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MediPoint: Non-Vascular Stents - Global Analysis and Market Forecasts

Summary

Non-vascular stent technology has evolved over the years such that these devices are routinely used in clinical practice for different indications. Although it is a mature market, both short and long-term complications associated with non-vascular stents continue to persist. This report focuses on four market categories within the non-vascular stent segment, which includes enteral stents (esophageal, gastroduodenal and colonic stents), pancreatic and biliary stents, airways stents and urinary tract stents (ureteral, prostate and urethral stents). The overall non-vascular stent market has been estimated in this report, which covers the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, China and India (10MM) up to 2021. The report provides an investigation of unmet needs, future adoption trends and compound annual growth rates (CAGR) for each geography and market segment. In addition, this report presents the current market drivers and barriers which will influence the future market growth of non-vascular stents in the 10MM.

Highlights

Key Questions Answered

- What is the current and future non-vascular stent market outlook in the developed and emerging markets? (Q). What trends are affecting the global non-vascular stents market?
- Which are the key, high growth markets that stent manufacturers should expand into? (Q). What non-vascular stent segments are growing the fastest?
- There are a few significant unmet needs. (Q). What are these unmet needs? (Q). What is the scope for more innovation and what are the end-users looking for in their products?
- Will biodegradable stent systems fulfill these unmet needs? (Q). What is physician perception and market outlook of this technology?
- What percent of global profits are from emerging markets? (Q). How will this change in the future?
- Boston Scientific currently dominates the global non-vascular stents market. (Q). What is their market share in the major global economies and which companies constitute the remainder of the market?

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 physicians and other stakeholders 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: Non-Vascular Stents - Global Analysis and Market Forecasts
1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 13
1.2 List of Figures 18
2 Introduction 22
2.1 Catalyst 23
2.2 Related Reports 23
3 Industry Overview 24
3.1 Overview 24
3.2 Non-Vascular Stenting Indications 25
3.2.1 Enteral Stents 25
3.2.2 Pancreatic and Biliary Stents 26
3.2.3 Airway Stents 27
3.2.4 Urinary Tract Stents 29
3.3 Types of Stents and Clinical Efficacy 30
3.3.1 Enteral Stents 30
3.3.2 Pancreatic and Biliary Stents 34
3.3.3 Airway Stents 36
3.3.4 Urinary Tract Stents 37
3.4 Procedure Trends 37
3.4.1 US 37
3.4.2 5EU 47
3.4.3 Asia-Pacific 56
3.4.4 South America 66
3.5 Market Access 74
3.5.1 Product Adoption 75
3.5.2 Regulation 82
3.5.3 Reimbursement 88
3.6 Regulatory Issues/Recalls (2011-2014) 98
3.6.1 Cordis Corporation Class II Recall of S.M.A.R.T Control Transhepatic Biliary Stent 98
3.7 Mergers, Acquisitions, and Other Deals 99
3.7.1 Medtronic Acquires Covidien 99
3.7.2 Beijing King Health Signs Distribution Agreement With Allium Medical 99
3.7.3 Cordis Acquires Flexible Stenting Solutions 99
3.7.4 Allium Medical Enters Into Distribution Agreement With Meizler UCB Biopharma 99
3.7.5 Gore and ConMed Extend Distribution Agreement 100
3.7.6 Allium Medical Acquires Gardia Medical 100
3.7.7 Flexible Stenting Solutions Raises Funds in Series B Financing 100
3.8 Economic Impact 100
4 Unmet Needs 103
4.1 Addressing the Complications 103
4.1.1 Enteral Stents 103
4.1.2 Pancreatic and Biliary Stents 104
4.1.3 Airway Stents 105
4.1.4 Urinary Tract Stents 105
4.2 Overcoming Stent Design Challenges 106
4.2.1 Stent Shortening 106
4.2.2 Stent Fracture 107
4.2.3 Flexibility 107
4.3 Simplify Delivery Systems 108
4.4 Disconnect Between Industry and Physicians 108
4.5 Indication-Specific Stents 109
4.6 Lack of Long-Term and Comparative Clinical Data 110
4.7 Refocus on Pipeline Products 111
4.8 Lack of Standardization 112
4.9 Cost-Containment 112
4.10 Need for An International Procedure Registry 113
5 Market Opportunity Analysis 115
5.1 Improve Stent Systems 115
5.2 Biodegradable Stents 115
5.3 Drug-Eluting Stents 119
5.4 Radiosensitization 121
5.5 Customized Stents 122
5.6 Emerging Markets 123
6 Market Drivers and Barriers 124
6.1 Driver: Rising Disease Prevalence 124
6.1.1 Cancer 124
6.1.2 Urolithiasis 125
6.2 Driver: Non-Malignant Stenting Applications to Drive the Market 125
6.2.1 Drainage 125
6.2.2 Bariatric Surgery 126
6.2.3 Neoadjuvant Treatment 127
6.2.4 Benign Strictures 128
6.3 Driver: Fully-Covered, Removable Metal Stents To Drive Future Growth 128
6.4 Driver: Preference for Minimally-Invasive Solutions 130
6.5 Driver: Increased Life Expectancy 130
6.6 Driver: Technological Advancements 131
6.7 Driver: Patient Demand and Awareness 132
6.8 Driver: Rising Competition and Innovation 133
6.9 Barrier: Availability of Venture Capital 133
6.10 Barrier: Burden of Rising Regulation 134
6.11 Barrier: Proving Long-Term Efficacy 135
6.12 Barrier: Medical Device Excise Tax 135
7 Competitive Assessment 137
7.1 Gastrointestinal Stents 137
7.1.1 Overview 137
7.1.2 WallFlex (Boston Scientific Corporation) 137
7.1.3 Evolution (Cook Medical) 139
7.1.4 Niti-S (Taewoong Medical) 141
7.1.5 Other Key Marketed Gastrointestinal Stents 144
7.2 Biliary Stents 145
7.2.1 Overview 145
7.2.2 WallFlex Biliary RX (Boston Scientific Corporation) 145
7.2.3 Cotton-Leung (Amsterdam) (Cook Medical) 148
7.2.4 Bonastent (EndoChoice) 149
7.2.5 Other Key Marketed Biliary Stents 151
7.3 Airway Stents 153
7.3.1 Overview 153
7.3.2 Dumon (Novatech) 153
7.3.3 Aero/Aero DV (Merit Endotek) 154
7.3.4 Ultraflex (Boston Scientific Corporation) 156
7.3.5 Other Key Marketed Airway Stents 158
7.4 Urinary Tract Stents 158
7.4.1 Overview 158
7.4.2 Polaris Ultra (Boston Scientific Corporation) 158
7.4.3 InLay Optima (C.R. Bard) 160
7.4.4 Other Key Marketed Urinary Tract Stents 161
8 Clinical Trials to Watch 162
8.1 Overview 162
8.2 Enteral Stents 162
8.3 Pancreatic and Biliary Stents 164
8.4 Airway Stents 165
8.5 Urinary Tract Stents 165
9 Current and Future Players 166
9.1 Trends in Corporate Strategy 166
9.2 Company Profiles 168
9.2.1 Allium Medical 168
9.2.2 Boston Scientific Corporation 170
9.2.3 ConMed 174
9.2.4 Cook Medical 177
9.2.5 C.R. Bard 179
9.2.6 Ella-CS 182
9.2.7 Merit Endotek 184
9.2.8 M.I. Tech 187
9.2.9 Micro-Tech (Nanjing) 188
9.2.10 Medtronic (Covidien) 191
9.2.11 Novatech 193
9.2.12 Olympus 195
9.2.13 Taewoong Medical 198
9.2.14 Xlumena 200
9.2.15 Other Companies 203
10 Market Outlook 205
10.1 Company Market Share 205
10.1.1 US 205
10.1.2 5EU 206
10.1.3 South America 207
10.1.4 Asia-Pacific 208
10.2 By Market Segment 209
10.2.1 Global Overview 209
10.2.2 Enteral Stents 211
10.2.3 Pancreatic and Biliary Stents 212
10.2.4 Airway Stents 214
10.2.5 Urinary Tract Stents 215
10.3 By Geography 217
10.3.1 Global Overview 217
10.3.2 US 219
10.3.3 EU 222
10.3.4 South America 239
10.3.5 Asia-Pacific 242
11 Appendix 254
11.1 Bibliography 254
11.2 Abbreviations 271
11.3 Research Methodology 276
11.3.1 Overview 276
11.3.2 Coverage 276
11.3.3 Secondary Research 276
11.4 Physicians and Specialists Included in this Study 278
11.5 Primary Research 281
11.5.1 Primary Research - Key Opinion Leader Interviews 281
11.5.2 Primary Research - Physician and Industry Interviews 282
11.5.3 Expert Panel Validation 283
11.6 Forecasting Methodology 284
11.7 About the Authors 285
11.7.1 Analysts 285
11.7.2 Global Head of Healthcare 286
11.8 About MediPoint 287
11.9 About GlobalData 287
11.10 Disclaimer 287

1.1 List of Tables
Table 1: Ideal Characteristics of a Stent 24
Table 2: Comparison of Silicone and Metal Airway Stents 36
Table 3: Enteral Stenting Procedure Volumes Forecast for the US, 2011-2021 38
Table 4: Pancreatic and Biliary Stents Procedure Volumes Forecast for the US, 2011-2021 40
Table 5: Airway Stenting Procedure Volumes Forecast for the US, 2011-2021 42
Table 6: Urinary Tract Stenting Procedure Volumes Forecast for the US, 2011-2021 44
Table 7: Enteral Stenting Procedure Volumes Forecast for the 5EU, 2011-2021 47
Table 8: Pancreatic and Biliary Stents Procedure Volumes Forecast for the 5EU, 2011-2021 49
Table 9: Airway Stenting Procedure Volumes Forecast for the 5EU, 2011-2021 51
Table 10: Urinary Tract Stenting Procedure Volumes Forecast for the 5EU, 2011-2021 53
Table 11: Enteral Stenting Procedure Volumes Forecast for APAC, 2011-2021 56
Table 12: Pancreatic and Biliary Stents Procedure Volumes Forecast for APAC, 2011-2021 59
Table 13: Airway Stenting Procedure Volumes Forecast for APAC, 2011-2021 61
Table 14: Urinary Tract Stenting Procedure Volumes Forecast for APAC, 2011-2021 63
Table 15: Enteral Stenting Procedure Volumes Forecast for South America, 2011-2021 66
Table 16: Pancreatic and Biliary Stents Procedure Volumes Forecast for South America, 2011-2021 68
Table 17: Airway Stenting Procedure Volumes Forecast for South America, 2011-2021 70
Table 18: Urinary Tract Stenting Procedure Volumes Forecast for South America, 2011-2021 72
Table 19: GPOs in the US and EU 81
Table 20: Regulatory Differences Between the US and EU for Obtaining Approval for Medical Devices 84
Table 21: Medicare National Average Reimbursement Rates for Non-Vascular Stenting Procedures, 2014 90
Table 22: Direct, Indirect, and Intangible Costs of Non-Vascular Stenting 101
Table 23: WallFlex Family Stent Product Portfolio 138
Table 24: WallFlex Stent Family SWOT Analysis 139
Table 25: Evolution Family Stent Product Portfolio 140
Table 26: Evolution Stent Family SWOT Analysis 141
Table 27: Niti-S Family Stent Product Portfolio 142
Table 28: Niti-S Stent Family SWOT Analysis 143
Table 29: Gastrointestinal Stents, Other Key Marketed Products 144
Table 30: WallFlex Biliary RX Stent Product Portfolio 147
Table 31: WallFlex Biliary RX Stent SWOT Analysis 147
Table 32: Cotton-Leung Stent Product Portfolio 149
Table 33: Cotton-Leung Stent SWOT Analysis 149
Table 34: Bonastent Product Portfolio 150
Table 35: Bonastent Stent SWOT Analysis 150
Table 36: Biliary Stents, Other Key Marketed Products 151
Table 37: Dumon Stent Product Portfolio 154
Table 38: Dumon Stent SWOT Analysis 154
Table 39: Aero/Aero DV Stent Product Portfolio 155
Table 40: Aero/Aero DV Stents SWOT Analysis 156
Table 41: Ultraflex Stent Product Portfolio 157
Table 42: Ultraflex Stent SWOT Analysis 157
Table 43: Airway Stents, Other Key Marketed Products 158
Table 44: Polaris Ultra Stent Product Portfolio 159
Table 45: Polaris Ultra Stent SWOT Analysis 159
Table 46: InLay Optima Stent Product Portfolio 160
Table 47: InLay Optima SWOT Analysis 160
Table 48: Urinary Tract Stents, Other Key Marketed Products 161
Table 49: Major Clinical Trials for Enteral Stents 163
Table 50: Major Clinical Trials for Pancreatic and Biliary Stents 164
Table 51: Major Clinical Trial for Airway Stents 165
Table 52: Company Profile - Allium Medical 168
Table 53: Allium Medical's Marketed Non-Vascular Stent Products 169
Table 54: SWOT Analysis - Allium Medical 170
Table 55: Company Profile - Boston Scientific Corporation 171
Table 56: Boston Scientific Corporation's Marketed Non-Vascular Stent Products 173
Table 57: SWOT Analysis - Boston Scientific Corporation 174
Table 58: Company Profile - ConMed 175
Table 59: ConMed, Key Marketed Non-Vascular Stent Products 176
Table 60: SWOT Analysis - ConMed 177
Table 61: Company Profile - Cook Medical 177
Table 62: Cook Medical, Key Marketed Non-Vascular Stent Products 178
Table 63: SWOT Analysis - Cook Medical 179
Table 64: Company Profile - C.R. Bard 180
Table 65: C.R. Bard, Key Marketed Non-Vascular Stent Products 181
Table 66: SWOT Analysis - C.R. Bard 182
Table 67: Company Profile - Ella-CS 182
Table 68: Ella-CS, Key Marketed Non-Vascular Stent Products 183
Table 69: SWOT Analysis - Ella-CS 184
Table 70: Company Profile - Merit Endotek 185
Table 71: Merit Endotek's Key Marketed Non-Vascular Stent Products 186
Table 72: SWOT Analysis - Merit Endotek 187
Table 73: SWOT Analysis - M.I. Tech 188
Table 74: Company Profile - Micro-Tech (Nanjing) 189
Table 75: Micro-Tech (Nanjing), Key Marketed Non- Vascular Stent Products 190
Table 76: SWOT Analysis - Micro-Tech (Nanjing) 191
Table 77: Medtronic (Covidien) Marketed Non-Vascular Stent Products 192
Table 78: SWOT Analysis - Medtronic (Covidien) 193
Table 79: Company Profile - Novatech 194
Table 80: Novatech's Marketed Non-Vascular Stent Products 194
Table 81: SWOT Analysis - Novatech 195
Table 82: Company Profile - Olympus 196
Table 83: Olympus' Key Marketed Non-Vascular Stent Products 197
Table 84: SWOT Analysis - Olympus 197
Table 85: Company Profile - Taewoong Medical 198
Table 86: Taewoong Medical Marketed Products 199
Table 87: SWOT Analysis - Taewoong Medical 200
Table 88: Company Profile - Xlumena 201
Table 89: Xlumena's Key Marketed Non-Vascular Stent Products 201
Table 90: SWOT Analysis - Xlumena 202
Table 91: Other Companies Involved in the Non-Vascular Stents Market, 2014 203
Table 92: Non-Vascular Stents Sales ($m) Forecast for the 10MM, 2011-2021 210
Table 93: Enteral Stents Sales ($m) Forecast for the 10MM, 2011-2021 211
Table 94: Pancreatic and Biliary Stents Sales ($m) Forecast for the 10MM, 2011-2021 213
Table 95: Airway Stents Sales ($m) Forecast for the 10MM, 2011-2021 214
Table 96: Urinary Tract Stents Sales ($m) Forecast for the 10MM, 2011-2021 216
Table 97: Non-Vascular Stents Sales ($m) Forecast for the 10MM, 2011-2021 217
Table 98: Non-Vascular Stents Sales ($m) Forecast for the US, 2011-2021 219
Table 99: Non-Vascular Stents Sales ($m) Forecast for the EU, 2011-2021 223
Table 100: Non-Vascular Stents Sales ($m) Forecast for France, 2011-2021 224
Table 101: Non-Vascular Stents Sales ($m) Forecast for Germany, 2011-2021 227
Table 102: Non-Vascular Stents Sales ($m) Forecast for Italy, 2011-2021 230
Table 103: Non-Vascular Stents Sales ($m) Forecast for Spain, 2011-2021 233
Table 104: Non-Vascular Stents Sales ($m) Forecast for the UK, 2011-2021 236
Table 105: Non-Vascular Stents Sales ($m) Forecast for Brazil, 2011-2021 239
Table 106: Non-Vascular Stents Sales ($m) Forecast for APAC, 2011-2021 242
Table 107: Non-Vascular Stents Sales ($m) Forecast for Japan, 2011-2021 243
Table 108: Non-Vascular Stents Sales ($m) Forecast for China, 2011-2021 247
Table 109: Non-Vascular Stents Sales ($m) Forecast for India, 2011-2021 250
Table 110: Non-Vascular Stents - Primary Call Count by Country 282
Table 111: Non-Vascular Stents - Primary Call Count by Type 283

1.2 List of Figures
Figure 1: Enteral Stent - Esophageal 25
Figure 2: Biliary Stent 27
Figure 3: Bronchial Stent 28
Figure 4: Prostatic and Urethral Stents 30
Figure 5: Development Timeline for Esophageal Stents 31
Figure 6: Development Timeline for Gastroduodenal Stents 33
Figure 7: Development Timeline for Colorectal Stents 34
Figure 8: Enteral Stenting Procedure Volumes Forecast for the US, 2011-2021 38
Figure 9: Enteral Stenting Procedure Volumes Forecast for the US By Stent Type, 2013 and 2021 39
Figure 10: Pancreatic and Biliary Stenting Procedure Volumes Forecast for the US, 2011-2021 40
Figure 11: Pancreatic and Biliary Stenting Procedure Volumes Forecast for the US By Stent Type, 2013 and 2021 41
Figure 12: Airway Stenting Procedure Volumes Forecast for the US, 2011-2021 42
Figure 13: Airway Stenting Procedure Volumes Forecast for the US By Stent Type, 2013 and 2021 43
Figure 14: Urinary Tract Stenting Procedure Volumes Forecast for the US, 2011-2021 45
Figure 15: Urinary Tract Stenting Procedure Volumes Forecast for the US By Stent Type, 2013 and 2021 46
Figure 16: Enteral Stenting Procedure Volumes Forecast for the 5EU, 2011-2021 47
Figure 17: Enteral Stenting Procedure Volumes Forecast for the 5EU By Stent Type, 2013 and 2021 48
Figure 18: Pancreatic and Biliary Stenting Procedure Volumes Forecast for the 5EU, 2011-2021 49
Figure 19: Pancreatic and Biliary Stenting Procedure Volumes Forecast for the 5EU By Stent Type, 2013 and 2021 50
Figure 20: Airway Stenting Procedure Volumes Forecast for the 5EU, 2011-2021 51
Figure 21: Airway Stenting Procedure Volumes Forecast for the 5EU By Stent Type, 2013 and 2021 52
Figure 22: Urinary Tract Stenting Procedure Volumes Forecast for the 5EU, 2011-2021 54
Figure 23: Urinary Tract Stenting Procedures Forecast for the 5EU By Stent Type, 2013 and 2021 55
Figure 24: Enteral Stenting Procedure Volumes Forecast for APAC, 2011-2021 57
Figure 25: Enteral Stenting Procedure Volumes Forecast for APAC By Stent Type, 2013 and 2021 58
Figure 26: Pancreatic and Biliary Stenting Procedure Volumes Forecast for APAC, 2011-2021 59
Figure 27: Pancreatic and Biliary Stenting Procedure Volumes Forecast for APAC By Stent Type, 2013 and 2021 60
Figure 28: Airway Stenting Procedure Volumes Forecast for APAC, 2011-2021 61
Figure 29: Airway Stenting Procedure Volumes Forecast for APAC By Stent Type, 2013 and 2021 62
Figure 30: Urinary Tract Stenting Procedure Volumes Forecast for APAC, 2011-2021 64
Figure 31: Urinary Tract Stenting Procedures Forecast for APAC By Stent Type, 2013 and 2021 65
Figure 32: Enteral Stenting Procedure Volumes Forecast for South America, 2011-2021 66
Figure 33: Enteral Stenting Procedure Volumes Forecast for South America By Stent Type, 2013 and 2021 67
Figure 34: Pancreatic and Biliary Stenting Procedure Volumes Forecast for South America, 2011-2021 68
Figure 35: Pancreatic and Biliary Stenting Procedure Volumes Forecast for South America By Stent Type, 2013 and 2021 69
Figure 36: Airway Stenting Procedure Volumes Forecast for South America, 2011-2021 70
Figure 37: Airway Stenting Procedure Volumes Forecast for South America By Stent Type, 2013 and 2021 71
Figure 38: Urinary Tract Stenting Procedure Volumes Forecast for South America, 2011-2021 72
Figure 39: Urinary Tract Stenting Procedures Forecast for South America By Stent Type, 2013 and 2021 73
Figure 40: US Non-Vascular Stents Market, By Company Share, 2013 205
Figure 41: 5EU Non-Vascular Stents Market, By Company Share, 2013 207
Figure 42: South American Non-Vascular Stents Market, By Company Share, 2013 208
Figure 43: APAC Non-Vascular Stents Market, By Company Share, 2013 209
Figure 44: Non-Vascular Stents Sales ($m) Forecast for the 10MM, 2011-2021 210
Figure 45: Enteral Stents Sales ($m) Forecast for the 10MM, 2011-2021 212
Figure 46: Pancreatic and Biliary Stents Sales ($m) Forecast for the 10MM, 2011-2021 213
Figure 47: Airway Stents Sales ($m) Forecast for the 10MM, 2011-2021 215
Figure 48: Urinary Tract Stents Sales ($m) Forecast for the 10MM, 2011-2021 216
Figure 49: Non-Vascular Stents Sales Forecast for the 10MM, 2011-2021 218
Figure 50: Non-Vascular Stents Sales ($m) Forecast for the US, 2011-2021 220
Figure 51: US Non-Vascular Stents Market, By Segment, 2013 and 2021 221
Figure 52: Non-Vascular Stents Sales ($m) Forecast for the EU, 2011-2021 223
Figure 53: Non-Vascular Stents Sales ($m) Forecast for France, 2011-2021 225
Figure 54: French Non-Vascular Stents Market, 2013 and 2021 226
Figure 55: Non-Vascular Stents Sales ($m) Forecast for Germany, 2011-2021 228
Figure 56: German Non-Vascular Stents Market, 2013 and 2021 229
Figure 57: Non-Vascular Stents Sales ($m) Forecast for Italy, 2011-2021 231
Figure 58: Italian Non-Vascular Stents Market, 2013 and 2021 232
Figure 59: Non-Vascular Stents Sales ($m) Forecast for Spain, 2011-2021 234
Figure 60: Spanish Non-Vascular Stents Market, 2013 and 2021 235
Figure 61: Non-Vascular Stents Sales ($m) Forecast for the UK, 2011-2021 237
Figure 62: UK Non-Vascular Stents Market, 2013 and 2021 238
Figure 63: Non-Vascular Stent Sales ($m) Forecast for Brazil, 2011-2021 240
Figure 64: Brazilian Non-Vascular Stents Market, 2013 and 2021 241
Figure 65: Non-Vascular Stents Sales ($m) Forecast for APAC, 2011-2021 243
Figure 66: Nonvascular Stents Sales ($m) Forecast for Japan, 2011-2021 244
Figure 67: Japanese Nonvascular Stents Market, 2013 and 2021 246
Figure 68: Non-Vascular Stents Sales ($m) Forecast for China, 2011-2021 248
Figure 69: Chinese Non-Vascular Stents Market, 2013 and 2021 249
Figure 70: Non-Vascular Stents ($m) Forecast for India, 2011-2021 251
Figure 71: Indian Non-Vascular Stents Market, 2013 and 2021 253
Figure 72: Non-Vascular Stents - Primary Call Count by Country 282
Figure 73: Non-Vascular Stents - Primary Call Count by Type 283

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