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市場調查報告書

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1374809

全球心臟植入電子設備市場 -2023-2030

Global Cardiac Implantable Electronic Devices Market -2023-2030

出版日期: 2023年11月01日 | 出版商:

DataM Intelligence | 英文 186 Pages | 商品交期: 約2個工作天內

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簡介目錄

概述

心律不整或心跳不均是指心跳速率或節律出現問題。心臟跳動可能太快、太慢或節奏奇怪。通常情況下，心率在體育鍛煉時會加快，而在放鬆或休息時會減慢。心臟植入式電子設備(CIED) 是電池供電的醫療設備，用於治療各種心臟疾病，這些設備包括永久性心律調節器(PPM)、自動植入式心臟復律去顫器(AICD) 和心臟再同步治療設備(CRT)。

CIED 用於監測和管理心律不整（PPM、AICD、CRT）並增強收縮功能 (CRT)。目前，據估計，全球每年植入的心臟植入電子設備（CIED）多達140萬個。據美國心臟學會稱，美國每年約有 20 萬個心律調節器被植入心搏過緩患者體內。

心律不整等心血管疾病病例的不斷增加、產品授權的增加、研究活動的積極成果、市場發展（包括合併、收購、產品推出、意識的提高等因素）預計將在預測期內推動全球心臟植入電子設備市場的成長。此外，新產品的推出和技術進步預計也將有助於預測期內的全球市場成長。

動力學

增加心臟植入電子設備的授權

不同監管機構對心臟植入電子設備的授權不斷增加，預計將在預測期內推動全球市場的成長。例如，2023年5月，全球心血管生物醫學研究和技術公司百多力（Biotronik）的世界上最重要的起搏器和（心臟再同步治療-起搏器）CRT-P心臟植入式電子設備系列獲得了左束授權的CE（Conformite Europeenne）許可。分支節奏。

此外，2022年1月，美敦力（Medtronic）是一家醫療技術公司，主要從事基於設備的醫療的設計、心臟植入電子設備、分銷和商業化，獲得了日本厚生勞動省的商業化和償還授權。 Micra AV 經導管心律調節系統(TPS)。這項授權擴大了日本這個全球最廣泛的市場之一適合獲得全球最小起搏器 Micra TPS 的患者數量。 Micra AV 建議用於治療房室傳導阻滯患者，房室傳導阻滯是一種心室（心房和心室）之間的電訊號變形的狀態。

心血管疾病病例不斷增加

包括心律不整在內的心血管疾病病例的不斷增加預計將在預測期內增加對心臟植入電子設備的需求。例如，根據 NIH 2020 年發布的研究，全球心房顫動患病人數約為 375.74 億例（佔全球居民的 0.51%），在過去二十年中再次增加了 33%。社會人口指數高的國家負荷增加最多，但社會人口指數中等的國家目前增幅最大。

心房顫動是一種非常典型的心律不整。根據評估，預計到2050 年，全球將有約600-1200 萬人患有這種疾病，其中美國預計將有600-1200 萬人患有這種疾病，到2060 年，歐洲將有1790 萬人患有這種疾病。心房顫動是缺血性中風的一個重要威脅因素，並會造成嚴重的經濟負擔。具有很高的發病率和死亡率。

同樣，根據 NIH 的數據，在廣大人群中，心律不整的盛行率預計為 1.5% 至 5%，其中心房顫動的盛行率很高。此外，根據英國心臟基金會 2023 年英國情況說明書，英國有超過 150 萬人被診斷出患有心房顫動，但其中相當一部分人沒有得到有效治療。據估計，英國至少有 27 萬名 65 歲以上的人患有未確診（或無症狀）心房顫動。

心臟植入電子設備召回

由於患者健康安全問題而從市場上召回的心臟植入電子設備預計將阻礙預測期內的全球市場成長。例如，2021 年 4 月，美國食品藥物管理局 (FDA) 宣布美敦力 (Medtronic) 召回近 35 萬件植入式心臟設備，因為這些設備在需要時提供高壓治療的能力始終存在問題。

根據 FDA 的聲明，低能量電擊或根本不電擊可能無法修復危及生命的心律不整，從而導致心臟驟停、其他嚴重傷害或死亡。此外，如果擁有這些設備之一的個人需要額外的手術過程來移除和更換該設備，則還有其他傷害威脅。召回中包含的特定心臟植入式電子設備包括 Cobalt XT、Cobalt 和 Crome ICD 以及 CRT-D； Claria MRI、Amplia MRI、Compia MRI、Viva 和 Brava CRT-D；以及 Visia AF、Visia AF MRI、Evera、Evera MRI、Primo MRI 和 Mirro MRI ICD。

設備成本高

設備和植入手術的高成本預計將阻礙預測期內的全球市場成長。例如，心律調節器的成本通常為 19,000 美元至 96,000 美元。預計費用還包括手術前後可能需要的植入費用、X 光或其他影像測試費用，以及後續訪問和需要完成的任何調整。

此外，如果沒有保險，費用可能從大約 20,000 美元到 100,000 美元不等。對於沒有任何保險的個人來說，起搏器和心臟輔助植入物的費用約為 19,000 美元至 96,000 美元或以上，具體取決於起搏器的類型、地點和住院時間。因此，由於成本高昂，大多數低收入者無法接受種植手術，減緩了預測期內的市場成長。

An arrhythmia, or uneven heartbeat, is a trouble with the rate or rhythm of the heartbeat. The heart may beat too fast, too slow, or with an odd rhythm. It is typical for the heart rate to race up in physical exercise and to slow down while relaxing or resting. Cardiac implantable electronic devices (CIEDs) are battery-powered medical devices employed for the treatment of a variety of cardiac conditions these devices include permanent pacemakers (PPMs), automated implantable cardioverter defibrillators (AICDs), and cardiac resynchronization therapy devices (CRTs).

CIEDs are utilized to monitor and manage arrhythmias (PPMs, AICDs, CRTs) and enhance systolic function (CRTs). Presently, it is assessed that up to 1.4 million cardiac implantable electronic devices (CIED) are implanted worldwide annually. According to the American College of Cardiology, roughly 200,000 pacemakers are implanted in the United States in individuals with bradycardic annually.

The growing cases of cardiovascular diseases including arrhythmias, increasing product authorizations, positive outcomes from research activities, market developments including mergers, acquisitions, products introductions, growing awareness among other factors are expected to boost the global cardiac implantable electronic devices market growth in the forecast period. Further, the new product launches and technological advancements also expected to contribute to the global market growth in the forecast period.

Dynamics

Increasing Cardiac Implantable Electronic Devices Authorizations

The increasing cardiac implantable electronic devices authorizations from distinct regulatory bodies are expected to boost the global market growth during the forecast period. For instance, in May 2023, Biotronik, a global cardiovascular biomedical research and technology corporation, obtained CE (Conformite Europeenne) clearance for the World's foremost pacemaker and (cardiac resynchronization therapy-pacemaker) CRT-P Cardiac Implantable Electronic Devices line authorized for left bundle branch pacing.

Moreover, in January 2022, Medtronic, a medical technology corporation involved in the designing, cardiac implantable electronic devicesion, distribution, and commercialization of device-based medical treatments, obtained Japan's Ministry of Health, Labor, and Welfare authorization for the commercialization and repayment of the Micra AV Transcatheter Pacing System (TPS). This authorization extends the number of patients in Japan, one of the most extensive markets in the globe, who are suitable to obtain the Micra TPS, the globe's tiniest pacemaker. The Micra AV is suggested to treat patients with AV block, a state in which the electrical signals between the chambers of the heart (the atria and the ventricle) are deformed.

Growing Cases of Cardiovascular Diseases

The growing cases of cardiovascular diseases including cardiac arrhythmias are expected to boost the demand for cardiac implantable electronic devices in the forecast period. For instnace, according to the NIH study published in 2020, the global preponderance of atrial fibrillation was around 37,574 million cases (0.51% of the global inhabitants), which grew again by 33% in the last two decades. The most elevated load is witnessed in nations with high socio-demographic index, though the most extensive current gain transpired in middle socio-demographic index nations.

Atrial fibrillation is a highly typical cardiac arrhythmia. It has been assessed that around 6-12 million individuals globally are expected to suffer from this disorder in the US by 2050 and 17.9 million individuals in Europe by 2060. Atrial fibrillation is a significant threat element for ischemic stroke and evokes a critical economic load along with substantial morbidity and mortality.

Again, according to the NIH, the preponderance of arrhythmias is anticipated to be 1.5% to 5% in the widespread population, with atrial fibrillation being highly expected. Further, according to the British Heart Foundation UK Factsheet 2023, over 1.5 million people in the UK have been diagnosed with atrial fibrillation, but a substantial number of them are not treated effectively. It is assessed that there are at the minimum 270,000 individuals aged above 65 with undiagnosed (or silent) atrial fibrillation in the UK.

Cardiac Implantable Electronic Devices Recalls

The cardiac implantable electronic devices recalls from the market owing to patient health safety concerns are expected to hamper the global market growth during the forecast period. For instance, in April 2021, the U.S. Food and Drug Administration (FDA) declared that Medtronic recalled almost 350,000 implantable cardiac devices owing to persistent problems with their capability to deliver high-voltage therapy when required.

According to the FDA declaration, a reduced-energy shock, or no shock at all, may fail to fix a life-threatening arrhythmia, which can lead to cardiac arrest, other severe injury, or death. Moreover, there are other threats of injury if an individual with one of these devices requires additional surgical processes to remove and replace the device. Specific cardiac implantable electronic devices included in the recall were the Cobalt XT, Cobalt and Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva, and Brava CRT-Ds; and Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, and Mirro MRI ICDs.

High Device Costs

The high cost of devices and implant procedures is expected to hamper the global market growth during the forecast period. For instance, the pacemaker's costs typically range from $19,000 to $96,000. The expense is also expected to include implantation costs, X-rays, or other imaging tests expenses that might be required before and post the procedure, and the follow-up visit and any adjustments that are required to be completed.

Moreover, the cost can differ anywhere from approximately $20,000 and $100,000, without insurance. For individuals without any insurance coverage, a pacemaker and heart-assist implant can cost around $19,000-$96,000 or above, depending on the kind of pacemaker, the site, and the span of the hospital stay. Thus, owing to the high costs majority of low earning population is unable to undergo implant procedure slowing the market growth in the forecast period.

Segment Analysis

The global cardiac implantable electronic devices market is segmented based on product, indication, end-user and region.

Implantable cardioverter-defibrillators (ICDs) Product Expected to Dominate Market

Owing to the increase in cardiac implantable electronic devices launches and approvals the Implantable cardioverter-defibrillators (ICDs) segment is estimated to hold the majority of the global market share in the forecast period. For instance, in October 2020, Abbott introduced its unique ICD and CRT-D in India, thus expanding its cardiac implantable electronic devices line in the nation. The corporation even obtained CE Mark clearance for its Gallant ICD and CRT-D devices in February 2020.

Moreover, in August 2022, Medtronic plc introduced an investigational extravascular implantable cardioverter defibrillator (EV ICD) system defibrillator with the tip positioned under the breastbone, beyond the heart and veins attained a defibrillation success rate of 98.7%, and satisfied its safety endpoints in global clinical investigations.

Further, in February 2023, Medtronic plc, obtained CE (Conformite Europeenne) Mark for its Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead for the treatment of dangerously rapid cardiac beats that can direct to premature cardiac arrest. The Aurora EV-ICD system delivers the life-saving advantages of conventional ICDs while dodging specific threats as its lead (thin wire) is positioned outside the heart and veins.

Geographical Penetration

Growing Cases of Cardiovascular Diseases

Owing to the increasing cases of cardiovascular disease in North America the region is estimated to dominate the global market during the forecast period. For instance, according to the Centers for Disease Control and Prevention, in the US, approximately 805,000 individuals have heart attacks, and one individual dies every 33 seconds from cardiovascular disease yearly. Moreover, according to the Arrhythmia Alliance Atrial fibrillation impacts nearly 1 out of 50 Americans under the age of 65 and about 1 out of 10 Americans over age 65. The prevalence of ventricular arrhythmias differs widely.

Furthermore, the increase in initiatives to support better practices and awareness in individuals with atrial fibrillation is expected to boost the regional market growth in the forecast period. For instance, the North American Thrombosis Forum's Atrial Fibrillation Action Initiative recognizes multidisciplinary most promising approaches for stroke precluding atrial fibrillation (Afib). The task is to deliver a comprehensive yet straightforward consensus record concentrated on stroke and bleeding threat examination in individuals with Afib and anticoagulation choices and management. The organization intends for this practical record to function as a reference for the whole medical society concerned with the care of individuals with Afib: primary care, emergency medicine, pharmacy, and cardiovascular medicine.

COVID-19 Impact Analysis

The COVID-19 pandemic inflicted challenges to the standard management of access and delivery of health care worldwide. It promoted the adoption of telemedicine and digital health, establishing a fresh epoch in the management of CIED patients. Patient results could be enhanced with device-based intensive monitoring corresponding with standard in-clinic follow-up at periodic intervals.

The pandemic background encouraged the quest for alternative solutions for practical patient follow-up, like validation of digital technologies, data management techniques, implementation of predictive analytics, cybersecurity, growth of restricted forms of remote CIED programming, and reimbursement. However, the pandemic disturbed the planned implant procedures which were rescheduled or cancelled negatively influencing the global market during the pandemic.

Key Developments

In April 2023, Aziyo Biologics, Inc., a corporation that designs and trades biologic developments to enhance compatibility between medical devices and patients, formed a distribution deal with LeMaitre Vascular, Inc., a provider of vascular devices, implants, and services.
In December 2021, LifeTech Scientific Corporation expanded its deals with Medtronic to advance the strategic partnership on the "HeartTone domestic pacemaker project" and to begin the partnership on domestically-made MRI-conditional pacemakers.
In June 2021, Medtronic Private Limited, India, launched the Micra AV, a miniaturized fully self-contained pacemaker that provides state-of-the-art pacing technology to atrioventricular (AV) block patients by a minimally invasive approach.

Competitive Landscape

The major global players in the market include: Abbott, Medtronic plc, Boston Scientific Corporation, Biotronic AG, Stryker, Microport Scientific Corporation, Koninklijke Philips N.V., Lepu Medical Technology (Beijing)Co.,Ltd., MEDICO S.R.L., and Vitatron among others.

Why Purchase the Report?

To visualize the global cardiac implantable electronic devices market segmentation based on product, indication, 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 cardiac implantable electronic 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 cardiac implantable electronic 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 Product
3.2. Snippet by Indication
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 Cardiac Implantable Electronic Devices Authorizations
  - 4.1.1.2. Growing Cases of Cardiovascular Diseases
- 4.1.2. Restraints
  - 4.1.2.1. Cardiac Implantable Electronic Devices Recalls
  - 4.1.2.2. High Device Costs
- 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. Patent Analysis
5.6. Technology Trend
5.7. End-User Trend
5.8. SWOT Analysis
5.9. 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 Product

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 7.1.2. Market Attractiveness Index, By Product
7.2. Pacemaker*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 7.2.3. Single-chamber
- 7.2.4. Dual-chamber
- 7.2.5. Biventricular
7.3. Implantable Cardioverter Defibrillators
- 7.3.1. Transvenous ICD
- 7.3.2. Subcutaneous ICD
7.4. Implantable Cardiac Loop Recorders

8. By Indication

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 8.1.2. Market Attractiveness Index, By Indication
8.2. Arrhythmia*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Heart Rhythm Monitoring
8.4. Heart Block/Failure
8.5. Others

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. Ambulatory Surgery Centers
9.5. Academic Research Institutes
9.6. 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 Product
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 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 Product
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 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 Product
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 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 Product
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 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 Product
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 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. Medtronic plc
12.3. Boston Scientific Corporation
12.4. Biotronic AG
12.5. Stryker
12.6. Microport Scientific Corporation
12.7. Koninklijke Philips N.V.
12.8. Lepu Medical Technology (Beijing)Co.,Ltd.
12.9. MEDICO S.R.L.
12.10. Vitatron

LIST NOT EXHAUSTIVE