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
- 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
- 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
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