- The author 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 1 in 10 women in the reproductive age group of 15-49 years.
- The majority of industry-sponsored drugs in active clinical development for endometriosis are in Phase II. Therapies in mid- and late-stage development for endometriosis focus on targets such as the gonadotropin-releasing hormone (GnRH) receptor, progesterone receptor, and luteinizing hormone receptor. Among these therapies, Elagolix, a first-in-class GnRH receptor antagonist, is closest to market. All pipeline drugs in mid- and late-stage development for endometriosis are administered via the oral route.
- Approved drugs in the endometriosis space target the GnRH 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 main high impact upcoming event in the endometriosis space is topline Phase III trial results for Relugolix. There were 11 licensing and asset acquisition activities involving endometriosis drugs during 2012-17. The largest deal was in 2017, when AstraZeneca obtained commercialization rights to Zoladex in the US and Canada from TerSera Therapeutics for $320m.
- A composition patent for Lupron is set to expire in 2019, opening the door to generic entry. Lupron’s sales ranked highest among drugs approved in the endometriosis space during 2012-16. Elagolix, which is estimated to be launched in 2018, is expected to achieve blockbuster sales by 2021.
- The distribution of clinical trials across Phase I-IV indicates that the majority of drugs are in the 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, yet forecasted prevalent cases of endometriosis are lower in North America as compared to Europe and Asia. Germany leads the major EU markets, while Japan has the top spot in Asia, where prevalent cases of endometriosis are highest.
- Clinical trial activity in the endometriosis space is dominated by completed trials, with only 10% of trials currently ongoing. Bayer, Takeda, AbbVie, and Neurocrine Biosciences have the highest number of completed clinical trials for endometriosis.
1 KEY TAKEAWAYS
2 DISEASE BACKGROUND
5 PIPELINE DRUGS
6 MARKETED DRUGS
- Approvals by country
7 KEY UPCOMING EVENTS
8 LICENSING AND ASSET ACQUISITION DEALS
- Takeda Continues To Shed Pipeline Assets In Roivant Deal
9 PARENT PATENTS
10 REVENUE OPPORTUNITY
11 CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Prescription information
List of Figures
Figure 1: Trends in prevalent cases of endometriosis, 2016-25
Figure 2: Pipeline drugs for endometriosis in the US
Figure 3: Pipeline drugs for endometriosis, by company
Figure 4: Pipeline drugs for endometriosis, by drug type
Figure 5: Pipeline drugs for endometriosis, by classifications
Figure 6: Key upcoming events in endometriosis
Figure 7: Licensing and asset acquisition deals in endometriosis, 2012-17
Figure 8: Parent patents in endometriosis
Figure 9: Clinical trials in endometriosis
Figure 10: Top 10 drugs for clinical trials in endometriosis
Figure 11: Top 10 companies for clinical trials in endometriosis
Figure 12: Trial locations in endometriosis
Figure 13: Endometriosis trials status
Figure 14: Endometriosis trials sponsors, by phase >List of Tables
List of Tables
Table 1: Prevalent cases of endometriosis, 2016-25
Table 2: Pipeline drugs for endometriosis in the US
Table 3: Marketed drugs for endometriosis
Table 4: Approvals by country for endometriosis
Table 5: Historical global sales, by drug ($m), 2012-16
Table 6: Forecasted global sales, by drug ($m), 2017-22