This Market Spotlight report covers the Uterine Fibroids market, comprising key marketed and pipeline drugs, clinical trials, Recent Events and Analyst Opinion, upcoming and regulatory events, probability of success, licensing and asset acquisition deals, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2021, there were approximately 97.2 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, Myfembree, 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.
• Industry-sponsored drugs in active clinical development for uterine fibroids are spread evenly across Phase I to the NDA/BLA stage.
• Therapies in development for uterine fibroids target progesterone receptor, gonadotropin-releasing hormone receptor, and collagen. The majority of pipeline drugs are administered via the oral route, with one product being developed in a subcutaneous formulation.
• The only high-impact upcoming event for drugs in the uterine fibroids space is an expected PDUFA date for Yselty. The overall likelihood of approval of a Phase I gynecology asset is 12.3%, and the average probability a drug advances from Phase III is 75%. Drugs, on average, take 11.5 years from Phase I to approval, compared to 12.7 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 53% of trials in Phase I–II, and 47% in Phase III–IV.
• The US has a substantial lead in the number of uterine fibroids clinical trials globally. The UK and Germany lead 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 overall number of clinical trials for uterine fibroids, followed by Takeda.