This Market Spotlight report covers the Uterine Fibroids market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming events, probability of success, regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals.
- The report estimates that in 2017, there were approximately 92.2 million prevalent cases of uterine fibroids worldwide in females aged 15 years and over, and forecasts that number to increase to 102.7 million prevalent cases by 2026.
- Lupron (leuprolide acetate), a gonadotropin-releasing hormone agonist, is the only approved drug for uterine fibroids. This drug is administered via the subcutaneous route.
- The majority of industry-sponsored drugs in active clinical development for uterine fibroids are in Phase III. Therapies in mid-to-late-stage development for uterine fibroids focus on targets such as the progesterone receptor, gonadotropin-releasing hormone receptor, and collagen. The majority of pipeline drugs are administered via the oral route, with one product being available in subcutaneous formulation.
- High-impact upcoming events for drugs in the uterine fibroids space comprise topline Phase III trial results for OBE2109 and relugolix, and an expected meeting with the FDA for ulipristal acetate.
- 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 uterine fibroids drugs during 2013-18. The clinical trials distribution across Phase I-IV indicates that the majority of trials for uterine fibroids have been in the early and mid-phases of development, with 62% of trials in Phase I-II, and 38% in Phase III-IV.
- The US has a substantial lead in the number of uterine fibroids clinical trials globally. Poland and the UK lead the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the uterine fibroids space is dominated by completed trials. Repros Therapeutics has the highest number of completed clinical trials for uterine fibroids, with 17 trials.
- Repros Therapeutics leads industry sponsors with the highest number of clinical trials for uterine fibroids, followed by Takeda.
Key Topics Covered:
Approvals by country
RECENT EVENTS AND ANALYST OPINION
Orilissa for Uterine Fibroids (August 22, 2018)
Ulipristal Acetate for Uterine Fibroids (August 21, 2018)
Ulipristal Acetate for Uterine Fibroids (May 18, 2018)
Orilissa for Uterine Fibroids (March 13, 2018)
Orilissa for Uterine Fibroids (February 21, 2018)
Ulipristal Acetate for Uterine Fibroids (February 9, 2018)
Vilaprisan for Uterine Fibroids (October 20, 2017)
Relugolix for Uterine Fibroids (October 2, 2017)
Proellex (Oral) for Uterine Fibroids (July 17, 2017)
Relugolix for Uterine Fibroids (May 7, 2017)
Ulipristal Acetate for Uterine Fibroids (January 17, 2017)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
Allergan's Ulipristal, Dogged By Liver Concerns, Gets An FDA Rejection
Esmya Review Held Back Gedeon Richter in First Half
Liver Damage Worries Lead To Further EU Restrictions On Richter's Esmya
EMA Panel Finalises Safety Probe Into Richter's Fibroid Drug Esmya
Richter Expects Esmya Sales To Drop 50% Following EU Restrictions Over Liver Concerns
Ultrasonic Aspirator Guidance Requires Warning On Uterine Use
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
Takeda Offloads Selected Japan Relugolix Rights
Allergan To Buy Repros And Stalled Uterine Fibroid Candidate
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
For more information about this report visit https://www.researchandmarkets.com/r/jfmydo