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Stakeholder Opinions: Sexual Dysfunction - The quest for the new Viagra continues Product Image

Stakeholder Opinions: Sexual Dysfunction - The quest for the new Viagra continues

  • Published: March 2010
  • 194 pages
  • Datamonitor

Introduction

Drug developers interested on the sexual dysfunction market are searching for the next Viagra. Companies are focusing on premature ejaculation and female hypoactive sexual desire disorder, which are suggested to be as prevalent as erectile dysfunction. As products advance through the pipeline, there are several challenges that will have to be addressed in order to succeed in these markets.

Scope

-Overview of erectile dysfunction, premature ejaculation and female sexual dysfunction disorders including epidemiology and key unmet needs.

-Summary of the drug classes currently used for the different sexual dysfunction disorders and an update of the latest proposed treatment guidelines.

-Evaluation of marketed brands and pipeline agents for erectile dysfunction, premature ejaculation and female sexual dysfunction disorders.

-Insights from interviews with seven leading US and European key opinion leaders in the field of male and female sexual dysfunction.

Highlights

The erectile dysfunction market will remain the most attractive and accepted one among the different sexual dysfunction disorders for the foreseeable future, READ MORE >

Overview
Catalyst
Summary
Executive Summary
Scope of the analysis
Datamonitor insight into the sexual dysfunction market
Related reports

1. Sexual Dysfunction - Patient Potential
Key findings
Definition
Male sexual dysfunction
Erectile dysfunction
Premature ejaculation
Female sexual dysfunction
Etiology
Classification of female sexual dysfunction
Epidemiology
Seven major markets
Problems with sexual dysfunction epidemiology studies
Male sexual dysfunction
US - premature ejaculation is the most prevalent male sexual dysfunction
Japan - half of men over 40 years experience at least one sexual dysfunction
France - prevalence of premature ejaculation varies greatly
Germany - a over 8 million men are affected by at least one sexual dysfunction
Italy - premature ejaculation is the most common sexual complaint
Spain - over 3 million men have at least one sexual dysfunction
UK - over 5 million men have at least one sexual dysfunction
Female sexual dysfunction
US - over 25 million women in the US lack interest in sex
Japan - trouble lubrication is the most common complaint among Japanese women over 40 years
France - prevalence rates are similar across different types of female sexual dysfunction
Germany - Over 9 million women experience hypoactive sexual desire disorder
Italy -Women over 60 years are by far more likely to experience a type of sexual dysfunction than younger women
Spain - over 3 million women report to lack sexual interest
UK - the majority of women experiencing a sexual dysfunction will have trouble with desire or pleasure
Rest of the world epidemiology
Lack of studies limited the assessment of sexual dysfunction market in the BRIC countries
Current treatment options
Erectile dysfunction
Non pharmacological treatment
Pharmacological
Premature ejaculation
Non pharmacological - the recommended first-line treatment
Pharmacological
Female sexual dysfunction
Non pharmacological
Pharmacological
Unmet need in sexual dysfunction
Need for approved drugs for female sexual dysfunction and premature ejaculation
Approving drugs for these conditions will allow the market to be developed
Alternatives to the drugs currently used off-label need to be developed
Need to raise awareness among physicians and patients about sexual dysfunction
Reducing the stigma associated with sexual dysfunctions
Physicians need to be educated about sexual dysfunction
Patients need to be educated about the condition and therapies available
Celebrity spokespeople can destigmatize the disease
Need for universal definition of various sexual dysfunction disorders
Female sexual dysfunction remains poorly defined
Premature ejaculation prevalence differs according to the definition used
Need for better drugs for the treatment of erectile dysfunction
Better efficacy
Improved safety
Need for less expensive drugs
Currently therapy for premature ejaculation in the EU depends on what you can afford
Getting the drugs reimbursed is just as important as having them approved by the regulatory bodies
2. Sexual Dysfunction - Market Potential
Key findings
Market definition for this report
Current market overview
Sexual dysfunction market
Regional dynamics - the sexual dysfunction market has been displaying continuous growth across all regions
ATC class dynamics - the majority of the market is formed by the G4E (erectile dysfunction) ATC class
Erectile dysfunction
Regional dynamics - erectile dysfunction market continues to grow despite the small decrease in sales in the EU
Brand dynamics
Female sexual dysfunction
Over half of patients will receive some drug treatment for female sexual dysfunction
Counseling and education are the most common treatment
Rest of the world snapshot
The global erectile dysfunction market continues to display growth
Datamonitor's market attractiveness assessment
The female sexual dysfunction will be the toughest market to develop
Opportunities and threats
Opportunities
Limited competition in the market and high prevalence make this is an interesting market
Use Europe to start breaking the barriers
Target other sexual disorders
New market players can compete on cost
Over-the-counter switch bypasses embarrassing physician consultations
Threats
Increased FDA pharmacovigilance makes sexual dysfunction drugs high-risk projects
A proportion of physicians will be against medicalizing female sexual dysfunction
Off-label prescription is likely to remain high in premature ejaculation and female sexual dysfunction
Generic sildenafil competition from 2013
Approving drugs for female sexual dysfunction may be harder due to overlap of disorders
FDA increases scrutiny towards direct-to-consumer (DTC) advertising
Drug counterfeiting remains an issue in the sexual dysfunction market
Fear of recreational use of sexual dysfunction drugs may increase regulatory inspection
3. Brand Dynamics
Key findings
Overview of competitive landscape
Erectile dysfunction - Viagra (sildenafil; Pfizer)
Drug profile
Viagra patent expiry
Clinical trial data
Product positioning
SWOT analysis
Erectile dysfunction - Cialis (tadalafil; Eli Lilly)
Drug profile
Product positioning
SWOT analysis
Erectile dysfunction - Levitra (vardenafil; Bayer/GlaxoSmithKline/Merck-Schering-Plough )
Drug profile
Marketing agreements
Product positioning
SWOT analysis
Premature ejaculation - Priligy (dapoxetine; Johnson & Johnson)
Drug profile
Development overview
Product positioning
First-to-market privilege is hindered by high cost
US approval
Safety concerns regarding SSRIs may hamper sales
SWOT analysis
Female sexual dysfunction - Intrinsa (testosterone patch, Procter & Gamble)
Drug profile
Product positioning
Launch in the US remains unlikely
SWOT analysis
4. Pipeline Analysis
Key findings
Pipeline overview
Erectile dysfunction - Avanafil (TA1790/Vivus)
Drug profile
Development overview
Product positioning
Short time to onset provides a differentiator but it will not secure a significant market share upon launch of generic Viagra
Clinical profile addresses some unmet needs
SWOT analysis
Premature ejaculation - PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma)
Drug profile
Development overview
Product positioning
Favorable clinical profile compared to Priligy
PSD502 could be cheaper than Priligy
Second-to-market status could be an advantage
SWOT analysis
Female sexual dysfunction - Flibanserin (BIMT-17; Boehringer Ingelheim)
Drug profile
Development overview
Product positioning
Unimpressive clinical trial data may delay approval
Long-term safety remains unknown
SWOT analysis
Female sexual dysfunction - LibiGel (testosterone gel; Antares/BioSante)
Drug profile
Development overview
Product positioning
LibiGel may be the first testosterone product to be indicated for female sexual dysfunction in the US
High-risk project - the FDA is cautious about approving hormones in women...
...however, BioSante's efforts to work closely to the FDA are likely to pay off
SWOT analysis
Key early-stage compounds
5. Case Studies
Introduction
Case study: Viagra (sildenafil; Pfizer)
From 'impotence' to 'erectile dysfunction': a lesson in disease rebranding
Direct-to-consumer marketing is essential to creating brand awareness
Following Viagra's example, marketers in new sexual dysfunction disorders in the US have to concentrate on direct to consumer marketing
Similarly to when Viagra first launched, marketers in the premature ejaculation and female sexual dysfunction markets face numerous challenges
Maintaining market share when competition increases
Indication expansion - Viagra for pulmonary arterial hypertension
Indication expansion - Viagra for female sexual dysfunction
Bibliography
Journals
Websites
Datamonitor reports
Appendix A
Data definitions, limitations and assumptions
Methodology
Indication-specific sales calculations
Standard units
Country group definitions
Rest of EU
Middle East and North Africa (MENA)
Rest of World
Appendix B
Contributing experts
Report methodology
About Datamonitor
About Datamonitor Healthcare
About the Genitourinary analysis team
Disclaimer
List of Tables
Table 1: Classification of sexual dysfunctions
Table 2: General classification of male sexual dysfunction
Table 3: Classification of erectile dysfunction
Table 4: Causes of secondary erectile dysfunction
Table 5: Differences between erectile dysfunction and premature ejaculation
Table 6: Proposed etiology for premature ejaculation
Table 7: Causes of female sexual dysfunction
Table 8: Conditions, procedures and drugs that can cause female sexual dysfunction
Table 9: General classification of female sexual dysfunction
Table 10: Prevalence of sexual dysfunction across the seven major markets (000s), 2010
Table 11: Prevalence of DSM-IV sexual dysfunction disorders
Table 12: Prevalence of male sexual dysfunction across the seven major markets (000s), 2010
Table 13: Trends in the prevalence of male sexual dysfunction across the seven major markets (000s), 2010-2020
Table 14: Prevalence of male sexual dysfunction in the US (000s), 2010
Table 15: Trends in the prevalence of male sexual dysfunction in the US (000s), 2010-2020
Table 16: Prevalence of male sexual dysfunction in Japan (000s), 2010
Table 17: Trends in the prevalence of male sexual dysfunction in Japan (000s), 2010-2020
Table 18: Prevalence of male sexual dysfunction in France (000s), 2010
Table 19: Trends in the prevalence of male sexual dysfunction in France (000s), 2010-2020
Table 20: Prevalence of male sexual dysfunction in Germany (000s), 2010
Table 21: Trends in the prevalence of male sexual dysfunction in Germany (000s), 2010-2020
Table 22: Prevalence of male sexual dysfunction in Italy (000s), 2010
Table 23: Trends in the prevalence of male sexual dysfunction in Italy (000s), 2010-2020
Table 24: Prevalence of male sexual dysfunction in Spain (000s), 2010
Table 25: Trends in the prevalence of male sexual dysfunction in male population aged 40-79 years in Spain (000s), 2010-2020
Table 26: Prevalence of male sexual dysfunction in the UK (000s), 2010
Table 27: Trends in the prevalence of male sexual dysfunction in the UK (000s), 2010-2020
Table 28: Prevalence of female sexual dysfunction across the seven major markets (000s), 2010
Table 29: Trends in the prevalence of female sexual dysfunction across the seven major markets (000s), 2010-2020
Table 30: Prevalence of female sexual dysfunction in the US (000s), 2010
Table 31: Trends in the prevalence of female sexual dysfunction in the US (000s), 2010-2020
Table 32: Prevalence of female sexual dysfunction in Japan (000s), 2010
Table 33: Trends in the prevalence of female sexual dysfunction in Japan (000s), 2010-2020
Table 34: Prevalence of female sexual dysfunction in France (000s), 2010
Table 35: Trends in the prevalence of female sexual dysfunction in France (000s), 2010-2020
Table 36: Prevalence of female sexual dysfunction in Germany (000s), 2010
Table 37: Trends in the prevalence of female sexual dysfunction in Germany (000s), 2010-2020
Table 38: Prevalence of female sexual dysfunction in Italy (000s), 2010
Table 39: Trends in the prevalence of female sexual dysfunction in Italy (000s), 2010-2020
Table 40: Prevalence of female sexual dysfunction in Spain (000s), 2010
Table 41: Trends in the prevalence of female sexual dysfunction in women aged 40-79 in Spain (000s), 2010-2020
Table 42: Female sexual dysfunction prevalence rates from the Global Study of Sexual Attitudes and Behaviors (GSSAB) study, 2005
Table 43: Prevalence of female sexual dysfunction in women aged 20-69 years in the UK (000s), 2010
Table 44: Trends in the prevalence of female sexual dysfunction in the UK (000s), 2010-2020
Table 45: Review of male sexual dysfunction prevalence studies in Brazil, India and China, 2010
Table 46: Review of female sexual dysfunction prevalence studies in Brazil, Russia, India and China (BRIC countries), 2010
Table 47: Leading pharmacological treatments for erectile dysfunction, 2010
Table 48: Treatment for female sexual dysfunction disorders
Table 49: Approved pharmacological treatments for premature ejaculation and female sexual dysfunction in the seven major markets, 2010
Table 50: Examples of online information tools for physicians and patients on sexual dysfunction
Table 51: International Classification of Diseases 10th Revision (ICD-10) codes used to define the sexual dysfunction market
Table 52: Seven major markets sexual dysfunction sales ($m) dynamics, 2004-09
Table 53: Seven major markets sexual dysfunction sales ($m) by ATC class, 2004-09
Table 54: Seven major markets erectile dysfunction sales ($m) dynamics, 2004-09
Table 55: Erectile dysfunction sales ($m) for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough in the seven major markets, 2004-09
Table 56: Percentage of women with female sexual disorders receiving each drug types as monotherapy or combination therapy in the US and five major EU markets, 2005
Table 57: Global erectile dysfunction sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) ($m) split by region, 2004-09
Table 58: Datamonitor's sexual dysfunction market attractiveness assessment, 2010t
Table 59: Datamonitor's sexual dysfunction market advantages and disadvantages assessment, 2010
Table 60: Summary of opportunities and threats in the sexual dysfunction market across the seven major markets, 2010
Table 61: Ex-manufacturer price of Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough) in the US and five major EU markets ($/SU), 2004-08
Table 62: Intrinsa (testosterone patch, Procter & Gamble) price in the UK ($), 2010
Table 63: Summary of epidemiology studies regarding recreational use of sildenafil
Table 64: Leading pharmacological treatments for erectile dysfunction in the seven major markets, 2010
Table 65: Viagra (sildenafil, Pfizer) - drug profile, 2010
Table 66: Cialis (tadalafil, Eli Lilly) - drug profile, 2010
Table 67: Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck) - drug profile, 2010
Table 68: Priligy (dapoxetine; Johnson & Johnson) - drug profile, 2010
Table 69: Priligy: summary of key clinical trials
Table 70: Intrinsa (testosterone patch, Procter & Gamble) - drug profile, 2010
Table 71: R&D drug pipeline for erectile dysfunction, 2010
Table 72: R&D drug pipeline for premature ejaculation, 2010
Table 73: R&D drug pipeline for female sexual dysfunction, 2010
Table 74: Avanafil (TA1790, Vivus) - drug profile, 2010
Table 75: TA1790: summary of key clinical trials
Table 76: REVIVE (TA-301) results for avanafil, 2009
Table 77: Comparison of time on onset and duration of effect between avanafil and other marketed phosphodiesterase type 5 inhibitors
Table 78: PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) - drug profile, 2010
Table 79: PSD502: summary of key clinical trials
Table 80: Flibanserin (BIMT-17; Boehringer Ingelheim) - drug profile, 2010
Table 81: Flibanserin: summary of key clinical trials
Table 82: DAHLIA flibanserin Phase III clinical trial results, 2009
Table 83: DAISY flibanserin Phase III clinical trial results, 2009
Table 84: VIOLET flibanserin Phase III clinical trial results, 2009
Table 85: ORCHID flibanserin Phase III clinical trial results, 2009
Table 86: LibiGel (testosterone gel, Antares/BioSante) - drug profile, 2010
Table 87: LibiGel: summary of key clinical trials
Table 88: Key pre-clinical products in development for sexual dysfunction, 2010
Table 89: Marketing challenges in the premature ejaculation and female sexual dysfunction markets
List of Figures
Figure 1: Major causes of secondary erectile dysfunction in the US
Figure 2: Erectile dysfunction treatment guidelines, 2010
Figure 3: Premature ejaculation treatment guidelines, 2010
Figure 4: Proposed treatment algorithm for hypoactive sexual desire disorder (HSDD)
Figure 5: Proposed treatment algorithm for female sexual arousal disorder (FSAD)
Figure 6: Proposed treatment algorithm for female orgasmic disorder
Figure 7: Proposed treatment algorithm for female dyspareunia (introital and deep)
Figure 8: Proposed treatment algorithm for female dyspareunia (vaginismus)
Figure 9: Unmet needs in male and female sexual dysfunction, 2010
Figure 10: Eli Lilly's 40over40 erectile dysfunction information homepage, 2010
Figure 11: Sexual dysfunction market sales ($m) across the seven major markets, 2004-09
Figure 12: Sexual dysfunction market sales dynamics ($m) across the seven major markets, 2004-09
Figure 13: Sexual dysfunction market sales ($m) across the five major EU markets, 2004-09
Figure 14: Seven major markets sexual dysfunction ATC sales ($m) dynamics, 2004-09
Figure 15: Seven major markets sexual dysfunction by ATC class, 2009
Figure 16: Seven major market erectile dysfunction sales ($m), 2004-09
Figure 17: Seven major markets erectile dysfunction sales ($m) dynamics, 2004-09
Figure 18: Brand sales ($m) dynamics for erectile dysfunction in the seven major markets, 2004-09
Figure 19: Female sexual dysfunction treatment in the US and the five major EU markets (5EU), 2005
Figure 20: Non-pharmacological treatment for female sexual dysfunction breakdown in the US and five major EU markets (5EU), 2005
Figure 21: Global sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) for erectile dysfunction ($m), 2004-09
Figure 22: Global sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) for erectile dysfunction ($m) dynamics, 2004-08
Figure 23: Datamonitor's sexual dysfunction market attractiveness assessment, 2010
Figure 24: Datamonitor's sexual dysfunction market attractiveness assessment according to stakeholder acceptance, 2010
Figure 25: Overlap of female sexual disorders
Figure 26: Viagra (sildenafil, Pfizer) sales across the seven major markets for erectile dysfunction, 2004-09
Figure 27: Global sales for Viagra (sildenafil, Pfizer), 2007-09
Figure 28: Viagra (sildenafil, Pfizer) SWOT analysis, 2010
Figure 29: Cialis (tadalafil, Eli Lilly) sales across the seven major markets for erectile dysfunction, 2004-09
Figure 30: Global sales for Cialis (tadalafil, Eli Lilly), 2007-09
Figure 31: Cialis (tadalafil, Eli Lilly) SWOT analysis, 2010
Figure 32: Global sales for Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ), 2004-09
Figure 33: Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) SWOT analysis, 2010
Figure 34: Priligy (dapoxetine; Johnson & Johnson) SWOT analysis, 2010
Figure 35: Total brand sales for Intrinsa (testosterone patch, Procter & Gamble) across the five major EU markets, 2008
Figure 36: Intrinsa (testosterone patch, Procter & Gamble) SWOT analysis, 2010
Figure 37: Pipeline for sexual dysfunction, 2010
Figure 38: Avanafil (TA1790, Vivus) SWOT analysis, 2010
Figure 39: PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) SWOT analysis, 2010
Figure 40: Flibanserin (BIMT-17; Boehringer Ingelheim) SWOT analysis, 2010
Figure 41: LibiGel (testosterone, Antares/BioSante) SWOT analysis, 2010
Figure 42: Examples of Viagra promotions
Figure 43: Promotional expenditure ($m) of the leading brands in the sexual dysfunction market in the seven major markets, 2007

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