Market Spotlight: Erectile Dysfunction
Market Spotlight: Erectile Dysfunction
$1,318.00
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.
Publisher: Datamonitor Healthcare
- Description
- Contents
This Market Spotlight report covers the Erectile Dysfunction market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and asset acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways:
- Datamonitor Healthcare estimates that in 2021, there were 412.5 million prevalent cases of erectile dysfunction in males aged 20 years and older worldwide, and forecasts that number to increase to 450.2 million cases by 2028.
- The approved drugs in the erectile dysfunction space target phosphodiesterase 5, prostaglandin E receptor 1, alpha 2 adrenergic receptor, and vasoactive intestinal peptide receptor. The majority of approved drugs in the erectile dysfunction space are administered via the oral route, with the remainder being intracavitary, intraurethral, intravenous, and sublingual/oral transmucosal formulations.
- The largest proportion of industry-sponsored drugs in active clinical development for erectile dysfunction are in Phase I and Phase II, with just a single product in the NDA/BLA stage.
- Therapies in development for erectile dysfunction focus on targets such as phosphodiesterase 5, alpha 1 and alpha 2 adrenergic receptors, dopamine receptors (D1, D2, D3, D4), potassium channels, voltage-gated calcium channels, and stem cells/other cell therapies. The largest proportion of these drugs are administered via the sublingual/oral transmucosal route.
- High-impact upcoming events for drugs in the erectile dysfunction space comprise an expected European approval decision as well as CHMP filing results for Wafesil.
- The overall likelihood of approval of a Phase I urology asset is 9.9%, and the average probability a drug advances from Phase III is 81.8%. Drugs, on average, take 9.6 years from Phase I to approval in the overall urology space.
- There are almost equal proportions of clinical trials for erectile dysfunction across Phase I/II and Phase III/IV. The US leads in terms of the number of erectile dysfunction clinical trials globally. France leads the major European markets, while China and South Korea share the top spot in Asia.
- Clinical trial activity in the erectile dysfunction space is dominated by completed trials. GSK has the highest number of completed clinical trials for erectile dysfunction, with eight trials.
- Pfizer leads industry sponsors with the highest overall number of clinical trials for erectile dysfunction, followed by GSK.
CONTENTS
5 OVERVIEW
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
8 TREATMENT
8 Oral therapies
8 Suppositories and injections
8 Vacuum erection devices (VEDs)
8 Surgery
10 EPIDEMIOLOGY
13 MARKETED DRUGS
16 PIPELINE DRUGS
21 KEY UPCOMING EVENTS
22 KEY REGULATORY EVENTS
22 Delay For Sanofi’s OTC Cialis Study In US Could Be Sign of Hurdles Holding Back Other Switches
22 Poland’s Adamed Secures Tadalafil Rx-To-OTC Switch In World First
22 No OTC Sildenafil In Germany After Committee Rejects All Rx-To-OTC Switches
23 Teva UK Enters Erectile Dysfunction Category With First Ever Rx-To-OTC Switch
23 Futura’s Drug-Free Erectile Dysfunction Gel On Track For US And EU Launch
24 PROBABILITY OF SUCCESS
25 LICENSING AND ASSET ACQUISITION DEALS
25 Futura Pens Deal With Cooper To Launch Erectile Dysfunction Gel In Europe
25 Futura Strikes Deal With Menarini To Commercialize MED3000 ED Gel In South Korea
25 Aspen Offloads Six In South Africa With Debt Still A Priority
26 Futura Strikes Deal To Commercialize Erectile Dysfunction Gel In Middle East
26 Futura Takes Drug-Free Erectile Dysfunction Gel To Latin America
27 REVENUE OPPORTUNITY
28 CLINICAL TRIAL LANDSCAPE
29 Sponsors by status
30 Sponsors by phase
32 BIBLIOGRAPHY
33 APPENDIX
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of erectile dysfunction, 2019–28
16 Figure 2: Overview of pipeline drugs for erectile dysfunction in the US
16 Figure 3: Pipeline drugs for erectile dysfunction, by company
17 Figure 4: Pipeline drugs for erectile dysfunction, by drug type
17 Figure 5: Pipeline drugs for erectile dysfunction, by classification
21 Figure 6: Key upcoming events in erectile dysfunction
24 Figure 7: Probability of success in the urology pipeline
28 Figure 8: Clinical trials in erectile dysfunction
28 Figure 9: Top 10 drugs for clinical trials in erectile dysfunction
29 Figure 10: Top 10 companies for clinical trials in erectile dysfunction
29 Figure 11: Trial locations in erectile dysfunction
30 Figure 12: Erectile dysfunction trials status
31 Figure 13: Erectile dysfunction trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of erectile dysfunction, 2019–28
14 Table 2: Marketed drugs for erectile dysfunction
18 Table 3: Pipeline drugs for erectile dysfunction in the US
27 Table 4: Historical global sales, by drug ($m), 2017–21
27 Table 5: Forecasted global sales, by drug ($m), 2022–26
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