2019 Market Spotlight: Erectile Dysfunction – ResearchAndMarkets.com

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.

Key Takeaways

• 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

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

TREATMENT

Oral therapies

Suppositories and injections

Vacuum erection devices (VEDs)

Surgery

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

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

PARENT PATENTS

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 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

For more information about this report visit https://www.researchandmarkets.com/r/x2ej19

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Related Topics: Sexual and Reproductive Health Drugs