Market Report Source

Overview

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.

Table of Contents

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

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