市場調査報告書：尿失禁治療薬

Abstract

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.

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

尿失禁治療薬市場

Pipeline and Commercial Insight: Urinary Incontinence - Lifecycle management strategies retain mid-term market growth

Abstract

Overview

Introduction

Scope

Highlights

Reasons to Purchase

Table of Contents