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Stakeholder Opinions: Urinary Tract Infections - Ciprofloxacin Leads the WayProduct Type: Market Research ReportPublished by: Datamonitor Published: July 2004 Product Code: R313-6961 Description IntroductionUrinary tract infections are one of the most common bacterial infections across the seven major markets, second only to respiratory tract infections. As a result, such infections generate a significant proportion of antibacterial revenue and are the focus of key players and new entrants alike. Scope Commercial overview of the current UTIs antibacterial market in the US, EU and Japan A description of presentation, diagnostic and treatment practices in selected countries, based on discussions with numerous key opinion leaders Examination of how the patent expiry of Cipro has impacted this market and how niche products have gained leverage in the UTIs sector Investigation into why and how antibacterial companies may tailor marketing strategies to the community or hospital setting Highlights UTIs are the second-most common type of bacterial infection, after those of the respiratory tract, with more than 35 million medically treated infections across the seven major markets each year. This translated into sales in excess of $1.1billion across key markets in 2003, with the majority of value derived from community management. The recent US patent expiry of Bayer's Cipro will result in the increased availability of cheaper versions of the leading UTI antibacterial. As a result, the recent decline in UTI market value is expected to continue over the next 2-3 years, as physicians switch to generic ciprofloxacin, despite the availability of once-daily Cipro XR. Community-based physicians across the major markets prescribe antibacterials for UTIs without knowledge of causative pathogens or specific site of infection. As a result, success in the community is driven by broad-spectrum activity, while the role for more specific therapies is currently limited in this sector. Reasons to Purchase Gain an understanding of current routes of presentation, diagnosis and treatment practices in key economic markets Learn about the key antibacterials prescribed for treating UTIs, the strengths and weaknesses of each and unmet needs in treating such infections Find out how patent expiry has impacted this sector, and how reformulation strategies may prevent generic incursion Table of Contents TABLE OF CONTENTSCHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the community-acquired RTI market 4 Urinary tract infections are the second most common type of bacterial infection, after those of the respiratory tract, with more than 35 million medically treated infections across the seven major markets each year (Stakeholder Insight: Bacterial Infection Epidemiology Database, 2003 - IMHC0067). This translated into sales in excess of $1.1 billion across key markets (US, Japan, UK, France, Italy and Spain) in 2003 (Stakeholder Insight: The Hospital Antibacterial Market, 2003 - DMHC1919; Midas Medical Data, IMS Health, April 2004), with the majority of value derived from community management. 4 The US patent expiry of Bayer’s Cipro (ciprofloxacin) will result in the increased availability of cheaper versions of the leading UTI antibacterial. As a result, the recent decline in UTI market value (CAGR 2001-03 = -0.28%) is expected to continue over the next two to three years, as physicians switch to generic ciprofloxacin, despite the availability of once-daily Cipro XR; 6 Despite the availability of effective pathogen-specific UTI diagnostics, such as Osmetech’s “eNose” technology, community-based physicians across the major markets still prescribe antibacterials for UTIs without knowledge of causative pathogens or specific site of infection. As a result, success in the community is driven by broad-spectrum activity and the role for more specific therapies is currently limited in this sector. 7 Key metrics 9 CHAPTER 2 DISEASE DEFINITION AND EPIDEMIOLOGY 21 Introduction 21 The urinary system 21 Epidemiology 22 Overview 22 Urinary tract infections by gender 24 Women 25 Men 27 Urinary tract infections by age 27 Pediatrics 29 Etiology 29 Nosocomial infections and resistance 30 Disease definition 30 Complicated/uncomplicated urinary tract infections 31 Recurrent urinary tract infections 32 Re-infection 32 Relapse 33 Urethritis 33 Cystitis 33 Pyelonephritis (kidney infection) 34 Asymptomatic urinary tract infection (bacteriuria) 34 Acute urethral syndrome 35 CHAPTER 3 PRESENTATION AND DIAGNOSIS 36 Presentation 36 Referral 37 Reasons for hospitalization 38 Nosocomial UTIs 39 Diagnosis 39 Physical examination 39 Urine samples 40 Collection 40 Dipstick tests 40 Urinalysis 40 Gram stain 41 Urine culture 41 Imaging techniques 42 Ultrasound 42 Nuclear scans 42 Magnetic resonance imaging (MRI) or computed tomography (CT) 42 X-rays 42 Cystoscopy 43 Country comparison 43 Unmet need in diagnosing UTIs 44 CHAPTER 4 MARKET ANALYSIS 46 Market definition 46 Market overview 47 Treatment options 49 Amoxicillin 50 Amoxicillin and clavulanic acid 50 Ciprofloxacin 50 Gatifloxacin 51 Levofloxacin 51 Imipenem and cilastin 51 Linezolid 52 Norfloxacin 52 Ofloxacin 52 Trimethoprim-sulfamethoxazole 53 Treatment options overview 53 Broad-spectrum versus selective antibiotics 56 Antibiotic resistance 57 Contraindications of current UTI-therapies 59 UK case study: treating pregnant women with lower UTIs 59 Therapeutic choice 60 Therapeutic choice by indication 62 Therapeutic choice for specific indications 65 Cystitis 65 Urethritis 68 Therapeutic choice by patient age and gender 70 Therapeutic choice by physician type 76 CHAPTER 5 STRATEGIC EVALUATION 77 Ciprofloxacin, generic incursion and patent expiry 77 Overview 77 Augmentin case study: the impact of patent expiry 77 US 79 EU 80 Physician prescribing and patent expiry 83 Cipro XR 87 Comparing the hospital and community sectors 90 Market overview 90 Hospital versus community pricing differences 91 Marketing in the community and hospitals 93 Targeting for large versus small companies 95 UTIs and the antibacterial lifecycle 96 The importance of UTIs 96 Product positioning and indication approval 97 Niche UTI products 100 APPENDIX A 102 Drug key facts 102 Opinion leader transcripts 108 US key opinion leader 108 1. Presentation 108 2. Diagnosis 109 3. Treatment 110 German key opinion leader 118 1. Epidemiology 118 2. Presentation 118 3. Diagnosis 119 4. Treatment 122 5. Other issues 131 UK key opinion leader 133 1. Epidemiology and definitions 133 2. Presentation 134 3. Diagnosis 135 4. Treatment 138 5. Other issues 147 French key opinion leader 147 1. Presentation 147 3. Treatment 151 Italian key opinion leader 160 1. Epidemiology and definitions 160 2. Presentation 162 3. Diagnosis 163 4. Treatment 166 5. Other issues 174 Spanish key opinion leader 175 1 Epidemiology and definition 175 2. Presentation 177 3. Diagnosis 178 4. Treatment 180 5. Other issues 189 List of tables 191 List of figures 191 Bibliography 195 Bibliography 195 Epidemiology 195 Websites 196 General 196 Sources 196 APPENDIX B 197 About Datamonitor 197 About Datamonitor Healthcare 197 Report methodology 198 Datamonitor Healthcare’s therapy area capabilities 198 About the infectious disease analysis team 199 Datamonitor Healthcare’s Consulting expertise 200 Datamonitor’s Therapeutic Consulting expertise 200 Key therapy team members 201 John Savopoulos, Lead analyst, Infectious Diseases 201 David Abramson, Therapeutic Lead Consultant 202 Disclaimer 203 |
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