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Women’s Health - US Analysis and Market Forecasts


The Women’s Health medical devices market encompasses treatments for conditions that are particular to the adult female anatomy. This includes abnormal uterine conditions, such as menorrhagia and uterine fibroids, as well as pelvic disorders such as female stress urinary incontinence. Moreover, there is a sub-segment of the female population that no longer desire to become pregnant, and seek permanent solutions to avoid conception.

In recent years, minimally invasive techniques and technologies have been developed to treat these conditions as alternatives to conventional surgery; these technologies are expected to see increased adoption in the coming years due to increased physician and patient awareness as well as an increasing number of women who are proactively seeking treatment for these embarrassing, and sometimes debilitating, conditions. However, recent lawsuits related to safety issues with some of these devices that are receiving widespread media attention, particularly in the urinary incontinence sling market, have caused some women to be skeptical of these newer technologies.

The technologies covered in this report include global endometrial devices, endometrial resection devices, uterine fibroid embolization agents, female sterilization devices, and female urinary incontinence slings. The report provides insights into the competitive landscape, the marketed and pipeline products, the current and emerging players and market analysis of the different device segments within the women’s health market in the US. The report also provides insight into the unmet needs and an understanding of physician perceptions of the market. This report is built using data and information sourced from secondary sources and primary research interviews with leading gynecologists, urogynecologists, interventional radiologists, and general surgeons, with in-house analysis conducted by GlobalData’s team of industry experts.

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Key Questions Answered

- What is the current and future women’s health market outlook in the US? What trends are affecting this market?
- Which are the key, high growth markets that manufacturers should expand into? Which markets are growing the fastest, and what are the top-selling products in each segment?
- What are the unmet needs with women’s health devices currently on the market? How will emerging technologies fulfill these unmet needs?
- What clinical factors and technical specifications influence a physician to use one type of device over another? What is physician perception and market outlook for women’s health devices?
- What are the challenges and complications that have hindered widespread adoption of newer technologies?
- With developing the next-generation of devices, what aspects of the technology are device manufacturers focused on optimizing? How will new entrants impact the US women’s health market?


- Overview of women’s health, including anatomy, epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines and modalities.
- Annualized total women’s health market revenue from 2011-2021 including adoption patterns in the US.
- Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement and regulatory considerations, and implications for the women’s health market.
- Pipeline analysis: Comprehensive data split across different stages of development, including a discussion of emerging trends and women’s health devices in development.
- Analysis of the current and future market competition in the US women’s health market. Insightful review of the key industry drivers, opportunities, barriers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- “What Physicians Think” quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. In this report you will understand the perceptions of leading gynecologists, urogynecologists, interventional radiologists, and general surgeons from around the world. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table Of Contents

Women’s Health - US Analysis and Market Forecasts
1 Table of Contents
1.1 List of Figures
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
3 Industry Overview
3.1 Overview
3.1.1 Anatomy
3.2 Indications
3.2.1 Overview
3.2.2 Abnormal Uterine Conditions
3.2.3 Female Urinary Incontinence
3.3 Clinical Presentation
3.3.1 Abnormal Uterine Conditions
3.3.2 Female Urinary Incontinence
3.4 Market Segmentation
3.5 Market Access
3.5.1 Purchasing Decisions
3.6 Influence of Clinical Trials
3.7 Adoption
3.8 Regulation
3.8.1 US
3.9 Reimbursement
3.9.1 US
3.10 Procedure Trends
3.10.1 By Region
3.11 Regulatory Issues/Recalls
3.11.1 Hologic Discontinues Manufacturing, Marketing, and Sales of Adiana
3.11.2 Recall of Numerous Transvaginal Mesh Products
3.12 MandAs, Key Partnerships
3.12.1 Bayer Health Acquires Conceptus for $1.1 Billion
3.12.2 Boston Scientific Acquires IoGyn for $65m
3.13 Economic Impact
3.13.1 Indirect Costs
3.13.2 Direct Costs
4 Unmet Needs
4.1 Overview
4.2 Endometrial Ablation/Resection Devices
4.2.1 Better Fluid Management
4.2.2 Improved Imaging Guidanc
4.2.3 Regulating Depth of Ablation
4.3 Uterine Fibroid Embolization Agents
4.3.1 Addressing Fibroid Recurrence
4.3.2 Assessing Effect on Fertility
4.3.3 Preventing Ovarian Failure
4.4 Female Sterilization Devices
4.4.1 Accelerated Scar Tissue Formation
4.4.2 Lack of Reversibility
4.4.3 Preventing Micro-insert Migration
4.4.4 Preventing Perforation
4.4.5 Trocar Size Reduction
4.5 Female Urinary Incontinence Slings
4.5.1 Anatomical Adaptation
4.5.2 Single-Incision Slings
5 Market Opportunity Analysis
5.1 Overview
5.2 Endometrial Ablation/Resection Devices
5.2.1 Targeted Fibroid Ablation
5.3 Uterine Fibroid Embolization Agents
5.3.1 Novel Agents
5.4 Female Sterilization Devices
5.4.1 Raising Patient Awareness
5.4.2 Rapid Transcervical Sterilization
5.5 Female Urinary Incontinence Slings
5.5.1 Materials and Coatings
5.5.2 European and APAC Markets
6 Market Drivers and Barriers
6.1 Endometrial Ablation/Resection
6.1.1 Driver: Patient Preference for Minimally Invasive Treatments
6.1.2 Driver: Growing Procedure Volume
6.1.3 Barrier: High Device and Procedure Cost
6.1.4 Substitute: Hysterectomy
6.1.5 Substitute: Intrauterine Devices
6.2 Uterine Fibroid Embolization Agents
6.2.1 Driver: Increasing Prevalence of Uterine Fibroids
6.2.2 Driver: Improving Imaging Capabilities
6.2.3 Barrier: Lack of Patient Awareness
6.2.4 Substitute: MRI-guided Focused Ultrasound
6.2.5 Substitute: Myomectomy
6.3 Female Sterilization Devices
6.3.1 Driver: Growing Female Population using Modern Contraception
6.3.2 Driver: Increasing Adoption of Transcervical Sterilization
6.3.3 Barrier: Patient Preference for Reversible Contraception
6.3.4 Substitute: Traditional Contraception
6.4 Female Urinary Incontinence Slings
6.4.1 Driver: Growing Treatment Rates and Use of Surgery
6.4.2 Barrier: Highly Litigious US Market
6.4.3 Substitute: Surgical Repair
6.4.4 Substitute: Pelvic Floor Electrical Stimulation
7 Competitive Assessment
7.1 Overview
7.2 Classification Based on Features
7.2.1 Endometrial Ablation Devices
7.2.2 Endometrial Resection Devices
7.2.3 Uterine Fibroid Embolization Agents
7.2.4 Female Sterilization Devices
7.2.5 Female Urinary Incontinence Slings
7.3 Key Product Profiles
7.3.1 Endometrial Ablation Devices
7.3.2 Endometrial Resection Devices
7.3.3 Uterine Fibroid Embolization Agents
7.3.4 Female Sterilization Devices
7.3.5 Female Urinary Incontinence Slings
8 Pipeline Assessment
8.1 Overview
8.2 Key Product Profiles
8.2.1 Endometrial Ablation Devices
8.2.2 Uterine Fibroid Embolization Agents
8.2.3 Female Sterilization Devices
8.2.4 Female Urinary Incontinence Slings
9 Clinical Trials to Watch
9.1 Overview
9.2 Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation
9.3 Post Market Study of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence (Solyx)
9.4 Safety and Effectiveness Study of Aegea Vapor System to Treat Excessive Uterine Bleeding
9.5 The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence (EASY)
10 Current and Future Players
10.1 Overview
10.2 Trends in Corporate Strategy
10.3 Company Profiles
10.3.1 American Medical Systems
10.3.2 AngioDynamics
10.3.3 Bayer Healthcare (Bayer AG)
10.3.4 Boston Scientific
10.3.5 BTG
10.3.6 Coloplast
10.3.7 Cook Medical
10.3.8 CooperSurgical
10.3.9 C.R. Bard
10.3.10 Ethicon (Johnson and Johnson)
10.3.11 Femcare-Nikomed (Utah Medical Products)
10.3.12 Hologic
10.3.13 Karl Storz
10.3.14 Olympus
10.3.15 Richard Wolf
10.3.16 Stryker
11 Market Outlook
11.1 By Geography
11.1.1 By Country
12 Appendix
12.1 Bibliography
12.2 Abbreviations
12.3 Report Methodology
12.3.1 Overview
12.3.2 Coverage
12.3.3 Secondary Research
12.4 Forecasting Methodology
12.5 Physicians and Specialists Included in This Study
12.6 Primary Research - Prescriber Survey
12.7 About the Authors
12.7.1 Analysts
12.7.2 Global Head of Healthcare
12.8 About GlobalData
12.9 Disclaimer

1.1 List of Figures
Table 1: Types of Uterine Fibroids
Table 2: Types of Female Urinary Incontinence
Table 3: Drug and Hormone Treatments for Menorrhagia
Table 4: Surgical Treatments for Menorrhagia
Table 5: Treatments for Stress, Urge, and Mixed Urinary Incontinence
Table 6: Market Segmentation for Women's Health Market
Table 7: FDA Medical Device Classification System
Table 8: CPT Codes and Description of Coverage for Gynecological Procedures
Table 9: APC Codes and Description of Coverage for Gynecological Procedures
Table 10: ICD-10 Codes Associated with Causes of Menorrhagia and Uterine Fibroids
Table 11: CPT Codes and Description of Coverage for Urinary Incontinence Sling Procedures
Table 12: APC Codes and Description of Coverage for Urinary Incontinence Sling Procedures
Table 13: ICD-10 Codes Associated with Female Stress Urinary Incontinence
Table 14: Endometrial Ablation Devices, SWOT Analysis, 2015
Table 15: Currently Marketed Endometrial Ablation Devices, 2015
Table 16: Endometrial Resection, SWOT Analysis, 2015
Table 17: Uterine Fibroid Embolization, SWOT Analysis, 2015
Table 18: Device-based Permanent Female Sterilization, SWOT Analysis, 2015
Table 19: Currently Marketed Notable Female Urinary Incontinence Slings, 2015
Table 20: Female Urinary Incontinence Slings, SWOT Analysis, 2015
Table 21: Product Profile - Cavaterm (Veldana Medical)
Table 22: Cavaterm, SWOT Analysis, 2015
Table 23: Product Profile - ThermaChoice (Ethicon)
Table 24: ThermaChoice, SWOT Analysis, 2015
Table 25: Product Profile - Genesys HTA (Boston Scientific)
Table 26: Genesys HTA, SWOT Analysis, 2015
Table 27: Product Profile - NovaSure (Hologic)
Table 28: NovaSure, SWOT Analysis, 2015
Table 29: Product Profile - Minerva Endometrial Ablation System (Minerva Surgical)
Table 30: Minerva Endometrial Ablation System, SWOT Analysis, 2015
Table 31: Product Profile - Her Option (CooperSurgical)
Table 32: Her Option, SWOT Analysis, 2015
Table 33: Product Profile - Acculis MTA (AngioDynamics)
Table 34: Acculis MTA, SWOT Analysis, 2015
Table 35: Product Profile - Acessa (Halt Medical)
Table 36: Acessa, SWOT Analysis, 2015
Table 37: Product Profile - Sonata (Gynesonics)
Table 38: Sonata, SWOT Analysis, 2015
Table 39: Product Profile - 26Fr Continuous Flow Resectoscope (Stryker)
Table 40: 26Fr Continuous Flow Resectoscope, SWOT Analysis, 2015
Table 41: Product Profile - Karl Storz Bipolar Resectoscope (Karl Storz)
Table 42: Karl Storz Bipolar Resectoscope, SWOT Analysis, 2015
Table 43: Product Profile - SurgMaster Resectoscope (Olympus)
Table 44: SurgMaster Resectoscope, SWOT Analysis, 2015
Table 45: Product Profile - Princess Resectoscope (Richard Wolf)
Table 46: Princess Resectoscope, SWOT Analysis, 2015
Table 47: Product Profile - Versapoint (Ethicon)
Table 48: Versapoint, SWOT Analysis, 2015
Table 49: Product Profile - Gelfoam (Pfizer)
Table 50: Gelfoam, SWOT Analysis, 2015
Table 51: Product Profile - Bead Block (BTG)
Table 52: Bead Block, SWOT Analysis, 2015
Table 53: Product Profile - Contour PVA Embolization Particles (Boston Scientific)
Table 54: Contour PVA Embolization Particles, SWOT Analysis, 2015
Table 55: Product Profile - PVA Foam Embolization Particles (Cook Medical)
Table 56: PVA Foam Embolization Particles, SWOT Analysis, 2015
Table 57: Product Profile - Embosphere Microspheres (Merit Medical Systems)
Table 58: Embosphere Microspheres, SWOT Analysis, 2015
Table 59: Product Profile - Filshie Clip (Femcare-Nikomed)
Table 60: Filshie Clip, SWOT Analysis, 2015
Table 61: Product Profile - Essure (Bayer Healthcare)
Table 62: Essure, SWOT Analysis, 2015
Table 63: Product Profile - Align Urethral Support System (C.R. Bard)
Table 64: Align Urethral Support System, SWOT Analysis, 2015
Table 65: Product Profile - Altis Single Incision Sling (Coloplast)
Table 66: Altis Single Incision Sling, SWOT Analysis, 2015
Table 67: Product Profile - Gynecare TVT (Ethicon)
Table 68: Gynecare TVT, SWOT Analysis, 2015
Table 69: Product Profile - MiniArc Single-Incision Sling (American Medical Systems)
Table 70: MiniArc Single-Incision Sling, SWOT Analysis, 2015
Table 71: Product Profile - Solyx (Boston Scientific)
Table 72: Solyx, SWOT Analysis, 2015
Table 73: Product Profile - Aegea Vapor System (Aegea Medical)
Table 74: Aegea Vapor System, SWOT Analysis, 2015
Table 75: Product Profile - Cryothermic Therapy (Channel Medsystems)
Table 76: Cryothermic Therapy, SWOT Analysis, 2015
Table 77: Product Profile - Biodegradable Bead
Table 78: Biodegradable Bead, SWOT Analysis, 2015
Table 79: Product Profile - FemBloc
Table 80: FemBloc, SWOT Analysis, 2015
Table 81: Product Profile - PTMC Mesh
Table 82: PTMC Mesh, SWOT Analysis, 2015
Table 83: Product Profile - sensiTVT
Table 84: sensiTVT, SWOT Analysis, 2015
Table 85: Company Profile - American Medical Systems
Table 86: American Medical Systems, SWOT Analysis, 2015
Table 87: Company Profile - AngioDynamics
Table 88: AngioDynamics, SWOT Analysis, 2015
Table 89: Company Profile - Bayer Healthcare
Table 90: Bayer Healthcare, SWOT Analysis, 2015
Table 91: Company Profile - Boston Scientific
Table 92: Boston Scientific, SWOT Analysis, 2015
Table 93: Company Profile - BTG
Table 94: BTG, SWOT Analysis, 2015
Table 95: Company Profile - Coloplast
Table 96: Coloplast, SWOT Analysis, 2015
Table 97: Company Profile - Cook Medical
Table 98: Cook Medical, SWOT Analysis, 2015
Table 99: Company Profile - CooperSurgical
Table 100: CooperSurgical, SWOT Analysis, 2015
Table 101: Company Profile - C.R. Bard
Table 102: C.R. Bard, SWOT Analysis, 2015
Table 103: Company Profile - Ethicon
Table 104: Ethicon, SWOT Analysis, 2015
Table 105: Company Profile - Femcare-Nikomed
Table 106: Femcare-Nikomed, SWOT Analysis, 2015
Table 107: Company Profile - Hologic
Table 108: Hologic, SWOT Analysis, 2015
Table 109: Company Profile - Karl Storz
Table 110: Karl Storz, SWOT Analysis, 2015
Table 111: Company Profile - Olympus
Table 112: Olympus, SWOT Analysis, 2015
Table 113: Company Profile - Richard Wolf
Table 114: Richard Wolf, SWOT Analysis, 2015
Table 115: Company Profile - Stryker
Table 116: Stryker, SWOT Analysis, 2015
Table 117: US Women's Health Market Forecast ($m) by Market Segment, 2011-2021
Table 118: US Endometrial Ablation Market Forecast ($m) by Market Segment, 2011-2021
Table 119: US Endometrial Resection Devices Market Forecast ($m) by Market Segment, 2011-2021
Table 120: US Uterine Fibroid Embolization Agents Market Forecast ($m) by Market Segment, 2011-2021
Table 121: US Female Sterilization Devices Market Forecast ($m) by Market Segment, 2011-2021
Table 122: US Female Urinary Incontinence Slings Market Forecast ($m), 2011-2021

1.2 List of Figures
Figure 1: Percentage Breakdown of Urinary Incontinence, by Type
Figure 2: Percentage of Patients with Menorrhagia Receiving Treatment, by Type
Figure 3: Percentage of Patients with Urinary Incontinence Receiving Treatment, by Type
Figure 4: US Procedure Volume Forecast, Endometrial Resection, 2011-2021
Figure 5: US Procedure Volume Forecast, Uterine Artery Embolization, 2011-2021
Figure 6: US Procedure Volume Forecast, Female Sterilization, 2011-2021
Figure 7: US Procedure Volume Forecast, Urinary Incontinence Slings, 2011-2021
Figure 8: US Women's Health Market Forecast ($m) by Segment, 2011-2021
Figure 9: US Women's Health Market Share by Market Segment, 2014 and 2021
Figure 10: US Endometrial Ablation Market Forecast ($m) by Market Segment, 2011-2021
Figure 11: US Endometrial Ablation Market Share by Market Segment, 2014 and 2021
Figure 12: US Resectoscopes Market Forecast ($m) by Market Segment, 2011-2021
Figure 13: US TCRE Electrodes Market Forecast ($m) by Market Segment, 2011-2021
Figure 14: US Uterine Fibroid Embolization Agents Market Forecast ($m) by Market Segment, 2011-2021
Figure 15: US Uterine Fibroid Embolization Agents Market Share by Market Segment, 2014 and 2021
Figure 16: US Female Sterilization Devices Market Forecast ($m) by Market Segment, 2011-2021
Figure 17: US Female Sterilization Devices Market Share by Market Segment, 2014 and 2021
Figure 18: US Female Urinary Incontinence Slings Market Forecast ($m), 2011-2021
Figure 19: Primary Research Participants, by Country

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