The global leadless pacemakers market is forecasted to be worth over US$ 1635 million by the end of 2033 and grow at a CAGR of over 13% from 2025 to 2033.
The pacemakers currently used to treat cardiac patients use lead as a primary material to connect pulse generator to heart chamber. This resulted in problems like lead fracture, breaking of the insulation which would in turn affect the lifecycle of the pacemaker. Due to all these factors, researchers developed the idea of leadless pacemakers. They are transplanted directly in the right ventricle of the heart where the heart muscles receive small electrical impulses from the pacemaker which will result in an acceptable heart rate. In addition to that, leadless pacemakers can be implanted within an hour as they are less invasive as compared to traditional pacemakers. Another advantage of using leadless pacemaker over a traditional pacemaker is that it has a low recovery time which improves its performance. But the most important reason for using leadless pacemakers is because it prevents the heart ventricle from causing any infection which is very critical considering it deals with the heart directly. The market growth for leadless pacemakers is huge as it also has an advantage of reducing the manufacturing cost which will help in penetrating the emerging economy markets during the forecast period.
Insights on Global Leadless Pacemakers Market:
By Product Type
- Micra transcatheter system
- Nanostim
- Wise CRT
Micra transcatheter pacing system currently leads the global market in this segment. No device dislodgement, an extended battery life, minimal complications post implantation and ease in retrieval are some of the advantages due to which it leads the market and it is expected to do the same during the forecast period. It has been implanted in more than 6000 patients across 30 countries since it was approved by the FDA in April 2016. Nanostim received approval from EMA in 2013 but due to obstacles like an early battery failure and spontaneous docking button detachment resulted in recalling the product which hampered its market position severely. It is thus expected to gain an average market growth rate during the forecast period.
By End User
- Hospitals
- Catheterization Laboratories
Hospitals are a major shareholder in this market segment across the world. Adoption of advanced and updated technologies combined with a superior infrastructure gains them a lot of tractions especially in developed economy markets and it is expected to do the same during the forecast period.
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Rest of the World
North America is leading the leadless pacemakers market, holding a 54.6% share of total revenue in 2024. This dominance can be attributed to several factors, including technological advancements, a high prevalence of heart diseases, and a skilled workforce. Moreover, the region benefits from a well-established healthcare infrastructure and supportive reimbursement policies, which enhance market growth.
In contrast, the Asia-Pacific region is anticipated to witness the highest compound annual growth rate (CAGR) of 15.1% during the forecast period. Increased healthcare spending, proactive government initiatives, and a rise in cardiovascular disease cases drive this rapid growth. Countries like China, Japan, and India are particularly experiencing a growing demand for leadless pacemakers due to their advantages over traditional devices.
Leadless Pacemakers Market Competitive Landscape:
- Medtronics
- St. Jude Medical LLC (Abbott Laboratories)
- Biotronic
- Boston Scientific
- Edwards Lifesciences
- Sorin Group
- Vitatron
- Lepu Medical
- Terumo Corp.
Medtronic and Abbott are the only companies who have developed single-chamber leadless pacemakers, therefore, dominating the global market and it is expected that they will dominate the market during the forecast period as well. Abbott has acquired St. Jude Medical who are developing a dual-channel leadless pacemaker and would be the first company in the world to do so if it succeeds.
Technological Advancements in the Leadless Pacemakers Market:
Recent advancements in leadless pacemaker technology have significantly improved their functionality and compatibility for patients. In May 2023, Medtronic plc received approval from the U.S. Food and Drug Administration (FDA) for its next-generation devices, the Micra AV2 and Micra VR2. These miniaturized leadless pacemakers feature extended battery life and simplified programming, enhancing the benefits of leadless pacing compared to previous models.
In addition, Abbott Laboratories obtained FDA approval in July 2023 for the AVEIR™ dual chamber (DR) leadless pacemaker system, marking it as the world’s first dual chamber leadless pacing system. This innovative device is designed to meet the needs of patients who require synchronized pacing between the atrium and ventricle, thereby expanding treatment options for those with irregular or slow heart rhythms.
Objectives of the Study:
- To provide with an exhaustive analysis on the global Leadless pacemaker market by product type, by end-user and by region
- To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
- To evaluate and forecast micro-markets and the overall market
- To predict the market size, in key regions (along with countries)—North America, Europe, Asia Pacific, Latin America, and Rest of the World
- To record evaluate and competitive landscape mapping- product launches, technological advancements, mergers and expansions
- Profiling of companies to evaluate their market shares, strategies, financials and core competencies
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