Market Report Source

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

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

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Objective of the analysis

Datamonitor insight into the urinary incontinence and overactive bladder market

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, pharmaceutical companies must able to demonstrate to physicians that there is a clear difference between their newer products and the more established products on the market. By focusing on the urgency and frequency symptoms, companies may be able to tap into an under-served market niche.

Stress urinary incontinence is considered the most common subtype of urinary incontinence. Nevertheless, poor awareness and limited treatment options for this condition 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.

Interstitial cystitis (IC) is considered a rare disorder and 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, many physicians prescribe a wide variety of treatments that are not specifically approved for IC but may treat one or more of the symptoms. However, experts in the field believe that this could be leading to suboptimal treatment outcomes, and highlight the need for research into this 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 for OAB/UI

Bothersome symptoms or symptoms affecting quality of life have the greatest impact on a patient’s decision to see a healthcare professional

Diagnosis

Physicians may underestimate the severity of condition

Physicians use different measures to assess severity of condition

Pharmaceutical companies can help improve presentation and diagnosis

Improve general public/patient awareness and aim to reduce stigma

Improve awareness and facilitate diagnosis/prescribing among front-line healthcare providers

CHAPTER 6 REFERRAL PATTERN

PCPs are typically the first healthcare professionals with whom patients will have discussed their symptoms

Referrals from PCPs to specialists increase with the severity 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 a pharmacological therapy

Decreasing the number of incontinence episodes is the key goal when treating a patient with UUI

Pharmacological interventions are introduced when UUI is affecting day-to-day activities

Tolterodine is the most popular first- and second-line drug treatment for UUI

Dry OAB treatment

Fewer patients with dry OAB receive pharmacotherapy than patients with UUI

Improving quality of life is the key goal when treating a patient with dry OAB

Pharmacological interventions are introduced when dry OAB is affecting day-to-day activities

Physicians’ treatment choice for dry OAB is typically the same as for UUI

Stress urinary incontinence

Pharmacological versus non-pharmacological therapy in SUI

Non-pharmacological therapies are the most popular treatment choice for SUI

Decreasing the number of incontinence episodes occurring upon exertion is the key goal when treating a patient with SUI

Pelvic-floor exercises are the most popular non-pharmacological therapy choice

Surgery is seen as the definitive treatment option for SUI but is not appropriate for all patients

Pharmacological interventions are introduced when SUI has any effect, or a significant effect, on day-to-day activities.

Tolterodine is the most popular first- and second-line drug treatment for SUI

Duloxetine is the most popular third-line drug treatment for SUI

Mixed urinary incontinence

Pharmacological versus non-pharmacological therapy

Treatment is usually based on the symptom that causes the greatest distress

Improving quality of life is the key goal when treating a patient with MUI

The majority of patients with MUI receive pharmacological therapy

Tolterodine and oxybutynin (immediate release) are the most popular first- and second-line drug treatment for MUI

Duloxetine is the most popular third-line drug treatment for MUI

Interstitial cystitis

Pharmacological treatment for IC

Tricyclic antidepressants are the most popular first-line drug treatment for IC

Oxybutynin (immediate release) is the most popular second-line drug treatment for IC

CHAPTER 8 DRUG INFLUENCES AND PERCEPTION OF CURRENT TREATMENTS

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 and overactive 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/or Incontinence

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 incontinence and 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 incontinence and overactive bladder

Contributing experts

US

Japan

Europe

APPENDIX C

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer