Summary

Leadless Cardiac Pacemaker Market Size
The global leadless cardiac pacemaker market size was valued at $268.96 million in 2024 and is projected to reach $431.58 million by 2030, growing at a CAGR of 8.2% during the forecast period.

Leadless Cardiac Pacemaker Market Overview
The leadless pacemaker is a small device implanted in the heart to regulate heartbeats and stimulate the lower chambers, ensuring a healthy rhythm. It functions by detecting slow heart rates and sending electrical signals to prompt the heart. Unlike traditional pacemakers, leadless ones don't need wires or a surgical pocket as they're inserted directly into the heart. They're commonly used for individuals with bradyarrhythmia, a condition characterized by slow heart rhythms due to issues with the heart's conduction system. Typically, these self-contained pacemakers are placed in the right ventricle of the heart.

Leadless Cardiac Pacemaker Market Dynamics
• The leadless cardiac pacemaker market is expected to witness significant growth in the future due to the increasing geriatric population, advancements in medical technology, and rising awareness of cardiac disorders.
• Additionally, increasing demand due to smaller device size and improved patient comfort are the prominent factors driving the growth of the market.
• However, technical restrictions of pacemakers and high initial costs are restraining the market growth.
• On the contrary, increasing financial allocations for the improvement of ambulatory surgical centers and growing acceptance of minimally invasive procedures are creating opportunities for market growth.

By Type, Micra Transcatheter Pacing System Segment to Hold Major Share in the Leadless Cardiac Pacemaker Market
The micra transcatheter pacing system segment is expected to hold a significant share in the leadless cardiac pacemaker market during the forecast period owing to the rising incidence of cardiovascular diseases, minimal post-implantation complications, and straightforward retrieval process. The Micra, a single-chamber pacemaker comparable in size to a vitamin, offers direct implantation into the heart, eliminating the need for conventional leads. The heightened incidence of cardiovascular ailments amplifies the necessity for Micra-transcatheter pacing, consequently propelling market growth. Moreover, the significant impact of cardiovascular diseases, accounting for approximately 17.9 million global deaths, as reported by the World Health Organization in June 2021, further underscores the critical role of Micra in addressing cardiac health concerns.

By Geography, North America is expected to have the highest CAGR during the forecast period
The North America is experiencing strong growth rate during the forecast period due to region's high prevalence of cardiovascular diseases, extensive adoption of leadless pacemakers, and the availability of reimbursement programs. Additionally, the rising incidence of atrial fibrillation among patients and the presence of major industry players are expected to further stimulate market growth. An example is the recent implantation of a dual-chamber leadless pacemaker system by the Cleveland Clinic in March 2022, marking the first such procedure in the United States as part of a global clinical trial. This initiative aims to provide heart rhythm patients with a more precise and minimally invasive treatment option, thereby reducing potential complications. Consequently, the market is poised to witness significant clinical trial activity throughout the forecast period, driven by these influential factors.

Key Target Audience:
• Healthcare Providers
• Medical Device Manufacturers
• Healthcare Payers
• Regulatory Authorities

List of the Key Players Profiled in the Report Includes:
• Edward Lifesciences Corporation
• SORIN S.p.A
• Lepu Medical Technology
• Vitatron
• Terumo Corporation
• BIOTRONIK SE & Co. KG
• Boston Scientific Corporation
• Medtronic Plc
• EBR Systems Inc.
• Abbott Laboratories Inc.
• MEDICO S.p.A.
• MicroPort Scientific Corporation

Recent Developments:
• In January 2024, Medtronic plc has unveiled the CE (Conformité Européenne) Mark approval for its Micra™ AV2 and Micra™ VR2, marking the launch of the next generation of its highly acclaimed miniature, leadless pacemakers. These latest innovations, known as the world's smallest pacemakers, boast extended battery life and simplified programming compared to previous Micra models. Despite their diminutive size, Micra AV2 and Micra VR2 continue to offer the myriad advantages of leadless pacing, including reduced complications compared to conventional pacemakers.
• In July 2023, Abbott has disclosed that the U.S. Food and Drug Administration (FDA) has granted approval for the AVEIR™ dual chamber (DR) leadless pacemaker system. This marks a significant milestone as it becomes the world's inaugural dual chamber leadless pacing system designed to address individuals with irregular or slow heart rhythms.

Market Segmentation:
The research report includes in-depth coverage of the industry analysis with size, share, and forecast for the below segments:

Market by, Type:
• Micra Transcatheter Pacing System
• Nanostim Leadless Cardiac Pacemaker
• Wireless Cardiac Simulation System

Market by, Application:
• Hospitals
• Ambulatory Surgical Centers
• Other Applications

Market by, Geography:
The leadless cardiac pacemaker market report also analyzes the major geographic regions and countries of the market. The regions and countries covered in the study include:
• North America (The United States, Canada, Mexico), Market Estimates, Forecast & Opportunity Analysis
• Europe (Germany, France, UK, Italy, Spain, Rest of Europe), Market Estimates, Forecast & Opportunity Analysis
• Asia Pacific (China, Japan, India, South Korea, Australia, New Zealand, Rest of Asia Pacific), Market Estimates, Forecast & Opportunity Analysis
• South America (Brazil, Argentina, Chile, Rest of South America), Market Estimates, Forecast & Opportunity Analysis
• Middle East & Africa (UAE, Saudi Arabia, Qatar, Iran, South Africa, Rest of Middle East & Africa), Market Estimates, Forecast & Opportunity Analysis

Scope of the Report:
The report “Global Leadless Cardiac Pacemaker Market: Industry Analysis, Opportunities and Forecast up to 2030” by Diligence Insights provides a detailed analysis of the present market and future outlook with market estimates and forecasts for all specified segments, encompassing both global and regional perspectives as outlined within the research framework. The study includes historical market data for the years 2022, 2023 and offers revenue estimations for 2024, and project forecasts spanning from 2025 to 2030. It places significant emphasis on the examination of market trends, key industry participants, supply chain developments, technological advancements, pivotal milestones, and prospective strategies. Comprehensive market assessments are carried out across major geographic regions, including North America, Europe, Asia Pacific, South America, and Middle East & Africa. As such, this report constitutes a valuable resource for current industry stakeholders, newcomers to the field, and potential investors.

The study offers an in-depth market analysis, drawing insights from industry experts across the value chain. A special focus has been made on 25 countries, including the United States, Canada, Mexico, the United Kingdom, Germany, Spain, France, Italy, China, Brazil, Saudi Arabia, and South Africa, among others. The market data has been meticulously collected through extensive primary interviews and comprehensive secondary research. Market size determination is rooted in the revenue generated from sales across all the specified segments and sub-segments as defined within the research scope. The market sizing analysis includes both top-down and bottom-up approaches for data validation and accuracy measures.

The report offers insights into the following aspects:
• Analysis of major market trends, factors driving, restraining, threatening, and providing opportunities for the market.
• Analysis of the market structure by identifying various segments and sub-segments of the market.
• Understand the revenue forecast of the market for North America, Europe, Asia-Pacific, South America, and Middle East & Africa.
• Analysis of opportunities by identification of high-growth segments/revenue pockets in the market.
• Understand major player profiles in the market and analyze their business strategies.
• Understand competitive developments such as joint ventures, alliances, mergers and acquisitions, and new product launches in the market.

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Table of Contents

1 Market Introduction
1.1 Market Definition
1.2 Research Scope and Segmentation
1.3 Stakeholders
1.4 List of Abbreviations

2 Executive Summary

3 Research Methodology
3.1 Identification of Data
3.2 Data Analysis
3.3 Verification
3.4 Data Sources
3.5 Assumptions

4 Market Dynamics
4.1 Market Drivers
4.2 Market Restraints
4.3 Market Opportunities
4.4 Market Challenges

5 Porter's Five Force Analysis
5.1 Bargaining Power of Suppliers
5.2 Bargaining Power of Buyers
5.3 Threat of New Entrants
5.4 Threat of Substitutes
5.5 Competitive Rivalry in the Market

6 Global Leadless Cardiac Pacemaker Market by, Type
6.1 Overview
6.2 Micra Transcatheter Pacing System
6.3 Nanostim Leadless Cardiac Pacemaker
6.4 Wireless Cardiac Simulation System

7 Global Leadless Cardiac Pacemaker Market by, Application
7.1 Overview
7.2 Hospitals
7.3 Ambulatory Surgical Centers
7.4 Other Applications

8 Global Leadless Cardiac Pacemaker Market by, Geography
8.1 Overview
8.2 North America
8.2.1 US
8.2.2 Canada
8.2.3 Mexico
8.3 Europe
8.3.1 Germany
8.3.2 France
8.3.3 UK
8.3.4 Italy
8.3.5 Spain
8.3.6 Rest of Europe
8.4 Asia Pacific
8.4.1 China
8.4.2 Japan
8.4.3 India
8.4.4 South Korea
8.4.5 Australia
8.4.6 New Zealand
8.4.7 Rest of Asia Pacific
8.5 South America
8.5.1 Brazil
8.5.2 Argentina
8.5.3 Chile
8.5.4 Rest of South America
8.6 Middle East & Africa
8.6.1 UAE
8.6.2 Saudi Arabia
8.6.3 Qatar
8.6.4 Iran
8.6.5 South Africa
8.6.6 Rest of Middle East & Africa

9 Key Developments

10 Company Profiling
10.1 Edward Lifesciences Corporation
10.1.1 Business Overview
10.1.2 Product/Service Offering
10.1.3 Financial Overview
10.1.4 SWOT Analysis
10.1.5 Key Activities
10.2 SORIN S.p.A
10.3 Lepu Medical Technology
10.4 Vitatron
10.5 Terumo Corporation
10.6 BIOTRONIK SE & Co. KG
10.7 Boston Scientific Corporation
10.8 Medtronic Plc
10.9 EBR Systems Inc.
10.10 Abbott Laboratories Inc.
10.11 MEDICO S.p.A.
10.12 MicroPort Scientific Corporation