Self-expanding Stents Market

Market Overview

The global self-expanding stents market size was valued at USD 3.3 billion in 2023 and is projected to reach USD 5.0 billion by 2032, registering a CAGR of 4.7% during the forecast period (2024-2032). Self-expanding stents market growth will be fueled by rising demand for less invasive procedures, an aging population, technical improvements, an increase in the prevalence of chronic diseases, rising healthcare expenditure, and favorable reimbursement laws.

Self-expanding stents are medical devices used in interventional cardiology and vascular surgery to treat narrowed or blocked arteries. Self-expanding stents have a unique design that allows them to expand automatically once deployed in the target blood vessel, unlike balloon-expandable stents, which must be inflated with a balloon catheter during deployment. This expansion is accomplished through the intrinsic properties of the stent material, which is typically nitinol (a nickel-titanium alloy) or other shape memory alloys that can return to their original shape when exposed to temperature changes or mechanical forces.

Various causes have contributed to the rise of the self-expanding stents market share. The rising prevalence of cardiovascular and peripheral artery illnesses around the world is a major cause. As the aging population grows and lifestyle factors contribute to these illnesses, the demand for minimally invasive therapies such as stent implantation increases. Technological innovations, such as improvements in stent design and materials, help to drive market expansion by increasing the efficacy and safety of these devices. Furthermore, continuous research and development initiatives to increase the use of self-expanding stents add to the market's growth.

Highlights

• Carotid Self-expanding Stents generate the highest revenue share by product.
• Carotid Artery influenced the market growth by application.
• Hospitals are the major end-users of the market.

Market Dynamics

Global Self-expanding Stents Market Drivers:

Increasing Prevalence of Cardiovascular Disease

Coronary artery disease (CAD) is one of the most common cardiovascular conditions in the world, characterized by narrowing or blockage of the coronary arteries caused by plaque buildup. CAD can cause angina (chest pain), a heart attack, and other life-threatening complications. According to the World Health Organization (WHO), cardiovascular disease (CVD) is the leading cause of death worldwide, killing an estimated 17.9 million people each year. CVDs include coronary heart disease, cerebrovascular disease, and rheumatic heart disease, among others. According to World Heart Vision 2030, the number of CVD deaths is expected to increase from 18.9 million in 2020 to more than 22.2 million in 2030 and 32.3 million by 2050. Several factors contribute to the rise in CAD prevalence, including aging populations, sedentary lifestyles, unhealthy dietary habits, tobacco use, and rising rates of obesity, diabetes, and hypertension.

Similarly, the American Heart Association (AHA) estimates that the prevalence of peripheral artery disease (PAD) in the United States will be 7-12 million by 2023, with a global total of 200 million. The prevalence varies according to age, gender, race, and ethnicity. For example, 2.5% of people aged 40-59 have PAD, while 18.8% of people aged 70 and up have it. 

Additionally, the growing prevalence of cardiovascular diseases, such as CAD and PAD, highlights the critical need for advanced treatment options like self-expanding stents. These devices are essential in restoring blood flow, relieving symptoms, and lowering the risk of cardiovascular events in patients with obstructive arterial disease. Self-expanding stents improve patient outcomes and quality of life in cardiovascular disease patients by addressing underlying pathology and improving vascular patency. 

Global Self-expanding Stents Market Restraints:

High Cost of Treatment

Self-expanding stent procedures can be costly, with expenses including the stent device, the method, hospitalization, and postoperative care. The high cost of treatment may cause financial difficulties for patients, particularly those who need adequate health insurance coverage or access to healthcare resources. Furthermore, reimbursement policies and coverage limitations for self-expanding stent procedures can differ between healthcare systems and payers, affecting patient access and affordability.

According to a study, the average in-hospital cost of a self-expanding stent is USD 3,500 higher than the average for a PTA stent. The study also discovered that professional fees for stent placement are significantly higher than for other procedures. Stents typically cost around USD 1,600, while angioplasty balloons can cost up to USD 600. In 2021, the average cost of an in-hospital ERCP with stent placement for patients with no complications was approximately USD 5,029. The high cost of stent placement procedures increases the overall market size and revenue generated by medical device manufacturers, healthcare providers, and payers. 

Moreover, the high cost of self-expanding stent treatment can be prohibitively expensive for patients, especially those who need adequate health insurance coverage or access to healthcare resources. Furthermore, reimbursement policies and coverage limits may differ between healthcare systems and payers, affecting patient access and affordability. 

Global Self-expanding Stents Market Opportunity:

Growing Aging Population and Disease Burden

The aging demographic profile of the world's population contributes to the rising prevalence of vascular diseases such as coronary artery disease (CAD), peripheral artery disease (PAD), and carotid artery disease. As the population ages, the prevalence of vascular conditions is expected to increase, presenting a significant market opportunity for self-expanding stents. These devices provide effective and long-lasting solutions for restoring blood flow in narrowed or blocked arteries, thereby reducing symptoms and improving patient outcomes. The growing demand for minimally invasive treatment options for the elderly creates an opportunity for self-expanding stents to address unmet medical needs and increase market penetration.

According to the American Heart Association, PAD affects approximately 8.5 million people in the United States, with a 20% prevalence among those aged 60 and up. The economic burden of PAD-related healthcare costs, such as hospitalizations, revascularization procedures, and long-term management, is significant, emphasizing the importance of practical and cost-effective treatment options like self-expanding stents.

Similarly, the growing aging population and disease burden create an attractive market opportunity for self-expanding stents to meet the unmet medical needs of elderly patients with vascular conditions. These devices provide safe, minimally invasive alternatives to traditional surgical procedures, allowing for timely revascularization and symptom relief in high-risk patient populations. Manufacturers can use this opportunity to improve patient outcomes and increase market penetration in the rapidly growing senior healthcare market by leveraging advanced stent technology, expanded indications, and targeted marketing strategies.

Regional Analysis

North America Dominates the Global Market

The global self-expanding stents market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America is the most significant global self-expanding stents market shareholder, estimated to grow at a CAGR of 4.9% over the forecast period. The rising prevalence of cardiovascular disease in North America is a significant growth driver for the self-expanding stents market. North America has seen an increase in the incidence of conditions such as coronary artery disease (CAD), peripheral artery disease (PAD), and carotid artery disease, which can be attributed to factors such as sedentary lifestyles, unhealthy eating habits, and an elderly population. Coronary artery disease (CAD), also known as coronary heart disease or ischemic heart disease, is the most prevalent form of heart disease in the United States, affecting approximately 20.5 million adults. 

In addition, as cardiovascular diseases continue to pose significant health risks, there is an increasing demand for effective and minimally invasive treatment options, such as self-expanding stents. Furthermore, the region's strong healthcare infrastructure and significant investments in R&D enable the rapid adoption of advanced self-expanding stent technologies.

Furthermore, companies are increasingly focusing on developing advanced products and implementing various business strategies, such as collaborations and acquisitions, to maintain their market position, contributing to market growth. For example, in August 2022, Medtronic introduced the latest drug-eluting coronary stent system, which employs a more deliverable system that includes an innovative dual-layer balloon, a lower profile for crossing, and increased catheter flexibility. These refinements point to a 16% increase in deliverability over the previous generation while maintaining superior radial strength.

Asia-Pacific is anticipated to exhibit a CAGR of 5.2% over the forecast period due to increased awareness of the importance of cardiovascular health, rising healthcare infrastructure development, and a growing emphasis on preventive and interventional cardiology practices. For example, in September 2023, C.R. Bard, Inc. presented positive results from the Lutonix iX stent clinical trial, indicating safety and efficacy in treating complicated coronary lesions.

The European self-expanding stents market is a significant segment of the larger medical device industry. Self-expanding stents are widely used in Europe to treat peripheral artery disease (PAD) in the femoropopliteal arteries. Population studies estimate that the prevalence of PAD in Western Europe is between 4 and 8%. According to the WHO European region, the prevalence of PAD in men aged 40-44 is 407.1, and in women, it is 940. The prevalence of PAD in men aged 95 and older is 18,664.74, whereas in women it is 26,896.52. 

Additionally, advancements in healthcare infrastructure, reimbursement policies, and medical device regulations promote market expansion and adoption of self-expanding stents in Europe.

Segmental Analysis

The global self-expanding stents market is segmented based on product, application, and end-use.

The market for self-expanding stents is further segmented by product into Carotid Self-expanding Stents, Gastrointestinal Self-expanding Stents, and Endovascular Self-expandable Stents.

The carotid self-expanding stents segment dominated, accounting for approximately 50% of the market in 2023. Carotid self-expanding stents are intended to treat stenosis (narrowing) in the carotid arteries, which are large blood vessels in the neck that supply oxygenated blood to the brain. These stents are implanted during minimally invasive endovascular procedures to restore blood flow and reduce the risk of stroke in patients with carotid artery disease. Carotid stenting is a less invasive alternative to surgical procedures like carotid endarterectomy, and it is especially useful for high-risk patients who may not be candidates for surgery due to comorbidities or anatomical considerations. These stents are made of flexible materials like nitinol and have a tapered or open-cell design to conform to the carotid arteries' unique anatomy and ensure long-term patency.

Notably present in the global market for self-expanding stent technology, they have gained significant traction due to several factors, including an aging population, increased prevalence rates of carotid artery disease, and continued advancements in endovascular techniques. Top medical device manufacturers provide various options for this type, including closed-cell or open-cell designs, dual-layered mesh structures, and embolic protection systems built into their product features list. This is the primary factor driving the segment's growth.

Gastrointestinal self-expanding stents treat obstructive lesions throughout the gastrointestinal tract, including the esophagus, stomach, duodenum, colon, and rectum. These stents are placed endoscopically to relieve symptoms and restore luminal patency in patients with malignant or benign strictures, fistulas, or obstructions caused by esophageal cancer, gastric outlet obstruction, colorectal cancer, or inflammatory bowel disease. Gastrointestinal stenting is a minimally invasive alternative to surgical interventions that provide patients with rapid symptom relief, improved nutritional intake, and a higher quality of life. These stents are typically made of biocompatible materials like nitinol or stainless steel, with a fully or partially covered design to prevent tissue ingrowth and migration.

The market can be bifurcated by application into Fem-Pop Artery, Biliary, Carotid Artery, Iliac Artery.

The carotid artery was the largest sales channel in 2023. Carotid artery self-expanding stents are intended to treat stenosis (narrowing) in the carotid arteries, which are large blood vessels in the neck that supply oxygenated blood to the brain. Carotid stenting is recommended for patients with carotid artery disease who are at high risk of having a stroke or experiencing a transient ischemic attack. These stents are implanted through minimally invasive endovascular procedures to restore blood flow and prevent embolic events by stabilizing atherosclerotic plaques and lowering the risk of plaque rupture or thrombosis. Carotid artery stenting is a less invasive alternative to carotid endarterectomy, especially for patients who have comorbidities or anatomical limitations that prevent surgery.

Carotid artery stenting (CAS) is becoming more widely recognized as an effective and less invasive treatment for carotid artery disease, a significant growth driver for this application. Furthermore, increasing the prevalence of sedentary lifestyles is expected to raise the incidence of heart-related diseases. Furthermore, clinical research and trials demonstrating the efficacy and long-term benefits of using self-expanding stents in carotid artery interventions support a positive outlook for this market segment. The emphasis on improving patient outcomes, lowering postoperative complications, and improving the overall quality of life for stroke patients is driving the growth of the self-expanding stent market.

The femoropopliteal segment comprises the femoral and popliteal arteries in the lower extremities. Self-expanding stents designed for femoropopliteal use treat peripheral artery disease (PAD) in these arteries. PAD in the femoropopliteal region is frequently characterized by intermittent claudication, leg pain, and reduced mobility due to decreased blood flow. Self-expanding stents placed in the femoropopliteal artery provide mechanical support, keep the vessel open, and improve blood flow to the lower limbs, reducing symptoms and preventing complications like critical limb ischemia and loss.

Based on end-use, the market is fragmented into Hospitals and ambulatory Surgical Centers.

Hospitals dominated the market, accounting for approximately 60% of the total. Self-expanding stents have a significant global market presence, with hospitals being the largest segment. Hospitals are a significant end-user segment for self-expanding stents. These medical facilities offer various healthcare services, such as diagnostic procedures, surgical interventions, and inpatient care for patients with vascular diseases. Hospitals frequently have specialized departments or units for cardiology, vascular surgery, interventional radiology, and endovascular interventions, where self-expanding stents are routinely used to treat conditions such as peripheral artery disease (PAD), coronary artery disease (CAD), carotid artery disease, and other vascular disorders. Hospitals typically have advanced imaging equipment, operating rooms, and skilled healthcare professionals trained in the placement and management of self-expanding stents, allowing them to handle complex vascular interventions and postoperative patient care.

The ambulatory surgery centers segment is expected to grow the fastest during the forecast period. Ambulatory surgical centers (ASCs), also known as outpatient surgery centers or day surgery centers, perform surgical and interventional procedures on an outpatient basis, allowing patients to receive treatment and then return home the same day. ASCs provide a convenient and cost-effective alternative to traditional hospital-based care for various medical procedures, including endovascular interventions using self-expanding stents. ASCs have specialized facilities, such as procedure rooms, recovery areas, and diagnostic imaging services, for performing minimally invasive procedures like angioplasty, stent placement, and angiography. Ambulatory Surgery Centers (ASCs) dominate the self-expanding stents market, making them the fastest-growing segment. Furthermore, the growing popularity of outpatient or ambulatory procedures is a major growth driver for ASCs.

Recent Developments

• January 2024- Abbott (NYSE: ABT) completed the first global procedures using its new Volt™ Pulsed Field Ablation (PFA) System to treat patients with everyday abnormal heart rhythms like atrial fibrillation (AFib).
• January 2024- Medtronic Diabetes received the world-first approval for the MiniMed™ 780G System with Simplera Sync™ disposable all-in-one sensor.
• March 2024- BIOTRONIK received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its Freesolve™ below-the-knee resorbable magnesium scaffold (BTK RMS). The newly CE-launched Freesolve RMS for coronary artery lesions, which is based on the BIOmag® magnesium alloy and the proven Orsiro® drug-eluting stent (DES) coating technology, offers safety, improved deliverability, optimal performance, and vessel support during and after implantation.