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1345442

全球心動過緩治療設備市場 - 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: 最快1-2個工作天內

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簡介目錄

概述

2022年，全球心動過緩治療設備市場規模達到89億美元，預計到2030年將達到130.7億美元，2023-2030年預測期間年複合成長率為5.0%。

多年來，全球心動過緩治療設備市場經歷了顯著的成長和轉變，影響其動態的因素有多種。心率緩慢等心血管疾病的增加、醫療設備的研發和政府投資是影響全球心動過緩治療設備的關鍵促進因素。經過充滿挑戰的2020年，心動過緩治療器械行業表現出了良好的韌性和適應性。

政府對心血管疾病的投資，特別是在發展中經濟體，將繼續推動起搏器的使用，並推動全球心動過緩治療設備市場的發展。全球心動過緩治療設備行業越來越重視更好地管理心動過緩。各自的舉措包括使用其他設備，例如用於治療心動過緩的除顫器，因為它們有時充當起搏器。

竇性心動過緩，佔市場佔有率的三分之一以上。同樣，北美在心動過緩治療設備市場上佔據主導地位，佔據了超過 1/3 的最大市場佔有率。該地區在醫療保健領域的快速投資以及全球心動過緩治療設備市場主要參與者的不斷崛起，使其成為最大的市場佔有率持有者。美國擁有最大的製造商和消費者群體。

動力學

不斷增加的新產品發布和監管批准

在高收入水平、投資和基礎設施發展的推動下，已開發經濟體的醫療保健行業不斷改善。一些國家對心動過緩治療設備的需求量很大，反映出它們的醫療保健行業不斷擴大。不斷增加的新產品發布以及監管部門的批准將成為推動市場成長的關鍵因素。

2023 年5 月18 日，Alizea 和Celea 植入式起搏器（目前市場上同類尺寸中壽命最長的起搏器）及其相關產品、SmartTouch XT 基於平板電腦的編程器、Vega 起搏導線和SmartView Connect總部位於法國的心律管理領域的全球先驅 MicroPort CRM 表示，藍牙家用監護儀均已獲得 FDA 批准。這代表著患者護理領域的巨大勝利，並體現了該公司對美國市場的奉獻精神。 AutoMRI 模式是 MicroPort CRM 創建的突破性算法，是 Alizea 和 Celea 產品的一項功能。

它可以提高患者在進行 MRI 掃描時的安全性和生活品質。要激活 MRI 模式，患者只需在掃描前十天去看心臟病專家一次。一旦模式設置完畢，起搏器在進入MRI視野時會自動切換到MRI模式，並在檢查後恢復到默認設置，大大提高了患者和醫護人員的工作效率。當植入 Vega 起搏導線時，這些設備被批准用於 1.5 或 3 Tesla MRI 掃描儀。

設備技術進步的數量不斷增加

心動過緩治療設備的不斷進步將推動未來一段時間市場的成長。例如，2023 年 5 月 20 日，世界上第一個雙腔無引線起搏器收到了雅培雙腔 (DR) AVEIR i2i 研究設備豁免 (IDE) 研究的最新成果，表明該起搏器滿足其要求安全性和性能的三個預定主要終點。該資訊還意味著 AVEIR DR 可能為那些心律慢於正常的人提供新的優勢。

憑藉首創的 i2i（植入物到植入物）技術，Abbott 創造了 AVEIR DR 無引線起搏器（DR 代表雙腔速率反應），旨在實現逐搏溝通與和諧位於兩個無引線起搏器之間，這是雙腔無引線起搏治療的基石。通過相互通訊，這兩個設備能夠感知錯過或延遲的心跳，然後對適當的心室進行起搏，這與其他無引線起搏器不同。

與設備相關的頻繁召回

過去幾年，由於不同原因，多次與這些起搏器相關的召回事件頻頻發生。例如，波士頓科學公司INGENIO 系列起搏器，也稱為心血管再同步治療起搏器(CRT-P)，用於低心率患者和患有中度至重度心力衰竭（一種心臟功能衰竭的疾病）的患者泵出足夠的血液以滿足身體的需要。

2021 年 8 月 10 日，由於可能進入安全模式，波士頓科學公司召回了 INGENIO 系列的 CRT-P 和起搏器。如果有問題的設備損壞，安全模式將充當備份。由於檢測肌肉收縮，安全模式下存在無意中失去起搏的危險。如果設備進入安全模式，則必須更換該設備，因為它無法重新編程。

使用受影響的產品可能會對健康產生嚴重的負面影響，例如需要立即更換設備、心率失控或因嚴重或危及生命的傷害而起搏（例如，醫療保健提供者需要臨時起搏）管理受控電脈衝來調節心臟），導致心力衰竭惡化，甚至死亡。已有 65 起事故記錄在案，其中 3 起需要對受傷患者進行臨時體外起搏。目前還沒有任何死亡報告。

與設備相關的併發症或風險

大約 2% 的起搏器使用者會出現血栓。這通常發生在植入起搏器一側的手臂區域。因此，手臂可能會變大。然而，它通常會在幾天內消失。這很少是一個重大問題。 1% 的起搏器感染者受到感染。在使用該設備的第一年，這種情況通常會發生。手術有可能無意中導致肺部破裂。這意味著空氣可以從肺部滲入胸部。氣胸一詞就是指此。

只有 1% 的人受到影響。通常，洩漏確實很小。不需要治療，因為它會自行好轉。起搏器發生故障的可能性很小，就像任何電子設備一樣。這稱為起搏器錯誤。如果導線被推離原位、脈衝發生器的電池耗盡或起搏器的控制電路因受到強大磁場而損壞，起搏器可能會發生故障。

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