Women’s Health: U.S. Markets for Female Urinary Incontinence Therapies
Women’s Health: U.S. Markets for Female Urinary Incontinence Therapies
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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.
Publisher: Medtech Insight
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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.
Table of Contents
EXECUTIVE SUMMARY…………………………………………………………………………. ES-1
i. Stress Urinary Incontinence ………………………………………………….. ES-1
ii. Overactive Bladder and Urge Incontinence ……………………………… ES-2
iii. Treatment …………………………………………………………………………… ES-4
a. Drug Therapy ……………………………………………………….. ES-5
b. Botulinum Toxin…………………………………………………….. ES-6
c. Bulking Agents ……………………………………………………… ES-6
d. Implantable Neurostimulation………………………………….. ES-7
e. Percutaneous Tibial Nerve Stimulation……………………… ES-7
f. Urethral Slings………………………………………………………. ES-8
g. Invasive Surgical Options……………………………………… ES-10
iv. Market Analysis …………………………………………………………………. ES-10
a. Combined Market Forecast …………………………………… ES-10
b. Overactive Bladder Drug Treatment Market Forecast .. ES-11
c. Injectable Urethral Bulking Agents Market Forecast….. ES-14
d. Urethral Sling Systems Market Forecast …………………. ES-14
v. Methodology……………………………………………………………………… ES-15
Exhibit ES-1: Female Urinary Incontinence Therapies,
Combined Market Forecast, 2012-2017 ………………………………… ES-12
1. CLINICAL OVERVIEW OF URINARY INCONTINENCE……………………….. 1-1
1.1 Anatomy of the Urinary System………………………………………………… 1-1
1.2 Types of Urinary Incontinence………………………………………………….. 1-2
1.2.1 Stress Urinary Incontinence ………………………………………. 1-2
1.2.1.1 Causes …………………………………………………….. 1-4
1.2.2 Overactive Bladder and Urge Incontinence………………….. 1-4
1.2.2.1 Causes …………………………………………………….. 1-5
1.3 Treatment ……………………………………………………………………………… 1-6
1.3.1 Prescription Drug Therapy…………………………………………. 1-7
1.3.2 Botulinum Toxin……………………………………………………….. 1-8
1.3.3 Bulking Agents ………………………………………………………… 1-8
1.3.4 Sacral Nerve Stimulation…………………………………………… 1-9
1.3.4.1 Implantable Neurostimulation………………………. 1-9
1.3.4.2 Percutaneous Tibial Nerve Stimulation …………. 1-9
1.3.5 Urethral Slings……………………………………………………….. 1-11
1.3.6 Surgical Options …………………………………………………….. 1-13
Exhibit 1-1: Urinary Voiding and Afferent Signaling………………………………………. 1-3
Exhibit 1-2: Sacral Neuromodulation with an Implanted Electrical Stimulator …. 1-10
2. DRUG TREATMENT FOR OVERACTIVE BLADDER ………………………….. 2-1
2.1 Selected Products ………………………………………………………………….. 2-2
2.1.1 Actavis……………………………………………………………………. 2-2
2.1.2 Allergan ………………………………………………………………… 2-10
2.1.3 Astellas Pharma …………………………………………………….. 2-12
2.1.4 Janssen Pharmaceuticals/Johnson & Johnson …………… 2-12
2.1.5 Merck……………………………………………………………………. 2-13
2.1.6 Pfizer ……………………………………………………………………. 2-14
2.1.7 Medications Under Development ……………………………… 2-19
2.1.7.1 Addex Therapeutics …………………………………. 2-19
2.1.7.2 Allergan ………………………………………………….. 2-20
2.1.7.3 AltheRx Pharmaceuticals ………………………….. 2-20
2.1.7.4 Ario Pharma/Seroba Kernel……………………….. 2-21
2.1.7.5 Astellas Pharma ………………………………………. 2-21
2.1.7.6 Dainippon Sumitomo Pharma with Nippon
Shinyaku…………………………………………………. 2-21
2.1.7.7 Ion Channel Innovations……………………………. 2-22
2.1.7.8 Kissei Pharmaceutical with Kyorin
Pharmaceutical/Kyorin Holdings…………………. 2-23
2.1.7.9 Lipella Pharmaceuticals ……………………………. 2-23
2.1.7.10 Merck …………………………………………………….. 2-25
2.1.7.11 Motif BioSciences…………………………………….. 2-25
2.1.7.12 Plethora Solutions ……………………………………. 2-25
2.1.7.13 Recordati………………………………………………… 2-26
2.1.7.14 Targacept ……………………………………………….. 2-26
2.1.7.15 Teva Pharmaceuticals/Teva Pharmaceutical
Industries………………………………………………… 2-26
2.1.7.16 TheraVida……………………………………………….. 2-27
2.2 Market Analysis ……………………………………………………………………. 2-28
2.2.1 Market Forecast …………………………………………………….. 2-28
2.2.2 Competitive Analysis ………………………………………………. 2-29
Exhibit 2-1: 2014, Selected Overactive Bladder Medications …………………………. 2-3
Exhibit 2-2: 2014, Selected Overactive Bladder Medications
Under Development………………………………………………………………… 2-4
Exhibit 2-3: Gelnique Application and Reductions in Urinary Incontinence
Episodes versus Placebo ………………………………………………………… 2-8
Exhibit 2-4: Application of the Oxytrol for Women Patch ……………………………… 2-15
Exhibit 2-5: Reduction in Daily Urinary Incontinence with the
Use of Oxybutynin ………………………………………………………………… 2-16
Exhibit 2-6: Overactive Bladder and the Function of Toviaz and
Behavioral Therapy ………………………………………………………………. 2-18
Exhibit 2-7: Empty Liposomes and Chemical Irritation ………………………………… 2-24
Exhibit 2-8: Overactive Bladder Drug Treatment, Market Forecast,
2012-2017 …………………………………………………………………………… 2-30
Exhibit 2-9: 2012, Market for Overactive Bladder Drug Treatment,
Share by Supplier…………………………………………………………………. 2-34
3. INJECTABLE URETHRAL BULKING AGENTS………………………………….. 3-1
3.1 Selected Products ………………………………………………………………….. 3-3
3.1.1 Boston Scientific………………………………………………………. 3-3
3.1.2 Coloplast ………………………………………………………………… 3-5
3.1.3 Uroplasty ………………………………………………………………… 3-5
3.1.4 Others…………………………………………………………………… 3-12
3.1.4.1 Speciality European Pharma……………………… 3-12
3.2 Market Analysis ……………………………………………………………………. 3-13
3.2.1 Procedure Volumes………………………………………………… 3-15
3.2.2 Market Forecast …………………………………………………….. 3-17
3.2.3 Competitive Analysis ………………………………………………. 3-17
Exhibit 3-1: The Coaptite Injectable Implant Procedure ………………………………… 3-4
Exhibit 3-2: The Macroplastique Injectable Bulking Agent……………………………… 3-7
Exhibit 3-3: Macroplastique Treatment, Key Efficacy Results at 12 Months……… 3-9
Exhibit 3-4: Macroplastique Treatment, Key Adverse Events……………………….. 3-11
Exhibit 3-5: The Bulkamid Urethral Bulking System and
Injection Technique ………………………………………………………………. 3-14
Exhibit 3-6: Injectable Urethral Bulking Therapy, Procedure
Volumes Forecast, 2012-2017 ……………………………………………….. 3-16
Exhibit 3-7: Injectable Urethral Bulking Agents, Market Forecast,
2012-2017 …………………………………………………………………………… 3-18
Exhibit 3-8: 2012, Injectable Urethral Bulking Agents Market,
Share by Supplier…………………………………………………………………. 3-20
4. URETHRAL SLING SYSTEMS …………………………………………………………. 4-1
4.1 Selected Products ………………………………………………………………….. 4-4
4.1.1 American Medical Systems/Endo Health Solutions……….. 4-4
4.1.2 Bard Medical/C.R. Bard…………………………………………… 4-20
4.1.3 Boston Scientific…………………………………………………….. 4-23
4.1.4 Caldera Medical …………………………………………………….. 4-26
4.1.5 Coloplast ………………………………………………………………. 4-29
4.1.6 Cook Medical/Cook Group ………………………………………. 4-32
4.1.7 Ethicon/Johnson & Johnson…………………………………….. 4-32
4.2 Lawsuits Related to Urethral Sling Systems……………………………… 4-38
4.2.1 American Medical Systems/Endo Health Solutions……… 4-42
4.2.2 Boston Scientific…………………………………………………….. 4-42
4.2.3 Ethicon/Johnson & Johnson…………………………………….. 4-43
4.3 Market Analysis ……………………………………………………………………. 4-43
4.3.1 Procedure Volumes………………………………………………… 4-43
4.3.2 Market Forecast …………………………………………………….. 4-46
4.2.3 Competitive Analysis ………………………………………………. 4-46
Exhibit 4-1: 2014, Selected Urethral Sling Systems ……………………………………… 4-5
Exhibit 4-2: The MiniArc Precise Sling System…………………………………………… 4-10
Exhibit 4-3: The MiniArc Single-Incision Sling ……………………………………………. 4-11
Exhibit 4-4: The MiniArc Pro Sling System………………………………………………… 4-13
Exhibit 4-5: The Monarc Subfascial Hammock…………………………………………… 4-15
Exhibit 4-6: Suprapubic and Transobturator Approaches to Mid-Urethral Sling
Placement Using the BioArc SP and BioArc TO Sling Systems …… 4-17
Exhibit 4-7: The 12-Step Mid-Urethral Sling Implant Procedure Using
the BioArc SP Sling System …………………………………………………… 4-18
Exhibit 4-8: The In-Fast Ultra Transvaginal Sling ……………………………………….. 4-21
Exhibit 4-9: The Ajust Adjustable Single-Incision Sling ……………………………….. 4-22
Exhibit 4-10: The Align Urethral Support System …………………………………………. 4-24
Exhibit 4-11: The PelviLace Biourethral Support System ………………………………. 4-25
Exhibit 4-12: Components of the Advantage Transvaginal Mid-Urethral
Sling System ……………………………………………………………………….. 4-27
Exhibit 4-13: Steps in Mid-Urethral Sling Placement Using the
Advantage Sling System ……………………………………………………….. 4-28
Exhibit 4-14: The Desara Sling System………………………………………………………. 4-30
Exhibit 4-15: Comparison of the Desara Sling System’s Mesh with
Other Slings…………………………………………………………………………. 4-31
Exhibit 4-16: The Aris Transobturator Sling System……………………………………… 4-33
Exhibit 4-17: The Biodesign Tension-Free Urethral Sling………………………………. 4-34
Exhibit 4-18: The TVT Abbrevo Tension-Free Sling System ………………………….. 4-36
Exhibit 4-19: Safety Advantages of Using the TVT Abbrevo Tension-Free
Sling System ……………………………………………………………………….. 4-37
Exhibit 4-20: Comparable Clinical Improvement at 36 months, Modified TVT
Obturator System versus the Original TVT Obturator System……… 4-39
Exhibit 4-21: TVT Tension-Free Support and TVT Exact Sling Systems,
Comparative Perforation and Voiding Dysfunction Rates……………. 4-40
Exhibit 4-22: Urethral Sling Placement, Procedure Volumes Forecast,
2012-2017 …………………………………………………………………………… 4-45
Exhibit 4-23: Urethral Sling Systems, Market Forecast, 2012-2017 ………………… 4-47
Exhibit 4-24: 2012, Urethral Sling Systems Market, Share by Supplier……………. 4-49
5. SACRAL NERVE STIMULATION ……………………………………………………… 5-1
5.1 Selected Products ………………………………………………………………….. 5-1
5.1.1 Medtronic………………………………………………………………… 5-2
5.1.2 Uroplasty ………………………………………………………………. 5-11
5.1.2.1 Urgent PC Revenues ……………………………….. 5-16
Exhibit 5-1: InterStim Device Implantation…………………………………………………… 5-3
Exhibit 5-2: The InterStim Therapy System…………………………………………………. 5-5
Exhibit 5-3: InterStim Therapy, 12-Month and 5-Year Sustained
Clinical Efficacy ……………………………………………………………………… 5-7
Exhibit 5-4: The Sacral Plexus ………………………………………………………………… 5-12
Exhibit 5-5: The Urgent PC Neuromodulation System ………………………………… 5-13
Exhibit 5-6: Percutaneous Tibial Nerve Stimulation Using the Urgent PC
Neuromodulation System, Meta-Analysis Summary…………………… 5-15
6. NONSURGICAL INCONTINENCE THERAPIES………………………………….. 6-1
6.1 Selected Products ………………………………………………………………….. 6-1
6.1.1 Floelle…………………………………………………………………….. 6-1
6.1.2 NexHand ………………………………………………………………… 6-3
6.1.3 Solace Therapeutics…………………………………………………. 6-5
6.1.4 Verathon/Roper Industries…………………………………………. 6-6
Exhibit 6-1: The Lyrette Transurethral SUI System and Benefits of Treatment …. 6-8
Exhibit 6-2: The Lyrette Procedure and Mechanism of Action………………………… 6-9
7. COMPANY PROFILES…………………………………………………………………….. 7-1
7.1 Actavis PLC…………………………………………………………………………… 7-1
7.2 Boston Scientific Corporation …………………………………………………… 7-4
7.3 Endo Health Solutions, Inc. ……………………………………………………… 7-7
7.4 Johnson & Johnson………………………………………………………………. 7-11
7.5 Medtronic, Inc………………………………………………………………………. 7-14
7.6 Merck & Company, Inc. …………………………………………………………. 7-16
7.7 Uroplasty, Inc……………………………………………………………………….. 7-19
Figure: Female Urinary Incontinence Therapies, Market Forecast, 2012-2017
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