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.
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 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.
High-impact upcoming events in the endometriosis space comprise topline Phase III results from two trials of relugolix. The overall likelihood of approval of a Phase I gynecology asset is 13.3%, and the average probability a drug advances from Phase III is 60%. Drugs, on average, take 10.6 years from Phase I to approval, compared to 12.4 years in the overall obstetrics/gynecology space.
There have been 10 licensing and asset acquisition deals involving endometriosis drugs during 2015-20. 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 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 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 38 trials.
Bayer leads industry sponsors with the highest overall number of clinical trials for endometriosis, followed by Takeda.
TABLE OF CONTENTS
- GnRH analogs
- Combined oral contraceptives
- Non-steroidal anti-inflammatory drugs
RECENT EVENTS AND ANALYST OPINION
- Relugolix for Endometriosis (October 31, 2019)
- Proellex (Oral) for Endometriosis (June 25, 2019)
KEY UPCOMING EVENTS
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Bayer, Hope Medicine Strike Hair Loss Antibody License
- Daewon Licenses Tium's Novel Endometriosis Therapeutic
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
LIST OF FIGURES
- Figure 1: Trends in prevalent cases of endometriosis, 2017-26
- Figure 2: Overview of 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 classification
- Figure 6: Key upcoming events in endometriosis
- Figure 7: Probability of success in the endometriosis pipeline
- Figure 8: Licensing and asset acquisition deals in endometriosis, 2015-20
- Figure 9: Parent patents in endometriosis
- Figure 10: Clinical trials in endometriosis
- Figure 11: Top 10 drugs for clinical trials in endometriosis
- Figure 12: Top 10 companies for clinical trials in endometriosis
- Figure 13: Trial locations in endometriosis
- Figure 14: Endometriosis trials status
- Figure 15: Endometriosis trials sponsors, by phase
LIST OF TABLES
- Table 1: Prevalent cases of endometriosis, 2017-26
- Table 2: Marketed drugs for endometriosis
- Table 3: Pipeline drugs for endometriosis in the US
- Table 4: Relugolix for Endometriosis (October 31, 2019)
- Table 5: Proellex (Oral) for Endometriosis (June 25, 2019)
- Table 6: Historical global sales, by drug ($m), 2014-18
- Table 7: Forecasted global sales, by drug ($m), 2020-24