Leadless Pacemakers Market Size, Share & Trends Analysis Report, By Pacing Chamber (Single Chamber, Dual Chamber), By End-use (Hospitals, Outpatient Facilities), By Region, And Segment Forecasts, 2024 - 2030

Leadless Pacemakers Market Size & Trends

The global leadless pacemakers market size was estimated at USD 625.47 million in 2023 and is expected to grow at a CAGR of 15.5% from 2024 to 2030. This is due to several factors, such as the growing geriatric population susceptible to cardiovascular diseases, increasing incidence of bradyarrhythmia, growing product approvals in developed countries, lucrative product pipeline for leadless pacemakers, and its benefits over the traditional pacemakers. According to the Cleveland Clinic, bradycardia symptoms are prevalent in 1 out of every 600 adults aged over 65. 

Moreover, the demand for leadless pacemakers is constantly growing due to the rising prevalence of arrhythmias that are generally severe or fatal, and the survival rate in numerous countries is low, mainly in cases of out-of-hospital attacks.As per reports published by the National Library of Medicine in June 2023, the anticipated prevalence of arrhythmias in general population was projected to range between 1.5% and 5%. Among these cardiac irregularities, atrial fibrillation (AF) is the most common subtype. Moreover, as per reports published by the Centers for Disease Control and Prevention (CDC), the prevalence of AF in the U.S. is likely to reach around 12.1 million individuals by 2030. In addition, leadless pacemakers are implanted in patients suffering from abnormal heart rhythms, especially those with heartbeats lower than 100 bpm, such as bradycardia. According to an NCBI article published in December 2023, the prevalence of bradycardia varies between 0.5% and 2.0% globally. 

According to WHO, the global population aged 60 and above is expected to increase significantly from around 1 billion in 2020 to about 1.4 billion in 2030 and almost double to around 2.1 billion by 2050. The number of elderly patients suffering from critical illnesses has significantly increased in recent years.

The above figure showcases the opportunity for the leadless pacemaker’ manufacturers to acquire the existing share from conventional pacemakers. Leadless pacemakers are a revolutionary advancement in cardiac technology that has the potential to replace conventional pacemakers. According to an article by the NCBI in June 2022, approximately 1.2 million pacemaker implantations are recorded annually. Furthermore, Abbott estimates that nearly 80% of patients require pacing of both the upper and lower chambers of the heart. The dual chamber leadless pacing system can pierce both the atria and ventricles, thereby reducing complications associated with traditional pacemakers. 

The reduced risk of infection and complications compared to traditional pacemakers further propels the market growth worldwide. Traditional pacemakers are being rapidly adopted in patients aged 18 and below. A research study led by the Children's Hospital of Philadelphia (CHOP) in April 2023 found leadless pacemakers to be safe for pediatric use. According to the research, only 16% of the pediatric patients undergoing leadless pacemaker implantation experienced a minor complication. In addition, in July 2023, the Children's Hospital Colorado Heart Institute implanted Abbott's first AVEIR leadless pacemaker for an 18-year-old patient. The patient suffered from severe vasovagal syndrome, a condition in which the heart rate drops rapidly in response to stress. 

Furthermore, the market is expected to benefit due to the growing product pipeline. For instance, Boston Scientific is becoming an upcoming competitor in the leadless pacemaker defibrillator system segment. In December 2022, the Cleveland Clinic successfully implanted Boston Scientific's leadless pacemaker defibrillator system in the first two patients globally as part of a clinical trial. Similarly, in July 2021, MicroPort Scientific Corporation announced the development of a leadless pacemaker with an aim to commercialize the product by 2028. 

Moreover, the increasing market demand is attributed to the rising prevalence of cardiovascular diseases, such as atrial fibrillation and bradycardia, globally. This is due to several factors, including an unhealthy lifestyle, obesity, and diabetes. According to the CDC, in June 2022, 37.3 million were diagnosed with diabetes. The prevalence of diabetes stands as a contributing factor to the onset of heart diseases, ultimately boosting the pacemaker market. 

Market Concentration & Characteristics

The market growth stage is high, and the pace of growth is accelerating. The leadless pacemakers industry is characterized by a high degree of innovation. Technological advancements in the market have been focused on improving device performance. The miniaturization of electronics, allowing for the development of smaller devices that can be implanted entirely within the right ventricle (RV), and the introduction of self-contained systems such as the Aveir and Micra have revolutionized leadless pacing. The development of a dual-chamber leadless pacemaker represents a significant advancement in the field of cardiac pacing technology. As demonstrated in the Aveir DR i2i trial, patients who require dual chamber pacing are offered the benefits of leadless technology. This innovation allows for atrial pacing and reliable atrioventricular synchrony without the associated risks of conventional pacemakers. 

The leadless pacemaker industry is characterized by a moderate level of merger and acquisition (M&A) activity by the leading players. Companies operating in the market have been actively pursuing mergers and acquisitions to strengthen their market position, expand their product portfolios, and leverage synergies to drive innovation. For instance, in August 2023, Medtronic announced the acquisition of the Penditure device technology from Syntheon LLC, enhancing its cardiac surgery product line to encompass left atrial appendage management.

Regulations play a crucial role in shaping the market. In the U.S., the FDA's Center for Devices and Radiological Health (CDRH) oversees the premarket approval process for leadless pacemakers. This includes reviewing these devices' safety, effectiveness, and quality before granting market authorization. Manufacturers must comply with FDA regulations for medical devices, including premarket notification (510(k)), Premarket Approval (PMA), and Quality System Regulations (QSR) outlined in 21 CFR Part 820.

The development of a dual-chamber leadless pacemaker represents a significant advancement in cardiac pacing technology. As demonstrated in the Aveir DR i2i trial, patients who require dual chamber pacing are offered the benefits of leadless technology. This innovation allows for atrial pacing and reliable atrioventricular synchrony without the associated risks of conventional pacemakers.

The market has been experiencing significant regional expansion as key players continuously develop and promote pacemaker treatments & approaches. For instance, in October 2022, Medtronic received FDA approval for expanded labeling for its SelectSecure MRI Sure Scan Model 3830 cardiac lead. This innovative lead is designed to tap into the heart's natural electrical system, delivering essential therapy to patients while minimizing potential complications commonly associated with traditional pacing methods, such as cardiomyopathy.

Pacing Chamber Insights

The single chamber segment accounted for the largest revenue market share of 54.84% in 2023. Single-chamber leadless pacemakers are suitable for a broader range of patients with bradycardia or heart block. Their simplicity and reliability make them a viable choice for patients who do not require the more advanced features provided by dual-chamber devices. This wider applicability contributes to their market dominance.

The dual chamber segment is estimated to be the fastest growing, with a CAGR of 16.3% during the forecast period. The rapid growth is attributed to their ability to address a broader range of cardiac conditions. The dual-chamber functionality allows for better synchronization of cardiac contractions and improved hemodynamic performance, enhancing patient outcomes. In February 2022, Abbott significantly advanced leadless pacing technology by successfully implanting the world's first patient with its investigational AVEIR dual-chamber leadless pacemaker system.

End-use Insights

The hospital segment dominated the market with a revenue share of 88.86% in 2023. Hospitals significantly influence market growth by functioning as crucial centers for patient recruitment and engagement in these trials. For instance, in March 2022, Cleveland Clinic achieved the first successful implantation of the dual-chamber leadless pacemaker system in a U.S. patient as a part of a global clinical trial. The research assessed the safety, functionality, and efficiency of Abbott's AVEIR leadless pacemaker system.

The outpatient facilities segment is expected to be the fastest growing, with a CAGR of 16.3% during the forecast period. The growth can be attributed to technological advancements, accessible training, and improved patient satisfaction. For instance, the European Society of Cardiology has training centers and offers certifications to various outpatient facilities globally that deal with leadless pacemakers to meet the highest standards.

Regional Insights

North America dominated the global leadless pacemakers market and accounted for 54.92% of the total market share in 2023. The growth can be attributed to technological advancements, increasing heart diseases, and accessibility and availability of skilled professionals. Moreover, in 2020, according to the American Heart Association, Inc., coronary heart disease (CHD) emerged as the primary contributor to cardiovascular disease (CVD)-related fatalities in the U.S., representing 41.2% of such deaths. It emphasizes the imperative for advanced technologies like leadless pacemakers to tackle heart rhythm irregularities linked to CHD and enhance broader cardiovascular health outcomes.

U.S. Leadless Pacemakers Market Trends

Leadless pacemakers market in the U.S.is expected to witness remarkable growth due to factors such as rapid technological advancements, the growing incidence of cardiovascular diseases, and supportive reimbursement policies. The increasing prevalence of heart disease and related conditions is expected to be a key driver of market growth. According to the CDC, heart disease remains the leading cause of death in the U.S., with an estimated 695,000 individuals succumbing to it in 2021. Moreover, various factors, such as the growing elderly population, the rising adoption of cutting-edge technologies, and the increasing demand for minimally invasive procedures, are fueling market expansion.

Europe Leadless Pacemakers Market Trends

The leadless pacemakers market in Europe is expected to exhibit significant growth. A rapidly aging population with a higher prevalence of heart rhythm disorders is a key factor driving market growth. Furthermore, growing awareness and acceptance of this technology are leading to wider adoption. Recent innovations such as dual-chamber leadless pacemakers with atrial pacing capabilities are expected to further propel market expansion. These advancements offer improved physiological pacing and a more natural heartbeat for patients.

UK leadless pacemakers market held a significant share in Europe. The major reason is the rising demand for these devices due to the growing geriatric population, which is more susceptible to bradycardia (slow heart rate). As reported in a 2023 study published in Heart ("89 Leadless pacemaker implantation, data from a tertiary cardiology center in London, UK"), a significant portion of leadless pacemaker recipients at St Thomas' Hospital in London had factors increasing their risk of complications with traditional pacemakers, such as previous infections or unsuitable vein anatomy. Leadless pacemakers offer a safer alternative in these cases.

Leadless pacemakers market in Germany is a major revenue in the European region. Germany showcased the highest pacemaker implant rates among all European countries, indicating a robust market for cardiac devices such as leadless pacemakers. The country's advanced healthcare infrastructure, skilled professionals, and favorable regulatory environment contribute to its prominence in the market. Notably, regulatory processes in Germany are overseen by the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), ensuring stringent quality standards and safety measures for medical devices like leadless pacemakers.

Frances leadless pacemaker market is anticipated to witness significant growth, attributed to the increase in technological advancements. With their benefits over traditional pacemakers, including a lower risk of complications and improved quality of life, leadless pacemakers are an attractive option for both healthcare providers and patients. The French healthcare system's focus on improving overall quality of care and adopting advanced medical technologies is also contributing to the market growth. Regulatory bodies in France, such as the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM), are responsible for evaluating and approving medical devices, including leadless pacemakers.

Asia Pacific Leadless Pacemakers Market Trends

The leadless pacemakers market in Asia Pacific is expected to witness the fastest CAGR of 16.9% over the forecast period. The growth can be attributed to the growing collaborations, increasing health expenditure, government initiatives, increasing CVD, and geographic expansion. For instance, in January 2023, Medtronic obtained regulatory approval from the Ministry of Health, Labor, and Welfare in Japan to distribute and reimburse the Micra AV Transcatheter Pacing System (TPS) commercially. Micra AV TPS is the smallest leadless pacemaker to treat AV block patients.

China leadless pacemakers market is expected to exhibit strong growth, driven by several critical factors, including a rapidly aging population, the rising prevalence of CVDs, and the increasing demand for minimally invasive medical devices. The potential for reduced healthcare costs and improved efficiency of procedures has also made leadless pacemakers an attractive option for healthcare providers and patients in China. In addition to these cost benefits, the demand for leadless pacemakers is expected to grow due to the rising emphasis on patient satisfaction and improved quality of life. Moreover, in terms of regulation, medical devices in China, including leadless pacemakers, are subject to rigorous safety and efficacy evaluations overseen by the National Medical Products Administration.

Leadless pacemakers market in Australia is expected to show lucrative growth. The regulatory process for medical devices, including leadless pacemakers, is overseen by the Therapeutic Goods Administration (TGA). TGA is responsible for evaluating and approving medical devices based on their safety, quality, and effectiveness. The regulatory approval process for leadless pacemakers in Australia involves rigorous assessments of clinical data, manufacturing processes, and quality control measures. Recent instances in the market include the successful implantation of leadless pacemakers in several hospitals, showcasing the growing adoption of these devices in Australia's healthcare system.

India leadless pacemakers market is witnessing a surge in growth, fueled by various factors such as the increasing incidence of cardiovascular disorders, expanding healthcare infrastructure, and a growing awareness of advanced cardiac care options. The adoption of leadless pacemakers in India is driven by their advantages over traditional pacemakers, including reduced risks of infection and lead-related complications, as well as a more comfortable patient experience. This trend is particularly pronounced among patients in India seeking minimally invasive treatment options, contributing to the rapid expansion in the market. In October 2023, doctors at Chandan Hospital successfully implanted a leadless pacemaker in a 65-year-old man. This achievement highlights the growing expertise and adoption of advanced cardiac care techniques in India.

Latin America Leadless Pacemakers Market Trends

The leadless pacemakers market in Latin America is expected to grow lucratively during the forecast period. The increasing prevalence of CVDs in the region is creating a higher demand for advanced cardiac care options such as leadless pacemakers. Moreover, there is a growing awareness among healthcare providers and patients in Latin America about the advantages of leadless pacemakers compared to traditional ones, including reduced risks of infection and lead-related complications. Furthermore, advancements in medical technology and improvements in the region's healthcare infrastructure are propelling the market expansion.

Brazil leadless pacemakers market is expected to grow significantly. The adoption of advanced leadless pacemakers, such as Medtronic's Micra AV and Micra VR Pacemakers, showcases Brazil's readiness to embrace cutting-edge cardiac technologies. As healthcare infrastructure improves and awareness regarding advanced cardiac devices increases, the demand for leadless pacemaker systems is expected to grow in Brazil, positioning the country as a key market for these innovative medical devices. In Brazil, the regulatory process for medical devices, including leadless pacemakers, is overseen by the Brazilian Health Regulatory Agency (ANVISA).

The leadless pacemakers market in Mexico is witnessing significant growth due to various factors, such as the increasing prevalence of cardiovascular diseases, rapid advancements in medical technology, and a growing awareness of advanced cardiac care options. Leadless pacemakers offer several advantages over traditional pacemakers, including reduced risks of infection & lead-related complications and improved patient comfort. These factors are driving the adoption of leadless pacemakers in Mexico, with more healthcare providers and patients opting for these innovative devices.

MEA Leadless Pacemakers Market Trends

The leadless pacemakers market in MEA is expected to grow steadily during the forecast period due to the growing focus on improving healthcare infrastructure and access to advanced medical technologies in the region. Government initiatives in several countries are playing a crucial role. For instance, Saudi Arabia's Vision 2030 healthcare transformation plan emphasizes adopting innovative medical technologies. This, coupled with increasing investments in healthcare facilities, is creating a more receptive environment for leadless pacemakers.

South Africa leadless pacemakers market is expected to witness significant growth in the coming years owing to the country's increasing geriatric population. For instance, according to the Republic of South Africa's Census 2022, around 5 million people were aged more than 60, constituting 9.2% of the total population. The rising number of people with disabilities countrywide is also boosting market demand.

The leadless pacemakers market in Saudi Arabia is growing at a rapid rate owing to the launch of innovative leadless pacemakers like Medtronic's Micra AV & VR Pacemakers in the market, indicating a growing trend of embracing cutting-edge cardiac technologies in the region. The demand for leadless pacemakers is expected to rise in Saudi Arabia as healthcare infrastructure improves, awareness regarding advanced cardiac devices increases, and patients seek minimally invasive treatment options for cardiac arrhythmias. This trend positions Saudi Arabia as a key market for leadless pacemakers within the Middle East region, reflecting the country's commitment to providing state-of-the-art healthcare solutions to its population.

Key Leadless Pacemakers Company Insights

The market is less competitive, with a few manufacturers. The market players are focusing on various strategic initiatives such as new product launches, geographical expansion, mergers and acquisitions, collaboration, product upgradation, and partnerships. For instance, in July 2023, the U.S. Food and Drug Administration (FDA) approved Abbott's leadless pacemaker, the AVEIR dual chamber (DR). It is designed to address patients with irregular heart rhythms.

Recent Developments

• In January 2024, Medtronic received CE Mark approval for its leadless devices,  Micra AV2 and Micra VR2. With this approval, the next-generation devices will be commercially available in the European region.

• In July 2023, Abbott's AVEIR DR, the first dual-chamber leadless pacemaker, received FDA approval. This innovation in leadless pacing technology treats abnormal or slow heart rhythms, expanding access to therapy for millions in the U.S.

• In May 2023, Medtronic's Micra AV2 and Micra VR2, the latest generation of miniaturized, leadless pacemakers, received FDA approval. This advancement in pacemaker technology offers longer battery life and simpler programming, expanding access to this therapy for patients.

Leadless Pacemakers Devices Market Report Scope

Global Leadless Pacemakers Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global leadless pacemakers market report based on pacing chamber, end-use, and region:

• Pacing Chamber Outlook (Revenue, USD Million, 2018 - 2030­)

  • Single Chamber

  • Dual Chamber

• End-use Outlook (Revenue, USD Million, 2018 - 2030­)

  • Hospitals

  • Outpatient Facilities

• Regional Outlook (Revenue, USD Million, 2018 - 2030­)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Norway

    • Sweden

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait