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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