+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

Market Spotlight: Overactive Bladder

  • ID: 4462203
  • Report
  • August 2020
  • Region: Global
  • 38 Pages
  • Datamonitor Healthcare
1 of 2

Enquire about COVID-19 updates for this product.

Enquire Now
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
  • The publisher 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.
  • 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 174 trials. Astellas also leads industry sponsors with the highest overall number of clinical trials for overactive bladder, followed by Pfizer
Note: Product cover images may vary from those shown
2 of 2
Overview

Key Takeaways

Disease Background

Treatment
  • Lifestyle modifications and control techniques
  • Medical and surgical treatment
  • Products and devices
Epidemiology

Marketed Drugs

Pipeline Drugs

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
Revenue Opportunity

Clinical Trial Landscape
  • Sponsors by status
  • Sponsors by phase
Bibliography
  • Prescription information
Appendix

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: Clinical trials in overactive bladder
Figure 10: Top 10 drugs for clinical trials in overactive bladder
Figure 11: Top 10 companies for clinical trials in overactive bladder
Figure 12: Trial locations in overactive bladder
Figure 13: Overactive bladder trials status
Figure 14: 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 ($m), 2015–19
Table 7: Forecasted global sales, by drug ($m), 2020–24
Note: Product cover images may vary from those shown
Adroll
adroll