This Market Spotlight report covers the Overactive Bladder market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
The author 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 prevalent cases by 2025.
The approved drugs in the overactive bladder space target calcium channel, muscarinic acetylcholine receptor, SNARE proteins, and beta-3 adrenergic receptor. The majority of these drugs are administered via the oral route.
The majority of industry-sponsored drugs in active clinical development for overactive bladder are in Phase II, with only one drug in NDA/BLA phase.
Therapies in development for overactive bladder focus on targets such as beta-3 adrenergic receptor, muscarinic acetylcholine receptor, SNARE proteins, and transient receptor potential vanilloid receptor 1. Majority of these therapies are being administered via the oral route, with the remainder being subcutaneous and intravesical formulations.
High-impact upcoming events include the expected CHMP opinion for Vesicare's supplemental filing, and the PDUFA date for Myrbetriq.
There were 19 licensing and asset acquisition activities involving overactive bladder drugs during 2012-17. The acquisition agreement in 2012 between Aspen and Novartis for $52.6m for the acquisition of two pharmaceutical products, Tofranil and Enablex, was the largest deal during the period.
The US product patent of Vesicare is set to expire in 2019, and the US patents of Detrol (formulation), Gelnique (method of use), and Oxytrol (method of use) are set to expire in 2020, which will open the door to generic entries.
Botox - Therapeutic sales ranked highest in the overactive bladder space during 2012-2016. The clinical trials distribution across Phase I-IV indicates that there is an even distribution of trials for overactive bladder, with 53.3% of trials in Phase I-II, and 46.7% 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 Pharma has the highest number of completed clinical trials for overactive bladder, with 159 completed trials.
Astellas Pharma leads industry sponsors with the highest number of clinical trials for overactive bladder, followed by Pfizer and Allergan.
Key Topics Covered:
TREATMENT Lifestyle modifications and control techniques Medical and surgical treatment Products and Devices
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS After Hiccups, Astellas's Mirabegron On Course For Indian Debut? Bluewind Medical Secures CE Mark For Tibial Neurostimulator For Overactive Bladder Will Axonics Square Up To Medtronic In Sacral Neuromodulation Market?
LICENSING AND ASSET ACQUISITION DEALS Roivant Launches Urovant, Gets Rights To Merck's Phase III Vibegron