VASCULAR CLOSURE DEVICE MARKET ANALYSIS

The global vascular closure device market size is expected to reach US$ 1,943.2 Mn by 2030, from US$ 1,283.8 Mn in 2023, at a CAGR of 6.1% during the forecast period.

Vascular closure devices are medical instruments used to achieve hemostasis of the femoral artery puncture site at the completion of a catheterization procedure. There are generally two main types of vascular closure devices: passive and active. Passive closure devices utilize the body's natural clotting response to achieve hemostasis. Examples include compression devices like manual pressure, sandbags, and bandages, which apply direct pressure to the puncture site. Active closure devices, on the other hand, provide a mechanical or procedural means to close and seal the puncture site. Examples include suture-based devices like the Angio-Seal, which deploys a collagen sponge anchor tethered to an ultra-thin suture that seals the hole from inside the artery. Other active devices use collagen plugs, like the per close ProGlide, which delivers a pre-loaded absorbable polyglycolic acid plug to the puncture site to promote clot formation and healing. While passive closure with manual compression is the traditional approach, active closure devices have gained popularity due to their ability to achieve hemostasis faster without the need for prolonged bed rest. This translates to reduced time for ambulation, a shortened hospital stay, and increased patient comfort and satisfaction. However, active closure also carries risks like infection, collapsing of the artery, or failure to properly seal the puncture site, which can result in bleeding complications. The choice of closure depends on the patient's risk factors, arteriotomy size, and physician preference.

Global Vascular Closure Device Market Regional Insights:

• North America is expected to dominate the global vascular closure device market over the forecast period owing to the presence of major players and advanced healthcare infrastructure in the region. The U.S. accounts for the largest share of the North American market due to factors such as the high demand for minimally invasive surgeries and rapid adoption of new technologies among medical professionals. Major brands, along with continuous investments in research & development (R&D), have enabled companies to roll out innovative product lines catering to local needs and physician preferences. This has reinforced the region's position as one of the most lucrative markets globally. However, patent expirations and pricing pressures from payers are some challenges companies may face going forward.
• Asia Pacific region is expected to second largest market for the global vascular closure device market during the forecast period. Increasing healthcare expenditures have boosted market opportunities. The growing awareness among patients regarding benefits of interventional procedures over open surgeries is another key factor propelling the market ahead. China dominates Asia Pacific due to its huge patient population and favorable government policies to modernize healthcare infrastructure. India is also witnessing significant market expansion backed by rising medical tourism, low manufacturing costs, and presence of global medtech leaders. While lack of skilled professionals and stringent regulatory processes still pose challenges, the future outlook for Asia Pacific appears bright.
• The Europe Passive vascular closure devices sub segment currently leads the vascular closure device market in Europe. Passive devices rely on natural wound healing processes to achieve hemostasis and do not require an active activation step. This keeps the surgical procedure simple without adding complexity. As the majority of vascular access procedures in Europe are performed via the femoral route, passive devices are well-suited for femoral artery closures.

Analyst View: The vascular closure device market is poised to grow at a steady pace over the next five years. The rising prevalence of cardiovascular diseases and increasing number of cardiovascular interventions are the major drivers propelling the demand for vascular closure devices. As more minimally invasive procedures are performed, the need for reliable devices to achieve hemostasis will continue to rise. North America currently dominates the vascular closure device market owing to the high adoption of advanced medical technologies and availability of favorable reimbursement policies in the region. However, Asia Pacific is expected to be the fastest-growing market as countries like China and India significantly ramp up spending on healthcare and modernize their healthcare infrastructures. While improved reimbursement and rising awareness about newer technologies present significant opportunities, inadequate clinical evidence sometimes poses a challenge for widespread adoption of certain novel devices. Product recalls and safety concerns also act as a restraints at times. High device costs further restrict market potential in price-sensitive developing regions. Device manufacturers should focus on further innovations to introduce safer, simple to use, and more effective products. Gaining regulatory approvals in Asia and other emerging markets early will help companies leverage future growth opportunities. Developing strong partnerships with hospitals and physicians is also crucial for vascular closure device companies to solidify their presence.

 Figure 1. Global Vascular Closure Device Market Share (%), by Region, 2023

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Global Vascular Closure Device Market Drivers:

• Rising geriatric population: Rising geriatric population globally is a significant factor fueling the growth of the global vascular closure devices market. As people age, they are more predisposed to a host of health issues, including an elevated risk of cardiovascular diseases (CVDs) such as coronary artery disease, peripheral vascular disease, and stroke. These conditions often necessitate diagnostic and therapeutic interventions like angiography and angioplasty, where vascular closure devices (VCDs) are crucial for post-procedure care. VCDs enable the rapid and effective closure of the arterial puncture site following catheterization procedures. For the elderly, who may face prolonged clotting times and other comorbidities, these devices are particularly beneficial as they can minimize complications related to bleeding, reduce the time to hemostasis, and subsequently reduce the length of hospital stays. Moreover, in the case of the geriatric population, minimally invasive procedures that use VCDs are desirable due to their reduced impact on the patient's body, leading to better outcomes and reduced recovery time. Given the higher susceptibility to complications among older adults, the convenience and efficiency offered by VCDs are crucial. This demographic shift presents a strong opportunity for the market's expansion, with an increasing volume of surgical interventions among this age group driving demand for VCDs. To address this growing market segment, manufacturers may focus on developing devices that are tailored to the needs of geriatric patients, ensuring safety and ease of use. Monitoring the evolving healthcare needs and preferences of this population will therefore be critical for market players looking to stay ahead in the competitive landscape of vascular closure devices. For instance, in 2020, the globally aged 60 years and older outnumbered children younger than 5 years. Between 2015 and 2050, the proportion of the world's population over 60 years will nearly double from 12% to 22%. The share of the population aged 60 years and over will increase from 1 million in 2020 to 1.4 million. By 2050, the world’s population of people aged 60 years and older will double (2.1 million). The number of people aged 80 years or older is expected to triple between 2020 and 2050 to reach 426 million.
• The proliferation of angioplasty procedures: The proliferation of angioplasty procedures is a key driver for the global vascular closure devices market. Angioplasty, a procedure used to open clogged heart arteries, is a common treatment for ischemic heart disease, which remains one of the leading causes of morbidity and mortality The demand for these procedures is on the rise, thanks to an increasing prevalence of cardiovascular diseases fueled by lifestyle factors such as unhealthy diets, lack of physical activity, and smoking, as well as the aging population. In angioplasty, vascular closure devices (VCDs) are essential as they offer fast and secure closure of the arterial puncture site. This is crucial, as it can significantly reduce the time required for hemostasis, the time to ambulation, and the overall length of hospital stays, thereby increasing hospital throughput and efficiency, which is beneficial economically for both hospitals and patients. The benefits of VCDs in terms of patient comfort and reduced complications, such as bleeding, hematoma, and pseudoaneurysm, have also been recognized by healthcare practitioners, further supporting their adoption. In addition to these clinical benefits, VCDs also play an important role in enabling patients to recover more rapidly, which is a vital factor in patient-centered care. With advancements in interventional cardiology, angioplasty procedures are becoming more complex, often involving large-bore catheters, which necessitate the use of specialized VCDs. The development of VCDs that are compatible with such procedures is expected to create new opportunities within the market. Moreover, as healthcare systems continue to evolve, there is a push towards reducing hospital readmission rates and improving clinical outcomes. Effective vascular closure devices are seen as a vital tool in achieving these goals, thus, manufacturers are focusing on innovation to cater to the growing needs of the healthcare sector. In conclusion, the rise in angioplasty procedures is indeed propelling the vascular closure devices market, and it is anticipated that this will continue to be a prominent growth factor in the coming years.
• The increasing prevalence of in cardiovascular disease (CVD) incidence: The increasing prevalence of cardiovascular disease (CVD) incidence globally is a significant factor driving the demand for vascular closure devices. The growth in the number of patients undergoing angiographic procedures, such as angioplasty, is directly proportional to the prevalence of cardiovascular conditions like coronary artery disease, stroke, heart failure, and peripheral arterial disease. These conditions often require diagnostic and interventional procedures that necessitate puncturing of blood vessels, where vascular closure devices (VCDs) are crucial. VCDs offer several advantages in post-procedural care by providing immediate hemostasis, reducing time to ambulation, and leading to improved patient outcomes. They mitigate potential complications, such as bleeding at the puncture site, which can lead to prolonged hospital stays and increased healthcare costs. Furthermore, as patients seek shorter recovery times and reduced hospitalization, VCDs align well with these preferences, supporting less invasive procedures with quicker recovery. The demand is also supported by the rise in minimally invasive surgeries being performed, which are becoming the standard of care for many cardiovascular interventions. Providers prefer these devices over traditional manual compression as they can significantly reduce the time required for the artery to close, ultimately leading to increased patient turnover and more efficient use of healthcare resources. To meet this growing demand, manufacturers are focusing on innovation, creating devices that are easier to use, more efficient, and compatible with various vascular procedures. The development of advanced materials and techniques also promises to enhance the safety profiles of these devices. However, as a market research analyst, it's crucial to monitor potential market restraints such as the availability of alternative wound closure methods, costs associated with VCDs, and reimbursement scenarios that vary across different regions. Considering these dynamics, it's evident that the increasing incidence of cardiovascular diseases is a primary driver for the vascular closure devices market, as they directly influence the volume of relevant surgical procedures performed. To capitalize on this growing market, manufacturers will need to focus on innovation, addressing cost and reimbursement challenges, and aligning with the trends in healthcare towards less invasive and more patient-centered care.
• Increasing demand for minimally invasive surgeries: The increasing demand for minimally invasive surgeries (MIS) is definitely a key factor propelling the global vascular closure device market forward. As healthcare continues to advance towards techniques that emphasize patient comfort and reduce recovery time, MIS has become increasingly popular. This trend has a direct positive impact on the VCD market, as these devices are integral to many minimally invasive cardiovascular procedures. During MIS, VCDs are used to close the small puncture made in the artery, typically in the groin or wrist, through which catheters and other devices are inserted. They offer a safer and more comfortable alternative to traditional methods, such as manual compression, by promoting faster hemostasis and reducing the risk of access site complications, like bleeding or hematoma formation. This enables patients to mobilize sooner and potentially results in shorter hospital stays and less post-procedural care. In addition to improving patient outcomes, VCDs aid hospitals in increasing procedural efficiency. By reducing the time clinicians spend managing the puncture site post-procedure, these devices enable healthcare professionals to treat more patients in less time, thereby optimizing the utilization of hospital resources. The increasing prevalence of cardiovascular diseases further underscores the need for efficient and effective MIS, which in turn drives the demand for VCDs. As technology continues to evolve, manufacturers are developing a wider range of VCDs to cater to various patient anatomies and procedural requirements. Overall, the convergence of the MIS trend with the growth in cardiovascular conditions presents a robust opportunity for the expansion of the VCD market. To maximize this potential, continuous innovation and awareness of reimbursement landscapes are essential, as these factors will significantly influence the adoption rate and market growth.

Global Vascular Closure Device Market Opportunities:

• Emerging economies with large patient pools: Emerging economies in the Asia Pacific and Latin America regions indeed represent key opportunities for the global vascular closure device market. These regions are witnessing substantial growth in healthcare infrastructure, increased healthcare spending, and a rising prevalence of lifestyle-related diseases that contribute to the incidence of cardiovascular conditions. As economies like China, India, Brazil, and others continue to develop, there is a growing middle class with greater access to healthcare services and increased willingness to invest in health. Moreover, governments in these regions are focusing on healthcare reform and upgrading medical facilities, which contributes to the heightened demand for advanced medical devices, including VCDs. Additionally, the healthcare systems in these countries are becoming more sophisticated, with an increasing number of hospitals and clinics that can perform complex cardiovascular procedures. This expansion is being accompanied by a growing cohort of healthcare professionals trained in interventional cardiology, further facilitating the adoption of VCDs. Pharmaceutical and medical device companies are recognizing the potential in these markets and are investing in establishing a strong presence. Companies are setting up distribution agreements, creating educational programs for local healthcare professionals, and undertaking clinical studies tailored to these populations. However, to successfully penetrate these markets, companies must navigate a diverse regulatory landscape and develop pricing strategies that reflect the economic realities and reimbursement environments of each country. Business models that incorporate partnerships with local entities and adapt products to meet regional needs are likely to thrive. Considering these factors, the evolving healthcare environments in emerging economies of the Asia Pacific and Latin America are ripe with opportunities for growth in the market. Focused attention on these regions, along with tailored market strategies, can enable companies to leverage the enormous potential presented by the expanding patient base and increasing healthcare capabilities.
• The Increasing healthcare expenditure: Increasing healthcare expenditure is a powerful driver for the global vascular closure device market. As countries around the world allocate more resources to their healthcare systems, this financial influx helps to improve healthcare infrastructure, expand the availability of medical services, and increase access to advanced medical technologies, including VCDs. Greater healthcare spending often correlates with better access to quality care, and this is particularly relevant for the treatment of cardiovascular diseases, which remain a leading cause of death globally. Investment in healthcare can lead to the acquisition of advanced medical devices, training of healthcare professionals, and improved patient care pathways. In countries with rising healthcare budgets, both public and private hospitals may be more inclined to invest in VCDs, which can streamline the management of vascular access sites after procedures like angiography or percutaneous coronary intervention (PCI). The use of VCDs helps to reduce time to hemostasis, patient recovery time, and overall treatment costs by shortening hospital stays and reducing the need for additional medical intervention due to complications. Moreover, as out-of-pocket healthcare expenditures decrease due to better funding of health services, patients may be more likely to undergo necessary medical procedures, which would further drive the demand for VCDs. This is especially important in emerging markets, where an increase in disposable income and healthcare funding is making previously unaffordable treatments more accessible. From a market perspective, companies could leverage increasing healthcare investments by aligning with government initiatives that aim to improve cardiovascular care, forming partnerships with healthcare providers, and working on cost-effective solutions that do not compromise on quality and safety. With this knowledge, companies can better strategize capitalizing on increasing healthcare expenditures to drive the market.
• New product launches: New product launches are a significant opportunity that can drive the global vascular closure device market. As clinical needs evolve and technological advancements occur, manufacturers that innovate and introduce new VCDs can gain a competitive edge and tap into unmet medical demands. The introduction of new products often comes with improved features such as enhanced safety profiles, greater efficacy, easier usability, and reduced complication rates. Additionally, new VCDs may cater to a broader range of procedures, including support for complex interventions involving large-bore sheaths or catering to patients with different anatomical challenges. When a new product is introduced, it not only enhances the treatment options available to clinicians but also provides an opportunity for medical facilities to improve their standard of care. This can lead to better patient outcomes and potentially lower the overall cost of cardiovascular care by reducing procedure time, hospital stay duration, and incidence of post-procedure complications. Moreover, with each innovative product, manufacturers can expand their market presence and establish a reputation as a leader in the market. This can be particularly advantageous when establishing relationships with emerging markets, where healthcare infrastructure is improving, and the demand for quality medical devices is increasing. Constant innovation and refreshment of product lines also help in satisfying the regulatory requirements that may change over time, ensuring compliance with the latest safety standards. In an industry where regulations are stringent and patient safety is paramount, staying updated with the latest trends and technology is crucial. From a strategic standpoint, companies in the market should invest in robust research and development (R&D) to facilitate the continuous introduction of differentiated products. They must also maintain vigorous engagement with regulatory bodies to ensure smooth approval processes and align their products with professional medical guidelines and standards of practice. In summary, new product launches are indeed a key opportunity to catalyze growth within the vascular closure devices market, leading to expanded options for healthcare providers and improved care for patients undergoing vascular procedures.

Global Vascular Closure Device Market Trends:

• The utilization of bioabsorbable vascular closure devices: The utilization of bioabsorbable vascular closure devices is emerging as a significant trend and represents a promising opportunity within the market. These devices, which are designed to be absorbed by the body over time, are gaining attention for their potential to reduce the risk of infection, minimize inflammation, and improve patient comfort compared to non-absorbable counterparts. Bioabsorbable VCDs are made from materials that the body can naturally break down and resorb, eliminating the need for a secondary procedure to remove the device. This characteristic is particularly beneficial for patients as it simplifies the post-procedural care and may lead to better long-term outcomes. Moreover, since there is nothing left behind in the body, the chances of chronic foreign body reactions are significantly reduced. The development and utilization of these bioabsorbable devices are in line with the broader movement towards more biocompatible medical implants and represent the intersection of material science innovation with clinical application. As stakeholders in healthcare continue to prioritize patient safety and quality of care, bioabsorbable VCDs align well with these goals, helping to advance the standard of treatment in interventional cardiology. These companies will likely benefit from the trend towards more biocompatible and patient-friendly medical devices. For market expansion, it's imperative to not only innovate but also to educate healthcare providers about the benefits and proper usage of these advanced devices. Moreover, regulatory clearances and favorable reimbursement scenarios will play pivotal roles in the adoption of bioabsorbable VCDs across various healthcare systems .In summary, the emergence of bioabsorbable vascular closure devices is a key trend that stands to significantly impact the market by addressing patient comfort, reducing complications, and supporting the broader shift towards more minimally invasive and patient-friendly medical treatments.
• The adoption of hybrid closure procedures: The adoption of hybrid closure procedures is indeed an emerging trend that can drive the global vascular closure device market. Hybrid closure procedures involve the use of multiple techniques or devices to achieve efficient and secure closure of the arterial puncture site after cardiovascular This can include a combination of passive and active closure approaches or integrating different types of technologies to enhance the procedure's success rate and patient outcomes. Hybrid procedures strive to combine the benefits of various closure methods to optimize hemostasis while minimizing the risk of vascular complications, such as bleeding or arterial occlusion. They are particularly significant for complex cases where a single-method approach may not be sufficiently effective or safe. For instance, a surgeon might use a VCD in conjunction with manual pressure or a topical hemostasis pad to ensure a blood-free and secure closure. This trend is driven by a continuous effort to improve patient care and reduce the cost burden of post-operative complications. As the healthcare industry progresses, there is a greater appreciation for personalized medicine, which involves tailoring medical treatments to the individual characteristics of each patient. Hybrid closure procedures can be seen as aligning with this philosophy, offering versatility to address varying patient anatomies and conditions. Manufacturers are recognizing this trend and are likely to invest in product innovations that can cater to hybrid procedural approaches. By providing a suite of complementary products, companies can position themselves as complete solution providers rather than as vendors of a single device type. The rise of hybrid closure procedures highlights the need for ongoing research and training for clinicians to understand the nuances of various VCDs and their synergistic applications. Moreover, with this trend gaining traction, the market has the potential for increased demand, encouraging further investment in the development and improvement of associated VCD technologies. Keeping an eye on this trend will be essential for market research, as the adoption of hybrid closure procedures represents both a significant opportunity for growth and a shift towards more comprehensive, patient-specific cardiovascular care.

Global Vascular Closure Device Market Restraints:

• The alternative closure methods: Alternative closure methods can pose significant competition. Manual compression remains the most common and conventional method for achieving hemostasis after a cardiovascular procedure. It is a low-cost option that does not require the use of additional devices, which can be appealing, especially in healthcare settings that have budget constraints or where the cost-effectiveness of VCDs is not clearly established. Additionally, the market also sees competition from topical hemostasis agents, these agents can include gels, patches, or pads that promote clotting at the site of arterial access and are relatively easy to use. There are also alternative mechanical devices that can offer cost advantages over more advanced VCDs and can be viewed as sufficient for achieving closure without the associated costs of newer technologies. Furthermore, the potential reluctance to adopt new technologies due to a lack of familiarity, training concerns, or uncertainty regarding clinical benefits compared to established methods can hamper the growth of VCDs. Moreover, while VCDs generally reduce time to ambulation and improve patient comfort, should issues arise related to the efficacy or safety profile of VCDs, this could also drive preference back to manual methods or alternative closure approaches. Understanding these market dynamics is crucial for VCD manufacturers. They need to clearly communicate the benefits of their products, offer competitive pricing, and provide adequate training to healthcare professionals. Additionally, they must demonstrate through clinical evidence that VCDs offer superior patient outcomes and healthcare efficiency to justify their adoption over alternative methods. Balancing innovation with cost and market education will therefore be essential in navigating the challenges posed by alternative closure methods and ensuring the sustained growth of the market.
• The potential risk of complications associated with vascular closure device (VCD) procedures: The potential risk of complications associated with vascular closure device (VCD) procedures can pose a challenge to the market's growth. Complications, though relatively infrequent, can range from minor issues such as hematoma, bleeding, and discomfort at the access site, to more serious adverse events such as vascular injury, infection, pseudoaneurysm, or arterial occlusion. Such complications, if they occur, can lead to patient discomfort, prolonged hospitalization, additional treatments, and increased healthcare costs. They can also influence the perception of VCDs among healthcare providers and patients, impacting the acceptance and use of these devices In doing so, the market can not only overcome this barrier but also accelerate the adoption of VCDs as a standard part of post-angiography and angioplasty care.

Recent Developments:

New product launches & Approval:

• On September 6, 2023, Boston Scientific Corporation, a medical device company, announced it had received U.S. Food and Drug Administration approval for the latest-generation WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device.
• In September 2022, Haemonetics Corporation, a global medical technology company, announced it had earned Conformité Européenne (CE) mark certification for its VASCADE vascular closure and VASCADE MVP venous vascular closure systems. The CE marking will allow Haemonetics to engage in the next steps of country-specific entrance of both products into the European Union (EU) and form the basis for entry into other geographies that recognize CE marking.
• In May 2022, Teleflex Incorporated, a leading global provider of medical technologies, announced that it received Health Canada approval for the MANTA Vascular Closure Device, the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure. This approval provide opportunity in the regulatory plan to expand the availability of the MANTA Device globally and provides access to another uniquely designed device from Teleflex for Canadian clinicians.

Acquisition, Collaboration and partnerships:

• On November 30, 2023, Johnson & Johnson Service Inc., a biotechnology company, announced the completion of the acquisition of Laminar, Inc., a privately held medical device company focused on eliminating the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AFib).

Figure 2. Global Vascular Closure Device Market Share (%), by Product Type, 2023

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Top companies in Vascular Closure Device Market:

• Abbott
• Cardiva Medical Inc.
• Terumo Corporation
• Johnson & Johnson Services Inc.
• Braun SE
• Biotronik SE & Co. KG
• MicroPort Scientific Corporation
• ConforMIS, Inc.
• Medtronic
• Transluminal Technologies LLC
• Cardinal Health
• Teleflex Incorporated
• Vasorum Ltd.
• Tricol Biomedical
• Merit Medical Systems, Inc.
• Stryker

Definition:

A vascular closure device (VCD) is a medical device used to achieve hemostasis of the small puncture made in the vessel wall after procedures such as angiography, angioplasty, or other interventional procedures where percutaneous access is used. Rather than achieving closure through traditional manual compression over the puncture site, VCDs are designed to seal or close the arterial puncture site immediately, allowing for quicker hemostasis, faster patient recovery, reduced time to ambulation (the ability for the patient to walk post-procedure), and improved overall patient comfort.

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