Market Spotlight: Uterine Fibroids
Market Spotlight: Uterine Fibroids
This Market Spotlight report covers the Uterine Fibroids market, comprising key pipeline and marketed drugs, clinical trials, upcoming events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
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.
- Datamonitor Healthcare estimates that in 2019, there were approximately 94.9 million prevalent cases of uterine fibroids worldwide in females aged 15 years and over, and forecasts that number to increase to 105.0 million prevalent cases by 2028.
- Lupron and relugolix, which target gonadotropin-releasing hormone receptor, and ulipristal acetate, which targets progesterone receptor, are the only approved drugs for uterine fibroids. These drugs are administered via the oral and subcutaneous routes.
- Half of the industry-sponsored drugs in active clinical development for uterine fibroids are in Phase III, with one drug in the NDA/BLA phase.
- Therapies in development for uterine fibroids focus on targets such as 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 a subcutaneous formulation.
- High-impact upcoming events for drugs in the uterine fibroids space comprise topline Phase III trial results and an expected meeting with the FDA for linzagolix, an estimated PDUFA date for Orilissa, and an expected CHMP opinion for 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 11 licensing and asset acquisition deals involving uterine fibroids drugs during 2015–20. The values have not been disclosed for any of these deals.
- The distribution of clinical trials across Phase I–IV indicates that the majority of trials for uterine fibroids have been in the early and mid-phases of development, with 60% of trials in Phase I–II, and 40% in Phase III–IV.
- The US has a substantial lead in the number of uterine fibroids clinical trials globally. The UK leads the major European 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.
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 Medical agents
13 MARKETED DRUGS
15 PIPELINE DRUGS
19 RECENT EVENTS AND ANALYST OPINION
19 Linzagolix for Uterine Fibroids (December 9, 2019)
21 Relugolix for Uterine Fibroids (July 23, 2019)
23 Multiple Drugs for Uterine Fibroids (June 25, 2019)
24 Relugolix for Uterine Fibroids (May 14, 2019)
25 Vilaprisan for Uterine Fibroids (December 5, 2018)
26 Ekobi 500 Embolization Microspheres for Uterine Fibroids (November 20, 2018)
29 KEY UPCOMING EVENTS
30 KEY REGULATORY EVENTS
30 Ulipristal Suspended In EU Pending Further Review
30 FDA Recommends Further Limiting Use Of Laparoscopic Power Morcellation
30 AbbVie Revs Up The Race To Market In Uterine Fibroids
30 Myovant Plans Q4 Uterine Fibroid Drug Filing In A Showdown With AbbVie
31 PROBABILITY OF SUCCESS
32 LICENSING AND ASSET ACQUISITION DEALS
32 Deals Shaping The Medical Industry, August 2019
32 QXMedical Gets Exclusive Rights To University of Minnesota Bioresorbable Technology
34 PARENT PATENTS
35 CLINICAL TRIAL LANDSCAPE
36 Sponsors by status
37 Sponsors by phase
38 Recent events
39 Prescription information
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of uterine fibroids, 2019–28
15 Figure 2: Overview of pipeline drugs for uterine fibroids in the US
15 Figure 3: Pipeline drugs for uterine fibroids, by company
16 Figure 4: Pipeline drugs for uterine fibroids, by drug type
16 Figure 5: Pipeline drugs for uterine fibroids, by classification
21 Figure 6: Linzagolix for Uterine Fibroids (December 9, 2019): Phase III – PRIMROSE 2
23 Figure 7: Relugolix for Uterine Fibroids (July 23, 2019): Phase III – LIBERTY 2
25 Figure 8: Relugolix for Uterine Fibroids (May 14, 2019): Phase III – LIBERTY 1
29 Figure 9: Key upcoming events in uterine fibroids
31 Figure 10: Probability of success in the uterine fibroids pipeline
32 Figure 11: Licensing and asset acquisition deals in uterine fibroids, 2015–20
34 Figure 12: Parent patents in uterine fibroids
35 Figure 13: Clinical trials in uterine fibroids
35 Figure 14: Top 10 drugs for clinical trials in uterine fibroids
36 Figure 15: Top 10 companies for clinical trials in uterine fibroids
36 Figure 16: Trial locations in uterine fibroids
37 Figure 17: Uterine fibroids trials status
38 Figure 18: Uterine fibroids trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of uterine fibroids, 2019–28
14 Table 2: Marketed drugs for uterine fibroids
17 Table 3: Pipeline drugs for uterine fibroids in the US
19 Table 4: Linzagolix for Uterine Fibroids (December 9, 2019)
22 Table 5: Relugolix for Uterine Fibroids (July 23, 2019)
23 Table 6: Multiple Drugs for Uterine Fibroids (June 25, 2019)
24 Table 7: Relugolix for Uterine Fibroids (May 14, 2019)
26 Table 8: Vilaprisan for Uterine Fibroids (December 5, 2018)
27 Table 9: Ekobi 500 Embolization Microspheres for Uterine Fibroids (November 20, 2018)
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