Product Code: DMKC0185398
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.
- 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.
- The largest proportion of industry-sponsored drugs in active clinical development for overactive bladder are in Phase II, with only one drug in the NDA/BLA stage.
- Therapies in development for overactive bladder focus on a wide variety of targets. The largest proportion of pipeline drugs are administered via the oral or intravesical routes, while one product is also being tested in an intramuscular formulation.
- The only high-impact upcoming event for drugs in the overactive bladder space is an estimated PDUFA date for vibegron. The overall likelihood of approval of a Phase I urology-other asset is 10.2%, 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.
- There have been 14 licensing and asset acquisition deals involving overactive bladder drugs during 2015-20. The $131.6m exclusive worldwide license agreement signed in 2018 between Juniper Pharmaceuticals and Dare Bioscience for the development and commercialization of Juniper's intravaginal ring (IVR) technology platform, including its three preclinical IVR candidates, 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 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 173 trials. Astellas also leads industry sponsors with the highest overall number of clinical trials for overactive bladder, followed by Pfizer.
TABLE OF CONTENTS
- Lifestyle modifications and control techniques
- Medical and surgical treatment
- Products and devices
RECENT EVENTS AND ANALYST OPINION
- Multiple Drugs for Overactive Bladder (June 25, 2019)
- Vibegron for Overactive Bladder (March 19, 2019)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Win For Axonics As England's NICE Says Rechargeable Neuromodulation Is Cost-Effective
- Keeping Track: Year-End Submissions Rush Brings Seven Novel Agents To US FDA
- FDA Expands Indication For Axonics's Incontinence System; Medtronic Claims Patent Infringement
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Deals Shaping The Medical Industry, October 2019
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
LIST OF FIGURES
- Figure 1: Trends in prevalent cases of overactive bladder, 2019-28
- Figure 2: Overview of pipeline drugs for overactive bladder in the US
- Figure 3: Pipeline drugs for overactive bladder, by company
- Figure 4: Pipeline drugs for overactive bladder, by drug type
- Figure 5: Pipeline drugs for overactive bladder, by classification
- Figure 6: Vibegron for Overactive Bladder (March 19, 2019): Phase III - EMPOWUR
- Figure 7: Key upcoming events in overactive bladder
- Figure 8: Probability of success in the overactive bladder pipeline
- Figure 9: Licensing and asset acquisition deals in overactive bladder, 2015-20
- Figure 10: Parent patents in overactive bladder
- Figure 11: Clinical trials in overactive bladder
- Figure 12: Top 10 drugs for clinical trials in overactive bladder
- Figure 13: Top 10 companies for clinical trials in overactive bladder
- Figure 14: Trial locations in overactive bladder
- Figure 15: Overactive bladder trials status
- Figure 16: Overactive bladder trials sponsors, by phase
LIST OF TABLES
- Table 1: Prevalent cases of overactive bladder, 2019-28
- Table 2: Marketed drugs for overactive bladder
- Table 3: Pipeline drugs for overactive bladder in the US
- Table 4: Multiple Drugs for Overactive Bladder (June 25, 2019)
- Table 5: Vibegron for Overactive Bladder (March 19, 2019)
- Table 6: Historical global sales, by drug ($m), 2014-18
- Table 7: Forecasted global sales, by drug ($m), 2020-24