DUBLIN–(BUSINESS WIRE)–The “Market Spotlight: Erectile Dysfunction” report has been added to ResearchAndMarkets.com’s offering.
This Market Spotlight report covers the Erectile Dysfunction 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 2017, there were 398.2 million prevalent cases of erectile dysfunction in males aged 20 years and older worldwide, and forecasts that number to increase to 446.4 million cases by 2026.
- The approved drugs in the erectile dysfunction space target phosphodiesterase 5 and prostaglandin E receptor 1. The majority of approved drugs in the erectile dysfunction space are administered via the oral route, with the remainder being intracavitary, intraurethral, and sublingual/oral transmucosal formulations.
- There are just seven industry-sponsored drugs in active clinical development for erectile dysfunction, three of which are in the NDA/BLA phase.
- Therapies in development for erectile dysfunction focus on targets such as phosphodiesterase 5, potassium channels, voltagegated calcium channels, and stem cells/other cell therapies. The majority of these drugs are administered via the oral route, with the remainder being sublingual/oral transmucosal and intramuscular/intravesical formulations.
- High-impact upcoming events in the erectile dysfunction space comprise estimated PDUFA dates for Tadalafil VersaFilm and APC-8000.
- The overall likelihood of approval of a Phase I urology asset is 16.1%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 8.6 years from Phase I to approval in the overall urology space.
- There have been 13 licensing and asset acquisition deals involving erectile dysfunction drugs during 2014-19. The $70m license and commercialization agreement signed in 2016 between VIVUS and Metuchen to commercialize and promote Stendra (avanafil) for therapeutic use in humans was the largest deal during the period.
- The distribution of clinical trials across Phase I-IV indicates that the majority of trials for erectile dysfunction have been in the late phases of development, with 66% of trials in Phase III-IV, and only 34% in Phase I-II.
- The US has a substantial lead in the number of erectile dysfunction clinical trials globally. Italy leads the major EU markets, while South Korea has the top spot in Asia.
- Clinical trial activity in the erectile dysfunction space is dominated by completed trials. Pfizer has the highest number of completed clinical trials for erectile dysfunction, with 24 trials.
- Pfizer leads industry sponsors with the highest number of clinical trials for erectile dysfunction, followed by GlaxoSmithKline.
Key Topics Covered
Suppositories and injections
Vacuum erection devices (VEDs)
RECENT EVENTS AND ANALYST OPINION
Vitaros for Erectile Dysfunction (February 16, 2018)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
Adamis Submits Sublingual Tadalafil, Pre-Filled Naloxone Syringe
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
Acerus Gains Canadian Rights To Metuchen’s Stendra
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
LIST OF FIGURES
Figure 1: Trends in prevalent cases of erectile dysfunction, 2017-26
Figure 2: Overview of pipeline drugs for erectile dysfunction in the US
Figure 3: Pipeline drugs for erectile dysfunction, by company
Figure 4: Pipeline drugs for erectile dysfunction, by drug type
Figure 5: Pipeline drugs for erectile dysfunction, by classification
Figure 6: Key upcoming events in erectile dysfunction
Figure 7: Probability of success in the erectile dysfunction pipeline
Figure 8: Licensing and asset acquisition deals in erectile dysfunction, 2014-19
Figure 9: Parent patents in erectile dysfunction
Figure 10: Clinical trials in erectile dysfunction
Figure 11: Top 10 drugs for clinical trials in erectile dysfunction
Figure 12: Top 10 companies for clinical trials in erectile dysfunction
Figure 13: Trial locations in erectile dysfunction
Figure 14: Erectile dysfunction trials status
Figure 15: Erectile dysfunction trials sponsors, by phase
LIST OF TABLES
Table 1: Prevalent cases of erectile dysfunction, 2017-26
Table 2: Marketed drugs for erectile dysfunction
Table 3: Pipeline drugs for erectile dysfunction in the US
Table 4: Vitaros for Erectile Dysfunction (February 16, 2018)
Table 5: Historical global sales, by drug ($m), 2013-17
Table 6: Forecasted global sales, by drug ($m), 2019-23
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Related Topics: Sexual and Reproductive Health Drugs