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

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Publication Date: 2010-03-04

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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.
  • Table of Contents

  • EXECUTIVE SUMMARY
    • Scope of the analysis
    • Datamonitor insight into the sexual dysfunction market
    • Related reports
  • TABLE OF CONTENTS
  • SEXUAL DYSFUNCTION – PATIENT POTENTIAL
    • Key findings
    • Definition
      • Male sexual dysfunction
      • Female sexual dysfunction
    • Epidemiology
      • Seven major markets
      • Male sexual dysfunction
      • Female sexual dysfunction
      • Rest of the world epidemiology
    • Current treatment options
      • Erectile dysfunction
      • Premature ejaculation
      • Female sexual dysfunction
    • Unmet need in sexual dysfunction
      • Need for approved drugs for female sexual dysfunction and premature ejaculation
      • Need to raise awareness among physicians and patients about sexual dysfunction
      • Need for universal definition of various sexual dysfunction disorders
      • Need for better drugs for the treatment of erectile dysfunction
      • Need for less expensive drugs
  • SEXUAL DYSFUNCTION – MARKET POTENTIAL
    • Key findings
    • Market definition for this report
    • Current market overview
      • Sexual dysfunction market
      • Erectile dysfunction
      • Female sexual dysfunction
    • 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
      • Threats
  • BRAND DYNAMICS
    • Key findings
    • Overview of competitive landscape
    • Erectile dysfunction – Viagra (sildenafil; Pfizer)
      • Drug profile
      • 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
      • Product positioning
      • SWOT analysis
    • Premature ejaculation – Priligy (dapoxetine; Johnson & Johnson)
      • Drug profile
      • Development overview
      • Product positioning
      • SWOT analysis
    • Female sexual dysfunction – Intrinsa (testosterone patch, Procter & Gamble)
      • Drug profile
      • Product positioning
      • SWOT analysis
  • PIPELINE ANALYSIS
    • Key findings
    • Pipeline overview
    • Erectile dysfunction – Avanafil (TA1790/Vivus)
      • Drug profile
      • Development overview
      • Product positioning
      • SWOT analysis
    • Premature ejaculation – PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma)
      • Drug profile
      • Development overview
      • Product positioning
      • SWOT analysis
    • Female sexual dysfunction – Flibanserin (BIMT-17; Boehringer Ingelheim)
      • Drug profile
      • Development overview
      • Product positioning
      • SWOT analysis
    • Female sexual dysfunction – LibiGel (testosterone gel; Antares/BioSante)
      • Drug profile
      • Development overview
      • Product positioning
      • SWOT analysis
    • Key early-stage compounds
  • 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
      • Maintaining market share when competition increases
  • BIBLIOGRAPHY
    • Journals
    • Websites
    • Datamonitor reports
  • APPENDIX A
    • Data definitions, limitations and assumptions
    • Methodology
      • Indication-specific sales calculations
      • Standard units
      • Country group definitions
  • APPENDIX B
    • Contributing experts
    • Report methodology
  • TABLES
    • Table: Classification of sexual dysfunctions
    • Table: General classification of male sexual dysfunction
    • Table: Classification of erectile dysfunction
    • Table: Causes of secondary erectile dysfunction
    • Table: Differences between erectile dysfunction and premature ejaculation
    • Table: Proposed etiology for premature ejaculation
    • Table: Causes of female sexual dysfunction
    • Table: Conditions, procedures and drugs that can cause female sexual dysfunction
    • Table: General classification of female sexual dysfunction
    • Table: Prevalence of sexual dysfunction across the seven major markets (000s), 2010
    • Table: Prevalence of DSM-IV sexual dysfunction disorders
    • Table: Prevalence of male sexual dysfunction across the seven major markets (000s), 2010
    • Table: Trends in the prevalence of male sexual dysfunction across the seven major markets (000s), 2010–2020
    • Table: Prevalence of male sexual dysfunction in the US (000s), 2010
    • Table: Trends in the prevalence of male sexual dysfunction in the US (000s), 2010–2020
    • Table: Prevalence of male sexual dysfunction in Japan (000s), 2010
    • Table: Trends in the prevalence of male sexual dysfunction in Japan (000s), 2010–2020
    • Table: Prevalence of male sexual dysfunction in France (000s), 2010
    • Table: Trends in the prevalence of male sexual dysfunction in France (000s), 2010–2020
    • Table: Prevalence of male sexual dysfunction in Germany (000s), 2010
    • Table: Trends in the prevalence of male sexual dysfunction in Germany (000s), 2010–2020
    • Table: Prevalence of male sexual dysfunction in Italy (000s), 2010
    • Table: Trends in the prevalence of male sexual dysfunction in Italy (000s), 2010–2020
    • Table: Prevalence of male sexual dysfunction in Spain (000s), 2010
    • Table: Trends in the prevalence of male sexual dysfunction in male population aged 40–79 years in Spain (000s), 2010–2020
    • Table: Prevalence of male sexual dysfunction in the UK (000s), 2010
    • Table: Trends in the prevalence of male sexual dysfunction in the UK (000s), 2010–2020
    • Table: Prevalence of female sexual dysfunction across the seven major markets (000s), 2010
    • Table: Trends in the prevalence of female sexual dysfunction across the seven major markets (000s), 2010–2020
    • Table: Prevalence of female sexual dysfunction in the US (000s), 2010
    • Table: Trends in the prevalence of female sexual dysfunction in the US (000s), 2010–2020
    • Table: Prevalence of female sexual dysfunction in Japan (000s), 2010
    • Table: Trends in the prevalence of female sexual dysfunction in Japan (000s), 2010–2020
    • Table: Prevalence of female sexual dysfunction in France (000s), 2010
    • Table: Trends in the prevalence of female sexual dysfunction in France (000s), 2010–2020
    • Table: Prevalence of female sexual dysfunction in Germany (000s), 2010
    • Table: Trends in the prevalence of female sexual dysfunction in Germany (000s), 2010–2020
    • Table: Prevalence of female sexual dysfunction in Italy (000s), 2010
    • Table: Trends in the prevalence of female sexual dysfunction in Italy (000s), 2010–2020
    • Table: Prevalence of female sexual dysfunction in Spain (000s), 2010
    • Table: Trends in the prevalence of female sexual dysfunction in women aged 40–79 in Spain (000s), 2010–2020
    • Table: Female sexual dysfunction prevalence rates from the Global Study of Sexual Attitudes and Behaviors (GSSAB) study, 2005
    • Table: Prevalence of female sexual dysfunction in women aged 20–69 years in the UK (000s), 2010
    • Table: Trends in the prevalence of female sexual dysfunction in the UK (000s), 2010–2020
    • Table: Review of male sexual dysfunction prevalence studies in Brazil, India and China, 2010
    • Table: Review of female sexual dysfunction prevalence studies in Brazil, Russia, India and China (BRIC countries), 2010
    • Table: Leading pharmacological treatments for erectile dysfunction, 2010
    • Table: Treatment for female sexual dysfunction disorders
    • Table: Approved pharmacological treatments for premature ejaculation and female sexual dysfunction in the seven major markets, 2010
    • Table: Examples of online information tools for physicians and patients on sexual dysfunction
    • Table: International Classification of Diseases 10th Revision (ICD-10) codes used to define the sexual dysfunction market
    • Table: Seven major markets sexual dysfunction sales ($m) dynamics, 2004–09
    • Table: Seven major markets sexual dysfunction sales ($m) by ATC class, 2004–09
    • Table: Seven major markets erectile dysfunction sales ($m) dynamics, 2004–09
    • Table: Erectile dysfunction sales ($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: 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: Global erectile dysfunction sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) ($m) split by region, 2004–09
    • Table: Datamonitor’s sexual dysfunction market attractiveness assessment, 2010t
    • Table: Datamonitor’s sexual dysfunction market advantages and disadvantages assessment, 2010
    • Table: Summary of opportunities and threats in the sexual dysfunction market across the seven major markets, 2010
    • Table: Ex-manufacturer price of Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough) in the US and five major EU markets ($/SU), 2004–08
    • Table: Intrinsa (testosterone patch, Procter & Gamble) price in the UK ($), 2010
    • Table: Summary of epidemiology studies regarding recreational use of sildenafil
    • Table: Leading pharmacological treatments for erectile dysfunction in the seven major markets, 2010
    • Table: Viagra (sildenafil, Pfizer) – drug profile, 2010
    • Table: Cialis (tadalafil, Eli Lilly) – drug profile, 2010
    • Table: Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck) – drug profile, 2010
    • Table: Priligy (dapoxetine; Johnson & Johnson) – drug profile, 2010
    • Table: Priligy: summary of key clinical trials
    • Table: Intrinsa (testosterone patch, Procter & Gamble) – drug profile, 2010
    • Table: R&D drug pipeline for erectile dysfunction, 2010
    • Table: R&D drug pipeline for premature ejaculation, 2010
    • Table: R&D drug pipeline for female sexual dysfunction, 2010
    • Table: Avanafil (TA1790, Vivus) – drug profile, 2010
    • Table: TA1790: summary of key clinical trials
    • Table: REVIVE (TA-301) results for avanafil, 2009
    • Table: Comparison of time on onset and duration of effect between avanafil and other marketed phosphodiesterase type 5 inhibitors
    • Table: PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) – drug profile, 2010
    • Table: PSD502: summary of key clinical trials
    • Table: Flibanserin (BIMT-17; Boehringer Ingelheim) – drug profile, 2010
    • Table: Flibanserin: summary of key clinical trials
    • Table: DAHLIA flibanserin Phase III clinical trial results, 2009
    • Table: DAISY flibanserin Phase III clinical trial results, 2009
    • Table: VIOLET flibanserin Phase III clinical trial results, 2009
    • Table: ORCHID flibanserin Phase III clinical trial results, 2009
    • Table: LibiGel (testosterone gel, Antares/BioSante) – drug profile, 2010
    • Table: LibiGel: summary of key clinical trials
    • Table: Key pre-clinical products in development for sexual dysfunction, 2010
    • Table: Marketing challenges in the premature ejaculation and female sexual dysfunction markets
  • FIGURES
    • Figure: Major causes of secondary erectile dysfunction in the US
    • Figure: Erectile dysfunction treatment guidelines, 2010
    • Figure: Premature ejaculation treatment guidelines, 2010
    • Figure: Proposed treatment algorithm for hypoactive sexual desire disorder (HSDD)
    • Figure: Proposed treatment algorithm for female sexual arousal disorder (FSAD)
    • Figure: Proposed treatment algorithm for female orgasmic disorder
    • Figure: Proposed treatment algorithm for female dyspareunia (introital and deep)
    • Figure: Proposed treatment algorithm for female dyspareunia (vaginismus)
    • Figure: Unmet needs in male and female sexual dysfunction, 2010
    • Figure: Eli Lilly’s 40over40 erectile dysfunction information homepage, 2010
    • Figure: Sexual dysfunction market sales ($m) across the seven major markets, 2004–09
    • Figure: Sexual dysfunction market sales dynamics ($m) across the seven major markets, 2004–09
    • Figure: Sexual dysfunction market sales ($m) across the five major EU markets, 2004–09
    • Figure: Seven major markets sexual dysfunction ATC sales ($m) dynamics, 2004–09
    • Figure: Seven major markets sexual dysfunction by ATC class, 2009
    • Figure: Seven major market erectile dysfunction sales ($m), 2004–09
    • Figure: Seven major markets erectile dysfunction sales ($m) dynamics, 2004–09
    • Figure: Brand sales ($m) dynamics for erectile dysfunction in the seven major markets, 2004–09
    • Figure: Female sexual dysfunction treatment in the US and the five major EU markets (5EU), 2005
    • Figure: Non-pharmacological treatment for female sexual dysfunction breakdown in the US and five major EU markets (5EU), 2005
    • Figure: Global sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) for erectile dysfunction ($m), 2004–09
    • Figure: Global sales for Viagra (sildenafil, Pfizer), Cialis (tadalafil, Eli Lilly) and Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) for erectile dysfunction ($m) dynamics, 2004–08
    • Figure: Datamonitor’s sexual dysfunction market attractiveness assessment, 2010
    • Figure: Datamonitor’s sexual dysfunction market attractiveness assessment according to stakeholder acceptance, 2010
    • Figure: Overlap of female sexual disorders
    • Figure: Viagra (sildenafil, Pfizer) sales across the seven major markets for erectile dysfunction, 2004–09
    • Figure: Global sales for Viagra (sildenafil, Pfizer), 2007–09
    • Figure: Viagra (sildenafil, Pfizer) SWOT analysis, 2010
    • Figure: Cialis (tadalafil, Eli Lilly) sales across the seven major markets for erectile dysfunction, 2004–09
    • Figure: Global sales for Cialis (tadalafil, Eli Lilly), 2007–09
    • Figure: Cialis (tadalafil, Eli Lilly) SWOT analysis, 2010
    • Figure: Global sales for Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ), 2004–09
    • Figure: Levitra (vardenafil, Bayer/GlaxoSmithKline/Merck-Schering-Plough ) SWOT analysis, 2010
    • Figure: Priligy (dapoxetine; Johnson & Johnson) SWOT analysis, 2010
    • Figure: Total brand sales for Intrinsa (testosterone patch, Procter & Gamble) across the five major EU markets, 2008
    • Figure: Intrinsa (testosterone patch, Procter & Gamble) SWOT analysis, 2010
    • Figure: Pipeline for sexual dysfunction, 2010
    • Figure: Avanafil (TA1790, Vivus) SWOT analysis, 2010
    • Figure: PSD502 (lidocaine and prilocaine spray, Plethora Solutions/Shionogi Pharma) SWOT analysis, 2010
    • Figure: Flibanserin (BIMT-17; Boehringer Ingelheim) SWOT analysis, 2010
    • Figure: LibiGel (testosterone, Antares/BioSante) SWOT analysis, 2010
    • Figure: Examples of Viagra promotions
    • Figure: Promotional expenditure ($m) of the leading brands in the sexual dysfunction market in the seven major markets, 2007
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