Bioresorbable Coronary Stents Market, 2028- Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Brand (Magmaris, Magnitude, MeRes-100, DESolve, Others), By End User (Hospitals & Clinics, Ambulatory Care Centers, Others), By Region, By Competition.
Published Date: November - 2024 | Publisher: MIR | No of Pages: 320 | Industry: Healthcare | Format: Report available in PDF / Excel Format
View Details Buy Now 2890 Download Sample Ask for Discount Request CustomizationBioresorbable Coronary Stents Market, 2028- Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Brand (Magmaris, Magnitude, MeRes-100, DESolve, Others), By End User (Hospitals & Clinics, Ambulatory Care Centers, Others), By Region, By Competition.
| Forecast Period | 2024-2028 |
| Market Size (2022) | USD 450.07 million |
| CAGR (2023-2028) | 10.30% |
| Fastest Growing Segment | Hospitals & Clinics |
| Largest Market | North America |
Market Overview
The Global Bioresorbable Coronary Stents Market has valued at USD 450.07 million in 2022 and is anticipated to project impressive growth in the forecast period with a CAGR of 10.30% through 2028. The field of cardiology has witnessed remarkable advancements in recent years, leading to better patient outcomes and improved quality of life for individuals with coronary artery disease (CAD). Among these advancements, bioresorbable coronary stents have emerged as a promising innovation. These stents represent a significant shift in the treatment of CAD, offering a solution that gradually dissolves within the body after its purpose is served.
Coronary artery disease is a prevalent cardiovascular condition characterized by the buildup of plaque inside the coronary arteries, which can restrict blood flow to the heart muscle. Left untreated, CAD can lead to chest pain (angina), heart attacks, and even heart failure. Traditionally, CAD has been treated using metal stents, which are implanted to keep the arteries open. However, these permanent metallic implants have their limitations.
The bioresorbable coronary stents market has witnessed significant growth over the past decade, driven by several factors.
Key Market Drivers
Rising Prevalence of Coronary Artery Disease is Driving the Global Bioresorbable Coronary Stents Market
Coronary artery disease (CAD) is a global health concern affecting millions of people worldwide. It is a condition in which the blood vessels that supply oxygen and nutrients to the heart become narrowed or blocked, leading to reduced blood flow and potentially life-threatening consequences. The management of CAD has seen significant advancements in recent years, and one of the emerging technologies making waves in this field is bioresorbable coronary stents. These innovative medical devices are becoming increasingly popular due to their potential to address some of the limitations of traditional metallic stents.
According to the World Health Organization (WHO), cardiovascular diseases, including CAD, were responsible for approximately 17.9 million deaths globally in 2019, making it the leading cause of death
Coronary stents are small, tube-like devices inserted into narrowed or blocked coronary arteries to keep them open, allowing for improved blood flow to the heart muscle. Traditional stents are typically made of metal, most commonly stainless steel or cobalt-chromium alloys. While these metallic stents have been successful in treating CAD, they have certain drawbacks, including the potential for long-term complications such as in-stent restenosis and the interference they pose with future diagnostic procedures like imaging.
Rising Patient Preference for Minimally Invasive Procedures Growth in Global Bioresorbable Coronary Stents
The preference for minimally invasive procedures has been steadily growing among patients, and this trend is a significant driver behind the increasing adoption of bioresorbable coronary stents. One of the most compelling reasons patients opt for minimally invasive procedures is the quicker recovery time. Compared to traditional open-heart surgeries, procedures involving bioresorbable stents are less invasive and often require shorter hospital stays. Minimally invasive procedures typically cause less pain and discomfort compared to their invasive counterparts. Smaller incisions and less tissue trauma contribute to a more comfortable post-operative experience. Minimally invasive procedures carry a lower risk of complications, such as infection and bleeding, which can be significant concerns with traditional surgeries. Patients can return to their regular activities sooner after minimally invasive procedures, leading to an overall improvement in their quality of life.
The patient preference for minimally invasive procedures aligns perfectly with the unique benefits of bioresorbable coronary stents. As more patients become aware of these advantages, there has been a significant increase in demand for BRS, thereby driving market growth. Patients are increasingly requesting bioresorbable stents, and healthcare providers are responding to this demand by incorporating these devices into their treatment options. Medical device manufacturers are investing in research and development to improve bioresorbable stent designs and materials, further enhancing their safety and effectiveness. Regulatory bodies are actively working to establish guidelines and standards for bioresorbable stents, ensuring their safety and efficacy, which in turn bolsters patient confidence.
Growing Surge in Healthcare Expenditure is Driving the Global Bioresorbable Coronary Stents Market
Healthcare expenditure across the globe has been on the rise for various reasons, including population growth, aging demographics, and the increasing prevalence of chronic diseases like coronary artery disease. Increased healthcare spending enables companies to invest in extensive research and development efforts to create more advanced and effective bioresorbable stents. This leads to the development of superior products with better patient outcomes. The funds allocated for healthcare research often support large-scale clinical trials that provide critical data on the safety and efficacy of bioresorbable stents. These trials are essential for gaining regulatory approvals and expanding market access. As healthcare expenditure increases, more patients have access to advanced medical treatments, including bioresorbable coronary stents. This expands the potential patient pool for these devices and drives market growth. Intensified competition and investment in the bioresorbable coronary stents market encourage innovation and the development of next-generation stent technologies, further enhancing patient care. The surge in healthcare expenditure is not limited to one region but is a global phenomenon. This contributes to the widespread adoption of bioresorbable coronary stents on a global scale.
Key Market Challenges
Efficacy and Safety Concerns
One of the primary challenges in the bioresorbable coronary stents market is ensuring the safety and efficacy of these devices. Clinical trials have raised concerns about the rate of stent thrombosis, which is the formation of blood clots within or around the stent. This issue can lead to life-threatening complications and has prompted questions about the overall safety of bioresorbable stents compared to traditional metallic stents.
Lack of Long-term Data
Long-term data on the performance of bioresorbable coronary stents is limited. While they offer the advantage of being absorbed by the body over time, questions remain about their long-term durability and effectiveness in preventing restenosis (the re-narrowing of arteries). Physicians and patients are often more comfortable with proven metallic stents due to their extensive track record.
Manufacturing Complexity
The production of bioresorbable stents is more complex than that of traditional stents. Ensuring consistency in stent composition, strength, and resorption rates is challenging. Any variability in these factors can impact patient outcomes and lead to regulatory hurdles.
Regulatory Hurdles
The regulatory approval process for bioresorbable stents is rigorous and time-consuming. Manufacturers must demonstrate the safety and effectiveness of these devices through extensive clinical trials. Even minor issues can delay approvals or lead to recalls, which can significantly impact market adoption.
Cost and Reimbursement
Bioresorbable coronary stents tend to be more expensive than traditional metallic stents. This cost difference can be a significant barrier to adoption, especially in regions with limited healthcare budgets. Additionally, securing reimbursement from insurance providers can be challenging, further hindering market growth.
Limited Market Penetration
The adoption of bioresorbable stents has been slower than anticipated due to the challenges mentioned above. Many physicians are hesitant to switch from proven metallic stents to bioresorbable alternatives, and patient awareness about these newer options is often limited.
Competition with Drug-Eluting Stents
Bioresorbable coronary stents face competition from drug-eluting stents, which are metallic stents coated with drugs that help prevent restenosis. These drug-eluting stents have a proven track record and are well-established in the market. Convincing physicians and patients to opt for bioresorbable stents over these tried-and-true devices can be challenging.
Key Market Trends
Technological Advancements
The field of medical technology has seen remarkable advancements in recent years, revolutionizing the way we diagnose and treat various health conditions. One such innovation that has gained significant attention is the development of bioresorbable coronary stents. These innovative medical devices are transforming the way we manage coronary artery disease, and their rapid adoption can be attributed to the continuous technological advancements in the medical industry.
The choice of materials is pivotal in the development of bioresorbable coronary stents. Continuous research into biocompatible and bioresorbable materials has led to the creation of stents that can maintain their mechanical integrity during the initial stages of implantation while subsequently degrading harmlessly. Advancements in material science have contributed significantly to the safety and efficacy of these stents.
Segmental Insights
Brand Insights
Based on the brand, the MeRes-100 segment emerged as the dominant player in the global market for Bioresorbable Coronary Stents in 2022. MeRes-100 is made from a biocompatible polymer called PLLA (Poly-L-Lactic Acid), which has a long history of safe use in medicine. This material gradually dissolves in the body over time, eliminating the need for a permanent implant. After implantation, the MeRes-100 stent provides support to the artery during the initial healing period. As the PLLA gradually breaks down, it allows the artery to regain its natural flexibility and function. This process typically takes about two to three years. Unlike metallic stents, which can remain in the body indefinitely, MeRes-100 minimizes the risk of long-term complications such as inflammation, thrombosis, and restenosis. Patients may require a shorter duration of dual antiplatelet therapy, reducing the burden of medication. MeRes-100 is designed with advanced features to aid in its deployment and post-implantation assessment. Radiopaque markers help physicians precisely position the stent, while the stent's thinner struts provide improved visibility on imaging tests, ensuring proper placement and apposition. The MeRes-100 stent has received regulatory approvals in various countries, making it accessible to a broader range of patients around the world. Clinical studies have shown promising results for the MeRes-100 stent. Patients who received this bioresorbable stent experienced comparable clinical outcomes to those who received traditional metallic stents. Moreover, the reduced need for long-term antiplatelet therapy and the avoidance of potential complications associated with permanent implants make it an appealing choice for both patients and physicians.
End User Insights
The Hospitals & Clinics Based segment is projected to experience rapid growth during the forecast period. Hospitals and clinics are equipped with highly trained medical professionals, including cardiologists and interventional radiologists, who are skilled in performing procedures involving bioresorbable coronary stents. These medical experts are crucial for diagnosing and treating coronary artery disease, which often requires stent implantation. Hospitals and clinics have access to advanced medical equipment and facilities necessary for performing stent implantation procedures. This includes state-of-the-art catheterization labs, operating rooms, and post-operative care units, ensuring safe and effective stent placement. Hospitals and clinics serve as primary points of care for patients with coronary artery disease. Patients often visit these facilities for diagnosis, treatment planning, and follow-up care. This ensures a steady and reliable stream of patients who may require bioresorbable coronary stents. Hospitals and clinics collaborate closely with medical device manufacturers to stay updated on the latest technological advancements and product offerings in the field of bioresorbable coronary stents. They often participate in clinical trials and research studies, helping to drive innovation in this market segment. ospitals, in particular, are well-equipped to handle emergency cases of acute coronary syndrome, where immediate intervention with stents may be necessary to save a patient's life. The availability of 24/7 emergency services in hospitals makes them indispensable for the treatment of such cases.
Regional Insights
North America emerged as the dominant player in the global Bioresorbable Coronary Stents market in 2022, holding the largest market share in terms of value. North America, particularly the United States, boasts a highly developed healthcare infrastructure with state-of-the-art medical facilities, advanced research centers, and a well-established regulatory framework. This infrastructure supports the development, clinical testing, and adoption of innovative medical devices like bioresorbable coronary stents. North American countries invest significantly in biomedical research and development (R&D). This has led to the development of cutting-edge technologies and medical devices, including bioresorbable coronary stents. Collaboration between academic institutions, medical device companies, and healthcare providers fosters innovation in this field. The United States Food and Drug Administration (FDA) has stringent regulatory standards for medical devices, including coronary stents. While this can pose challenges, it also ensures that only safe and effective products reach the market. Companies that can meet these rigorous standards gain a competitive edge and can tap into the large patient population for clinical trials. North America has a well-trained and experienced healthcare workforce, including interventional cardiologists who are familiar with the latest medical technologies. They are more likely to adopt and recommend bioresorbable coronary stents when they become found at.
Recent Developments
- In January 2023, The FDA has granted approval forBiosensors International's BioFreedom Drug Coated Coronary Stent (DCS) System –P190020. This medical device is designed to address the narrowing of coronaryarteries resulting from coronary artery disease. The system comprises acatheter delivery mechanism and a 316L stainless steel stent. The stent iscoated with Biolimus A9 medication and notably lacks any additional componentssuch as polymers or carriers to regulate drug release.
- In July 2023, Lifetech Scientific Corp.'sthree-year, first-in-humans trial demonstrated the safety and effectiveness oftheir fully biodegradable iron-based absorbable coronary scaffold for treatingnon-complex coronary lesions that had not been previously addressed with aninterventional device.
- In September 2022, Chandigarh's PGI has achieved agroundbreaking milestone by conducting the world's inaugural robot-assistedimplantation of a bioresorbable stent with great success.
- In March 2020, the National Pharmaceutical PricingAuthority (NPPA) granted a five-year exemption to Meril Life Sciences under the"Drug Price Control Order 2013" clause, relieving them from pricerestrictions. The authorities requested Meril Life Sciences to provideinformation regarding the pricing they plan to set for the stent.
Key Market Players
- Boston Scientific Corporation
- Medtronicplc
- AbbottLaboratories ltd.
- STENTYSS.A.
- Cordiscorporation
- Biotronikinc.
- LepuMedical Technology (Beijing) Co., Ltd.
- CookIndia Medical Devices Pvt. Ltd
- XTENTInc.
- KyotoMedical Planning Co., Ltd
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