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Market Spotlight: Erectile Dysfunction

  • ID: 4775108
  • Report
  • February 2020
  • Region: Global
  • 33 pages
  • Datamonitor Healthcare
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FEATURED COMPANIES

  • GlaxoSmithKline
  • Metuchen
  • Pfizer
  • VIVUS
  • MORE
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 research estimates that in 2017, there were 398.2 million prevalent cases of erectile dysfunction in males aged 20 years and older worldwide, and forecasts that number to increase to 446.4 million cases by 2026.
  • 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.
  • The overall likelihood of approval of a Phase I urology asset is 13.4%, 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.
  • There have been 12 licensing and asset acquisition deals involving erectile dysfunction drugs during 2015–20. The $70m license and commercialization agreement signed in 2016 between VIVUS and Metuchen to commercialize and promote Stendra (avanafil) for therapeutic use in humans was the largest deal.
  • 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 67% of trials in Phase III–IV, and 33% in Phase I–II.
  • The US leads in terms of the number of erectile dysfunction clinical trials globally. France, Germany, and Italy lead 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
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FEATURED COMPANIES

  • GlaxoSmithKline
  • Metuchen
  • Pfizer
  • VIVUS
  • MORE
1. OVERVIEW

2. KEY TAKEAWAYS

3. DISEASE BACKGROUND

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

6. MARKETED DRUGS

7. PIPELINE DRUGS

8. RECENT EVENTS AND ANALYST OPINION
  • Multiple Drugs for Erectile Dysfunction (June 25, 2019)
  • Tadalafil PharmFilm for Erectile Dysfunction (May 8, 2019)
9. KEY REGULATORY EVENTS
  • Pfizer Building Viagra As Pan-European Consumer Health Brand With Rx-To-OTC Switch In Norway
  • Poland Switches from Rx-To-OTC Mylan's Duspatalin For IBS, Plus Orion's Erectile Dysfunction Treatment
  • Adamis Submits Sublingual Tadalafil, Pre-Filled Naloxone Syringe
10. PROBABILITY OF SUCCESS

11. LICENSING AND ASSET ACQUISITION DEALS

12. PARENT PATENTS

13. REVENUE OPPORTUNITY

14. CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
15. BIBLIOGRAPHY
  • Prescription information
16. APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of erectile dysfunction, 2017–26
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: Probability of success in the erectile dysfunction pipeline
Figure 7: Licensing and asset acquisition deals in erectile dysfunction, 2015–20
Figure 8: Parent patents in erectile dysfunction
Figure 9: Clinical trials in erectile dysfunction
Figure 10: Top 10 drugs for clinical trials in erectile dysfunction
Figure 11: Top 10 companies for clinical trials in erectile dysfunction
Figure 12: Trial locations in erectile dysfunction
Figure 13: Erectile dysfunction trials status
Figure 14: Erectile dysfunction trials sponsors, by phase

LIST OF TABLES
Table 1: Prevalent cases of erectile dysfunction, 2017–26
Table 2: Marketed drugs for erectile dysfunction
Table 3: Pipeline drugs for erectile dysfunction in the US
Table 4: Multiple Drugs for Erectile Dysfunction (June 25, 2019)
Table 5: Tadalafil PharmFilm for Erectile Dysfunction (May 8, 2019)
Table 6: Historical global sales, by drug ($m), 2014–18
Table 7: Forecasted global sales, by drug ($m), 2020–24
Note: Product cover images may vary from those shown
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  • VIVUS
  • Metuchen
  • Pfizer
  • GlaxoSmithKline
Note: Product cover images may vary from those shown
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