Overview

This Market Spotlight report covers the Endometriosis market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2021, there were 193.9 million prevalent cases of diagnosed endometriosis in women aged 15–49 years worldwide, and forecasts that number to increase to 205.3 million prevalent cases by 2030.
• The approved drugs in the endometriosis space target the gonadotropin-releasing hormone (GnRH) receptor, progesterone receptor, follicle-stimulating hormone (FSH), gonadotropin-releasing hormone (GnRH), and androgen receptors. The majority of marketed drugs are administered via the subcutaneous route, while the remainder are oral and intramuscular formulations.
• The majority of industry-sponsored drugs in active clinical development for endometriosis are in Phase II, with only one drug in the NDA/BLA phase.
• Therapies in development for endometriosis focus on targets such as the gonadotropin-releasing hormone (GnRH) receptor, prolactin/prolactin receptor, progesterone receptor, luteinizing hormone receptor (LHR), androgen receptors, and folliclestimulating hormone (FSH). The majority of pipeline drugs are administered via the oral route, with two products being tested in topical and subcutaneous formulations.
• High-impact upcoming events for drugs in the endometriosis space comprise topline Phase III trial results for Trelstar, and an estimated PDUFA date for Orgovyx.
• 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 endometriosis have been in the early and mid-phases of development, with 72% of trials in Phase I–II, and only 28% in Phase III–IV.
• The US has a substantial lead in the number of endometriosis clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
• Clinical trial activity in the endometriosis space is dominated by completed trials. Bayer has the highest number of completed clinical trials for endometriosis, with 47 trials.
• Bayer leads industry sponsors with the highest overall number of clinical trials for endometriosis, followed by AbbVie and Takeda.