WOMEN'S HEALTH: U.S. MARKETS FOR FEMALE URINARY INCONTINENCE THERAPIES

191 Pages | 52 Exhibits | 2014 Analysis | Forecasts Through 2017

OVERVIEW:
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 CONTENTS:
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 
	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 
		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 
	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 
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



COMPANIES COVERED:

  1. Actavis PLC
  2. Addex Therapeutics LTD
  3. Allergan, Inc.
  4. AltheRx Pharmaceuticals, Inc.
  5. American Medical Systems, Inc./ Endo Health Solutions, Inc.
  6. Antares Pharma, Inc.
  7. Ario Pharma LTD/Seroba Kernel
  8. Astellas Pharma, Inc.
  9. C.R. Bard, Inc.
  10. Boston Scientific Corporation
  11. Caldera Medical, Inc.
  12. Coloplast A/S
  13. Contura International A/S/ Speciality European Pharma LTD
  14. Cook Medical, Inc./Cook Group, Inc.
  15. Dainippon Sumitomo Pharma Co. LTD
  16. Endo Health Solutions, Inc.
  17. Ethicon, Inc./Johnson & Johnson
  18. Floelle, Inc.
  19. Ion Channel Innovations LLC
  20. Janssen Pharmaceuticals, Inc./ Johnson & Johnson
  21. Johnson & Johnson
  22. Kissei Pharmaceutical Co. LTD
  23. Kyorin Pharmaceutical Co. LTD/ Kyorin Holdings, Inc.
  24. Lipella Pharmaceuticals, Inc.
  25. Medtronic, Inc.
  26. Merck & Company, Inc.
  27. Merz Aesthetics, Inc./ Merz Pharma GmbH & Co. KGaA
  28. Motif BioSciences, Inc.
  29. NexHand, Inc.
  30. Pfizer, Inc.
  31. Plethora Solutions Holdings PLC
  32. Recordati S.p.A
  33. Solace Therapeutics, Inc.
  34. Syntaxin LTD/Ipsen SA
  35. Targacept, Inc.
  36. Teva Pharmaceuticals USA/ Teva Pharmaceutical Industries LTD
  37. TheraVida, Inc.
  38. Verathon, Inc./Roper Industries, Inc.
  39. Uroplasty, Inc.
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