Market Spotlight: Uterine Fibroids

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Report
40 Pages
May 2021
Region: Global
Citeline
ID: 4462174

This Market Spotlight report covers the Uterine Fibroids market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

The publisher 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, Orgovyx, and ORIAHNN, 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.
The largest proportion of 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 developed in a subcutaneous formulation.
High-impact upcoming events for drugs in the uterine fibroids space comprise expected CHMP opinions for Yselty and Orgovyx, as well as a PDUFA date for Orgovyx.
The overall likelihood of approval of a Phase I gynecology asset is 11.9%, and the average probability a drug advances from Phase III is 70%. Drugs, on average, take 11.8 years from Phase I to approval, compared to 13.0 years in the overall obstetrics/gynecology space.
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 overall number of clinical trials for uterine fibroids, followed by Takeda.

OVERVIEWKEY TAKEAWAYS

DISEASE BACKGROUND

Subtypes

TREATMENT

Surgery
Medical agents

EPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

Orgovyx for Uterine Fibroids (March 24, 2021)
Yselty for Uterine Fibroids (July 6, 2020)
Yselty for Uterine Fibroids (December 9, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

New EU Filings
EMA’s CHMP Makes Decision On Esmya
EMA Safety Panel Recommends Withdrawing Esmya Authorizations
Myovant’s Relugolix Chases AbbVie’s Elagolix In Women’s Health Market
FDA Approves First Medical Treatment For Fibroid-Related Heavy Menstrual Bleeding
Myovant Sciences’ Relugolix Among 14 New Hopefuls At EMA

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

Pfizer Gains New Commercial Drug Orgovyx In Deal With Myovant
Hologic Acquires Acessa To Add ProVu Fibroid Treatment
Myovant Licenses Ex-US Relugolix Rights To Gedeon Richter

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase
Recent events

BIBLIOGRAPHYAPPENDIX

LIST OF FIGURES

Figure 1: Trends in prevalent cases of uterine fibroids, 2019–28
Figure 2: Overview of pipeline drugs for uterine fibroids in the US
Figure 3: Pipeline drugs for uterine fibroids, by company
Figure 4: Pipeline drugs for uterine fibroids, by drug type
Figure 5: Pipeline drugs for uterine fibroids, by classification
Figure 6: Orgovyx for Uterine Fibroids (March 24, 2021): Phase III - Withdrawal (w/Estradiol + Norethindrone Acetate)
Figure 7: Yselty for Uterine Fibroids (July 6, 2020): Phase III - PRIMROSE 1
Figure 8: Yselty for Uterine Fibroids (December 9, 2019): Phase III - PRIMROSE 2
Figure 9: Key upcoming events in uterine fibroids
Figure 10: Probability of success in the gynecology pipeline
Figure 11: Clinical trials in uterine fibroids
Figure 12: Top 10 drugs for clinical trials in uterine fibroids
Figure 13: Top 10 companies for clinical trials in uterine fibroids
Figure 14: Trial locations in uterine fibroids
Figure 15: Uterine fibroids trials status
Figure 16: Uterine fibroids trials sponsors, by phase

LIST OF TABLES

Table 1: Prevalent cases of uterine fibroids, 2019–28
Table 2: Marketed drugs for uterine fibroids
Table 3: Pipeline drugs for uterine fibroids in the US
Table 4: Orgovyx for Uterine Fibroids (March 24, 2021)
Table 5: Yselty for Uterine Fibroids (July 6, 2020)
Table 6: Yselty for Uterine Fibroids (December 9, 2019)
Table 7: Historical global sales, by drug ($m), 2016–20
Table 8: Forecasted global sales, by drug ($m), 2021–25

Table of Contents

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