Biodegradable Stents Market

Market Overview

The global biodegradable stents market was valued at USD 0.851 billion in 2023. It is expected to reach USD 5.731 billion by 2032, growing at a CAGR of 23.60% during the forecast period (2024-32). The future growth of the biodegradable stents market is driven by the rising prevalence of cardiovascular diseases, including coronary artery disease, high blood pressure, cardiac arrest, and artery blockage.

Highlights

• Polymer-based dominates the product type segment
• Coronary artery dominates the application segment
• Hospital dominates the end-user segment
• North America is the highest shareholder in the global market

A stent is a medical device that expands blood vessels and keeps them from becoming blocked. It is inserted into the body's internal duct. Biodegradable stents, sometimes called bioresorbable stents or naturally-dissolving stents, are composed of substances absorbed by the body and function by enlarging internal ducts or vessels to remove blockages brought on by plague deposition. Biodegradable stents, which offer potential advantages in specific clinical scenarios, are made to gradually degrade over time, in contrast to traditional metallic stents that stay in the body permanently. These devices are made so that the stents dissolve within the body at predetermined intervals after the drug has been eluted.

Market Dynamics

Global Biodegradable Stents Market Drivers:

Growing Prevalence of Coronary Artery Disease

A major push for developments in cardiovascular medicine is the increasing incidence of coronary artery disease (CAD), which is a major worldwide health concern. The coronary arteries are vital for delivering blood and oxygen to the heart muscle; when they become narrowed or blocked, a condition known as coronary artery disease occurs. In the treatment of coronary artery disease (CAD), biodegradable stents offer an alternative to the more conventional metallic stents. 

Furthermore, the need for new and improved treatments for coronary artery disease (CAD) is being driven by the rising global incidence of the condition. In 2021, 375,476 people will lose their lives to coronary heart disease, making it the most common form of heart disease. A little over 5% of adults (or 1 in 20) have coronary artery disease. Nearly half of all coronary artery disease (CAD) fatalities in 2021 will occur in adults younger than 65.

Increasing Awareness and Acceptance

Increasing acceptance and awareness are important factors influencing public opinions, actions, and reactions to various topics, including health-related matters. These variables may greatly impact treatment adherence, early disease detection, disease prevention, and the uptake of new medical technology in the healthcare setting. The advantages of biodegradable stents are better understood by both patients and healthcare providers, leading to their increased acceptance as a treatment option for specific cardiovascular conditions.

Furthermore, the medical community's understanding of biodegradable stents is aided by well-conducted clinical trials and research studies on their safety and effectiveness. Peer-reviewed literature contributes to the diffusion of scientific knowledge and increases trust in the technology. For instance, the Venous Self-Expanding Stent system, which treats iliofemoral venous outflow obstruction, received approval from the U.S. Food and Drug Administration (FDA) in October 2020. Moreover, Abbott reported in June 2021 that the Abbott XIENCE stent—utilized for patients at high risk of bleeding—had received FDA approval.

Global Biodegradable Stents Market Restraints:

Regulatory Challenges

New medical devices, like biodegradable stents, can face lengthy and challenging regulatory approval processes. Biodegradable stent development and regulatory approval entail several obstacles to guaranteeing these medical devices' security, effectiveness, and caliber. Regulatory obstacles could impact the rate at which these devices hit the biodegradable stents market. These regulatory hurdles need a concerted effort from regulatory agencies, clinical experts, and industry stakeholders. 

Furthermore, the FDA may occasionally call an advisory committee meeting to get feedback on the device from outside experts. The overall review timeline may be extended by scheduling these meetings and incorporating committee recommendations. Moreover, the FDA could impose post-market surveillance requirements as a prerequisite for approval. These specifications could support the long-term supervision of the device by requiring continuous performance monitoring and reporting unfavorable occurrences, hindering biodegradable stents market growth over the forecast period.

Global Biodegradable Stents Market Opportunities:

Reduced Long-Term Complications

The long-term risks connected with metallic stents, like late stent thrombosis and in-stent restenosis, may be lessened by the transient nature of biodegradable stents, which progressively dissolve over time. Due to this unique feature, biodegradable stents may be desirable for some patient populations. According to Dr. Stone, the head of the nationwide multi-center study, there may be benefits in less risks associated with traditional metal stents and a decreased need for follow-up procedures once the stent dissolves. 

Furthermore, the damaged blood vessels are temporarily supported by biodegradable stents. Unlike permanent metallic stents, biodegradable stents are intended to dissolve gradually over time rather than stay in the body indefinitely. This interim support meets the urgent need for vascular support in the early stages of the healing process. Moreover, the utilization of biodegradable stents in coronary stent technology offers several benefits over durable polymers, including complete drug elution and decreased inflammatory response. This approach may also reduce late complications like endothelial dysfunction, thrombosis, stent strut uncovering, and mal-apposition.

Regional Analysis

Based on region, the global biodegradable stents market is segmented into North America, Asia-Pacific, Europe, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global biodegradable stents market shareholder and is expected to expand substantially over the forecast period. This is associated with elevated blood pressure and cholesterol levels in the regional population, which causes an increase in artery diseases. For instance, approximately 15 million people suffer from coronary diseases in the U.S. Apart from this, the increasing population of tobacco smoking and obesity leading to artery diseases is also increasing the demand for biodegradable stents for eluting drugs. Moreover, the sophisticated healthcare system in North America makes it easier for new medical technologies to be adopted.

Modern medical facilities and a well-defined regulatory environment are important for the creation and application of cutting-edge medical devices, such as biodegradable stents. According to Statista, the Cardiology Devices market in the United States is anticipated to generate USD 26.57 billion in revenue by 2024. It is expected to grow at a CAGR of 6.27% between 2024 and 2028, reaching a market volume of USD 33.89 billion. It is important to remember that, when looking at countries worldwide, the United States is expected to produce the most revenue, reaching USD 26.57 billion in 2024. Such factors propel regional market growth over the forecast period.

Europe is predicted to witness substantial growth over the forecast period. This is due to the rising incidence of coronary artery cases, including ischemic heart disease, angina, myocardial infarction, unstable angina, and sudden cardiac arrest. The rising prevalence of cardiovascular diseases in Europe has increased the need for cardiac stent devices, fueling market growth. For instance, cardiovascular disease is responsible for approximately 4 million deaths per year in Europe and 1.9 million deaths in the European Union. The majority of these deaths are caused by coronary heart disease (CHD), accounting for 47% of all deaths in Europe and 40% of all deaths in the European Union. Moreover, the healthcare system in Europe is well-established and sophisticated, which makes it easier for patients to adopt cutting-edge medical technology. 

Furthermore, the development and implementation of cutting-edge medical devices, such as biodegradable stents, are facilitated by the availability of cutting-edge medical facilities and a robust regulatory environment. Therefore, various market players are investing to improve their market share, which is expected to propel the regional market. For instance, the biopharma company Corteria will put the €65 million (USD 71 million) it raised in a Series A round led by investment firms OrbiMed in the US and Jeito Capital in the EU toward developing its cardiovascular pipeline for clinical trials. Two new Corteria's board of directors members are Andreas Wallnoefer of Jeito Capital and Erez Chimovits of OrbiMed. The company's approach focuses on identifying therapeutic targets related to acute and worsening human heart failure.

Segmental Analysis

The global market for biodegradable stents is segmented into products, applications, absorption rate, and end-user.

Based on product, the global biodegradable stents market is segmented into polymer-based, biodegradable stents, and metal-based biodegradable stents.

The polymer-based segment dominates the global market. The degradability and clinical application potential of biodegradable polymeric vascular stents for the treatment of cardiovascular disease have drawn the attention of numerous researchers in recent years. A class of medical devices called polymer-based biodegradable stents is intended to treat cardiovascular conditions, specifically coronary artery disease. Polymer-based stents can be designed with particular mechanical characteristics to maximize their effectiveness and adjust to the changing conditions of blood vessels. Moreover, biodegradable polymers are used in the construction of these stents, and they gradually disintegrate within the body. 

Based on application, the global biodegradable stents market is segmented into coronary artery disease and peripheral artery disease.

The coronary artery segment dominates the global market. The constriction or occlusion of the coronary arteries is a symptom of coronary artery disease (CAD), which can cause the heart muscle to receive less blood. In the context of coronary artery disease, biodegradable stents temporarily support the structural integrity of blood vessels. According to the Centers for Disease Control and Prevention, coronary artery disease affects about 1 in 13 Americans who are 18 and older. Several benefits are available with biodegradable stents tailored for coronary applications as opposed to conventional permanent stents. A new era in interventional cardiology has begun with biodegradable stents (BDS). It is intended that BDS will provide temporary support to the vessel wall for approximately three to six months following implantation in CAD. The inserted BDS will degrade and be absorbed, and the vessel wall will heal and return to normal.

Based on absorption rate, the global biodegradable stents market is segmented into slow absorption rate, intermediate absorption rate, and fast absorption rate.

In the early stages after implantation, slow degradation may help remodel the vessel wall more gradually and keep it under control, lowering the risk of acute complications like thrombosis or vessel recoil. One of the most important factors influencing the therapeutic outcomes and effectiveness of biodegradable stents is their rate of absorption or degradation. Biodegradable stents decompose naturally over time, but the rate at which this happens determines the extent to which the stents function, are safe, and endure over time. The stent's mechanical support for the blood vessel can last longer because its absorption rate is slower. This sustained support might be helpful during the most important stages of a vessel's healing and remodeling.

Based on end-users, the global biodegradable stents market is segmented into hospital and cardiac centers.

The hospital segment owns the highest market share. Cardiac procedures like angioplasty and stent placement are within the scope of practice at hospitals with interventional cardiology departments. The number of cardiovascular surgeries is anticipated to gradually increase, from 10,581 cases in 2014 to 15,501 cases in 2040, a 46.5% increase. A total of 245 cardiothoracic surgeons were employed in 2014. In the next five years, there will likely be 184 surgeons employed, 249 retiring, and 309 actively involved in the field—a rise of −24.9%, 1.6%, and 26.1% from 2014 levels, respectively. This increase in surgeries is expected to propel hospital segment growth.

Recent Developments

• August 2022- The Department of Cardiology at the Advanced Cardiac Centre of the PGIMER performed the world's first robotically assisted bioresorbable stent implantation as an interventional procedure. The head of the Department of Cardiology, Yash Paul Sharma, and his team handled the case. With 90% stenosis of the major coronary arteries and coronary artery disease, the patient was 47 years old. Bioresorbable stents were successfully implanted in the patient using the Cardiac Cath Lab's Corindus Robotic Arm.