Market Spotlight: Myelodysplastic Syndrome (MDS)
|出版日期||內容資訊||英文 51 Pages
|市場焦點:骨髓發育不良症候群 (MDS) Market Spotlight: Myelodysplastic Syndrome (MDS)|
|出版日期: 2019年10月25日||內容資訊: 英文 51 Pages||
本報告提供骨髓發育不良症候群 (MDS) 市場相關調查分析，提供主要開發平台·上市藥，臨床試驗，法規趨勢，專利資訊，罹患率的10年預測，許可證·收購交易，收益預測等系統性資訊。
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