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, erythropoietin receptor, BCR-ABL fusion protein, KIT/c-KIT, plateletderived 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 SY-1425, 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 8.3%, and the average probability a drug advances from Phase III is 58.3%. 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 113 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
28 RECENT EVENTS AND ANALYST OPINION
28 Pevonedistat for MDS (September 1, 2021)
29 Eprenetapopt for MDS (July 21, 2021)
30 Eprenetapopt for MDS (December 28, 2020)
32 Guadecitabine for MDS (October 14, 2020)
33 Estybon (Intravenous) for MDS (August 24, 2020)
36 KEY UPCOMING EVENTS
37 KEY REGULATORY EVENTS
37 Magrolimab Falls Off The Fast Track As Gilead Reveals New Clinical Holds
37 Revlimid Rivals Debut In Canada
38 PROBABILITY OF SUCCESS
39 LICENSING AND ASSET ACQUISITION DEALS
39 Roivant Licenses Clinical Candidate From Eisai
39 Merck’s $11.5bn Acceleron Buy Partially Fills Future Keytruda Revenue Gap
39 Advaxis Agrees To Merge With BioSight
39 CASI Obtains Greater China Rights To Cleave Cancer Candidate
40 Medexus Pharmaceuticals Licenses Exclusive Rights To Commercialize medac’s Treosulfan
41 REVENUE OPPORTUNITY
43 CLINICAL TRIAL LANDSCAPE
44 Sponsors by status
45 Sponsors by phase
46 Recent events
48 BIBLIOGRAPHY
49 APPENDIX
LIST OF FIGURES
14 Figure 1: Trends in incident cases of MDS, 2019–28
18 Figure 2: Overview of pipeline drugs for MDS in the US
18 Figure 3: Pipeline drugs for MDS, by company
19 Figure 4: Pipeline drugs for MDS, by drug type
19 Figure 5: Pipeline drugs for MDS, by classification
30 Figure 6: Eprenetapopt for MDS (July 21, 2021): Phase II – Post-Transplant
32 Figure 7: Eprenetapopt for MDS (December 28, 2020): Phase III – Frontline (w/Azacitidine)
33 Figure 8: Guadecitabine for MDS (October 14, 2020): Phase III – ASTRAL-3
35 Figure 9: Estybon (Intravenous) for MDS (August 24, 2020): Phase III – INSPIRE (HR-MDS)
36 Figure 10: Key upcoming events in MDS
38 Figure 11: Probability of success in the hematologic pipeline
43 Figure 12: Clinical trials in MDS
43 Figure 13: Top 10 drugs for clinical trials in MDS
44 Figure 14: Top 10 companies for clinical trials in MDS
44 Figure 15: Trial locations in MDS
45 Figure 16: MDS trials status
46 Figure 17: MDS trials sponsors, by phase
LIST OF TABLES
13 Table 1: Incident cases of MDS, 2019–28
16 Table 2: Marketed drugs for MDS
20 Table 3: Pipeline drugs for MDS in the US
28 Table 4: Pevonedistat for MDS (September 1, 2021)
29 Table 5: Eprenetapopt for MDS (July 21, 2021)
31 Table 6: Eprenetapopt for MDS (December 28, 2020)
32 Table 7: Guadecitabine for MDS (October 14, 2020)
34 Table 8: Estybon (Intravenous) for MDS (August 24, 2020)
41 Table 9: Historical global sales, by drug ($m), 2016–20
42 Table 10: Forecasted global sales, by drug ($m), 2022–26
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