Market Spotlight: Endometriosis

This Market Spotlight report covers the Endometriosis market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, 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 2016, there were 186.9 million prevalent cases of endometriosis in women aged 15–49 years worldwide, and forecasts that number to increase to 196.6 million prevalent cases by 2025.
• 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, while one drug is in the NDA phase.
• Therapies in mid-to-late-stage development for endometriosis focus on targets such as the gonadotropin-releasing hormone receptor, progesterone receptor, and luteinizing hormone receptor. Among these therapies, elagolix, an oral GnRH receptor inhibitor, is closest to market. All pipeline drugs in mid-to-late-stage development for endometriosis are administered via the oral route.
• High impact upcoming events in the endometriosis space comprise topline Phase III trial results for Relugolix, an end of Phase II meeting with the FDA for Proellex (Oral), topline Phase II trial results for OBE2109, and an expected PDUFA date for elagolix’s NDA.
• There have been 12 licensing and asset acquisition deals involving endometriosis drugs during 2013–18. The largest deal was in 2017, when AstraZeneca obtained commercialization rights to Zoladex in the US and Canada from TerSera Therapeutics for $320m.
• Zoladex’s device patent is set to expire in 2022. The distribution of clinical trials across Phase I–IV indicates that the majority of trials for endometriosis have been in early and mid-phases of development, with 76% of trials in Phase I–II, and only 24% in Phase III–IV.
• The US has a substantial lead in the number of endometriosis clinical trials globally. Germany leads the major EU 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 30 trials. Bayer also leads industry sponsors with the highest number of overall clinical trials for endometriosis, followed by Takeda.