Market Spotlight: Overactive Bladder
Market Spotlight: Overactive Bladder
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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
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.
- 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.
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 Lifestyle modifications and control techniques
9 Medical and surgical treatment
10 Products and devices
14 MARKETED DRUGS
18 Approvals by country
22 PIPELINE DRUGS
29 RECENT EVENTS AND ANALYST OPINION
29 Vibegron for Overactive Bladder (March 3, 2018)
30 Solifenacin/Mirabegron for Overactive Bladder (August 17, 2017)
33 KEY UPCOMING EVENTS
34 KEY REGULATORY EVENTS
34 After Hiccups, Astellas’s Mirabegron On Course For Indian Debut?
35 PROBABILITY OF SUCCESS
36 LICENSING AND ASSET ACQUISITION DEALS
36 Urovant Licenses OAB Gene Therapy From Ion Channel Innovations
36 Roivant Launches Urovant, Gets Rights To Merck’s Phase III Vibegron
38 PARENT PATENTS
39 REVENUE OPPORTUNITY
40 CLINICAL TRIAL LANDSCAPE
41 Trials by status
42 Trials by phase
43 Recent events
44 Prescription information
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of overactive bladder, 2017–26
22 Figure 2: Overview of pipeline drugs for overactive bladder in the US
23 Figure 3: Pipeline drugs for overactive bladder, by company
23 Figure 4: Pipeline drugs for overactive bladder, by drug type
23 Figure 5: Pipeline drugs for overactive bladder, by classification
30 Figure 6: Vibegron for Overactive Bladder (March 3, 2018): Phase IIb – 008 – vs. Placebo/Detrol
32 Figure 7: Solifenacin/Mirabegron for Overactive Bladder (August 17, 2017): Phase III – SYNERGY II (Long-Term Safety)
33 Figure 8: Key upcoming events in overactive bladder
35 Figure 9: Probability of success in the overactive bladder pipeline
36 Figure 10: Licensing and asset acquisition deals in overactive bladder, 2013–18
38 Figure 11: Parent patents in overactive bladder
40 Figure 12: Clinical trials in overactive bladder
40 Figure 13: Top 10 drugs for clinical trials in overactive bladder
41 Figure 14: Top 10 companies for clinical trials in overactive bladder
41 Figure 15: Trial locations in overactive bladder
42 Figure 16: Overactive bladder trials status
43 Figure 17: Overactive bladder trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of overactive bladder, 2017–26
15 Table 2: Marketed drugs for overactive bladder
19 Table 3: Approvals by country for overactive bladder
25 Table 4: Pipeline drugs for overactive bladder in the US
29 Table 5: Vibegron for Overactive Bladder (March 3, 2018)
31 Table 6: Solifenacin/Mirabegron for Overactive Bladder (August 17, 2017)
39 Table 7: Historical global sales, by drug ($m), 2013–17
39 Table 8: Forecasted global sales, by drug ($m), 2018–22
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