Pipeline and Commercial Insight: Urinary Incontinence - Lifecycle management strategies
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Women's Health pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Contributing experts - page 4
- Datamonitor insight into the urinary incontinence market - page 4
- Related reports - page 7
- CHAPTER 2 MARKET OVERVIEW AND POTENTIAL - page 9
- Market and disease definition - page 10
- Normal bladder function - page 10
- Urinary Incontinence - page 10
- Relationship between overactive bladder and urinary Incontinence - page 11
- "Wet" overactive bladder is a form of urge urinary Incontinence - page 11
- Dry overactive bladder can impact on quality of life - page 12
- Definition of urinary incontinence market - page 13
- Market potential - page 14
- Epidemiology of urinary Incontinence - page 14
- Prevalence of urinary Incontinence - page 14
- Prevalence high, but treatment rates are likely to be low - page 14
- Stress urinary incontinence is the most common form of urinary Incontinence - page 15
- Patient population with urinary Incontinence likely to rise with the ageing of the general population - page 16
- Etiology of urinary Incontinence - page 17
- Urge urinary Incontinence symptoms from overactive bladder - page 17
- Stress urinary incontinence - page 17
- Mixed urinary incontinence - page 18
- Unmet need in urinary Incontinence - page 18
- Efficacy in controlling symptoms - page 18
- Reduction of side-effect profile - page 18
- Alternative delivery mechanism - page 21
- Reduced pill burden - page 21
- Alternative targets - page 22
- Stress urinary incontinence - page 22
- Epidemiology of urinary Incontinence - page 14
- Current treatment classes and mechanisms - page 24
- Treatment algorithm - page 24
- Behavioral techniques - page 24
- Pharmacological treatment - page 25
- Medical devices - page 26
- Surgery - page 27
- Treatment algorithm - page 24
- Current market value and future market forecasts - page 28
- Current market dynamics - page 28
- Anticholinergics dominate current market - page 28
- The US generated more revenue from urinary Incontinence therapies than the EU and Japan combined - page 29
- The urinary Incontinence market is set to grow throughout the forecast period - page 30
- Near-term growth-reformulations - page 31
- Medium-term growth-life-cycle management strategies, novel products and new markets - page 32
- Long-term outlook-patent expiries take their toll - page 32
- Current market dynamics - page 28
- Market and disease definition - page 10
- CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES - page 33
- Marketed brands overview - page 34
- Detrol (LA) (tolterodine) - page 35
- Drug overview - page 35
- Forecasts to 2016 - page 37
- SWOT analysis - page 39
- Clinical trial data - page 39
- Detrol's clinical trial program and study designs - page 39
- Efficacy of Detrol - page 40
- Detrol side effects - page 44
- Detrol drug-drug interactions - page 45
- Mechanism of action - page 46
- Ditropan (oxybutynin/oxybutynin chloride) - page 46
- Ditropan drug overview - page 46
- Ditropan extended release - page 48
- Forecasts to 2016 - page 49
- SWOT analysis - page 50
- Clinical trial data - page 50
- Ditropan's clinical program and study designs - page 50
- Efficacy of Ditropan XL - page 51
- Ditropan XL side effects - page 51
- Oxytrol/Kentera (oxybutynin transdermal patch) - page 52
- Drug overview - page 52
- Forecasts to 2016 - page 54
- SWOT analysis - page 55
- Clinical trial data - page 55
- Oxytrol clinical program and study designs - page 55
- Efficacy of Oxytrol - page 55
- Side effects of Oxytrol - page 56
- Mechanism of action - page 56
- Sanctura (trospium chloride) - page 57
- Drug overview - page 57
- Forecasts to 2016 - page 58
- Clinical trial data - page 60
- Sanctura clinical program and study designs - page 60
- Efficacy of Sanctura - page 60
- Side effects of Sanctura - page 60
- Mechanism of action - page 61
- Vesicare (solifenacin succinate) - page 61
- Drug overview - page 61
- Forecasts to 2016 - page 64
- SWOT analysis - page 65
- Clinical trial data - page 65
- Vesicare's clinical trial program and study designs - page 65
- Efficacy of Vesicare - page 66
- Side effects of Vesicare - page 66
- Mechanism of action - page 67
- Enablex (Darifenacin) - page 67
- Drug overview - page 67
- Forecasts to 2016 - page 69
- SWOT analysis - page 70
- Clinical trial data - page 70
- Enablex's clinical trial program and study designs - page 70
- Efficacy of Enablex - page 71
- Side effects of Enablex - page 71
- Yentreve (duloxetine) - page 71
- Drug overview - page 71
- Forecasts to 2016 - page 74
- Clinical trial data - page 74
- Efficacy and side effect profile observed in clinical trial program - page 75
- Mictonorm/Detrunorm/BUP-4 (propiverine) - page 78
- Drug overview - page 78
- Forecasts to 2016 - page 79
- Clinical trial data - page 80
- Efficacy - page 80
- Side-effect profile - page 80
- Drug-drug interactions - page 80
- Hormone therapy (Estradiol) - page 81
- Others - page 82
- CHAPTER 4 FORECAST ANALYSIS - page 83
- Key events - page 84
- New product launches - page 85
- Key drug launch assumptions - page 85
- Product launches in Japan - page 86
- Darifenacin (Enablex) - page 86
- Imidafenacin (ONO-8025) (KRP-197) (Staybla/Uritos) - page 86
- Reformulations - page 87
- Detrol LA, Toviaz - page 87
- Sanctura, Sanctura XR - page 87
- Oxybutynin - page 88
- Patent expiries - page 88
- Sanctura - page 88
- Detrol LA - page 89
- Yentreve - page 89
- Raft of patent expires in 2015 - page 89
- New product launches - page 85
- Data definitions, limitations and assumptions - page 89
- Standard units - page 89
- Japanese market data - page 89
- Derivation of sales forecasts and pricing trends - page 90
- Forecast methodology - page 90
- Key events - page 84
- CHAPTER 5 GLOBAL OPPORTUNITIES AND THREATS - page 91
- Key opportunities - page 92
- Stress urinary incontinence - page 92
- Room for a non-anticholinergic treatment - page 93
- Niche topical market - page 93
- Increased awareness - page 94
- Elderly population - page 94
- Key threats - page 95
- Generic anticholinergics - page 95
- Behavioral/surgical techniques - page 96
- Anticholinergic brands dominant - page 96
- Key opportunities - page 92
- CHAPTER 6 PIPELINE OVERVIEW - R&D DYNAMICS AND APPROACH - page 97
- Pipeline overview - page 98
- Classification of pipeline products - page 98
- Cholinergics - page 98
- Adrenergic drugs - page 99
- NK-1 modulators - page 99
- Other drug classes - page 99
- Clinical trial design - page 100
- Clinical trial endpoints in urinary Incontinence - page 100
- Subjective outcome measures - page 100
- Quantification of symptoms - page 100
- Diaries - page 100
- Pad weighing tests - page 102
- Quality of life - page 102
- Choice of endpoints - page 102
- Specific safety aspects - page 103
- CHAPTER 7 LATE-STAGE DRUG ANALYSIS & FORECASTS - page 104
- Late-stage pipeline overview - page 105
- Cholinergic class pipeline drugs - page 107
- Pipeline summary - page 107
- Sanctura XR - page 108
- Drug overview - page 108
- Forecasts to 2016 - page 109
- Marketing factors - page 111
- Patient potential - page 111
- Satisfaction of unmet needs - page 112
- Clinical trial data - page 113
- Toviaz (fesoterodine) - page 114
- Drug overview - page 114
- Forecasts to 2016 - page 115
- Marketing factors - page 117
- Patient potential - page 118
- Satisfaction of unmet needs - page 118
- Clinical trial data - page 119
- Oxybutynin transdermal gel - page 121
- Drug overview - page 121
- Antares Pharma's oxybutynin gel - page 122
- Watson Pharmaceuticals' oxybutynin gel - page 122
- Forecasts to 2016 - page 123
- Marketing factors - page 126
- Patient potential - page 127
- Satisfaction of unmet needs - page 127
- Oxybutynin TVR - page 128
- Botox - page 129
- Drug overview - page 129
- Forecasts to 2016 - page 130
- Marketing factors - page 132
- Patient potential - page 133
- Satisfaction of unmet needs - page 133
- Clinical trial data - page 135
- SVT-40776 - page 136
- Adrenergic class pipeline drugs - page 137
- Pipeline summary - page 138
- YM-178 - page 138
- Drug overview: - page 138
- Forecasts to 2016 - page 139
- Clinical trial data - page 139
- PSD-503 - page 139
- MN-246 - page 141
- NK-1 modulator class pipeline drugs - page 142
- Pipeline summary - page 142
- NK-1 antagonist-theoretical clinical profile and forecast - page 142
- Forecasts to 2016 - page 144
- Patient potential - page 144
- Satisfaction of unmet needs - page 145
- Casopitant (Rezonic) - page 146
- SSR-240600 - page 146
- TA-5538 - page 146
- Other pipeline drugs - page 147
- Pipeline summary - page 147
- VD3 analog (Elocalcitol) - page 147
- Drug overview - page 147
- Forecasts to 2016 - page 148
- Marketing factors - page 150
- Patient potential - page 150
- Unmet needs - page 150
- Clinical trial data - page 151
- RCD-1 - page 152
- FP-1097 - page 152
- URG-101 - page 152
- MK-0634 - page 153
- FE-106483 - page 153
- F-2695 - page 153
- Recently suspended/discontinued drugs - page 153
- Cizolirtine - page 153
- (+)-(S,S) Reboxetine - page 154
- REC-0545 - page 155
- Saredutant - page 155
- KW-7158 - page 155
- KUC-7483 - page 155
- CHAPTER 8 EARLY-STAGE PROJECTS - page 156
- Key Phase I and earlier compounds in development for urinary Incontinence - page 157
- Phase I overview - page 157
- Stem cell therapy for SUI - page 159
- Vanilloid agents - page 159
- Key Phase I and earlier compounds in development for urinary Incontinence - page 157
- BIBLIOGRAPHY - page 161
- Journal papers - page 161
- Websites - page 163
- DM reports - page 168
- APPENDIX - page 169
- Report methodology - page 169
- Contributing experts - page 171
- About Datamonitor - page 171
- About Datamonitor Healthcare - page 171
- About the Women's Health and Urology analysis team - page 172
- Disclaimer - page 174
- Report methodology - page 169
- List of Tables
- Table 1: Definitions of urge urinary Incontinence , stress urinary Incontinence and mixed urinary Incontinence, according to the ICS - page 11
- Table 2: Prevalence of urinary Incontinence across the seven major markets, 2007 - page 14
- Table 3: Detrol/Detrol LA: key facts - page 37
- Table 4: Confidence intervals for the difference between Detrol and placebo - page 41
- Table 5: Confidence intervals for the difference between Detrol LA and placebo - page 44
- Table 6: Ditropan/Ditropan XL: key facts - page 47
- Table 7: Oxytrol: key facts - page 53
- Table 8: Sanctura: key facts - page 58
- Table 9: Vesicare: key facts - page 63
- Table 10: Enablex: key facts - page 68
- Table 11: Yentreve: key facts - page 73
- Table 12: Forecast launch dates in the US and 5EU - page 85
- Table 13: Forecast launch dates in Japan - page 86
- Table 14: Pivotal patent expiries for key marketed drugs in the US and 5EU - page 88
- Table 15: Key pipeline drugs in late-stage development for urinary Incontinence, 2007 - page 106
- Table 16: Key late-stage development pipeline, cholinergic class, 2007 - page 107
- Table 17: Key factors impacting sales of Sanctura XR, 2007-16 - page 110
- Table 18: Key factors impacting sales of Toviaz, 2007-16 - page 116
- Table 19: Key factors impacting sales of oxybutynin gel, 2007-16 - page 125
- Table 20: Key factors impacting sales of Botox, 2007-16 - page 131
- Table 21: Key late-stage development pipeline, adrenergic class, 2007 - page 138
- Table 22: Key late-stage development pipeline, NK-1 modulator class, 2007 - page 142
- Table 23: Key late-stage development pipeline, other classes, 2007 - page 147
- Table 24: Key factors impacting sales of Elocalcitol, 2007-16 - page 149
- Table 25: Projects in Phase I and Preclinical development for urinary Incontinence, 2007 - page 157
- Table 26: Datamonitor drug assessment parameters - page 170
- List of Figures
- Figure 1: Drug assessment summary overview of key marketed and pipeline urinary incontinence drugs, 2007 - page 6
- Figure 2: Historical (2003-06) and forecast (2007-16) urinary Incontinence sales revenue for key marketed and pipeline drugs across the 7MM - page 7
- Figure 3: Relationship between urinary Incontinence and OAB - page 12
- Figure 4: Female population suffering from each OAB/urinary Incontinence subtype - page 15
- Figure 5: Female urinary Incontinence /OAB patients according to age group, across the seven major markets - page 16
- Figure 6: Risks of specific side effects, according to interviewed physicians - page 20
- Figure 7: urinary Incontinence -specific sales revenue, 7MM, 2003-06 - page 28
- Figure 8: urinary Incontinence -specific sales by revenue, by region and country, 2006 - page 29
- Figure 9: urinary Incontinence -specific sales by standard unit, by region and country, 2006 - page 30
- Figure 10: urinary Incontinence total market value in the US, Japan and 5EU, 2003-16 - page 31
- Figure 11: Current marketed drugs-clinical and commercial assessment - page 34
- Figure 12: Sales (2006) and sales growth (2005-06) for key urinary Incontinence products - page 35
- Figure 13: Detrol LA urinary Incontinence -specific sales revenue, 7MM, 2003-16 - page 38
- Figure 14: Detrol LA SWOT analysis - page 39
- Figure 15: Ditropan XL urinary Incontinence -specific sales revenue, 7MM, 2003-16 - page 49
- Figure 16: Ditropan XL SWOT analysis - page 50
- Figure 17: Oxytrol urinary Incontinence -specific sales revenue, 7MM, 2003-16 - page 54
- Figure 18: Oxytrol SWOT analysis - page 55
- Figure 19: Sanctura urinary Incontinence -specific sales revenue, 7MM, 2003-16 - page 58
- Figure 20: Vesicare urinary Incontinence -specific sales revenue, 7MM, 2003-16 - page 64
- Figure 21: Vesicare SWOT analysis - page 65
- Figure 22: Enablex urinary Incontinence -specific sales revenue, 7MM, 2003-16 - page 69
- Figure 23: Enablex SWOT analysis - page 70
- Figure 24: Yentreve urinary Incontinence -specific sales revenue, 7MM, 2003-16 - page 74
- Figure 25: Mictonorm urinary Incontinence -specific sales revenue, 7MM, 2003-16 - page 79
- Figure 26: Impact of each key event on the urinary Incontinence market across the seven major markets, 2007-2016 - page 84
- Figure 27: SUI most prevalent indication - page 92
- Figure 28: Generic urinary Incontinence sales, 7MM, 2003-16 - page 95
- Figure 29: Drugs in late-stage development by class, 2007+ - page 98
- Figure 30: Key late-stage pipeline overview, 2007 - page 105
- Figure 31: Forecast urinary Incontinence sales for Sanctura XR 7MM, 2007-16 - page 109
- Figure 32: Drug assessment summary for Sanctura XR, 2007 - page 110
- Figure 33: Forecast urinary Incontinence sales for Toviaz, 7MM, 2007-16 - page 115
- Figure 34: Drug assessment summary for Toviaz, 2007 - page 117
- Figure 35: Forecast urinary Incontinence sales for oxybutynin gel 7MM, 2007-16 - page 123
- Figure 36: Drug assessment summary for Oxybutynin gel, 2007 - page 126
- Figure 37: Forecast urinary Incontinence sales for Botox, 7MM, 2007-16 - page 130
- Figure 38: Drug assessment summary for Botox, 2007 - page 132
- Figure 39: Forecast urinary Incontinence sales for an NK-1 antagonist 7MM, 2007-16 - page 144
- Figure 40: Forecast urinary Incontinence sales for Elocalcitol 7MM, 2007-16 - page 148
- Figure 41: Drug assessment summary for Elocalcitol, 2007 - page 149
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