Pipeline and Commercial Insight: Testosterone Replacement Therapy - Topical formulations drive market growth

Introduction

The testosterone replacement therapy market grew with an impressive compound annual growth rate [CAGR]: 24.3% from 2005 to 2009 to reach $838m sales. While these drugs can reverse the symptoms of testosterone deficiency rather efficaciously, only an estimated 5% of affected people receive treatment.
Scope

* Patient potential analysis across the seven major markets
* Review of the key needs supported by key opinion leaders
* Current and future market dynamics in the seven major markets, including analysis and forecast for current leading brands
* R&D pipeline analysis with detailed profiles and forecasts of key agents, including Eli Lilly's Axiron (testosterone)

Highlights

Testosterone preparations come in a variety of formulations including injections and transdermal ones. While gels dominate the market in the US, in the EU there is a preference for injectables due to cost constraints.

The US is by far the largest market for testosterone replacement drugs, with sales in excess of $800m and accounting for almost 96% of the total sales value in 2009 and showing the strongest growth.

The deal with Eli Lilly is advantageous for Acrux. Axiron (testosterone) is the first metered dose transdermal system to reach this market. Driven by Eli Lilly's experience in the men's health arena and its marketing and sales resources, Axiron uptake which will become the leading drug in 2019.
Reasons to Purchase

* Understand patient population dynamics
* Gain insight into the unmet needs of current testosterone treatment and to what extent pipeline drugs will address these issues
* Identify licensing opportunities based on company portfolio and market needs
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TABLE OF CONTENTS
Overview 1
Catalyst 1
Summary 1
About Datamonitor Healthcare 2
About the Genitourinary pharmaceutical analysis team 2
EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the testosterone replacement therapy market 3
Related reports 4
1. Patient Potential 7
Definition 7
Symptoms 8
Causes 9
Diagnosis 10
Epidemiology 12
Treatment 17
Unmet needs 22
2. Market overview 26
Market definition for this report 26
Seven major markets 27
US current and future market overview 39
Japan: current and future market overview 44
Five major EU current and future market overview 46
Key companies 52
3. Brand dynamics 55
Overview of competitive landscape 55
Androgel (testosterone gel; Abbott/Solvay) 55
Testim (testosterone gel; Auxilium) 59
Androderm (testosterone patch; Watson) 63
Tostran (testosterone; ProStrakan/Endo Pharma) 66
4. Pipeline dynamics 71
Pipeline overview 71
Axiron (testosterone transdermal metered-dose transdermal system; Acrux/Eli Lilly) 73
BIBLIOGRAPHY 79
Patient potential 79
Market overview 80
Pipeline dynamics 81
Datamonitor reports 81
APPENDIX A – MARKET ASSUMPTIONS 82
Forecasting assumptions 82
Data definitions, limitations and assumptions 83
Derivation of sales forecasts and pricing trends 84
Forecast methodology 84
APPENDIX B 85
Contributing experts 85
Report methodology 85
About Datamonitor 85
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