Market Spotlight: Uterine Fibroids
発行: Datamonitor Healthcare
ページ情報: 英文 38 Pages
This Market Spotlight report covers the Uterine Fibroids market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming events, probability of success, regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals.
Datamonitor Healthcare estimates that in 2019, there were approximately 94.9 million prevalent cases of uterine fibroids worldwide in females aged 15 years and over, and forecasts that number to increase to 105.0 million prevalent cases by 2028.
Lupron, relugolix, and ORIAHNN, which target gonadotropin-releasing hormone receptor, and ulipristal acetate, which targets progesterone receptor, are the only approved drugs for uterine fibroids. These drugs are administered via the oral and subcutaneous routes.
The largest proportion of industry-sponsored drugs in active clinical development for uterine fibroids are in Phase III, with one drug in the NDA/BLA phase.
Therapies in development for uterine fibroids focus on targets such as progesterone receptor, gonadotropin-releasing hormone receptor, and collagen. The majority of pipeline drugs are administered via the oral route, with one product being available in a subcutaneous formulation.
High-impact upcoming events for drugs in the uterine fibroids space comprise topline Phase III trial results and an expected meeting with the FDA for linzagolix; and an estimated PDUFA date as well as an expected CHMP opinion for relugolix.
The overall likelihood of approval of a Phase I gynecology asset is 14.5%, and the average probability a drug advances from Phase III is 63.6%. Drugs, on average, take 11.8 years from Phase I to approval, compared to 13.0 years in the overall obstetrics/gynecology space.
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for uterine fibroids have been in the early and mid-phases of development, with 59% of trials in Phase I-II, and 41% in Phase III-IV.
The US has a substantial lead in the number of uterine fibroids clinical trials globally. The UK leads the major European markets, while Japan has the top spot in Asia.
Clinical trial activity in the uterine fibroids space is dominated by completed trials. Repros Therapeutics has the highest number of completed clinical trials for uterine fibroids, with 17 trials.
Repros Therapeutics leads industry sponsors with the highest number of clinical trials for uterine fibroids, followed by Takeda