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 2017, there were 367,200 incident cases of myelodysplastic syndrome (MDS) worldwide, and forecasts that number to increase to 401,700 incident cases by 2026.
- Approved drugs in the MDS space target DNA methyltransferase, BCR-ABL fusion protein, KIT/c-KIT, platelet-derived growth factor receptor, erythropoietin receptor, angiogenesis, E3 ubiquitin ligase, the immune system, and DNA synthesis. 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, with only one drug in the NDA/BLA stage.
- 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, Phase II/III and Phase III updated trial results, an expected CHMP opinion, and an estimated PDUFA date.
- The overall likelihood of approval of a Phase I hematologic asset is 10%, and the average probability a drug advances from Phase III is 59.6%. Drugs, on average, take 8.9 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There have been 17 licensing and asset acquisition deals involving MDS drugs during 2015–20. The $1.8bn exclusive global collaboration and license agreement made in December 2018 between Argenx and Cilag to evaluate cusatuzumab (ARGX-110), an anti-CD70 SIMPLE Antibody, in acute myeloid leukemia (AML), high-risk MDS, and other hematological malignancies was the largest deal.
- 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 EU 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 98 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
14 MARKETED DRUGS
17 PIPELINE DRUGS
29 RECENT EVENTS AND ANALYST OPINION
29 APR-246 for MDS (December 9, 2019)
30 ASTX727 for MDS (December 9, 2019)
31 Magrolimab for MDS (December 9, 2019)
33 MBG453 for MDS (December 9, 2019)
34 Venclexta for MDS (December 9, 2019)
35 Vidaza for MDS (December 9, 2019)
37 CX-01 for MDS (July 31, 2019)
38 Pracinostat for MDS (July 31, 2019)
39 Magrolimab for MDS (July 11, 2019)
40 ASTX727 for MDS (June 6, 2019)
42 Magrolimab for MDS (May 15, 2019)
43 Multiple Drugs for MDS (May 13, 2019)
43 Revilimid for MDS (February 27, 2019)
44 Reblozyl for MDS (December 2, 2018)
47 KEY UPCOMING EVENTS
48 KEY REGULATORY EVENTS
48 Celgene Eyes Second Indication For Reblozyl
48 MAA Positive Opinions
49 PROBABILITY OF SUCCESS
50 LICENSING AND ASSET ACQUISITION DEALS
50 Onconova Grants Canadian Rigosertib Rights To Knight
50 Deals Shaping The Medical Industry, September 2019
51 HanX To Develop, Sell Onconova’s Rigosertib In China
52 PARENT PATENTS
54 REVENUE OPPORTUNITY
55 CLINICAL TRIAL LANDSCAPE
56 Sponsors by status
57 Sponsors by phase
58 Recent events
59 BIBLIOGRAPHY
59 Prescription information
61 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in incident cases of MDS, 2017–26
17 Figure 2: Overview of pipeline drugs for MDS in the US
17 Figure 3: Pipeline drugs for MDS, by company
18 Figure 4: Pipeline drugs for MDS, by drug type
18 Figure 5: Pipeline drugs for MDS, by classification
31 Figure 6: ASTX727 for MDS (December 9, 2019): Phase III – ASCERTAIN (vs. Decitabine)
33 Figure 7: Magrolimab for MDS (December 9, 2019): Phase Ib – w/Azacitidine (AML/MDS)
37 Figure 8: Vidaza for MDS (December 9, 2019): Phase II – w/Durvalumab
42 Figure 9: ASTX727 for MDS (June 6, 2019): Phase III – ASCERTAIN (vs. Decitabine)
46 Figure 10: Reblozyl for MDS (December 2, 2018): Phase III – MEDALIST
47 Figure 11: Key upcoming events in MDS
49 Figure 12: Probability of success in the MDS pipeline
50 Figure 13: Licensing and asset acquisition deals in MDS, 2015–20
52 Figure 14: Parent patents in MDS, 2020–28
53 Figure 15: Parent patents in MDS, 2028–34
55 Figure 16: Clinical trials in MDS
55 Figure 17: Top 10 drugs for clinical trials in MDS
56 Figure 18: Top 10 companies for clinical trials in MDS
56 Figure 19: Trial locations in MDS
57 Figure 20: MDS trials status
58 Figure 21: MDS trials sponsors, by phase
LIST OF TABLES
12 Table 1: Incident cases of MDS, 2017–26
15 Table 2: Marketed drugs for MDS
19 Table 3: Pipeline drugs for MDS in the US
29 Table 4: APR-246 for MDS (December 9, 2019)
30 Table 5: ASTX727 for MDS (December 9, 2019)
32 Table 6: Magrolimab for MDS (December 9, 2019)
34 Table 7: MBG453 for MDS (December 9, 2019)
35 Table 8: Venclexta for MDS (December 9, 2019)
36 Table 9: Vidaza for MDS (December 9, 2019)
38 Table 10: CX-01 for MDS (July 31, 2019)
39 Table 11: Pracinostat for MDS (July 31, 2019)
40 Table 12: Magrolimab for MDS (July 11, 2019)
41 Table 13: ASTX727 for MDS (June 6, 2019)
42 Table 14: Magrolimab for MDS (May 15, 2019)
43 Table 15: Multiple Drugs for MDS (May 13, 2019)
44 Table 16: Revilimid for MDS (February 27, 2019)
45 Table 17: Reblozyl for MDS (December 2, 2018)
54 Table 18: Historical global sales, by drug ($m), 2014–18
54 Table 19: Forecasted global sales, by drug ($m), 2020–24
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