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, 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 2016, there were 579.6 million prevalent cases of overactive bladder worldwide among adults aged 20 years and older, and forecasts that number to increase to 649.4 million by 2025.
• 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.
• The majority of the industry-sponsored drugs in active clinical development for overactive bladder are in Phase II, with only one drug in Phase III.
• Therapies in development for overactive bladder focus on a wide variety of targets. The majority of the pipeline drugs are administered via the oral route, with the remainder being tested in subcutaneous, intravesical, and intramuscular formulations.
• High-impact upcoming events for drugs in the overactive bladder space comprise topline Phase III trial results for vibegron. The overall likelihood of approval of a Phase I urology-other asset is 12.9%, and the average probability a drug advances from Phase III is 78.6%. Drugs, on average, take 7.9 years from Phase I to approval, compared to 8.1 years in the overall urology space.
• There have been 23 licensing and asset acquisition deals involving overactive bladder drugs during 2013–18. The $131.6m exclusive worldwide license agreement between Juniper Pharmaceuticals and Daré Bioscience in April 2018 for the development and commercialization of Juniper’s intravaginal ring (IVR) technology platform, including its three preclinical IVR candidates targeting unmet needs in women’s health, was the largest deal.
• The clinical trials distribution 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 EU 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 163 trials.
• Astellas leads the industry sponsors with the highest number of clinical trials for overactive bladder, followed by Pfizer.