Market Report Source

Overview

Introduction

The UI market is set to continue to grow over the next 6 years, reaching over $2.5 billion in 2012, a 68% increase from 2006. Lifecycle management strategies, novel formulations and follow-on products will drive the majority of this growth, with key brands expected to be Pfizer’s Detrol LA (tolterodine) and Toviaz (fesoterodine), GSK’s Vesicare (solifenacin), and Novartis’ Enablex (darifenacin).

Scope

Analysis of patient potential, unmet needs and clinical trial design in UI. Overview of key marketed brands, late- and early-stage pipeline drugs, and cell therapies. Indication-specific sales volume and value forecasts to 2016 of marketed brands, generics, and key late-stage pipeline drugs. Identification of future market events that are expected to affect UI drug revenues.

Highlights

Pfizer’s Detrol LA (tolterodine) will remain the market leading UI brand through to 2012 when it comes off patent. At this point Detrol LA will be followed by the other second generation anticholinergics, GSK’s Vesicare (solifenacin), Novartis’ Enablex (darifenacin) and Pfizer’s chemical reformulation Toviaz (fesoterodine). Following the patent expiry of the key brands, Detrol LA in 2012, and Enablex/Vesicare in 2015, a novel mechanism of action is required for long-term market growth. Examples of the possible mechanisms of action include the NK-1 antagonists and the adrenergic modulators. Datamonitor has identified a great untapped patient base in the US stress urinary incontinence (SUI) market. A drug that could come into this market would benefit from exclusivity, being the only treatment approved for SUI in the US with a potential 28 million patient base.

Reasons to Purchase

Benchmark key late-stage UI pipeline compounds against current market leading brands. Assess region-specific (US, Japan, 5EU) sales forecasts of key late-stage pipeline drugs and marketed brands. Understand unmet needs and opportunities in the UI market based on key opinion leader comments.

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
Contributing experts
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