Overview

This Market Spotlight report covers the Overactive Bladder market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, 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 2019, there were 545.0 million prevalent cases of overactive bladder worldwide among adults aged 20 years and older, and forecasts that number to increase to 607.6 million prevalent cases by 2028.
• The approved drugs in the overactive bladder space target the calcium channel, muscarinic acetylcholine receptor, SNARE proteins, and beta-3 adrenergic receptor. The majority of these drugs are administered via the oral route, with the remainder being available in intramuscular, intravesical, intradermal, intraarticular, topical, and transdermal formulations.
• All industry-sponsored drugs in active clinical development for overactive bladder are currently in Phase II. Therapies in development for overactive bladder focus on targets such as beta-3 adrenergic receptor, P2 (purine) receptors, potassium channels, and voltage-gated calcium channels. These drugs are administered via oral, intramuscular, and intravesical routes.
• The only high-impact upcoming event for drugs in the overactive bladder space is topline Phase III trial results for Gemtesa. The overall likelihood of approval of a Phase I urology-other asset is 7.6%, and the average probability a drug advances from Phase III is 75%. Drugs, on average, take 10.0 years from Phase I to approval, compared to 9.0 years in the overall urology space.
• The distribution of clinical trials across Phase I–IV indicates that just over half of trials in overactive bladder have been in the early and mid-phases of development, with 54% of trials in Phase I–II, and 46% in Phase III–IV.
• The US has a substantial lead in the number of overactive bladder clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
• Clinical trial activity in the overactive bladder space is dominated by completed trials. Astellas has the highest number of completed clinical trials for overactive bladder, with 177 trials. Astellas also leads industry sponsors with the highest overall number of clinical trials for overactive bladder, followed by Pfizer.