尿失禁と過活動膀胱の管理：世界的概要

Abstract

Overview

Introduction

Although there are many marketed treatments for overactive bladder, there are few available for stress urinary incontinence or interstitial cystitis. Furthermore, despite available treatments for overactive bladder, many are associated with side effects leading to poor treatment compliance. With significant unmet needs remaining in these markets, there are clear opportunities for new entrants.

Scope

• Overview of epidemiology, presentation and referral patterns, and diagnostic assessment for UUI, SUI, MUI, dry OAB, and IC
• Role and use of non-pharmacological versus pharmacological treatment for UUI, SUI, MUI, dry OAB, and IC
• Influences on treatment choice and perception of current drug therapies including tolterodine, oxybutynin, darifenacin, solifenacin and duloxetine
• Evaluation of unmet needs and future outlook including awareness of the R&D drug pipeline

Report Highlights

Drug therapy for urinary disorders has predominantly focused on the overactive bladder market - particularly urge urinary incontinence (UUI). However, as the UUI market becomes increasingly crowded, product differentiation is key. By focusing on the urgency and frequency symptoms, companies may be able to tap into an under-served market niche.

Stress urinary incontinence (SUI) is considered the most common subtype of urinary incontinence, but poor awareness and limited treatment options have impacted presentation, diagnosis and treatment rates. The recent approval of duloxetine in the EU presents physicians with a much-needed treatment alternative, but uptake has been slow.

Poor understanding of the underlying causes of interstitial cystitis (IC) have made diagnosis, management and development of effective drugs for this disorder difficult. With many physicians resorting to treatments that are not specifically approved for IC, experts in the field believe that this could be leading to suboptimal treatment outcomes.

Reasons to Purchase

• Forecast product sales by understanding key aspects of epidemiology, diagnosis and treatment
• Gain a better understanding of the challenges facing current and future players in the overactive bladder and urinary incontinence market
• Identify physicians' key concerns including unmet needs and the attributes that physicians believe are desirable for future treatments

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the CNS pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Objective of the analysis
  • Datamonitor insight into the urinary incontinence andoveractive bladder market
    • Drug therapy for urinary disorders has predominantlyfocused on the overactive bladder market-particularly urge urinaryincontinence (UUI). However, as the UUI market becomes increasinglycrowded, pharmaceutical companies must able to demonstrate to physiciansthat there is a clear difference between their newer products and the moreestablished products on the market. By focusing on the urgency andfrequency symptoms, companies may be able to tap into an under-servedmarket niche.
    • Stress urinary incontinence is considered the most commonsubtype of urinary incontinence. Nevertheless, poor awareness and limitedtreatment options for this condition have impacted presentation, diagnosisand treatment rates. The recent approval of duloxetine in the EU presentsphysicians with a much-needed treatment alternative, but uptake has beenslow.
    • Interstitial cystitis (IC) is considered a rare disorderand poor understanding of its underlying causes have made diagnosis,management, and development of effective drugs for the disorder difficult.At present there are few effective treatments for IC and as a result, manyphysicians prescribe a wide variety of treatments that are notspecifically approved for IC but may treat one or more of the symptoms.However, experts in the field believe that this could be leading tosuboptimal treatment outcomes, and highlight the need for research intothis area.
• CHAPTER 2 OAB AND UI TREATMENT TREES
  • UUI
  • Dry OAB
  • SUI
  • MUI
  • IC
• CHAPTER 3 INTRODUCTION
  • Normal bladder function
  • Definition of urinary incontinence and overactive bladder
    • Urinary Incontinence
    • Overactive bladder-wet versus dry
    • Interstitial cystitis
  • Etiology
    • Overactive bladder-wet and dry
    • SUI
    • MUI
    • Interstitial cystitis
• CHAPTER 4 EPIDEMIOLOGY
  • Stress urinary incontinence is the most common form of UI
  • The prevalence of OAB/UI varies according to study
    • US
    • EU
    • Japan
    • Other markets
  • Prevalence of OAB/UI usually rises with increasing age
  • Interstitial cystitis is rare
• CHAPTER 5 PRESENTATION AND DIAGNOSIS
  • Presentation
    • Less than half of patients seek treatment for UI/OAB
    • A variety of reasons for patients failing to seek help forOAB/UI
    • Bothersome symptoms or symptoms affecting quality of lifehave the greatest impact on a patient's decision to see a healthcareprofessional
  • Diagnosis
    • Physicians may underestimate the severity of condition
    • Physicians use different measures to assess severity ofcondition
    • Pharmaceutical companies can help improve presentation anddiagnosis
      • Improve general public/patient awareness and aim to reducestigma
      • Improve awareness and facilitate diagnosis/prescribingamong front-line healthcare providers
• CHAPTER 6 REFERRAL PATTERN
  • PCPs are typically the first healthcare professionals withwhom patients will have discussed their symptoms
  • Referrals from PCPs to specialists increase with theseverity of the condition
• CHAPTER 7 CURRENT TREATMENT
  • OAB (UUI and dry OAB)
    • Pharmacological versus non-pharmacological therapy
    • UUI treatment
      • The majority of patients with UUI receive apharmacological therapy
      • Decreasing the number of incontinence episodes is the keygoal when treating a patient with UUI
      • Pharmacological interventions are introduced when UUI isaffecting day-to-day activities
      • Tolterodine is the most popular first- and second-linedrug treatment for UUI
    • Dry OAB treatment
      • Fewer patients with dry OAB receive pharmacotherapy thanpatients with UUI
      • Improving quality of life is the key goal when treating apatient with dry OAB
      • Pharmacological interventions are introduced when dry OABis affecting day-to-day activities
      • Physicians' treatment choice for dry OAB is typically thesame as for UUI
  • Stress urinary incontinence
    • Pharmacological versus non-pharmacological therapy in SUI
      • Non-pharmacological therapies are the most populartreatment choice for SUI
      • Decreasing the number of incontinence episodes occurringupon exertion is the key goal when treating a patient with SUI
      • Pelvic-floor exercises are the most popularnon-pharmacological therapy choice
      • Surgery is seen as the definitive treatment option for SUIbut is not appropriate for all patients
      • Pharmacological interventions are introduced when SUI hasany effect, or a significant effect, on day-to-day activities.
      • Tolterodine is the most popular first- and second-linedrug treatment for SUI
      • Duloxetine is the most popular third-line drug treatmentfor SUI
  • Mixed urinary incontinence
    • Pharmacological versus non-pharmacological therapy
      • Treatment is usually based on the symptom that causes thegreatest distress
      • Improving quality of life is the key goal when treating apatient with MUI
      • The majority of patients with MUI receive pharmacologicaltherapy
      • Tolterodine and oxybutynin (immediate release) are themost popular first- and second-line drug treatment for MUI
      • Duloxetine is the most popular third-line drug treatmentfor MUI
  • Interstitial cystitis
    • Pharmacological treatment for IC
      • Tricyclic antidepressants are the most popular first-linedrug treatment for IC
      • Oxybutynin (immediate release) is the most popularsecond-line drug treatment for IC
• CHAPTER 8 DRUG INFLUENCES AND PERCEPTION OF CURRENTTREATMENTS
  • Attributes that most influence prescribing choice
  • Physician perception of marketed products for OAB/UI
    • Physician perception of marketed drugs for OAB
    • Physician perception of marketed drugs for SUI
    • Physician perception of drugs for MUI
    • Physician perception of drugs for IC
    • Switch from first- to second-line therapy
  • Unmet needs
• CHAPTER 9 PIPELINE PRODUCTS
  • Pipeline overview
  • Physician awareness
• APPENDIX A
  • Key products in late-stage development
    • Staybla/Uritos (imidafenacin) (ONO-8025) (KRP-197)
    • Urespan (temiverine hydrochloride)
    • Fesoterodine
      • Phase II trials
      • Phase III
    • Esoxybutynin
  • Bibliography
    • Introduction
    • Epidemiology
    • Presentation and diagnosis
    • Current treatment
    • Pipeline Products
  • Websites
• APPENDIX B
  • Physician research methodology
  • Physician Sample breakdown
  • Urinary Incontinence and Overactive Bladder Insight Study- Physician Questionnaire
    • Section One Overview of Urinary Incontinence andoveractive Bladder
      • Epidemiology
      • Presentation
      • Diagnosis
      • Referral pattern
    • Section Two Stress Urinary Incontinence
      • Diagnosis and treatment of SUI
      • Non-pharmacological treatment
      • Pharmacological treatment for SUI
    • Section Three Overactive Bladder With Urge Symptoms and/orIncontinence
      • Diagnosis and treatment of UUI
      • Pharmacological treatment for UUI
      • Diagnosis and treatment of 'dry OAB'
      • Pharmacological treatment for dry OAB
    • Section Four Mixed Stress/Urge Urinary Incontinence
      • Diagnosis and treatment of mixed SUI/UUI
      • Non-pharmacological treatment
      • Pharmacological treatment for mixed SUI/UUI
    • Section Five Interstitial Cystitis
      • Diagnosis and treatment of IC
      • Pharmacological treatment for IC
    • Section Six Drug Profiles
      • Section A: Drug influences on physicians' choice
      • Section B: The general treatment of urinary incontinenceand overactive bladder
  • Urinary Incontinence and Overactive Bladder Insight Study- Continence nurse questionnaire
    • Section One Epidemiology
    • Section Two Presentation and help seeking behavior
    • Section Three Diagnosis and management
      • Referral pattern
    • Section Four Treatment
      • Non-pharmacological treatment
      • Pharmacological treatment
    • Section Five General
      • Section A: Drug influences
      • Section B: The general treatment of urinary incontinenceand overactive bladder
  • Contributing experts
    • US
    • Japan
    • Europe
• APPENDIX C
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the CNS analysis team
    • Disclaimer
• List of Tables
  • Table 1: Definitions of UUI, SUI and MUI, according tothe ICS
  • Table 2: Level of symptoms physicians consider to bemild, moderate and severe
  • Table 3: The severity index developed by Sandvik et al.(2003)
  • Table 4: Interviewed physicians' rankings of specificindicators in determining the severity of OAB/UI subtype
  • Table 5: Percentage of total patients across the sevenmajor markets presenting to PCP with a subtype of OAB/UI and treated bythat PCP
  • Table 6: First-line pharmacological treatmentsprescribed for UUI, by type of physician
  • Table 7: Second-line pharmacological treatmentsprescribed for UUI, by type of physician
  • Table 8: Overview of non-pharmacological treatments forSUI
  • Table 9: First-line pharmacological treatments for SUI,by type of physician prescribing
  • Table 10: Second-line pharmacological treatments forSUI, by type of physician prescribing
  • Table 11: Third-line pharmacological treatments for SUI,by type of physician prescribing
  • Table 12: First-line pharmacological treatments for MUI, by type of physician prescribing
  • Table 13: Second-line pharmacological treatments forMUI, by type of physician prescribing
  • Table 14: Third-line pharmacological treatments for MUI,by type of physician prescribing
  • Table 15: First-line pharmacological treatments for ICacross seven major markets, by type of physician prescribing
  • Table 16: Second-line pharmacological treatments for IC,by type of physician prescribing
  • Table 17: Compounds in late-stage development (Phase IIIand above) for OAB/UI across the seven major markets
  • Table 18: Compounds in Phase II development for OAB/UIacross the seven major markets
  • Table 19: Compounds in Phase I development for OAB/UIacross the seven major markets
  • Table 20: Compounds in preclinical development forOAB/UI across the seven major markets
  • Table 21: Physician sample by country and respondenttype
• List of Figures
  • Figure 1: Prevalence, presentation, diagnosis andtreatment of UUI across the seven major markets
  • Figure 2: Prevalence, presentation, diagnosis andtreatment of dry OAB across the seven major markets
  • Figure 3: Prevalence, presentation, diagnosis andtreatment of SUI across the seven major markets
  • Figure 4: Prevalence, presentation, diagnosis andtreatment of MUI across the seven major markets
  • Figure 5: Prevalence, presentation, diagnosis andtreatment of IC across the seven major markets
  • Figure 6: Normal bladder function
  • Figure 7: Relationship between UI and OAB
  • Figure 8: Female population suffering from each OAB/UIsubtype
  • Figure 9: Female OAB/UI patients according to age group,across the seven major markets
  • Figure 10: Female patients with IC who also suffer fromincontinence
  • Figure 11: Female sufferers who seek treatment forOAB/UI
  • Figure 12: Reasons patients do not seek or delay seekingmedical help, according to interviewed continence nurses, US
  • Figure 13: Motivators/triggers for seeking help,according to interviewed continence nurses
  • Figure 14: Female patients receiving an accuratediagnosis on initial presentation to a physician
  • Figure 15: Diagnosed patients with severity of OAB/UIsubtype
  • Figure 16: Influence of educational methods onencouraging patients to seek physician treatment, according to interviewedcontinence nurses
  • Figure 17: Percentage of patients with mild, moderateand severe OAB/UI disorders who have treatment overseen by PCP versusspecialist
  • Figure 18: Percentage of patients with mild, moderateand severe UUI who receive treatment, by type of treatment administered
  • Figure 19: Points at which interviewed physiciansconsider it appropriate to introduce pharmacological interventions forUUI, across seven major markets
  • Figure 20: Percentage of patients being treated formild, moderate and severe dry OAB who receive pharmacological treatment
  • Figure 21: Types of treatments being administered topatients with mild, moderate and severe SUI
  • Figure 22: Percentage of patients for whomnon-pharmacological intervention is recommended for SUI
  • Figure 23: Point at which physicians consider itappropriate to introduce pharmacological interventions for SUI, across theseven major markets
  • Figure 24: Percentage of patients with MUI who receivetreatment, by type of treatment
  • Figure 25: Percentage of patients recommendednon-pharmacological intervention for MUI
  • Figure 26: Point at which physicians consider itappropriate to introduce pharmacological interventions for MUI, across theseven major markets
  • Figure 27: Percentage of patients with IC who receivetreatment, by type of treatment
  • Figure 28: Time at which physicians consider itappropriate to introduce pharmacological interventions for IC, across theseven major markets
  • Figure 29: Influence of therapy attributes on treatmentchoice for each OAB/UI disorder
  • Figure 30: Influence of side effects on prescribingdecision
  • Figure 31: Risks of specific side effects, according tointerviewed physicians
  • Figure 32: Performance of key drugs used for UUI againstattributes that interviewed physicians consider influential when choosingtherapy
  • Figure 33: Performance of key drugs used in SUI againstattributes that interviewed physicians consider influential in therapydecisions
  • Figure 34: Performance of key drugs used for MUI againstattributes that interviewed physicians consider influential when choosingtherapy
  • Figure 35: Performance of key drugs used for IC againstattributes that interviewed physicians consider influential when choosingtherapy
  • Figure 36: Key reasons for switching from a first-lineto a second-line therapy
  • Figure 37: Most significant unmet needs in UI and OAB,according to interviewed physicians across the seven major markets
  • Figure 38: Interviewed physicians' awareness of newtreatments for OAB/UI