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Women’s Health: U.S. Markets for Female Urinary Incontinence Therapies
Report #A472
- February 2014
191 Pages – 52 Exhibits – 7 Company Profiles

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.

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


February 2014


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Reports are produced exclusively by Medtech Insight, through extensive primary and secondary research among the clinicians, researchers, and competitors in the marketplace, and draw upon the industry expertise of a network of industry insiders. Medtech Insight exhaustively corroborates the data as a baseline for completing forward-looking analysis and providing insight into product, technology and market evolution.





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

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



1.1 Anatomy of the Urinary System

1.2 Types of Urinary Incontinence

1.2.1 Stress Urinary Incontinence Causes

1.2.2 Overactive Bladder and Urge Incontinence 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 Implantable Neurostimulation 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



2.1 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 Addex Therapeutics Allergan AltheRx Pharmaceuticals Ario Pharma/Seroba Kernel Astellas Pharma Dainippon Sumitomo Pharma with Nippon Shinyaku Ion Channel Innovations Kissei Pharmaceutical with Kyorin Pharmaceutical/Kyorin Holdings Lipella Pharmaceuticals Merck Motif BioSciences Plethora Solutions Recordati Targacept Teva Pharmaceuticals/Teva Pharmaceutical Industries 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



3.1 Selected Products

3.1.1 Boston Scientific

3.1.2 Coloplast

3.1.3 Uroplasty

3.1.4 Others 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



4.1 Selected Products

4.1.1 American Medical Systems/Endo Health Solutions

4.1.2 Bard Medical/C.R. Bard

4.1.3 Boston Scientific

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



5.1 Selected Products

5.1.1 Medtronic

5.1.2 Uroplasty Urgent PC Revenues


Exhibit 5-1:      InterStim Device Implantation

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



6.1 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



7.1       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.




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