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SUMMARY
Overview
Introduction
The treatment of menopausal symptoms is a common clinical challenge, with
vasomotor symptoms affecting an estimated 75% of women aged over 50 years.
Hormone replacement therapy (HRT) has formed the mainstay of treatment for
almost 60 years and is highly efficacious. However, concerns surrounding the
safety of HRT have led to an increase in demand for non-hormonal alternatives.
Scope
- Overview of menopause, including a review of the prevalence of vasomotor
symptoms to better understand the size of the target patient population.
- Summary of topical issues in the treatment of menopausal symptoms and
rationale for a non-hormonal approach treatment.
- Review of pipeline non-hormonal drugs and analysis of their future
potential in relation to currently available hormone replacement therapy.
- Insight from interviews with seven key international experts in the field
of menopause and associated treatments
Highlights
The key opportunity for non-hormonal treatments lies in capturing sales that
have been lost by the hormonal treatments since the WHI results. Despite
increased demand, the current R&D pipeline for non-hormonals is small and
lacks innovation. Wyeth's Pristiq could be first to market although regulatory
delays indicate possible non-approval.
Returning confidence in HRT among gynecologists and the recent upturn in sales
of these therapies represents a growing barrier to entry for non-hormonal drug
companies. Nevertheless, prevailing mistrust of HRT among primary care
physicians (PCPs) and eligible patients represents a key market opportunity
for non-hormonals.
In view of the lower efficacy of non-hormonals compared to HRT, it is expected
that uptake will be strongest among patient groups for whom HRT is
contraindicated, as well as highly symptomatic patients who do not wish to
receive HRT due to safety concerns. Mildly symptomatic patients also represent
a key target group.
Reasons to Purchase
- Understand key opinion leaders views on topical issues in the current and
future treatment of menopausal symptoms.
- Explore the R&D pipeline for non-hormonals and the future directions of
the market as identified by interviewed KOLs.
- Identify the drivers and resistors for key non-hormonal drug treatments in
the market.
TABLE OF CONTENTS
- ABOUT DATAMONITOR HEALTHCARE
- About the Urology and Gender-specific Healthpharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Market definition for this report
- Objective of the analysis
- Strategic scoping and focus
- Datamonitor insight into the non-hormonal menopause market
- Contributing experts
- Related reports
- CHAPTER 2 PATIENT POTENTIAL
- Condition definition
- Symptoms of the menopause
- Pathogenesis of vasomotor symptoms has not yet been fullyelucidated
- Vasomotor symptoms affect 75% of women over the age of 50
- Prevalence of vasomotor symptoms is associated withchanges in
menopausal status
- There exist ethnic and cultural variations in theprevalence of
menopausal symptoms
- Menopausal symptoms negatively impact quality of life
- Patient presentation and diagnosis
- Approximately 60% of symptomatic women seek help withmenopausal
symptoms
- Companies developing non-hormonal treatments would benefitfrom
targeting mildly symptomatic patients
- Diagnosis of menopause is usually made by menstrual andmedical
history
- Identifying the target population
- The average age of onset of natural menopause is 51 years
- Genetics and cigarette smoking can influence the timing ofnatural
menopause
- Over 166 million women in the seven major markets are peri-or
post-menopausal
- Approximately 115 million women in the seven major marketswill
experience menopausal symptoms
- Over 68 million women will seek treatment for menopausalsymptoms in
the seven major markets in 2008
- The target patient population will grow by 34% by 2050 inthe seven
major markets
- The proportion of postmenopausal women living indeveloping nations
is set to grow
- Women aged 45-55 are not the only patients to experiencemenopausal
symptoms
- Premature ovarian failure occurs in women younger than age40
- Premature ovarian failure affects over 1 million women inthe seven
major markets
- Surgically induced and medical menopause
- Breast cancer patients and survivors experience hotflashes
- CHAPTER 3 CURRENT MARKET SITUATION AND FUTURE POTENTIAL
- Current treatment options
- Hormonal therapies are the mainstay of treatment forsymptoms of the
menopause
- Complementary and alternative medicine: popular yetlacking in
long-term data
- Efficacy studies of complementary and alternativemedicines are
inconsistent and inconclusive
- Professional organizations provide contrastingrecommendations
regarding use of herbal treatments
- Non-hormonal treatments are presently prescribed off-label
- CNS drugs are the most widely prescribed off-labeltreatments
- Treatment guidelines acknowledge that non-hormonalalternatives show
promise
- The rationale for a non-hormonal approach to treatment
- Patients and physicians will welcome non-hormonalmenopause treatments
- Women's Health Initiative identified important riskfactors
associated with the use of HRT
- Breast cancer patients and survivors require non-hormonaltreatment
options due to contraindication of HRT
- Patients with cardiovascular disorders are also a targetpopulation
for non-hormonal treatments
- Market potential of non-hormonal treatments for menopausalsymptoms
- Non-hormonal treatments have the potential to capture atleast $535m
across the US and 5EU
- Nevertheless, HRT will remain the mainstay of treatment
- Prescriber confidence with HRT is slowly returning
- Patients' ongoing mistrust of HRT represents a marketopportunity for
non-hormonal treatments
- CHAPTER 4 R&D PIPELINE OVERVIEW AND CLINICAL TRIALDESIGN
- Introduction
- Historically, antidepressants have been investigated aspotential
treatments
- The ideal non-hormonal treatment of menopausal symptoms
- Pipeline overview
- Small pipeline consists exclusively of reformulatedcentrally acting
drugs
- Non-hormonal pipeline is of a comparable size to the HRTpipeline
- Interest continues in serotonergic mechanisms
- Wyeth: endeavoring to maintain share of the menopausemarket
- Future potential of pipeline non-hormonal treatments formenopausal
symptoms
- Efficacy does not match that of conventional hormonaltherapies
- However, regulatory approval will increase acceptance andprescriber
confidence
- Targeting of co-morbid conditions offers benefit topatients
- Safety concerns surrounding use of non-hormonals formenopausal
symptoms must be addressed
- Physicians concerns over the long-term safety ofantidepressant use
in non-depressed women need to be allayed
- Treatment considerations for breast cancer patients andsurvivors
- Stigma surrounding use of antidepressants for anon-psychiatric
indication
- Serotonergic drugs
- Pristiq (desvenlafaxine)
- Drug overview
- Pristiq is set to be the first non-hormonal treatmentapproved for
menopausal symptoms
- Generic Effexor is unlikely to limit uptake of Pristiq formenopausal
symptoms
- Pristiq - strengths and weaknesses
- Clinical trial data
- Org-50081 (esmirtazapine maleate)
- Drug overview
- Phase III clinical trial design
- Datamonitor comments
- CPT-347
- Drug overview
- Datamonitor comments
- Anticonvulsants
- Gabapentin GR/Xenolev CR
- Drug overview
- Guidelines already recognize gabapentin as an alternativeto HRT
- Reported comparable efficacy between gabapentin andestrogen
- Gabapentin may be of particular benefit to breast cancerpatients
- Gabapentin GR/Xenolev CR - strengths and weaknesses
- Clinical trial data
- Recently discontinued pipeline products
- Keppra (levetiracetam, injectable)
- Clinical trial design in non-hormonal treatment research
- Inclusion and exclusion criteria
- Primary and secondary endpoints
- Principal primary endpoint: patient-reported hot flashfrequency and
severity
- Secondary endpoint measures
- Key challenges in menopausal symptom clinical trials
- Interventions for menopausal symptoms elicit a highplacebo response
- Subjective versus objective measures of vasomotor symptoms
- BIBLIOGRAPHY
- Journal papers
- Websites
- Datamonitor reports
- APPENDIX
- Contributing experts
- Report methodology
- Market sizing caveats
- ATC classes
- ICD-10 codes
- Data definitions, limitations and assumptions
- Standard Units
- HRT for menopause specific sales calculations
- About Datamonitor
- About Datamonitor Healthcare
- About the Gender-specific Health analysis team
- Disclaimer
- List of Tables
- Table 1: Prevalence of menopausal symptoms in women aged40-54 in the
7MM, 2008
- Table 2: Frequency of menopausal symptoms in a sample ofwomen aged 40-55
years old, by menopausal transition phase
- Table 3: The potential treatable population formenopausal symptoms
across the seven major markets, 2008
- Table 4: Number of women who experience menopausalsymptoms in the
menopausal transition period in the seven major markets,2008
- Table 5: Number of women seeking treatment formenopausal symptoms in the
seven major markets, 2008
- Table 6: Number of women with premature ovarian failurein the seven
major markets , 2008
- Table 7: Crude female invasive breast cancer incidencerates (per 100,000
persons) in the seven major markets, 2002
- Table 8: Forecast incidence of invasive female breastcancer in the seven
major markets, 2002-17
- Table 9: Key trials of antidepressant drugs formenopausal symptoms, 2008
- Table 10: Non-hormonal drugs in development for thetreatment of
menopausal symptoms, 2008
- Table 11: Organon/Schering Plough's marketed gynecologyand fertility
products, 2008
- Table 12: Primary efficacy outcomes of Gabapentin GRPhase II study
- List of Figures
- Figure 1: Model of the pathogenesis of hot flashes
- Figure 2: Healthcare seeking behavior for menopausalsymptoms
- Figure 3: Number of women in the menopausal symptomstreatment pathway in
the seven major markets, 2008
- Figure 4: Projection of the female population over 45years old across
the seven major markets, 2005-2050
- Figure 5: Market share and growth of total off-labelnon-hormonal
prescription market across the seven major markets, 2006-07
- Figure 6: Sales revenue of key non-hormonal brandsprescribed off-label
for menopausal symptoms, 2007
- Figure 7: Timeline of key studies affecting the HRTmarket
- Figure 8: Event rates in the Women's Health Initiativestudy
- Figure 9: Value of the HRT for menopausal symptomsmarket in the 6MM,
1999-2007
- Figure 10: Estimated revenue potential of non-hormonaltreatments in the
US and 5EU combined, 2007
- Figure 11: Drugs in the HRT and non-hormonal developmentpipeline by
stage, 2008
- Figure 12: Comparison of efficacy data of key pipelinedrugs and Premarin
for vasomotor menopausal symptoms
- Figure 13: Pristiq: strengths and weaknesses formenopausal symptoms, 2008
- Figure 14: Gabapentin GR: strengths and weaknesses formenopausal
symptoms, 2008
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