Published : May-2020
No. of Pages : 193
1.1 List of Tables
1.2 List of Figures
2 Myelodysplastic Syndromes: Executive Summary
2.1 Moderate Growth Expected in MDS Market Between 2018 and 2028
2.2 Drug Developers Position Agents to Fill Key Vacancies in the Treatment Paradigms for Higher- and Lower-Risk MDS
2.3 Unmet Needs Persist in Difficult-to-Treat MDS Subgroups, Leaving Substantial Opportunity for Future Players
2.4 Current Late-Stage MDS Pipeline Offers a Range of New Options for Patients in the Front-Line and Later Treatment Settings
2.5 What Do Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Clinical Presentation and Diagnosis
4.3 Classification
4.3.1 WHO Classification Criteria for MDS
4.3.2 IPSS-R Classification
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for MDS (2018-2028)
5.5.1 Diagnosed Incident Cases of MDS
5.5.2 Age-Specific Diagnosed Incident Cases of MDS
5.5.3 Sex Specific Diagnosed Incident Cases of MDS
5.5.4 Diagnosed Incident Cases of MDS/MPN
5.5.5 Diagnosed Incident Cases of MDS by Subtype
5.5.6 Diagnosed Incident Cases of Primary/Secondary MDS
5.5.7 Diagnosed Incident Cases of MDS by Risk Group
5.5.8 Diagnosed Incident Cases of MDS by Mutations
5.5.9 Five-Year Diagnosed Prevalent Cases of MDS
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
5.6.3 Strengths of the Analysis
6 Current Treatment Options
7 Unmet Needs and Opportunity Assessment
8 R&D Strategies
9 Pipeline Assessment
10 Pipeline Valuation Analysis
11 Appendix
List of Tables
Table 1: Myelodysplastic Syndromes: Key Metrics in the 7MM
Table 2: Common cytogenetic abnormalities in MDS
Table 3: Frequent mutations in MDS
Table 4: Tests used in the Diagnosis of MDS
Table 5: 2016 WHO Classification Criteria for MDS
Table 6: Cytopenia-defining values for MDS
Table 7: IPSS-R Prognostic Risk Categories/Scores and Clinical Outcomes
Table 8: IPSS-R Prognostic Score Values
Table 9: MDS Cytogenetic Scoring System
Table 10: Risk Factors and Comorbidities for MDS
Table 11: Leading Treatments for MDS and Country-Specific Launch Dates, 2020
Table 12: Treatment Guidelines for MDS
Table 13: IWG 2006 Proposed Modified Response Criteria for Altering the Natural History of MDS
Table 14: IWG 2006 Proposed Modified Response Criteria for Hematologic Improvement
Table 15: IWG 2018 Suggested Modified HI-E Criteria for Response Evaluation
Table 16: IWG 2018 Suggested Modified HI-P and HI-N Criteria for Response Evaluation
Table 17: Comparison of Therapies in Development for HR-MDS and LR-MDS, 2018-2028
Table 18: Innovative Early Stage Approaches for MDS, 2020
Table 19: Clinical Benchmark of Key Pipeline Drugs - HR-MDS
Table 20: Clinical Benchmark of Key Pipeline Drugs - HR-MDS
Table 21: Clinical Benchmark of Key Pipeline Drugs - HR-MDS - Allogeneic HSCT
Table 22: Clinical Benchmark of Key Pipeline Drugs - LR-MDS
Table 23: Clinical Benchmark of Key Pipeline Drugs - LR-MDS
Table 24: Commercial Benchmark of Key Pipeline Drugs - HR-MDS
Table 25: Commercial Benchmark of Key Pipeline Drugs - HR-MDS
Table 26: Commercial Benchmark of Key Pipeline Drugs - HR-MDS -HSCT
Table 27: Commercial Benchmark of Key Pipeline Drugs - LR-MDS
Table 28: Commercial Benchmark of Key Pipeline Drugs - LR-MDS
Table 29: MDS Market - Global Drivers and Barriers, 2018-2028
Table 30: Key Events Impacting Sales for MDS in the US, 2018-2028
Table 31: Key Events Impacting Sales for MDS in the 5EU, 2018-2028
Table 32: Key Events Impacting Sales for MDS in Japan, 2018-2028
Table 33: Key Historical and Projected Launch Dates for MDS
Table 34: Key Historical and Projected Patent/Exclusivity Expiry Dates for MDS
Table 35: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for MDS in 2018 and 2028
Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, HR-MDS
Figure 3: Competitive Assessment of Omidubicel Against the Standard of Care, HR-MDS
Figure 4: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, LR-MDS
Figure 5: Key Therapeutic Mechanisms in MDS
Figure 6: 8MM, Diagnosed Incidence Rates of MDS, Men and Women, Ages ?18 Years, Cases per 100,000 Population, 2008?2028
Figure 7: Sources Used for Diagnosed Incident Cases of MDS
Figure 8: Sources Used for Diagnosed Incident Cases of MDS/MPN
Figure 9: Sources Used for Diagnosed Incident Cases of MDS Subtypes
Figure 10: Sources Used for Diagnosed Incident Cases of Primary/Secondary MDS
Figure 11: Sources Used for Five-Year Diagnosed Prevalent Cases of MDS
Figure 12: 8MM, Diagnosed Incident Cases of MDS, Men and Women, Ages ?18 Years, N, 2018
Figure 13: 8MM, Age-Specific Diagnosed Incident Cases of MDS, Men and Women, Ages ?18 Years, N, 2018
Figure 14: 8MM, Sex-Specific Diagnosed Incident Cases of MDS, Men and Women, Ages ?18 Years, N, 2018
Figure 15: 8MM, Diagnosed Incident Cases MDS/MPN, Men and Women, Ages ?18 Years, N, 2018
Figure 16: 8MM, Proportion of Diagnosed Incident Cases of MDS by Subtype, Men and Women, Ages ?18 Years, N, 2018
Figure 17: 8MM, Proportion of Diagnosed Incident Cases of Primary/Secondary MDS, Men and Women, Ages ?18 Years, 2018
Figure 18: 8MM, Diagnosed Incident Cases of MDS by Risk Group, Men and Women, Ages ?18 Years, N, 2018
Figure 19: 8MM, Diagnosed Incident Cases of MDS by Mutation, Men and Women, Ages ?18 Years, N, 2018
Figure 20: 8MM, Five-Year Diagnosed Prevalent Cases of MDS, Men and Women, Ages ?18 Years, N, 2018
Figure 21: NCCN Treatment Flow for HR-MDS
Figure 22: NCCN Treatment Flow for LR-MDS
Figure 23: Unmet Needs and Opportunities in MDS
Figure 24: Overview of the Development Pipeline in MDS
Figure 25: Key Phase II/III Trials for Promising Pipeline Agents that GlobalData Expects be Licensed for MDS in the 7MM During the Forecast Period
Figure 26:Competitive Assessment of Marketed and Pipeline Drugs Benchmarked Against the SOC, HR-MDS
Figure 27:Competitive Assessment of Omidubicel Against the SOC, HR-MDS
Figure 28:Competitive Assessment of Marketed and Pipeline Drugs Benchmarked Against the SOC, LR-MDS
Figure 29: Global Sales Forecast by Country for MDS in 2018 and 2028
Figure 30: Global MDS Sales Forecast by Class, 2018 and 2028
Figure 31: US MDS Sales Forecast by Class, 2018 and 2028
Figure 32: 5EU MDS Sales Forecast by Class, 2018 and 2028
Figure 33: Japan MDS Sales Forecast by Class, 2018 and 2028
