Global Biodegradable Stents Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Stents;
Coronary Stents and Peripheral Stents.By Material Type;
Polymer-based Stents and Metallic Stents.By Application;
Cardiovascular, Orthopedics, Cosmetic Surgery, General Surgery, Cranial, and Others.By End Users;
Hospital, Specialty Clinics, and Ambulatory Care Centers.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa, and Latin America - Report Timeline (2021 - 2031).Introduction
Global Biodegradable Stents Market (USD Million), 2021 - 2031
In the year 2024, the Global Biodegradable Stents Market was valued at USD 393.68 million. The size of this market is expected to increase to USD 1,034.51 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 14.8%.
The global healthcare industry is witnessing a paradigm shift towards the development and adoption of advanced medical devices that offer superior efficacy and safety profiles while minimizing environmental impact. In line with this trend, biodegradable stents have emerged as a promising innovation in the field of interventional cardiology and vascular surgery. Biodegradable stents, also known as bioresorbable or absorbable stents, are temporary implants designed to provide mechanical support to diseased or narrowed arteries while gradually degrading and resorbing into the body over time.
The Global Biodegradable Stents Market is experiencing significant growth driven by several factors, including the rising prevalence of cardiovascular diseases (CVDs), increasing demand for minimally invasive procedures, and growing preference for bioresorbable scaffolds over traditional metallic stents. CVDs, including coronary artery disease (CAD) and peripheral artery disease (PAD), represent a leading cause of morbidity and mortality worldwide, driving the need for innovative treatment options such as biodegradable stents.
Unlike permanent metallic stents, biodegradable stents offer several potential advantages, including reduced risk of late stent thrombosis, elimination of long-term foreign body presence, and restoration of vessel vasomotion. These attributes make biodegradable stents particularly suitable for treating complex lesions, bifurcation lesions, and patients with high bleeding risk or long life expectancy. Additionally, biodegradable stents facilitate vessel healing and remodeling, enabling the restoration of physiological vascular function and facilitating future revascularization if necessary.
The Global Biodegradable Stents Market is characterized by intense research and development activities aimed at improving stent design, biocompatibility, and degradation kinetics. Key players in the market are investing in the development of next-generation biodegradable stents with enhanced mechanical properties, drug-eluting capabilities, and advanced imaging features to optimize stent performance and clinical outcomes. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have provided regulatory pathways and guidelines for the approval and commercialization of biodegradable stents, further fueling market growth.
Despite the promising prospects, the global biodegradable stents market faces challenges related to long-term clinical outcomes, device thrombosis, and manufacturing scalability. Clinical studies evaluating the safety and efficacy of biodegradable stents over extended follow-up periods are ongoing, aiming to address concerns regarding late adverse events and scaffold degradation.
Global Biodegradable Stents Market Recent Developments
-
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).
Segment Analysis
The Global Biodegradable Stents Market is segmented by stent type into coronary stents and peripheral stents, addressing different vascular areas. Coronary stents are the most widely used biodegradable stents, designed to support coronary arteries after procedures like angioplasty. These stents are vital for preventing restenosis, offering a temporary solution that dissolves after the artery has healed, reducing long-term complications such as thrombosis. As cardiovascular diseases continue to rise globally, the demand for coronary biodegradable stents is expected to grow, driven by their ability to reduce patient risks and improve recovery. In contrast, peripheral stents are used to treat conditions in peripheral arteries, such as those in the legs or arms. These biodegradable stents are crucial for managing peripheral vascular diseases, with the same benefits of temporary support and reduced long-term complications, making them increasingly popular in vascular surgeries.
In terms of material type, the market is divided into polymer-based stents and metallic stents, each offering distinct advantages. Polymer-based stents are made from biodegradable polymers, which gradually dissolve after the targeted tissue has healed. These stents are flexible, biocompatible, and less likely to cause long-term irritation or inflammation, making them ideal for softer tissues. They are widely used in cardiovascular and other applications, as they can be designed to match the mechanical properties needed for a wide range of medical conditions. On the other hand, metallic stents are made from biodegradable metals like magnesium and zinc, offering higher mechanical strength and better durability during the healing process. These stents are primarily used in cardiovascular and orthopedic applications, where a strong yet temporary support structure is required before the body absorbs the stent.
The application of biodegradable stents spans a broad range of medical fields, including cardiovascular, orthopedics, cosmetic surgery, general surgery, cranial, and others. In cardiovascular applications, both coronary and peripheral stents play a critical role in preventing restenosis after angioplasty procedures. Orthopedic applications involve the use of biodegradable stents in bone repair, where they support bone fractures or joint reconstruction temporarily. In cosmetic surgery, biodegradable stents may be used to support soft tissues or in reconstructive surgeries. Other applications, such as cranial and general surgery, also benefit from biodegradable stents as they provide temporary support in delicate surgeries. The market is also segmented by end users, including hospitals, specialty clinics, and ambulatory care centers. Hospitals are the largest end users, as they perform a variety of complex surgeries requiring advanced stent solutions. Specialty clinics and ambulatory care centers are increasingly adopting biodegradable stents, particularly for less invasive procedures, where shorter recovery times and fewer complications are essential. As the market for biodegradable stents grows, advancements in materials and stent designs will likely lead to broader adoption across these diverse end-user settings.
Global Biodegradable Stents Segment Analysis
In this report, the Global Biodegradable Stents Market has been segmented by Stents, Material Type, Application, End Users, and Geography.
Global Biodegradable Stents Market, Segmentation by Product Type
The Global Biodegradable Stents Market has been segmented by Stents into Coronary Stents, Peripheral Stents.
Coronary stents are specifically designed for the treatment of coronary artery disease (CAD), which involves the narrowing or blockage of arteries supplying blood to the heart muscle. These stents are used to support narrowed arteries and improve blood flow to the heart, thereby alleviating symptoms such as chest pain (angina) and reducing the risk of heart attacks.
Peripheral stents, on the other hand, are utilized in the treatment of peripheral artery disease (PAD), which affects arteries outside the heart, typically in the legs. PAD can lead to symptoms such as leg pain, numbness, and difficulty walking due to reduced blood flow to the legs. Peripheral stents are deployed to open narrowed or blocked arteries in the legs, restoring blood flow and improving symptoms and mobility for patients with PAD.
Coronary stents are primarily used in the management of CAD, a leading cause of morbidity and mortality worldwide, while peripheral stents address the unique challenges posed by PAD, particularly in the lower extremities. By offering specialized stent solutions for coronary and peripheral vascular diseases, manufacturers can effectively address the diverse clinical needs of patients and healthcare providers. This segmentation enables targeted product development, marketing strategies, and clinical research initiatives tailored to specific vascular indications, ultimately enhancing patient outcomes and driving market growth in the global biodegradable stents market.
Global Biodegradable Stents Market, Segmentation by Material Type
The Global Biodegradable Stents Market has been segmented by Material Type into Polymer-based Stents and Metallic Stents.
The Global Biodegradable Stents Market is segmented by material type into polymer-based stents and metallic stents, each catering to different medical needs and offering unique benefits. Polymer-based stents are made from biocompatible polymers that gradually degrade in the body over time, eliminating the need for permanent implants. These stents are designed to provide temporary support to blood vessels or other tissues, with the material breaking down after the vessel has healed. Polymer-based stents are particularly advantageous in reducing long-term complications associated with permanent stents, such as restenosis or inflammation. The development of advanced biodegradable polymers that are both strong and flexible is expanding the use of these stents in a variety of medical procedures.
On the other hand, metallic stents are made from biodegradable metals like magnesium, iron, or zinc. These stents provide the structural strength required for long-term support but are designed to degrade after fulfilling their purpose. Metallic biodegradable stents have gained traction in vascular procedures, such as coronary artery stenting, where their ability to provide temporary scaffolding while being resorbed by the body is essential for reducing the risk of restenosis without requiring long-term intervention. The use of metallic materials also allows for better control over the stent's mechanical properties, such as strength and flexibility, while maintaining biocompatibility.
The market's growth is driven by the increasing preference for biodegradable stents that eliminate the need for long-term implantation, reducing patient risk and enhancing recovery. The choice between polymer-based and metallic stents largely depends on the specific medical condition and the targeted application. Polymer-based stents are often used in softer, more flexible tissue applications, while metallic stents are more suitable for areas requiring higher mechanical strength. As technology advances, both types are being improved to enhance their biodegradability, strength, and safety, leading to a broader adoption in clinical practice. The increasing demand for minimally invasive treatments and the growing preference for biodegradable solutions are expected to further propel the market for both material types.
Global Biodegradable Stents Market, Segmentation by Application
The Global Biodegradable Stents Market has been segmented by Application into Cardiovascular, Orthopedics, Cosmetic Surgery, General Surgery, Cranial, and Others.
The Global Biodegradable Stents Market is segmented by application, with key categories including cardiovascular, orthopedics, cosmetic surgery, general surgery, cranial, and others. The cardiovascular segment is one of the largest and most significant, as biodegradable stents are widely used in coronary and peripheral artery diseases to prevent restenosis. These stents offer temporary support to blood vessels, promoting healing while gradually dissolving to reduce the risk of long-term complications, such as blood clots. The growing prevalence of heart diseases and the demand for minimally invasive procedures are fueling the adoption of biodegradable coronary stents, further driving market growth in the cardiovascular segment.
In orthopedics, biodegradable stents are gaining traction, especially in bone and joint repair applications. These stents provide temporary structural support during the healing process of fractures or after joint reconstruction. Once the bone or tissue has healed, the biodegradable stent gradually dissolves, eliminating the need for a second procedure to remove the stent. This application is particularly beneficial in pediatric orthopedics, where the need for non-permanent solutions is high. The cosmetic surgery application also benefits from biodegradable stents, particularly in reconstructive and aesthetic procedures. These stents help in soft tissue support and provide a temporary scaffold to aid in the healing of post-surgical areas, such as those in facial surgeries or breast reconstruction. Their biodegradable nature ensures that no long-term implants are required, which is increasingly desirable in the field of cosmetic surgery.
The general surgery and cranial segments are also important applications for biodegradable stents. In general surgery, biodegradable stents are used to support healing tissues after surgeries such as gastrointestinal or abdominal procedures. They help in reducing complications, like infections and tissue regrowth issues, providing a safer and more efficient healing process. The cranial segment benefits from biodegradable stents used in neurological surgeries to support delicate brain tissues during recovery. These stents are especially important in complex surgeries, where maintaining the structural integrity of the cranial area is crucial. The others category includes niche applications such as gastrointestinal surgeries, urological procedures, and dental surgeries, where biodegradable stents provide temporary support, ensuring patient comfort and faster recovery times. The increasing focus on minimally invasive, effective, and patient-friendly solutions is expected to drive the growth of biodegradable stents across these diverse application areas.
Global Biodegradable Stents Market, Segmentation by End Users
The Global Biodegradable Stents Market has been segmented by End Users into Hospital, Specialty Clinics, and Ambulatory Care Centers.
Hospitals serve as the primary setting for interventional procedures involving biodegradable stents, offering comprehensive diagnostic, therapeutic, and surgical services for patients with coronary and peripheral artery diseases. These facilities are equipped with advanced imaging modalities, catheterization laboratories, and cardiac care units, enabling the delivery of specialized care and interventions for patients requiring stent placement.
Specialty clinics focusing on cardiovascular care play a vital role in the management of patients with coronary and peripheral artery diseases. These clinics provide outpatient services, diagnostic testing, and interventional procedures, including stent placement, in a specialized setting dedicated to cardiovascular health. Specialty clinics often collaborate with hospitals and academic medical centers to offer multidisciplinary care and access to treatment options, including biodegradable stents, for patients with complex cardiovascular conditions.
Ambulatory care centers offer convenient and efficient healthcare services for patients requiring outpatient procedures, including stent placement. These facilities provide a range of diagnostic and treatment services in a comfortable and accessible environment, catering to the needs of patients seeking minimally invasive interventions for coronary and peripheral artery diseases. Ambulatory care centers offer streamlined workflows, shorter wait times, and cost-effective care options, making them increasingly popular for interventional procedures such as stent implantation.
Global Biodegradable Stents Market, Segmentation by Geography
In this report, the Global Biodegradable Stents Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Global Biodegradable Stents Market Share (%), by Geographical Region, 2024
North America represents a significant market for biodegradable stents, driven by factors such as a high prevalence of cardiovascular diseases, advanced healthcare infrastructure, and strong research and development activities. The region is characterized by widespread adoption of innovative medical technologies and a favorable regulatory environment, supporting market growth and product innovation.
Europe is another key region in the biodegradable stents market, with countries such as Germany, the United Kingdom, and France leading in healthcare expenditure and technological innovation. The region benefits from robust healthcare systems, academic research institutions, and collaborative efforts among industry stakeholders, fostering market expansion and adoption of biodegradable stent technologies.
The Asia Pacific region is experiencing rapid growth in the biodegradable stents market, fueled by increasing healthcare expenditure, rising prevalence of cardiovascular diseases, and expanding access to advanced medical care. Countries such as China, India, and Japan are investing in healthcare infrastructure and technology adoption, driving market opportunities for biodegradable stent manufacturers and suppliers.
The Middle East and Africa region is witnessing growing demand for biodegradable stents, driven by improving healthcare access, rising awareness of cardiovascular diseases, and government initiatives to enhance healthcare infrastructure. While the market in this region is still developing, there is significant potential for growth and investment in cardiovascular interventions and medical devices.
Latin America represents an emerging market for biodegradable stents, with countries such as Brazil, Mexico, and Argentina showing increasing adoption of advanced medical technologies and improving access to healthcare services. The region offers opportunities for market expansion due to a growing burden of cardiovascular diseases and efforts to modernize healthcare infrastructure.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Biodegradable Stents Market. These factors include; Market Drivers, Restraints, and Opportunities Analysis.
Drivers, Restraints and Opportunities Analysis
Drivers:
- Increasing Prevalence of Cardiovascular Diseases
- Preference for Minimally Invasive Procedures
- Increasing Healthcare Expenditure
- Focus on Patient Outcomes and Quality of Life
-
Growing Aging Population - The growing aging population serves as a significant driver for the biodegradable stents market. As the global population ages, there is a corresponding increase in the prevalence of cardiovascular diseases, such as coronary artery disease (CAD) and peripheral artery disease (PAD), which are common among older adults. Aging is associated with physiological changes in the cardiovascular system, including arterial stiffness, endothelial dysfunction, and atherosclerosis, leading to an elevated risk of cardiovascular events and necessitating interventions such as stent placement. Elderly patients often present with complex vascular conditions and comorbidities, making them particularly vulnerable to the adverse effects of traditional metallic stents, such as late stent thrombosis and restenosis. Biodegradable stents offer a promising alternative for this population due to their temporary nature and potential for vessel healing and restoration. By providing transient mechanical support to diseased arteries while gradually resorbing over time, biodegradable stents reduce the risk of long-term complications associated with permanent metallic implants, making them well-suited for elderly patients with multiple comorbidities.
The aging population represents a growing segment of healthcare consumers with unique healthcare needs and preferences. Older adults often prioritize interventions that optimize functional status, independence, and quality of life while minimizing treatment burden and adverse effects. Biodegradable stents align with these patient-centered care principles by offering improved clinical outcomes, reduced long-term complications, and enhanced quality of life compared to conventional metallic stents. As a result, there is a growing demand among elderly patients and healthcare providers for biodegradable stents as a safer and more effective treatment option for coronary and peripheral artery diseases.
Restraints:
- Clinical Efficacy and Long-Term Safety Concerns
- Technological Complexity and Manufacturing Challenges
- Limited Clinical Evidence and Adoption Barriers
-
Potential for Device Thrombosis and Complications - The potential for device thrombosis and complications represents a significant restraint for the biodegradable stents market. Despite advancements in stent technology, concerns persist regarding the occurrence of device thrombosis, restenosis, and other adverse events associated with biodegradable stents. These complications may arise due to various factors, including incomplete scaffold degradation, delayed endothelialization, and inflammatory responses triggered by the stent implantation. Device thrombosis, in particular, is a serious complication characterized by the formation of blood clots within or around the stent, leading to acute vessel occlusion and potentially life-threatening consequences such as myocardial infarction or stroke. While biodegradable stents aim to mitigate the risk of late stent thrombosis associated with permanent metallic implants, concerns remain about the timing and completeness of scaffold degradation, which may affect vessel healing and predispose to thrombotic events.
Restenosis, or the re-narrowing of the treated artery, can occur following stent placement, necessitating repeat interventions and impacting long-term clinical outcomes. Delayed endothelialization, inadequate vessel remodeling, and local inflammatory reactions may contribute to restenosis and compromise the efficacy of biodegradable stents in maintaining vessel patency over time. The potential for device thrombosis and complications poses challenges for clinicians, patients, and regulatory agencies in evaluating the safety and efficacy of biodegradable stents compared to traditional metallic stents. Addressing these concerns requires comprehensive clinical data, post-market surveillance, and risk mitigation strategies to minimize adverse events and optimize patient outcomes.
Opportunities:
- Focus on Precision Medicine and Personalized Therapies
- Expansion of Indications and Clinical Applications
- Patient Education and Empowerment
-
Healthcare Policy and Reimbursement Reform - Healthcare policy and reimbursement reform present significant opportunities for the biodegradable stents market. As healthcare systems worldwide undergo transformation and strive for greater value-based care, policy and reimbursement reforms can create favorable conditions for the adoption and utilization of innovative medical technologies such as biodegradable stents. One opportunity lies in the alignment of healthcare policies and reimbursement models with patient outcomes and cost-effectiveness. Value-based reimbursement models incentivize healthcare providers to deliver high-quality care that improves patient outcomes and reduces overall healthcare costs. Biodegradable stents, with their potential to enhance patient outcomes and reduce long-term complications compared to traditional metallic stents, align well with value-based care principles. By demonstrating the clinical and economic value of biodegradable stents through real-world evidence and health economic studies, manufacturers can leverage reimbursement reforms to secure favorable coverage and reimbursement rates for their products.
Healthcare policy and reimbursement reforms can drive innovation and market access by promoting equitable access to innovative medical technologies. Policies that support early adoption of breakthrough medical devices, streamline regulatory pathways, and facilitate market entry can accelerate the availability and adoption of biodegradable stents. Reimbursement reforms that prioritize patient access, clinical effectiveness, and healthcare cost containment create an environment conducive to investment in research and development, clinical trials, and commercialization efforts for biodegradable stents. Healthcare policy and reimbursement reforms offer opportunities for stakeholder collaboration and advocacy to shape policy decisions and reimbursement policies. Manufacturers, healthcare providers, patient advocacy groups, and policymakers can collaborate to advocate for favorable reimbursement policies, coverage decisions, and coding guidelines for biodegradable stents. By engaging in dialogue with regulatory agencies, payers, and healthcare decision-makers, stakeholders can influence policy reforms that support market access, reimbursement, and adoption of biodegradable stents.
Competitive Landscape Analysis
Key players in Global Biodegradable Stents Market include:
- Boston Scientific Corporation
- ELLA
- CS, s.r.o
- Abbott
- Lepu Medical Technology Co., Ltd
- Terumo Corporation
- Kyoto Medical Planning Co., Ltd.
- QualiMed
- Elixir Medical Corporation
- ENDOCOR GmbH
- BIOTRONIK SE & Co. KG
- Amaranth Medical, Inc.
- Arterial Remodeling Technologies SA.
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Stents
- Market Snapshot, By Material Type
- Market Snapshot, By Application
- Market Snapshot, By End Users
- Market Snapshot, By Region
- Global Biodegradable Stents Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Increasing Prevalence of Cardiovascular Diseases
- Preference for Minimally Invasive Procedures
- Increasing Healthcare Expenditure
- Focus on Patient Outcomes and Quality of Life
- Growing Aging Population
- Restraints
- Clinical Efficacy and Long-Term Safety Concerns
- Technological Complexity and Manufacturing Challenges
- Limited Clinical Evidence and Adoption Barriers
- Potential for Device Thrombosis and Complications
- Opportunities
- Focus on Precision Medicine and Personalized Therapies
- Expansion of Indications and Clinical Applications
- Patient Education and Empowerment
- Healthcare Policy and Reimbursement Reform
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Biodegradable Stents Market, By Stents, 2021 - 2031 (USD Million)
- Coronary Stents
- Peripheral Stents
- Global Biodegradable Stents Market, By Material Type, 2021 - 2031 (USD Million)
- Polymer-based Stents
- Metallic Stents
- Global Biodegradable Stents Market, By Application, 2021 - 2031 (USD Million)
- Cardiovascular
- Orthopedics
- Cosmetic Surgery
- General Surgery
- Cranial
- Others
- Global Biodegradable Stents, By End Users, 2021 - 2031 (USD Million)
- Hospital
- Specialty Clinics
- Ambulatory Care Centers
- Global Biodegradable Stents, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Biodegradable Stents Market, By Stents, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Boston Scientific Corporation
- ELLA
- CS, s.r.o
- Abbott
- Lepu Medical Technology Co., Ltd
- Terumo Corporation
- Kyoto Medical Planning Co., Ltd.
- QualiMed
- Elixir Medical Corporation
- ENDOCOR GmbH
- BIOTRONIK SE & Co. KG
- Amaranth Medical, Inc.
- Arterial Remodeling Technologies SA.
- Company Profiles
- Analyst Views
- Future Outlook of the Market