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:

• Datamonitor Healthcare 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 and prostaglandin E receptor 1. The majority of approved drugs in the erectile dysfunction space are administered via the oral route, with the remainder being intracavitary, intraurethral, and sublingual/oral transmucosal formulations.
• There are just seven industry-sponsored drugs in active clinical development for erectile dysfunction, two of which are 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 majority of these drugs are administered via the oral route, with the remainder being sublingual/oral transmucosal and intramuscular/intravesical formulations.
• The only high-impact upcoming event in the erectile dysfunction space is an estimated PDUFA date for Tadalafil VersaFilm. The overall likelihood of approval of a Phase I urology asset is 15.9%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 8.5 years from Phase I to approval in the overall urology space.
• There have been 13 licensing and asset acquisition deals involving erectile dysfunction drugs during 2014–19. 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 during the period.
• 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 only 33% in Phase I–II.
• The US has a substantial lead in the number of erectile dysfunction clinical trials globally. France and Italy lead the major EU 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