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Biodegradable Stents: Global Markets

Publisher Name :
Date: 04-Apr-2019
No. of pages: 102

Report Scope:

This report reviews both global and regional markets of the biodegradable stents market according to available types and application areas. The report analyzes the current market status and trends, and provides growth forecasts for the five-year period 2018 to 2023. The analysis also discusses R&D issues, including global regulatory scenarios and other commercialization hurdles. Additionally, this comprehensive report examines technology developers/manufacturers of biodegradable stents, their product types and geographical product presence (wherever data is available).

The biodegradable stents market is divided into the following types -

- Polymer-based.

- Metal-based.

The report differentiates BDS from conventional metallic DES that have a matrix coating of bioresorbable polymer and antiproliferative drug. These devices, which have typical metallic nondegradable stent backbones, are known as bioresorbable polymer DES, bioabsorbable polymer DES or biodegradable polymer DES. Therefore, this report concentrates only on the BDS market for fully bioabsorbable or biodegradable stents.

The only applications of the biodegradable stent market that have been analyzed in this report includes -

- BDS for vascular disease.

- Coronary BDS.

- Non-coronary vascular BDS.

- BDS for non-vascular disease.

- Ureteral.

- Gastrointestinal.

- Biliary.

- Pancreatic.

- Others.

The report also offers a detailed patent analysis with information on the strategic initiatives of market players within the past five years.

The report specifically excludes stents that are not fully biodegradable and also stents that have bioabsorbable coatings which are not fully bioabsorbable. The report also excludes biomaterial technology/product and equipment providers.

Estimated values used are based on manufacturers' total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

Summary

Biodegradable stents/scaffolds (BDS) are an appealing treatment option in both vascular and nonvascular intervention. Although many stent manufacturers have been conducting R&D into novel BDS technology, adoption rate of the technology in clinical care remains low due to complex medical policies and regulations. Most advanced healthcare technologies like biodegradable stents/scaffolds (BDS) require long-term clinical evidence of therapeutic effects at an early stage of commercialization. Key factors driving growth prospects for BDS include a surge in disease incidences due to affluence and lifestyle changes, resulting increase in demand for better disease diagnosis and treatment, and

infrastructure growth driven partially by a fast-growing cluster of corporate hospitals.

The global market for biodegradable stents is still developing with only a handful of products having reached the market. Many are still in pipeline, development, or clinical trial stage. However, the stringent regulatory scenarios across the world coupled with BDS's high price tag are hindering market growth. Abbott Vascular's Absorb BVS is the most widely used and researched BDS-eluting everolimus drug. Presently, the product is off the commercial market due to low commercial sales. In order to meet the safety requirement and other unmet needs of the market, researchers and corporate players are making iterative approaches in developing newer generation BDS products by applying the lessons

learned from the older generation.

The major limitation of current generation of BDS is that they lack certain technical characteristics of the current generation DES. Appropriate patient and lesion selection, application of an optimal implantation technique, intravascular imaging guidance, specific DAPT regimen, and overcoming/improvement of the device limitations are key factors of the technology's potential during the next five years.

Because thicker struts have procedural limitations and reduced vascular healing, miniaturization of strut thickness while maintaining the radial strength is the key requisite for improving current outcomes of BDS technology. Manufacturers are involved in adopting several strategies to improve radial strength and consequently decrease strut thickness of the polymeric scaffold. These include polymer blending, annealing (heat treatment), polymer orientation and extraction of higher molecular weight components. PLLA is the most widely used and researched biomaterial for use in BDS devices as core stent materials. Metallic stent Mg based alloys are finding increased recognition, however. Research is being conducted on many other biomaterials for their suitability as an alternative for metallic DES.

The ripple effects of reduced prices have slashed BDS global sales in 2017 and 2018. The global BDS market fell to REDACTED in 2017 from REDACTED in 2016. In addition, the market withdrawal of the only FDA-approved BDS product, "Absorb GT1" from Abbott Laboratories, in early 2017 induced the global BDS market to fall more than REDACTED that same year. However, anticipated new product launches and increased product penetration in new geographical locations should push the market into recovery in 2018.

Both vascular and non-vascular stenting procedures are expected to grow, but the declining prices of stents is inhibiting overall market growth. Although the ASP of stents has dropped in the past decade, a debate surrounds keeping advanced medical technologies like BDS within the premium product bracket.

Biodegradable Stents: Global Markets

Table of Contents

Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Methodology and Information Sources
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports

Chapter 2 Summary and Highlights

Chapter 3 Market and Technology Background
Technology Overview
Unmet Needs of Current Metallic DES
Very Late Stent Thrombosis and Restenosis
Implications of the Removal of a Permanent Implant
Technology Background
Technological Advantages of Biodegradable Stents
Technological Disadvantages
BDS Material Platform and Classification
Polymeric Biodegradable Stents
Metallic Biodegradable Stents
Market Regulation
Key Drivers
Growing Cardiovascular Intervention Market
Aging Populations
Emerging Middle Class
Increased Health Awareness
Key Challenges
Regulatory Issues
High Cost of Products/Procedure
Safety Issues
Visualization of the Scaffold for Implantation
Scaffold Deliverability
Scaffold Implantation
Radial Strength
Low Ductility
Market Trends

Chapter 4 Market Breakdown by Application Type
Biodegradable Vascular Stents (BVS)
Biodegradable Stents for Coronary Disease
Biodegradable Stents for Non-coronary Vascular Disease
BDS for Non-vascular Disease
Ureteral Stents
Gastrointestinal Stents
Bile Duct/Pancreatic Stents
Tracheobronchial/Pulmonary Stents

Chapter 5 Market Breakdown by Region
North America
U.S.
APAC
India
China
European Union
ROW
Brazil

Chapter 6 Patent Review
Patent Review by Year
Patent Review by Country
Patent Review by Assignee
Patent Review by Application

Chapter 7 Company Profiles
ABBOTT VASCULAR INC.
AKINA INC.
AMARANTH MEDICAL INC.
AMG INTERNATIONAL GMBH
ARTERIAL REMODELING TECHNOLOGIES S.A. (ART)
ARTERIUS LTD.
BIOTRONIK INC.
BOSTON SCIENTIFIC CORP.
CARDIONOVUM GMBH
ELIXIR MEDICAL CORP.
ELLA-CS S.R.O.
ENDOCOR GMBH
HYDRUSTENT
KYOTO MEDICAL PLANNING CO. LTD.
LEPU MEDICAL TECHNOLOGY (BEIJING) CO. LTD.
LIFETECH SCIENTIFIC CORP.
LYRA THERAPEUTICS
MERIL LIFE SCIENCES
MICELL TECHNOLOGIES INC.
MICROPORT SCIENTIFIC CORP.
REVA MEDICAL INC.
S3V VASCULAR TECHNOLOGIES
SAHAJANAND MEDICAL TECHNOLOGIES (SMT)
SINO MEDICAL SCIENCES TECHNOLOGY INC. (SINOMED)
STENTYS S.A.
TEPHA INC.
TERUMO CARDIOVASCULAR SYSTEMS CORP.
ZORION MEDICAL INC.

Chapter 8 Appendix
Acronyms
Glossary
Countries That Require CE Marking

List of Tables

Summary Table : Global Market for Biodegradable Stents, by Region, Through 2023
Table 1 : Properties of Biodegradable Materials Commonly Used in Biodegradable Stents
Table 2 : Global Market for Biodegradable Stents for Vascular and Non-vascular Disease, Through 2023
Table 3 : Global Market for Biodegradable Vascular Stents, Through 2023
Table 4 : Global Market for Biodegradable Stents for Coronary and Non-coronary Vascular Disease, Through 2023
Table 5 : Global Market for Biodegradable Stents for Coronary Disease, Through 2023
Table 6 : CE-Marking-Approved Bioresorbable Scaffolds
Table 7 : Global Market for Biodegradable Stents for Coronary Disease, by Region, Through 2023
Table 8 : Other Biodegradable Stents in R&D
Table 9 : Global Market for Biodegradable Stents for Non-coronary Vascular Disease, Through 2023
Table 10 : Global Market for Biodegradable Stents for Non-coronary Vascular Disease, by Region, Through 2023
Table 11 : Global Market for Biodegradable Stents for Peripheral Artery Disease, Through 2023
Table 12 : Global Market for Biodegradable Stents for Peripheral Vascular Disease, by Type, Through 2023
Table 13 : Global Market for Biodegradable Stents for Non-vascular Disease, Through 2023
Table 14 : Global Market for Biodegradable Stents for Non-vascular Disease, by Region, Through 2023
Table 15 : Global Market for Biodegradable Ureteral Stents, Through 2023
Table 16 : Global Market for Gastrointestinal Biodegradable Stents, Through 2023
Table 17 : Global Market for Biliary/Pancreatic Biodegradable Stents, Through 2023
Table 18 : Global Market for Biodegradable Stents, by Region, Through 2023
Table 19 : North American Market for Biodegradable Stents, Through 2023
Table 20 : North American Market for Biodegradable Stents for Vascular Disease, Through 2023
Table 21 : U.S. Market for Biodegradable Stents, Through 2023
Table 22 : U.S. Market for Biodegradable Stents for Vascular Disease, Through 2023
Table 23 : U.S. Market for Biodegradable Stents for Coronary Disease, Through 2023
Table 24 : U.S. Market for Biodegradable Stents for Peripheral Artery Disease, Through 2023
Table 25 : U.S. Market for Biodegradable Stents for Other Non-coronary Vascular (Carotid) Diseases, Through 2023
Table 26 : U.S. Market for Biodegradable Stents for Non-vascular Disease, Through 2023
Table 27 : APAC Market for Biodegradable Stents, Through 2023
Table 28 : APAC Market for Biodegradable Stents for Coronary Disease, Through 2023
Table 29 : APAC Market for Biodegradable Stents for Peripheral Artery Disease, Through 2023
Table 30 : APAC Market for Biodegradable Stents for Other Non-coronary Vascular (Carotid) Diseases, Through 2023
Table 31 : APAC Market for Biodegradable Stents for Vascular Disease, Through 2023
Table 32 : APAC Market for Biodegradable Stents for Non-vascular Disease, Through 2023
Table 33 : Indian Market for Biodegradable Stents, Through 2023
Table 34 : Number of Coronary Stents Implanted in India, Through 2017
Table 35 : European Union Market for Biodegradable Stents, Through 2023
Table 36 : European Union Market for Biodegradable Stents for Coronary Disease, Through 2023
Table 37 : European Union Market for Biodegradable Stents for Peripheral Artery Disease, Through 2023
Table 38 : European Union Market for Biodegradable Stents for Non-coronary Vascular Disease, Through 2023
Table 39 : European Union Market for Biodegradable Stents for Vascular Disease, Through 2023
Table 40 : European Union Market for Biodegradable Stents for Non-vascular Disease, Through 2023
Table 41 : ROW Market for Biodegradable Stents, Through 2023
Table 42 : ROW Market for Coronary Biodegradable Stents, Through 2023
Table 43 : ROW Market for Biodegradable Stents for Peripheral Artery Disease, Through 2023
Table 44 : ROW Market for Biodegradable Stents for Non-coronary Vascular Disease, Through 2023
Table 45 : ROW Market for Biodegradable Stents for Vascular Disease, Through 2023
Table 46 : ROW Market for Biodegradable Stents for Non-vascular Disease, Through 2023
Table 47 : ROW Market for Biodegradable Stents, by Country, Through 2023
Table 48 : Patents and Patent Applications on Biodegradable Stents, Through 2018
Table 49 : Abbott Laboratories: Company Financials, Through 2017
Table 50 : Boston Scientific Corp.: Company Financials, Through 2017
Table 51 : Lepu Medical Corp.: Company Financials, Through 2017
Table 52 : Lifetech Scientific Corp.: Company Financials, Through 2017
Table 53 : Microport Scientific Corp.: Company Financials, Through 2017
Table 54 : Stentys S.A.: Company Financials, Through 2017
Table 55 : Acronyms Used in the Biodegradable Stents Industry
Table 56 : Glossary of Terms Used in the Biodegradable Stents Industry

List of Figures

Summary Figure : Global Market for Biodegradable Stents, by Region, 2016-2023
Figure 1 : Global Market Shares of Biomaterials Used in Biodegradable Stents, by Type, 2016
Figure 2 : Global Market Shares of Biomaterials Used in Biodegradable Stents, by Type of Material, 2023
Figure 3 : Global Market for Biodegradable Stents for Cardiovascular Disease, by Region, 2018-2023
Figure 4 : Forecast Global Population Share, by Age Group, 2050
Figure 5 : Global Market Shares of Biodegradable Stents for Vascular and Non-vascular Disease, 2018
Figure 6 : Global Market Shares of Biodegradable Stents for Vascular and Non-vascular Disease, 2023
Figure 7 : Global Market Shares of Biodegradable Stents for Coronary and Non-coronary Vascular Disease, 2018
Figure 8 : Global Market Shares of Biodegradable Stents Coronary and Non-coronary Vascular Disease, 2023
Figure 9 : Global Market Penetration of Biodegradable Stents for Peripheral Vascular Disease, by Type, 2016-2023
Figure 10 : Global Market Shares of Biodegradable Stents for Peripheral Vascular Disease, by Type, 2023
Figure 11 : Global Market Shares of Biodegradable Stents for Non-vascular Disease, by Type, 2018
Figure 12 : Global Market Shares of Biodegradable Stents for Non-vascular Disease, by Type, 2023
Figure 13 : Global Market Shares of Biodegradable Stents, by Region, 2018
Figure 14 : Global Market Shares of Biodegradable Stents, by Region, 2023
Figure 15 : North American Market Shares of Biodegradable Stents, by Application, 2023
Figure 16 : APAC Market Shares of Biodegradable Stents, by Application, 2023
Figure 17 : Indian Market Volume Shares of Stents, by Type, 2016
Figure 18 : European Union Market Shares of Biodegradable Stents, by Disease Application, 2023
Figure 19 : ROW Market Shares of Biodegradable Stents, by Application, 2023
Figure 20 : Number of Patents on Biodegradable Stents, 2012-2017
Figure 21 : Global Market Shares of Patents on Biodegradable Stents, by Country, 2012-2017
Figure 22 : Global Patents on Biodegradable Stents Published by Top Patents Offices, 2015-2017
Figure 23 : Patents Granted to Assignees with at Least Five Patents on Biodegradable Stents, 2012-2017
Figure 24 : Global Market Shares of Patents on Biodegradable Stents, by Application, 2012-2017

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