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.
• Prevalence proportions for erectile dysfunction range between 14.0–22.0% in males aged 20 years and older worldwide, during 2017–26.
• Approved drugs in the erectile dysfunction space target phosphodiesterase 5 and prostaglandin E receptor 1. These therapies are administered via the oral, intracavitary, intraurethral, and sublingual/oral transmucosal routes.
• There are just six industry-sponsored drugs in active clinical development for erectile dysfunction, two of which have reached the NDA/BLA phase.
• Therapies in development for erectile dysfunction focus on targets such as phosphodiesterase 5 and stem cells/other cell therapies. The former are administered via the oral route.
• High impact upcoming events in the erectile dysfunction space include estimated PDUFA dates for Tadalafil PharmFilm and Tadalafil VersaFilm.
• The overall likelihood of approval of a Phase I urology asset is 17.2%, and the average probability a drug advances from Phase III is 84.2%. Drugs, on average, take 8.2 years from Phase I to approval in the overall urology space.
• There have been 14 licensing and asset acquisition deals involving erectile dysfunction drugs during 2013–18. The license, commercialization, and supply agreement signed in 2013 between VIVUS and Menarini to commercialize and promote Spedra (avanafil) for $172.5m, 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 66% of trials in Phase III–IV, and only 34% in Phase I–II.
• The US has a substantial lead in the number of erectile dysfunction clinical trials globally. Italy leads 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 number of clinical trials for erectile dysfunction, followed by GlaxoSmithKline.