This Market Spotlight report covers the Endometriosis market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, 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.

Key Takeaways

• Datamonitor Healthcare estimates that in 2019, there were 191.0 million prevalent cases of endometriosis in women aged 15–49 years worldwide, and forecasts that number to increase to 201.8 million prevalent cases by 2028.
• Endometriosis affects an estimated one in 10 women in the reproductive age group of 15–49 years. The approved drugs in the endometriosis space target the gonadotropin-releasing hormone receptor, progesterone receptor, follicle-stimulating hormone, and androgen receptors. The majority of marketed drugs are administered via the subcutaneous route, while oral and intramuscular formulations are also available.
• The majority of industry-sponsored drugs in active clinical development for endometriosis are in Phase II, with two drugs in Phase III.
• Therapies in development for endometriosis focus on targets such as the gonadotropin-releasing hormone receptor, progesterone receptor, luteinizing hormone receptor, androgen receptors, and follicle-stimulating hormone. The majority of pipeline drugs are administered via the oral route, with only one product being tested as a topical formulation.
• Topline Phase III trial results for Trelstar is the only high-impact upcoming event in the endometriosis space. The overall likelihood of approval of a Phase I gynecology asset is 16%, and the average probability a drug advances from Phase III is 70%. 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 endometriosis have been in the early and mid-phases of development, with 73% of trials in Phase I–II, and only 27% 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 42 trials.
• Bayer leads industry sponsors with the highest overall number of clinical trials for endometriosis, followed by AbbVie and Takeda.