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Bioabsorbable Scaffolds - US 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 future US Market, as BASs are currently unavailable. 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. Large-scale, long-term studies need to be conducted to demonstrate their clinical efficacy, and once approved new stent technologies need to be integrated appropriately into the existing reimbursement systems within the US before widespread adoption will be seen. 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.

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Highlights

Key Questions Answered

- What is the current and future market outlook for Bioabsorbable Scaffolds in the US region? What trends are affecting the Bioabsorbable Scaffold market?
- What are the market sizes of each bioabsorbable scaffold segment?
- What clinical factors and technical specifications will influence a physician to use bioabsorbable scaffolds over conventional DES and BMS stents?
- What are unmet needs in the bioabsorbable scaffold market? What are the clinical and non-clinical barriers in this space?

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

Bioabsorbable Scaffolds - US Analysis and Market Forecasts
1 Table of Contents

2 Executive Summary
2.1 Key Metrics in the 10 Major Markets
2.2 Technological Trends
2.3 Key Players in the Bioabsorbable Scaffold Market
2.4 Bioabsorbable Scaffold Market Outlook
2.5 What Do Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
4 Disease Overview
4.1 Coronary Artery Disease
4.2 Peripheral Artery Disease
4.3 Anatomy and Physiology
4.4 Pathophysiology
4.4.1 Coronary Artery Disease
4.4.2 Peripheral Artery Disease
4.5 Clinical Presentation
4.5.1 Symptoms of Coronary Artery Disease
4.5.2 Symptoms of Peripheral Artery Disease
4.6 Risk Factors
4.6.1 Coronary Artery Disease
4.6.2 Peripheral Artery Disease
4.7 Disease Segments
4.7.1 Coronary Artery Disease
4.7.2 Peripheral Artery Disease
4.8 Diagnosis
4.8.1 Coronary Artery Disease
4.8.2 Peripheral Artery Disease
4.9 Clinical Outcomes
4.9.1 Treatment Paradigm
4.9.2 Treatment Modalities
4.9.3 Coronary/Peripheral Artery Bypass Grafting
4.9.4 Interventional Cardiology
5 Competitive Assessment
5.1 Overview
5.2 Absorb BVS - Abbott Vascular
5.2.1 Efficacy
5.3 Remedy - Kyoto Medical Planning
5.3.1 Efficacy
5.4 DESolve - Elixir Medical Corperation
5.4.1 Efficacy
5.5 Pure - Arterial Remodeling Technologies
5.5.1 Efficacy
6 Unmet Needs
6.1 Develop a Fully-Bioabsorbable Stent
6.2 Reduce the Risk of Complications
6.3 Reduce the Need for Stent-in-Stent Procedures
6.4 Long-Term Clinical Data
6.5 Reduce the Rate of Stent Fracture
6.6 Dual Anti-Platelet Therapy
6.7 Imaging
7 Pipeline Products
7.1 Overview
7.2 Coronary Artery Disease - Pipeline Products
7.2.1 Overview
7.2.2 Polymer-Based Bioabsorbable Scaffolds
7.2.3 Metallic Bioabsorbable Scaffolds
7.2.4 Summary
7.3 Peripheral Artery Disease - Peripheral Bioabsorbable Scaffold Product Pipeline
7.3.1 Overview
7.3.2 Summary
8 Industry Overview
8.1 Procedure Trends
8.1.1 Coronary Artery Disease
8.1.2 Peripheral Artery Disease
9 Market Access
9.1 Overview
9.2 Regulatory Process
9.2.1 United States
9.3 Physician Decision-Making Process
9.4 Role of Group Purchasing Organizations
9.5 Lack of Clinical Data
9.6 Regional-Level Control
9.7 Cost Considerations
9.7.1 United States
9.8 Reimbursement Trends
9.8.1 United States
9.9 Regulatory Issues/Recalls
9.10 Product Recalls
10 Mergers and Acquisitions
10.1 ART and Terumo Corparation
10.2 Xenogenics Corporation and Multicell Technologies
10.3 Icon Interventional Systems and Ariad Pharmaceuticals
10.4 Boston Scientific Corporation
11 Current and Future Players
11.1 Overview
11.2 Trends in Corporate Strategy
11.3 Company Profiles
11.3.1 Abbott Vascular
11.3.2 Kyoto Medical Planning Co., Ltd.
11.3.3 Arterial Remodeling Technologies
11.3.4 Elixir Medical Corporation
11.3.5 Cardionovum
11.3.6 Reva Medical
11.3.7 OrbusNeich Medical
11.3.8 Amaranth Medical
11.3.9 Biotronik
11.3.10 Lepu Medical Technology
11.3.11 HuaAn Biotechnology Co., Ltd.
11.3.12 Lifetech Scientific (Shenzhen) Co., LTD. (Lifetech Shenzhen)
11.3.13 Arterius
11.3.14 S3V Vascular Technologies
11.3.15 Tepha Inc.
11.3.16 Zorion Medical
11.3.17 Xenogenics Corporation
11.3.18 Meril Life Sciences
11.3.19 Boston Scientific Corporation
11.3.20 Icon Interventional Systems
12 Market Drivers, Opportunities and Barriers
12.1 Market Drivers
12.1.1 Rising Prevalence of Disease
12.1.2 Avoid Stent-in-Stent Procedures
12.1.3 Reduce/Eliminate Dual Anti-Platelet Therapy
12.1.4 Availability of Long-Term Data
12.1.5 Treatment Considerations
12.1.6 Accurate Stent Placement
12.1.7 Expected Launch of BAS in the US
12.2 Opportunities
12.2.1 BAS Segmentation
12.2.2 Expanding the Indications for BAS
12.2.3 Target High-Risk Patients
12.2.4 Improve Deliverability of BAS
12.2.5 Emerging Markets
12.3 Market Barriers
12.3.1 Slow Adoption
12.3.2 Complications Associated with BAS
12.3.3 High Average Selling Price
12.3.4 Reimbursement
12.3.5 Substitutes
13 Market Outlook and Forecast
13.1 United States
13.1.1 Overview
13.1.2 Market Analysis
14 Appendix
14.1 Bibliography
14.2 Abbreviations
14.3 Report Methodology
14.3.1 Overview
14.3.2 Coverage
14.3.3 Primary Research -Key Opinion Leader Interviews
14.3.4 Primary Research Interviews - Physician and Industry Participants
14.3.5 Physician Survey
14.3.6 Expert Panel Validation
14.3.7 Secondary Research
14.4 Forecasting Methodology
14.5 Physicians and Specialists Included in This Study
14.6 About the Authors
14.6.1 Analysts
14.6.2 James Coutcher, Global Head of Healthcare
14.7 About GlobalData
14.8 Contact Us
14.9 Disclaimer

1.1 List of Tables
Table 1: Bioabsorbable Scaffolds, Key Metrics in the 10MM, 2014-2021
Table 2: Symptoms of CAD
Table 3: Symptoms of PAD
Table 4: Risk Factors Associated With CAD
Table 5: Risk Factors Associated With PAD
Table 6: Disease Segments for CAD
Table 7: Disease Segments for PAD
Table 8: Methods for Diagnosing CAD
Table 9: Methods for Diagnosing PAD
Table 10: Types of CABG
Table 11: Drugs Incorporated Into DES
Table 12: Marketed BAS Products
Table 13: Absorb BVS Product Profile
Table 14: Absorb BVS Clinical Trials
Table 15: Absorb BVS SWOT Analysis, 2015
Table 16: Remedy Product Profile
Table 17: Remedy SWOT Analysis, 2015
Table 18: DESolve Product Profile
Table 19: DESolve Clinical Trials
Table 20: DESolve SWOT Analysis, 2015
Table 21: Pure Product Profile
Table 22: Pure SWOT Analysis, 2015
Table 23: Coronary BAS Product Pipeline, 2015
Table 24: Igaki-Tamai Stent SWOT Analysis, 2015
Table 25: Fantom Scaffold SWOT Analysis, 2015
Table 26: ART18Z Scaffold SWOT Analysis, 2015
Table 27: Fortitude Scaffold SWOT Analysis, 2015
Table 28: ArterioSorb Scaffold SWOT Analysis, 2015
Table 29: Xinsorb Scaffold SWOT Analysis, 2015
Table 30: Ideal BioStent SWOT Analysis, 2015
Table 31: DREAMS Scaffold SWOT Analysis, 2015
Table 32: Peripheral BAS Product Pipeline, 2015
Table 33: Magic Explorer Scaffold SWOT Analysis, 2015
Table 34: ESPRIT BVS Stent SWOT Analysis, 2015
Table 35: GPOs in the US and EU
Table 36: Abbott Vascular Company Profile
Table 37: Marketed BAS Products by Abbott Vascular
Table 38: Pipeline BAS Products by Abbott Vascular
Table 39: Abbott Vascular SWOT Analysis, 2015
Table 40: Kyoto Medical Planning Company Profile
Table 41: Marketed BAS Products by Kyoto Medical Planning
Table 42: Pipeline BAS Products by Kyoto Medical Planning
Table 43: Kyoto Medical Planning SWOT Analysis, 2015
Table 44: ART Company Profile
Table 45: Marketed BAS Products by ART
Table 46: ART's BAS Pipeline Products
Table 47: ART SWOT Analysis, 2015
Table 48: Elixir Medical Corporation Company Profile
Table 49: Marketed BAS Products by Elixir Medical
Table 50: Elixir Medical Corporation SWOT Analysis, 2015
Table 51: Cardionovum Company Profile
Table 52: Cardionovum's BAS Pipeline Products
Table 53: Cardionovum SWOT Analysis, 2015
Table 54: REVA Medical's BAS Pipeline Products
Table 55: REVA Medical SWOT Analysis, 2015
Table 56: OrbusNeich Medical Company Profile
Table 57: OrbusNeich Medical's BAS Pipeline Products
Table 58: OrbusNeich Medical SWOT Analysis, 2015
Table 59: Amaranth Medical Company Profile
Table 60: Amaranth Medical's BAS Pipeline Products
Table 61: Amaranth Medical SWOT Analysis, 2014
Table 62: Biotronik Company Profile
Table 63: Biotronik's BAS Pipeline Products
Table 64: Biotronik SWOT Analysis, 2015
Table 65: Lepu Medical Technology Company Profile
Table 66: Lepu Medical Technology's BAS Pipeline Products
Table 67: Lepu Medical Technology SWOT Analysis, 2015
Table 68: HuaAn Biotechnology Co., Ltd. Company Profile
Table 69: HuaAn Biomedical Co., Ltd.'s BAS Pipeline Products
Table 70: HuaAn Biomedical Co., Ltd. SWOT Analysis, 2015
Table 71: Lifetech Scientific Co., LTD Company Profile
Table 72: Lifetech Scientific's BAS Pipeline Products
Table 73: Lifetech Scientific SWOT Analysis, 2015
Table 74: Arterius Company Profile
Table 75: Arterius BAS Pipeline Products
Table 76: Arterius SWOT Analysis, 2015
Table 77: S3V Vascular Technologies Company Profile
Table 78: S3V Vascular Technologies' BAS Pipeline Product
Table 79: S3V Vascular Technologies SWOT Analysis, 2015
Table 80: Tepha Inc. Company Profile
Table 81: Tepha Inc.'s BAS Pipeline Product
Table 82: Tepha Inc. SWOT Analysis, 2015
Table 83: Zorion Medical Company Profile
Table 84: Zorion Medical's BAS Pipeline Product
Table 85: Zorion Medical SWOT Analysis, 2015
Table 86: Xenogenics Corporation Company Profile
Table 87: Xenogenics Corporation's BAS Pipeline Product
Table 88: Xenogenics Corporation SWOT Analysis, 2015
Table 89: Meril Life Sciences Company Profile
Table 90: Meril Life Science's BAS Pipeline Product
Table 91: Meril Life Sciences SWOT Analysis, 2015
Table 92: Boston Scientific Corporation Company Profile
Table 93: Boston Scientific Corporation SWOT Analysis, 2015
Table 94: Icon Interventional Systems Company Profile
Table 95: US BAS Market Revenue ($m), 2012-2021
Table 96: Primary Research Interviews Completed
Table 97: Physicians Surveyed, By Country

1.2 List of Figures
Figure 1: BAS Global Market Share Comparison By Major Market, 2014 and 2021
Figure 2: Anatomy of the Human Heart
Figure 3: Pathophysiology of CAD
Figure 4: Pathophysiology of PAD
Figure 5: Treatment Modalities - CAD
Figure 6: Treatment Modalities - PAD
Figure 7: Types of Stents Used to Treat CAD and PAD
Figure 8: US Drug-Eluting and Bare Metal Stenting Procedure Volume, 2012-2021
Figure 9: US Peripheral Stenting Procedure Volume, By Artery, 2012-2021
Figure 10: US BAS Market Revenue ($m), 2012-2021

Companies Mentioned
Abbott Vascular
Kyoto Medical Planning Co., Ltd.
Arterial Remodeling Technologies
Elixir Medical Corporation
Cardionovum
Reva Medical
OrbusNeich Medical
Amaranth Medical
Biotronik
Lepu Medical Technology
HuaAn Biotechnology Co., Ltd.
Lifetech Scientific

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