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.
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.
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