Biodegradable Stents: Global Markets

Publish Date: May 2019 | Category: Agriculture & Plant | Publisher: BCC Research | Status: Publish

The global market for biodegradable stents should grow from $106.7 million in 2018 to $378.0 million by 2023 with a compound annual growth rate (CAGR) of 28.8% for the period of 2018-2023.

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.

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

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