Pipeline and Commercial Insight: Hormonal Replacement Therapy for Menopausal Symptoms - Safety fears continue to haunt the market

Introduction

Sales of hormone replacement therapies treating menopausal symptoms have seen a sharp decline in recent years as a result of safety concerns raised by the Women's Health Initiative (WHI) study in 2002. Coupling this with Pfizer's acquisition of Wyeth, the leading estrogen manufacturer, the future direction of the market is uncertain.
Scope

* Patient potential analysis across the seven major markets
* Review of the key needs supported by key opinion leaders from the US and Europe
* 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 Pfizer's Aprela

Highlights

Recovery of the HRT market following the WHI has been slow. In recent years an increase in sales in the USwhich remains the largest marketwas despite the continuous volume decrease.

Premarin remains the market leading drug accounting for over 37% of total sales in 2009 across the seven major markets. The difficulty in replicating the exact conjugated estrogen composition will continue to protect it from generic incursion for the foreseeable future.

The future of Aprela continues to be uncertain and the US Food and Drug Administration may decide not to approve the drug due to safety concerns. Nevertheless, should the drug launch Pfizer could drive market growth in an attempt to restore the multibillion market.
Reasons to Purchase

* Understand patient population and prescription dynamics
* Gain insight into the unmet needs of HRT for menopausal symptoms 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 hormone replacement therapy for menopausal symptoms market 3
Related reports 4
1. Patient potential 7
Definition 7
Symptoms 8
Epidemiology 11
Treatment 18
Unmet needs 22
2. Market overview 29
Market definition for this report 29
Seven major markets 30
US: current and future market overview 44
Japan: current and future market overview 49
Five major EU markets: current and future market overview 52
3. Brand dynamics 58
Overview of competitive landscape 58
Premarin (conjugated estrogens, Pfizer) 59
Prempro (conjugated estrogens and medroxyprogesterone acetate; Pfizer) 63
Vagifem (estradiol hemihydrate; Novo Nordisk/Sanofi-Aventis) 68
Evamist (estradiol transdermal spray; Acrux/KV Pharmaceutical) 71
4. Pipeline dynamics 76
Pipeline overview 76
Aprela (conjugated estrogens and bazedoxifene; Pfizer) 79
Other drugs in development 87
5. Key companies and dynamics 88
Recent strategic partnerships/deals 88
Wyeth (now Pfizer) 89
Bayer Schering 90
BIBLIOGRAPHY 92
Patient potential 92
Market overview 94
Brand dynamics 94
Pipeline dynamics 95
Key companies and dynamics 95
Datamonitor reports 96
APPENDIX A – MARKET ASSUMPTIONS 97
Forecasting assumptions 97
Data definitions, limitations and assumptions 98
Derivation of sales forecasts and pricing trends 99
Forecast methodology 100
APPENDIX B 101
Contributing experts 101
Report methodology 101
About Datamonitor 101
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