Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Women' s Health pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Contributing experts
- Datamonitor insight into the urinary incontinence market
- Related reports
- CHAPTER 2 MARKET OVERVIEW AND POTENTIAL
- Market and disease definition
- Normal bladder function
- Urinary Incontinence
- Relationship between overactive bladder and UI
- "Wet" overactive bladder is a form of urge UI
- Dry overactive bladder can impact on quality of life
- Definition of urinary incontinence market
- Market potential
- Epidemiology of UI
- Prevalence of UI
- Prevalence high, but treatment rates are likely to be low
- Stress urinary incontinence is the most common form of UI
- Patient population with UI likely to rise with the ageing of the
general population
- Etiology of UI
- Urge UI symptoms from overactive bladder
- Stress urinary incontinence
- Mixed urinary incontinence
- Unmet need in UI
- Efficacy in controlling symptoms
- Reduction of side-effect profile
- Alternative delivery mechanism
- Reduced pill burden
- Alternative targets
- Stress urinary incontinence
- Current treatment classes and mechanisms
- Treatment algorithm
- Behavioral techniques
- Pharmacological treatment
- Medical devices
- Surgery
- Current market value and future market forecasts
- Current market dynamics
- Anticholinergics dominate current market
- The US generated more revenue from UI therapies than the EU and
Japan combined
- The UI market is set to grow throughout the forecast period
- Near-term growth-reformulations
- Medium-term growth-life-cycle management strategies, novel products
and new markets
- Long-term outlook-patent expiries take their toll
- CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES
- Marketed brands overview
- Detrol (LA) (tolterodine)
- Drug overview
- Forecasts to 2016
- SWOT analysis
- Clinical trial data
- Detrol' s clinical trial program and study designs
- Efficacy of Detrol
- Detrol side effects
- Detrol drug-drug interactions
- Mechanism of action
- Ditropan (oxybutynin/oxybutynin chloride)
- Ditropan drug overview
- Ditropan extended release
- Forecasts to 2016
- SWOT analysis
- Clinical trial data
- Ditropan' s clinical program and study designs
- Efficacy of Ditropan XL
- Ditropan XL side effects
- Oxytrol/Kentera (oxybutynin transdermal patch)
- Drug overview
- Forecasts to 2016
- SWOT analysis
- Clinical trial data
- Oxytrol clinical program and study designs
- Efficacy of Oxytrol
- Side effects of Oxytrol
- Mechanism of action
- Sanctura (trospium chloride)
- Drug overview
- Forecasts to 2016
- Clinical trial data
- Sanctura clinical program and study designs
- Efficacy of Sanctura
- Side effects of Sanctura
- Mechanism of action
- Vesicare (solifenacin succinate)
- Drug overview
- Forecasts to 2016
- SWOT analysis
- Clinical trial data
- Vesicare' s clinical trial program and study designs
- Efficacy of Vesicare
- Side effects of Vesicare
- Mechanism of action
- Enablex (Darifenacin)
- Drug overview
- Forecasts to 2016
- SWOT analysis
- Clinical trial data
- Enablex' s clinical trial program and study designs
- Efficacy of Enablex
- Side effects of Enablex
- Yentreve (duloxetine)
- Drug overview
- Forecasts to 2016
- Clinical trial data
- Efficacy and side effect profile observed in clinical trial program
- Mictonorm/Detrunorm/BUP-4 (propiverine)
- Drug overview
- Forecasts to 2016
- Clinical trial data
- Efficacy
- Side-effect profile
- Drug-drug interactions
- Hormone therapy (Estradiol)
- Others
- CHAPTER 4 FORECAST ANALYSIS
- Key events
- New product launches
- Key drug launch assumptions
- Product launches in Japan
- Darifenacin (Enablex)
- Imidafenacin (ONO-8025) (KRP-197) (Staybla/Uritos)
- Reformulations
- Detrol LA, Toviaz
- Sanctura, Sanctura XR
- Oxybutynin
- Patent expiries
- Sanctura
- Detrol LA
- Yentreve
- Raft of patent expires in 2015
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- CHAPTER 5 GLOBAL OPPORTUNITIES AND THREATS
- Key opportunities
- Stress urinary incontinence
- Room for a non-anticholinergic treatment
- Niche topical market
- Increased awareness
- Elderly population
- Key threats
- Generic anticholinergics
- Behavioral/surgical techniques
- Anticholinergic brands dominant
- CHAPTER 6 PIPELINE OVERVIEW - R&D DYNAMICS AND APPROACH
- Pipeline overview
- Classification of pipeline products
- Cholinergics
- Adrenergic drugs
- NK-1 modulators
- Other drug classes
- Clinical trial design
- Clinical trial endpoints in UI
- Subjective outcome measures
- Quantification of symptoms
- Diaries
- Pad weighing tests
- Quality of life
- Choice of endpoints
- Specific safety aspects
- CHAPTER 7 LATE-STAGE DRUG ANALYSIS & FORECASTS
- Late-stage pipeline overview
- Cholinergic class pipeline drugs
- Pipeline summary
- Sanctura XR
- Drug overview
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Toviaz (fesoterodine)
- Drug overview
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Oxybutynin transdermal gel
- Drug overview
- Antares Pharma' s oxybutynin gel
- Watson Pharmaceuticals' oxybutynin gel
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Oxybutynin TVR
- Botox
- Drug overview
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- SVT-40776
- Adrenergic class pipeline drugs
- Pipeline summary
- YM-178
- Drug overview:
- Forecasts to 2016
- Clinical trial data
- PSD-503
- MN-246
- NK-1 modulator class pipeline drugs
- Pipeline summary
- NK-1 antagonist-theoretical clinical profile and forecast
- Forecasts to 2016
- Patient potential
- Satisfaction of unmet needs
- Casopitant (Rezonic)
- SSR-240600
- TA-5538
- Other pipeline drugs
- Pipeline summary
- VD3 analog (Elocalcitol)
- Drug overview
- Forecasts to 2016
- Marketing factors
- Patient potential
- Unmet needs
- Clinical trial data
- RCD-1
- FP-1097
- URG-101
- MK-0634
- FE-106483
- F-2695
- Recently suspended/discontinued drugs
- Cizolirtine
- (+)-(S,S) Reboxetine
- REC-0545
- Saredutant
- KW-7158
- KUC-7483
- CHAPTER 8 EARLY-STAGE PROJECTS
- Key Phase I and earlier compounds in development for UI
- Phase I overview
- Stem cell therapy for SUI
- Vanilloid agents
- BIBLIOGRAPHY
- Journal papers
- Websites
- DM reports
- APPENDIX
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the Women' s Health and Urology analysis team
- Disclaimer
- List of Tables
- Table 1: Definitions of UUI, SUI and MUI, according to the ICS
- Table 2: Prevalence of UI across the seven major markets, 2007
- Table 3: Detrol/Detrol LA: key facts
- Table 4: Confidence intervals for the difference between Detrol and
placebo
- Table 5: Confidence intervals for the difference between Detrol LA and
placebo
- Table 6: Ditropan/Ditropan XL: key facts
- Table 7: Oxytrol: key facts
- Table 8: Sanctura: key facts
- Table 9: Vesicare: key facts
- Table 10: Enablex: key facts
- Table 11: Yentreve: key facts
- Table 12: Forecast launch dates in the US and 5EU
- Table 13: Forecast launch dates in Japan
- Table 14: Pivotal patent expiries for key marketed drugs in the US and
5EU
- Table 15: Key pipeline drugs in late-stage development for UI, 2007
- Table 16: Key late-stage development pipeline, cholinergic class, 2007
- Table 17: Key factors impacting sales of Sanctura XR, 2007-16
- Table 18: Key factors impacting sales of Toviaz, 2007-16
- Table 19: Key factors impacting sales of oxybutynin gel, 2007-16
- Table 20: Key factors impacting sales of Botox, 2007-16
- Table 21: Key late-stage development pipeline, adrenergic class, 2007
- Table 22: Key late-stage development pipeline, NK-1 modulator class,
2007
- Table 23: Key late-stage development pipeline, other classes, 2007
- Table 24: Key factors impacting sales of Elocalcitol, 2007-16
- Table 25: Projects in Phase I and Preclinical development for UI, 2007
- Table 26: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Drug assessment summary overview of key marketed and
pipeline urinary incontinence drugs, 2007
- Figure 2: Historical (2003-06) and forecast (2007-16) UI sales revenue
for key marketed and pipeline drugs across the 7MM
- Figure 3: Relationship between UI and OAB
- Figure 4: Female population suffering from each OAB/UI subtype
- Figure 5: Female UI/OAB patients according to age group, across the
seven major markets
- Figure 6: Risks of specific side effects, according to interviewed
physicians
- Figure 7: UI-specific sales revenue, 7MM, 2003-06
- Figure 8: UI-specific sales by revenue, by region and country, 2006
- Figure 9: UI-specific sales by standard unit, by region and country,
2006
- Figure 10: UI total market value in the US, Japan and 5EU, 2003-16
- Figure 11: Current marketed drugs-clinical and commercial assessment
- Figure 12: Sales (2006) and sales growth (2005-06) for key UI products
- Figure 13: Detrol LA UI-specific sales revenue, 7MM, 2003-16
- Figure 14: Detrol LA SWOT analysis
- Figure 15: Ditropan XL UI-specific sales revenue, 7MM, 2003-16
- Figure 16: Ditropan XL SWOT analysis
- Figure 17: Oxytrol UI-specific sales revenue, 7MM, 2003-16
- Figure 18: Oxytrol SWOT analysis
- Figure 19: Sanctura UI-specific sales revenue, 7MM, 2003-16
- Figure 20: Vesicare UI-specific sales revenue, 7MM, 2003-16
- Figure 21: Vesicare SWOT analysis
- Figure 22: Enablex UI-specific sales revenue, 7MM, 2003-16
- Figure 23: Enablex SWOT analysis
- Figure 24: Yentreve UI-specific sales revenue, 7MM, 2003-16
- Figure 25: Mictonorm UI-specific sales revenue, 7MM, 2003-16
- Figure 26: Impact of each key event on the UI market across the seven
major markets, 2007-2016
- Figure 27: SUI most prevalent indication
- Figure 28: Generic UI sales, 7MM, 2003-16
- Figure 29: Drugs in late-stage development by class, 2007+
- Figure 30: Key late-stage pipeline overview, 2007
- Figure 31: Forecast UI sales for Sanctura XR 7MM, 2007-16
- Figure 32: Drug assessment summary for Sanctura XR, 2007
- Figure 33: Forecast UI sales for Toviaz, 7MM, 2007-16
- Figure 34: Drug assessment summary for Toviaz, 2007
- Figure 35: Forecast UI sales for oxybutynin gel 7MM, 2007-16
- Figure 36: Drug assessment summary for Oxybutynin gel, 2007
- Figure 37: Forecast UI sales for Botox, 7MM, 2007-16
- Figure 38: Drug assessment summary for Botox, 2007
- Figure 39: Forecast UI sales for an NK-1 antagonist 7MM, 2007-16
- Figure 40: Forecast UI sales for Elocalcitol 7MM, 2007-16
- Figure 41: Drug assessment summary for Elocalcitol, 2007
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