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无引线空间製造商全球市场规模、份额、产业趋势分析报告:2023-2030 年按类型、最终用途、地区分類的展望与预测Global Leadless Pacemakers Market Size, Share & Industry Trends Analysis Report By Type (Micra Transcatheter Pacing System, and Others), By End-use (Hospitals, and Outpatient Facilities), By Regional Outlook and Forecast, 2023 - 2030 |
到 2030 年,无引线太空船市场规模预计将达到 8.277 亿美元,预测期内市场CAGR率为 15.2%。
根据 KBV Cardinal 矩阵中发布的分析,美敦力公司 (Medtronic PLC) 和雅培实验室 (Abbott Laboratories) 是市场上的领先参与者。波士顿科学公司、Integer Holdings Corporation 和 Terumo Corporation 等公司是该市场的主要创新者。 2023 年 9 月,波士顿科学公司宣布收购Lillyvant Medsystems,这是一家专门从事脊椎疼痛治疗的私人医疗设备公司。此次收购将 Relievant Medsystems 经临床验证的技术与 Boston Scientific 的策略相结合,为需要个人化医疗的个人扩大了治疗选择。
COVID-19 的影响
疫情期间,许多医院和医疗机构推迟或取消了择期手术,以节省资源并降低病毒传播的风险。因此,无引线起搏器植入术已经减少,因为它通常被认为是一种选择性的、非紧急的手术。包括无引线起搏器在内的医疗设备的全球供应链因製造和运输的封锁和限製而受到干扰。这有可能延迟医疗设备的供应并阻止患者获得这些尖端技术。医疗保健提供者已指示资源和工作人员应对 COVID-19 病例激增的情况。这种对非新冠疫情卫生服务的注意力和资源的转移影响了无引线起搏器的普及和植入。
市场成长要素
微创手术需求不断成长
微创手术的发展减少了导线放置和手术切口的需要,降低了手术风险并提高了患者的舒适度。这种侵入性的减少不仅提高了病患的安全性,也缩短了復原时间。接受无引线心律调节器植入的患者住院时间较短,术后不适也较少。这种快速康復使患者能够快速恢復日常生活和活动。这些程序为获得医疗设施可能受到限制的偏远和农村医疗保健环境开闢了新的可能性。因此,对微创手术的需求迅速增加,推动市场扩张。
心律不整盛行率上升
心律不整盛行率的上升是多种因素的复杂组合,从人口变化到生活方式的选择,再到医疗保健的进步。高血压是心律不整的既定危险因子。高血压会导致心臟结构和电讯号发生变化,增加心律不整的可能性。同样,糖尿病与心律不整,特别是心房颤动的风险增加有关。此外,心律不整的盛行率并不限于特定年龄组,而是影响不同阶层的个体。所有年龄层患有心律不整的患者,从老年人到年轻人,都可以从这些设备中受益。因此,心律不整的日益普及正在推动对无引线起搏器的需求。
市场抑制因素
监管和报销挑战
监管挑战,例如医疗设备复杂且漫长的核准流程,可能会大大推迟无引线起搏器的推出。监管机构要求对安全性和有效性进行彻底评估,导致产品认证的时间更长。监管核准的延迟不仅使患者无法获得先进的医疗解决方案,还会增加製造商的上市时间,影响他们提供尖端设备的能力。这些设备的经济负担可能会阻止医疗保健提供者和患者选择无引线起搏器作为起搏解决方案,儘管它们具有潜在的好处。这种经济负担可能会阻止人们选择这些设备,特别是当有更具成本效益的替代疗法可用时。所有这些因素都会阻碍市场的成长。
按类型分類的展望
按类型划分,市场可分为 Micra 经导管起搏系统和其他系统。其他细分市场在2022年也获得了可观的市场成长。无引线心律调节器,包括 NanoStim 和 WiSE CRT 系统等设备,与传统引线心律调节器相比具有多种优势。 Nanostim 非常紧凑,大约有一个大维生素胶囊的大小。这种小尺寸可实现侵入性较小的手术,并实现更谨慎和舒适的植入。 WiSE CRT 系统专为心臟再同步治疗(一种心臟衰竭治疗方法)而设计。无需传统起搏导线即可提供心臟再同步的优点。 NanoStim 和 WiSE CRT 系统均具有显着优势,包括微创植入、紧凑设计、降低感染风险、美容功效和长电池寿命。
最终用途展望
依最终用途,市场分为医院和门诊病人。 2022 年,医院业务在市场中占据最大的收益占有率。医院可以更有效地分配资源,因为他们不需要专门的手术室或手术团队专用植入心律调节器。这可以节省成本并为其他重要的医疗程序释放资源。由于没有引线离开人体,因此几乎消除了与引线插入部位相关的感染疾病风险。医院可以受益于与设备相关的较低感染率。
区域展望
从区域来看,我们对北美、欧洲、亚太地区和拉丁美洲地区的市场进行了分析。 2022 年,北美市场占据最大的收益占有率。在北美,对无引线起搏器的需求正在稳定成长。这些因素凸显了心臟起搏技术的发展以及心律不整治疗向更加以患者为中心、侵入性较小且技术先进的选择的转变。无引线心律调节器不需要引线,引线容易受到感染疾病。这项功能在北美等感染控制是重中之重的地区受到高度重视。
The Global Leadless Pacemakers Market size is expected to reach $827.7 million by 2030, rising at a market growth of 15.2% CAGR during the forecast period.
European patients and healthcare providers are increasingly valuing minimally invasive procedures. Thus, the European region would register nearly 28% share of the market by 2030. The catheter-based implantation of leadless pacemakers eliminates the need for surgical pockets and leads, reducing pain, scarring, and recovery time. Europe possesses a well-developed healthcare infrastructure with advanced medical facilities and resources. Many outpatient facilities as well as hospitals in this region are equipped to perform leadless pacemaker implantations and provide necessary follow-up care.
The major strategies followed by the market participants are Mergers & Acquisitionas the key developmental strategy to keep pace with the changing demands of end users. For instance, In August, 2022, Medtronic plc completed the acquisition of Affera, Inc., expanding its cardiac ablation portfolio with the addition of a groundbreaking cardiac mapping and navigation platform, featuring a fully integrated diagnostic, focal pulsed field, and radiofrequency ablation solution. Moreover, In April, 2023, Abbott Laboratories completed the acquisition of Cardiovascular Systems, Inc. (CSI), a medical device company known for its innovative atherectomy system in the treatment of peripheral and coronary artery disease. This acquisition enhances Abbott's offerings for vascular disease treatment, incorporating CSI's leading atherectomy system, which prepares vessels for angioplasty or stenting to restore blood flow.
Based on the Analysis presented in the KBV Cardinal matrix; Medtronic PLC and Abbott Laboratories are the forerunners in the Market. Companies such as Boston Scientific Corporation, Integer Holdings Corporation and Terumo Corporation are some of the key innovators in the Market. In September, 2023, Boston Scientific Corporation announced the acquisition of Relievant Medsystems, Inc., a privately held medical device company specializing in vertebrogenic pain treatment. This acquisition enables the integration of Relievant Medsystems' clinically backed technology with Boston Scientific's strategies, expanding treatment options for individuals in need of personalized care.
COVID-19 Impact
During the pandemic, many hospitals and healthcare facilities postponed or canceled elective procedures to free up resources and reduce the risk of virus transmission. This led to a decrease in leadless pacemaker implantations, as these procedures are often considered elective and non-urgent. The global supply chain for medical devices, including leadless pacemakers, experienced disruptions due to lockdowns and restrictions on manufacturing and transportation. This led to delays in the availability of devices and potentially impacted patients' access to these advanced technologies. Hospitals and healthcare providers redirected resources and staff to handle the surge of COVID-19 cases. This diversion of attention and resources from non-COVID medical services affected the promotion and implantation of leadless pacemakers.
Market Growth Factors
Growing demand for minimally invasive procedures
The development of minimally invasive procedures has decreased the need for lead placement and surgical incisions, lowering surgical risks and enhancing patient comfort. This reduction in invasiveness has not only translated into enhanced patient safety but also quicker recovery times. Patients undergoing leadless pacemaker implantation experience shorter hospital stays and reduced post-operative discomfort. This quick recovery benefits patients by allowing them to return to their daily routines and activities more swiftly. These procedures have opened up new possibilities for remote and rural healthcare settings, where access to healthcare facilities may be limited. As a result, the rapidly increasing demand for minimally invasive procedures will aid in the expansion of the market.
Rising prevalence of cardiac arrhythmias
The rising prevalence of cardiac arrhythmias is a complex interplay of multiple factors, from demographic changes to lifestyle choices and advances in healthcare. High blood pressure is a well-established risk factor for arrhythmias. It can lead to changes in the heart's structure and electrical signaling, increasing the likelihood of arrhythmias. Similarly, diabetes is associated with an increased risk of arrhythmias, particularly atrial fibrillation. Furthermore, the prevalence of arrhythmias is not limited to specific age groups; it affects individuals across various demographics. Patients of all ages who experience cardiac arrhythmias, from the elderly to younger individuals, can benefit from these devices. Therefore, the rising prevalence of arrhythmias is boosting the demand for leadless pacemakers.
Market Restraining Factors
Regulatory and reimbursement challenges
Regulatory challenges, such as the complex and lengthy approval process for medical devices, can significantly delay the introduction of leadless pacemakers. Regulatory agencies require thorough evaluations of safety and efficacy, leading to prolonged timeframes for product clearance. Delays in regulatory approval not only hinder patients' access to advanced medical solutions but also increase the time-to-market for manufacturers, impacting their ability to offer cutting-edge devices. The economic burden of these devices can deter both healthcare providers and patients from choosing leadless pacemakers as a pacing solution despite their potential benefits. Such financial burdens may discourage some individuals from opting for these devices, especially if more cost-effective alternatives are available. All these factors may hamper the growth of the market.
Type Outlook
Based on type, the market is bifurcated into micra transcatheter pacing system and others. The other segment procured a considerable growth rate in the market in 2022. Leadless pacemakers, including devices like Nanostim and WiSE CRT System, offer several benefits compared to traditional pacemakers with leads. Nanostim is remarkably compact, similar in size to a large vitamin capsule. This small size allows for a less invasive procedure and results in a more unobtrusive and comfortable implantation. The WiSE CRT System is designed for cardiac resynchronization therapy, a treatment for heart failure. It offers the benefits of cardiac resynchronization without the need for traditional pacing leads. Both Nanostim and the WiSE CRT System provide significant advantages, such as minimally invasive implantation, compact designs, reduced infection risk, cosmetic benefits, and long-lasting battery life.
End-use Outlook
On the basis of end-use, the market is divided into hospitals and outpatient facilities. The hospitals segment acquired the largest revenue share in the market in 2022. Hospitals can efficiently allocate resources, as there is no need for specialized surgical suites or surgical teams dedicated to pacemaker implantations. This can lead to cost savings and the reallocation of resources to other critical medical procedures. With no leads that exit the body, the risk of infections related to lead entry sites is virtually eliminated. Hospitals can benefit from reduced rates of device-related infections.
Regional Outlook
Region-wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment witnessed the maximum revenue share in the market in 2022. The demand for leadless pacemakers is steadily increasing in North America due to several factors contributing to their growing adoption in the region. These factors highlight the evolving landscape of cardiac pacing technology and the shift towards more patient-centric, minimally invasive, and technologically advanced options for treating cardiac arrhythmias. Leadless pacemakers eliminate the need for leads that can be susceptible to infection. In regions like North America, where infection control is a priority, this feature is highly valued.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Medtronic PLC, Abbott Laboratories, Boston Scientific Corporation, Biotronik SE & Co. KG, Lepu Medical Technology Co., Ltd, Integer Holdings Corporation, MicroPort Scientific Corporation, Osypka AG, Terumo Corporation, and EBR Systems, Inc.
Strategies Deployed in Leadless Pacemakers Market
Partnerships, Collaborations, and Agreements:
Jul-2022: Medtronic plc has formed a strategic partnership with CathWorks, a privately held company headquartered in Kefar Sava, Israel, investing up to $75 million and co-promoting the FFRangio System globally. The agreement included an option for Medtronic to acquire CathWorks based on milestones, with CathWorks having the right to compel the acquisition if Medtronic opts out.
Sep-2021: Terumo Cardiovascular partnered with Etiometry to provide enhanced monitoring insights for adult cardiac surgery patients. This collaboration expanded technologies and enabled the utilization of clinical-decision support tools throughout a patient's hospital stay, offering a more comprehensive view of critical data for improved and informed bedside decisions during the transition from the operating room to the ICU.
Product Launches and Product Expansions:
Feb-2022: Abbott Laboratories has revealed the world's first patient implants of a dual-chamber leadless pacemaker system in its AVEIR DR i2i™ pivotal clinical study. The implant of Abbott's investigational Aveir dual-chamber leadless pacemaker marks a notable technological milestone in leadless pacing, representing the first such occurrence globally within the pivotal trial.
Jan-2022: Medtronic received regulatory approval and launched the Micra AV Transcatheter Pacing System in Japan. This pacemaker was designed to treat patients with AV block, addressing impaired electrical signals between the heart's chambers. The Micra TPS is the world's first leadless pacemaker, with the initial version (Micra VR) approved in Japan in 2017 for patients requiring single-chamber pacing.
Jun-2021: Medtronic PLC has introduced the MICRA AV, a pacemaker smaller than conventional ones, offering a leadless and minimally invasive solution for patients with complete heart block. This innovation, following Medtronic's legacy of inventing and disrupting, provides a cosmetically invisible option for those in need.
Acquisition and Mergers:
Sep-2023: Boston Scientific Corporation has announced the acquisition of Relievant Medsystems, Inc., a privately held medical device company specializing in vertebrogenic pain treatment. This acquisition enables the integration of Relievant Medsystems' clinically backed technology with Boston Scientific's strategies, expanding treatment options for individuals in need of personalized care.
Apr-2023: Abbott Laboratories completed the acquisition of Cardiovascular Systems, Inc. (CSI), a medical device company known for its innovative atherectomy system in the treatment of peripheral and coronary artery disease. This acquisition enhances Abbott's offerings for vascular disease treatment, incorporating CSI's leading atherectomy system, which prepares vessels for angioplasty or stenting to restore blood flow.
Aug-2022: Medtronic plc completed the acquisition of Affera, Inc., expanding its cardiac ablation portfolio with the addition of a groundbreaking cardiac mapping and navigation platform, featuring a fully integrated diagnostic, focal pulsed field, and radiofrequency ablation solution.
May-2022: Medtronic PLC completed the acquisition of Intersect ENT, integrating PROPEL and SINUVA into its portfolio. PROPEL implants, maintaining sinus patency and delivering steroids, and SINUVA implants, treating nasal polyps in ethmoid sinus surgery patients, are now part of Medtronic's offerings.
Feb-2022: Boston Scientific has completed the acquisition of Baylis Medical Company Inc. This integration enables Boston Scientific to incorporate Baylis platforms into its existing electrophysiology and structural heart offerings, reinforcing its position in the rapidly growing cardiology markets.
Sep-2021: Boston Scientific Corporation completed the acquisition of Devoro Medical, Inc., a developer of a medical device intended to restore blood flow. Through this acquisition, the WOLF Thrombectomy Platform was integrated into Boston Scientific's products. Additionally, this acquisition provided the physicians with the necessary tools needed for the treatment.
Trials and Approval:
Dec-2022: Biotronik SE & Co. KG has initiated the first patient enrollment in BIO-CONDUCT, an FDA-approved investigational device exemption (IDE) trial. The study examines the use of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area, a location not currently approved for the Solia S lead.
Dec2021: Boston Scientific Corporation has started the MODULAR ATP clinical trial to assess the mCRM Modular Therapy System, which includes the EMBLEM™ MRI S-ICD System and the EMPOWER™ MPS, aiming to be the first leadless pacemaker capable of delivering bradycardia pacing support and antitachycardia pacing (ATP).
Market Segments covered in the Report:
By Type
By End-use
By Geography
Companies Profiled
Unique Offerings from KBV Research