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全球经导管心律调节系统 (TPS) 市场 - 2024-2031

Global Transcatheter Pacing System (TPS) Market - 2024-2031

出版日期: 2024年12月04日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2个工作天内

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简介目录

概述

2023年，全球经导管心律调节系统（TPS）市场规模达20.849亿美元，预计2031年将达到45.181亿美元，2024-2031年预测期间复合年增长率为10.2%。

经导管心律调节系统 (TPS) 是一种尖端的心臟节律技术，可透过导管将心律调节器直接植入心臟，因此无需手术导线。该系统经过专门设计，可向心臟传递电脉衝，确保为经历各种类型心搏过缓的患者保持适当的心率。

经导管起搏系统 (TPS) 设备无需导线即可操作，这显着降低了感染和导线移位等併发症的风险。植入过程是透过静脉引入的导管进行的，通常可以缩短恢復时间并减少患者的不适。 Micra TPS 等设备明显小于传统起搏器，直径不到 2.5 厘米，这简化了植入过程并增强了体内的可管理性。这些因素推动了全球经导管起搏系统（TPS）市场的扩张。

市场动态：

驱动程式和限制

心血管疾病盛行率增加

心血管疾病盛行率的增加极大地推动了全球经导管起搏系统（TPS）市场的成长，预计将在整个市场预测期内推动成长。

心臟相关疾病，尤其是房室（AV）传导阻滞的发生率不断增加，是推动经导管起搏系统（TPS）市场成长的重要因素。当调节心室的电讯号受到干扰时，就会发生房室传导阻滞，这可能会导致心臟功能低下和严重的健康併发症。随着越来越多的人被诊断出患有 AV 传导阻滞，对有效起搏解决方案（例如 Micra AV 等先进设备）的需求正在增加。

被诊断患有房室传导阻滞的患者数量正在增加，这主要是由于人口老化和心血管疾病的增加。高血压、糖尿病和心臟衰竭等疾病会显着导致心臟内电传导的下降。报告表明，包括房室传导阻滞在内的缓慢性心律不整在老年人中尤其普遍，每 600 名 65 岁以上的人中约有 1 人受影响。

例如，根据 NCBI 2024 年 2 月的一份研究出版物，房室传导阻滞的确切盛行率尚未确定，主要是因为没有专门检查其频率的全面的基于人群的研究。然而，据估计，自体抗体介导的先天性房室传导阻滞的发生率约为每 15,000 名新生儿中就有 1 人发生。所有这些因素都需要经导管起搏系统（TPS）。

此外，关键参与者的策略（例如伙伴关係和协作以及产品发布）将推动全球经导管起搏系统（TPS）市场的成长。例如，2021年7月，微创科学公司子公司微创心律管理有限公司宣布巨额投资1.5亿美元，旨在推动植入式装置和除颤器的开发。这项投资强调了该公司对心臟护理创新的承诺，特别是在心律管理领域。

此外，2021年1月，美敦力推出了Micra AV，这是世界上最小的起搏器，专为房室传导阻滞患者设计。这种创新设备代表了心臟节律技术的重大进步，提供了微创治疗方法。所有这些因素都需要全球经导管起搏系统（TPS）市场。

此外，对无引线起搏器的需求不断增长有助于全球经导管起搏系统（TPS）市场的扩张。

设备成本高

设备的高成本将阻碍全球经导管心律调节系统（TPS）市场的成长。

设备的高成本是全球经导管起搏系统 (TPS) 市场的重大限制，影响了这些先进技术的采用以及需要心臟起搏解决方案的患者的可及性。

手术时间可能成为市场上昂贵设备的关键因素。美敦力 (Medtronic) 的 Micra 预计售价约为 10,000 美元，而传统起搏器的平均售价通常约为 2,500 美元。我们的假设是，手术成本的降低将使 Micra 成为一种具有成本效益的选择。即使程序时间的微小减少也可能显着影响这些设备的整体成本效益，凸显了采用效率的重要性。

许多医院和诊所的运作都受到严格的预算限制，特别是在医疗资金有限的地区。与经导管心律调节系统 (TPS) 相关的高成本可能会限制医疗机构取得这些设备的能力，导致他们倾向于更传统、更具成本效益的替代方案。经导管起搏系统 (TPS) 相关的成本上升可能会造成市场鸿沟，只有较富裕的患者或已开发国家的患者才能负担得起这些先进技术。这种细分限制了製造商的潜在客户群，并可能减缓整体经导管起搏系统（TPS）市场的扩张，特别是在预算限制更为明显的新兴市场。

因此，上述因素可能限制全球经导管节律系统（TPS）市场的潜在成长。

A transcatheter pacing system (TPS) is a cutting-edge cardiac pacing technology that facilitates the direct implantation of a pacemaker into the heart using a catheter, thereby removing the necessity for surgical leads. This system is specifically engineered to deliver electrical impulses to the heart, ensuring it maintains an appropriate heart rate for patients experiencing various types of bradycardia.

Transcatheter pacing system (TPS) devices operate without leads, which significantly lowers the risk of complications such as infections and lead dislodgement. The implantation process is conducted via a catheter introduced through a vein, often leading to quicker recovery times and reduced patient discomfort. Devices such as the Micra TPS are notably smaller than traditional pacemakers, measuring under 2.5 cm in diameter, which simplifies the implantation process and enhances manageability within the body. These factors have driven the global transcatheter pacing system (TPS) market expansion.

Market Dynamics: Drivers & Restraints

Increasing Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases is significantly driving the growth of the global transcatheter pacing system (TPS) market and is expected to drive throughout the market forecast period.

The increasing incidence of heart-related conditions, especially atrioventricular (AV) block, is a significant factor driving the growth of the transcatheter pacing system (TPS) market. AV block occurs when the electrical signals that regulate the heart's chambers are disrupted, which can lead to inefficient heart function and serious health complications. As more individuals are diagnosed with AV block, the need for effective pacing solutions, such as advanced devices like the Micra AV, is on the rise.

The number of patients diagnosed with AV block is rising, largely due to an aging population and an increase in cardiovascular diseases. Conditions like hypertension, diabetes, and heart failure contribute significantly to the decline in electrical conduction within the heart. Reports indicate that bradyarrhythmias, including AV block, are particularly prevalent among older adults, affecting approximately 1 in every 600 individuals over the age of 65.

For instance, according to an NCBI research publication in February 2024, the exact prevalence of AV blocks is not well established, primarily because there are no comprehensive population-based studies that specifically examine their frequency. However, it is estimated that autoantibody-mediated congenital AV block occurs in about 1 in every 15,000 births. All these factors demand the transcatheter pacing system (TPS).

Furthermore, key players' strategies such as partnerships & collaborations, and product launches would drive this global transcatheter pacing system (TPS) market growth. For instance, In July 2021, MicroPort Cardiac Rhythm Management Limited, a subsidiary of MicroPort Scientific Corporation, announced a significant investment of US$150 million aimed at advancing the development of implantable devices and defibrillators. This investment underscores the company's commitment to innovation in cardiac care, particularly in the realm of heart rhythm management.

Also, in January 2021, Medtronic launched the Micra AV, the world's smallest pacemaker designed specifically for patients with atrioventricular (AV) block. This innovative device represents a significant advancement in cardiac pacing technology, offering a minimally invasive approach to treatment. All these factors demand the global transcatheter pacing system (TPS) market.

Moreover, the rising demand for leadless pacemakers contributes to the global transcatheter pacing system (TPS) market expansion.

High Costs of Devices

The high costs of devices will hinder the growth of the global transcatheter pacing system (TPS) market.

The high costs of devices represent a significant restraint within the global transcatheter pacing system (TPS) market, impacting both the adoption of these advanced technologies and their accessibility to patients in need of cardiac pacing solutions.

Procedural time could become a crucial factor for the costly devices in the market. Medtronic's Micra is estimated to be priced around $10,000, while traditional pacemakers typically average about $2,500. The assumption is that savings from reduced surgical costs would make the Micra a cost-effective option. Even minor reductions in procedural time could significantly influence the overall cost-effectiveness of these devices, highlighting the importance of efficiency in their adoption.

Many hospitals and clinics operate under strict budget constraints, particularly in areas with limited healthcare funding. The high costs associated with transcatheter pacing system (TPS)can restrict healthcare facilities' ability to acquire these devices, leading them to favor more traditional, cost-effective alternatives. The elevated costs associated with transcatheter pacing system (TPS) can create a divide in the market, where only wealthier patients or those in developed countries can afford these advanced technologies. This segmentation restricts the potential customer base for manufacturers and may slow overall transcatheter pacing system (TPS) market expansion, particularly in emerging markets where budget constraints are more pronounced.

Thus, the above factors could be limiting the global transcatheter pacing system (TPS) market's potential growth.

Segment Analysis

The global transcatheter pacing system (TPS) market is segmented based on product type, application, end-user, and region.

Product Type:

The leadless pacemakers segment is expected to dominate the global transcatheter pacing system (TPS) market share

The leadless pacemakers segment holds a major portion of the global transcatheter pacing system (TPS) market share and is expected to continue to hold a significant portion of the global transcatheter pacing system (TPS) market share during the forecast period.

Leadless pacemakers are advanced, compact devices engineered to deliver electrical impulses directly to the heart, ensuring it maintains a proper rhythm and rate. Unlike traditional pacemakers that rely on leads and external components, leadless pacemakers are self-contained units implanted directly into the heart. This innovation in cardiac care technology offers numerous significant advantages.

Leadless pacemakers are typically inserted through a catheter that is guided via a vein in the leg (usually the femoral vein). This approach greatly reduces the need for invasive surgical procedures associated with traditional pacemaker implantation, which often requires an incision in the chest and the placement of leads that connect to the heart. The catheter-based method minimizes surgical risks, such as infections and complications related to larger surgical wounds. Thus, all these factors demand the transcatheter pacing system (TPS).

Furthermore, key players in the industry have technological advancements and investments in leadless pacemakers that would drive this segment's growth in the global transcatheter pacing system (TPS) market. For instance, in February 2022, Abbott announced a significant advancement in cardiac pacing technology with the successful implantation of the AVEIR dual-chamber leadless pacemaker system as part of its AVEIR DR i2i pivotal clinical study. This milestone marks the world's first patient implants of a dual-chamber leadless pacemaker, representing a groundbreaking development in leadless pacing technology.

Also, in April 2022, Cairdac SAS successfully closed its first funding round, raising nearly $18.5 million to further develop its innovative autonomous leadless pacemaker system known as ALPS (Autonomous Leadless Pacing System). This funding round saw participation from five French private equity funds and banks, highlighting strong investor confidence in Cairdac's technology and its potential impact on cardiac care. These factors have solidified the segment's position in the global transcatheter pacing system (TPS) market.

Geographical Analysis

North America is expected to hold a significant position in the global transcatheter pacing system (TPS) market share

North America holds a substantial position in the global transcatheter pacing system (TPS) market and is expected to hold most of the market share.

The increasing prevalence of heart-related conditions, particularly bradyarrhythmia and atrioventricular (AV) block, is a major driver for the transcatheter pacing system (TPS) market. As the population ages and lifestyle-related health issues become more common, there is a heightened demand for effective cardiac pacing solutions to manage these conditions.

According to the CDC, heart disease remains the leading cause of death among men, women, and various racial and ethnic groups. It claims a life every 33 seconds due to cardiovascular disease. In 2022, heart disease resulted in 702,880 fatalities, accounting for one in five deaths. The economic impact of heart disease is substantial, costing approximately $252.2 billion from 2019 to 2020. This figure encompasses healthcare services, medications, and lost productivity due to premature death in the U.S.

Ongoing advancements in pacing technology, such as the introduction of leadless pacemakers and sophisticated algorithms for synchronized pacing, are enhancing the safety and effectiveness of transcatheter systems. These innovations attract healthcare providers and patients who are looking for modern treatment options that minimize complications associated with traditional pacemakers.

Moreover, in this region, a major number of key players' presence, well-advanced healthcare infrastructure, strong investment in research and development, favorable regulatory environment, and product launches & approvals help to propel this global transcatheter pacing system (TPS) market. For instance, in May 2023, Medtronic plc announced that it received U.S. Food and Drug Administration (FDA) approval for its next-generation leadless pacemakers, the Micra AV2 and Micra VR2. These devices represent a significant advancement in cardiac pacing technology, building on the success of the original Micra pacemaker, which was the first leadless device approved by the FDA.

Also, in July 2023, Abbott recently announced that the U.S. Food and Drug Administration (FDA) has approved its AVEIR dual chamber (DR) leadless pacemaker system, marking a significant milestone as it becomes the world's first dual chamber leadless pacing system. This innovative technology is designed to treat patients with abnormal or slow heart rhythms, particularly those who require pacing in both the right atrium and right ventricle of the heart.

Thus, the above factors are consolidating the region's position as a dominant force in the global transcatheter pacing system (TPS) market.

Asia Pacific is growing at the fastest pace in the global transcatheter pacing system (TPS) market

Asia Pacific holds the fastest pace in the global transcatheter pacing system (TPS) market and is expected to hold most of the market share.

The Asia-Pacific region is witnessing rapid population aging, with projections indicating that the number of individuals aged 60 and older will rise from 630 million in 2020 to approximately 1.3 billion by 2050. This demographic shift is expected to lead to a higher prevalence of age-related health issues, particularly cardiovascular diseases. As people age, they become more susceptible to conditions such as bradyarrhythmia and atrioventricular (AV) block, which are linked to the natural decline in cardiac function that occurs with aging. Consequently, there is an increasing demand for effective cardiac pacing solutions to manage these conditions.

For instance, according to The Lancet Regional Health - Western Pacific research publication in August 2024, between 2025 and 2050, crude cardiovascular mortality in Asia is projected to increase by 91.2%, despite a 23.0% decrease in the age-standardized cardiovascular mortality rate (ASMR). Ischaemic heart disease is expected to account for 115 deaths per 100,000 population, while stroke will contribute 63 deaths per 100,000 population, making them the leading causes of ASMR by 2050.

Central Asia will have the highest ASMR at 676 deaths per 100,000 population, which is over three times higher than the overall ASMR for Asia, estimated at 186 deaths per 100,000 population. In contrast, high-income regions within Asia will see an ASMR of only 22 deaths per 100,000. Throughout Asia, high systolic blood pressure will be the primary contributor to ASMR, resulting in 105 deaths per 100,000 population, except in Central Asia, where high fasting plasma glucose levels will dominate with 546 deaths per 100,000 population.

Furthermore, key players in the region product launches & approvals and government initiatives that would drive this global transcatheter pacing system (TPS) market growth. For instance, in January 2022, Medtronic plc announced that it had received approval from Japan's Ministry of Health, Labor, and Welfare for the sale and reimbursement of its Micra AV Transcatheter Pacing System (TPS). This approval is significant as it allows for the launch of the Micra AV, which is the world's smallest leadless pacemaker, in one of the largest medical markets globally.

Thus, the above factors are consolidating the region's position as the fastest-growing force in the global transcatheter pacing system (TPS) market.

Competitive Landscape

The major global players in the transcatheter pacing system (TPS) market include Medtronic, Abbott Laboratories, Boston Scientific Corporation, BIOTRONIK, MicroPort Scientific Corporation., EBR Systems, Inc., Lepu Medical Technology (Beijing) Co., Ltd., Acutus Medical, Inc., AED Brands, and Zoll Medical among others.

Key Developments

In August 2024, MicroPort CRM achieved EU Medical Device Regulation (MDR) approval for three of its pacemakers ALIZEA, BOREA, and CELEA. This approval signifies that these devices meet the stringent safety and efficacy standards set by the European Union for medical devices.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, and product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global transcatheter pacing system (TPS) market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Application
3.3. Snippet by End-User
3.4. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing Prevalence of Cardiovascular Diseases
- 4.1.2. Restraints
  - 4.1.2.1. High Costs of Devices
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Patent Analysis
5.5. Regulatory Analysis
5.6. SWOT Analysis
5.7. Unmet Needs

6. By Product Type

6.1. Introduction
- 6.1.1. Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 6.1.2. Market Attractiveness Index, By Product Type
6.2. Leadless Pacemakers *
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Conventional Pacemakers
- 6.3.1. Single-Chamber Pacemaker
- 6.3.2. Dual-Chamber Pacemaker
- 6.3.3. Biventricular Pacemaker
6.4. Multi-Site Pacing Systems
6.5. Others

7. By Application

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 7.1.2. Market Attractiveness Index, By Application
7.2. Bradycardia*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Atrial Fibrillation
7.4. Heart Block
7.5. Others

8. By End-User

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 8.1.2. Market Attractiveness Index, By End-User
8.2. Hospitals*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Specialty Clinics
8.4. Ambulatory Surgical Centers
8.5. Others

9. By Region

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 9.1.2. Market Attractiveness Index, By Region
9.2. North America
- 9.2.1. Introduction
- 9.2.2. Key Region-Specific Dynamics
- 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.2.6.1. U.S.
  - 9.2.6.2. Canada
  - 9.2.6.3. Mexico
9.3. Europe
- 9.3.1. Introduction
- 9.3.2. Key Region-Specific Dynamics
- 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.3.6.1. Germany
  - 9.3.6.2. U.K.
  - 9.3.6.3. France
  - 9.3.6.4. Spain
  - 9.3.6.5. Italy
  - 9.3.6.6. Rest of Europe
9.4. South America
- 9.4.1. Introduction
- 9.4.2. Key Region-Specific Dynamics
- 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.4.6.1. Brazil
  - 9.4.6.2. Argentina
  - 9.4.6.3. Rest of South America
9.5. Asia-Pacific
- 9.5.1. Introduction
- 9.5.2. Key Region-Specific Dynamics
- 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.5.6.1. China
  - 9.5.6.2. India
  - 9.5.6.3. Japan
  - 9.5.6.4. South Korea
  - 9.5.6.5. Rest of Asia-Pacific
9.6. Middle East and Africa
- 9.6.1. Introduction
- 9.6.2. Key Region-Specific Dynamics
- 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

10.1. Competitive Scenario
10.2. Market Positioning/Share Analysis
10.3. Mergers and Acquisitions Analysis

11. Company Profiles

11.1. Medtronic*
- 11.1.1. Company Overview
- 11.1.2. Product Portfolio and Description
- 11.1.3. Financial Overview
- 11.1.4. Key Developments
11.2. Abbott Laboratories
11.3. Boston Scientific Corporation
11.4. BIOTRONIK
11.5. MicroPort Scientific Corporation.
11.6. EBR Systems, Inc.
11.7. Lepu Medical Technology (Beijing) Co., Ltd.
11.8. Acutus Medical, Inc.
11.9. AED Brands
11.10. Zoll Medical

LIST NOT EXHAUSTIVE