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市場調查報告書
商品編碼
1384882
無引線心臟節律器全球市場規模、佔有率、產業趨勢分析報告:2023-2030 年依類型、最終用途、地區分類的展望與預測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,無引線心臟節律器市場規模預計將達到 8.277 億美元,預測期內市場CAGR率為 15.2%。
根據 KBV Cardinal 矩陣中發布的分析,美敦力公司 (Medtronic PLC) 和雅培實驗室 (Abbott Laboratories) 是市場上的領先參與者。波士頓科學公司、Integer Holdings Corporation 和 Terumo Corporation 等公司是該市場的主要創新者。 2023 年 9 月,波士頓科學公司宣布收購Lillyvant Medsystems,這是一家專門從事脊椎疼痛治療的私人醫療設備公司。此次收購將 Relievant Medsystems 經臨床驗證的技術與 Boston Scientific 的策略相結合,為需要個人化醫療的個人擴大了治療選擇。
COVID-19 的影響
疫情期間,許多醫院和醫療機構推遲或取消了擇期手術,以節省資源並降低病毒傳播的風險。因此,無引線起搏器植入術已經減少,因為它通常被認為是一種選擇性的、非緊急的手術。包括無引線起搏器在內的醫療設備的全球供應鏈因製造和運輸的封鎖和限制而受到干擾。這有可能延遲醫療設備的供應並阻止患者獲得這些尖端技術。醫療保健提供者已指示資源和工作人員應對 COVID-19 病例激增的情況。這種轉移到非新冠疫情衛生服務的注意力和資源影響了無引線起搏器的普及和植入。
市場成長要素
微創手術需求不斷成長
微創手術的發展減少了導線放置和手術切口的需要,降低了手術風險並提高了患者的舒適度。這種侵入性的減少不僅提高了病患的安全性,也縮短了復原時間。接受無引線心律調節器植入的患 者住院時間較短,術後不適也較少。這種快速康復使患者能夠快速恢復日常生活和活動。這些程序為獲得醫療設施可能受到限制的偏遠和農村醫療保健環境開闢了新的可能性。因此,對微創手術的需求迅速增加,推動市場擴張。
心律不整盛行率上升
心律不整盛行率的上升是多種因素的複雜組合,從人口變化到生活方式的選擇,再到醫療保健的進步。高血壓是心律不整的既定危險因子。高血壓會導致心臟結構和電訊號發生變化,增加心律不整的可能性。同樣,糖尿病與心律不整,特別是心房顫動的風險增加有關。此外,心律不整的盛行率並不限於特定年齡層,而是影響不同階層的個體。所有年齡層患有心律不整的患者,從老年人到年輕人,都可以從這些設備中受益。因此,心律不整的日益普及正在推動對無引線起搏器的需求。
市場抑制因素
監管和報銷課題
監管課題,例如醫療設備複雜且漫長的核准流程,可能會大大推遲無引線起搏器的推出。監管機構要求對安全性和有效性進行徹底評估,導致產品認證的時間更長。監管核准的延遲不僅使患者無法獲得先進的醫療解決方案,還會增加製造商的上市時間,影響他們提供尖端設備的能力。這些設備的經濟負擔可能會阻止醫療保健提供者和患者選擇無引線起搏器作為起搏解決方案,儘管它們具有潛在的好處。這種經濟負擔可能會阻止人們選擇這些設備,特別是當有更具成本效益的替代療法可用時。所有這些因素都會阻礙市場的成長。
依類型分類的展望
依類型分類,市場可分為 Micra 經導管起搏系統和其他系統。其他區隔市場在2022年也獲得了可觀的市場成長。無引線心律調節器,包括 NanoStim 和 WiSE CRT 系統等設備,與傳統引線心律調節器相比具有多種優勢。 Nanostim 非常緊湊,大約有一個大維生素膠囊的大小。這種小尺寸可實現侵入性較小的手術,並實現更謹慎和舒適的植入。 WiSE CRT 系統專為心臟再同步治療(一種心臟衰竭治療方法)而設計。無需傳統起搏導線即可提供心臟再同步的優點。 NanoStim 和 WiSE CRT 系統均具有顯著優勢,包括微創植入、緊湊設計、降低感染風險、美容功效和長電池壽命。
最終用途展望
依最終用途,市場分為醫院和門診病人。 2022 年,醫院業務在市場中佔最大的收益佔有率。醫院可以更有效地分配資源,因為他們不需要專門的手術室或手術團隊專用植入心律調節器。這可以節省成本並為其他重要的醫療程序釋放資源。由於沒有引線離開人體,因此幾乎消除了與引線插入部位相關的感染疾病風險。醫院可以受益於與設備相關的較低感染率。
區域展望
從區域來看,本報告對北美、歐洲、亞太地區和拉丁美洲地區的市場進行了分析。 2022 年,北美市場佔最大的收益佔有率。在北美,對無引線起搏器的需求正在穩定成長。這些因素凸顯了心臟起搏技術的發展以及心律不整治療向更加以患者為中心、侵入性較小且技術先進的選擇的轉變。無引線心律調節器不需要引線,引線容易受到感染疾病。這項功能在北美等感染控制是重中之重的地區受到高度重視。
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