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MediPoint: Bioabsorbable Scaffolds - Global Analysis and Market Forecasts

Summary

Coronary artery disease (CAD) and peripheral artery disease (PAD) are global public health and socioeconomic issues that affect millions of lives each year. Bioabsorbable scaffolds (BAS), which provide transient support to the vessel, are viable alternatives to permanent drug-eluting stents (DES) and bare metal stents (BMS) implants. In the report, BAS are defined as fully-bioabsorbable devices that are used in stenting procedures that completely disappear from the target vessel overtime. Stents such as BioMatrix Flex by Biosensors International and Synergy by Boston Scientific Corporation are not included in the report because they are metallic DES with bioabsorbable polymer coatings. Absorption of the bioabsorbable polymer coating still leaves behind a permanent BMS inside the vessel.

This report focuses on the BAS market in Europe (France, Germany, Italy, Spain, and the UK), India and Brazil, and the future markets of the US, China, and Japan. The global BAS markets are determined for the 10 countries covered in the report. This report identifies the unmet needs in the market, provides an understanding of physician perception of BAS, and evaluates the adoption of BAS in the future. Through GlobalData’s analysis, it is evident that although there will be early adopters in Europe and eventually in the US, the widespread adoption of BAS will be slow. Large-scale, long-term studies need to be conducted to demonstrate their clinical efficacy, and new stent technologies need to be integrated appropriately into the existing reimbursement systems throughout Europe and the US. To successfully market BAS, companies need to design novel scaffold platforms that address the current unmet needs of conventional drug-eluting and BMS, and show superior clinical performance to the stents that are currently marketed and being used in modern clinics.

Highlights

Key Questions Answered

- What is the current and future outlook of bioabsorbable scaffolds in developed and emerging markets?
- What trends are affecting the global bioabsorbable scaffold market?
- What are the market sizes of each bioabsorbable scaffold segment?
- What are unmet needs in the bioabsorbable scaffold market? What are the clinical and non-clinical barriers in this space?
- What is the physician perception and market outlook of bioabsorbable scaffolds, which are considered to be the fourth revolution in interventional cardiology?

Reasons to buy

- “What Do 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. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table Of Contents

MediPoint: Bioabsorbable Scaffolds - Global Analysis and Market Forecasts
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 15
1.2 List of Figures 20
2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
3 Disease Overview 24
3.1 Coronary Artery Disease 24
3.2 Peripheral Artery Disease 24
3.3 Anatomy and Physiology 25
3.4 Pathophysiology 26
3.4.1 Coronary Artery Disease 26
3.4.2 Peripheral Artery Disease 27
3.5 Clinical Presentation 28
3.5.1 Symptoms of Coronary Artery Disease 28
3.5.2 Symptoms of Peripheral Artery Disease 28
3.6 Risk Factors 29
3.6.1 Coronary Artery Disease 29
3.6.2 Peripheral Artery Disease 29
3.7 Disease Segments 30
3.7.1 Coronary Artery Disease 30
3.7.2 Peripheral Artery Disease 30
3.8 Diagnosis 31
3.8.1 Coronary Artery Disease 31
3.8.2 Peripheral Artery Disease 32
3.9 Clinical Outcomes 33
3.9.1 Treatment Paradigm 33
3.9.2 Treatment Modalities 33
3.9.3 Coronary/Peripheral Artery Bypass Grafting 36
3.9.4 Interventional Cardiology 37
4 Competitive Assessment 42
4.1 Overview 42
4.2 Absorb BVS - Abbott Vascular 43
4.2.1 Efficacy 45
4.3 Remedy - Kyoto Medical Planning 49
4.3.1 Efficacy 51
4.4 DESolve - Elixir Medical Corperation 52
4.4.1 Efficacy 54
4.5 Pure - Arterial Remodeling Technologies 56
4.5.1 Efficacy 57
5 Unmet Needs 59
5.1 Develop a Fully-Bioabsorbable Stent 59
5.2 Reduce the Risk of Complications 59
5.3 Reduce the Need for Stent-in-Stent Procedures 60
5.4 Long-Term Clinical Data 60
5.5 Reduce the Rate of Stent Fracture 61
5.6 Dual Anti-Platelet Therapy 61
5.7 Imaging 61
6 Pipeline Products 62
6.1 Overview 62
6.2 Coronary Artery Disease - Pipeline Products 62
6.2.1 Overview 62
6.2.2 Polymer-Based Bioabsorbable Scaffolds 64
6.2.3 Metallic Bioabsorbable Scaffolds 78
6.2.4 Summary 81
6.3 Peripheral Artery Disease - Peripheral Bioabsorbable Scaffold Product Pipeline 82
6.3.1 Overview 82
6.3.2 Summary 88
7 Industry Overview 90
7.1 Procedure Trends 90
7.1.1 Global Coronary and Peripheral Stenting Procedure Trends 90
7.1.2 Coronary Artery Disease 93
7.1.3 Peripheral Artery Disease 98
8 Market Access 105
8.1 Overview 105
8.2 Regulatory Process 106
8.2.1 United States 106
8.2.2 5EU 107
8.2.3 Asia-Pacific 108
8.2.4 Brazil 111
8.3 Physician Decision-Making Process 112
8.4 Role of Group Purchasing Organizations 114
8.5 Lack of Clinical Data 117
8.6 Regional-Level Control 118
8.7 Cost Considerations 120
8.7.1 United States 120
8.7.2 5EU 121
8.7.3 Asia-Pacific 122
8.7.4 Brazil 123
8.8 Reimbursement Trends 124
8.8.1 United States 124
8.8.2 5EU 125
8.8.3 Asia-Pacific 130
8.8.4 Brazil 133
8.9 Regulatory Issues/Recalls 134
8.10 Product Recalls 134
9 Mergers and Acquisitions 136
9.1 ART and Terumo Corparation 136
9.2 Xenogenics Corporation and Multicell Technologies 136
9.3 Icon Interventional Systems and Ariad Pharmaceuticals 136
9.4 Boston Scientific Corporation 137
10 Current and Future Players 138
10.1 Overview 138
10.2 Trends in Corporate Strategy 138
10.3 Company Profiles 139
10.3.1 Abbott Vascular 139
10.3.2 Kyoto Medical Planning Co., Ltd. 142
10.3.3 Arterial Remodeling Technologies 144
10.3.4 Elixir Medical Corporation 147
10.3.5 Cardionovum 150
10.3.6 Reva Medical 152
10.3.7 OrbusNeich Medical 154
10.3.8 Amaranth Medical 156
10.3.9 Biotronik 158
10.3.10 Lepu Medical Technology 161
10.3.11 HuaAn Biotechnology Co., Ltd. 163
10.3.12 Lifetech Scientific (Shenzhen) Co., LTD. (Lifetech Shenzhen) 165
10.3.13 Arterius 168
10.3.14 S3V Vascular Technologies 169
10.3.15 Tepha Inc. 171
10.3.16 Zorion Medical 173
10.3.17 Xenogenics Corporation 175
10.3.18 Meril Life Sciences 177
10.3.19 Boston Scientific Corporation 179
10.3.20 Icon Interventional Systems 181
11 Market Drivers, Opportunities and Barriers 183
11.1 Market Drivers 183
11.1.1 Rising Prevalence of Disease 183
11.1.2 Avoid Stent-in-Stent Procedures 184
11.1.3 Reduce/Eliminate Dual Anti-Platelet Therapy 185
11.1.4 Availability of Long-Term Data 185
11.1.5 Treatment Considerations 186
11.1.6 Accurate Stent Placement 186
11.1.7 Expected Launch of BAS in the US 187
11.2 Opportunities 187
11.2.1 BAS Segmentation 187
11.2.2 Expanding the Indications for BAS 188
11.2.3 Target High-Risk Patients 189
11.2.4 Improve Deliverability of BAS 190
11.2.5 Emerging Markets 190
11.3 Market Barriers 190
11.3.1 Slow Adoption 190
11.3.2 Complications Associated with BAS 191
11.3.3 High Average Selling Price 192
11.3.4 Reimbursement 193
11.3.5 Substitutes 194
12 Market Outlook and Forecast 196
12.1 Global Market Overview 196
12.2 United States 198
12.2.1 Overview 198
12.2.2 Market Analysis 199
12.3 France 201
12.3.1 Overview 201
12.3.2 Market Analysis 201
12.4 Germany 203
12.4.1 Overview 203
12.4.2 Market Analysis 204
12.5 Italy 206
12.5.1 Overview 206
12.5.2 Market Analysis 206
12.6 Spain 209
12.6.1 Overview 209
12.6.2 Market Analysis 209
12.7 United Kingdom 211
12.7.1 Overview 211
12.7.2 Market Analysis 211
12.8 Japan 213
12.8.1 Overview 213
12.8.2 Market Analysis 213
12.9 Brazil 215
12.9.1 Overview 215
12.9.2 Market Analysis 216
12.10 China 217
12.10.1 Overview 217
12.10.2 Market Analysis 217
12.11 India 220
12.11.1 Overview 220
12.11.2 Market Analysis 220
13 Appendix 223
13.1 Bibliography 223
13.2 Abbreviations 238
13.3 Report Methodology 244
13.3.1 Overview 244
13.3.2 Coverage 244
13.3.3 Secondary Research 244
13.4 Forecasting Methodology 245
13.5 Physicians and Specialists Included in This Study 246
13.6 About the Authors 248
13.6.1 Analysts 248
13.6.2 James Coutcher, Global Head of Healthcare 249
13.7 About GlobalData 250
13.8 Disclaimer 250

1.1 List of Tables
Table 1: Symptoms of CAD 28
Table 2: Symptoms of PAD 28
Table 3: Risk Factors Associated With CAD 29
Table 4: Risk Factors Associated With PAD 30
Table 5: Disease Segments for CAD 30
Table 6: Disease Segments for PAD 31
Table 7: Methods for Diagnosing CAD 32
Table 8: Methods for Diagnosing PAD 32
Table 9: Types of CABG 36
Table 10: Drugs Incorporated Into DES 39
Table 11: Marketed BAS Products 42
Table 12: Absorb BVS Product Profile 44
Table 13: Absorb BVS Clinical Trials 48
Table 14: Absorb BVS SWOT Analysis, 2015 49
Table 15: Remedy Product Profile 50
Table 16: Remedy SWOT Analysis, 2015 52
Table 17: DESolve Product Profile 53
Table 18: DESolve Clinical Trials 55
Table 19: DESolve SWOT Analysis, 2015 56
Table 20: Pure Product Profile 57
Table 21: Pure SWOT Analysis, 2015 58
Table 22: Coronary BAS Product Pipeline, 2015 63
Table 23: Igaki-Tamai Stent SWOT Analysis, 2015 65
Table 24: Fantom Scaffold SWOT Analysis, 2015 67
Table 25: ART18Z Scaffold SWOT Analysis, 2015 68
Table 26: Fortitude Scaffold SWOT Analysis, 2015 70
Table 27: ArterioSorb Scaffold SWOT Analysis, 2015 71
Table 28: ArterioSorb Scaffold SWOT Analysis, 2015 73
Table 29: Xinsorb Scaffold SWOT Analysis, 2015 74
Table 30: Ideal BioStent SWOT Analysis, 2015 75
Table 31: DREAMS Scaffold SWOT Analysis, 2015 80
Table 32: Peripheral BAS Product Pipeline, 2015 83
Table 33: Magic Explorer Scaffold SWOT Analysis, 2015 85
Table 34: ESPRIT BVS Stent SWOT Analysis, 2015 86
Table 35: GPOs in the US and EU 115
Table 36: Abbott Vascular Company Profile 139
Table 37: Marketed BAS Products by Abbott Vascular 140
Table 38: Pipeline BAS Products by Abbott Vascular 141
Table 39: Abbott Vascular SWOT Analysis, 2015 141
Table 40: Kyoto Medical PlanningCompany Profile 142
Table 41: Marketed BAS Products by Kyoto Medical Planning 143
Table 42: Pipeline BAS Products by Kyoto Medical Planning 144
Table 43: Kyoto Medical Planning SWOT Analysis, 2015 144
Table 44: ART Company Profile 145
Table 45: Marketed BAS Products by ART 145
Table 46: ART's BAS Pipeline Products 146
Table 47: ART SWOT Analysis, 2015 147
Table 48: Elixir Medical Corporation Company Profile 148
Table 49: Marketed BAS Products by Elixir Medical 149
Table 50: Elixir Medical Corporation SWOT Analysis, 2015 150
Table 51: Cardionovum Company Profile 150
Table 52: Cardionovum's BAS Pipeline Products 151
Table 53: Cardionovum SWOT Analysis, 2015 152
Table 54: REVA Medical's BAS Pipeline Products 153
Table 55: REVA Medical SWOT Analysis, 2015 154
Table 56: OrbusNeich Medical Company Profile 155
Table 57: OrbusNeich Medical's BAS Pipeline Products 155
Table 58: OrbusNeich Medical SWOT Analysis, 2015 156
Table 59: Amaranth Medical Company Profile 157
Table 60: Amaranth Medical's BAS Pipeline Products 157
Table 61: Amaranth Medical SWOT Analysis, 2014 158
Table 62: Biotronik Company Profile 159
Table 63: Biotronik's BAS Pipeline Products 160
Table 64: Biotronik SWOT Analysis, 2015 161
Table 65: Lepu Medical Technology Company Profile 162
Table 66: Lepu Medical Technology's BAS Pipeline Products 162
Table 67: Lepu Medical Technology SWOT Analysis, 2015 163
Table 68: HuaAn Biotechnology Co., Ltd. Company Profile 164
Table 69: HuaAn Biomedical Co., Ltd.'s BAS Pipeline Products 165
Table 70: HuaAn Biomedical Co., Ltd. SWOT Analysis, 2015 165
Table 71: Lifetech Scientific Co., LTD Company Profile 166
Table 72: Lifetech Scientific's BAS Pipeline Products 167
Table 73: Lifetech Scientific SWOT Analysis, 2015 167
Table 74: Arterius Company Profile 168
Table 75: Arterius BAS Pipeline Products 169
Table 76: Arterius SWOT Analysis, 2015 169
Table 77: S3V Vascular Technologies Company Profile 170
Table 78: S3V Vascular Technologies' BAS Pipeline Product 171
Table 79: S3V Vascular Technologies SWOT Analysis, 2015 171
Table 80: Tepha Inc.Company Profile 172
Table 81: Tepha Inc.'s BAS Pipeline Product 172
Table 82: Tepha Inc. SWOT Analysis, 2015 173
Table 83: Zorion MedicalCompany Profile 174
Table 84: Zorion Medical's BAS Pipeline Product 174
Table 85: Zorion Medical SWOT Analysis, 2015 175
Table 86: Xenogenics Corporation Company Profile 176
Table 87: Xenogenics Corporation's BAS Pipeline Product 176
Table 88: Xenogenics Corporation SWOT Analysis, 2015 177
Table 89: Meril Life Sciences Company Profile 178
Table 90: Meril Life Science's BAS Pipeline Product 178
Table 91: Meril Life Sciences SWOT Analysis, 2015 179
Table 92: Boston Scientific Corporation Company Profile 180
Table 93: Boston Scientific Corporation SWOT Analysis, 2015 181
Table 94: Icon Interventional Systems Company Profile 182
Table 95: Global BAS Market Revenue ($m), 2012-2021 197
Table 96: US BAS Market Revenue ($m), 2012-2021 199
Table 97: France BAS Market Revenue ($m), 2012-2021 202
Table 98: Germany BAS Market Revenue ($m), 2012-2021 204
Table 99: Italy BAS Market Revenue ($m), 2012-2021 207
Table 100: Spain BAS Market Revenue ($m), 2012-2021 210
Table 101: UK BAS Market Revenue ($m), 2012-2021 212
Table 102: Japan BAS Market Revenue ($m), 2012-2021 214
Table 103: Brazil BAS Market Revenue ($m), 2012-2021 216
Table 104: China BAS Market Revenue ($m), 2012-2021 218
Table 105: India BAS Market Revenue ($m), 2012-2021 221

1.2 List of Figures
Figure 1: Anatomy of the Human Heart 25
Figure 2: Pathophysiology of CAD 26
Figure 3: Pathophysiology of PAD 27
Figure 4: Treatment Modalities - CAD 34
Figure 5: Treatment Modalities - PAD 35
Figure 6: Types of Stents Used to Treat CAD and PAD 38
Figure 7: Global Coronary Artery Procedure Volume. By Stent Type, 2012-2021 91
Figure 8: Global Peripheral Artery Drug-Eluting and Bare-Metal Stenting Procedure Volume, By Artery Type, 2012-2021 91
Figure 9: Global Adoption Pattern of Stents Used to Treat CAD, 2021 92
Figure 10: Global Peripheral Bioabsorbable Scaffolding Procedure Volume, By Artery, 2012-2021 93
Figure 11: US Drug-Eluting and Bare Metal Stenting Procedure Volume, 2012-2021 94
Figure 12: 5EU Procedure Volume ofStents Used in Coronary Interventions, 2012-2021 96
Figure 13: APAC Procedure Volume of Stents Used in Coronary Interventions, 2012-2021 97
Figure 14: Brazil Procedure Volume of Stents Used in Coronary Interventions, 2012-2021 98
Figure 15: US Peripheral Stenting Procedure Volume, By Artery, 2012-2021 99
Figure 16: 5EU Peripheral Stenting Procedure Volume, by Artery, 2012-2021 100
Figure 17: Peripheral Drug-Eluting and Bare Metal Stent Usage, By Artery, 2014 and 2021 101
Figure 18: Peripheral BAS Use, By Artery, 2014 and 2021 102
Figure 19: APAC Peripheral Stenting Procedure Volume, by Artery, 2012-2021 103
Figure 20: Brazil Peripheral Stenting Procedure Volume, By Artery, 2012-2021 104
Figure 21: Global Coronary and Peripheral BAS Market Revenue ($m), 2012-2021 196
Figure 22: Global BAS Market Revenue, by Geography, 2014 and 2021 198
Figure 23: US BAS Market Revenue ($m), 2012-2021 200
Figure 24: France BAS Market Revenue ($m), 2012-2021 202
Figure 25: France Coronary and Peripheral BAS Market Revenue ($m), 2012-2021 202
Figure 26: Germany BAS Market Revenue ($m), 2012-2021 204
Figure 27: Germany Coronary and Peripheral BAS Market Revenue ($m), 2012-2021 205
Figure 28: Italy BAS Market Revenue ($m), 2012-2021 207
Figure 29: Italy Coronary and Peripheral BAS Market Revenue ($m), 2012-2021 208
Figure 30: Spain BAS Market Revenue ($m), 2012-2021 210
Figure 31: Spain Coronary and Peripheral BAS Market Revenue for Spain ($m), 2012-2021 210
Figure 32: UK BAS Market Revenue ($m), 2012-2021 212
Figure 33: UK Coronary and Peripheral BAS Market Revenue ($m), 2012-2021 212
Figure 34: Japan BAS Market Revenue ($m), 2012-2021 215
Figure 35: Brazil BAS Market Revenue ($m), 2012-2021 217
Figure 36: China BAS Market Revenue ($m), 2012-2021 218
Figure 37: India BAS Market Revenue ($m), 2012-2021 221

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