BIODEGRADABLE STENTS MARKET ANALYSIS

The global biodegradable stents size is estimated to be at US$ 388.9 Mn in 2023 and is expected to reach US$ 634.7 Mn by 2030, growing at a compound annual growth rate (CAGR) of 7.2% from 2023 to 2030.

The global biodegradable stents market has witnessed considerable growth in the past few years owing to the rising awareness regarding minimally invasive procedures. Biodegradable stents gradually dissolve after being deployed in the target site such as blocked arteries or other narrow blood vessels. They do not require subsequent removal surgeries, thereby proving cost-effective for patients. Moreover, biodegradable stents minimize vascular injury and prevent complications usually associated with permanent metal stents. The emergence of bioabsorbable polymers for manufacturing stents that get absorbed by the body over time has transformed the landscape of interventional cardiology. With ongoing technical advancements, biodegradable stents are expected to gradually displace the conventional drug-eluting metallic stents.

Global Biodegradable Stents Market Regional Insights

• North America: North America is the largest market for global biodegradable stents, which accounted for a share of over 45.0% in 2023. The rising geriatric population who are more prone to cardiovascular diseases as well as the growing prevalence of lifestyle diseases like diabetes are driving the demand for biodegradable stents in the region. Additionally, the advantages offered by biodegradable stents like eliminating the need for permanent implantations and removals are boosting their adoption over metallic drug-eluting stents.
• Europe: Europe is the second-largest market for global biodegradable stents, which accounted for a share of over 30.3% in 2023. The European biodegradable stents market has been flourishing at a rapid pace owing to the rising awareness about the benefits of biodegradable stents. Moreover, growing awareness about the advantages of biodegradable stents, such as reduced long-term complications, are augmenting the demand of biodegradable stents.
• Asia Pacific: Asia Pacific is the fastest-growing market for global biodegradable stents, which accounted for a share of over 20.4% in 2023. With rising incidence of cardiovascular diseases and increasing preference for minimally invasive procedures, the demand for biodegradable stents has been growing substantially across major countries in Asia Pacific such as China, India, Japan, and South Korea. Moreover, favorable government policies supporting biomedical research and development along with improving access to quality healthcare infrastructure have boosted the biodegradable stents market in Asia Pacific.

Figure 1. Global Biodegradable Stents Market Share (%), by Region, 2023

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Analyst’s Views

The global biodegradable stents market has strong growth potential over the forecast period. The market is expected to be driven by the rising prevalence of cardiovascular diseases worldwide and the increasing demand for minimally invasive procedures. Biodegradable stents completely dissolve and disappear from the body after scaffolding the artery, eliminating the need for lifelong dual antiplatelet therapy. This major benefit over conventional metallic stents is expected to boost their adoption in the coming years.

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 Trends:

• Introduction of newer materials: The introduction of newer materials is having a significant impact on the global biodegradable stents market. Biodegradable stents made from various polymeric materials are rapidly replacing conventional bare-metal and drug-eluting metallic stents due to distinct advantages they provide. Traditionally, stents were made from non-degradable metals like stainless steel and alloys. However, with advancement in material science and biotechnology, bioresorbable polymers are now being used extensively to manufacture stents that dissolve and disappear from the body over time. For instance, in April 23, 2023, Shanghai MicroPort Medical (Group) Co., Ltd., a medical device manufacturer announced the online publication in the EuroIntervention journal of the design of the Target-First study. This European study aims to determine whether short dual antiplatelet therapy (DAPT) is non-inferior to standard DAPT for patients with acute myocardial infarction (AMI) who have underwent complete revascularization with Firehawk, an abluminal in-groove biodegradable polymer rapamycin eluting stent.
• Innovation of custom-made designs: The innovation of custom-made designs is having a significant impact on the global biodegradable stents market. With the development of advanced 3D printing and computer modeling techniques, doctors are now able to create fully customized stents tailored specifically for each patient's unique anatomy. This shift towards personalization is increasing patient outcomes and satisfaction.
• Rising clinical trials: The rising trend of clinical trials for biodegradable stents is positively influencing the global biodegradable stents market. Clinical trials play a very important role in evaluating the safety and efficacy of newly developed biodegradable stents before they are approved for commercial use in patients. For instance, in September 2020, Abbott, a medical device company, announced the start of the LIFE-BTK clinical trial to evaluate the safety and effectiveness of the company's new Esprit BTK Everolimus Eluting Resorbable Scaffold System. This is the first Investigational Device Exemption (IDE) trial in the U.S. to evaluate a fully bioresorbable stent to treat blocked arteries below the knees, or critical limb ischemia (CLI), in people battling advanced stages of peripheral artery disease (PAD).

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.

Figure 2. Global Biodegradable Stents Market Share (%), by Product Type, 2023

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Recent Developments

New product approvals/launches

• In February 2022, the Ultrathin Strut Orsiro Coronary Drug-Eluting Stent (DES) by BIOTRONIK, a medical device company, set a new clinical benchmark. The final 5-year data from the BIOFLOW-V trial confirms Orsiro DES' superior safety, reaffirming Orsiro's status as the clinical benchmark for DES.
• In June 2021, QualiMed, a wholly-owned subsidiary of a Q3 Medical Devices Limited, announced that it has received CE mark approval for a dedicated percutaneous biodegradable metal alloy-based stent implant for biliary applications, the UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent (BEBS).

Collaboration, partnership, and agreement

• On May 30, 2023, CoSo Health, a global healthcare logistics company, announced the signing a U.S. distribution agreement with Medinol, a healthcare company dedicated to the science of cardiovascular intervention, for EluNIR, a new generation, thin-strut drug-eluting stent (DES).
• In October 2022, Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies, announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance, a Switzerland-based company at the forefront of transformative drug-eluting balloons.
• In September 2022, Gentinge, a global medical technological company, announced a supply partnership with Medtronic, a medical device company, which recently received CE mark for the Radiant covered stent, the first covered stent indicated for chimney endovascular aneurysm repair (ChEVAR).

Top Companies in the Global Biodegradable Stents Market

• Boston Scientific Corporation
• Abbott
• Kyoto Medical Planning Co., Ltd.
• QualiMed
• Elixir Medical Corporation
• ENDOCOR GmbH
• BIOTRONIK SE & Co. KG
• Amaranth Medical, Inc.
• Arterial Remodeling Technologies SA.

Definition: Biodegradable stents, also known as bioresorbable or bioabsorbable stents, are a type of medical device used primarily in the treatment of coronary and peripheral artery diseases. The use of biodegradable stents can reduce the risk of long-term complications associated with traditional stents such as thrombosis and restenosis. They also have the potential to restore the natural movement and function of the artery after treatment.