Global Leadless Pacemakers Market Size, Share & Industry Trends Analysis Report By Type (Micra Transcatheter Pacing System, and Others), By End-use (Hospitals, and Outpatient Facilities), By Regional Outlook and Forecast, 2023 - 2030

Global Leadless Pacemakers Market Size, Share & Industry Trends Analysis Report By Type (Micra Transcatheter Pacing System, and Others), By End-use (Hospitals, and Outpatient Facilities), By Regional Outlook and Forecast, 2023 - 2030

The Global Leadless Pacemakers Market size is expected to reach $827.7 million by 2030, rising at a market growth of 15.2% CAGR during the forecast period.

European patients and healthcare providers are increasingly valuing minimally invasive procedures. Thus, the European region would register nearly 28% share of the market by 2030. The catheter-based implantation of leadless pacemakers eliminates the need for surgical pockets and leads, reducing pain, scarring, and recovery time. Europe possesses a well-developed healthcare infrastructure with advanced medical facilities and resources. Many outpatient facilities as well as hospitals in this region are equipped to perform leadless pacemaker implantations and provide necessary follow-up care.

The major strategies followed by the market participants are Mergers & Acquisitionas the key developmental strategy to keep pace with the changing demands of end users. For instance, In August, 2022, Medtronic plc completed the acquisition of Affera, Inc., expanding its cardiac ablation portfolio with the addition of a groundbreaking cardiac mapping and navigation platform, featuring a fully integrated diagnostic, focal pulsed field, and radiofrequency ablation solution. Moreover, In April, 2023, Abbott Laboratories completed the acquisition of Cardiovascular Systems, Inc. (CSI), a medical device company known for its innovative atherectomy system in the treatment of peripheral and coronary artery disease. This acquisition enhances Abbott's offerings for vascular disease treatment, incorporating CSI's leading atherectomy system, which prepares vessels for angioplasty or stenting to restore blood flow.

Based on the Analysis presented in the KBV Cardinal matrix; Medtronic PLC and Abbott Laboratories are the forerunners in the Market. Companies such as Boston Scientific Corporation, Integer Holdings Corporation and Terumo Corporation are some of the key innovators in the Market. In September, 2023, Boston Scientific Corporation announced the acquisition of Relievant Medsystems, Inc., a privately held medical device company specializing in vertebrogenic pain treatment. This acquisition enables the integration of Relievant Medsystems' clinically backed technology with Boston Scientific's strategies, expanding treatment options for individuals in need of personalized care.

COVID-19 Impact

During the pandemic, many hospitals and healthcare facilities postponed or canceled elective procedures to free up resources and reduce the risk of virus transmission. This led to a decrease in leadless pacemaker implantations, as these procedures are often considered elective and non-urgent. The global supply chain for medical devices, including leadless pacemakers, experienced disruptions due to lockdowns and restrictions on manufacturing and transportation. This led to delays in the availability of devices and potentially impacted patients' access to these advanced technologies. Hospitals and healthcare providers redirected resources and staff to handle the surge of COVID-19 cases. This diversion of attention and resources from non-COVID medical services affected the promotion and implantation of leadless pacemakers.

Market Growth Factors

Growing demand for minimally invasive procedures

The development of minimally invasive procedures has decreased the need for lead placement and surgical incisions, lowering surgical risks and enhancing patient comfort. This reduction in invasiveness has not only translated into enhanced patient safety but also quicker recovery times. Patients undergoing leadless pacemaker implantation experience shorter hospital stays and reduced post-operative discomfort. This quick recovery benefits patients by allowing them to return to their daily routines and activities more swiftly. These procedures have opened up new possibilities for remote and rural healthcare settings, where access to healthcare facilities may be limited. As a result, the rapidly increasing demand for minimally invasive procedures will aid in the expansion of the market.

Rising prevalence of cardiac arrhythmias

The rising prevalence of cardiac arrhythmias is a complex interplay of multiple factors, from demographic changes to lifestyle choices and advances in healthcare. High blood pressure is a well-established risk factor for arrhythmias. It can lead to changes in the heart's structure and electrical signaling, increasing the likelihood of arrhythmias. Similarly, diabetes is associated with an increased risk of arrhythmias, particularly atrial fibrillation. Furthermore, the prevalence of arrhythmias is not limited to specific age groups; it affects individuals across various demographics. Patients of all ages who experience cardiac arrhythmias, from the elderly to younger individuals, can benefit from these devices. Therefore, the rising prevalence of arrhythmias is boosting the demand for leadless pacemakers.

Market Restraining Factors

Regulatory and reimbursement challenges

Regulatory challenges, such as the complex and lengthy approval process for medical devices, can significantly delay the introduction of leadless pacemakers. Regulatory agencies require thorough evaluations of safety and efficacy, leading to prolonged timeframes for product clearance. Delays in regulatory approval not only hinder patients' access to advanced medical solutions but also increase the time-to-market for manufacturers, impacting their ability to offer cutting-edge devices. The economic burden of these devices can deter both healthcare providers and patients from choosing leadless pacemakers as a pacing solution despite their potential benefits. Such financial burdens may discourage some individuals from opting for these devices, especially if more cost-effective alternatives are available. All these factors may hamper the growth of the market.

Type Outlook

Based on type, the market is bifurcated into micra transcatheter pacing system and others. The other segment procured a considerable growth rate in the market in 2022. Leadless pacemakers, including devices like Nanostim and WiSE CRT System, offer several benefits compared to traditional pacemakers with leads. Nanostim is remarkably compact, similar in size to a large vitamin capsule. This small size allows for a less invasive procedure and results in a more unobtrusive and comfortable implantation. The WiSE CRT System is designed for cardiac resynchronization therapy, a treatment for heart failure. It offers the benefits of cardiac resynchronization without the need for traditional pacing leads. Both Nanostim and the WiSE CRT System provide significant advantages, such as minimally invasive implantation, compact designs, reduced infection risk, cosmetic benefits, and long-lasting battery life.

End-use Outlook

On the basis of end-use, the market is divided into hospitals and outpatient facilities. The hospitals segment acquired the largest revenue share in the market in 2022. Hospitals can efficiently allocate resources, as there is no need for specialized surgical suites or surgical teams dedicated to pacemaker implantations. This can lead to cost savings and the reallocation of resources to other critical medical procedures. With no leads that exit the body, the risk of infections related to lead entry sites is virtually eliminated. Hospitals can benefit from reduced rates of device-related infections.

Regional Outlook

Region-wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment witnessed the maximum revenue share in the market in 2022. The demand for leadless pacemakers is steadily increasing in North America due to several factors contributing to their growing adoption in the region. These factors highlight the evolving landscape of cardiac pacing technology and the shift towards more patient-centric, minimally invasive, and technologically advanced options for treating cardiac arrhythmias. Leadless pacemakers eliminate the need for leads that can be susceptible to infection. In regions like North America, where infection control is a priority, this feature is highly valued.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Medtronic PLC, Abbott Laboratories, Boston Scientific Corporation, Biotronik SE & Co. KG, Lepu Medical Technology Co., Ltd, Integer Holdings Corporation, MicroPort Scientific Corporation, Osypka AG, Terumo Corporation, and EBR Systems, Inc.

Strategies Deployed in Leadless Pacemakers Market

Partnerships, Collaborations, and Agreements:

Jul-2022: Medtronic plc has formed a strategic partnership with CathWorks, a privately held company headquartered in Kefar Sava, Israel, investing up to $75 million and co-promoting the FFRangio System globally. The agreement included an option for Medtronic to acquire CathWorks based on milestones, with CathWorks having the right to compel the acquisition if Medtronic opts out.

Sep-2021: Terumo Cardiovascular partnered with Etiometry to provide enhanced monitoring insights for adult cardiac surgery patients. This collaboration expanded technologies and enabled the utilization of clinical-decision support tools throughout a patient's hospital stay, offering a more comprehensive view of critical data for improved and informed bedside decisions during the transition from the operating room to the ICU.

Product Launches and Product Expansions:

Feb-2022: Abbott Laboratories has revealed the world's first patient implants of a dual-chamber leadless pacemaker system in its AVEIR DR i2i™ pivotal clinical study. The implant of Abbott's investigational Aveir dual-chamber leadless pacemaker marks a notable technological milestone in leadless pacing, representing the first such occurrence globally within the pivotal trial.

Jan-2022: Medtronic received regulatory approval and launched the Micra AV Transcatheter Pacing System in Japan. This pacemaker was designed to treat patients with AV block, addressing impaired electrical signals between the heart's chambers. The Micra TPS is the world's first leadless pacemaker, with the initial version (Micra VR) approved in Japan in 2017 for patients requiring single-chamber pacing.

Jun-2021: Medtronic PLC has introduced the MICRA AV, a pacemaker smaller than conventional ones, offering a leadless and minimally invasive solution for patients with complete heart block. This innovation, following Medtronic's legacy of inventing and disrupting, provides a cosmetically invisible option for those in need.

Acquisition and Mergers:

Sep-2023: Boston Scientific Corporation has announced the acquisition of Relievant Medsystems, Inc., a privately held medical device company specializing in vertebrogenic pain treatment. This acquisition enables the integration of Relievant Medsystems' clinically backed technology with Boston Scientific's strategies, expanding treatment options for individuals in need of personalized care.

Apr-2023: Abbott Laboratories completed the acquisition of Cardiovascular Systems, Inc. (CSI), a medical device company known for its innovative atherectomy system in the treatment of peripheral and coronary artery disease. This acquisition enhances Abbott's offerings for vascular disease treatment, incorporating CSI's leading atherectomy system, which prepares vessels for angioplasty or stenting to restore blood flow.

Aug-2022: Medtronic plc completed the acquisition of Affera, Inc., expanding its cardiac ablation portfolio with the addition of a groundbreaking cardiac mapping and navigation platform, featuring a fully integrated diagnostic, focal pulsed field, and radiofrequency ablation solution.

May-2022: Medtronic PLC completed the acquisition of Intersect ENT, integrating PROPEL and SINUVA into its portfolio. PROPEL implants, maintaining sinus patency and delivering steroids, and SINUVA implants, treating nasal polyps in ethmoid sinus surgery patients, are now part of Medtronic's offerings.

Feb-2022: Boston Scientific has completed the acquisition of Baylis Medical Company Inc. This integration enables Boston Scientific to incorporate Baylis platforms into its existing electrophysiology and structural heart offerings, reinforcing its position in the rapidly growing cardiology markets.

Sep-2021: Boston Scientific Corporation completed the acquisition of Devoro Medical, Inc., a developer of a medical device intended to restore blood flow. Through this acquisition, the WOLF Thrombectomy Platform was integrated into Boston Scientific's products. Additionally, this acquisition provided the physicians with the necessary tools needed for the treatment.

Trials and Approval:

Dec-2022: Biotronik SE & Co. KG has initiated the first patient enrollment in BIO-CONDUCT, an FDA-approved investigational device exemption (IDE) trial. The study examines the use of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area, a location not currently approved for the Solia S lead.

Dec2021: Boston Scientific Corporation has started the MODULAR ATP clinical trial to assess the mCRM Modular Therapy System, which includes the EMBLEM™ MRI S-ICD System and the EMPOWER™ MPS, aiming to be the first leadless pacemaker capable of delivering bradycardia pacing support and antitachycardia pacing (ATP).

Scope of the Study

Market Segments covered in the Report:

By Type

• Micra Transcatheter Pacing System
• Others

By End-use

• Hospitals
• Outpatient Facilities

By Geography

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
• Germany
• UK
• France
• Russia
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• South Korea
• Singapore
• Malaysia
• Rest of Asia Pacific
• LAMEA
• Brazil
• Argentina
• UAE
• Saudi Arabia
• South Africa
• Nigeria
• Rest of LAMEA

Companies Profiled

• Medtronic PLC
• Abbott Laboratories
• Boston Scientific Corporation
• Biotronik SE & Co. KG
• Lepu Medical Technology Co., Ltd
• Integer Holdings Corporation
• MicroPort Scientific Corporation
• Osypka AG
• Terumo Corporation
• EBR Systems, Inc.

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