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全球心动过缓治疗设备市场 - 2023-2030

Global Bradycardia Treatment Devices Market - 2023-2030

出版日期: 2023年09月06日 | 出版商:

DataM Intelligence | 英文 186 Pages | 商品交期: 约2个工作天内

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简介目录

概述

2022年，全球心动过缓治疗设备市场规模达到89亿美元，预计到2030年将达到130.7亿美元，2023-2030年预测期间复合年增长率为5.0%。

多年来，全球心动过缓治疗设备市场经历了显着的增长和转变，影响其动态的因素有多种。心率缓慢等心血管疾病的增加、医疗设备的研发和政府投资是影响全球心动过缓治疗设备的关键驱动因素。经过充满挑战的2020年，心动过缓治疗器械行业表现出了良好的韧性和适应性。

政府对心血管疾病的投资，特别是在发展中经济体，将继续推动起搏器的使用，并推动全球心动过缓治疗设备市场的发展。全球心动过缓治疗设备行业越来越重视更好地管理心动过缓。各自的倡议包括使用其他设备，例如用于治疗心动过缓的除颤器，因为它们有时充当起搏器。

窦性心动过缓，占市场份额的三分之一以上。同样，北美在心动过缓治疗设备市场上占据主导地位，占据了超过 1/3 的最大市场份额。该地区在医疗保健领域的快速投资以及全球心动过缓治疗设备市场主要参与者的不断崛起，使其成为最大的市场份额持有者。美国拥有最大的製造商和消费者群体。

动力学

不断增加的新产品发布和监管批准

在高收入水平、投资和基础设施发展的推动下，发达经济体的医疗保健行业不断改善。一些国家对心动过缓治疗设备的需求量很大，反映出它们的医疗保健行业不断扩大。不断增加的新产品发布以及监管部门的批准将成为推动市场增长的关键因素。

2023 年5 月18 日，Alizea 和Celea 植入式起搏器（目前市场上同类尺寸中寿命最长的起搏器）及其相关产品、SmartTouch XT 基于平板电脑的编程器、Vega 起搏导线和SmartView Connect总部位于法国的心律管理领域的全球先驱 MicroPort CRM 表示，蓝牙家用监护仪均已获得 FDA 批准。这代表着患者护理领域的巨大胜利，并体现了该公司对美国市场的奉献精神。 AutoMRI 模式是 MicroPort CRM 创建的突破性算法，是 Alizea 和 Celea 产品的一项功能。

它可以提高患者在进行 MRI 扫描时的安全性和生活质量。要激活 MRI 模式，患者只需在扫描前十天去看心脏病专家一次。一旦模式设置完毕，起搏器在进入MRI视野时会自动切换到MRI模式，并在检查后恢復到默认设置，大大提高了患者和医护人员的工作效率。当植入 Vega 起搏导线时，这些设备被批准用于 1.5 或 3 Tesla MRI 扫描仪。

设备技术进步的数量不断增加

心动过缓治疗设备的不断进步将推动未来一段时间市场的增长。例如，2023 年 5 月 20 日，世界上第一个双腔无引线起搏器收到了雅培双腔 (DR) AVEIR i2i 研究设备豁免 (IDE) 研究的最新成果，表明该起搏器满足其要求安全性和性能的三个预定主要终点。该信息还意味着 AVEIR DR 可能为那些心律慢于正常的人提供新的优势。

凭藉首创的 i2i（植入物到植入物）技术，Abbott 创造了 AVEIR DR 无引线起搏器（DR 代表双腔速率反应），旨在实现逐搏沟通与和谐位于两个无引线起搏器之间，这是双腔无引线起搏治疗的基石。通过相互通信，这两个设备能够感知错过或延迟的心跳，然后对适当的心室进行起搏，这与其他无引线起搏器不同。

与设备相关的频繁召回

过去几年，由于不同原因，多次与这些起搏器相关的召回事件频频发生。例如，波士顿科学公司INGENIO 系列起搏器，也称为心血管再同步治疗起搏器(CRT-P)，用于低心率患者和患有中度至重度心力衰竭（一种心臟功能衰竭的疾病）的患者泵出足够的血液以满足身体的需要。

2021 年 8 月 10 日，由于可能进入安全模式，波士顿科学公司召回了 INGENIO 系列的 CRT-P 和起搏器。如果有问题的设备损坏，安全模式将充当备份。由于检测肌肉收缩，安全模式下存在无意中失去起搏的危险。如果设备进入安全模式，则必须更换该设备，因为它无法重新编程。

使用受影响的产品可能会对健康产生严重的负面影响，例如需要立即更换设备、心率失控或因严重或危及生命的伤害而起搏（例如，医疗保健提供者需要临时起搏）管理受控电脉衝来调节心臟），导致心力衰竭恶化，甚至死亡。已有 65 起事故记录在案，其中 3 起需要对受伤患者进行临时体外起搏。目前还没有任何死亡报告。

与设备相关的并发症或风险

大约 2% 的起搏器使用者会出现血栓。这通常发生在植入起搏器一侧的手臂区域。因此，手臂可能会变大。然而，它通常会在几天内消失。这很少是一个重大问题。 1% 的起搏器感染者受到感染。在使用该设备的第一年，这种情况通常会发生。手术有可能无意中导致肺部破裂。这意味着空气可以从肺部渗入胸部。气胸一词就是指此。

只有 1% 的人受到影响。通常，洩漏确实很小。不需要治疗，因为它会自行好转。起搏器发生故障的可能性很小，就像任何电子设备一样。这称为起搏器错误。如果导线被推离原位、脉衝发生器的电池耗尽或起搏器的控制电路因受到强大磁场而损坏，起搏器可能会发生故障。

Overview

Global Bradycardia Treatment Devices market reached US$ 8.9 billion in 2022 and is expected to reach US$ 13.07 billion by 2030, growing with a CAGR of 5.0% during the forecast period 2023-2030.

The global bradycardia treatment devices market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. Rising cardiovascular disorders such as slow heart rate, research and development and government investments in medical devices are among the key drivers impacting bradycardia treatment devices globally. After the challenging year of 2020, the bradycardia treatment devices industry showed decent resilience and adaptability.

Government investments in cardiovascular disorders, particularly in developing economies, will continue to drive utilization of pacemakers and boost the global bradycardia treatment devices market. The global bradycardia treatment devices industry is placing increasing emphasis on better management of bradycardia. The respective initiatives includes the use of other devices, such as defibrillators for treatment of bradycardia as sometimes they function as pacemakers.

The sinus bradycardia, accounts for over one third of the market share. Similarly, the North America dominates the bradycardia treatment devices market, capturing the largest market share of over 1/3rd. The region's rapid investments in healthcare and rising major players in the bradycardia treatment devices market globally, makes it the largest market share holder. United States has the largest pool of manufacturers as well as consumers.

Dynamics

Growing Novel Product Launches and Regulatory Approvals

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by high income levels, investments and infrastructure development. Several countries have experienced substantial demand for bradycardia treatment devices, reflecting their expanding healthcare industries. Rising novel product launches along with regulatory approvals for the same will be a crucial factor driving the growth of the market.

On May 18, 2023, the Alizea and Celea implantable pacemakers, which are currently the longest-lasting pacemakers for their size on the market, as well as its associated products, SmartTouch XT tablet-based programmer, the Vega pacing leads, and SmartView Connect Bluetooth home monitor, have all received FDA approval, according to MicroPort CRM, a global pioneer in the field of Cardiac Rhythm Management with headquarters in France. This represents a huge victory for patient care and illustrates the firm's dedication to the American market. The AutoMRI mode, a ground-breaking algorithm created by MicroPort CRM, is a feature of the Alizea and Celea products.

It improves patient safety and quality of life while undergoing an MRI scan. To activate the MRI mode, patients just need to see their cardiologist once in the ten days before to their scan. Once the mode is set up, the pacemaker automatically shifts to the MRI mode while entering the MRI field and returns to its default settings after the exam, greatly enhancing the efficiency of both patients and medical personnel. These devices are approved for use in 1.5 or 3 Tesla MRI scanners when implanted with Vega pacing leads.

Rising Number of Technological Advancements in Devices

Rising technological advancements in the devices for treatment of bradycardia will drive the growth of the market in coming period of time. For instance, on May 20, 2023, the first dual-chamber leadless pacemaker in the world received late-breaking outcomes from the dual-chamber (DR) AVEIR i2i Investigational Device Exemption (IDE) research from Abbott, demonstrating that the pacemaker met its three predetermined primary endpoints for safety and performance. The information also implies that AVEIR DR might provide new advantages for those who have slower-than-normal heart rhythms.

With the first-of-its-kind i2i (implant-to-implant) technology, Abbott created the AVEIR DR leadless pacemaker-the DR standing for dual-chamber rate response-with the intention of enabling beat-to-beat communication and harmony between two leadless pacemakers, the cornerstone of dual-chamber leadless pacing therapy. By communicating with one another, the two devices are able to sense a missed or delayed heartbeat and subsequently pace the proper heart chamber, unlike other leadless pacemakers.

Frequent Recalls Associated with the Devices

Several recalls have been linked with these pacemakers owing to different reasons frequently in past few years. Foe instance, pacemakers from the Boston Scientific INGENIO family, also known as cardiovascular resynchronization therapy pacemakers (CRT-Ps), are used in patients with low heart rates and those who have moderate to severe heart failure, a disease in which the heart is unable to pump enough blood to meet the body's requirements.

On August 10, 2021, due to the possibility of entering safety mode, Boston Scientific has recalled CRT-Ps and pacemakers from the INGENIO family. If the device in question is broken, safety mode is meant to act as a backup. Due to the detection of muscle contractions, there is a danger of inadvertent pacing loss in safety mode. The device must be replaced if it enters safety mode since it cannot be reprogrammed.

The use of the impacted product may have severe negative health effects, such as the need for promptly device replacement, loss of heart rate control or pacing with serious or life-threatening injury (for instance, the requirement for temporary pacing in which a healthcare provider administers controlled electric pulses to regulate a heart), worsening heart failure, and death. There have been 65 documented incidences, three of which required temporary external pacing for the injured patients. There haven't been any reported fatalities.

Complications or Risks Related to the Device

A blood clot occurs in about 2% of pacemaker users. This typically occurs in the region of the arm on the side the pacemaker was implanted. The arm may enlarge as a result of this. However, it normally disappears within a few days. Rarely is it a major issue. A pacemaker infection affects 1% of those who have one. Within the initial year of using the device, this typically occurs. There is a chance that the surgery will unintentionally rupture the lung. This implies that air can seep into the chest from the lung. The term pneumothorax refers to this.

Only 1% of persons are affected. Usually, the leak is really little. One won't need therapy because it will get better on its own. The pacemaker has a tiny probability of failing, much like any electronic device. This is known as a pacemaker error. A pacemaker can malfunction if the lead is pushed out of place, the pulse generator's battery dies, or the pacemaker's control circuits are harmed by being subjected to powerful magnetic fields.

Segment Analysis

The global bradycardia treatment devices market is segmented based on type, devices, end user and region.

High Advantages and Advancements of Pacemaker Devices

A pacemaker keeps track of the beat of the heart. It sends electrical signals to the heart to enhance pace and bring about a normal rhythm if it notices an anomaly. Some pacemakers use leads, which are a number of wires surgically attached to the heart, to connect to the heart. A leadless pacemaker, which doesn't need wires, is implanted into the heart. Leadless pacemakers are implanted straight inside the heart and contain no wires. The physician makes a tiny incision through the groin to implant these pacemakers. He or she directs the heart with a catheter, a long, slender, hollow tube. The device, which is about the dimensions of a large vitamin, travels down the catheter. The right ventricular wall is where the leadless pacemaker is fixed.

A tiny device called a pacemaker containing leads is inserted beneath the skin of the chest. This pacemaker, which is about the size of a pair of half-dollars pushed together, is equipped with a small battery and computer that are connected via one or two leads, which are thin, flexible wires with insulation. The device's leads extend into the heart, wherein the tips include electrode sensors that track cardiac rhythm and transmit data to the pacemaker.

Geographical Penetration

North America Accounted for Largest Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Due to the rising need for bradycardia treatment devices in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for bradycardia treatment devices.

Increasing expenditure on healthcare and rising research studies, advancement of technologies for different devices for bradycardia, and increase in pharmaceutical and medical devices business establishment across the region are also contributing to the growth of bradycardia treatment devices market share of this region.

The key healthcare organizations' and businesses' joint research initiatives are also expected to contribute to the rising demand, as will new product development, which constantly looks to improve present options. The market in this area is growing as people become more aware of various novel devices such as defibrillator, for treatment purposes. The aforementioned elements further attest to North America's hegemonic position in the world.

North America continues to be a key player in the global bradycardia treatment devices market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising cardiovascular disorders have fueled the demand for bradycardia treatment devices in the region. United States have been proactive in executing several initiatives or researches, stimulating bradycardia treatment devices demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global bradycardia treatment devices market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the medical device sector, with a significant consumer of bradycardia treatment devices, was significantly impacted.

Several efforts all throughout the world were impacted by the pandemic's broad lockdowns and limitations that started in early 2020. Major pharmaceutical or medical device industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for bradycardia treatment devices. As a result, many medical device plants either suspended or reduced production to align with the reduced demand.

The COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials to the pharmaceuticals manufacturing plants. Movement limitations and border closures caused production and supply delays. Additionally, some nations experienced a lack of raw resources as a result of supply chain network interruptions.

With the outbreak of the pandemic, many pharmaceutical or medical device manufacturing units faced labor shortages as workers fell sick or were unable to travel to work due to lockdown restrictions. To curb the spread of the virus, pharmaceutical plants implemented stringent safety measures, reducing the number of workers allowed on-site at a time. However, these measures were vital to safeguard the health of the workforce and maintain essential operations during the pandemic.

Russia-Ukraine War Impact Analysis

The medical device businesses are starting to worry regarding their capacity to continue operating, much like other parts of the world. Russia's invasion of Ukraine has an effect on millions of people not only in this nation in Eastern Europe but also all around the world. Device developers will thus experience delays in the development process, a loss of business consistency, and the possibility of non-compliance for devices/drugs already on the market.

For many years, clinical trials in several therapeutic fields have benefited significantly from the participation of Ukraine, Russia, and other CIS nations. Clinical trial durations can frequently be accelerated by incorporating more patients into studies when there is availability to skilled investigators, high-quality patient populations, and big patient populations. Trials that are delayed in Russia and Ukraine as well as relocation to other regions of Europe for fresh trials are currently viable choices. These factors will impact the global bradycardia treatment devices market.

By Type

Sinus Bradycardia
Sinus Pause
Sick Sinus Syndrome
Tachy-brady Syndrome
Heart Block

By Devices

Pacemakers
- Single Chamber Pacemaker
- Dual Chamber Pacemaker

Defibrillator

By End User

Hospitals
Specialty Clinics
Others

By Region

North America
- U.S.
- Canada
- Mexico

Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe

South America
- Brazil
- Argentina
- Rest of South America

Asia-Pacific
- China
- India
- Japan
- Australia
- Rest of Asia-Pacific

Middle East and Africa

Key Developments

On July 5, 2023, the AVEIR dual chamber leadless pacemaker system, the first dual chamber leadless pacing system in the world that serves patients with aberrant or sluggish heart rhythms, has received FDA approval, according to a statement from Abbott. The approval dramatically expands the availability of leadless pacing for hundreds of thousands of people across the United States because more than 80% of persons who require a pacemaker require pacing both in the right atrium and the right ventricle.
On May 1, 2023, the FDA has given the green light to the next generation of the company's industry-leading miniaturized, lead-free pacemakers, the Micra AV2 and Micra VR2, according to Medtronic plc, an international innovator in healthcare technology. The Micra AV2 and Micra VR2, the smallest pacemakers in the world, provide more battery life and easier programming than earlier Micra models while still offering the many benefits of leadless pacing, including fewer issues than conventional pacemakers.

Competitive Landscape

The major global players in the market include: Abbott, BIOTRONIK, NIHON KOHDEN CORPORATION, Lepu Medical Technology (Beijing) Co Ltd., MEDICO S.R.L., OSCOR Inc, OSYPKA MEDICAL, MicroPort Scientific Corporation, Boston Scientific Corporation and Medtronic.

Why Purchase the Report?

To visualize the global bradycardia treatment devices market segmentation based on type, devices, end user and region as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of bradycardia treatment devices market-level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as excel consisting of key products of all the major players.

The global bradycardia treatment devices market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

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 Type
3.2. Snippet by Devices
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. Growing Novel Product Launches and Regulatory Approvals
  - 4.1.1.2. Rising Number of Technological Advancements in Devices
- 4.1.2. Restraints
  - 4.1.2.1. Frequent Recalls Associated with the Devices
  - 4.1.2.2. Complications or Risks Related to the Device
- 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. Regulatory Analysis
5.5. Russia-Ukraine War Impact Analysis
5.6. DMI Opinion

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID
- 6.1.2. Scenario During COVID
- 6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 7.1.2. Market Attractiveness Index, By Type
7.2. Sinus Bradycardia*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Sinus Pause
7.4. Sick Sinus Syndrome
7.5. Tachy-brady Syndrome
7.6. Heart Block

8. By Devices

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices
- 8.1.2. Market Attractiveness Index, By Devices
8.2. Pacemakers*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 8.2.3. Single Chamber Pacemaker
- 8.2.4. Dual Chamber Pacemaker
8.3. Defibrillator

9. By End User

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 9.1.2. Market Attractiveness Index, By End User
9.2. Hospitals*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Specialty Clinics
9.4. Others

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.6.1. U.S.
  - 10.2.6.2. Canada
  - 10.2.6.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.6.1. Germany
  - 10.3.6.2. UK
  - 10.3.6.3. France
  - 10.3.6.4. Italy
  - 10.3.6.5. Spain
  - 10.3.6.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.6.1. Brazil
  - 10.4.6.2. Argentina
  - 10.4.6.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.6.1. China
  - 10.5.6.2. India
  - 10.5.6.3. Japan
  - 10.5.6.4. Australia
  - 10.5.6.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. Abbott*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. BIOTRONIK
12.3. NIHON KOHDEN CORPORATION
12.4. Lepu Medical Technology (Beijing)Co Ltd.
12.5. MEDICO S.R.L.
12.6. OSCOR Inc
12.7. OSYPKA MEDICAL
12.8. MicroPort Scientific Corporation
12.9. Boston Scientific Corporation
12.10. Medtronic

LIST NOT EXHAUSTIVE

13. Appendix

13.1. About Us and Services
13.2. Contact Us

02-2729-4219

+886-2-2729-4219

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