Market Spotlight: Myelodysplastic Syndrome (MDS)
Market Spotlight: Myelodysplastic Syndrome (MDS)
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This Market Spotlight report covers the Myelodysplastic Syndrome (MDS) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, probability of success, upcoming and regulatory events, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
This Market Spotlight report covers the Myelodysplastic Syndrome (MDS) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, probability of success, upcoming and regulatory events, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways
- Datamonitor Healthcare estimates that in 2019, there were 238,000 incident cases of myelodysplastic syndrome (MDS) worldwide, and forecasts that number to increase to 313,500 incident cases by 2028.
- Approved drugs in the MDS space target DNA synthesis, angiogenesis, E3 ubiquitin ligase, the immune system, transforming growth factor-beta and superfamily, erythropoietin receptor, BCR-ABL fusion protein, KIT/c-KIT, platelet-derived growth factor receptor, PPAR gamma, cytidine deaminase, and DNA methyltransferase. These therapies are administered via the intravenous, oral, and subcutaneous routes.
- The greatest proportion of industry-sponsored drugs in active clinical development for MDS are in Phase II. Therapies in development for MDS focus on a wide variety of targets. The majority of pipeline drugs in the MDS space are administered via the intravenous or oral routes, with the remainder being subcutaneous or intradermal formulations.
- High-impact upcoming events for drugs in the MDS space comprise topline Phase III trial results for magrolimab and Reblozyl, topline Phase II trial results for MBG453, and updated Phase II/III trial results for imetelstat.
- The overall likelihood of approval of a Phase I hematologic asset is 8.7%, and the average probability a drug advances from Phase III is 58.5%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.7 years in the overall oncology space.
- The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for MDS have been in the early and mid-phases of development, with 89% of trials in Phase I–II, and only 11% in Phase III–IV.
- The US has a substantial lead in the number of MDS clinical trials globally. France leads the major European markets, while Japan has the top spot in Asia.
- Clinical trial activity in the MDS space is dominated by completed trials. Bristol Myers Squibb has the highest number of completed clinical trials for MDS, with 112 trials.
- Bristol Myers Squibb leads the industry sponsors with by far the highest overall number of clinical trials for MDS
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Subtypes
10 TREATMENT
10 Supportive therapy
10 Growth factors
10 Chemotherapy
11 Immune treatments
11 Stem cell transplant
12 EPIDEMIOLOGY
15 MARKETED DRUGS
18 PIPELINE DRUGS
30 RECENT EVENTS AND ANALYST OPINION
30 Pevonedistat for MDS (September 1, 2021)
31 Eprenetapopt for MDS (July 21, 2021)
32 Eprenetapopt for MDS (December 28, 2020)
34 Guadecitabine for MDS (October 14, 2020)
35 Estybon (Intravenous) for MDS (August 24, 2020)
37 Onureg for MDS (June 12, 2020)
38 Pevonedistat for MDS (May 29, 2020)
41 KEY UPCOMING EVENTS
42 KEY REGULATORY EVENTS
42 Revlimid Rivals Debut In Canada
42 Krka, Accord And Xeris Pick Up European Nods
43 PROBABILITY OF SUCCESS
44 LICENSING AND ASSET ACQUISITION DEALS
44 Merck’s $11.5bn Acceleron Buy Partially Fills Future Keytruda Revenue Gap
44 Advaxis Agrees To Merge With BioSight
44 CASI Obtains Greater China Rights To Cleave Cancer Candidate
45 Medexus Pharmaceuticals Licenses Exclusive Rights To Commercialize medac’s Treosulfan
45 Agios Sells Cancer Portfolio To Servier To Focus On Genetic Diseases
46 REVENUE OPPORTUNITY
48 CLINICAL TRIAL LANDSCAPE
49 Sponsors by status
50 Sponsors by phase
51 Recent events
53 BIBLIOGRAPHY
54 APPENDIX
LIST OF FIGURES
14 Figure 1: Trends in incident cases of MDS, 2019–28
18 Figure 2: Overview of pipeline drugs for MDS in the US
18 Figure 3: Pipeline drugs for MDS, by company
19 Figure 4: Pipeline drugs for MDS, by drug type
19 Figure 5: Pipeline drugs for MDS, by classification
32 Figure 6: Eprenetapopt for MDS (July 21, 2021): Phase II – Post-Transplant
34 Figure 7: Eprenetapopt for MDS (December 28, 2020): Phase III – Frontline (w/Azacitidine)
35 Figure 8: Guadecitabine for MDS (October 14, 2020): Phase III – ASTRAL-3
37 Figure 9: Estybon (Intravenous) for MDS (August 24, 2020): Phase III – INSPIRE (HR-MDS)
38 Figure 10: Onureg for MDS (June 12, 2020): Phase III – 003 (Low-Risk)
40 Figure 11: Pevonedistat for MDS (May 29, 2020): Phase II – w/Azacitidine
41 Figure 12: Key upcoming events in MDS
43 Figure 13: Probability of success in the hematologic pipeline
48 Figure 14: Clinical trials in MDS
48 Figure 15: Top 10 drugs for clinical trials in MDS
49 Figure 16: Top 10 companies for clinical trials in MDS
49 Figure 17: Trial locations in MDS
50 Figure 18: MDS trials status
51 Figure 19: MDS trials sponsors, by phase
LIST OF TABLES
13 Table 1: Incident cases of MDS, 2019–28
16 Table 2: Marketed drugs for MDS
20 Table 3: Pipeline drugs for MDS in the US
30 Table 4: Pevonedistat for MDS (September 1, 2021)
31 Table 5: Eprenetapopt for MDS (July 21, 2021)
33 Table 6: Eprenetapopt for MDS (December 28, 2020)
34 Table 7: Guadecitabine for MDS (October 14, 2020)
36 Table 8: Estybon (Intravenous) for MDS (August 24, 2020)
37 Table 9: Onureg for MDS (June 12, 2020)
39 Table 10: Pevonedistat for MDS (May 29, 2020)
46 Table 11: Historical global sales, by drug ($m), 2016–20
47 Table 12: Forecasted global sales, by drug ($m), 2021–25
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