Market Spotlight: Myelodysplastic Syndrome (MDS)
|出版日||ページ情報||英文 51 Pages
|注目市場の分析：骨髄異形成症候群 (MDS) Market Spotlight: Myelodysplastic Syndrome (MDS)|
|出版日: 2019年10月25日||ページ情報: 英文 51 Pages||
当レポートでは、骨髄異形成症候群 (MDS) 市場について調査分析し、主要パイプライン・上市薬、臨床試験、規制動向、特許情報、罹患率の10ヶ年予測、ライセンス・買収取引、収益予測など、体系的な情報を提供しています。
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.
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, and the immune system. 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 9.6%, and the average probability a drug advances from Phase III is 58.3%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
There have been 20 licensing and asset acquisition deals involving MDS drugs during 2014-19. 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. Celgene has the highest number of completed clinical trials for MDS, with 93 trials.
Celgene leads the industry sponsors with by far the highest overall number of clinical trials for MDS