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心血管設備

市場調查報告書

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1374877

全球先進心臟監測設備市場 - 2023-2030

Global Advanced Cardiac monitoring 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: 最快1-2個工作天內

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簡介目錄

概述

心臟監測設備是醫生/醫務人員建議的微型設備，用於遠距離觀察患者的心臟狀態。最先進的技術使設備能夠檢測到最輕微的潛在聲音和心跳異常。這些小小的不規則和異常被稱為心律不整。如果總是出現心律不整，則表示心臟有問題，需要醫療救助。

透過心臟監測設備，重要的心臟健康資訊都可以被觀察、記錄並立即呈現給醫生，從而消除了重複訪問醫生辦公室的需要，並允許護理部門遠端處理心臟健康狀況。根據設備是臨時的還是永久的以及需要獲取什麼類型的資料，心臟監測方法可能會有所不同。

心血管疾病病例的增加、產品授權的增加、研究活動的正面成果、市場發展（包括合併、收購、產品推出、意識的提高等因素）預計將推動預測期內全球先進心臟監測設備市場的成長。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

增加產品發布和授權

產品的推出和不同監管機構的授權預計將在預測期內推動全球市場的成長。例如，2021 年 2 月，Remo Care Solutions 推出了 Remo。 Cardia 是一種遠端心臟監測系統，利用人工智慧即時監測和分析患者的生命徵象。此外，2021 年11 月，專注於提供創新遠距生物辨識監測產品的日常醫療技術公司Biotricity Inc. 推出了Bioheart，這是一款直接面對消費者的心臟監測儀，提供了醫生使用的精確持續心臟監測技術。

此外，2021 年 7 月，雅培在美國推出了可插入式心臟監視器 (ICM) Jot Dx。該技術可以遠端檢測個人心律不整並提高診斷精度。同樣，2022 年 4 月，美敦力 (Medtronic) 推出了兩種 AccuRhythm AI 演算法，旨在透過基於雲端的更新在歐洲用於 LINQ II 插入式心臟監視器 (ICM)。 AccuRhythm AI 使用人工智慧 (AI) 處理 LINQ II 收集的心律事件資料，提高醫療人員獲取資料的精確度，以便他們能夠合理分析和治療不規則心律。

心血管疾病病例不斷增加

預計心血管疾病病例的增加將在預測期內增加對先進心臟監測設備的需求。例如，根據世界心臟基金會2023 年報告，全球心血管疾病(CVD) 死亡人數從1990 年的1,210 萬人猛增至2021 年的2,050 萬人，接近所有死亡人數的三分之一，並且評估的1.21 億CVD 死亡率整體呈現成長趨勢。 CVD 再次成為 2021 年全球死亡的首要原因，五分之四的 CVD 死亡發生在低收入和中等收入國家 (LMIC)。

此外，根據英國心臟基金會的《2023 年全球心臟和循環系統疾病情況說明書》，全球約有6.2 億人患有心臟和循環系統疾病，由於生活方式的不同、人口老化和人口成長以及生存率的提高，這一數字一直在增加。心臟病和中風的發病率預計會持續上升，如果這些趨勢持續下去。

此外，據估計，全球每 13 個人中就有 1 人患有心臟或循環系統疾病。全球約有三分之一的死亡是由心臟和循環系統疾病造成的，預計到 2021 年將有 2,050 萬人死亡，平均每天有 56,000 人死亡，即每 1.5 秒就有 1 人死亡。同樣，根據澳洲衛生和老年護理部的數據，心血管疾病導致澳洲約 27% 的傷亡，約 120 萬澳洲人患有一種或多種心臟或血管疾病。

網路安全威脅與違規行為

與心臟監測設備相關的網路安全威脅的存在預計將阻礙預測期內的全球市場成長。例如，2023 年 7 月，網路安全和基礎設施安全局 (CISA) 發出警報，稱醫療設備公司美敦力 (Medtronic) 的心臟設備存在極端漏洞。此外，在安全更新中，這家醫療科技巨頭宣稱，它已經確定了一個可選的消息傳遞元素，如果允許，授權用戶可以操縱該缺陷，從而導致心臟設備資料可能的遺漏、竊取或轉換。

該公司起草了針對當前軟體問題的修復方案，並分配了進一步的軟體更新，以撤回訊息傳遞元素。此外，違反監管準則可能會導致產品召回，從而在預測期內減緩全球市場成長。例如，美國食品藥物管理局 (FDA) 已向心臟監測公司 iRhythm IRTC 發出通知，指出其開發違反了 FDA 設備和標籤規範。

誤報率高

預計誤報的高頻率也將阻礙預測期內全球市場的成長。例如，根據題為「循環：心律不整和電生理學」的文章中發表的新資料，用於追蹤心律不整的植入式循環記錄器(ILR) 很容易出現誤報警報，ILR 是針對潛在心律不整個體的典型診斷設備，允許長期遠端患者監測。文章的結論是，研究中的所有警報中有59.8% 是錯誤的，房性心動過速(AT)/心房顫動(AF)AT/AF (74.2%) 和心搏停止(76.8%) 警報的假陽性率較高。

此外，通常在醫務室中，重症監護病房 (ICU) 患者監護儀的假心律不整警報率極高，無論其商標和費用如何。這些錯誤分配的警報會擾亂個人的休息，耗盡醫院資源，並使醫務人員對可能發生的緊急情況麻木不仁，這被稱為誤報疲勞。根據評估，床邊監視器分配的危及生命的心電圖 (ECG) 警報中有 43% 不準確，某些類型的警報甚至高達 90%。

A cardiac monitoring device is a miniature device suggested by the doctor/medic to observe a patient's cardiac state from a distance, remotely. State-of-the-art technology facilitates the device to detect even the slightest potential sounds and abnormalities in the heartbeat. These small irregularities and anomalies are anointed heart arrhythmias. If the arrhythmias transpire invariably, there is an issue in the heart that requires medical assistance.

With a cardiac monitoring device, significant cardiac health information can all be observed, documented, and presented to the physician immediately eliminating the requirement for repeated visits to the medic's office and permitting the care unit to handle the cardiac health remotely. Cardiac monitoring approaches can differ based on whether the device is temporary or permanent and what sort of data needs to be apprehended.

The growing cases of cardiovascular diseases, increasing product authorizations, positive outcomes from research activities, market developments including mergers, acquisitions, product introductions, growing awareness among other factors are expected to boost the global advanced cardiac monitoring 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 Product Launches and Authorizations

The product launches and authorizations from distinct regulatory bodies are expected to boost the global market growth during the forecast period. For instance, in February 2021, Remo Care Solutions introduced Remo. Cardia is a remote cardiac monitoring system that utilizes artificial intelligence to monitor and analyze patients' vitals in real time. Moreover, in November 2021, Biotricity Inc., an everyday medical technology corporation concentrated on providing innovative, remote biometric monitoring products, launched Bioheart, a direct-to-consumer heart monitor that presents the exact constant heart monitoring technology utilized by physicians.

Further, in July 2021 Abbott introduced Jot Dx, the insertable cardiac monitor (ICM) in the United States. This technology permits remote detection and enhanced diagnostic precision of cardiac arrhythmias in individuals. Similarly, in April 2022, Medtronic introduced two AccuRhythm AI algorithms intended to be used for LINQ II insertable cardiac monitors (ICM) via cloud-based updates in Europe. AccuRhythm AI uses artificial intelligence (AI) to heart rhythm event data gathered by LINQ II, enhancing the precision of data medics obtain so they can reasonably analyze and treat irregular heart rhythms.

Growing Cases of Cardiovascular Diseases

The growing cases of cardiovascular diseases are expected to boost the demand for advanced cardiac monitoring devices in the forecast period. For instance, according to the World Heart Foundation Report 2023, deaths from cardiovascular disease (CVD) bounced worldwide from 12.1 million in 1990 to 20.5 million in 2021, near to a third of all deaths and a general growth on the assessed 121 million CVD mortalities. Again, CVD was the top reason of death globally in 2021, with four in five CVD deaths happening in low- and middle-income nations (LMICs).

Moreover, according to the British Heart Foundation's Global Heart & Circulatory Diseases Factsheet 2023, about 620 million individuals are living with cardiac and circulatory conditions across the globe this number has been increasing owing to varying lifestyles, an aging, and growing inhabitants, and enhanced survival rates from heart attacks and strokes and is estimated to persist to increase if these trends persist.

Further, globally it is assessed that 1 in 13 individuals are living with a cardiac or circulatory disorder. Heart and circulatory conditions cause about 1 in 3 deaths worldwide, an estimated 20.5 million casualties in 2021, an average of 56,000 individuals per day, or one death every 1.5 seconds. Again, according to the Department of Health and Aged Care Government of Australia, Cardiovascular conditions cause around 27% of casualties in Australia and about 1.2 million Australians have 1 or more heart or vascular diseases.

Cybersecurity Threats and Violation of Regulations

The presence of cybersecurity threats associated with cardiac monitoring devices is expected to hamper the global market growth during the forecast period. For instance, in July 2023, The Cybersecurity and Infrastructure Security Agency (CISA) alerted of an extreme vulnerability in a cardiac device from medical device corporation Medtronic. Moreover, in a security update, the medtech giant declared that it had pinpointed an optional messaging element that, if allowed, a licensed user could manipulate the flaw, directing to the possible omission, stealing, or transformation of cardiac device data.

The corporation drafted a fix for the problem on the present software and has allocated a further software update that withdraws the messaging element. Furthermore the the violation of regulatory guidelines can cause product recalls slowing the global market growth during the forecast period. For instance, the Food and Drug Administration (FDA) has given a notice to the heart monitoring corporation iRhythm IRTC, noting that its developments enclose breaches of FDA device and labeling norms.

High Frequency of False Positive Alarms

The high frequency of false positive alarms is also expected to hamper the global market growth during the forecast period. For instance, according to new data published in an article titled "Circulation: Arrhythmia and Electrophysiology," the implantable loop recorders (ILR) employed to follow cardiac arrhythmias are liable to false positive alerts, ILRs are typical diagnostic devices for individuals with a potential arrhythmia, permitting for long-term remote patient monitoring. The article concluded that 59.8% of all alerts in the study were wrong, with elevated false-positive rates for atrial tachycardia (AT)/atrial fibrillation (AF)AT/AF (74.2%) and asystole (76.8%) alerts.

Further, typically in infirmaries, false arrhythmia alarm rates are extremely elevated in intensive care units (ICUs) patient monitors irrespective of their trademarks and expenses. These falsely allocated alarms disrupt individuals' rest, empty hospital resources, and desensitize the infirmary team to possible emergencies, anointed as false alarm fatigue. It has been assessed that 43% of life-threatening electrocardiogram (ECG) alarms allocated by bedside monitors are inaccurate, with some types of alarms being as elevated as 90%.

Segment Analysis

The global advanced cardiac monitoring devices market is segmented based on device type, indication, end-user and region.

ECG Monitors Device Type Expected to Dominate Market

With the increase in the ECG monitor product market introductions and market developments in this segment the ECG monitor device type is expected to dominate the global market in the forecast period. For instance, in May 2022, AliveCor introduced the KardiaMobile Card, a credit card-sized, tiniest personal ECG device designed to enhance health outputs and reduce the expense of cardiac therapy. A single-lead ECG of medical quality is produced in 30 seconds via the KardiaMobile Card, which fits comfortably into any wallet.

Moreover, in August 2023, Clario, a healthcare research technology corporation that provides top endpoint technology products for clinical investigations, expanded its partnership with AliveCor, the top leader in FDA-cleared personal electrocardiogram (ECG) technology. This partnership intends to allow trial participants to accumulate medical-grade six-lead ECG readings in the convenience of their residences via KardiaRx, a clinical-trial-focused app.

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, June 2022 update around 20.1 million adults aged 20 and older had coronary heart disease (CAD) in 2020 in the United States. It even noted that coronary heart condition is the highly typical type of heart condition in the United States.

Furthermore, the increase in market developments in this region is also contributing to the regional market growth in the forecast period. For instance, in November 2022, OMRON Healthcare, Co., Ltd., a multinational healthcare corporation, collaborated with Cardio Signal, a U.S.-established health technology corporation, aspired to get innovations in premature cardiovascular condition detection to help clinicians at the forefront of Population Health management.

Similarly, in July 2021, Nihon Kohden Digital Health Solutions Inc., the U.S. regional development associate of Nihon Kohden, completed the acquisition of 100% shares of Advanced Medical Predictive Devices, Diagnostics, and Displays, Inc., following this acquisition, Nihon Kohden's long-term intends to develop innovative healthcare monitoring devices to crack global medical issues and to deliver better future to individuals with from diverse conditions.

COVID-19 Impact Analysis

COVID-19 unexpectedly increased patient safety, prior to the COVID-19 pandemic, patient monitoring for harm and multiple strategies to avert damage were related to where the individuals were treated in the hospital. The challenges raised by the Coronavirus disease 2019 (COVID-19) pandemic to the health service globally directed to a quick transformation of infection condition protocols in-hospital.

Although the integration of technology in the clinical workplace is yet in its babyhood, it has rapidly progressed via the Gartner Hype Cycle for rising technologies and its adoption has additionally quickened after the coronavirus disease 2019 (COVID-19) pandemic and the fierce growth of telehealth. The COVID-19 pandemic has led to an acceleration in healthcare innovation, with the adoption of telemedicine taking residence nearly overnight. Additional wearable patient monitoring devices are used to help improve the availability of monitoring and therapy of patients and to support addressing the deduction of healthcare provider exposure to SARS-CoV-2, especially for people with heart disease.

By Device Type

ECG Monitors
Insertable Cardiac Monitor
Holter Monitor
Event Recorder
Mobile cardiac Telemetry
Smart Wearables
Implantable Cardiac Loop Recorders
Others

By Indication

Bradycardia
Tachycardia
Atrial and Ventricular Fibrillation
Others

By End-User

Hospitals
Specialty Clinics
Ambulatory Surgery Centers
Academic Research Institutes
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

In July 2023, Biotricity Inc., a Technology-as-a-Service (TaaS) corporation functioning in the remote cardiac monitoring domain of consumer healthcare, reinforced connections with Amazon and Google. The company is extending its AI technology development in remote cardiac care, leveraging its proprietary AI technology to deliver a suite of predictive monitoring devices to improve new condition profiling, enhance patient control, and revolutionize the healthcare enterprise for disease precluding.
In May 2023, Abbott, obtained U.S. Food and Drug Administration (FDA) clearance for its Assert-IQ insertable cardiac monitor (ICM), offering medics a unique choice for diagnostic evaluation and long-term monitoring of individuals experiencing irregular heartbeats.
In January 2023, Royal Philips, a multinational leader in health technology, and Masimo, a multinational medical technology corporation, expanded their collaboration to increase individual monitoring capacities in-home telehealth applications with the Masimo W1 state-of-the-art health tracking watch. The W1 intends to merge with Philips's enterprise patient monitoring ecosystem to proffer the vanguard of telemonitoring and telehealth.

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., GE HEALTHCARE, and Nihon Kohden among others.

Why Purchase the Report?

To visualize the global advanced cardiac monitoring devices market segmentation based on device type, 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 advanced cardiac monitoring 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 advanced cardiac monitoring 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 Device Type
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 Product Launches and Authorizations
  - 4.1.1.2. Growing Cases of Cardiovascular Diseases
- 4.1.2. Restraints
  - 4.1.2.1. Cybersecurity Threats and Violation of Regulations
  - 4.1.2.2. High Frequency of False Positive Alarms
- 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 Device Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 7.1.2. Market Attractiveness Index, By Device Type
7.2. ECG Monitors*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Insertable Cardiac Monitor
7.4. Holter Monitor
7.5. Event Recorder
7.6. Mobile cardiac Telemetry
7.7. Smart Wearables
7.8. Implantable Cardiac Loop Recorders
7.9. Others

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. Bradycardia*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Tachycardia
8.4. Atrial and Ventricular Fibrillation
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 Device Type
- 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 Device Type
- 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 Device Type
- 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 Device Type
- 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 Device Type
- 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. GE HEALTHCARE
12.10. Nihon Kohden

LIST NOT EXHAUSTIVE