Global Leadless Pacemaker Market Grows at a Staggering CAGR of 8.2%

Introduction

A leadless pacemaker is a type of heart device used to treat patients with slow heart rates or arrhythmias, offering an alternative to traditional pacemakers that use leads (wires) to connect the device to the heart. Unlike conventional pacemakers, leadless pacemakers are small, self-contained units that are implanted directly into the heart, typically in the right ventricle. They are about the size of a pill and do not require the usual chest incision or lead placement.

Market Dynamics

Increasing clinical trials and regulatory approvals drive the global market

The growing number of clinical trials and regulatory approvals is significantly accelerating the global market. Leading medical device companies are dedicating significant resources to research and development, aiming to improve the safety, effectiveness, and longevity of leadless pacemakers. Regulatory agencies such as the U.S. FDA and the European Medicines Agency are increasingly approving next-generation leadless pacemakers, facilitating their broader adoption in clinical practice.

For example, in May 2023, Medtronic received U.S. FDA approval for its Micra AV2 and Micra VR2, the world’s smallest leadless pacemakers. These advanced devices offer extended battery life, enhanced programming, and fewer complications compared to traditional pacemakers. Such innovations in battery life, efficiency, and overall performance are expected to further drive the adoption of leadless pacemakers, improving patient outcomes and advancing the field of cardiac care.

Expansion of dual-chamber leadless pacemakers creates tremendous opportunities

The introduction of dual-chamber leadless pacemakers presents a major growth opportunity for the market. Unlike traditional single-chamber devices, dual-chamber pacemakers offer improved synchronization between the atrium and ventricle, leading to better cardiac function for a broader range of patients.

• In July 2023, Abbott received U.S. FDA approval for the AVEIR Dual Chamber (DR) leadless pacemaker, the first of its kind for patients with abnormal or slow heart rhythms. With more than 80% of pacemaker patients requiring dual-chamber pacing, this innovation fills a crucial gap, providing a minimally invasive solution with enhanced cardiac synchronization.

This breakthrough is expected to drive the wider adoption of dual-chamber leadless pacemakers, improving patient outcomes and expanding treatment options for cardiac rhythm management.

Regional Analysis

North America holds a dominant position in the global leadless pacemaker market, driven by the high prevalence of cardiovascular diseases, particularly arrhythmias, and the rapid adoption of minimally invasive cardiac procedures. The region benefits from a well-established healthcare infrastructure, significant investments in R&D, and strong regulatory frameworks that facilitate the approval and commercialization of new technologies. Moreover, favorable reimbursement policies, widespread clinical acceptance, and the presence of leading medical device manufacturers contribute to the region's market strength.

Key Highlights

• The global leadless pacemaker market size was valued at USD 809.69 million in 2024 and is projected to grow from USD 910.08 million in 2025 to reach USD 1,713.18 million by 2033, exhibiting a CAGR of 8.2% during the forecast period (2025-2033).
• Based on product type, the global leadless pacemaker market is segmented into single-chamber leadless pacemakers and double-chamber leadless pacemakers. The single-chamber leadless pacemakers segment is the largest revenue contributor.
• Based on end-users, the global leadless pacemaker market is segmented into hospitals and clinics, ambulatory surgery centers, and others. The hospitals and clinics segment is the largest revenue contributor to the market.
• North America is the highest shareholder in the global market

Competitive Players

1. Abbott
2. Medtronic
3. EBR Systems Inc.
4. Boston Scientific Corporation
5. MicroPort Scientific Corporation

Recent Developments

• In December 2024, Abbott successfully completed the world’s first-in-human leadless LBBAP procedures using its investigational AVEIR CSP leadless pacemaker. This milestone strengthens Abbott’s position in the leadless pacemaker market, expanding its innovation pipeline and paving the way for future regulatory approvals.

Segmentation

1. By Product Type
   1. Single Chamber Leadless Pacemaker
   2. Double Chamber Leadless Pacemaker
2. By End-User
   1. Hospitals
   2. Ambulatory Surgery Centers
   3. Others
3. By Regions
   1. North America
   2. Europe
   3. Asia-Pacific
   4. Latin America
   5. The Middle East and Africa