Women%s Health: U.S. Markets for Female Urinary Incontinence Therapies

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Women%s Health: U.S. Markets for Female Urinary Incontinence Therapies Published on March 2014

Report Summary Incontinence may be defined as the involuntary loss of bladder or bowel control. In the United States (U.S.), urinary incontinence (UI) is highly prevalent. According to the National Association for Continence (NAFC), the condition affects more than 200 million people worldwide, with a conservative estimate of 25 million adults in the U.S. experiencing chronic or transient UI. The NAFC estimates that 75% to 80% of the UI population comprises women, with 9 million to 13 million suffering severe symptoms. Additionally, an estimated 3.3 million women in the U.S. have pelvic organ prolapse (POP), a condition that may result in UI, and an estimated 18.0 million people suffer from fecal incontinence. Despite the high prevalence, urinary incontinence remains vastly undertreated, with an estimated two-thirds of those with the condition forgoing treatment and less than one-half consulting a physician. This report focuses on minimally invasive therapy systems and medications designed for the treatment of female UI, including OAB pharmaceutical or drug treatments, injectable urethral bulking agents, and urethral sling systems, of which the OAB drug treatments market contributes the vast majority of revenues. In 2012, the value of the U.S. female UI therapies market (as defined by the scope of this report) totaled approximately $1,255.4 million. The majority of sales were derived from OAB drug revenues due to a large population base, wide availability of prescription and OTC products, and ease of use. Over the forecast period covered by this report, total sales in this market are expected to increase at a compound annual rate of 6.6%, reaching an estimated $1,727.2 million in the year 2017. This dynamic, new report from Medtech Insight includes analyses of products, current/forecast markets, competitors, and opportunities in the U.S. female urinary incontinence therapies market. Covered topics in this report include an overview of female urinary incontinence and core therapies, including drug treatments for OAB; injectable urethral bulking agents; urethral sling systems; sacral nerve stimulation, and emerging drugs and technologies.

Table of Content EXECUTIVE SUMMARY i. Stress Urinary Incontinence ii. Overactive Bladder and Urge Incontinence iii. Treatment a. Drug Therapy b. Botulinum Toxin c. Bulking Agents d. Implantable Neurostimulation e. Percutaneous Tibial Nerve Stimulation f. Urethral Slings g. Invasive Surgical Options iv. Market Analysis a. Combined Market Forecast

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>> Get this Report Now by email! b. Overactive Bladder Drug Treatment Market Forecast c. Injectable Urethral Bulking Agents Market Forecast d. Urethral Sling Systems Market Forecast v. Methodology Exhibit ES-1: Female Urinary Incontinence Therapies, Combined Market Forecast, 2012-2017 1. CLINICAL OVERVIEW OF URINARY INCONTINENCE 1.1 Anatomy of the Urinary System 1.2 Types of Urinary Incontinence 1.2.1 Stress Urinary Incontinence 1.2.1.1 Causes 1.2.2 Overactive Bladder and Urge Incontinence 1.2.2.1 Causes 1.3 Treatment 1.3.1 Prescription Drug Therapy 1.3.2 Botulinum Toxin 1.3.3 Bulking Agents 1.3.4 Sacral Nerve Stimulation 1.3.4.1 Implantable Neurostimulation 1.3.4.2 Percutaneous Tibial Nerve Stimulation 1.3.5 Urethral Slings 1.3.6 Surgical Options Exhibit 1-1: Urinary Voiding and Afferent Signaling Exhibit 1-2: Sacral Neuromodulation with an Implanted Electrical Stimulator 2. DRUG TREATMENT FOR OVERACTIVE BLADDER 2.1 Selected Products 2.1.1 Actavis 2.1.2 Allergan 2.1.3 Astellas Pharma 2.1.4 Janssen Pharmaceuticals/Johnson & Johnson 2.1.5 Merck 2.1.6 Pfizer 2.1.7 Medications Under Development 2.1.7.1 Addex Therapeutics 2.1.7.2 Allergan 2.1.7.3 AltheRx Pharmaceuticals 2.1.7.4 Ario Pharma/Seroba Kernel 2.1.7.5 Astellas Pharma 2.1.7.6 Dainippon Sumitomo Pharma with Nippon Shinyaku 2.1.7.7 Ion Channel Innovations 2.1.7.8 Kissei Pharmaceutical with Kyorin Pharmaceutical/Kyorin Holdings 2.1.7.9 Lipella Pharmaceuticals 2.1.7.10 Merck

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>> Get this Report Now by email! 2.1.7.11 Motif BioSciences 2.1.7.12 Plethora Solutions 2.1.7.13 Recordati 2.1.7.14 Targacept 2.1.7.15 Teva Pharmaceuticals/Teva Pharmaceutical Industries 2.1.7.16 TheraVida 2.2 Market Analysis 2.2.1 Market Forecast 2.2.2 Competitive Analysis Exhibit 2-1: 2014, Selected Overactive Bladder Medications Exhibit 2-2: 2014, Selected Overactive Bladder Medications Under Development Exhibit 2-3: Gelnique Application and Reductions in Urinary Incontinence Episodes versus Placebo Exhibit 2-4: Application of the Oxytrol for Women Patch Exhibit 2-5: Reduction in Daily Urinary Incontinence with the Use of Oxybutynin Exhibit 2-6: Overactive Bladder and the Function of Toviaz and Behavioral Therapy Exhibit 2-7: Empty Liposomes and Chemical Irritation Exhibit 2-8: Overactive Bladder Drug Treatment, Market Forecast, 2012-2017 Exhibit 2-9: 2012, Market for Overactive Bladder Drug Treatment, Share by Supplier 3. INJECTABLE URETHRAL BULKING AGENTS 3.1 Selected Products 3.1.1 Boston Scientific 3.1.2 Coloplast 3.1.3 Uroplasty 3.1.4 Others 3.1.4.1 Speciality European Pharma 3.2 Market Analysis 3.2.1 Procedure Volumes 3.2.2 Market Forecast 3.2.3 Competitive Analysis Exhibit 3-1: The Coaptite Injectable Implant Procedure Exhibit 3-2: The Macroplastique Injectable Bulking Agent Exhibit 3-3: Macroplastique Treatment, Key Efficacy Results at 12 Months Exhibit 3-4: Macroplastique Treatment, Key Adverse Events Exhibit 3-5: The Bulkamid Urethral Bulking System and Injection Technique Exhibit 3-6: Injectable Urethral Bulking Therapy, Procedure Volumes Forecast, 2012-2017 Exhibit 3-7: Injectable Urethral Bulking Agents, Market Forecast, 2012-2017 Exhibit 3-8: 2012, Injectable Urethral Bulking Agents Market, Share by Supplier 4. URETHRAL SLING SYSTEMS 4.1 Selected Products 4.1.1 American Medical Systems/Endo Health Solutions 4.1.2 Bard Medical/C.R. Bard 4.1.3 Boston Scientific

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>> Get this Report Now by email! 4.1.4 Caldera Medical 4.1.5 Coloplast 4.1.6 Cook Medical/Cook Group 4.1.7 Ethicon/Johnson & Johnson 4.2 Lawsuits Related to Urethral Sling Systems 4.2.1 American Medical Systems/Endo Health Solutions 4.2.2 Boston Scientific 4.2.3 Ethicon/Johnson & Johnson 4.3 Market Analysis 4.3.1 Procedure Volumes 4.3.2 Market Forecast 4.2.3 Competitive Analysis Exhibit 4-1: 2014, Selected Urethral Sling Systems Exhibit 4-2: The MiniArc Precise Sling System Exhibit 4-3: The MiniArc Single-Incision Sling Exhibit 4-4: The MiniArc Pro Sling System Exhibit 4-5: The Monarc Subfascial Hammock Exhibit 4-6: Suprapubic and Transobturator Approaches to Mid-Urethral Sling Placement Using the BioArc SP and BioArc TO Sling Systems Exhibit 4-7: The 12-Step Mid-Urethral Sling Implant Procedure Using the BioArc SP Sling System Exhibit 4-8: The In-Fast Ultra Transvaginal Sling Exhibit 4-9: The Ajust Adjustable Single-Incision Sling Exhibit 4-10: The Align Urethral Support System Exhibit 4-11: The PelviLace Biourethral Support System Exhibit 4-12: Components of the Advantage Transvaginal Mid-Urethral Sling System Exhibit 4-13: Steps in Mid-Urethral Sling Placement Using the Advantage Sling System Exhibit 4-14: The Desara Sling System Exhibit 4-15: Comparison of the Desara Sling System's Mesh with Other Slings Exhibit 4-16: The Aris Transobturator Sling System Exhibit 4-17: The Biodesign Tension-Free Urethral Sling Exhibit 4-18: The TVT Abbrevo Tension-Free Sling System Exhibit 4-19: Safety Advantages of Using the TVT Abbrevo Tension-Free Sling System Exhibit 4-20: Comparable Clinical Improvement at 36 months, Modified TVT Obturator System versus the Original TVT Obturator System Exhibit 4-21: TVT Tension-Free Support and TVT Exact Sling Systems, Comparative Perforation and Voiding Dysfunction Rates Exhibit 4-22: Urethral Sling Placement, Procedure Volumes Forecast, 2012-2017 Exhibit 4-23: Urethral Sling Systems, Market Forecast, 2012-2017 Exhibit 4-24: 2012, Urethral Sling Systems Market, Share by Supplier 5. SACRAL NERVE STIMULATION 5.1 Selected Products 5.1.1 Medtronic 5.1.2 Uroplasty 5.1.2.1 Urgent PC Revenues Exhibit 5-1: InterStim Device Implantation

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>> Get this Report Now by email! Exhibit 5-2: The InterStim Therapy System Exhibit 5-3: InterStim Therapy, 12-Month and 5-Year Sustained Clinical Efficacy Exhibit 5-4: The Sacral Plexus Exhibit 5-5: The Urgent PC Neuromodulation System Exhibit 5-6: Percutaneous Tibial Nerve Stimulation Using the Urgent PC Neuromodulation System, Meta-Analysis Summary 6. NONSURGICAL INCONTINENCE THERAPIES 6.1 Selected Products 6.1.1 Floelle 6.1.2 NexHand 6.1.3 Solace Therapeutics 6.1.4 Verathon/Roper Industries Exhibit 6-1: The Lyrette Transurethral SUI System and Benefits of Treatment Exhibit 6-2: The Lyrette Procedure and Mechanism of Action 7. COMPANY PROFILES 7.1 Actavis PLC 7.2 Boston Scientific Corporation 7.3 Endo Health Solutions, Inc. 7.4 Johnson & Johnson 7.5 Medtronic, Inc. 7.6 Merck & Company, Inc. 7.7 Uroplasty, Inc.

APPENDIX: COMPANY LISTING

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