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市場調查報告書
商品編碼
1558350
2030 年血管閉合裝置市場預測:按產品、接取模式、應用、最終用戶和地區進行的全球分析Vascular Closure Devices Market Forecasts to 2030 - Global Analysis By Product, Access Mode, Application, End User and By Geography |
根據 Stratistics MRC 的數據,2024 年全球血管閉合裝置市場規模為 13 億美元,預計在預測期內將以 8.3% 的複合年成長率成長,到 2030 年達到 21 億美元。血管閉合裝置 (VCD) 是一種用於密封或閉合血管穿孔的醫療裝置,通常在血管造影術或經皮冠狀動脈介入治療等導管手術後使用。這些裝置對於最大限度地減少出血、減少併發症以及透過加速穿刺部位的止血來加速恢復至關重要。 VCD 透過多種機制運行,包括機械壓縮、組織黏合劑以及專用塞子或補片的部署。 VCD透過有效阻斷血管入口,預防血腫、出血、感染疾病等併發症,讓患者更快恢復正常活動。
據英國心臟基金會稱,到 2024 年,全球將有約 6.2 億人患有心臟或循環系統疾病。根據醫療保險和醫療補助服務中心(CMS.gov)的資料,2023年,美國將在醫療保健方面支出約4.7兆美元,佔國民經濟的18%。
人們越來越偏好微創治療
人們對微創手術的日益偏好正在推動血管閉合裝置 (VCD) 的進步。 VCD 對於基於導管的干涉後有效閉合通路部位至關重要。隨著醫療保健轉向微創手術以加快患者康復時間並最大限度地減少併發症,VCD 正在不斷發展以滿足這些需求。現代 VCD 透過使用先進的材料和技術來確保快速、安全地閉合血管網路基地台,從而提高安全性、有效性和患者舒適度。這一趨勢反映了醫學領域更廣泛的趨勢,即採用更小切口、更少疼痛和更快恢復正常活動的手術。
臨床風險和併發症
血管閉合裝置 (VCD) 旨在在基於導管的手術後閉合股動脈通路部位,目的是最大限度地減少出血並加速康復。 VCD 的使用與臨床風險和併發症相關,阻礙了其有效性。主要風險包括感染、血腫形成、血管損傷,可導致肢體缺血、血栓症等併發症。也可能存在與設備相關的問題,例如密封不充分或設備移位,這可能導致出血或動脈損傷。
心血管手術增加
隨著血管成形術和支架置入術等手術的增加,對高效、安全和有效的 VCD 的需求正在迅速增加。現代VCD旨在快速止血,減少出血和感染等併發症,縮短復原時間。 VCD 技術的創新包括改進材料以實現更好的組織密封、提高臨床醫生的易用性以及適應各種血管通路部位的設計。這些進步不僅加快了患者的康復速度,還提高了手術效率,並解決了介入心臟病學增加的複雜性和頻率。
智慧財產權挑戰
由於智慧財產權(IP)問題,血管閉合裝置(VCD)產業面臨重大挑戰。專利糾紛和限制性智慧財產權主張可能會阻止新參與企業開發和銷售自己的設備,從而阻礙創新。現有公司通常持有涵蓋基礎技術的廣泛專利,為新興企業和其他競爭對手設置了障礙。這種情況可能會導致昂貴的法律訴訟並轉移研發資源。嚴格的智慧財產權法規可能會減緩新的、可能更好的設備進入市場的速度,並限制患者照護的進步。結果,市場受到限制,創新放緩,醫療設備成本居高不下,影響了患者的取得和治療選擇。
由於選擇性手術的中斷和醫療保健優先事項的變化,COVID-19 大流行對血管閉合裝置 (VCD) 市場產生了重大影響。由於世界各地的醫院都專注於治療新冠肺炎 (COVID-19)嚴重病例,許多非緊急手術,包括需要血管通路的手術,被推遲或取消。這暫時減少了對 VCD 的需求,VCD 用於在導管手術後關閉動脈通路部位。供應鏈中斷和限制影響了這些儀器的生產和分銷。這次疫情也加速了遠端和微創診斷技術的採用,進一步影響了 VCD 的傳統使用。
預計主動逼近器部分在預測期內將達到最大
預計主動逼近器領域在預測期內將是最大的。主動接近器顯著提高了血管閉合裝置的有效性和易用性,從而徹底改變了血管閉合裝置。這些先進的設備利用動態機制來確保導管插入後留下的穿刺部位閉合。與依賴靜壓或手動操作的傳統被動方法不同,主動逼近器施加受控且可調節的力來精確對準和密封血管開口。這項創新可以實現可靠的閉合,同時最大限度地減少出血和感染等併發症。
預計腦血管介入領域在預測期內複合年成長率最高
預計腦血管介入領域在預測期內複合年成長率最高。腦血管介入領域的重點是提高血管閉合的準確性、降低併發症發生率、縮短恢復時間。現代 VCD 具有創新功能,例如改進的止血劑和適應性閉合機制,以改善進入部位的密封性並最大限度地減少對周圍組織的創傷。此外,結合即時影像和先進的追蹤系統可以實現更精確的設備放置和監控。
由於最尖端科技的整合、醫療培訓的改善、監管流程的簡化等,歐洲地區在預測期內佔據最大的市場佔有率。先進的 VCD 對於導管插入術等手術後密封動脈穿刺至關重要,該全部區域醫療保健設施和研究的投資正在增加。增強的基礎設施正在促進全部區域創新設備的開發和部署,從而提供更高的準確性、安全性和患者舒適度。配備最先進工具和設備的醫院和診所將能夠更有效地利用這些先進的 VCD,從而改善手術結果並縮短恢復時間。這些因素正在推動區域成長。
由於採用血管閉合裝置(VCD)並確保嚴格的安全性和有效性標準,預計歐洲地區在預測期內將顯著成長。歐盟的法規結構,包括醫療設備法規 (MDR) 和體外診斷法規 (IVDR),要求對這些設備進行嚴格的臨床評估、品管措施和上市後監督。這種監管監督透過要求製造商遵守高標準、推動技術進步和改善整個全部區域的患者治療結果來促進創新。
According to Stratistics MRC, the Global Vascular Closure Devices Market is accounted for $1.3 billion in 2024 and is expected to reach $2.1 billion by 2030 growing at a CAGR of 8.3% during the forecast period. Vascular closure devices (VCDs) are medical instruments designed to seal or close punctures in blood vessels, typically following catheter-based procedures like angiography or percutaneous coronary interventions. These devices are crucial for minimizing bleeding, reducing complications, and expediting recovery by facilitating faster hemostasis at the puncture site. VCDs operate through various mechanisms, including mechanical compression, tissue adhesives, or the deployment of specialized plugs or patches. By effectively sealing the vascular entry point, VCDs help prevent complications such as hematomas, bleeding, or infections, and allow patients to resume normal activities more quickly.
According to the British Heart Foundation, in 2024, there are around 620 million people living with heart and circulatory diseases across the world. According to the data by Centers for Medicare and Medicaid Services (CMS.gov) shows that in 2023, the U.S. spent approximately USD 4.7 trillion on healthcare, constituting 18% of the national economy.
Growing preference for minimally invasive procedures
The increasing preference for minimally invasive procedures is driving advancements in Vascular Closure Devices (VCDs), which are crucial for efficiently closing access sites after catheter-based interventions. As healthcare shifts towards less invasive techniques to reduce patient recovery times and minimize complications, VCDs are evolving to meet these demands. Modern VCDs offer improved safety, efficacy, and patient comfort by using advanced materials and technologies to ensure rapid and secure closure of vascular access points. This trend reflects a broader movement in medicine towards procedures that involve smaller incisions, less pain, and quicker returns to normal activities.
Clinical risks and complications
Vascular Closure Devices (VCDs) are designed to close femoral artery access sites after catheter-based procedures, aiming to minimize bleeding and expedite recovery. Their use carries clinical risks and complications that can impede their effectiveness. Key risks include infection, hematoma formation, and vascular injury, which can lead to complications like limb ischemia or thrombosis. There is also the potential for device-related issues such as inadequate sealing or device migration, which can cause bleeding or arterial damage.
Rise in cardiovascular procedures
As the volume of procedures like angioplasty and stent placements rises, the demand for efficient, safe, and effective VCDs has surged. Modern VCDs are designed to provide faster hemostasis, reduce complications such as bleeding and infection, and shorten recovery times. Innovations in VCD technology include improved materials for better tissue sealing, enhanced ease of use for clinicians, and designs that accommodate various vascular access sites. These advancements not only facilitate quicker patient recovery but also enhance procedural efficiency, aligning with the growing complexity and frequency of cardiovascular interventions.
Intellectual property challenges
The vascular closure device (VCD) industry faces significant challenges due to intellectual property (IP) issues. Patent disputes and restrictive IP claims can stifle innovation by preventing new entrants from developing or marketing their own devices. Established companies often hold broad patents that cover fundamental technologies, creating barriers for startups and other competitors. This situation can lead to expensive legal battles, which divert resources away from research and development. Stringent IP regulations can delay the introduction of new, potentially better devices to the market, limiting advancements in patient care. The result is a constrained market where innovation is slowed, and the cost of devices may remain high, impacting accessibility and treatment options for patients.
The COVID-19 pandemic significantly impacted the vascular closure devices (VCDs) market due to disruptions in elective procedures and a shift in healthcare priorities. As hospitals worldwide focused on managing severe COVID-19 cases, many non-urgent procedures, including those requiring vascular access, were postponed or canceled. This led to a temporary decline in demand for VCDs, which are used to close the arterial access site after catheter-based procedures. Supply chain disruptions and restrictions affected the production and distribution of these devices. The pandemic also accelerated the adoption of remote and less invasive diagnostic techniques, further impacting the traditional usage of VCDs.
The Active Approximators segment is expected to be the largest during the forecast period
Active Approximators segment is expected to be the largest during the forecast period. Active approximators are revolutionizing vascular closure devices by significantly improving their efficacy and ease of use. These advanced devices utilize dynamic mechanisms to securely close the puncture site left after catheterization procedures. Unlike traditional passive methods that rely on static pressure or manual manipulation, active approximators apply controlled, adjustable forces to precisely align and seal the vascular opening. This innovation enhances the device's ability to achieve a reliable closure with minimal complications, such as bleeding or infection.
The Cerebrovascular Interventions segment is expected to have the highest CAGR during the forecast period
Cerebrovascular Interventions segment is expected to have the highest CAGR during the forecast period. Cerebrovascular Interventions segment focus on increasing the precision of vascular closure, reducing complication rates, and shortening recovery times. Modern VCDs are designed with innovative features such as improved hemostatic agents and more adaptable closure mechanisms, which ensure better sealing of the access site and minimal trauma to surrounding tissues. Additionally, the incorporation of real-time imaging and advanced tracking systems allows for more accurate device placement and monitoring.
Europe region commanded the largest market share over the extrapolated period driven by the integration of cutting-edge technologies, improved medical training, and streamlined regulatory processes. Advanced VCDs, which are crucial for sealing arterial punctures after procedures like catheterizations, are benefiting from increased investment in healthcare facilities and research across the region. Enhanced infrastructure facilitates the development and deployment of innovative devices that offer greater precision, safety, and patient comfort throughout the region. Hospitals and clinics equipped with state-of-the-art tools and facilities can more effectively utilize these advanced VCDs, leading to improved procedural outcomes and reduced recovery times. These elements are boosting the regional growth.
Europe region is projected to witness substantial growth during the forecast period due to the adoption of Vascular Closure Devices (VCDs) by ensuring stringent safety and efficacy standards. The European Union's regulatory framework, including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), mandates rigorous clinical evaluations, quality control measures, and post-market surveillance for these devices. This regulatory oversight fosters innovation by encouraging manufacturers to adhere to high standards, thus driving advancements in technology and improving patient outcomes across the region.
Key players in the market
Some of the key players in Vascular Closure Devices market include Abbott Laboratories, Boston Scientific Corporation, Cardinal Health, Inc, Endologix, Inc, GE Healthcare, HeartWare International, Inc, Medtronic PLC, Nipro Corporation, Stryker Corporation and Terumo Corporation.
In June 2024, Haemonetics Corporation has announced the launch of its new VASCADE MVP XL mid-bore venous closure device. The VASCADE MVP XL system adds to Haemonetics VASCADE line of vascular closure devices by using novel collapsible disc technology with a patented resorbable collagen patch that promotes fast hemostasis.
In November 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).
In February 2023, the LockeT product was introduced to the market by Catheter Precision, Inc., a wholly-owned subsidiary of Ra Medical Systems, Inc. The first shipments of the product to its distributors will start right away. When a catheter is inserted through the skin into a blood artery and subsequently removed after an operation, LockeT can be utilized in combination with the closure of the percutaneous wound site.