positioned itself as a differentiated immunotherapy candidate targeting patients with r/r disease and limited treatment options. Positive late-stage data could support uptake in a high-unmet-need setting where therapeutic alternatives remain limited.

Drug Class/Insights into Leading Emerging and Marketed Therapies in MDS (2022-2036 Forecast)

The MDS market (2022-2036 forecast) is evolving from a landscape historically dominated by supportive care and hypomethylating agents toward a more targeted and biomarker-driven treatment paradigm. Advances in disease biology have led to the development of therapies addressing ineffective hematopoiesis.

  • Telomerase Inhibitors: Imetelstat represents the first telomerase inhibitor approved for LR-MDS patients with transfusion-dependent anemia. This class targets malignant hematopoietic progenitor cells by inhibiting telomerase activity. It's approval has introduced a novel disease-modifying approach beyond supportive care and erythropoiesis-stimulating agents.
  • Bcl-2 Inhibitors: Venetoclax and lisaftoclax belong to the Bcl-2 inhibitor class, which promotes apoptosis of malignant hematopoietic cells. Venetoclax-based combinations have generated considerable interest in HR-MDS, while lisaftoclax is being developed as a next-generation Bcl-2 inhibitor with the potential to offer differentiated efficacy and safety profiles.
  • Cell Therapy: Orca-T belongs to the allogeneic cell therapy class and is designed to optimize outcomes following hematopoietic stem cell transplantation. Unlike conventional pharmacological therapies, this approach seeks to improve transplant success while reducing complications such as graft-versus-host disease, representing a highly specialized therapeutic strategy for eligible patients.

MDS innovation is no longer driven by a single therapeutic mechanism but rather by a convergence of erythroid maturation agents, telomerase inhibitors, targeted molecular therapies, apoptosis-inducing agents, immune modulators, and cellular therapies. This diversification is expected to reshape treatment algorithms, increase patient stratification based on molecular and clinical characteristics, and drive sustained market growth throughout the forecast period.

Myelodysplastic Syndrome (MDS) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the MDS drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

Among approved therapies, luspatercept is expected to maintain strong uptake in LR-MDS patients with anemia, supported by its established efficacy in reducing transfusion burden and its expanding role in earlier lines of treatment. Imetelstat is anticipated to witness increasing adoption among transfusion-dependent LR-MDS patients following ESA failure, driven by its novel telomerase inhibition mechanism and durable transfusion independence outcomes. Meanwhile, Ivosidenib is expected to experience more selective uptake due to its applicability to the relatively small subset of patients harboring IDH1 mutations, although its precision-medicine approach supports strong value within this niche population.

The emerging MDS pipeline is expected to drive increased competition across both lower-risk and higher-risk disease segments. Venetoclax is expected to achieve strong uptake in HR-MDS, supported by its established clinical use in AML and promising combination data with hypomethylating agents. Lisaftoclax (APG-2575) may emerge as a competitive next-generation Bcl-2 inhibitor if it demonstrates advantages in efficacy or tolerability over existing Bcl-2-based regimens. Bexmarilimab is likely to gain traction in R/R MDS, where unmet need remains high, while ofirnoflast and R289 may see selective adoption if their novel immune and inflammatory pathway-targeting approaches translate into meaningful clinical benefit.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in Myelodysplastic Syndrome (MDS)

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report....

Myelodysplastic Syndrome (MDS) Therapies Price Scenario & Trends

Pricing and analogue assessment of MDS therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Myelodysplastic Syndrome (MDS)

To keep up with MDS market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the MDS emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in MDS, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights at the country level. Centers such as Stanford MDS Center, Memorial Sloan Kettering Cancer Center, and University Medical Center Mainz etc. were contacted. Their opinion helps understand and validate current and emerging MDS therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in MDS.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of MDS, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of MDS, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the MDS market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM MDS market.

Report Insights

  • Myelodysplastic Syndrome (MDS) Patient Population Forecast
  • Myelodysplastic Syndrome (MDS) Therapeutics Market Size
  • Myelodysplastic Syndrome (MDS) Pipeline Analysis
  • Myelodysplastic Syndrome (MDS) Market Size and Trends
  • Myelodysplastic Syndrome (MDS) Market Opportunity (Current and Forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-Enabled Market Research Report
  • 11-Year Forecast
  • Myelodysplastic Syndrome (MDS) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Myelodysplastic Syndrome (MDS) Treatment Addressable Market (TAM)
  • Myelodysplastic Syndrome (MDS) Competitive Landscape
  • Myelodysplastic Syndrome (MDS) Major Companies Insights
  • Myelodysplastic Syndrome (MDS) Price Trends and Analogue Assessment
  • Myelodysplastic Syndrome (MDS) Therapies Drug Adoption/Uptake
  • Myelodysplastic Syndrome (MDS) Therapies Peak Patient Share Analysis

Report Assessment

  • Myelodysplastic Syndrome (MDS) Current Treatment Practices
  • Myelodysplastic Syndrome (MDS) Unmet Needs
  • Myelodysplastic Syndrome (MDS) Clinical Development Analysis
  • Myelodysplastic Syndrome (MDS) Emerging Drugs Product Profiles
  • Myelodysplastic Syndrome (MDS) Market attractiveness
  • Myelodysplastic Syndrome (MDS) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the MDS market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of MDS?
  • What are the disease risks, burdens, and unmet needs of MDS? What will be the growth opportunities across the 7MM concerning the patient population with MDS?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of MDS? What are the current guidelines for treating MDS in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the MDS market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.
Product Code: DIMI0320

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Myelodysplastic Syndrome (MDS)

4. Key Events

  • 4.1. Upcoming Key Catalyst
  • 4.2. Key Conferences And Meetings
  • 4.3. Key Transactions And Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Methodology of Myelodysplastic Syndrome (MDS)

6. Myelodysplastic Syndrome (MDS) Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Myelodysplastic Syndrome (MDS) By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Myelodysplastic Syndrome (MDS) By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Myelodysplastic Syndrome (MDS)

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Signs And Symptoms
  • 7.4. Diagnosis
    • 7.4.1. Differential Diagnosis
    • 7.4.2. Diagnostic Algorithm
    • 7.4.3. Diagnostic Guidelines
  • 7.5. Treatment and Management
    • 7.5.1. Treatment Algorithm
    • 7.5.2. Treatment Guidelines

8. Epidemiology and Patient Population of Myelodysplastic Syndrome (MDS)

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Myelodysplastic Syndrome (MDS) Total Incident Cases in the 7MM
  • 8.4. The United States
    • 8.4.1. Myelodysplastic Syndrome (MDS) Total Incident Cases in the United States
    • 8.4.2. Myelodysplastic Syndrome (MDS) Age-specific Incident Cases in the United States
    • 8.4.3. Myelodysplastic Syndrome (MDS) Subtype-specific Incident Cases in the United States
    • 8.4.4. Myelodysplastic Syndrome (MDS) Risk-specific Incident Cases in the United States
    • 8.4.5. Myelodysplastic Syndrome (MDS) Mutation-specific Incident Cases in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Myelodysplastic Syndrome (MDS) Total Incident Cases in EU4 and the UK
    • 8.5.4. Myelodysplastic Syndrome (MDS) Age-specific Incident Cases in EU4 and the UK
    • 8.5.5. Myelodysplastic Syndrome (MDS) Subtype-specific Incident Cases in EU4 and the UK
    • 8.5.6. Myelodysplastic Syndrome (MDS) Risk-specific Incident Cases in EU4 and the UK
    • 8.5.4. Myelodysplastic Syndrome (MDS) Mutation-specific Incident Cases in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Myelodysplastic Syndrome (MDS) Total Incident Cases in Japan
    • 8.6.2. Myelodysplastic Syndrome (MDS) Age-specific Incident Cases in Japan
    • 8.6.5. Myelodysplastic Syndrome (MDS) Subtype-specific Incident Cases in Japan
    • 8.6.6. Myelodysplastic Syndrome (MDS) Risk-specific Incident Cases in Japan
    • 8.6.5. Myelodysplastic Syndrome (MDS) Mutation-specific Incident Cases in Japan

9. Patient Journey of Myelodysplastic Syndrome (MDS)

10. Marketed Therapies of Myelodysplastic Syndrome (MDS)

  • 10.1. Marketed Competitive Landscape of Myelodysplastic Syndrome (MDS)
  • 10.2. Imetelstat (RYTELO): Geron
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Analyst Views
  • 10.3. Ivosidenib (TIBSOVO): Servier
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Other Developmental Activities
    • 10.3.4. Summary of Pivotal Trials
    • 10.3.5. Analyst Views

11. Emerging Therapies of Myelodysplastic Syndrome (MDS)

  • 11.1. Emerging Competitive Landscape of Myelodysplastic Syndrome (MDS)
  • 11.2. Venetoclax (VENCLEXTA): AbbVie
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trial Information
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analyst Views
  • 11.3. Orca-T: OrcaBio
    • 11.3.1. Product Description
    • 11.3.2. Other Developmental Activities
    • 11.3.3. Clinical Development
      • 11.3.3.1. Clinical Trial Information
    • 11.3.4. Safety and Efficacy
    • 11.3.5. Analyst Views

12. Myelodysplastic Syndrome (MDS): Seven Major Market Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Myelodysplastic Syndrome (MDS)
  • 12.3. Conjoint Analysis of Myelodysplastic Syndrome (MDS)
  • 12.4. Key Market Forecast Assumptions
    • 12.4.1. Cost Assumptions
    • 12.4.2. Pricing Trends
    • 12.4.3. Analogue Assessment
    • 12.4.4. Launch Year and Therapy Uptakes
  • 12.5. Total Market Size of Myelodysplastic Syndrome (MDS) in the 7MM
  • 12.6. The United States
    • 12.6.1. Total Market Size of Myelodysplastic Syndrome (MDS) in the United States
    • 12.6.2. Market Size of Myelodysplastic Syndrome (MDS) by Therapies in the United States
  • 12.7. EU4 and the UK
    • 12.7.1. Total Market Size of Myelodysplastic Syndrome (MDS) in EU4 and the UK
    • 12.7.2. Market Size of Myelodysplastic Syndrome (MDS) by Therapies in EU4 and the UK
  • 12.8. Japan
    • 12.8.1. Total Market Size of Myelodysplastic Syndrome (MDS) in Japan
    • 12.8.2. Market Size of Myelodysplastic Syndrome (MDS) by Therapies in Japan

13. Unmet Needs of Myelodysplastic Syndrome (MDS)

14. SWOT Analysis of Myelodysplastic Syndrome (MDS)

15. KOL Views of Myelodysplastic Syndrome (MDS)

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement

  • 16.1. The US
  • 16.2. In EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of Myelodysplastic Syndrome (MDS) Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

Product Code: DIMI0320

List of Tables

  • Table 1: Summary of Myelodysplastic Syndrome (MDS) Market, and Epidemiology (2022-2036)
  • Table 2: Key Events
  • Table 3: Total Incident Population of MDS in the 7MM (2022-2036)
  • Table 4: Total Incident Population of MDS in the US (2022-2036)
  • Table 5: Age-specific Incident Population of MDS in the United States (2022-2036)
  • Table 6: Subtype-specific Incident Population of MDS in the US (2022-2036)
  • Table 7: Risk-specific incident population of MDS in the United States (2022-2036)
  • Table 8: Mutation-specific incident population of MDS in the United States (2022-2036)
  • Table 9: Total Incidence of MDS in EU-5 (2022-2036)
  • Table 10: Age-specific Incident Population of MDS in EU-5 (2022-2036)
  • Table 11: Subtype-specific Incident Population of MDS in EU-5 (2022-2036)
  • Table 12: Risk-specific incident population of MDS in EU5 (2022-2036)
  • Table 13: Mutation-specific incident population of MDS in EU5 (2022-2036)
  • Table 14: Total Incident Population of MDS in Japan (2022-2036)
  • Table 15: Age-specific Incident Population of MDS in Japan (2022-2036)
  • Table 16: Subtype-specific Incident Population of MDS in Japan (2022-2036)
  • Table 17: Risk-specific incident population of MDS in Japan (2022-2036)
  • Table 18: Mutation-specific incident population of MDS in Japan (2022-2036)
  • Table 19: Organizations Contributing Toward the Fight Against Myelodysplastic Syndrome
  • Table 20: Reblozyl, Clinical Trial Description, 2021
  • Table 21: Inqovi, Clinical Trial Description, 2021
  • Table 22: Comparison of emerging drugs under development
  • Table 23: Comparison of emerging drugs under development
  • Table 24: Roxadustat (FG-4592), Clinical Trial Description, 2021
  • Table 25: Venclexta (Venetoclax) + Azacitidine, Clinical Trial Description, 2021
  • Table 26: Magrolimab +- Azacitidine, Clinical Trial Description, 2021
  • Table 27: Sabatolimab (MBG453) + Azacitidine), Clinical Trial Description, 2021
  • Table 28: SY-1425 + Azacitidine, Clinical Trial Description, 2021
  • Table 29: Pevonedistat + Azacitidine, Clinical Trial Description, 2021
  • Table 30: Glasdegib + Azacitidine, Clinical Trial Description, 2021
  • Table 31: Imetelstat, Clinical Trial Description, 2021
  • Table 32: Eltanexor, Clinical Trial Description, 2021
  • Table 33: Bemcentinib, Clinical Trial Description, 2021
  • Table 34: Enasidenib, Clinical Trial Description, 2021
  • Table 35: CPX-351, Clinical Trial Description, 2021
  • Table 36: APR-246 + Azacitidine, Clinical Trial Description, 2021
  • Table 37: Fludarabine + Busulfan +- Clofarabine, Clinical Trial Description, 2021
  • Table 38: Treosulfan +- fludarabine, Clinical Trial Description, 2021
  • Table 39: Market Size of MDS in the 7MM in USD Million (2022-2036)
  • Table 40: Market Size of MDS by First Line therapies in the 7MM, in USD Million (2022-2036)
  • Table 41: Market Size of MDS by Second Line therapies in the 7MM, in USD Million (2022-2036)
  • Table 42: Key Market Forecast Assumptions for FG-4592 (Roxadustat) (for 1LOT)
  • Table 43: Key Market Forecast Assumptions for Venclexta +- Azacitidine (for 1LOT)
  • Table 44: Key Market Forecast Assumptions for Magrolimab +Azacitidine (for 1LOT)
  • Table 45: Key Market Forecast Assumptions for Pevonedistat +- Azacitidine (for 1LOT)
  • Table 46: Key Market Forecast Assumptions for SY-1425 + Azacitidine (for 1LOT)
  • Table 47: Key Market Forecast Assumptions for Glasdegib + Azacitidine (for 1LOT)
  • Table 48: Key Market Forecast Assumptions for Imetelstat (for 2LOT)
  • Table 49: Key Market Forecast Assumptions for Bemcentinib (for 2LOT)
  • Table 50: Key Market Forecast Assumptions for Eltanexor (ATG 016/KPT-8602) (for 2LOT)
  • Table 51: Key Market Forecast Assumptions for Enasidenib + Azacitidine (for 2LOT)
  • Table 52: Key Market Forecast Assumptions for CPX-351 (for 2LOT)
  • Table 53: Key Market Forecast Assumptions for Eprenetapopt
  • Table 54: Market Size of MDS in the US, USD Million (2022-2036)
  • Table 55: Market Size of MDS by First Line therapies in the US, USD Million (2022-2036)
  • Table 56: Market Size of MDS by therapies in the US, USD Million (2022-2036)
  • Table 57: EU5 Market Size of MDS in USD Million (2022-2036)
  • Table 58: Market Size of MDS by First Line Therapies in EU5, USD Million (2022-2036)
  • Table 59: EU5 Market Size of MDS by Second Line Therapies in USD Million (2022-2036)
  • Table 60: Japan Market Size of MDS in Japan, USD Million (2022-2036)
  • Table 61: Market Size of MDS by First Line Therapies in Japan, USD Million (2022-2036)
  • Table 62: Market Size of MDS by Second Line Therapies in Japan, USD Million (2022-2036)

List of Figures

  • Figure 1: Total Incident Population of MDS in the 7MM (2022-2036)
  • Figure 2: Total Incident Population of MDS in the US (2022-2036)
  • Figure 3: Age-specific Incident Population of MDS in the United States (2022-2036)
  • Figure 4: Subtype-specific Incident Population of MDS in the US (2022-2036)
  • Figure 6: IPSS-R Risk-specific incident population of MDS in the United States (2022-2036)
  • Figure 5: IPSS Risk-specific incident population of MDS in the United States (2022-2036)
  • Figure 7: Mutation-specific incident population of MDS in the United States (2022-2036)
  • Figure 8: Total Incident Population of MDS in EU5 (2022-2036)
  • Figure 9: Age-specific Incident Population of MDS in EU-5 (2022-2036)
  • Figure 10: Subtype-specific Incident Population of MDS in EU-5 (2022-2036)
  • Figure 11: IPSS-R Risk-specific incident population of MDS in EU5 (2022-2036)
  • Figure 12: IPSS Risk-specific incident population of MDS in EU5 (2022-2036)
  • Figure 13: Mutation-specific incident population of MDS in EU-5 (2022-2036)
  • Figure 14: Total Incident Population of MDS in Japan (2022-2036)
  • Figure 15: Age-specific Incident Population of MDS in Japan (2022-2036)
  • Figure 16: Subtype-specific Incident Population of MDS in Japan (2022-2036)
  • Figure 17: IPSS-R Risk-specific incident population of MDS in Japan (2022-2036)
  • Figure 18: IPSS Risk-specific incident population of MDS in Japan (2022-2036)
  • Figure 19: Mutation-specific incident population of MDS in Japan (2022-2036)
  • Figure 20: Market Size of MDS in the 7MM in USD Million (2022-2036)
  • Figure 21: Market Size of MDS by First Line Therapies in the 7MM, in USD Million (2022-2036)
  • Figure 22: Market Size of MDS by Second Line Therapies in the 7MM, in USD Million (2022-2036)
  • Figure 22: Market Size of MDS in the US, USD Millions (2022-2036)
  • Figure 23: Market Size of MDS by First Line therapies in the US, USD Million (2022-2036)
  • Figure 24: Market Size of MDS by therapies in the US, USD Million (2022-2036)
  • Figure 25: Market Size of MDS in EU5, USD Million (2022-2036)
  • Figure 26: EU5 Market Size of MDS by First Line Therapies in USD Million (2022-2036)
  • Figure 27: EU5 Market Size of MDS by Second Line Therapies in USD Million (2022-2036)
  • Figure 28: Market Size of MDS in Japan, USD Million (2022-2036)
  • Figure 29: Japan Market Size of MDS by First Line Therapies, USD Million (2022-2036)
  • Figure 30: Japan Market Size of MDS by Second Line Therapies, USD Million (2022-2036)
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