MediPoint: Hernia Repair - US Analysis and Market Forecasts

Summary

Dramatic improvements in access to and quality of healthcare in the Asia Pacific region, concurrent with the introduction of next-generation biologic and composite meshes in developed countries and adoption of laparoscopic techniques worldwide, will drive hernia repair market growth in the US, Europe and Asia Pacific. Saturated with numerous players and a library of different products, the fiercely-competitive hernia mesh industry has experienced notable improvements recently in device quality and affordability, as companies strive for increased physician adoption in established markets and strategize entry into new regions.

The report provides a comprehensive evaluation of the global hernia market, including development and sales of inguinal, incisional and umbilical hernia repair products. Included within is an analysis of the drivers, opportunities and barriers impacting growth in the mesh market worldwide, with in-depth breakdown by surgical technique to highlight the fast adoption of laparoscopic methods. The report identifies and evaluates key trends and unmet needs shaping the global market through 2019, emphasizing testimonials from top physicians around the world who are implanting the devices.

The United States is currently one of the largest markets for all three types of hernia mesh repairs covered in this forecast. In 2012, the country had the largest market for overall hernia repair and umbilical hernia repair out of the ten major markets (France, Germany, Italy, Spain, United Kingdom, Brazil, India, China, and Japan). The country has the second largest market for inguinal hernia repair and incisional hernia repair.

GlobalData built this report using data and information sourced from secondary sources, as well as primary research interviews with leading Herniologists and General Surgeons around the world, and in-house analysis conducted by GlobalData’s team of industry experts.

Scope

- An overview of hernia, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized US hernia repair market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for hernia repair
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the hernia repair sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as herniologists

Reasons to buy

- Understand the trends shaping and driving the US hernia repair Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the US hernia repair market through 2018.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What’s the next big thing in US hernia repair market landscape? Identify, understand and capitalize.

Table Of Contents

1 Table of Contents
1 Table of Contents 7


2 Introduction 21
2.1 Catalyst 22
3 Disease Overview 23
3.1 Anatomy and Physiology 23
3.1.1 Inguinal Hernias 23
3.1.2 Incisional Hernias 25
3.1.3 Umbilical Hernias 26
3.2 Pathophysiology 27
3.2.1 Inguinal Hernia 27
3.2.2 Incisional Hernia 29
3.2.3 Umbilical Hernia 29
3.3 Clinical Presentation 30
3.3.1 Symptoms 30
3.3.2 Diagnosis 31
3.3.3 Clinical Outcomes 32
3.4 Epidemiology 37
3.4.1 Inguinal Hernias 37
3.4.2 Incisional Hernias 40
3.4.3 Umbilical Hernias 43
3.5 Economic Impact 45
3.5.1 Open versus Laparoscopic Repair 45
3.5.2 Watchful Waiting 46
3.5.3 US 47
4 Competitive Assessment 48
4.1 Overview 48
4.2 Large Pore Meshes 49
4.2.1 Overview 49
4.2.2 Angimesh R2 (Angiologica) 52
4.2.3 Assumesh (Assut Europe) 54
4.2.4 Cristalene (Abiss Analytical Biosurgical Systems) 55
4.2.5 Hexapro Mesh (Agency for Medical Innovation) 56
4.2.6 Optilene Mesh (B. Braun) 57
4.2.7 Omyra Mesh (B. Braun) 61
4.2.8 ProLite Ultra Mesh (Atrium Medical) 63
4.2.9 Surgimesh 1 and 2 and XLIGHT (Aspide Medical) 65
4.2.10 Surgimesh PET 2D (Aspide Medical) 66
4.2.11 Surgimesh WN (Aspide Medical) 68
4.2.12 Vypro Mesh (Ethicon) 70
4.3 Small Pore Meshes 72
4.3.1 Overview 72
4.3.2 Premilene Mesh (B. Braun) 74
4.3.3 Prolene Mesh (Ethicon) 76
4.3.4 ProLite Mesh (Atrium Medical) 78
4.3.5 Repol Angimesh (Angiologica) 79
4.4 Composite Meshes 81
4.4.1 Overview 81
4.4.2 4DDome (Cousin Biotech) 83
4.4.3 B-Foil (Assut Europe) 85
4.4.4 Biomesh CA.B.S Air Composite (Cousin Biotech) 86
4.4.5 C-QUR Mesh (Atrium Medical) 87
4.4.6 C-QUR TacShield (Atrium Medical) 88
4.4.7 C-QUR V-Patch (Atrium Medical) 90
4.4.8 C-QUR CentriFX (Atrium Medical) 91
4.4.9 C-QUR FX Mesh (Atrium Medical) 92
4.4.10 Parietex Composite (Covidien) 93
4.4.11 Parietex ProGrip Self Fixating Mesh (Covidien) 95
4.4.12 Sorbimesh (Assut Europe) 96
4.4.13 Surgimesh Cible (Aspide Medical) 98
4.4.14 Surgimesh Diablo (Aspide Medical) 99
4.4.15 Surgimesh M.O.P.P. (Aspide Medical) 101
4.4.16 Surgimesh XB (Aspide Medical) 102
4.4.17 Ultrapro Mesh (Ethicon) 104
4.5 3D Meshes 105
4.5.1 Overview 105
4.5.2 3DMax Mesh (C.R. Bard) 109
4.5.3 Bio-A Hernia Plug (W. L. Gore and Associates) 110
4.5.4 Laparomesh (Assut Europe) 112
4.5.5 Perfix Plug (C.R. Bard) 113
4.5.6 ProLoop Mesh (Atrium Medical) 115
4.5.7 Surgimesh Easyplug (Aspide Medical) 116
4.5.8 Surgimesh PET 3D (Aspide Medical) 119
4.5.9 Surgimesh XD (Aspide Medical) 120
4.5.10 Repol Plug Cap (Angiologica) 122
4.6 Biologic Hernia Meshes 123
4.6.1 Overview 123
4.6.2 AlloDerm Regenerative Tissue Matrix (LifeCell) 125
4.6.3 Allomax Surgical Graft (Davol) 128
4.6.4 Biodesign Hernia Graft (Cook Medical) 131
4.6.5 Permacol Surgical Implant (Covidien) 134
4.6.6 Strattice (LifeCell) 136
5 Unmet Needs 137
5.1 Overview 137
5.2 Specialized Laparoscopic Clinics 138
5.3 Increased investigation of TAPP versus TEP procedures 139
5.4 Competitive Pricing for Premium Hernia Meshes 140
5.5 Economic and Financial Impact of Laparoscopic Techniques 141
5.6 Research and Development of Self-Fixating Meshes 142
5.7 Registry for Laparoscopic Hernia Repair 144
6 Pipeline Products 145
6.1 Overview 145
6.2 Clinical Trial Analysis 146
6.2.1 Overview 146
6.2.2 Trials to Watch 146
7 Industry Overview 148
7.1 Procedure Trends 148
7.1.1 US 148
7.2 Market Access 149
7.2.1 Cost Concerns 149
7.2.2 Group Purchasing Organizations 150
7.2.3 Distribution Networks 151
7.2.4 Access to Healthcare 151
7.3 Reimbursement Trends 152
7.3.1 Overview 152
7.3.2 US 152
7.4 Regulatory Issues/Recalls 153
7.5 Added Indications 153
7.6 Mergers and Acquisitions/Key Partnerships 154
7.6.1 Baxter Acquires Synovis Life Technologies 154
7.6.2 Covidien Acquires Tissue Science Laboratories 154
8 Current and Future Players 155
8.1 Trends in Corporate Strategy 155
8.2 Company Profiles 156
8.2.1 Abiss Analytic Biosurgical Solutions 156
8.2.2 AMI: Agency for Medical Innovation 157
8.2.3 Angiologica 158
8.2.4 Aspide Medical 160
8.2.5 Assut Europe 161
8.2.6 Atrium Medical 162
8.2.7 B. Braun Surgical 164
8.2.8 Cook Medical 166
8.2.9 Cousin Biotech 168
8.2.10 Covidien 169
8.2.11 C.R. Bard 171
8.2.12 Ethicon 173
8.2.13 FEG Textiltechnik mbH 175
8.2.14 Proxy Biomedical 176
8.2.15 TEI Biosciences 177
8.2.16 W. L. Gore and Associates 178
9 Market Drivers and Opportunities and Barriers 181
9.1 Market Drivers 181
9.1.1 Consistent Hernia Prevalence 181
9.1.2 Transition from Open Hernia Repair to Laparoscopic Hernia Repair 181
9.1.3 Fall of Watchful Waiting 183
9.1.4 Residents Being Trained on Laparoscopic Technique 185
9.2 Opportunities 187
9.2.1 Invest in Composite Meshes Designed Specifically for Laparoscopic Repair 187
9.2.2 Market Meshes to Specialized Centers 188
9.2.3 Focus on Countries Experiencing Increasing Composite Mesh Adoption 189
9.2.4 Develop Business Relationships with Robotic Surgery Equipment Manufacturers 190
9.3 Market Barriers 191
9.3.1 Group Purchasing Organizations 191
9.3.2 Reimbursement 192
9.3.3 Cost 193
9.3.4 Self-Gripping Technology 193
9.3.5 Mosquito Net Mesh 195
10 Country Outlooks and Forecasts 197
10.1 US 197
10.1.1 Overall Hernia Repair Market 197
10.1.2 Inguinal Hernia Repair Market 199
10.1.3 Incisional Hernia Repair Market 199
10.1.4 Umbilical Hernia Repair Market 200
11 Appendix 201
11.1 Bibliography 201
11.2 Abbreviations 216
11.3 Report Methodology 217
11.3.1 Overview 217
11.3.2 Coverage 217
11.3.3 Primary Research 218
11.3.4 Secondary Research 219
11.3.5 Forecasting Methodology 219
11.4 General Surgeons and Herniologists Included in this Study 220
11.5 About the Authors 221
11.5.1 Joseph A. Gregory, Analyst, Surgical Devices 221
11.5.2 Derek Archila, MBA, Director of Research and Analysis, Medical Devices 221
11.6 Global Head of Healthcare 222
11.6.1 Bonnie Bain, Ph.D., Global Head of Healthcare 222
11.7 About MediPoint 222
11.8 About GlobalData 223
11.9 Contact Us 223
11.10 Disclaimer 223

1.1 List of Tables
Table 1: Layers of the Abdominal Wall 23
Table 2: Distribution by Sex in the Major Markets, 2012 38
Table 3: Inguinal Hernia, Distribution by Age in the Major Markets, 2012 38
Table 4: Hernia Mesh Classifications 48
Table 5: Large Pore SWOT Analysis, 2013 51
Table 6: Product Profile - Angimesh R2 53
Table 7: Product Profile - Assumesh 54
Table 8: Product Profile - Cristalene 56
Table 9: Product Profile - Hexapro Mesh 57
Table 10: Product Profile - Optilene Mesh 58
Table 11: Product Profile - Optilene Mesh LP 59
Table 12: Product Profile - Optilene Mesh Elastic 60
Table 13: Product Profile - Omyra Mesh 62
Table 14: Product Profile - ProLite Ultra Mesh 64
Table 15: Product Profile - Surgimesh 1 and 2 and XLIGHT 65
Table 16: Product Profile - Surgimesh PET 2D 67
Table 17: Product Profile - Surgimesh WN 69
Table 18: Product Profile - Vypro Mesh 71
Table 19: Small Pore SWOT Analysis, 2013 73
Table 20: Product Profile - Premilene Mesh 74
Table 21: Product Profile - Premilene Mesh Plug 75
Table 22: Product Profile - Prolene Mesh 77
Table 23: Product Profile - ProLite Mesh 78
Table 24: Product Profile - Repol Angimesh 80
Table 25: Composite Meshes SWOT Analysis, 2013 81
Table 26: Product Profile - 4DDome 83
Table 27: Product Profile - B-Foil 85
Table 28: Product Profile - Biomesh CA.B.S. Air Composite 86
Table 29: Product Profile - C-QUR Mesh 87
Table 30: Product Profile - C-QUR TacShield 89
Table 31: Product Profile - C-QUR V-Patch 90
Table 32: Product Profile - C-QUR CentriFX 91
Table 33: Product Profile - C-QUR FX Mesh 92
Table 34: Product Profile - Parietex Composite 94
Table 35: Product Profile - Parietex ProGrip Self Fixating Mesh 95
Table 36: Product Profile - Sorbimesh 97
Table 37: Product Profile - Surgimesh Cible 98
Table 38: Product Profile - Surgimesh Diablo 100
Table 39: Product Profile - Surgimesh M.O.P.P. 101
Table 40: Product Profile - Surgimesh XB 103
Table 41: Product Profile - Ultrapro Mesh 104
Table 42: 3D Meshes SWOT Analysis, 2013 107
Table 43: Product Profile - 3DMax Mesh 109
Table 44: Product Profile - Bio-A Hernia Plug 111
Table 45: Product Profile - Laparomesh 113
Table 46: Product Profile - Perfix Plug 114
Table 47: Product Profile - ProLoop FX Mesh 115
Table 48: Product Profile - Easyplug 118
Table 49: Product Profile - Surgimesh PET 3D 120
Table 50: Product Profile - Surgimesh XD 121
Table 51: Product Profile - Repol Plug Cap 122
Table 52: Biological Meshes SWOT Analysis, 2013 124
Table 53: Product Profile - AlloDerm Regenerative Tissue Matrix 127
Table 54: Product Profile - Allomax Surgical Graft 129
Table 55: Product Profile - Biodesign Hernia Graft 132
Table 56: Product Profile - Permacol Surgical Implant 135
Table 57: Product Profile - Strattice 136
Table 58: Overall Unmet Needs - Current Level of Attainment and Importance 137
Table 59: Company Portfolio - Abyss Analytic Biosurgical Solutions 156
Table 60: Abyss Analytic Biosurgical Solutions SWOT Analysis, 2013 157
Table 61: Company Portfolio - AMI: Agency for Medical Innovation 157
Table 62: AMI: Agency for Medical Innovation SWOT Analysis, 2013 158
Table 63: Company Portfolio - Angiologica 158
Table 64: Angiologica SWOT Analysis, 2012 159
Table 65: Company Portfolio - Aspide Medical 160
Table 66: Aspide Medical SWOT Analysis, 2013 161
Table 67: Company Portfolio - Assut Europe 161
Table 68: Assut Europe SWOT Analysis, 2013 162
Table 69: Company Portfolio - Atrium Medical 162
Table 70: Atrium Medical SWOT Analysis, 2013 163
Table 71: Company Portfolio - B. Braun 165
Table 72: B. Braun SWOT Analysis, 2012 166
Table 73: Company Portfolio - Cook Medical 166
Table 74: Cook Medical SWOT Analysis, 2013 167
Table 75: Company Portfolio - Cousin Biotech 168
Table 76: Cousin Biotech SWOT Analysis, 2013 168
Table 77: Company Portfolio - Covidien 169
Table 78: Covidien SWOT Analysis, 2013 170
Table 79: Company Portfolio - C. R. Bard 171
Table 80: C. R. Bard SWOT Analysis, 2013 172
Table 81: Company Portfolio - Ethicon 173
Table 82: Ethicon SWOT Analysis, 2013 174
Table 83: Company Portfolio - FEG Textiltechnik 175
Table 84: FEG Textiltechnik SWOT Analysis, 2013 175
Table 85: Company Portfolio - Proxy Biomedical 176
Table 86: Proxy Biomedical SWOT Analysis, 2013 176
Table 87: Company Portfolio - TEI Biosciences 177
Table 88: TEI Biosciences SWOT Analysis, 2013 177
Table 89: Company Portfolio - W. L. Gore and Associates 179
Table 90: W. L. Gore and Associates SWOT Analysis, 2012 180
Table 91: US Hernia Mesh Repair Sales ($m) Forecast, 2010-2019 198

1.2 List of Figures
Figure 1: Inguinal Hernia 24
Figure 2: Layers of the Abdominal Wall 25
Figure 3: Anatomy of an Umbilical Hernia 26
Figure 4: Indirect Inguinal Hernia 27
Figure 5: Direct Inguinal Hernia 28
Figure 6: Entrance Points for Laparoscopic Inguinal Hernia Repair 35
Figure 7: Prevalence of Total Inguinal Hernias in the US, 2010-2019 40
Figure 8: Prevalence of Total Incisional Hernias in the US, 2010-2019 42
Figure 9: Prevalence of Total Umbilical Hernias in the US, 2010-2019 44
Figure 10: Global Company Market Share, Large Pore Meshes, 2012 52
Figure 11: Structure of Angimesh R2 52
Figure 12: Structure of Assumesh 54
Figure 13: Structure of Cristalene 55
Figure 14: Structure of Hexapro Mesh 56
Figure 15: Structure of Optilene Mesh 58
Figure 16: Structure of Optilene Mesh LP 59
Figure 17: Structure of Optilene Mesh Elastic 60
Figure 18: Structure of Omyra Mesh 61
Figure 19: Structure of ProLite Ultra Mesh 63
Figure 20: Structure of Surgimesh 1 and 2 and XLIGHT 65
Figure 21: Structure of Surgimesh PET 2D 66
Figure 22: Structure of Surgimesh WN 68
Figure 23: Structure of Vypro Mesh 70
Figure 24: Global Company Market Share, Small Pore Meshes, 2012 73
Figure 25: Structure of Premilene Mesh 74
Figure 26: Structure of Premilene Mesh Plug 75
Figure 27: Structure of Prolene Mesh 76
Figure 28: Structure of ProLite Mesh 78
Figure 29: Structure of Repol Angimesh 79
Figure 30: Global Company Market Share, Composite Meshes, 2012 82
Figure 31: Structure of the 4DDome 83
Figure 32: Structure of B-Foil 85
Figure 33: Structure of the Biomesh CA.B.S. Air Composite 86
Figure 34: Structure of C-QUR Mesh 87
Figure 35: Structure of C-QUR TacShield 88
Figure 36: Structure of C-QUR V-Patch 90
Figure 37: Structure of C-QUR CentriFX 91
Figure 38: Structure of C-QUR FX Mesh 92
Figure 39: Structure of Parietex Composite 93
Figure 40: Structure of Parietex ProGrip Self Fixating Mesh 95
Figure 41: Structure of Sorbimesh 96
Figure 42: Structure of Surgimesh Cible 98
Figure 43: Structure of Surgimesh Diablo 99
Figure 44: Structure of Surgimesh M.O.P.P. 101
Figure 45: Structure of Surgimesh XB 102
Figure 46: Structure of Ultrapro Mesh 104
Figure 47: Global Company Market Share, Composite Meshes, 2012 108
Figure 48: Structure of the 3DMax Mesh 109
Figure 49: Structure of the Bio-A Hernia Plug 110
Figure 50: Structure of Laparomesh 112
Figure 51: Structure of Perfix Plug 113
Figure 52: Structure of ProLoop Mesh 115
Figure 53: Structure of Surgimesh Easyplug Standard 116
Figure 54: Structure of Surgimesh WN Easyplug 117
Figure 55: Structure of Surgimesh WN Easyplug No Touch 117
Figure 56: Structure of Surgimesh PET 3D 119
Figure 57: Structure of Surgimesh XD 120
Figure 58: Structure of Repol Plug Cap 122
Figure 59: Global Company Market Share, Biological Meshes, 2012 125
Figure 60: Structure of the AlloDerm Regenerative Tissue Matrix 126
Figure 61: Structure of the Allomax Surgical Graft 128
Figure 62: Structure of the Biodesign Hernia Graft 131
Figure 63: Structure of the Permacol Surgical Implant 134
Figure 64: Open versus Laparoscopic Procedure Volumes, US, 2010-2019 148
Figure 65: US Hernia Mesh Repair Sales ($m) Forecast, 2010-2019 198

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