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Market Spotlight: Erectile Dysfunction

  • ID: 4775108
  • Report
  • February 2021
  • Region: Global
  • Datamonitor Healthcare
This Market Spotlight report covers the Erectile Dysfunction market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, 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 401.4 million prevalent cases of erectile dysfunction in males aged 20 years and older worldwide, and forecasts that number to increase to 450.2 million cases by 2028.

Prevalence proportions for erectile dysfunction range between 14.0% and 22.0% in males aged 20 years and older worldwide. The approved drugs in the erectile dysfunction space target phosphodiesterase 5, prostaglandin E receptor 1, alpha 2 adrenergic receptor, and vasoactive intestinal peptide receptor. The majority of approved drugs in the erectile dysfunction space are administered via the oral route, with the remainder being intracavitary, intraurethral, intravenous, and sublingual/oral transmucosal formulations.

The largest proportion of industry-sponsored drugs in active clinical development for erectile dysfunction are in Phase I, with only one drug in the NDA/BLA phase.

Therapies in development for erectile dysfunction focus on targets such as phosphodiesterase 5, potassium channels, voltagegated calcium channels, and stem cells/other cell therapies. The largest proportion of these drugs are administered via the sublingual/oral transmucosal route.

High-impact upcoming events for drugs in the erectile dysfunction space comprise an expected European approval decision as well as CHMP filing results for Wafesil.

The overall likelihood of approval of a Phase I urology asset is 11.6%, and the average probability a drug advances from Phase III is 77.3%. Drugs, on average, take 9.0 years from Phase I to approval in the overall urology space.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for erectile dysfunction have been in the late phases of development, with 68% of trials in Phase III-IV, and 32% in Phase I-II.

The US leads in terms of the number of erectile dysfunction clinical trials globally. France leads the major European markets, while South Korea has the top spot in Asia.

Clinical trial activity in the erectile dysfunction space is dominated by completed trials. Pfizer has the highest number of completed clinical trials for erectile dysfunction, with 24 trials.

Pfizer leads industry sponsors with the highest overall number of clinical trials for erectile dysfunction, followed by GlaxoSmithKline.
Note: Product cover images may vary from those shown
OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

TREATMENT
  • Oral therapies
  • Suppositories and injections
  • Vacuum erection devices (VEDs)
  • Surgery
EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS
  • Viagra Connect To Launch In Ireland Following Rx-to-OTC Switch
  • Futura’s Revolutionary ED Treatment One Step Closer To US And EU OTC Approval
  • Switzerland Approves Raft Of Rx-To-OTC Switches
  • Perrigo Launches OTC Viagra Rival In UK
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Neurotrope Moves Into Men’s Health Via Merger With Metuchen
  • Advanz Gets Commercial Rights To Alprostadil Products From UCB
REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
BIBLIOGRAPHY
  • Prescription information
APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of erectile dysfunction, 2019–28
Figure 2: Overview of pipeline drugs for erectile dysfunction in the US
Figure 3: Pipeline drugs for erectile dysfunction, by company
Figure 4: Pipeline drugs for erectile dysfunction, by drug type
Figure 5: Pipeline drugs for erectile dysfunction, by classification
Figure 6: Key upcoming events in erectile dysfunction
Figure 7: Probability of success in the urology pipeline
Figure 8: Clinical trials in erectile dysfunction
Figure 9: Top 10 drugs for clinical trials in erectile dysfunction
Figure 10: Top 10 companies for clinical trials in erectile dysfunction
Figure 11: Trial locations in erectile dysfunction
Figure 12: Erectile dysfunction trials status
Figure 13: Erectile dysfunction trials sponsors, by phase

LIST OF TABLES
Table 1: Prevalent cases of erectile dysfunction, 2019–28
Table 2: Marketed drugs for erectile dysfunction
Table 3: Pipeline drugs for erectile dysfunction in the US
Table 4: Historical global sales, by drug ($m), 2015–19
Table 5: Forecasted global sales, by drug ($m), 2021–25
Note: Product cover images may vary from those shown
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