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MediPoint: Aortic Stent Grafts - APAC 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.

In this report, GlobalData analyzes the use of stent graft systems for treating patients with AAA and TAA for APAC (Japan, China, and India). Within each segment, the revenue stream from stent graft sales are tracked and estimated based on GlobalData’s primary and secondary research.

Scope

- An overview of Aortic Stent Grafts, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized APAC Aortic Stent Grafts market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
- Investigation of current and future market competition for Aortic Stent Grafts.
- 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 Aortic Stent Grafts sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as doctors

Reasons to buy

- Understand the trends shaping and driving the APAC Aortic Stent Grafts market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the APAC Aortic Stent Grafts 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 the APAC Aortic Stent Grafts market landscape? Identify, understand and capitalize.

Table Of Contents

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

2 Introduction 20
2.1 Catalyst 21
2.2 Related Reports 22
2.3 Upcoming Related Reports 22
3 Industry Overview 23
3.1 Overview 23
3.2 Indications 25
3.2.1 Aortic Abdominal Aneurysm 25
3.2.2 Thoracic Aortic Aneurysm 25
3.2.3 Aortic Dissection 26
3.3 Clinical Outcomes 27
3.3.1 Lifestyle Changes 28
3.3.2 Medication 29
3.3.3 Open Surgery 29
3.3.4 Endovascular Repair 30
3.4 Procedure Trends 32
3.4.1 Endovascular Aneurysm Repair 32
3.4.2 Thoracic Endovascular Aneurysm Repair 33
3.5 Market Access 33
3.5.1 Adoption 35
3.5.2 Regulation 39
3.5.3 Reimbursement 42
3.6 Regulatory Issues/Recalls 45
3.6.1 Anaconda Back on the Market in March 2014 after a Voluntary Recall of Anaconda by Vascutek 45
3.6.2 Terminated FDA's Class II Recall of TriVascular's Ovation Prime in April 2014 45
3.7 Mergers, Deals, and Acquisitions 46
3.7.1 Medtronic Acquires Covidien 46
3.7.2 TriVascular Launches $100m Initial Public Offering 46
3.7.3 Lombard Medical Pursues US Initial Public Offering 46
3.7.4 TriVascular Raises $40m in Series E Financing 46
3.7.5 LifeTech Scientific Creates Partnership with Medtronic 47
3.7.6 LeMaitre Vascular Terminates Distribution Agreement with Endologix 47
3.7.7 Jotec Enters Licensing Agreement with Hydromer 47
3.7.8 Endologix Public Offering of Notes 47
3.7.9 Aptus Endosystems Secures Financing 47
3.7.10 Altura Medical Secures Financing 48
3.7.11 Endologix Acquires Nellix Endovascular 48
3.8 Economic Impact 48
3.8.1 Economic Impact of Aneurysms 48
3.8.2 Treatment Costs of Aortic Aneurysms 50
4 Unmet Needs 52
4.1 Addressing the Complications 52
4.1.1 Endoleaks 52
4.1.2 Ischemic Complications 53
4.1.3 Limb Thrombosis 53
4.1.4 Infection 54
4.1.5 Paraplegia in Thoracic Aortic Aneurysm 54
4.2 The Seal and Landing Zone 55
4.3 Short Neck 56
4.4 Cost Containment 57
4.5 More Low Profile Systems 58
4.6 Customized Fenestrated Stent Grafts 59
4.7 Multi-Branch Stent Grafts 60
4.8 Thoracic Endovascular Aneurysm Repair Unmet Needs 60
4.9 Long-Term Clinical Data 61
5 Market Opportunity Analysis 62
5.1 Emerging Markets 62
5.2 Thoracic Aortic Disease Market 63
5.3 Addition of Physician Training Programs 64
5.4 Disruptive Technologies 65
5.5 Minimally Invasive Trend 66
6 Market Drivers, Barriers, and Substitutes 67
6.1 Driver: Rising Disease Prevalence 67
6.1.1 Diabetes Mellitus 67
6.1.2 Hypertension 67
6.1.3 Obesity 67
6.1.4 Tobacco Use 68
6.2 Driver: Aging 68
6.3 Driver: Imaging 69
6.4 Driver: Improved Clinical Outcomes with Endovascular Therapy 70
6.5 Driver: Time Savings 71
6.6 Driver: Patient Demand and Awareness 71
6.7 Driver: Technological Developments 72
6.7.1 Custom Branched and Fenestrated Stent Grafts 72
6.7.2 Low Profile Delivery Systems 73
6.8 Driver: Rising Competition and Innovation 74
6.9 Barrier: Availability of Venture Capital 74
6.10 Barrier: Burden of Rising Regulation 75
6.11 Barrier: High Treatment Cost 76
6.12 Barrier: Proving Long-Term Efficacy 77
6.13 Barrier: High Radiation Dosages with Excessive Imaging 78
6.14 Surgical Limitations 78
6.15 Barrier: Medical Device Excise Tax 79
6.16 Substitute: Open Surgery 79
6.17 Substitute: Chimney Technique versus Fenestrated Grafts 80
7 Competitive Assessment 82
7.1 Overview 82
7.2 Key Marketed Products 82
7.2.1 Endovascular Aneurysm Repair and Thoracic Endovascular Aneurysm Repair Products 82
8 Pipeline Assessment 93
8.1 Overview 93
8.2 Product Profiles 93
8.2.1 Altura Medical Endograft 93
8.2.2 Cordis INCRAFT 94
8.2.3 EndoSpan Horizon 95
8.2.4 EndoSpan Nexus 96
8.2.5 MicroPort Scientific Castor Branched Stent Graft System 97
8.2.6 BiFlow Medical Novel Side-Branch Stent 98
8.2.7 Endoluminal Sciences Endograft Mechanism 99
8.2.8 Medtronic Valiant Mona LSA Stent Graft System 100
8.2.9 Endologix Ventana Fenestrated Stent Graft 100
9 Clinical Trials to Watch 102
9.1 Overview 102
9.2 Altura Medical 102
9.3 Cook Medical 103
9.4 Gore Medical 105
9.5 Terumo Corporation 106
9.6 Endologix 106
9.7 TriVascular 108
9.8 Bolton Medical 109
9.9 Medtronic 110
9.10 Cordis Corporation 112
10 Current and Future Players 113
10.1 Overview 113
10.2 Trends in Corporate Strategy 113
10.3 Company Profiles 114
10.3.1 Cook Medical 114
10.3.2 Endologix 117
10.3.3 Gore Medical 120
10.3.4 Medtronic 122
10.3.5 Terumo Corporation 125
10.3.6 Altura Medical 127
10.3.7 Aptus Endosystems 129
10.3.8 Bolton Medical 131
10.3.9 Braile Biomedica 132
10.3.10 B. Braun 135
10.3.11 Cardiatis 136
10.3.12 LeMaitre Vascular 138
10.3.13 Lifetech Scientific 140
10.3.14 Getinge Group 142
10.3.15 Grikin Advanced Materials 145
10.3.16 Johnson and Johnson's Cordis Corporation 146
10.3.17 Jotec 148
10.3.18 Lombard Medical 150
10.3.19 MicroPort Scientific Corporation 151
10.3.20 Nano Endoluminal 154
10.3.21 TriVascular 156
10.3.22 Weike Medical Apparatus and Instrument 159
10.3.23 YTH Biological Material Scitech 159
11 Market Outlook 160
11.1 By Market Segment 160
11.1.1 Overview 160
11.1.2 Endovascular Aneurysm Repair 161
11.1.3 Thoracic Endovascular Aneurysm Repair 162
11.2 By Geography 163
11.2.1 APAC Overview 163
12 Appendix 173
12.1 Bibliography 173
12.2 Abbreviations 187
12.3 Research Methodology 190
12.3.1 Overview 190
12.3.2 Coverage 190
12.3.3 Secondary Research 190
12.4 Physicians and Specialists Included in this Study 192
12.4.1 Christopher Abularrage, MD, FACS 192
12.4.2 Gaspar Mestres Alomar, MD 192
12.4.3 Enio Buffolo, MD, PhD 192
12.4.4 Ludovic Canaud, MD, PhD 192
12.4.5 Holger Eggebrecht, MD 192
12.4.6 Daisuke Fukui, MD, PhD 192
12.4.7 Germano Melissano, MD 192
12.4.8 Dr. Raghuram Sekhar MS, FRCS (Edinburgh), FRCS (Glasgow) 192
12.4.9 Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS (Gen Surg), DIC 193
12.4.10 Jiang Xiong, MD, PhD 193
12.5 Primary Research 194
12.5.1 Primary Research - Key Opinion Leader Interviews 194
12.5.2 Primary Research - Physician and Industry Interviews 194
12.5.3 Expert Panel Validation 195
12.6 Forecasting Methodology 196
12.7 About the Authors 197
12.7.1 Analysts 197
12.7.2 Global Head of Healthcare 198
12.8 About MediPoint 199
12.9 About GlobalData 199
12.10 Disclaimer 199

1.1 List of Tables

Table 1: Summary of Indications, Symptoms, and Treatments 24
Table 2: Thoracic Aortic Aneurysm Types 26
Table 3: Medications for Reducing Risk of Aneurysm Growth and Rupture 29
Table 4: Advantages and Disadvantages of Open Repair versus Endovascular Repair 31
Table 5: Direct and Indirect Costs of Open Surgery and Endovascular Repair 50
Table 6: Comparison Costs and Other Variables for Treating AAA By Open Repair and Stent Grafts in 2012 ($US) 51
Table 7: Endoleak Types 52
Table 8: Zenith Family Marketed Products 84
Table 9: Zenith AAA SWOT 84
Table 10: Zenith TAA SWOT 85
Table 11: Endologix's Marketed Products 86
Table 12: AFX Endovascular SWOT 86
Table 13: IntuiTrak Powerlink System SWOT 86
Table 14: Gore Medical's Marketed Products 88
Table 15: Gore AAA Product SWOT 88
Table 16: Gore TAA Product SWOT 89
Table 17: Medtronic's Marketed Products 90
Table 18: Medtronic AAA Product SWOT 91
Table 19: Medtronic TAA Product SWOT 91
Table 20: Terumo Corporation Marketed Products 92
Table 21: Terumo Corporation AAA Product SWOT 92
Table 22: SWOT Analysis - Altura Medical Endograft 94
Table 23: SWOT Analysis - Cordis INCRAFT 95
Table 24: SWOT Analysis - EndoSpan Horizon 96
Table 25: SWOT Analysis - EndoSpan Nexus 97
Table 26: SWOT Analysis - MicroPort Scientific Castor Branched Stent Graft System 98
Table 27: SWOT Analysis - BiFlow Medical Novel Side-Branch Stent 99
Table 28: SWOT Analysis - Endoluminal Sciences Endograft Mechanism 99
Table 29: SWOT Analysis - Medtronic Valiant Mona LSA Stent Graft 100
Table 30: SWOT Analysis - Endologix Ventana Fenestrated Stent Graft 101
Table 31: Major Clinical Trials of Altura Medical's Aortic Stent Grafts 103
Table 32: Major Clinical Trials of Cook Medical's Aortic Stent Grafts 104
Table 33: Major Clinical Trials of Gore Medical's Aortic Stent Grafts 105
Table 34: Major Clinical Trials of Terumo's Aortic Stent Grafts 106
Table 35: Major Clinical Trials of Endologix's Aortic Stent Grafts 107
Table 36: Major Clinical Trials of TriVascular's Aortic Stent Grafts 108
Table 37: Major Clinical Trials of Bolton Medical's Aortic Stent Grafts 109
Table 38: Major Clinical Trials of Medtronic's Aortic Stent Grafts 110
Table 39: Major Clinical Trials of Cordis' Aortic Stent Grafts 112
Table 40: Company Profile - Cook Medical 115
Table 41: Cook Medical Marketed Products 116
Table 42: SWOT Analysis - Cook Medical 117
Table 43: Company Profile - Endologix Inc. 118
Table 44: Endologix Marketed Products 119
Table 45: Endologix Pipeline Products 119
Table 46: SWOT Analysis - Endologix Inc. 119
Table 47: Company Profile - Gore Medical 120
Table 48: Gore Medical Marketed Products 121
Table 49: SWOT Analysis - Gore Medical 122
Table 50: Company Profile - Medtronic 123
Table 51: Medtronic Marketed Products 124
Table 52: SWOT Analysis - Medtronic 124
Table 53: Company Profile - Terumo Corporation 125
Table 54:Terumo Corporation Marketed Products 126
Table 55: SWOT Analysis - Terumo Corporation 127
Table 56: Company Profile - Altura Medical Inc. 127
Table 57: Altura Medical Inc. Marketed Products 128
Table 58: SWOT Analysis - Altura Medical Inc. 128
Table 59: Company Profile - Aptus Endosystems, Inc. 129
Table 60: Aptus Endosystems Inc. Marketed Products 130
Table 61: SWOT Analysis - Aptus Endosystems Inc. 130
Table 62: Company Profile - Bolton Medical 131
Table 63: Bolton Medical Marketed Products 132
Table 64: SWOT Analysis - Bolton Medical 132
Table 65: Company Profile - Braile Biomedica 133
Table 66: Braile Biomedica Marketed Products 134
Table 67: SWOT Analysis - Braile Biomedica 134
Table 68: Company Profile - B. Braun 135
Table 69: B. Braun Marketed Products 136
Table 70: SWOT Analysis - B. Braun 136
Table 71: Company Profile - Cardiatis 137
Table 72: Cardiatis Marketed Products 137
Table 73: SWOT Analysis - Cardiatis 138
Table 74: Company Profile - LeMaitre Vascular 139
Table 75: LeMaitre Vascular Medical Marketed Products 139
Table 76: SWOT Analysis - LeMaitre Vascular 140
Table 77: Company Profile - Lifetech Scientific 141
Table 78: Lifetech Scientific Marketed Products 141
Table 79: SWOT Analysis - Lifetech Scientific 142
Table 80: Company Profile - Getinge Group 143
Table 81: Getinge Group Marketed Products 144
Table 82: SWOT Analysis - Getinge Group 144
Table 83: Company Profile - Grikin Advanced Materials 145
Table 84: Grikin Advanced Materials Marketed Products 145
Table 85: SWOT Analysis - Grikin Advanced Materials 146
Table 86: Company Profile - Johnson and Johnson Cordis Corporation 146
Table 87: Cordis Corporation's Pipeline Product 147
Table 88: SWOT Analysis - Cordis Corporation 147
Table 89: Company Profile - Jotec 148
Table 90: Jotec's Marketed Products 149
Table 91: SWOT Analysis - Jotec 149
Table 92: Company Profile - Lombard Medical 150
Table 93: Lombard Medical Marketed Products 151
Table 94: SWOT Analysis - Lombard Medical 151
Table 95: Company Profile - Microport Scientific Corporation 152
Table 96: MicroPort Scientific Marketed Products 153
Table 97: SWOT Analysis - MicroPort Scientific 154
Table 98: Company Profile - Nano Endoluminal 155
Table 99: Nano Endoluminal Medical Marketed Products 155
Table 100: SWOT Analysis - Nano Endoluminal 156
Table 101: Company Profile - TriVascular 157
Table 102: TriVascular Marketed Products 158
Table 103: SWOT Analysis - TriVascular 158
Table 104: APAC Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011-2020 160
Table 105: APAC Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011-2020 161
Table 106: APAC Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011-2020 163
Table 107: Aortic Stent Grafts Sales ($m) Forecast for the APAC Region, 2011-2020 164
Table 108: Aortic Stent Grafts Sales ($m) Forecast for Japan, 2011-2020 167
Table 109: Aortic Stent Grafts Sales ($m) Forecast for China, 2011-2020 168
Table 110: Aortic Stent Grafts Sales ($m) Forecast for India, 2011-2020 171

1.2 List of Figures

Figure 1: Treatment Methodology Markov Model 28
Figure 2: Aortic Stent Graft Product Image 31
Figure 3: APAC Abdominal Aortic Stent Grafts Procedure Volume, 2011-2020 32
Figure 4: APAC Thoracic Aortic Stent Grafts Procedure Volume, 2011-2020 33
Figure 5: APAC Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011-2020 161
Figure 6: APAC Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011-2020 162
Figure 7: APAC Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011-2020 163
Figure 8: APAC Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 165
Figure 9: Japan Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 167
Figure 10: China Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 169
Figure 11: India Sales ($m) Forecast for Aortic Stent Grafts, 2011-2020 172
Figure 12: Aortic Stent Graft Primary Research, Supply and Demand-Side Interviews 195

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