Market Spotlight: Uterine Fibroids
Market Spotlight: Uterine Fibroids
$1,318.00
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
- Description
- Contents
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.
Key Takeaways
- Datamonitor Healthcare 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 a 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 13.6%, and the average probability a drug advances from Phase III is 62.5%. Drugs, on average, take 11.0 years from Phase I to approval, compared to 12.7 years in the overall obstetrics/gynecology space.
- There have been 12 licensing and asset acquisition deals involving uterine fibroids drugs during 2014–19. 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 61% of trials in Phase I–II, and 39% in Phase III–IV.
- The US has a substantial lead in the number of uterine fibroids clinical trials globally. The UK leads 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.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Subtypes
9 TREATMENT
9 Surgery
9 Medical agents
10 EPIDEMIOLOGY
13 MARKETED DRUGS
15 PIPELINE DRUGS
20 RECENT EVENTS AND ANALYST OPINION
20 Relugolix for Uterine Fibroids (July 23, 2019)
21 Multiple Drugs for Uterine Fibroids (June 25, 2019)
22 Relugolix for Uterine Fibroids (May 14, 2019)
24 Vilaprisan for Uterine Fibroids (December 05, 2018)
25 Orilissa for Uterine Fibroids (August 22, 2018)
27 Ulipristal Acetate for Uterine Fibroids (August 21, 2018)
28 Ulipristal Acetate for Uterine Fibroids (May 18, 2018)
29 Orilissa for Uterine Fibroids (March 13, 2018)
31 KEY UPCOMING EVENTS
32 KEY REGULATORY EVENTS
32 AbbVie Revs Up The Race To Market In Uterine Fibroids
32 Myovant Plans Q4 Uterine Fibroid Drug Filing In A Showdown With AbbVie
33 PROBABILITY OF SUCCESS
34 LICENSING AND ASSET ACQUISITION DEALS
34 Deals Shaping The Medical Industry, August 2019
34 QXMedical Gets Exclusive Rights To University of Minnesota Bioresorbable Technology
36 PARENT PATENTS
37 REVENUE OPPORTUNITY
38 CLINICAL TRIAL LANDSCAPE
39 Sponsors by status
40 Sponsors by phase
41 Recent events
42 BIBLIOGRAPHY
42 Prescription information
43 APPENDIX
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of uterine fibroids, 2017–26
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: Relugolix for Uterine Fibroids (July 23, 2019): Phase III – LIBERTY 2
24 Figure 7: Relugolix for Uterine Fibroids (May 14, 2019): Phase III – LIBERTY 1
27 Figure 8: Orilissa for Uterine Fibroids (August 22, 2018): Phase III – ELARIS UF-EXTEND
30 Figure 9: Orilissa for Uterine Fibroids (March 13, 2018): Phase III – ELARIS UF-II
31 Figure 10: Key upcoming events in uterine fibroids
33 Figure 11: Probability of success in the uterine fibroids pipeline
34 Figure 12: Licensing and asset acquisition deals in uterine fibroids, 2014–19
36 Figure 13: Parent patents in uterine fibroids
38 Figure 14: Clinical trials in uterine fibroids
38 Figure 15: Top 10 drugs for clinical trials in uterine fibroids
39 Figure 16: Top 10 companies for clinical trials in uterine fibroids
39 Figure 17: Trial locations in uterine fibroids
40 Figure 18: Uterine fibroids trials status
41 Figure 19: Uterine fibroids trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of uterine fibroids, 2017–26
14 Table 2: Marketed drugs for uterine fibroids
17 Table 3: Pipeline drugs for uterine fibroids in the US
20 Table 4: Relugolix for Uterine Fibroids (July 23, 2019)
22 Table 5: Multiple Drugs for Uterine Fibroids (June 25, 2019)
23 Table 6: Relugolix for Uterine Fibroids (May 14, 2019)
25 Table 7: Vilaprisan for Uterine Fibroids (December 05, 2018)
26 Table 8: Orilissa for Uterine Fibroids (August 22, 2018)
27 Table 9: Ulipristal Acetate for Uterine Fibroids (August 21, 2018)
28 Table 10: Ulipristal Acetate for Uterine Fibroids (May 18, 2018)
29 Table 11: Orilissa for Uterine Fibroids (March 13, 2018)
37 Table 12: Historical global sales, by drug ($m), 2014–18
37 Table 13: Forecasted global sales, by drug ($m), 2019–23
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