Market Spotlight: Hereditary Angioedema
|出版日期||內容資訊||英文 39 Pages
|遺傳性血管水腫 (HAE):焦點市場分析 Market Spotlight: Hereditary Angioedema|
|出版日期: 2020年12月03日||內容資訊: 英文 39 Pages||
Takeda (武田藥品工業) ，HAE的臨床試驗的總數是最多的贊助商，其次是Bio Cryst。
本報告提供遺傳性血管水腫 (HAE)的治療藥市場相關分析，在疾病概要和患者數的變化、預測，目前的主要治療方法，現在開發中臨床實驗的進展與上市計劃，主要的治療藥的市場趨勢預測 (今後10年份)，資本交易的動向等調查。
This Market Spotlight report covers the Hereditary Angioedema market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Datamonitor Healthcare estimates that in 2019, using the most commonly cited prevalence estimate of 1:50,000, there were approximately 154,300 prevalent cases of hereditary angioedema (HAE) worldwide, and forecasts that number to increase to approximately 168,100 prevalent cases by 2028.
The approved drugs in the HAE space target complement pathway, androgen receptors, follicle-stimulating hormone, gonadotropin-releasing hormone, progesterone receptor, bradykinin B2 receptor, and the kinin-kallikrein system. These are commonly administered via the intravenous or subcutaneous routes, with one product being available in an oral formulation.
The majority of industry-sponsored drugs in active clinical development for HAE are in Phase I, with only one drug in the NDA/BLA stage.
Therapies in development for HAE focus on targets such as the kinin-kallikrein system, coagulation factor XII, and bradykinin B2 receptor. The majority of pipeline drugs are administered via the oral route, with the remainder being tested as subcutaneous formulations.
High-impact upcoming events for drugs in the HAE space comprise topline Phase II trial results for KVD900; topline Phase III trial results, an expected CHMP opinion, and an estimated PDUFA date for Orladeyo; and a data exclusivity expiration for Ruconest.
The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 19.5%, and the average probability a drug advances from Phase III is 68.6%. Drugs, on average, take 9.9 years from Phase I to approval, compared to 9.2 years in the overall autoimmune/immunology space.
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for HAE have been in the early and midphases of development, with 53% of trials in Phase I-II, and 47% in Phase III-IV.
The US has the highest number of HAE clinical trials globally. Germany leads the major European markets, while Israel has the top spot in Asia.
Clinical trial activity in the HAE space is dominated by completed trials. Takeda has the highest number of completed clinical trials for HAE, with 36 trials.
Takeda leads industry sponsors with the highest overall number of clinical trials for HAE, followed by BioCryst.