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.
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
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
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