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 2021, there were 411.4 million prevalent cases of erectile dysfunction in males aged 20 years and older worldwide, and forecasts that number to increase to 461.4 million cases by 2030.
• 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.
• Industry-sponsored drugs in active clinical development for erectile dysfunction are evenly spread across Phase I to Phase III. 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. These therapies are administered via the oral, sublingual/oral transmucosal, intranasal, intramuscular, and intravesical formulations.
• 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 8.1%, and the average probability a drug advances from Phase III is 75%. Drugs, on average, take 9.7 years from Phase I to approval in the overall urology space.
• There are equal proportions of clinical trials for erectile dysfunction across Phase I/II and Phase III/IV. The US leads in terms of the number of erectile dysfunction clinical trials globally. France and Germany lead the major European markets, while China has the top spot in Asia.
• Clinical trial activity in the erectile dysfunction space is dominated by completed trials. GSK and Pfizer have the highest number of completed clinical trials for erectile dysfunction, with seven trials each.
• Pfizer leads industry sponsors with the highest overall number of clinical trials for erectile dysfunction, followed by GSK and Vigonvita Life Sciences.