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

Key Takeaways:

• Datamonitor Healthcare 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.
• 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 and Phase II, with just a single product in the NDA/BLA stage.
• Therapies in development for erectile dysfunction focus on targets such as phosphodiesterase 5, alpha 1 and alpha 2 adrenergic receptors, dopamine receptors (D1, D2, D3, D4), potassium channels, voltage-gated 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 9.6%, and the average probability a drug advances from Phase III is 78.3%. Drugs, on average, take 9.6 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 62% of trials in Phase III–IV, and 38% 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. GlaxoSmithKline has the highest number of completed clinical trials for erectile dysfunction, with 20 trials.
• GlaxoSmithKline leads industry sponsors with by far the highest overall number of clinical trials for erectile dysfunction.