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
Key Takeaways
- The publisher 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 III trial results for pevonedistat, magrolimab, and Reblozyl; topline Phase II trial results for eprenetapopt, KER-050, and 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 58.9%. Drugs, on average, take 9.4 years from Phase I to approval, compared to 9.6 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 106 trials.
- Bristol Myers Squibb leads the industry sponsors with by far the highest overall number of clinical trials for MDS.
Table of Contents
OVERVIEWKEY TAKEAWAYSEPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGSKEY UPCOMING EVENTSPROBABILITY OF SUCCESSREVENUE OPPORTUNITYAPPENDIX
DISEASE BACKGROUND
TREATMENT
RECENT EVENTS AND ANALYST OPINION
KEY REGULATORY EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
BIBLIOGRAPHY
LIST OF FIGURES
LIST OF TABLES