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Stakeholder Opinion: Erectile Dysfunction
Identifying product differentiation and patient segmentation strategies

  • Publication Date:December 2006
  • Publisher:Datamonitor
  • Product Type: Report
  • Pages:120

Stakeholder Opinion: Erectile Dysfunction Identifying product differentiation and patient segmentation strategies

Introduction

The erectile dysfunction market grew 3.5% from 2005 to be worth $1.95 billion in 2005 and is almost entirely composed of sales from three brands: Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). Despite the dominance of these products, several opportunities exist for a successful market entry.

Scope

  • Patient potential, unmet needs and epidemiological trends in erectile dysfunction
  • Pipeline overview including key company players, product profiles, and pipeline issues
  • Case study analysis of market leaving brands: Pfizer's Viagra; ICOS-Lilly's Cialis; and Bayer/Schering-Plough/GlaxoSmithKline's Levitra
  • Analysis of the future direction of the market as supported by the views of interviewed key international opinion leaders

Highlights

PDE-5 inhibitors will remain the mainstay of ED treatment, having an excellent efficacy and safety profile. New PDE-5 inhibitors need a unique clinical advantage to compete with the established products. Udenafil goes some way to achieve this, offering a rapid onset of action and a favorable half-life, but is unlikely to surpass market leaders.

An estimated 30% of the ED patient population is refractory to PDE-5 inhibitors and this represents a considerable target market for manufactures of novel products. In terms of new mechanisms of action, opinion leaders are unconvinced by what is in the current pipeline. They are encouraged, however, by the new drug delivery methods in development.

Developing treatments for niche patient subgroups provides an opportunity to minimize competition with established therapies. Diabetes-related ED, prostatectomy patients and cardiovascular disease may be commercially viable groups. This chronic treatment of ED may require once-daily dosing and hence represents an avenue for companies to explore.

Reasons to Purchase

  • Understand opinion leaders' views on topical issues in the erectile dysfunction market
  • Formulate product launch strategies based on current market dynamics and the successful strategies employed by existing players
  • Assess the competitive environment upon launch of a product based on the analysis of key pipeline products and R&D strategies.
  • Datamonitor's therapeutic area studies comprise the following features:
  • Chapter 1 Executive Summary
    • Objective of the analysis
    • Datamonitor insight into the erectile dysfunction market
  • Chapter 2 Market Overview
    • Introduction and scope
    • Market definition for this report
    • Etiology
    • Physiology of penile erection
    • Pathophysiology of erectile dysfunction
    • Psychogenic erectile dysfunction
    • Neurogenic erectile dysfunction
    • Endocrinologic erectile dysfunction
    • Vasculogenic erectile dysfunction
    • Confounds in identifying erectile dysfunction risk factors
    • Treatment Overview
    • Drug therapy
    • PDE-5 inhibitors transformed the market
    • PDE-5 inhibitors are not without drawbacks
    • Alprostadil dogged by undesirable administration methods.
    • Hormonal therapy is useful in combination
    • Non-pharmacological therapy
    • Sexual counseling for psychogenic and organic impotence
    • Vacuum devices are efficacious for most
    • Implants associated with high patient satisfaction
    • The efficacy and acceptance of surgical procedures varies widely
    • Epidemiology
    • Wealth of studies show considerable variability
    • Previously reported prevalence estimates
    • Identifying the target population
    • Data caveats
    • Treated patient numbers may not grow as fast as erectile dysfunction prevalence
    • Unmet need
    • Need for treatment options for patients unresponsive to PDE-5 inhibitors
    • Improved patient guidance is needed to control drug expectations
    • Market dynamics
    • Key players
    • Regional analysis
    • Seven major market total grew 3.5% to $1.95 billion in 2005 – US has over two-thirds share
    • Strong growth in the European markets
    • Brand analysis
    • Blockbuster Viagra still market leader but sales hit by competition from Cialis and Levitra
    • Pharmacological profile helps Cialis challenge Viagra
    • Levitra continues to gain market share
    • Delivery mode restricts sales of Caverject
    • Growth for diagnostic Viridal
    • Muse's market share diminishes
    • Brand analysis by region
    • Cialis overtakes Viagra in the French market
    • Market expansion in Germany allows market growth of big three
    • Growth of big three in the UK
    • Levitra challenges Viagra in Japan
    • Full-year 2006 forecasts
    • Growth rates appear to stabilize across the market in 2006
    • Cialis and Levitra continued to capture Viagra's market share in 2006
  • Chapter 3 Pipeline Analysis
    • Pipeline overview
    • Varied pipeline looks to capitalize on gaps in the market
    • Small companies look for opening in erectile dysfunction market
    • PDE-5 inhibitors will remain the mainstay of treatment
    • 'Me-too' PDE-5 inhibitors do not address major clinical needs
    • Time of onset and action provide opportunity for differentiation
    • Rush of generics from 2012 will massively increase competition
    • Can other mechanisms of action challenge PDE-5 inhibitors?
    • MSH/melanocortin agonists: a brand new class
    • Dopamine agonists must hope for a better reception second time around
    • PGE-1 agonist use is dependent on cream formulation
    • Gaps in treatable patient population creates opportunity for new products
    • The growing diabetic population is a commercially viable target
    • Post surgery use is set to increase
    • Non-erectile dysfunction indications for PDE-5 inhibitors: cardiovascular disorders
    • Chronic versus immediate treatment
    • New delivery modes will have mixed success in challenging oral formulations
    • Injections will remain as last line drug treatment options
    • Creams and gels avoid GI metabolism but may irritate partner
    • Oral inhaled and intranasal therapies offer quick onset of action
    • Eroxon creates speculation about over-the-counter erectile dysfunction products
    • Topical drugs are well suited to the OTC market
    • OTC expands the customer base to include sufferers that find it difficult approaching health professionals about their condition
    • FDA requirements for OTC drug applications
    • Key pipeline company analysis
    • Pfizer has a speculative back-up plan
  • Uk-357903 May Be A Viagra Reformulation
    • Pfizer is likely biding its time to assess other opportunities
    • Key pipeline product profiles
    • Comparative drug (Viagra)
    • Drug overview
    • Clinical Trials
    • Invicorp (aviptadil and phentolamine mesylate)
    • Drug overview
    • Clinical trial results
    • Patient potential
    • Marketing factors
    • Udenafil/ DA-8159
    • Drug overview
    • Clinical trial results
    • Patient potential
    • Marketing factors
    • Apomorphine/VR-004
    • Drug Overview
    • Clinical trial
    • Patient potential
    • Marketing factors
    • Bremelanotide (PT-141)
    • Drug Overview
    • Clinical trial results: Part 1
    • Clinical trial results: Part 2
    • Patient potential
    • Marketing factors
    • Alprox-TD/Befar (alprostadil cream)
    • Drug Overview
    • Clinical trial results
    • Patient potential
    • Marketing factors
  • Gpi-1485
    • Drug Overview
    • Clinical trial results
    • Patient potential
    • Marketing factors
    • Eroxon/MED2002
    • Drug Overview
    • Clinical trials
    • Clinical trials
    • Patient potential
    • Marketing factors
  • Chapter 4 Case Study Analysis
    • Introduction
    • Creation of a super-brand
    • Case study: Viagra
    • Direct-to-consumer marketing successfully quashes erectile dysfunction taboo
    • Impact of safety fears minimized
    • Pfizer's problem solving strategies
    • Generating brand familiarity to rival Viagra
    • Case study: Cialis (tadalafil)
    • A two-stage marketing process
    • Capitalizing on differentiating factors: 'the drug that allows spontaneity'
    • Reformulations can expand the target patient population
    • Me-toos can compete based on a lower price point
    • Case study: Levitra (vardenafil)
    • Pricing helps Levitra in the US
    • Forced to follow suit with marketing
    • High risk head-to-head trials may pay off
  • Bibliography
    • References
    • Websites
  • Appendix
    • Contributing experts
    • Prevalence methodology
    • About Datamonitor
    • About Datamonitor Healthcare
    • About the Women's Health and Urology analysis team
    • Disclaimer
  • +44 20 8816 8548

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