BIODEGRADABLE STENTS MARKET ANALYSIS

Market Challenges And Opportunities

• High cost of biodegradable stents
• Limited applications

Global Biodegradable Stents Market Drivers:

• Increasing product approvals: The key market players in the market are focused on research and development activities in order to get product approvals from regulatory authorities, which will drive the growth of the market over the forecast period. For instance, in September 2021, Biotronik, a medical device company, announced that its Orsiro Mission bioabsorbable polymer coronary drug-eluting stent system has been approved by the Food and Drug Administration (FDA). The device's first implantation and full commercial availability in the U.S. was also reported by the company.
• Rising cardiovascular diseases: The rising disease burden of cardiovascular diseases coupled with the various merits of biodegradable stents, such as reducing follow-up procedures and long-term complications, is a key factor propelling the demand for biodegradable stents. Regulatory approvals and reimbursement coverage for biodegradable stents in developed regions are also fueling their adoption. As the geriatric population increases, with that prevalence of cardiovascular diseases also increases. For instance, according to data published in October 2022, by The World Health Organization (WHO), the number of people aged 60 years or over is projected to double to more than 1.4 billion globally by 2050.
• Government funding for R&D activities: Government funding for R&D activities is playing a major role in driving the growth of the global biodegradable stents market. Several governments across the world are increasing their funding for biomedical research with a focus on developing innovative biodegradable solutions. This increasing R&D investment is expected to translate into more product approvals and commercial launches in the coming years. As clinical data demonstrating the safety and efficacy of biodegradable stents accumulates due to supported research projects, regulatory bodies are anticipated to approve their use for more coronary and peripheral vascular applications.

Global Biodegradable Stents Market Opportunities:

• Technological advancements: Technological advancements are poised to provide significant opportunities in the global biodegradable stents market. With continued medical research and development investment, biodegradable stents are rapidly evolving to become a safer and more effective alternative to traditional permanent metal stents. For instance, Health Canada, drug regulatory authority, approved BIOTRONIK's Orsiro drug-eluting stent (DES) system in April 2021. It is the first and only ultrathin strut DES to perform better than Xience DES1, the previous clinical standard. Almost three million people have received treatment with Orsiro globally to date.
• Advantages over conventional metal stents: The biodegradable stents market has shown significant promise in recent years owing to the key advantages it offers over conventional metal stents. Biodegradable stents are made from biodegradable polymers that slowly dissolve and are absorbed by the body over time without requiring additional procedures to remove them. This offers patients a more convenient option compared to lifelong dependence on metal stents.

Global Biodegradable Stents Market Restraints:

• High cost of biodegradable stents: The high costs associated with biodegradable stents pose a significant challenge in the widespread adoption of these medical devices. Unlike conventional metal stents that can be used multiple times, biodegradable stents are intended for single use and eventually fully dissolve inside the body, eliminating the need for potential future operations to remove them. However, this unique property of biodegradability also makes them more expensive to produce.
• Limited applications: The limited availability of biodegradable stents is significantly restraining the growth of the global biodegradable stents market. Biodegradable stents are still at a nascent stage of development and large-scale commercial production and adoption is yet to begin. Only a handful of companies globally have received regulatory approvals to market biodegradable stents and the approved products have certain limitations in terms of application.
• Risk of restenosis: The risk of restenosis has been one of the major factors restraining the growth of the global biodegradable stents market. Restenosis refers to the re-narrowing or re-blockage of an artery after an intervention like angioplasty or stenting. When a stent is implanted in an artery, there is a possibility of tissues growing back inside the stent, causing the artery to narrow again over time. This typically occurs in 10-20% of the cases where a bare-metal stent is used.