Market Report Source

Overview

Introduction

In 2007, the market value of HRT for menopausal symptoms saw its first upturn since the Women’s Health initiative (WHI) study results in 2002; highly publicized findings which linked HRT to cancer and cardiovascular safety risks. The recent growth of the market is due in part to the increasing price of HRT products but can only be sustained by a similar increase in volume sales.

Scope of this report

• Analysis of patient potential, unmet needs, market dynamics, and clinical trial design in HRT, supported by opinion leader comment.
• Assessment of pipeline drugs and future treatment trends and their impact on prescribing patterns and behavior.
• Sales based market forecasts to 2017, providing a breakdown by dose-strength, marketed brands and pipeline drugs, drug class and region.
• A review of the opportunities and threats facing HRT manufacturers in the seven major markets.

Research and analysis highlights

The market growth seen from 2006 to 2007 will be maintained by a growing number of women requesting pharmaceutical treatment for their menopausal symptoms in the next decade. The value of the seven major markets combined is expected to grow by over $1 billion as volume sales increase by 0.5% and innovative products set higher price points.

New mechanisms of action that prevent the agents from affecting breast and uterine tissue should diminish safety concerns and revolutionize the HRT market. Two late-stage pipeline products, Wyeth’s Aprela (bazedoxifene, conjugated equine estrogen) and Bionovo’s MF-101 (liquiritigenin) are expected to generate combined revenue of $893m in 2017.

Reactive strategies, such as the launch of alternatively delivered therapies and low dose reformulations, were useful, short-term revenue generators in the wake of the WHI publication. Now the market profile must be raised, and physician/patient education used to maintain growth in the long term.

Key reasons to read this report

• Quantify the future size of the HRT market and the number of women currently eligible for treatment for menopausal symptoms in the US, 5EU, and Japan.
• Understand unmet needs, and opportunities/threats in the HRT market based on key opinion leader comments.
• Benchmark key late-stage HRT compounds against current market leading brands.

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY
Objective of the analysis
Datamonitor insight into the hormone replacement therapy (HRT) market
Contributing experts
Related reports
Upcoming related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW
Market definition for this report
ATC classes
ICD-10 codes
IMS sales data
Research and development
Strategic scoping and focus
Disease overview
Symptoms of the menopause
The impact of symptoms on quality of life
The impact of symptoms and treatment seeking
Premature ovarian failure
Surgically induced and medical menopause
Identifying the target population
Over 166 million women in the 7MM are peri- or postmenopausal
Approximately 115 million women in the 7MM will experience menopausal symptoms
Over 68 million women will seek treatment for menopausal symptoms in the 7MM
Premature ovarian failure affects over 1 million women in the 7MM
Treatment options
Treatment guidelines
US – AACE menopause guidelines
EU – MHRA guidelines
Contraindications to HRT
Estrogen only preparations
Estrogen and progestogen preparations
Topical sex hormones

CHAPTER 3 GLOBAL MARKET ASSESSMENT
Current market situation
WHI-induced market decline stabilizes at $1.5 billion in 2007
Despite an increase in market value from 2006-07, volume sales continued to fall
Small price increases lessen the impact of falling volume sales
US market sales account for 85% of the total 7MM revenue
Germany is the largest and most robust of the EU markets
Majority of the seven major markets show growth in 2007
Spanish market leads the way in recuperating losses
Estrogen only preparations generate highest revenue
Wyeth products still hold the first and second market position
2006-07 sales performance of the top 10 HRT brands for menopausal symptoms
2006-07 sales performance of the top 10 HRT brands for menopausal symptoms, by class
Market opportunity and threats
Opportunities
An ageing and changing population structure grows the treatable population
New variety in market will facilitate shift in treatment paradigms
Threats
Competition from non-hormonal treatments for menopause
The boom of the so-called ‘bio-identical’ hormone market
Poor dissemination of subsequent HRT research by the media
Unmet need in the HRT market
New mechanism of actions could revolutionize HRT
Raising the profile of HRT will expand the treatable population
Physician education across specialties will standardize knowledge
A measure of dose suitability will facilitate individualized therapy

CHAPTER 4 R&D PIPELINE OVERVIEW AND CLINICAL TRIAL DESIGN
Pipeline overview: old lifecycle management strategies give way to fundamental changes
Aprela’s launch will begin the restoration of the market
Companies unwilling to invest heavily in HRT research and development
Bayer Schering aims to maintain its position in Women’s Health
Brand loyalty created by commitment to market will overcome pipeline weakness
Short-term pipeline strategies have already been exploited
Products with an alternative delivery method are limited to a patient subset
Low-dose reformulation was an essential yet unsustainable strategy
Novel mechanisms of action could radically alter the HRT market
Head-to-head trials will help new compounds to reach their full potential
The first drug to market: Divigel (estradiol)
Forecasts to 2017
Divigel: capable of a competitive price point
Out-licensing is a key strategy for Orion
Patient share will depend on exact labeling approved in Japan
Clinical trial design in HRT research
FDA revised guidelines
Estrogen only drugs
Estrogen plus progestogen drugs
European Medicine Agency guidelines
Efficacy: treatment of symptoms related to estrogen deficiency
Safety: endometrial safety
Secondary safety endpoints

CHAPTER 5 ESTROGEN AGONISTS LATE STAGE DRUG ANALYSIS & FORECASTS
Overview for the estrogen agonists
Comparative forecasts
Comparative Datamonitor drug assessment summary
Current comparator therapy: Premarin
Premarin, Prempro and the WHI study
The damning results of the WHI – HRT linked to serious cardiovascular events and cancer
HRT use fell substantially as a result
Methodological inaccuracies in the WHI since revealed
Key clinical trials: the HOPE study
Effects on vasomotor symptoms
Efficacy on vulvar and vaginal atrophy
Effect on bone mineral density
Marketing and patient factors
Evamist (estradiol)
Drug overview
Forecasts to 2017
Datamonitor drug assessment
Patient potential
Marketing factors
Evamist will benefit from specialist manufacturers throughout development
Clinical trials
Aprela (estradiol, bazedoxifene)
Drug overview
Forecasts to 2017
Datamonitor drug assessment
Patient potential
SERMs and TSECs could revolutionize treatment of menopausal symptoms
Marketing factors
Large gains to be made if pathway to approval can be smoothed
Clinical trial data
Clinical trial 1
Clinical trial 2
MF-101 (estradiol)
Drug overview
Forecasts to 2017
Datamonitor drug assessment
Patient potential
New mechanism of action stirs excitement over potentially improved safety
Marketing factors
Bionovo’s portfolio will strengthen in the long term
Clinical trial data
232802
Drug overview
Marketing and patient factors
GSK branches into Women’s Health
Clinical trial data
Phase II trial methodology

CHAPTER 6 ESTROGEN AND PROGESTOGEN AGONISTS LATE STAGE DRUG ANALYSIS & FORECASTS
Overview for the estrogen and progestogen agonists
Comparative forecasts
Comparative Datamonitor drug assessment summary
Definition of current comparator therapy: Prempro
Prempro’s key clinical trials
The WHI findings
Key clinical trials: the HOPE study
Effects on vasomotor symptoms
Effects on vulvar and vaginal atrophy
Effects on the endometrium
Effects on bone mineral density
Marketing and patient factors
Angeliq low-low (ethinyl estradiol, drospirenone)
Drug overview
Forecasts to 2017
Datamonitor drug assessment
Patient potential
Marketing factors
Strong marketing support cannot help if patients are refractory to treatment

CHAPTER 7 FORECAST ANALYSIS
Key events
New product launches in the 7MM
Evamist: chosen launch market has most latent potential
Angeliq low-low: useful strategy to combat Angeliq generics
Aprela: strong uptake in time
MF-101: battling Aprela in the US
Patent expiries in the 7MM
FemHRT (ethinyl estradiol, norethindrone acetate)
Activelle (estradiol, norethindrone acetate)
Estalis (estradiol, norethisterone acetate)
Prempro (CEE, medroxyprogesterone acetate)
Angeliq (estradiol, drospirenone)
Prices and pricing assumptions
Product positioning
Datamonitor’s pipeline drug assessment model

BIBLIOGRAPHY
Journal papers
Websites

APPENDIX
Contributing experts
Report methodology
Datamonitor’s drug assessment summary
Data definitions, limitations and assumptions
Standard Units
Estimated 2007 sales revenue
HRT for menopause specific sales calculations
Derivation of sales forecasts and pricing trends
Estimation of launch dates
Forecasts
Japanese Market Data
About Datamonitor
About Datamonitor Healthcare
About the Gender-specific Health analysis team
Disclaimer

List of Tables
Table 1: Frequency of menopausal symptoms in a sample of women aged 40-55 years old, by menopausal transition phase
Table 2: The potential treatable population for menopausal symptoms, in the 7MM, 2008?
Table 3: The number of women who experience menopausal symptoms in the menopausal transition period, in the 7MM, 2008
Table 4: The number of women seeking treatment for menopausal symptoms, in the 7MM, 2008
Table 5: Number of women in the 7MM with POF, 2008
Table 6: The top 10 products, by 2007 sales, in the 7MM HRT market
Table 7: Sales of estrogen only preparations used for the treatment of menopausal symptoms in the 7MM, 2007
Table 8: Sales of estrogen and progestogen preparations of HRT used for the treatment of menopausal symptoms in the 7MM, 2007
Table 9: Sales of topical sex hormones used for the treatment of menopausal symptoms in the 7MM, 2007
Table 10: Summary of key opportunities and threats in the HRT market across the 7MM, 2007
Table 11: Novel non-hormonal agents in development for the potential treatment of menopausal symptoms, 2008
Table 12: Pipeline products in development as HRT for menopausal symptoms, 2008
Table 13: Bayer Schering’s brand revenue from the HRT market for menopausal symptoms (excluding osteoporosis), 2007
Table 14: Key estrogen agonist products in late-stage R&D pipeline for the treatment of menopausal symptoms, 2008
Table 15: Premarin: key facts
Table 16: Key estrogen and progestogen agonist products in late-stage R&D pipeline for the treatment of menopausal symptoms, 2008
Table 17: Prempro: key facts
Table 18: Datamonitor’s launch dates for HRT products in the US, 5EU and Japanese market, 2008-2017
Table 19: Expiry dates for HRT products in the US, 5EU and Japanese market, 2008-2017
Table 20: Datamonitor’s prices per standard unit and pricing assumptions of the forecast pipeline products, 2008
Table 21: Datamonitor’s ‘research and clinical’ drug assessment parameters
Table 22: Datamonitor’s ‘commerical drug assessment parameters
Table 23: Estimation of launch dates by phase of development

List of Figures
Figure 1: The menopausal transition
Figure 2: Frequency of menopausal symptoms in a sample of women aged 40-55 years old
Figure 3: Number of women in the 7MM menopausal symptoms treatment pathway, 2008
Figure 4: Value of the HRT for menopausal symptoms market in the 7MM, 2003-07
Figure 5: Volume sales of HRT products by class in the 7MM combined, 2003-07
Figure 6: Value sales of HRT products, by class, in the 7MM combined, 2003-07
Figure 7: Value of the HRT for menopausal symptoms market in the 5EU and Japan, 2003-07f
Figure 8: Year-on-year growth for HRT for menopausal symptoms in the 7MM, 2003-07f for
Figure 9: Market share and market growth of the HRT markets in the 7MM, 2006-07
Figure 10: Sales of HRT products for menopausal symptoms by class in the 7MM, 2007
Figure 11: Sales performance of the top 10 HRT brands for menopausal symptoms in the 7MM, 2006—07
Figure 12: Sales performance of key estrogen only (G3E) HRT brands in the 7MM, 2006-07
Figure 13: Sales performance of key estrogen and progestogen (G3F) HRT brands in the 7MM, 2006—07
Figure 14: Sales performance of key topical sex hormone (G2F) HRT brands in the 7MM, 2006—07
Figure 15: Number of women (million) aged 45 years and above in the 7MM, 2007 and 2017
Figure 16: The potential threat of new mechanisms of action on the existing HRT market
Figure 17: Google trend analysis of media coverage of ‘WHI’ from 2005-08.
Figure 18: Unmet need in the HRT market according to opinion leaders, 2008
Figure 19: Drugs in the HRT development pipeline by stage, 2008
Figure 20: Drugs in the HRT development pipeline by mechanism of action, 2008
Figure 21: Datamonitor’s forecast of sales for Divigel in Japan 2007f-2017
Figure 22: Datamonitor’s sales forecast for estrogen agonists for the treatment of menopausal symptoms across the 7MM, 2007-2017
Figure 23: Datamonitor’s competitive positioning analysis for Premarin, Aprela, MF-101 and Evamist in the 7MM, 2008-2017
Figure 24: The Wyeth Prem Range, 2008
Figure 25: Total promotional spend for the Prem range in the US, 1999-2006
Figure 26: Datamonitor’s sales forecast of Evamist across the 7MM($m), 2007-2017
Figure 27: Datamonitor’s competitive positioning analysis for Evamist, relative to Premarin in the 7MM, 2008-2017
Figure 28: Datamonitor’s forecast of sales for Aprela across the 7MM 7MM($m), 2007-2017
Figure 29: Datamonitor’s competitive positioning analysis for Aprela, relative to Premarin in the 7MM, 2008-2017
Figure 30: Datamonitor’s forecast of sales for MF-101 across the 7MM ($m), 2007-2017
Figure 31: Datamonitor’s competitive positioning analysis for MF-101, relative to Premarin in the 7MM7MM, 2008-2017
Figure 32: Datamonitor’s comparative forecast of sales for the estrogen and progestogen agonists for the treatment of menopausal symptoms across the 7MM ($m), 2007-2017
Figure 33: Datamonitor’s competitive positioning analysis for Prempro, and Angeliq low-low in the 7MM, 2008-2017
Figure 34: Volume and values sales of Prempro in the 7MM, 2003-07
Figure 35: Datamonitor’s forecast of sales for Angeliq low-low across the 7MM ($m), 2007-2017
Figure 36: Datamonitor’s competitive positioning analysis for Angeliq low-low, relative to Prempro, in the seven major markets, 2008-2017
Figure 37: Impact of key events on the HRT market for menopausal symptoms, 2008-2017
Figure 38: Datamonitor’s pipeline assessment model for forecast products in the HRT for menopausal symptoms market, 2008