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.
- Datamonitor Healthcare estimates that in 2017, there were 188.7 million prevalent cases of endometriosis in women aged 15-49 years worldwide, and forecasts that number to increase to 199.1 million prevalent cases by 2026. 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 one drug each in Phase I and Phase III.
- Therapies in mid-to-late-stage 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 in mid-to-late-stage development for endometriosis are administered via the oral route, with only one product being tested as a topical formulation.
- High-impact upcoming events in the endometriosis space comprise topline Phase III trial results for Relugolix. The overall likelihood of approval of a Phase I gynecology asset is 13.1%, and the average probability a drug advances from Phase III is 62.5%. Drugs, on average, take 11.1 years from Phase I to approval, compared to 12.0 years in the overall obstetrics/gynecology space.
- There have been 12 licensing and asset acquisition deals involving endometriosis drugs during 2014-19. The largest deal was in 2017, when AstraZeneca obtained commercialization rights to Zoladex in the US and Canada from TerSera Therapeutics for $320m.
- 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 75% of trials in Phase I-II, and only 25% 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 34 trials.
- Bayer leads industry sponsors with the highest number of clinical trials for endometriosis, followed by Takeda.