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MediPoint: Aortic Stent Grafts - Global Analysis and Market Forecasts

Summary

Aortic stent grafts are most commonly used to reinforce a weak spot in an artery, which is known as an aneurysm. The stent grafts are designed to seal tightly with the patient’s native artery above and below the aneurysm, and are used to treat abdominal aortic aneurysms as well as thoracic aortic aneurysms. Aortic aneurysms, as opposed to aneurysms found elsewhere in the body, are potentially very serious, as a burst aorta results in massive internal bleeding that can be fatal unless treated rapidly by an experienced emergency medical team. Since their introduction in patients in 1991, aortic stent graft devices have gained wide acceptance and availability, with their adoption fueled in great part by advances in stent-graft design and by a variety of devices for various anatomic features. Over time, these devices have gained traction for use in patients with ruptured aneurysms because they are minimally invasive and have shorter recovery times.

This report focuses on the aortic stent graft implant market for abdominal and thoracic aneurysms. The abdominal aortic market comprises about 80-90% of the market, with the niche market being the thoracic one. The thoracic aneurysm repair market is still a young market where there is a strong pipeline of products from both the large manufacturers and small emerging players. For most manufacturers, following the successful launch of an AAA product, the thoracic stent graft segment presents the opportunity with the most unmet needs for pursuit.

The 10MM are covered and forecast in this report, which provides the unmet needs, future adoption, and Compound Annual Growth Rates (CAGRs) in both the abdominal stent graft and thoracic stent graft markets. GlobalData’s analysis demonstrates this market to be a young and growing market, subject to rapid technological development and with much room for product adoption. The global aortic stent grafts market is determined for the 10 countries with insight into the competitive landscape, the marketed and pipeline products, the current and emerging players and market analysis. The report identifies the unmet needs in the market while providing an understanding of physicians’ perceptions and decision-making processes in using and evaluating the adoption of the stent graft.

Highlights

Key Questions Answered

- (Q). What is the current and future aortic stent market outlook in the developed and emerging markets? (Q). What trends are affecting the global stent graft market fro both AAA and TAA?
- (Q). Which are the key, high growth markets that stent manufacturers should expand into? (Q). Who are the up and coming new players in the stent graft market?
- The traditional open surgery approach has been used for decades. (Q). What are the drivers moving physicians to take the endovascular approach instead? (Q). What are the unmet needs for current generation products?
- (Q). What clinical factors and technical specifications influence a physician to use one type of stent graft over another? (Q). What is physician perception and market outlook of endovascular repair?
- (Q). What are the challenges and complications of stent grafts that have hindered widespread adoption?
- (Q). With developing the next-generation of aortic stent grafts and what are the disruptive technologies and game changing trends that manufacturers are focusing on?

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 Vascular 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

MediPoint: Aortic Stent Grafts - Global Analysis and Market Forecasts
1 Table of Contents

2 Introduction 23
2.1 Catalyst 24
2.2 Related Reports 25
2.3 Upcoming Related Reports 25
3 Industry Overview 26
3.1 Overview 26
3.2 Indications 27
3.2.1 Aortic Abdominal Aneurysm 27
3.2.2 Thoracic Aortic Aneurysm 28
3.2.3 Aortic Dissection 29
3.3 Clinical Outcomes 30
3.3.1 Lifestyle Changes 31
3.3.2 Medication 32
3.3.3 Open Surgery 32
3.3.4 Endovascular Repair 33
3.4 Procedure Trends 35
3.4.1 Global 35
3.4.2 US 38
3.4.3 EU 40
3.4.4 Asia-Pacific 42
3.4.5 South America 45
3.5 Market Access 47
3.5.1 Adoption 49
3.5.2 Regulation 56
3.5.3 Reimbursement 62
3.6 Regulatory Issues/Recalls 75
3.6.1 Anaconda Back on the Market in March 2014 after a Voluntary Recall of Anaconda by Vascutek 75
3.6.2 Terminated FDA's Class II Recall of TriVascular's Ovation Prime in April 2014 75
3.7 Mergers, Deals, and Acquisitions 75
3.7.1 Medtronic Acquires Covidien 75
3.7.2 TriVascular Launches $100m Initial Public Offering 76
3.7.3 Lombard Medical Pursues US Initial Public Offering 76
3.7.4 TriVascular Raises $40m in Series E Financing 76
3.7.5 LifeTech Scientific Creates Partnership with Medtronic 76
3.7.6 LeMaitre Vascular Terminates Distribution Agreement with Endologix 77
3.7.7 Jotec Enters Licensing Agreement with Hydromer 77
3.7.8 Endologix Public Offering of Notes 77
3.7.9 Aptus Endosystems Secures Financing 77
3.7.10 Altura Medical Secures Financing 77
3.7.11 Endologix Acquires Nellix Endovascular 78
3.8 Economic Impact 78
3.8.1 Economic Impact of Aneurysms 78
3.8.2 Treatment Costs of Aortic Aneurysms 79
4 Unmet Needs 81
4.1 Addressing the Complications 81
4.1.1 Endoleaks 81
4.1.2 Ischemic Complications 82
4.1.3 Limb Thrombosis 83
4.1.4 Infection 83
4.1.5 Paraplegia in Thoracic Aortic Aneurysm 83
4.2 The Seal and Landing Zone 84
4.3 Short Neck 85
4.4 Cost Containment 86
4.5 More Low Profile Systems 87
4.6 Customized Fenestrated Stent Grafts 88
4.7 Multi-Branch Stent Grafts 89
4.8 Thoracic Endovascular Aneurysm Repair Unmet Needs 90
4.9 Long-Term Clinical Data 91
5 Market Opportunity Analysis 92
5.1 Emerging Markets 92
5.2 Thoracic Aortic Disease Market 93
5.3 Addition of Physician Training Programs 94
5.4 Disruptive Technologies 95
5.5 Minimally Invasive Trend 96
6 Market Drivers, Barriers, and Substitutes 97
6.1 Driver: Rising Disease Prevalence 97
6.1.1 Diabetes Mellitus 97
6.1.2 Hypertension 97
6.1.3 Obesity 98
6.1.4 Tobacco Use 98
6.2 Driver: Aging 98
6.3 Driver: Imaging 99
6.4 Driver: Improved Clinical Outcomes with Endovascular Therapy 100
6.5 Driver: Time Savings 101
6.6 Driver: Patient Demand and Awareness 101
6.7 Driver: Technological Developments 102
6.7.1 Custom Branched and Fenestrated Stent Grafts 102
6.7.2 Low Profile Delivery Systems 103
6.8 Driver: Rising Competition and Innovation 104
6.9 Barrier: Availability of Venture Capital 104
6.10 Barrier: Burden of Rising Regulation 105
6.11 Barrier: High Treatment Cost 106
6.12 Barrier: Proving Long-Term Efficacy 108
6.13 Barrier: High Radiation Dosages with Excessive Imaging 108
6.14 Surgical Limitations 109
6.15 Barrier: Medical Device Excise Tax 109
6.16 Substitute: Open Surgery 110
6.17 Substitute: Chimney Technique versus Fenestrated Grafts 111
7 Competitive Assessment 113
7.1 Overview 113
7.2 Key Marketed Products 113
7.2.1 Endovascular Aneurysm Repair and Thoracic Endovascular Aneurysm Repair Products 113
8 Pipeline Assessment 124
8.1 Overview 124
8.2 Product Profiles 124
8.2.1 Altura Medical Endograft 124
8.2.2 Cordis INCRAFT 125
8.2.3 EndoSpan Horizon 126
8.2.4 EndoSpan Nexus 127
8.2.5 MicroPort Scientific Castor Branched Stent Graft System 128
8.2.6 BiFlow Medical Novel Side-Branch Stent 129
8.2.7 Endoluminal Sciences Endograft Mechanism 130
8.2.8 Medtronic Valiant Mona LSA Stent Graft System 131
8.2.9 Endologix Ventana Fenestrated Stent Graft 131
9 Clinical Trials to Watch 133
9.1 Overview 133
9.2 Altura Medical 133
9.3 Cook Medical 134
9.4 Gore Medical 136
9.5 Terumo Corporation 137
9.6 Endologix 137
9.7 TriVascular 138
9.8 Bolton Medical 139
9.9 Medtronic 140
9.10 Cordis Corporation 142
10 Current and Future Players 143
10.1 Overview 143
10.2 Trends in Corporate Strategy 143
10.3 Company Profiles 144
10.3.1 Cook Medical 144
10.3.2 Endologix 147
10.3.3 Gore Medical 150
10.3.4 Medtronic 152
10.3.5 Terumo Corporation 155
10.3.6 Altura Medical 157
10.3.7 Aptus Endosystems 158
10.3.8 Bolton Medical 160
10.3.9 Braile Biomedica 162
10.3.10 B. Braun 165
10.3.11 Cardiatis 166
10.3.12 LeMaitre Vascular 168
10.3.13 Lifetech Scientific 170
10.3.14 Getinge Group 172
10.3.15 Grikin Advanced Materials 175
10.3.16 Johnson and Johnson's Cordis Corporation 176
10.3.17 Jotec 178
10.3.18 Lombard Medical 180
10.3.19 MicroPort Scientific Corporation 181
10.3.20 Nano Endoluminal 184
10.3.21 TriVascular 186
10.3.22 Weike Medical Apparatus and Instrument 189
10.3.23 YTH Biological Material Scitech 189
11 Market Outlook 190
11.1 Company Market Share 190
11.1.1 Global Market Share 190
11.1.2 US Market Share 193
11.1.3 EU Market Share 195
11.2 By Market Segment 197
11.2.1 Overview 197
11.2.2 Endovascular Aneurysm Repair 198
11.2.3 Thoracic Endovascular Aneurysm Repair 199
11.3 By Geography 200
11.3.1 Global Overview 200
11.3.2 US 204
11.3.3 EU 206
11.3.4 Asia-Pacific 218
11.3.5 South America 227
12 Appendix 230
12.1 Bibliography 230
12.2 Abbreviations 246
12.3 Research Methodology 250
12.3.1 Overview 250
12.3.2 Coverage 250
12.3.3 Secondary Research 250
12.4 Physicians and Specialists Included in this Study 252
12.4.1 Christopher Abularrage, MD, FACS 252
12.4.2 Gaspar Mestres Alomar, MD 252
12.4.3 Enio Buffolo, MD, PhD 252
12.4.4 Ludovic Canaud, MD, PhD 252
12.4.5 Holger Eggebrecht, MD 252
12.4.6 Daisuke Fukui, MD, PhD 252
12.4.7 Germano Melissano, MD 252
12.4.8 Dr. Raghuram Sekhar MS, FRCS (Edinburgh), FRCS (Glasgow) 252
12.4.9 Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS (Gen Surg), DIC 253
12.4.10 Jiang Xiong, MD, PhD 253
12.5 Primary Research 254
12.5.1 Primary Research - Key Opinion Leader Interviews 254
12.5.2 Primary Research - Physician and Industry Interviews 254
12.5.3 Expert Panel Validation 255
12.6 Forecasting Methodology 256
12.7 About the Authors 257
12.7.1 Analysts 257
12.7.2 Global Head of Healthcare 258
12.8 About MediPoint 259
12.9 About GlobalData 259
12.10 Disclaimer 259

1.1 List of Tables

Table 1: Summary of Indications, Symptoms, and Treatments 27
Table 2: Thoracic Aortic Aneurysm Types 29
Table 3: Medications for Reducing Risk of Aneurysm Growth and Rupture 32
Table 4: Advantages and Disadvantages of Open Repair versus Endovascular Repair 34
Table 5: Global Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 35
Table 6: Global Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 37
Table 7: Group Purchasing Organizations in the US and EU 55
Table 8: Regulatory Differences between the US and EU 57
Table 9: Medicare National Average of Inpatient Hospital Payment for EVAR and TEVAR, 2013-2014 64
Table 10: Medicare Coding Guide for EVAR and TEVAR, 2014 64
Table 11: Direct and Indirect Costs of Open Surgery and Endovascular Repair 80
Table 12: Comparison Costs and Other Variables for Treating AAA By Open Repair and Stent Grafts in 2012 ($US) 80
Table 13: Endoleak Types 81
Table 14: Zenith Family Marketed Products 115
Table 15: Zenith AAA SWOT 115
Table 16: Zenith TAA SWOT 116
Table 17: Endologix's Marketed Products 117
Table 18: AFX Endovascular SWOT 117
Table 19: IntuiTrak Powerlink System SWOT 117
Table 20: Gore Medical's Marketed Products 119
Table 21: Gore AAA Product SWOT 119
Table 22: Gore TAA Product SWOT 120
Table 23: Medtronic's Marketed Products 121
Table 24: Medtronic AAA Product SWOT 122
Table 25: Medtronic TAA Product SWOT 122
Table 26: Terumo Corporation Marketed Products 123
Table 27: Terumo Corporation AAA Product SWOT 123
Table 28: SWOT Analysis - Altura Medical Endograft 125
Table 29: SWOT Analysis - Cordis INCRAFT 126
Table 30: SWOT Analysis - EndoSpan Horizon 127
Table 31: SWOT Analysis - EndoSpan Nexus 128
Table 32: SWOT Analysis - MicroPort Scientific Castor Branched Stent Graft System 129
Table 33: SWOT Analysis - BiFlow Medical Novel Side-Branch Stent 130
Table 34: SWOT Analysis - Endoluminal Sciences Endograft Mechanism 130
Table 35: SWOT Analysis - Medtronic Valiant Mona LSA Stent Graft 131
Table 36: SWOT Analysis - Endologix Ventana Fenestrated Stent Graft 132
Table 37: Major Clinical Trials of Altura Medical's Aortic Stent Grafts 134
Table 38: Major Clinical Trials of Cook Medical's Aortic Stent Grafts 135
Table 39: Major Clinical Trials of Gore Medical's Aortic Stent Grafts 136
Table 40: Major Clinical Trials of Terumo's Aortic Stent Grafts 137
Table 41: Major Clinical Trials of Endologix's Aortic Stent Grafts 138
Table 42: Major Clinical Trials of TriVascular's Aortic Stent Grafts 139
Table 43: Major Clinical Trials of Bolton Medical's Aortic Stent Grafts 140
Table 44: Major Clinical Trials of Medtronic's Aortic Stent Grafts 141
Table 45: Major Clinical Trials of Cordis' Aortic Stent Grafts 142
Table 46: Company Profile - Cook Medical 145
Table 47: Cook Medical Marketed Products 146
Table 48: SWOT Analysis - Cook Medical 147
Table 49: Company Profile - Endologix Inc. 148
Table 50: Endologix Marketed Products 149
Table 51: Endologix Pipeline Products 149
Table 52: SWOT Analysis - Endologix Inc. 149
Table 53: Company Profile - Gore Medical 150
Table 54: Gore Medical Marketed Products 151
Table 55: SWOT Analysis - Gore Medical 152
Table 56: Company Profile - Medtronic 153
Table 57: Medtronic Marketed Products 154
Table 58: SWOT Analysis - Medtronic 154
Table 59: Company Profile - Terumo Corporation 155
Table 60:Terumo Corporation Marketed Products 156
Table 61: SWOT Analysis - Terumo Corporation 157
Table 62: Company Profile - Altura Medical Inc. 157
Table 63: Altura Medical Inc. Marketed Products 158
Table 64: SWOT Analysis - Altura Medical Inc. 158
Table 65: Company Profile - Aptus Endosystems, Inc. 159
Table 66: Aptus Endosystems Inc. Marketed Products 160
Table 67: SWOT Analysis - Aptus Endosystems Inc. 160
Table 68: Company Profile - Bolton Medical 161
Table 69: Bolton Medical Marketed Products 162
Table 70: SWOT Analysis - Bolton Medical 162
Table 71: Company Profile - Braile Biomedica 163
Table 72: Braile Biomedica Marketed Products 164
Table 73: SWOT Analysis - Braile Biomedica 164
Table 74: Company Profile - B. Braun 165
Table 75: B. Braun Marketed Products 166
Table 76: SWOT Analysis - B. Braun 166
Table 77: Company Profile - Cardiatis 167
Table 78: Cardiatis Marketed Products 167
Table 79: SWOT Analysis - Cardiatis 168
Table 80: Company Profile - LeMaitre Vascular 169
Table 81: LeMaitre Vascular Medical Marketed Products 169
Table 82: SWOT Analysis - LeMaitre Vascular 170
Table 83: Company Profile - Lifetech Scientific 171
Table 84: Lifetech Scientific Marketed Products 171
Table 85: SWOT Analysis - Lifetech Scientific 172
Table 86: Company Profile - Getinge Group 173
Table 87: Getinge Group Marketed Products 174
Table 88: SWOT Analysis - Getinge Group 174
Table 89: Company Profile - Grikin Advanced Materials 175
Table 90: Grikin Advanced Materials Marketed Products 175
Table 91: SWOT Analysis - Grikin Advanced Materials 176
Table 92: Company Profile - Johnson and Johnson Cordis Corporation 176
Table 93: Cordis Corporation's Pipeline Product 177
Table 94: SWOT Analysis - Cordis Corporation 177
Table 95: Company Profile - Jotec 178
Table 96: Jotec's Marketed Products 179
Table 97: SWOT Analysis - Jotec 179
Table 98: Company Profile - Lombard Medical 180
Table 99: Lombard Medical Marketed Products 181
Table 100: SWOT Analysis - Lombard Medical 181
Table 101: Company Profile - Microport Scientific Corporation 182
Table 102: MicroPort Scientific Marketed Products 183
Table 103: SWOT Analysis - MicroPort Scientific 184
Table 104: Company Profile - Nano Endoluminal 185
Table 105: Nano Endoluminal Medical Marketed Products 185
Table 106: SWOT Analysis - Nano Endoluminal 186
Table 107: Company Profile - TriVascular 187
Table 108: TriVascular Marketed Products 188
Table 109: SWOT Analysis - TriVascular 188
Table 110: Global Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011-2020 197
Table 111: Global Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011-2020 198
Table 112: Global Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011-2020 200
Table 113: Aortic Stent Grafts Sales ($m) for the Major Markets, 2011-2020 201
Table 114: Aortic Stent Grafts Sales ($m) for the US, 2011-2020 204
Table 115: Aortic Stent Grafts Sales ($m) Forecast for the 5EU, 2011-2020 207
Table 116: Aortic Stent Grafts Sales ($m) Forecast for France, 2011-2020 209
Table 117: Aortic Stent Grafts Sales ($m) Forecast for Germany, 2011-2020 211
Table 118: Aortic Stent Grafts Sales ($m) Forecast for Italy, 2011-2020 214
Table 119: Aortic Stent Grafts ($m) Forecast for Spain, 2011-2020 216
Table 120: Aortic Stent Grafts Sales ($m) Forecast for the UK, 2011-2020 218
Table 121: Aortic Stent Grafts Sales ($m) Forecast for the APAC Region, 2011-2020 219
Table 122: Aortic Stent Grafts Sales ($m) Forecast for Japan, 2011-2020 222
Table 123: Aortic Stent Grafts Sales ($m) Forecast for China, 2011-2020 223
Table 124: Aortic Stent Grafts Sales ($m) Forecast for India, 2011-2020 226
Table 125: Aortic Stent Grafts Sales ($m) Forecast for Brazil, 2011-2020 229

1.2 List of Figures
Figure 1: Treatment Methodology Markov Model 31
Figure 2: Aortic Stent Graft Product Image 34
Figure 3: Global Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 36
Figure 4: Global Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 37
Figure 5: US Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 39
Figure 6: US Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 40
Figure 7: EU Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 41
Figure 8: EU Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 42
Figure 9: APAC Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 44
Figure 10: APAC Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 45
Figure 11: South America Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 46
Figure 12: South America Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 47
Figure 13: Global Market Share for EVAR, 2013 192
Figure 14: Global Market Share for TEVAR, 2013 193
Figure 15: US Market Share for EVAR, 2013 194
Figure 16: US Market Share for TEVAR, 2013 195
Figure 17: EU Market Share for EVAR, 2013 196
Figure 18: EU Market Share for TEVAR, 2013 196
Figure 19: Global Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011-2020 198
Figure 20: Global Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011-2020 199
Figure 21: Global Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011-2020 200
Figure 22: Aortic Stent Grafts Sales ($m) for the Major Markets, 2011-2020 202
Figure 23: Aortic Stent Grafts by Major Market, 2013 and 2020 203
Figure 24: US Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 205
Figure 25: 5EU Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 208
Figure 26: France Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 210
Figure 27: Germany Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 212
Figure 28: Italy Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 214
Figure 29: Spain Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 216
Figure 30: UK Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 218
Figure 31: APAC Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 220
Figure 32: Japan Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 222
Figure 33: China Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 224
Figure 34: India Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 227
Figure 35: Brazil Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 229
Figure 36: Aortic Stent Graft Primary Research, Supply and Demand-Side Interviews 255

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