更年期障害のためのホルモン補充療法

Abstract

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

• 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.

Report 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.

Reasons to Purchase

• 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

• ABOUT DATAMONITOR HEALTHCARE
  • About the Urology and Gender-specific Healthpharmaceutical analysis team
• 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- orpostmenopausal
      • Approximately 115 million women in the 7MM will experiencemenopausal symptoms
      • Over 68 million women will seek treatment for menopausalsymptoms in the 7MM
      • Premature ovarian failure affects over 1 million women inthe 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 in2007
      • Despite an increase in market value from 2006-07, volumesales continued to fall
      • Small price increases lessen the impact of falling volumesales
    • 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 marketposition
      • 2006-07 sales performance of the top 10 HRT brands formenopausal symptoms
      • 2006-07 sales performance of the top 10 HRT brands formenopausal symptoms, by class
  • Market opportunity and threats
    • Opportunities
      • An ageing and changing population structure grows thetreatable population
      • New variety in market will facilitate shift in treatmentparadigms
    • 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 treatablepopulation
    • Physician education across specialties will standardizeknowledge
    • A measure of dose suitability will facilitateindividualized therapy
• CHAPTER 4 R&D PIPELINE OVERVIEW AND CLINICAL TRIALDESIGN
  • Pipeline overview: old lifecycle management strategiesgive way to fundamental changes
    • Aprela' s launch will begin the restoration of the market
      • Companies unwilling to invest heavily in HRT research anddevelopment
    • Bayer Schering aims to maintain its position in Women' sHealth
      • Brand loyalty created by commitment to market willovercome pipeline weakness
    • Short-term pipeline strategies have already been exploited
      • Products with an alternative delivery method are limitedto a patient subset
      • Low-dose reformulation was an essential yet unsustainablestrategy
    • Novel mechanisms of action could radically alter the HRTmarket
      • Head-to-head trials will help new compounds to reach theirfull 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 inJapan
  • 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 estrogendeficiency
      • 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 seriouscardiovascular 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 manufacturersthroughout development
    • Clinical trials
  • Aprela (estradiol, bazedoxifene)
    • Drug overview
    • Forecasts to 2017
    • Datamonitor drug assessment
    • Patient potential
      • SERMs and TSECs could revolutionize treatment ofmenopausal symptoms
    • Marketing factors
      • Large gains to be made if pathway to approval can besmoothed
    • 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 potentiallyimproved 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 STAGEDRUG 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 arerefractory 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 Angeliqgenerics
      • 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 ofwomen aged 40-55 years old, by menopausal transition phase
  • Table 2: The potential treatable population formenopausal symptoms, in the 7MM, 2008?
  • Table 3: The number of women who experience menopausalsymptoms in the menopausal transition period, in the 7MM, 2008
  • Table 4: The number of women seeking treatment formenopausal 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 7MMHRT market
  • Table 7: Sales of estrogen only preparations used forthe treatment of menopausal symptoms in the 7MM, 2007
  • Table 8: Sales of estrogen and progestogen preparationsof HRT used for the treatment of menopausal symptoms in the 7MM, 2007
  • Table 9: Sales of topical sex hormones used for thetreatment of menopausal symptoms in the 7MM, 2007
  • Table 10: Summary of key opportunities and threats inthe HRT market across the 7MM, 2007
  • Table 11: Novel non-hormonal agents in development forthe potential treatment of menopausal symptoms, 2008
  • Table 12: Pipeline products in development as HRT formenopausal symptoms, 2008
  • Table 13: Bayer Schering' s brand revenue from the HRTmarket for menopausal symptoms (excluding osteoporosis), 2007
  • Table 14: Key estrogen agonist products in late-stageR&D pipeline for the treatment of menopausal symptoms, 2008
  • Table 15: Premarin: key facts
  • Table 16: Key estrogen and progestogen agonist productsin 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 inthe US, 5EU and Japanese market, 2008-2017
  • Table 19: Expiry dates for HRT products in the US, 5EUand Japanese market, 2008-2017
  • Table 20: Datamonitor' s prices per standard unit andpricing assumptions of the forecast pipeline products, 2008
  • Table 21: Datamonitor' s ' research and clinical' drugassessment parameters
  • Table 22: Datamonitor' s ' commerical drug assessmentparameters
  • Table 23: Estimation of launch dates by phase ofdevelopment
• List of Figures
  • Figure 1: The menopausal transition
  • Figure 2: Frequency of menopausal symptoms in a sampleof women aged 40-55 years old
  • Figure 3: Number of women in the 7MM menopausal symptomstreatment pathway, 2008
  • Figure 4: Value of the HRT for menopausal symptomsmarket in the 7MM, 2003-07
  • Figure 5: Volume sales of HRT products by class in the7MM combined, 2003-07
  • Figure 6: Value sales of HRT products, by class, in the7MM combined, 2003-07
  • Figure 7: Value of the HRT for menopausal symptomsmarket in the 5EU and Japan, 2003-07f
  • Figure 8: Year-on-year growth for HRT for menopausalsymptoms in the 7MM, 2003-07f for
  • Figure 9: Market share and market growth of the HRTmarkets in the 7MM, 2006-07
  • Figure 10: Sales of HRT products for menopausal symptomsby class in the 7MM, 2007
  • Figure 11: Sales performance of the top 10 HRT brandsfor 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 andprogestogen (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 andabove in the 7MM, 2007 and 2017
  • Figure 16: The potential threat of new mechanisms ofaction 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 toopinion leaders, 2008
  • Figure 19: Drugs in the HRT development pipeline bystage, 2008
  • Figure 20: Drugs in the HRT development pipeline bymechanism of action, 2008
  • Figure 21: Datamonitor' s forecast of sales for Divigelin Japan 2007f-2017
  • Figure 22: Datamonitor' s sales forecast for estrogenagonists for the treatment of menopausal symptoms across the 7MM,2007-2017
  • Figure 23: Datamonitor' s competitive positioninganalysis 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 inthe US, 1999-2006
  • Figure 26: Datamonitor' s sales forecast of Evamistacross the 7MM($m), 2007-2017
  • Figure 27: Datamonitor' s competitive positioninganalysis for Evamist, relative to Premarin in the 7MM, 2008-2017
  • Figure 28: Datamonitor' s forecast of sales for Aprelaacross the 7MM 7MM($m), 2007-2017
  • Figure 29: Datamonitor' s competitive positioninganalysis for Aprela, relative to Premarin in the 7MM, 2008-2017
  • Figure 30: Datamonitor' s forecast of sales for MF-101across the 7MM ($m), 2007-2017
  • Figure 31: Datamonitor' s competitive positioninganalysis for MF-101, relative to Premarin in the 7MM7MM, 2008-2017
  • Figure 32: Datamonitor' s comparative forecast of salesfor the estrogen and progestogen agonists for the treatment of menopausalsymptoms across the 7MM ($m), 2007-2017
  • Figure 33: Datamonitor' s competitive positioninganalysis for Prempro, and Angeliq low-low in the 7MM, 2008-2017
  • Figure 34: Volume and values sales of Prempro in the7MM, 2003-07
  • Figure 35: Datamonitor' s forecast of sales for Angeliqlow-low across the 7MM ($m), 2007-2017
  • Figure 36: Datamonitor' s competitive positioninganalysis for Angeliq low-low, relative to Prempro, in the seven majormarkets, 2008-2017
  • Figure 37: Impact of key events on the HRT market formenopausal symptoms, 2008-2017
  • Figure 38: Datamonitor' s pipeline assessment model forforecast products in the HRT for menopausal symptoms market, 2008