Overview


According to FutureWise analysis the market for leadless pacemakers in 2023 is US$ 260 million, and is expected to reach US$ 430 million by 2031 at a CAGR of 7.7%.

Pacemakers send small electrical pulses to the heart muscles in order to keep the heart rate stable or to stimulate the lower chambers. A catheter, a thin long tube, is used to implant leadless pacemakers. A catheter is inserted into the femoral vein through a very small incision in patients’ groin. This area is numbed with a local anesthetic. The doctor uses an X-ray machine to guide the catheter to patient’s heart. After inserting the catheter, doctor will place the pacemaker in the right ventricle. It is tested to ensure that the device has been properly installed and programmed. The catheter is removed and pressure is applied to the incision site in order to close it. Pacemaker technology has advanced rapidly, including rate and output, to allow non-invasive connection with devices and better battery technology to increase the pulse generator's life duration by a year.

Every year, more than one million cardiac pacemakers are implanted throughout the world with about 200,000 of those procedures taking place in the US alone. These numbers are predicted to rise as a result of the ageing population and rising pace indicators. Cardiac pacemaker technology has advanced rapidly since the first pacemaker was implanted in the 1950s. The implantation and administration of transvenous cardiac pacemakers have undergone a revolution and transformation due to advances in battery life, pacemaker lead quality, algorithmic programming, and rate responsiveness (TV-PPM). The Nanostim Leadless Cardiac Pacemaker and the Medtronic Micra Transcatheter Pacing System are the two leadless pacing systems that are currently available. Both of these pacing systems use a catheter delivery system to be inserted into the femoral vein, but they differ in terms of size, fixation to the heart, and responsiveness.

FutureWise Market Research has published a report that provides an insightful analysis of leadless pacemakers’ market trends that are affecting the overall market growth. This report will provide a detailed analysis of market share, regional insights, and competitor analysis that includes stature of key manufacturers operational in this industry. According to the analysis conducted by FutureWise research analysts, the leadless pacemakers’ market is estimated to register a considerable growth rate over the forecast period. This report lists the market segments and potential prospects available across this industry, in addition providing crucial information on the total valuation currently held by the industry. Moreover, this report will assist key management individuals in an organisation to enhance their decisions pertaining to business expansion as well as strategic changes for increasing customer base.

  • Medtronics
  • St. Jude Medical LLC (Abbott Laboratories)
  • Biotronic
  • Boston Scientific
  • Edwards Lifesciences
  • Sorin Group
  • Vitatron
  • Lepu Medical
  • Terumo Corp.

(Note: The list of the major players will be updated with the latest market scenario and trends)

Recent developments by key players in Leadless Pacemaker Market:

In February 2022: as part of the AVEIR DR i2i pivotal clinical trial, Abbott revealed a dual-chamber leadless pacemaker device. The first patient in the pivotal study to receive Abbott's investigational Aveir dual-chamber leadless pacemaker marks a notable technological milestone for leadless pacing technology.

As the prevalence of cardiovascular diseases rises, so does the market for cardiac pacemakers. Cardiovascular disease (CVD) refers to heart or blood vessel abnormalities. Cardiovascular pacemakers, which generate electrical activity, are used to treat patients with cardiovascular disorders. Over one million cardiac pacemakers are implanted worldwide each year, with approximately 200,000 implanted in the United States alone. The aging population and rising pace indicators are anticipated to cause an increase in these numbers. As a result of the aging population and the increased prevalence of cardiovascular diseases, cardiac pacemakers are expected to boost the market growth. Since the first pacemaker was implanted in the 1950s, cardiac pacemaker technology has advanced rapidly. Reduced generator size, increased battery longevity, improved pacemaker lead quality, and algorithmic and rate-responsive programming have all revolutionized and transformed cardiac pacemaker implantation and management. Leadless pacemakers can only provide single-chamber ventricular pacing and have no defibrillation capability. Companies can increase brand recognition by developing dual-chamber and multi-chamber pacing, providing professional education and training, and expanding distribution reach, among other things. The development of new features in pacemakers has the potential to increase revenue in this target market. Despite these advancements in the field of cardiac pacemakers, the possibility of complications and technical failure must always be considered. The Food and Drug Administration (FDA) in the United States is alerting medical professionals about the risk of serious complications if a heart perforation occurs during the implantation of a leadless pacemaker. Cardiac perforation is a rare side effect of any pacemaker device implant. Cardiac perforation can cause serious problems or even death.

By Technology

  • Micra Transcatheter Pacing System
  • Nanostim Leadless Pacemakers
  • Wireless Cardiac Simulation System

By Indication

  • Atrial Fibrillation
  • High Degree Atrioventricular Block
  • Sinus node dysfunction
  • Others

By End-user

  • Hospitals
  • ASCs

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

This market research report also emphasis on factors affecting the growth rate in various regions listed above. A deep-down analysis of region will also be provided in the final version of this market which is based on conclusion of primary interviews and secondary data point gathered during the process.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. North America registered highest share in the market in 2022. Due to the high prevalence of cardiovascular disorders, the high adoption rates of leadless pacemakers, and the accessibility of reimbursements, the North American area is dominating the market for leadless cardiac pacemakers. Moreover, during the course of the forecast period, the presence of significant competitors in the region and the rising number of patients with atrial fibrillation are anticipated to fuel market expansion. According to American Heart Association data published in 2022, 6 million Americans, or 1.8% of the population, were estimated to have heart failure in 2021. As a result, during the forecast period, the high prevalence of heart failure in the nation is anticipated to boost demand for leadless cardiac pacemakers. Also, Medtronic Plc holds more than 90% of the global market for leadless pacemakers.


  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the Leadless Pacemakers Market by technology, by indication, 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— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape mapping- product launches, technological advancements, mergers and expansions

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Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Leadless Pacemakers Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Leadless Pacemakers Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Leadless Pacemakers Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Leadless Pacemakers Market, By Technology Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Micra Transcatheter Pacing System
        2. Nanostim Leadless Pacemakers
        3. Wireless Cardiac Simulation System

  • 8.   Leadless Pacemakers Market, By Indication Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Atrial Fibrillation
        2. High Degree Atrioventricular Block
        3. Sinus node dysfunction
        4. Others

  • 9.   Leadless Pacemakers Market, By End user Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Hospitals
        2. ASCs

  • 10.   North America Leadless Pacemakers Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 11.   Latin America Leadless Pacemakers Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 12.   Europe Leadless Pacemakers Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 13.   Asia Pacific Leadless Pacemakers Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 14.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 15.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 16.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. Medtronics
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. St. Jude Medical LLC (Abbott Laboratories)
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Biotronic
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Boston Scientific
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Edwards Lifesciences
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Sorin Group
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Vitatron
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Lepu Medical
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. Terumo Corp.
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview

  • 17.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the regulations initiated by healthcare administrations
        5. The overall economic slowdown of the developing and developed nations
  • 18.   FutureWise SME Key Takeaway Points for Client
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