Overactive bladder is characterized by urinary urgency, and is generally accompanied by increased voiding frequency, nocturia, and incontinence. The disease affects men and women across the world, and has an adverse effect on quality of life. Prevalence and symptom severity increase with age, and the symptoms of overactive bladder persist for years in the majority of patients. Postmenopausal status has been associated with increased risk for overactive bladder in women, while in men, the presence of prostate problems increases risk. Diseases such as depression, heart disease, arthritis, hypertension, benign prostatic hypertrophy, neurological conditions, prostatitis, mobility limitations, and recurrent urinary tract infections (UTIs) are predictors of overactive bladder in men. In women, depression, irritable bowel syndrome, neurological conditions, arthritis, sleep apnea, and recurrent UTI all have a greater possibility of being associated with overactive bladder. Furthermore, behavioral and lifestyle factors also play a role in the development of overactive bladder.

Key Takeaways

• Datamonitor Healthcare estimates that in 2017, there were 589.6 million prevalent cases of overactive bladder worldwide among adults aged 20 years and older, and forecasts that number to increase to 660.3 million prevalent cases by 2026.
• 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 industry-sponsored drugs in active clinical development for overactive bladder are in Phase II, with only one product in Phase III.
• Therapies in development for overactive bladder focus on a wide variety of targets. The majority of pipeline drugs are administered via the oral route, with the remainder being tested in intravesical and intramuscular formulations.
• Topline Phase IIb trial results for solabegron is the only high-impact upcoming event for drugs in the overactive bladder space. The overall likelihood of approval of a Phase I urology-other asset is 13.5%, and the average probability a drug advances from Phase III is 78.6%. Drugs, on average, take 8.9 years from Phase I to approval, compared to 8.5 years in the overall urology space.
• There have been 14 licensing and asset acquisition deals involving overactive bladder drugs during 2014–19. The $25m agreement signed between UroGen and Allergan in 2016, pursuant to which UroGen granted an exclusive worldwide license to Allergan to develop and commercialize pharmaceutical products that contain UroGen’s proprietary RTGel and clostridial toxins, including Botox, was the largest deal.
• 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 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 170 trials. Astellas also leads industry sponsors with the highest overall number of clinical trials for overactive bladder, followed by Pfizer.