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

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, although Johnson & Johnson is well positioned to develop the premature ejaculation area with the launch of Priligy (dapoxetine) in the EU.

Companies entering the sexual dysfunction market will have to follow the example of Viagra (sildenafil, Pfizer) and invest heavily in direct to consumer marketing in the US. A strong marketing message will be vital to raising awareness and beginning the campaign to destigmatize the different disorders.

There is high R&D risk in the associated with the development of drugs for female sexual dysfunction due to the lack of clear disorder definition and trial endpoints, the strong placebo effect of drugs and the scrutiny of regulatory bodies. As such Boehringer Ingelheim's flibanserin and BioSante's LibiGel (testosterone) approval is not guaranteed.

Reasons to Purchase

*Understand the prevalence of erectile dysfunction, premature ejaculation and female sexual dysfunction.

*Identify the key clinical unmet needs in the treatment of male and female sexual dysfunction as determined by interviewed key opinion leaders.

*Evaluate the potential of key strategies companies can employ to increase their presence in the sexual dysfunction disorder markets.

[Studien Infos ausblenden]

Overview 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the Genitourinary pharmaceutical analysis team 2
Executive Summary 3
Scope of the analysis 3
Datamonitor insight into the sexual dysfunction market 3
Related reports 5
Table of Contents 6
1. Sexual Dysfunction - Patient Potential 7
Key findings 7
Definition 8
Male sexual dysfunction 9
Erectile dysfunction 10
Premature ejaculation 13
Female sexual dysfunction 15
Etiology 17
Classification of female sexual dysfunction 19
Epidemiology 20
Seven major markets 20
Problems with sexual dysfunction epidemiology studies 20
Male sexual dysfunction 22
US - premature ejaculation is the most prevalent male sexual dysfunction 23
Japan - half of men over 40 years experience at least one sexual dysfunction 25
France - prevalence of premature ejaculation varies greatly 26
Germany - a over 8 million men are affected by at least one sexual dysfunction 28
Italy - premature ejaculation is the most common sexual complaint 29
Spain - over 3 million men have at least one sexual dysfunction 30
UK - over 5 million men have at least one sexual dysfunction 31
Female sexual dysfunction 33
US - over 25 million women in the US lack interest in sex 34
Japan - trouble lubrication is the most common complaint among Japanese women over 40 years 36
France - prevalence rates are similar across different types of female sexual dysfunction 37
Germany - Over 9 million women experience hypoactive sexual desire disorder 38
Italy -Women over 60 years are by far more likely to experience a type of sexual dysfunction than younger women 39
Spain - over 3 million women report to lack sexual interest 40
UK - the majority of women experiencing a sexual dysfunction will have trouble with desire or pleasure 41
Rest of the world epidemiology 42
Lack of studies limited the assessment of sexual dysfunction market in the BRIC countries 42
Current treatment options 44
Erectile dysfunction 44
Non pharmacological treatment 45
Pharmacological 46
Premature ejaculation 48
Non pharmacological - the recommended first-line treatment 49
Pharmacological 50
Female sexual dysfunction 51
Non pharmacological 57
Pharmacological 58
Unmet need in sexual dysfunction 59
Need for approved drugs for female sexual dysfunction and premature ejaculation 60
Approving drugs for these conditions will allow the market to be developed 61
Alternatives to the drugs currently used off-label need to be developed 62
Need to raise awareness among physicians and patients about sexual dysfunction 63
Reducing the stigma associated with sexual dysfunctions 64
Physicians need to be educated about sexual dysfunction 65
Patients need to be educated about the condition and therapies available 67
Celebrity spokespeople can destigmatize the disease 68
Need for universal definition of various sexual dysfunction disorders 69
Female sexual dysfunction remains poorly defined 69
Premature ejaculation prevalence differs according to the definition used 70
Need for better drugs for the treatment of erectile dysfunction 71
Better efficacy 71
Improved safety 72
Need for less expensive drugs 72
Currently therapy for premature ejaculation in the EU depends on what you can afford 72
Getting the drugs reimbursed is just as important as having them approved by the regulatory bodies 73
2. Sexual Dysfunction - Market Potential 74
Key findings 74
Market definition for this report 75
Current market overview 76
Sexual dysfunction market 76
Regional dynamics - the sexual dysfunction market has been displaying continuous growth across all regions 76
ATC class dynamics - the majority of the market is formed by the G4E (erectile dysfunction) ATC class 80
Erectile dysfunction 83
Regional dynamics - erectile dysfunction market continues to grow despite the small decrease in sales in the EU 83
Brand dynamics 86
Female sexual dysfunction 88
Over half of patients will receive some drug treatment for female sexual dysfunction 88
Counseling and education are the most common treatment 89
Rest of the world snapshot 92
The global erectile dysfunction market continues to display growth 92
Datamonitor's market attractiveness assessment 95
The female sexual dysfunction will be the toughest market to develop 99
Opportunities and threats 101
Opportunities 102
Limited competition in the market and high prevalence make this is an interesting market 102
Use Europe to start breaking the barriers 102
Target other sexual disorders 103
New market players can compete on cost 104
Over-the-counter switch bypasses embarrassing physician consultations 106
Threats 106
Increased FDA pharmacovigilance makes sexual dysfunction drugs high-risk projects 106
A proportion of physicians will be against medicalizing female sexual dysfunction 108
Off-label prescription is likely to remain high in premature ejaculation and female sexual dysfunction 109
Generic sildenafil competition from 2013 109
Approving drugs for female sexual dysfunction may be harder due to overlap of disorders 110
FDA increases scrutiny towards direct-to-consumer (DTC) advertising 111
Drug counterfeiting remains an issue in the sexual dysfunction market 112
Fear of recreational use of sexual dysfunction drugs may increase regulatory inspection 112
3. Brand Dynamics 115
Key findings 115
Overview of competitive landscape 116
Erectile dysfunction - Viagra (sildenafil; Pfizer) 116
Drug profile 116
Viagra patent expiry 117
Clinical trial data 118
Product positioning 118
SWOT analysis 120
Erectile dysfunction - Cialis (tadalafil; Eli Lilly) 121
Drug profile 121
Product positioning 122
SWOT analysis 124
Erectile dysfunction - Levitra (vardenafil; Bayer/GlaxoSmithKline/Merck-Schering-Plough ) 125
Drug profile 125
Marketing agreements 126
Product positioning 126
SWOT analysis 127
Premature ejaculation - Priligy (dapoxetine; Johnson & Johnson) 128
Drug profile 128
Development overview 129
Product positioning 131
First-to-market privilege is hindered by high cost 131
US approval 131
Safety concerns regarding SSRIs may hamper sales 133
SWOT analysis 134
Female sexual dysfunction - Intrinsa (testosterone patch, Procter & Gamble) 134
Drug profile 134
Product positioning 135
Launch in the US remains unlikely 137
SWOT analysis 137
4. Pipeline Analysis 139
Key findings 139
Pipeline overview 140
Erectile dysfunction - Avanafil (TA1790/Vivus) 144
Drug profile 144
Development overview 145
Product positioning 147
Short time to onset provides a differentiator but it will not secure a significant market share upon launch of generic Viagra 147
Clinical profile addresses some unmet needs 148
SWOT analysis 149
Premature ejaculation - PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) 150
Drug profile 150
Development overview 151
Product positioning 153
Favorable clinical profile compared to Priligy 153
PSD502 could be cheaper than Priligy 153
Second-to-market status could be an advantage 153
SWOT analysis 154
Female sexual dysfunction - Flibanserin (BIMT-17; Boehringer Ingelheim) 154
Drug profile 154
Development overview 155
Product positioning 159
Unimpressive clinical trial data may delay approval 160
Long-term safety remains unknown 161
SWOT analysis 162
Female sexual dysfunction - LibiGel (testosterone gel; Antares/BioSante) 162
Drug profile 162
Development overview 163
Product positioning 165
LibiGel may be the first testosterone product to be indicated for female sexual dysfunction in the US 165
High-risk project - the FDA is cautious about approving hormones in women... 165
...however, BioSante's efforts to work closely to the FDA are likely to pay off 165
SWOT analysis 166
Key early-stage compounds 168
5. Case Studies 169
Introduction 169
Case study: Viagra (sildenafil; Pfizer) 169
From 'impotence' to 'erectile dysfunction': a lesson in disease rebranding 169
Direct-to-consumer marketing is essential to creating brand awareness 170
Following Viagra's example, marketers in new sexual dysfunction disorders in the US have to concentrate on direct to consumer marketing 172
Similarly to when Viagra first launched, marketers in the premature ejaculation and female sexual dysfunction markets face numerous challenges 173
Maintaining market share when competition increases 174
Indication expansion - Viagra for pulmonary arterial hypertension 175
Indication expansion - Viagra for female sexual dysfunction 175
Bibliography 177
Journals 177
Websites 184
Datamonitor reports 187
Appendix A 188
Data definitions, limitations and assumptions 188
Methodology 188
Indication-specific sales calculations 188
Standard units 188
Country group definitions 189
Rest of EU 189
Middle East and North Africa (MENA) 189
Rest of World 189
Appendix B 190
Contributing experts 190
Report methodology 190
About Datamonitor 191
About Datamonitor Healthcare 191
About the Genitourinary analysis team 192
Disclaimer 194
List of Tables
Table 1: Classification of sexual dysfunctions 8
Table 2: General classification of male sexual dysfunction 10
Table 3: Classification of erectile dysfunction 10
Table 4: Causes of secondary erectile dysfunction 12
Table 5: Differences between erectile dysfunction and premature ejaculation 14
Table 6: Proposed etiology for premature ejaculation 15
Table 7: Causes of female sexual dysfunction 17
Table 8: Conditions, procedures and drugs that can cause female sexual dysfunction 18
Table 9: General classification of female sexual dysfunction 19
Table 10: Prevalence of sexual dysfunction across the seven major markets (000s), 2010 20
Table 11: Prevalence of DSM-IV sexual dysfunction disorders 21
Table 12: Prevalence of male sexual dysfunction across the seven major markets (000s), 2010 22
Table 13: Trends in the prevalence of male sexual dysfunction across the seven major markets (000s), 2010-2020 23
Table 14: Prevalence of male sexual dysfunction in the US (000s), 2010 24
Table 15: Trends in the prevalence of male sexual dysfunction in the US (000s), 2010-2020 25
Table 16: Prevalence of male sexual dysfunction in Japan (000s), 2010 26
Table 17: Trends in the prevalence of male sexual dysfunction in Japan (000s), 2010-2020 26
Table 18: Prevalence of male sexual dysfunction in France (000s), 2010 27
Table 19: Trends in the prevalence of male sexual dysfunction in France (000s), 2010-2020 27
Table 20: Prevalence of male sexual dysfunction in Germany (000s), 2010 28
Table 21: Trends in the prevalence of male sexual dysfunction in Germany (000s), 2010-2020 29
Table 22: Prevalence of male sexual dysfunction in Italy (000s), 2010 29
Table 23: Trends in the prevalence of male sexual dysfunction in Italy (000s), 2010-2020 30
Table 24: Prevalence of male sexual dysfunction in Spain (000s), 2010 31
Table 25: Trends in the prevalence of male sexual dysfunction in male population aged 40-79 years in Spain (000s), 2010-2020 31
Table 26: Prevalence of male sexual dysfunction in the UK (000s), 2010 32
Table 27: Trends in the prevalence of male sexual dysfunction in the UK (000s), 2010-2020 32
Table 28: Prevalence of female sexual dysfunction across the seven major markets (000s), 2010 33
Table 29: Trends in the prevalence of female sexual dysfunction across the seven major markets (000s), 2010-2020 33
Table 30: Prevalence of female sexual dysfunction in the US (000s), 2010 34
Table 31: Trends in the prevalence of female sexual dysfunction in the US (000s), 2010-2020 35
Table 32: Prevalence of female sexual dysfunction in Japan (000s), 2010 36
Table 33: Trends in the prevalence of female sexual dysfunction in Japan (000s), 2010-2020 36
Table 34: Prevalence of female sexual dysfunction in France (000s), 2010 37
Table 35: Trends in the prevalence of female sexual dysfunction in France (000s), 2010-2020 37
Table 36: Prevalence of female sexual dysfunction in Germany (000s), 2010 38
Table 37: Trends in the prevalence of female sexual dysfunction in Germany (000s), 2010-2020 38
Table 38: Prevalence of female sexual dysfunction in Italy (000s), 2010 39
Table 39: Trends in the prevalence of female sexual dysfunction in Italy (000s), 2010-2020 39
Table 40: Prevalence of female sexual dysfunction in Spain (000s), 2010 40
Table 41: Trends in the prevalence of female sexual dysfunction in women aged 40-79 in Spain (000s), 2010-2020 41
Table 42: Female sexual dysfunction prevalence rates from the Global Study of Sexual Attitudes and Behaviors (GSSAB) study, 2005 41
Table 43: Prevalence of female sexual dysfunction in women aged 20-69 years in the UK (000s), 2010 42
Table 44: Trends in the prevalence of female sexual dysfunction in the UK (000s), 2010-2020 42
Table 45: Review of male sexual dysfunction prevalence studies in Brazil, India and China, 2010 43
Table 46: Review of female sexual dysfunction prevalence studies in Brazil, Russia, India and China (BRIC countries), 2010 44
Table 47: Leading pharmacological treatments for erectile dysfunction, 2010 47
Table 48: Treatment for female sexual dysfunction disorders 52
Table 49: Approved pharmacological treatments for premature ejaculation and female sexual dysfunction in the seven major markets, 2010 60
Table 50: Examples of online information tools for physicians and patients on sexual dysfunction 67
Table 51: International Classification of Diseases 10th Revision (ICD-10) codes used to define the sexual dysfunction market 75
Table 52: Seven major markets sexual dysfunction sales ($m) dynamics, 2004-09 80
Table 53: Seven major markets sexual dysfunction sales ($m) by ATC class, 2004-09 82
Table 54: Seven major markets erectile dysfunction sales ($m) dynamics, 2004-09 86
Table 55: Erectile dysfunction sales ($m) for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough in the seven major markets, 2004-09 88
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 91
Table 57: Global erectile dysfunction sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) ($m) split by region, 2004-09 95
Table 58: Datamonitor's sexual dysfunction market attractiveness assessment, 2010t 98
Table 59: Datamonitor's sexual dysfunction market advantages and disadvantages assessment, 2010 99
Table 60: Summary of opportunities and threats in the sexual dysfunction market across the seven major markets, 2010 102
Table 61: Ex-manufacturer price of Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough) in the US and five major EU markets ($/SU), 2004-08 105
Table 62: Intrinsa (testosterone patch, Procter & Gamble) price in the UK ($), 2010 106
Table 63: Summary of epidemiology studies regarding recreational use of sildenafil 114
Table 64: Leading pharmacological treatments for erectile dysfunction in the seven major markets, 2010 116
Table 65: Viagra (sildenafil, Pfizer) - drug profile, 2010 117
Table 66: Cialis (tadalafil, Eli Lilly) - drug profile, 2010 122
Table 67: Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck) - drug profile, 2010 126
Table 68: Priligy (dapoxetine; Johnson & Johnson) - drug profile, 2010 129
Table 69: Priligy: summary of key clinical trials 130
Table 70: Intrinsa (testosterone patch, Procter & Gamble) - drug profile, 2010 135
Table 71: R&D drug pipeline for erectile dysfunction, 2010 141
Table 72: R&D drug pipeline for premature ejaculation, 2010 142
Table 73: R&D drug pipeline for female sexual dysfunction, 2010 143
Table 74: Avanafil (TA1790, Vivus) - drug profile, 2010 145
Table 75: TA1790: summary of key clinical trials 146
Table 76: REVIVE (TA-301) results for avanafil, 2009 147
Table 77: Comparison of time on onset and duration of effect between avanafil and other marketed phosphodiesterase type 5 inhibitors 148
Table 78: PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) - drug profile, 2010 151
Table 79: PSD502: summary of key clinical trials 152
Table 80: Flibanserin (BIMT-17; Boehringer Ingelheim) - drug profile, 2010 155
Table 81: Flibanserin: summary of key clinical trials 157
Table 82: DAHLIA flibanserin Phase III clinical trial results, 2009 158
Table 83: DAISY flibanserin Phase III clinical trial results, 2009 158
Table 84: VIOLET flibanserin Phase III clinical trial results, 2009 159
Table 85: ORCHID flibanserin Phase III clinical trial results, 2009 159
Table 86: LibiGel (testosterone gel, Antares/BioSante) - drug profile, 2010 163
Table 87: LibiGel: summary of key clinical trials 164
Table 88: Key pre-clinical products in development for sexual dysfunction, 2010 168
Table 89: Marketing challenges in the premature ejaculation and female sexual dysfunction markets 173
List of Figures
Figure 1: Major causes of secondary erectile dysfunction in the US 13
Figure 2: Erectile dysfunction treatment guidelines, 2010 45
Figure 3: Premature ejaculation treatment guidelines, 2010 49
Figure 4: Proposed treatment algorithm for hypoactive sexual desire disorder (HSDD) 53
Figure 5: Proposed treatment algorithm for female sexual arousal disorder (FSAD) 54
Figure 6: Proposed treatment algorithm for female orgasmic disorder 55
Figure 7: Proposed treatment algorithm for female dyspareunia (introital and deep) 56
Figure 8: Proposed treatment algorithm for female dyspareunia (vaginismus) 57
Figure 9: Unmet needs in male and female sexual dysfunction, 2010 59
Figure 10: Eli Lilly's 40over40 erectile dysfunction information homepage, 2010 63
Figure 11: Sexual dysfunction market sales ($m) across the seven major markets, 2004-09 77
Figure 12: Sexual dysfunction market sales dynamics ($m) across the seven major markets, 2004-09 78
Figure 13: Sexual dysfunction market sales ($m) across the five major EU markets, 2004-09 79
Figure 14: Seven major markets sexual dysfunction ATC sales ($m) dynamics, 2004-09 81
Figure 15: Seven major markets sexual dysfunction by ATC class, 2009 83
Figure 16: Seven major market erectile dysfunction sales ($m), 2004-09 84
Figure 17: Seven major markets erectile dysfunction sales ($m) dynamics, 2004-09 85
Figure 18: Brand sales ($m) dynamics for erectile dysfunction in the seven major markets, 2004-09 87
Figure 19: Female sexual dysfunction treatment in the US and the five major EU markets (5EU), 2005 89
Figure 20: Non-pharmacological treatment for female sexual dysfunction breakdown in the US and five major EU markets (5EU), 2005 90
Figure 21: Global sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) for erectile dysfunction ($m), 2004-09 93
Figure 22: Global sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) for erectile dysfunction ($m) dynamics, 2004-08 94
Figure 23: Datamonitor's sexual dysfunction market attractiveness assessment, 2010 96
Figure 24: Datamonitor's sexual dysfunction market attractiveness assessment according to stakeholder acceptance, 2010 97
Figure 25: Overlap of female sexual disorders 110
Figure 26: Viagra (sildenafil, Pfizer) sales across the seven major markets for erectile dysfunction, 2004-09 119
Figure 27: Global sales for Viagra (sildenafil, Pfizer), 2007-09 120
Figure 28: Viagra (sildenafil, Pfizer) SWOT analysis, 2010 121
Figure 29: Cialis (tadalafil, Eli Lilly) sales across the seven major markets for erectile dysfunction, 2004-09 123
Figure 30: Global sales for Cialis (tadalafil, Eli Lilly), 2007-09 124
Figure 31: Cialis (tadalafil, Eli Lilly) SWOT analysis, 2010 125
Figure 32: Global sales for Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ), 2004-09 127
Figure 33: Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) SWOT analysis, 2010 128
Figure 34: Priligy (dapoxetine; Johnson & Johnson) SWOT analysis, 2010 134
Figure 35: Total brand sales for Intrinsa (testosterone patch, Procter & Gamble) across the five major EU markets, 2008 136
Figure 36: Intrinsa (testosterone patch, Procter & Gamble) SWOT analysis, 2010 138
Figure 37: Pipeline for sexual dysfunction, 2010 144
Figure 38: Avanafil (TA1790, Vivus) SWOT analysis, 2010 150
Figure 39: PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) SWOT analysis, 2010 154
Figure 40: Flibanserin (BIMT-17; Boehringer Ingelheim) SWOT analysis, 2010 162
Figure 41: LibiGel (testosterone, Antares/BioSante) SWOT analysis, 2010 167
Figure 42: Examples of Viagra promotions 171
Figure 43: Promotional expenditure ($m) of the leading brands in the sexual dysfunction market in the seven major markets, 2007 172

[Inhaltsverzeichnis ausblenden]