- The author estimates that in 2016, there were 356,800 incident cases of myelodysplastic syndrome (MDS) worldwide, and forecasts that number to increase to 390,800 incident cases by 2025.
- The majority of industry-sponsored drugs in active clinical development for MDS are in Phase II. Therapies in mid- and late-stage development for MDS focus on a wide variety of targets. The majority of the pipeline drugs in mid- to late-stage development for MDS are administered via the oral route.
- Approved drugs in the MDS space target DNA methyltransferase, BCR-ABL fusion protein, KIT/c-KIT, platelet-derived growth factor receptor, erythropoietin receptor, angiogenesis, and E3 ubiquitin ligase. The majority of approved therapies are administered via the intravenous route; however, a few products are available in oral and subcutaneous formulations.
- High-impact upcoming events for drugs in the MDS space include topline Phase III and Phase II trial results. There were 16 licensing and asset acquisition activities involving MDS drugs during 2012-17, six of which occurred in 2014. The largest deal during this period was the $935m exclusive licensing agreement in 2014 between Geron Corporation and Janssen Biotech to develop and commercialize Geron Corporation’s imetelstat (a telomerase inhibitor) globally for oncology, including hematologic malignancies, and other human therapeutics uses.
- Revlimid’s sales have ranked highest in the MDS space during 2012-16 and are forecasted to remain the highest during the forecast period (2017-22).
- The clinical trials distribution across Phases I-IV indicates that the majority of the drugs are in early and mid-phases of development, with 90% of trials in Phase I-II, and only 10% 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.
- Celgene has the highest number of completed clinical trials for MDS. The company has also had the highest number of Phase II and Phase III clinical trials for MDS, with a count of 83 and 12, respectively
2 DISEASE BACKGROUND
- Myelodysplastic syndrome subtypes
- Supportive therapy
- Growth factors
- Stem cell transplant
5 PIPELINE DRUGS
6 MARKETED DRUGS
- Approvals by country
8 LICENSING AND ASSET ACQUISITION DEALS
- ImmunoGen And Jazz Sign ADC Option Agreement
10 REVENUE OPPORTUNITY
11 CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
- Prescription information
List of Figures
Figure 1: Trends in incident cases of myelodysplastic syndrome, 2016-25
Figure 2: Pipeline drugs for myelodysplastic syndrome in the US
Figure 3: Pipeline drugs for myelodysplastic syndrome, by company
Figure 4: Pipeline drugs for myelodysplastic syndrome, by drug type
Figure 5: Pipeline drugs for myelodysplastic syndrome, by classifications
Figure 6: Key upcoming events in myelodysplastic syndrome
Figure 7: Licensing and asset acquisition deals in myelodysplastic syndrome, 2012-17
Figure 8: Parent patents in myelodysplastic syndrome
Figure 9: Clinical trials in myelodysplastic syndrome
Figure 10: Top 10 drugs for clinical trials in myelodysplastic syndrome
Figure 11: Top 10 companies for clinical trials in myelodysplastic syndrome
Figure 12: Trial locations in myelodysplastic syndrome
Figure 13: Myelodysplastic syndrome trials status
Figure 14: Myelodysplastic syndrome trials sponsors, by phase
List of Tables
Table 1: Incident cases of myelodysplastic syndrome, 2016-25
Table 2: Pipeline drugs for myelodysplastic syndrome in the US
Table 3: Marketed drugs for myelodysplastic syndrome
Table 4: Approvals by country for myelodysplastic syndrome
Table 5: Historical global sales, by drug ($m), 2012-16
Table 6: Forecasted global sales, by drug ($m), 2017-22