無導線心律調節器市場機會、成長動力、產業趨勢分析及 2025 - 2034 年預測

2024年，全球無導線心律調節器市場規模達4.205億美元，預計2034年將以9.8%的複合年成長率成長，達到11億美元。由於心臟病發病率的不斷上升、保險覆蓋範圍的擴大以及全行業向微創治療方案的轉型，該市場正日益受到關注。無導線心律調節器代表著心律治療領域的重大飛躍，其緊湊的設計可直接植入心臟，無需傳統的導線和手術腔。這些系統旨在減少感染、脫位和手術風險等併發症。

隨著篩檢和影像技術的進步，早期心臟病診斷的增多，正推動精準心臟設備的普及。患者受益於更快的康復、更少的併發症以及長期穩定的心律。無導線心律調節器的日益普及也反映了心臟病學領域更廣泛的趨勢——即優先考慮小型化、減少創傷以及與生理起搏需求的無縫整合。技術繼續發揮關鍵作用，新型設備具有更長的電池壽命、即時監測功能，並與不斷發展的心臟護理標準相容，有助於重新定義心律不整治療的未來。

2024年，單腔心室節律器市場佔據96.9%的市場佔有率，這得益於其簡化的植入程序、成本效益以及在治療心動過緩等​​疾病方面的成熟應用。這種成長源自於人們對先進起搏方案的日益青睞，這些方案能夠增強心房和心室之間的協調，從而最佳化心臟功能並改善患者的生活品質。

2024年，醫院和診所市佔率為46.6%。這些醫療機構憑藉著完善的基礎設施、訓練有素的心臟專科醫生以及高階診療設備的便利，成為心臟診斷和無導線心律調節器植入的主要中心。擁有先進導管室和影像室的醫療機構能夠更好地執行複雜的植入手術，並將風險降至最低，這使得醫院和診所成為患者和醫生的首選。

2024年，美國無導線心律調節器市場規模達1.941億美元。北美市場佔據全球主導地位，其中美國佔據主導地位，這得益於其強大的醫療保健體系、廣泛採用的新一代技術以及大量經驗豐富的醫療保健提供者。不斷成長的心律不整患者群體，加上保險支付方和政府機構的大力支持，正在推動市場持續成長。此外，大型醫療器材製造商的入駐以及高度活躍的臨床研究管道，正在鞏固區域市場的成長。

塑造全球無導線心律調節器市場的關鍵參與者包括美敦力和雅培，這兩家公司均持續引領該領域的創新和擴張。參與無導線心律調節器市場競爭的公司正積極投資研發，以期將具有更長使用壽命、更優無線通訊和更精準起搏功能的下一代設備推向市場。在新的地理區域擴大臨床試驗和獲得監管部門的批准仍然是擴大患者可及性的策略重點。各公司也專注於微型化以及雙腔和多腔起搏解決方案的開發，以滿足更廣泛的臨床需求。與醫院和學術機構的策略合作正在促進更深層的市場滲透和現實世界的驗證。

目錄

第1章：方法論與範圍

第2章：執行摘要

第3章：行業洞察

• 產業生態系統分析
• 產業衝擊力
  • 成長動力
    • 心臟病盛行率不斷上升
    • 技術進步
    • 優惠的報銷政策
    • 微創手術日益受到青睞
  • 產業陷阱與挑戰
    • 無導線心律調節器成本高
  • 市場機會
    • 與穿戴式技術整合以實現遠端監控
    • 滲透到醫療基礎設施不斷改善的新興市場
• 成長潛力分析
• 報銷場景
• 監管格局
  • 美國
  • 歐洲
• 技術和創新格局
  • 當前的技術趨勢
  • 新興技術
• 未來市場趨勢
• 2021 - 2034 年無導線心律調節器銷售（台）
• 投資前景
• 品牌分析
• 啟動場景
• 管道分析
• 差距分析
• 波特的分析
• PESTEL分析

第4章：競爭格局

• 介紹
• 公司市佔率分析
  • 全球的
  • 北美洲
  • 歐洲
  • 亞太地區
  • 拉丁美洲
  • MEA
• 公司矩陣分析
• 主要市場參與者的競爭分析
• 競爭定位矩陣
• 關鍵進展
  • 併購
  • 夥伴關係和合作
  • 新產品發布
  • 擴張計劃

第5章：市場估計與預測：依產品類型，2021 - 2034 年

• 主要趨勢
• 單腔心室心律調節器
• 雙腔心律調節器

第6章：市場估計與預測：依最終用途，2021 - 2034 年

• 主要趨勢
• 醫院和診所
• 心臟護理中心
• 門診手術中心
• 其他最終用途

第7章：市場估計與預測：按地區，2021 - 2034 年

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 荷蘭
• 亞太地區
  • 中國
  • 日本
  • 印度
  • 澳洲
  • 韓國
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第8章：公司簡介

• Abbott
• Medtronic

The Global Leadless Pacemakers Market was valued at USD 420.5 million in 2024 and is estimated to grow at a CAGR of 9.8% to reach USD 1.1 billion by 2034. The market is gaining traction due to the growing incidence of cardiac conditions, favorable insurance coverage, and an industry-wide transition toward less invasive treatment options. Leadless pacemakers represent a significant leap in cardiac rhythm therapy, offering a compact design that is implanted directly into the heart, eliminating the need for traditional leads and surgical pockets. These systems are designed to reduce complications such as infections, dislodgements, and procedural risks.

The increase in early-stage cardiac diagnoses, supported by advances in screening and imaging technologies, is encouraging the adoption of precision-based cardiac devices. Patients benefit from faster recovery, fewer complications, and long-term rhythm stability. The rising preference for leadless pacemakers also reflects a wider trend in cardiology-one that prioritizes miniaturization, reduced trauma, and seamless integration with physiological pacing requirements. Technology continues to play a critical role, with newer devices offering superior battery life, real-time monitoring capabilities, and compatibility with evolving standards in cardiac care, helping to redefine the future of arrhythmia treatment.

In 2024, single-chamber ventricular pacemakers segment held 96.9% share, driven by their simplified implantation procedure, cost efficiency, and proven use in treating conditions like bradycardia. This growth stems from the increasing preference for advanced pacing options that enhance coordination between atria and ventricles, leading to optimized heart function and improved patient quality of life.

The hospitals and clinics segment held 46.6% share in 2024. These healthcare facilities are primary hubs for cardiac diagnosis and leadless pacemaker implantation due to their comprehensive infrastructure, presence of trained cardiac specialists, and access to high-end diagnostic and therapeutic equipment. Facilities with advanced catheterization labs and imaging suites are better equipped to perform complex implantations with minimal risk, making hospitals and clinics the preferred setting for both patients and practitioners.

U.S Leadless Pacemakers Market was valued at USD 194.1 million in 2024. North America dominates the global landscape, led by the U.S., owing to its robust healthcare systems, widespread adoption of next-generation technologies, and an extensive base of experienced healthcare providers. A growing patient pool with arrhythmic conditions, along with strong support from insurance payers and government bodies, is driving sustained demand. Furthermore, the presence of major medical device manufacturers and a highly active pipeline of clinical research is solidifying regional market growth.

Key players shaping the Global Leadless Pacemakers Market include Medtronic and Abbott, both of which continue to lead innovation and expansion in the sector. Companies competing in the leadless pacemakers market are actively investing in R&D to bring next-generation devices to market with improved longevity, wireless communication, and precision pacing features. Expansion of clinical trials and regulatory approvals across new geographic regions remains a strategic priority to widen patient access. Firms are also focusing on miniaturization and the development of dual-chamber and multi-chamber pacing solutions to meet a broader range of clinical needs. Strategic collaborations with hospitals and academic institutions are enabling deeper market penetration and real-world validation.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definition
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/Country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
• 1.6 Forecast model
• 1.7 Research assumptions and limitations

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Product type trends
  • 2.2.3 End use trends
• 2.3 CXO perspectives: Strategic imperatives
  • 2.3.1 Key decision points for industry executives
  • 2.3.2 Critical success factors for market players
• 2.4 Future outlook and strategic recommendations

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing prevalence of cardiac disorders
    • 3.2.1.2 Technological advancements
    • 3.2.1.3 Favorable reimbursement policies
    • 3.2.1.4 Growing preference for minimally invasive procedures
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High cost of leadless pacemakers
  • 3.2.3 Market opportunities
    • 3.2.3.1 Integration with wearable tech for remote monitoring
    • 3.2.3.2 Penetration into emerging markets with an improving healthcare infrastructure
• 3.3 Growth potential analysis
• 3.4 Reimbursement scenario
• 3.5 Regulatory landscape
  • 3.5.1 U.S.
  • 3.5.2 Europe
• 3.6 Technology and innovation landscape
  • 3.6.1 Current technological trends
  • 3.6.2 Emerging technologies
• 3.7 Future market trends
• 3.8 Leadless pacemakers volume (Units), 2021 - 2034
• 3.9 Investment landscape
• 3.10 Brand analysis
• 3.11 Start-up scenario
• 3.12 Pipeline analysis
• 3.13 Gap analysis
• 3.14 Porter's analysis
• 3.15 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
  • 4.2.1 Global
  • 4.2.2 North America
  • 4.2.3 Europe
  • 4.2.4 Asia Pacific
  • 4.2.5 Latin America
  • 4.2.6 MEA
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Key developments
  • 4.6.1 Mergers and acquisitions
  • 4.6.2 Partnerships and collaborations
  • 4.6.3 New product launches
  • 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Product Type, 2021 - 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Single-chamber ventricular pacemakers
• 5.3 Dual-chamber pacemakers

Chapter 6 Market Estimates and Forecast, By End Use, 2021 - 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Hospitals and clinics
• 6.3 Cardiac care centers
• 6.4 Ambulatory surgical centers
• 6.5 Other end use

Chapter 7 Market Estimates and Forecast, By Region, 2021 - 2034 ($ Mn)

• 7.1 Key trends
• 7.2 North America
  • 7.2.1 U.S.
  • 7.2.2 Canada
• 7.3 Europe
  • 7.3.1 Germany
  • 7.3.2 UK
  • 7.3.3 France
  • 7.3.4 Spain
  • 7.3.5 Italy
  • 7.3.6 Netherlands
• 7.4 Asia Pacific
  • 7.4.1 China
  • 7.4.2 Japan
  • 7.4.3 India
  • 7.4.4 Australia
  • 7.4.5 South Korea
• 7.5 Latin America
  • 7.5.1 Brazil
  • 7.5.2 Mexico
  • 7.5.3 Argentina
• 7.6 Middle East and Africa
  • 7.6.1 South Africa
  • 7.6.2 Saudi Arabia
  • 7.6.3 UAE

Chapter 8 Company Profiles

• 8.1 Abbott
• 8.2 Medtronic