Market Spotlight: Myelodysplastic Syndrome (MDS)
Market Spotlight: Myelodysplastic Syndrome (MDS)
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This Market Spotlight report covers the myelodysplastic syndrome market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence 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 market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, probability of success, upcoming events, patent information, 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 receptor, erythropoietin receptor, BCR-ABL fusion protein, KIT/c-KIT, platelet-derived growth factor receptor, 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 II and Phase III trial results, as well as Phase II/III and Phase III updated trial results.
- The overall likelihood of approval of a Phase I hematologic asset is 9.5%, and the average probability a drug advances from Phase III is 60.3%. Drugs, on average, take 9.3 years from Phase I to approval, compared to 9.5 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 104 trials.
- Bristol Myers Squibb leads the industry sponsors with by far the highest overall number of clinical trials for MDS.
CONTENTS
7 OVERVIEW
8 KEY TAKEAWAYS
9 DISEASE BACKGROUND
9 Subtypes
11 TREATMENT
11 Supportive therapy
11 Growth factors
11 Chemotherapy
12 Immune treatments
12 Stem cell transplant
13 EPIDEMIOLOGY
16 MARKETED DRUGS
19 PIPELINE DRUGS
31 RECENT EVENTS AND ANALYST OPINION
31 Guadecitabine for MDS (October 14, 2020)
32 Estybon (Intravenous) for MDS (August 24, 2020)
33 Onureg for MDS (June 12, 2020)
35 Pevonedistat for MDS (May 29, 2020)
37 Eprenetapopt for MDS (December 9, 2019)
39 Inqovi for MDS (December 9, 2019)
40 Magrolimab for MDS (December 9, 2019)
42 MBG453 for MDS (December 9, 2019)
43 Venclexta for MDS (December 9, 2019)
44 Vidaza for MDS (December 9, 2019)
46 DSTAT for MDS (July 31, 2019)
47 Pracinostat for MDS (July 31, 2019)
48 Magrolimab for MDS (July 11, 2019)
49 Inqovi for MDS (June 6, 2019)
51 Magrolimab for MDS (May 15, 2019)
52 Multiple Drugs for MDS (May 13, 2019)
53 KEY UPCOMING EVENTS
54 KEY REGULATORY EVENTS
54 Takeda Aims To Take Higher-Risk MDS Therapy Beyond Monotherapy
54 Keeping Track: US FDA Set For Speed With Approvals Of Inqovy, Rukobia, Dojolvy, Phesgo; Keytruda Loses Chance At AA In HCC
54 Crunch Time At EMA For Luspatercept And Glasdegib
54 Celgene Eyes Second Indication For Reblozyl
55 PROBABILITY OF SUCCESS
56 LICENSING AND ASSET ACQUISITION DEALS
56 Gilead Calls Forty Seven Buyout Complementary To Kite, Other IO Efforts
56 Deals Shaping The Medical Industry, January 2020
56 Onconova Grants Canadian Rigosertib Rights To Knight
57 REVENUE OPPORTUNITY
58 CLINICAL TRIAL LANDSCAPE
59 Sponsors by status
60 Sponsors by phase
61 Recent events
63 BIBLIOGRAPHY
63 Prescription information
65 APPENDIX
LIST OF FIGURES
15 Figure 1: Trends in incident cases of MDS, 2019–28
19 Figure 2: Overview of pipeline drugs for MDS in the US
19 Figure 3: Pipeline drugs for MDS, by company
20 Figure 4: Pipeline drugs for MDS, by drug type
20 Figure 5: Pipeline drugs for MDS, by classification
32 Figure 6: Guadecitabine for MDS (October 14, 2020): Phase III – ASTRAL-3
33 Figure 7: Estybon (Intravenous) for MDS (August 24, 2020): Phase III – INSPIRE (HR-MDS)
35 Figure 8: Onureg for MDS (June 12, 2020): Phase III – 003 (Low-Risk)
37 Figure 9: Pevonedistat for MDS (May 29, 2020): Phase II – w/Azacitidine
40 Figure 10: Inqovi for MDS (December 9, 2019): Phase III – ASCERTAIN (vs. Decitabine)
42 Figure 11: Magrolimab for MDS (December 9, 2019): Phase Ib – w/Azacitidine (AML/MDS)
46 Figure 12: Vidaza for MDS (December 9, 2019): Phase II – w/Durvalumab
51 Figure 13: Inqovi for MDS (June 6, 2019): Phase III – ASCERTAIN (vs. Decitabine)
53 Figure 14: Key upcoming events in MDS
55 Figure 15: Probability of success in the hematologic pipeline
58 Figure 16: Clinical trials in MDS
58 Figure 17: Top 10 drugs for clinical trials in MDS
59 Figure 18: Top 10 companies for clinical trials in MDS
59 Figure 19: Trial locations in MDS
60 Figure 20: MDS trials status
61 Figure 21: MDS trials sponsors, by phase
LIST OF TABLES
14 Table 1: Incident cases of MDS, 2019–28
17 Table 2: Marketed drugs for MDS
21 Table 3: Pipeline drugs for MDS in the US
31 Table 4: Guadecitabine for MDS (October 14, 2020)
32 Table 5: Estybon (Intravenous) for MDS (August 24, 2020)
34 Table 6: Onureg for MDS (June 12, 2020)
35 Table 7: Pevonedistat for MDS (May 29, 2020)
38 Table 8: Eprenetapopt for MDS (December 9, 2019)
39 Table 9: Inqovi for MDS (December 9, 2019)
41 Table 10: Magrolimab for MDS (December 9, 2019)
43 Table 11: MBG453 for MDS (December 9, 2019)
44 Table 12: Venclexta for MDS (December 9, 2019)
45 Table 13: Vidaza for MDS (December 9, 2019)
47 Table 14: DSTAT for MDS (July 31, 2019)
48 Table 15: Pracinostat for MDS (July 31, 2019)
49 Table 16: Magrolimab for MDS (July 11, 2019)
50 Table 17: Inqovi for MDS (June 6, 2019)
51 Table 18: Magrolimab for MDS (May 15, 2019)
52 Table 19: Multiple Drugs for MDS (May 13, 2019)
57 Table 20: Historical global sales, by drug ($m), 2015–19
57 Table 21: Forecasted global sales, by drug ($m), 2020–24
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