GlobalData has released its medical devices report, “MediPoint: Drug-Eluting Balloons South American Analysis and Market Forecasts”. The report is an essential source of information and analysis on the drug-eluting balloons (DEB) market in South America (SA), specifically Brazil. The report provides in-depth insight into the use of DEB in SA for coronary and peripheral applications in the lower extremity including in-stent restenosis, bifurcation lesions, small vessel disease, femoropopliteal artery and below-the-knee lesions, chronic total occlusions, acute myocardial infarction and lesions in diabetics.

The DEB market in SA, specifically Brazil was assessed to identify and determine whether the current unmet needs are addressed, understand the challenges of DEB angioplasty and evaluate the current and future adoption of DEB for select coronary and peripheral indications. The South American sales expectations are discussed through careful analysis of adoption patterns of using DEB in practice.

Clients can use this report to better understand the scope of this technology and for strategic planning to explore opportunities in this dynamic market. The report provides insights into the competitive landscape, the marketed and pipeline DEB products, the current and emerging players and comparative market analysis of different types of interventional techniques used to treat coronary and peripheral artery disease. This report is built using data and information sourced from secondary sources and primary research interviews and survey with leading Interventional Cardiologists and Interventional Radiologists, with in-house analysis conducted by GlobalData’s team of industry experts.

Scope

• An overview of coronary artery disease and peripheral artery disease in the lower extremity, which includes epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines and modalities.

 

• Annualized total drug-eluting balloon market revenue by type of disease, annual cost of disease and drug-eluting balloons adoption pattern and procedure data in SA from 2010-2012 and forecast for seven years to 2019.

 

• Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement and regulatory considerations, evaluating market access and implications of the drug-eluting balloon market.

 

• Pipeline analysis: comprehensive data split across different stages of development, emerging trends and DEB designs in development, including investigation of DEB coating technology, antiproliferative agent used, balloon and catheter design and durability.

 

• Analysis of the current and future market competition in the South American drug-eluting balloon market. Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

 

Reasons to buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

 

• Develop business strategies by understanding the trends shaping and driving the DEB market in SA.

 

• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the South American DEB market in the future.

 

• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

 

• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

 

• Track device sales in the South American DEB market by disease and indication from 2010-2019.

 

• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

 

Table of Contents

 

1 Table of Contents 8

1.1 List of Tables 17

1.2 List of Figures 23

 

2 Introduction 25

2.1 Catalyst 26

 

3 Disease Overview 27

3.1 Overview 27

3.1.1 Coronary Artery Disease 27

3.1.2 Peripheral Artery Disease 27

3.2 Anatomy and Physiology 28

3.2.1 Coronary Arteries 28

3.2.2 Peripheral Arteries of the Lower Extremity 29

3.3 Pathophysiology 31

3.3.1 Coronary Artery Disease 31

3.3.2 Peripheral Artery Disease 32

3.4 Clinical Presentation 33

3.4.1 Symptoms 33

3.4.2 Risk Factors 36

3.4.3 Disease Classification 37

3.4.4 Diagnosis 39

3.4.5 Clinical Outcomes 42

3.5 Epidemiology 75

3.5.1 Coronary Artery Disease 75

3.5.2 Peripheral Artery Disease 77

3.6 Economic Impact of Coronary and Peripheral Artery Disease 79

3.6.1 Cost of Coronary Artery Disease 79

3.6.2 Cost of Peripheral Artery Disease 80

 

4 Competitive Assessment 81

4.1 Overview 81

4.2 Product Profiles by Company 83

4.2.1 Aachen Resonance 84

4.2.2 B. Braun 87

4.2.3 Biotronik 93

4.2.4 Blue Medical 96

4.2.5 Cardionovum 102

4.2.6 C.R. Bard 108

4.2.7 Concept Medical Research 114

4.2.8 Cook Medical 118

4.2.9 Eurocor 120

4.2.10 Medrad (Bayer Healthcare) 134

4.2.11 Medtronic 137

4.2.12 Minvasys 145

 

5 Unmet Needs 148

5.1 Need for Better Clinical Outcomes in Specific Lesions 148

5.1.1 Chronic Total Occlusions 148

5.1.2 Small-Vessel Coronary Lesions 149

5.1.3 Long Lesions 149

5.1.4 Heavily-Calcified and Uncrossable/Undilatable Lesions 150

5.1.5 Bifurcation Lesions 150

5.2 Need for Better Revascularization of the Femoropopliteal Artery 151

5.3 Difficulty in Treating the Infrapopliteal Artery 153

5.4 Eliminating Mechanisms of Failure with Balloon Angioplasty 154

5.5 Addressing Challenges of Stenting 156

5.5.1 Risk of Post-Procedural Complications 156

5.5.2 In-Stent Restenosis 157

5.5.3 Stent-In-Stent Procedures 159

5.5.4 Prolonged Dual Antiplatelet Therapy 160

5.5.5 Lack of Homogenous Drug Distribution 161

5.5.6 Delayed Healing 161

5.5.7 Stent Fracture 162

5.5.8 Negative Vessel Remodeling 163

5.5.9 Long-Term Vessel Patency 163

5.6 Need for Effective Therapy for Specific Patient Populations 164

5.7 Lack of Clinical Data 165

5.8 Addressing the Complications of Bypass Surgery 165

5.9 Need to Improve Medical Therapy 166

5.10 Comparative Studies on Exercise Therapy for PAD 167

 

6 Pipeline Products 168

6.1 Overview 168

6.2 Pipeline by Stage of Development 169

6.3 Pipeline Product Profiles 171

6.3.1 NF-?B Decoy Oligo DEB 171

6.3.2 Drug-Coated AngioSculpt 173

6.3.3 BioPath 176

6.3.4 BioStream 177

6.3.5 Boston Scientific Drug-Coated Balloon 178

6.3.6 Coroflex DEBlue 179

6.3.7 Covidien Drug-Coated Balloon 181

6.3.8 Caliber Therapeutics DEB 183

6.3.9 Elixir Medical Corporation DCB 184

6.3.10 LifeTech Scientific Corporation DEB 184

6.3.11 Micell Technologies Drug-Coated Balloon 184

6.3.12 Drug-Coated Chocolate DEB 186

6.3.13 Passeo-18 Lux 188

6.3.14 Vascular Nanotransfer Technologies Drug-Coated Balloon 189

6.3.15 WOMBAT DCB 190

 

7 Clinical Trial Analysis 192

7.1 Overview 192

7.2 Clinical Trials to Watch 192

7.2.1 Drug-Eluting Balloons 192

7.2.2 Vascular Stents 206

 

8 Industry Overview 211

8.1 Procedure Trends 211

8.1.1 Factors Contributing to the Rise of Coronary and Peripheral Interventions 211

8.1.2 Coronary Artery Disease 212

8.1.3 Peripheral Artery Disease 213

8.2 Physician Decision-Making Process 215

8.3 Market Access 217

8.3.1 Regulatory Process 217

8.3.2 Adoption 218

8.4 Regulatory Issues/Recalls 220

8.4.1 Product Recalls 220

8.5 Mergers and Acquisitions/Partnerships 220

8.5.1 Biosensors International and Eurocor 220

8.5.2 Boston Scientific Corporation and Guidant Corporation 221

8.5.3 Covidien and ev3, CV Ingenuity 221

8.5.4 C.R. Bard and Lutonix 222

8.5.5 Micell Technologies and Maxcor Lifescience 222

8.5.6 Medrad and Bayer 223

8.5.7 Medtronic and Invatec 223

 

9 Current and Future Players 224

9.1 Overview 224

9.2 Trends in Corporate Strategy 225

9.3 Company Profiles 228

9.3.1 Aachen Resonance 228

9.3.2 AnGes MG 229

9.3.3 AngioScore 231

9.3.4 AVIDAL Vascular 233

9.3.5 B. Braun 235

9.3.6 Biosensors International 237

9.3.7 Biotronik 239

9.3.8 Blue Medical 241

9.3.9 Boston Scientific Corporation 243

9.3.10 Caliber Therapeutics 245

9.3.11 Cardionovum 247

9.3.12 Concept Medical Research 249

9.3.13 Cook Medical 251

9.3.14 Covidien 253

9.3.15 C.R. Bard 255

9.3.16 Elixir Medical Corporation 257

9.3.17 Eurocor 259

9.3.18 LifeTech Scientific Corporation 261

9.3.19 Medtronic 263

9.3.20 Micell Technologies 265

9.3.21 Minvasys 266

9.3.22 TriReme Medical 268

9.3.23 Vascular Nanotransfer Technologies 270

 

10 Market Drivers, Opportunities, Barriers and Substitutes 272

10.1 Market Drivers 272

10.1.1 Rising Prevalence of Disease 273

10.1.2 Viable Treatment for Select Indications 274

10.1.3 No Metal Left Behind 279

10.1.4 Avoid Stent-in-Stent Procedures 280

10.1.5 Reduce the Need for Prolonged Dual Antiplatelet Therapy 281

10.1.6 Enhanced Vessel Healing and Better Patency 281

10.1.7 Technical Feasibility of Future Interventions 282

10.1.8 DEB as an Adjunctive Therapy 283

10.1.9 Limb Amputation 283

10.1.10 Cost Savings 284

10.1.11 Availability of Long-Term and Cost-Effective Data 285

10.1.12 Launch of DEB in the US 285

10.2 Opportunities 286

10.2.1 Improve DEB Design 286

10.2.2 DEB Hybrid Systems (DEB + Stent) 290

10.2.3 Target Indications Where Stenting is Not Satisfactory 291

10.2.4 Challenges in Treating the Femoropopliteal and Infrapopliteal Arteries 294

10.2.5 Target Challenging Patient Populations 295

10.2.6 Launch DEB in the Japanese Market 296

10.2.7 Emerging Markets 297

10.3 Market Barriers 298

10.3.1 Slow Adoption 298

10.3.2 High Selling Prices 302

10.3.3 Lack of Reimbursement 303

10.3.4 US FDA Regulatory Challenges 304

10.3.5 Healthcare Cost-Cutting and Reimbursement 305

10.3.6 Availability of Venture Capital 306

10.3.7 Medical Device Excise Tax 307

10.4 Market Substitutes 307

10.4.1 Vascular Stents 307

10.4.2 Liquid Drug Delivery Catheter 311

 

11 Drug-Eluting Balloon Market Analysis 314

11.1 Market Distribution by Indication 314

11.2 Primary Versus Adjunctive Therapy 316

11.3 Comparative Market Analysis 317

11.3.1 Coronary Artery Disease 318

11.3.2 Peripheral Artery Disease in the Lower Extremity 320

 

12 Country Outlooks & Forecasts 322

12.1 Brazil 322

12.1.1 Overview 322

12.1.2 Market Analysis 322

 

13 Appendix 325

13.1 Bibliography 325

13.2 Abbreviations 348

13.3 Report Methodology 352

13.3.1 Overview 352

13.3.2 Coverage 352

13.3.3 Secondary Research 352

13.3.4 Forecasting Methodology 353

13.4 Physicians and Specialists Included in this Study 355

13.5 Physician Survey 358

13.6 About the Authors 359

13.6.1 Analysts 359

13.6.2 Global Head of Healthcare 360

13.7 About MediPoint 361

13.8 About GlobalData 361

13.9 Disclaimer 361

 

List of Tables

 

Table 1: Classification Systems for Determining the Severity of PAD Symptoms 35

Table 2: Risk Factors Associated with CAD and PAD 36

Table 3: Types of Atherosclerotic Lesions 38

Table 4: Treatment Guidelines to Improve the Symptoms of CAD* 43

Table 5: TASC II Classification of Iliac Artery Lesions 45

Table 6: TASC II Classification of Femoropopliteal Artery Lesions 46

Table 7: TASC II Classification of Infrapopliteal Artery Lesions 47

Table 8: Types of Coronary Artery Bypass Grafting 58

Table 9: Complications of Coronary/Peripheral Artery Bypass Surgery 59

Table 10: Indications for Using Drug-Eluting Balloons 62

Table 11: Drug-Eluting Balloon Coating Characteristics 65

Table 12: Drugs Incorporated Into Drug-Eluting Stents 68

Table 13: Types of Lesions Treated Using Atherectomy 71

Table 14: Prevalence of CAD in the Population Age ?65 Years in Brazil (millions), 2010-2019 76

Table 15: Prevalence of PAD in the Population Age ?65 Years in Brazil (millions), 2010-2019 78

Table 16: Direct and Indirect Healthcare Costs 79

Table 17: Brazilian DEB Market ($m) for Treating Coronary and Peripheral Artery Disease, 2012 81

Table 18: Marketed DEB Products 83

Table 19: Elutax SV Product Portfolio 84

Table 20: Elutax SV SWOT Analysis, 2013 86

Table 21: SeQuent Please Product Portfolio 87

Table 22: SeQuent Please SWOT Analysis, 2013 92

Table 23: Pantera Lux Product Portfolio 93

Table 24: Pantera Lux SWOT Analysis, 2013 95

Table 25: Pioneer Product Portfolio 96

Table 26: Pioneer SWOT Analysis, 2013 98

Table 27: Protégé Product Portfolio 99

Table 28: Protégé SWOT Analysis, 2013 102

Table 29: Restore DEB Product Portfolio 103

Table 30: Restore DEB SWOT Analysis, 2013 104

Table 31: Legflow DEB Product Portfolio 105

Table 32: Legflow DEB SWOT Analysis, 2013 107

Table 33: Other DEB Products Developed by Cardionovum 108

Table 34: Lutonix Product Portfolio 109

Table 35: Lutonix SWOT Analysis, 2013 114

Table 36: Magic Touch Product Portfolio 115

Table 37: Magic Touch SWOT Analysis, 2013 117

Table 38: Advance 18 PTX Product Portfolio 118

Table 39: Advance 18 PTX SWOT Analysis, 2013 120

Table 40: Dior Product Portfolio 121

Table 41: Dior SWOT Analysis, 2013 127

Table 42: Freeway Family of DEB Product Portfolio 128

Table 43: Freeway Family of DEB SWOT Analysis, 2013 131

Table 44: Magical Product Portfolio 132

Table 45: Magical SWOT Analysis, 2013 134

Table 46: Cotavance Product Portfolio 135

Table 47: Cotavance SWOT Analysis, 2013 137

Table 48: IN.PACT Family DEB Product Portfolio 138

Table 49: IN.PACT SWOT Analysis, 2013 145

Table 50: Danubio Product Portfolio 146

Table 51: Danubio SWOT Analysis, 2013 147

Table 52: Global DEB Pipeline Products 170

Table 53: NF-?B Decoy Oligo DEB SWOT Analysis, 2013 173

Table 54: AngioSculpt SWOT Analysis, 2013 175

Table 55: BioPath SWOT Analysis, 2013 177

Table 56: BioStream SWOT Analysis, 2013 178

Table 57: Boston Scientific DEB SWOT Analysis, 2013 179

Table 58: Coroflex DEBlue SWOT Analysis, 2013 181

Table 59: Covidien DCB SWOT Analysis, 2013 183

Table 60: Micell Technologies' DCB SWOT Analysis, 2013 185

Table 61: Drug-Coated Chocolate DEB SWOT Analysis, 2013 187

Table 62: Passeo-18 Lux SWOT Analysis, 2013 189

Table 63: Vascular Nanotransfer Technologies DCB SWOT Analysis, 2013 190

Table 64: WOMBAT DCB SWOT Analysis, 2013 191

Table 65: Aachen Resonance Company Profile 228

Table 66: Aachen Resonance, Marketed DEB Product 229

Table 67: Aachen Resonance SWOT Analysis, 2013 229

Table 68: AnGes MG Company Profile 230

Table 69: AnGes MG, Pipeline DEB Product 231

Table 70: AnGes MG SWOT Analysis, 2013 231

Table 71: AngioScore Company Profile 232

Table 72: AngioScore, Pipeline DEB Product 232

Table 73: AngioScore SWOT Analysis, 2013 233

Table 74: AVIDAL Vascular Company Profile 233

Table 75: AVIDAL Vascular, Pipeline DEB Product 234

Table 76: AVIDAL Vascular SWOT Analysis, 2013 235

Table 77: B. Braun Company Profile 235

Table 78: B. Braun, Marketed and Pipeline DEB Products 236

Table 79: B. Braun SWOT Analysis, 2013 237

Table 80: Biosensors International Company Profile 238

Table 81: Biosensors International, Pipeline DEB Products 238

Table 82: Biosensors International SWOT Analysis, 2013 239

Table 83: Biotronik Company Profile 240

Table 84: Biotronik, Marketed and Pipeline DEB Products 240

Table 85: Biotronik SWOT Analysis, 2013 241

Table 86: Blue Medical Company Profile 242

Table 87: Blue Medical, Marketed DEB Products 243

Table 88: Blue Medical SWOT Analysis, 2013 243

Table 89: Boston Scientific Corporation Company Profile 244

Table 90: Boston Scientific Corporation, Pipeline DEB Product 244

Table 91: Boston Scientific Corporation SWOT Analysis, 2013 245

Table 92: Caliber Therapeutics Company Profile 245

Table 93: Caliber Therapeutics, Pipeline DEB Product 246

Table 94: Caliber Therapeutics SWOT Analysis, 2013 247

Table 95: Cardionovum Company Profile 247

Table 96: Cardionovum, Marketed and Pipeline DEB Products 248

Table 97: Cardionovum SWOT Analysis, 2013 249

Table 98: Concept Medical Research Company Profile 249

Table 99: Concept Medical Research, Marketed DEB Product 250

Table 100: Concept Medical Research SWOT Analysis, 2013 251

Table 101: Cook Medical Company Profile 251

Table 102: Cook Medical, Marketed DEB Product 252

Table 103: Cook Medical SWOT Analysis, 2013 253

Table 104: Covidien Company Profile 254

Table 105: Covidien, Pipeline DEB Product 254

Table 106: Covidien SWOT Analysis, 2013 255

Table 107: C.R. Bard Company Profile 255

Table 108: C.R. Bard, Marketed DEB Products 256

Table 109: C.R. Bard SWOT Analysis, 2013 257

Table 110: Elixir Medical Corporation Company Profile 257

Table 111: Elixir Medical Corporation, Pipeline DEB Product 258

Table 112: Elixir Medical Corporation SWOT Analysis, 2013 258

Table 113: Eurocor Company Profile 259

Table 114: Eurocor, Marketed DEB Products 260

Table 115: Eurocor SWOT Analysis, 2013 260

Table 116: LifeTech Scientific Corporation Company Profile 261

Table 117: LifeTech Scientific, Pipeline DEB Product 262

Table 118: LifeTech Scientific SWOT Analysis, 2013 262

Table 119: Medtronic Company Profile 263

Table 120: Medtronic, Marketed DEB Products 264

Table 121: Medtronic SWOT Analysis, 2013 264

Table 122: Micell Technologies Company Profile 265

Table 123: Micell Technologies, Pipeline DEB Product 266

Table 124: Micell Technologies SWOT Analysis, 2013 266

Table 125: Minvasys Company Profile 267

Table 126: Minvasys, Marketed DEB Product 267

Table 127: Minvasys SWOT Analysis, 2013 268

Table 128: TriReme Medical Company Profile 268

Table 129: TriReme Medical, Pipeline DEB Product 269

Table 130: TriReme Medical SWOT Analysis, 2013 269

Table 131: Vascular Nanotransfer Technologies Company Profile 270

Table 132: Vascular Nanotransfer Technologies, Pipeline DEB Product 271

Table 133: Vascular Nanotransfer Technologies SWOT Analysis, 2013 271

Table 134: Percent of Patients with CAD or PAD Receiving Stenting with DEB Angioplasty, Brazil, 2012 and 2018 (N=11) 316

Table 135: DEB Sales ($m) Forecast for Brazil, 2010-2019 322

Table 136: Physicians Surveyed, By Country 358

 

List of Figures

 

Figure 1: Coronary Arteries of the Human Heart 28

Figure 2: Peripheral Arteries of the Lower Extremity 29

Figure 3: Pathophysiology of Coronary Artery Disease 31

Figure 4: Pathophysiology of Peripheral Artery Disease 32

Figure 5: Treatment Modalities - Coronary Artery Disease 49

Figure 6: Percent of Patients with CAD Who Receive Each Therapy Option Only, Brazil, 2012 and 2019 (N=5) 50

Figure 7: Treatment Modalities - Peripheral Artery Disease 51

Figure 8: Percent of Patients with PAD Who Receive Each Therapy Option Only, Brazil, 2012 (N=6) 52

Figure 9: Percent of Patients with PAD Who Receive Each Therapy Option Only, Brail, 2012 (N=6) 52

Figure 10: Drug-Eluting Balloon 61

Figure 11: Types of Stents Used to Treat CAD and PAD 67

Figure 12: Bare Metal Stent 67

Figure 13: Drug-Eluting Stent 68

Figure 14: Covered Stents 69

Figure 15: Bioabsorbable Stent - Remedy 70

Figure 16: Types of Atherectomy 72

Figure 17: Prevalence of CAD in the Population Age ?65 Years in Brazil (millions), 2010-2019 76

Figure 18: Prevalence of PAD in the Population Age ?65 Years in Brazil (millions), 2010-2019 78

Figure 19: Brazilian DEB Market Share for Treating Peripheral Artery Disease in the Lower Extremity, 2012 82

Figure 20: Image of the Protégé DEB 100

Figure 21: Percent of CAD and PAD Patients with Acute Vessel Recoil After Standard Balloon Angioplasty, Brazil, 2012 and 2018 (N=11) 155

Figure 22: Percent of CAD and PAD Patients with Thrombosis After Stenting, Brazil, 2012 and 2018 (N=11) 157

Figure 23: Percent of CAD and PAD Patients with ISR, Brazil, 2012 and 2018 (N=11) 158

Figure 24: Percent of CAD and PAD Patients Who Receive Stent-In-Stent Procedures, Brazil, 2012 and 2018 (N=11) 159

Figure 25: Percent of CAD and PAD Patients with Stent Fracture, Brazil, 2012 and 2018 (N=11) 162

Figure 26: Global DEB Pipeline Products by Stage of Development, 2013 169

Figure 27: AngioSculpt Scoring Balloon Expansion Profile 174

Figure 28: Drug-Coated Chocolate DEB 186

Figure 29: Population (? 65 years) of CAD Patients Receiving Interventional Procedures, South America*, 2010-2019 212

Figure 30: Population (? 65 years) with PAD Receiving Interventional Procedures for the Peripheral Arteries in the Lower Extremity, South America*, 2010-2019 213

Figure 31: Population (? 65 years) with PAD Receiving DEB Angioplasty for the Peripheral Arteries in the Lower Extremity, South America*, 2010-2019 214

Figure 32: DEB Market for Treating CAD and PAD in the Lower Extremity, Company Share (%), 2012 224

Figure 33: DEB Market for Each Type of Disease, Company Share (%), 2012 226

Figure 34: Importance of Each Therapy Attribute in Adopting DEB for the Treatment of CAD and PAD, Global, 2012 (N=112) 287

Figure 35: Brazilian DEB Market Distribution (%) by Indication, 2012 and 2018 (N=11) 315

Figure 36: Percent of Patients with CAD Receiving Each Type of Interventional Technique Only, Brazil, 2018 (N=5) 319

Figure 37: Percent of Patients with Lower Limb PAD Receiving Each Type of Interventional Technique Only, Brazil, 2018 (N=6) 320

Figure 38: Brazilian DEB Balloons Market ($m) for Coronary and Peripheral Applications, 2010-2019 323