Women s Health - US Analysis and Market Forecasts

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1 Women s Health - US Analysis and Market Forecasts

2 Women s Health - US Analysis and Market Forecasts BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen years. BioPortfolio offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, BioPortfolio is well positioned to coordinate our customers' orders sourced from over 50 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or reportstore@bioportfolio.com 2

3 Women s Health - US Analysis and Market Forecasts Women s Health - US Analysis and Market Forecasts Summary 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. *This is an on-demand report and will be delivered within 4 working days (excluding weekends) of the purchase. Highlights 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? 3

4 - 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? Scope - Overview of women s health, including anatomy, epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines and modalities. - Annualized total women s health market revenue from 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. Additional Details Publisher : Global Data Reference : GDME1170CFR Number of Pages : 0 Report Format : PDF Publisher Information : 4

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6 Table Of Contents for Women s Health - US Analysis and Market Forecasts 1 Table of Contents1.1 List of Tables1.2 List of Figures2 Introduction2.1 Catalyst 2.2 Related Reports 3 Industry Overview3.1 Overview3.1.1 Anatomy3.2 Indications3.2.1 Overview3.2.2 Abnormal Uterine Conditions3.2.3 Female Urinary Incontinence3.3 Clinical Presentation3.3.1 Abnormal Uterine Conditions3.3.2 Female Urinary Incontinence3.4 Market Segmentation3.5 Market Access3.5.1 Purchasing Decisions3.6 Influence of Clinical Trials3.7 Adoption3.8 Regulation3.8.1 US3.9 Reimbursement US3.10 Procedure Trends By Region3.11 Regulatory Issues/Recalls Hologic Discontinues Manufacturing, Marketing, and Sales of Adiana Recall of Numerous Transvaginal Mesh Products 3.12 M&As, Key Partnerships Bayer Health Acquires Conceptus for $1.1 Billion Boston Scientific Acquires IoGyn for $65m3.13 Economic Impact Indirect Costs Direct Costs4 Unmet Needs4.1 Overview4.2 Endometrial Ablation/Resection Devices Better Fluid Management4.2.2 Improved Imaging Guidanc4.2.3 Regulating Depth of Ablation4.3 Uterine Fibroid Embolization Agents4.3.1 Addressing Fibroid Recurrence4.3.2 Assessing Effect on Fertility4.3.3 Preventing Ovarian Failure4.4 Female Sterilization Devices4.4.1 Accelerated Scar Tissue Formation4.4.2 Lack of Reversibility4.4.3 Preventing Micro-insert Migration4.4.4 Preventing Perforation4.4.5 Trocar Size Reduction4.5 Female Urinary Incontinence Slings4.5.1 Anatomical Adaptation4.5.2 Single-Incision Slings5 Market Opportunity Analysis5.1 Overview5.2 Endometrial Ablation/Resection Devices Targeted Fibroid Ablation5.3 Uterine Fibroid Embolization Agents5.3.1 Novel Agents5.4 Female Sterilization Devices5.4.1 Raising Patient Awareness5.4.2 Rapid Transcervical Sterilization 5.5 Female Urinary Incontinence Slings5.5.1 Materials and Coatings5.5.2 European and APAC Markets6 Market Drivers and Barriers6.1 Endometrial Ablation/Resection Driver: Patient Preference for Minimally Invasive Treatments6.1.2 Driver: Growing Procedure Volume6.1.3 Barrier: High Device and Procedure Cost Substitute: Hysterectomy6.1.5 Substitute: Intrauterine Devices6.2 Uterine Fibroid Embolization Agents6.2.1 Driver: Increasing Prevalence of Uterine Fibroids6.2.2 Driver: Improving Imaging Capabilities6.2.3 Barrier: Lack of Patient Awareness6.2.4 Substitute: MRI-guided Focused Ultrasound6.2.5 Substitute: Myomectomy6.3 Female Sterilization Devices6.3.1 Driver: Growing Female Population using Modern Contraception6.3.2 Driver: Increasing Adoption of Transcervical Sterilization6.3.3 Barrier: Patient Preference for Reversible Contraception6.3.4 Substitute: Traditional Contraception6.4 Female Urinary Incontinence Slings6.4.1 Driver: Growing Treatment Rates and Use of Surgery6.4.2 Barrier: Highly Litigious US Market6.4.3 Substitute: Surgical Repair6.4.4 Substitute: Pelvic Floor Electrical Stimulation7 Competitive Assessment7.1 Overview7.2 Classification Based on Features7.2.1 Endometrial Ablation Devices7.2.2 Endometrial Resection Devices7.2.3 Uterine Fibroid Embolization Agents7.2.4 Female Sterilization Devices7.2.5 Female Urinary Incontinence Slings7.3 Key Product Profiles7.3.1 Endometrial Ablation Devices7.3.2 Endometrial Resection Devices7.3.3 Uterine Fibroid Embolization Agents7.3.4 Female Sterilization Devices7.3.5 Female Urinary Incontinence Slings8 Pipeline Assessment8.1 Overview8.2 Key Product Profiles8.2.1 Endometrial Ablation Devices8.2.2 Uterine Fibroid Embolization Agents8.2.3 Female Sterilization Devices8.2.4 Female Urinary Incontinence Slings9 Clinical Trials to Watch9.1 Overview9.2 Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation9.3 Post Market Study of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence (Solyx)9.4 Safety & Effectiveness Study of Aegea Vapor System to Treat Excessive Uterine Bleeding9.5 The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence (EASY)10 Current and Future Players10.1 Overview10.2 Trends in Corporate Strategy10.3 Company Profiles American Medical Systems AngioDynamics Bayer Healthcare (Bayer AG) Boston Scientific BTG Coloplast Cook Medical CooperSurgical C.R. Bard Ethicon (Johnson & Johnson) Femcare-Nikomed (Utah Medical Products) Hologic Karl Storz Olympus Richard Wolf Stryker11 Market Outlook11.1 By Geography By Country12 Appendix12.1 Bibliography12.2 Abbreviations12.3 Report Methodology Overview Coverage Secondary Research12.4 Forecasting Methodology12.5 Physicians and Specialists Included in This Study12.6 Primary Research - Prescriber Survey12.7 About the Authors Analysts Global Head of Healthcare12.8 About GlobalData12.9 Disclaimer 6

7 List Of Tables in Women s Health - US Analysis and Market Forecasts 1.1 List of Tables 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) 7

8 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,

9 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 9

10 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 ($m) by Market Segment, Table 118: US Endometrial Ablation Market Forecast ($m) by Market Segment, Table 119: US Endometrial Resection Devices Market Forecast ($m) by Market Segment, Table 120: US Uterine Fibroid Embolization Agents Market Forecast ($m) by Market Segment,

11 Table 121: US Female Sterilization Devices Market Forecast ($m) by Market Segment, Table 122: US Female Urinary Incontinence Slings Market Forecast ($m),

12 List Of Figures, Charts and Diagrams in Women s Health - US Analysis and Market Forecasts 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, Figure 5: US Procedure Volume Forecast, Uterine Artery Embolization, Figure 6: US Procedure Volume Forecast, Female Sterilization, Figure 7: US Procedure Volume Forecast, Urinary Incontinence Slings, Figure 8: US Women s Health Market Forecast ($m) by Segment, Figure 9: US Women s Health Market Share by Market Segment, 2014 and 2021 Figure 10: US Endometrial Ablation Market Forecast ($m) by Market Segment, Figure 11: US Endometrial Ablation Market Share by Market Segment, 2014 and 2021 Figure 12: US Resectoscopes Market Forecast ($m) by Market Segment, Figure 13: US TCRE Electrodes Market Forecast ($m) by Market Segment, Figure 14: US Uterine Fibroid Embolization Agents Market Forecast ($m) by Market Segment, Figure 15: US Uterine Fibroid Embolization Agents Market Share by Market Segment, 2014 and 2021 Figure 16: US Female Sterilization Devices Market Forecast ($m) by Market Segment, Figure 17: US Female Sterilization Devices Market Share by Market Segment, 2014 and 2021 Figure 18: US Female Urinary Incontinence Slings Market Forecast ($m), Figure 19: Primary Research Participants, by Country 12

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