心臟 POC 測試設備市場 - 增長、趨勢、COVID-19 影響和預測（2022-2027 年）

在預測期間（2022-2027 年），心臟 POC 測試設備市場預計將以 6.5% 的複合年增長率增長。

COVID-19 大流行對心臟 POC 測試設備的製造和分銷產生了重大影響。此外，由於與 COVID-19 相關的措施導致心血管疾病檢測的縮減對心臟 POC 檢測設備市場產生了負面影響，尤其是在 2020 年。由於為 COVID-19 患者保留的醫療資源導致心血管疾病診斷延遲也是對市場產生負面影響的因素之一。然而，政府封鎖、供應鏈中斷和貿易禁令也在影響心臟 POC 測試設備市場。

根據 Tarun Dalia 等人於 2021 年 2 月在《印度心臟雜誌》上發表的一篇研究論文，COVID 患者發生充血性心力衰竭 (CHF) 與死亡率增加和預後更差有關。非倖存者和重症 COVID-19 患者發生急性心肌損傷和心力衰竭的風險也增加。像這樣的研究表明了診斷冠狀病毒感染患者心臟病的重要性。因此，人們對快速檢測和早期診斷心髒病的需求日益增長，預計將在預測期內為目標市場創造有利可圖的機會。

此外，心血管疾病患病率的增加、技術的進步、門診檢測服務利用率的提高、優惠的報銷政策等是推動心臟POC檢測設備市場增長的主要因素。我來了。例如，根據世界衛生組織 (WHO) 2021 年 6 月更新的數據，全球約有 3350 萬人患有心房顫動 (AFib)，這是最常見的嚴重心律失常類型。此外，美國心臟協會 2020 年心臟和中風統計更新發現，美國每年發生超過 356,000 例院外心臟驟停 (OHCA)，其中 90.0% 以上是致命的。非創傷性 OHCA 的年發病率為 356,461 例，估計每天發生 1,000 例。因此，對早期發現心髒病和感染的快速 POC 測試的需求正在增加，這有望在研究期間促進市場的增長。此外，隨著全球人口老齡化，預計患有心髒病的患者人數將增加，預計在預測期內對心髒病 POC 檢測設備的需求將增加。

對研發活動的投資不斷增加，以及因心髒病負擔增加而導致的即時檢測需求增加，預計將推動目標市場的增長。例如，根據美國衛生與公眾服務部 2021 年 11 月的一份報告，拜登政府已宣布將投資約 6.5 億美元用於快速診斷測試和提高國內診斷製造能力。預計這將增加對快速和即時檢測的需求，這將對研究目標市場的增長產生重大影響。

此外，市場參與者不斷推出的產品預計將進一步推動該市場的增長。例如，2021 年 7 月，Beckman Coulter Inc. 與 Quidel Corporation 簽訂了最終協議，以獲取製造、分銷和銷售用於 Beckman Coulter 分析儀的 BNP 測試的所有權利。根據協議條款，Quidel 將繼續為 Beckman Coulter 製造和供應某些與測試相關的組件，而 BNP 測試將由 Beckman Coulter 獨家製造。同樣，在 2020 年 7 月，Sphingotech 推出了 CE-IVD 標記的即時檢驗“IB10 Sphingotest Bio-ADM”，定量測量了生物活性腎上腺髓質素 (bio-ADM) 的血液濃度。預計這將增加向患者引入心臟 POC 設備，並成為市場增長的驅動力。

但是，預計工人缺乏操作知識和嚴格的法規會抑制市場增長。

主要市場趨勢

分析器部分預計將在預測期內增長

該分析儀提供高分辨率即時診斷，用於檢測心肌梗塞和心房顫動等心髒病。這些設備監測心臟分泌的□和蛋白質的數量。此外，量化全血、血清和血漿中生物標誌物濃度的能力是推動分析儀行業增長的關鍵因素，因為它在臨床診斷中的有用性。使用該分析儀，可以測試各種類型的生物標誌物，例如心肌標誌物肌鈣蛋白 I、NT-proBNP、h-FABP、CK-MB 和肌紅蛋白。

此外，這一細分市場的增長還得益於領先公司推出的能夠一次性提供高靈敏度、快速和準確結果的創新產品，以及有助於臨床診斷的產品的增加。例如，2021 年 4 月，Siemens-Herchiners 獲得了 Atellica VTLi 患者側免疫分析分析儀的 CE 標誌。 Atellica VTLi 分析儀使用患者的指尖血樣在 8 分鐘內為臨床醫生提供實驗室標準、高靈敏度的心肌肌鈣蛋白 I (hs-cTnI) 結果。

因此，由於上述因素，預計該行業在預測期內將出現可觀的增長。

預計北美將主導心臟 POC 測試設備市場

由於該國心血管疾病發病率增加等因素，預計北美將在心臟 POC 測試設備市場佔據最大的市場份額。此外，人口增長、人口老齡化、遺傳易感性和行為風險因素導致熱相關疾病的發病率上升。缺乏運動、不健康的生活方式、不良的飲食習慣、慢性壓力、吸煙和過度飲酒。這些風險因素可能以高血壓、高血糖、血脂水平以及超重和肥胖的形式產生長期影響。中風和心臟驟停是這些風險因素可能導致的兩種典型結果。與 CVD 發病相關的經濟負擔也是日本非常關注的問題。根據美國心臟協會 2021 年 1 月更新的數據，到 2035 年，45.0% 的美國人口可能會因高度肥胖、過度吸煙和不健康的生活方式而患有心髒病。

一些公司將推出各種策略，例如合作夥伴關係、新產品發布和併購，以保持其市場份額。例如，2021 年 4 月，羅氏宣布了基於 Elecsys 技術的高靈敏度心肌肌鈣蛋白 T (cTnT-hs) 和 N 端腦利鈉□前體檢測這兩種關鍵心臟生物標誌物的五項新用途。 (NT-proBNP)。這些臨床生物標誌物有助於診斷心肌梗塞並有效控制心力衰竭。

因此，由於上述市場發展，預計北美市場在預測期內將增長。

其他特典

• Excel 格式的市場預測 (ME) 表
• 3 個月的分析師支持

內容

第 1 章介紹

• 研究假設和市場定義
• 調查範圍

第 2 章研究方法

第 3 章執行摘要

第 4 章市場動態

• 市場概覽
• 市場促進因素
  • 心血管疾病的發病率和患病率不斷上升
  • 心臟POC檢測設備的技術進步
• 市場抑制因素
  • 工人缺乏操作知識
  • 行業內的嚴格規定
• 波特五力分析
  • 新進入者的威脅
  • 買方/消費者議價能力
  • 供應商的議價能力
  • 替代品的威脅
  • 競爭公司之間的敵對關係

第 5 章市場細分（基於價值的市場規模:百萬美元）

• 按產品類型
  • 心臟標誌物測試
    • 心肌肌鈣蛋白 (cTn) 測試
    • 肌紅蛋白測試
    • 肌酸激□ MB 同工□ (CK-MB) 測試
    • 複合檢測試劑盒
    • 用於測量腦利鈉□ (BNP)
  • 分析器
• 按最終用戶
  • 醫院
  • 診斷機構
  • 其他最終用戶
• 按地區
  • 北美
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 意大利
    • 西班牙
    • 其他歐洲地區
  • 亞太地區
    • 中國
    • 日本
    • 印度
    • 澳大利亞
    • 韓國
    • 其他亞太地區
  • 中東和非洲
    • 海合會
    • 南非
    • 其他中東和非洲
  • 南美洲地區
    • 巴西
    • 阿根廷
    • 其他南美洲

第 6 章競爭格局

• 公司簡介
  • Abbott Laboratories
  • ACON Laboratories, Inc.
  • Alfa Scientific Designs, Inc.
  • American Screening Corporation, Inc.
  • Beckman Coulter Inc.（Danaher Corporation）
  • Biomerica, Inc.
  • Bio-Rad Laboratories, Inc.
  • F. Hoffmann-La Roche AG
  • LifeSign LLC
  • Nano-Ditech Corporation
  • Nexus Dx, Inc.
  • Nova Biomedical Corporation
  • PTS Diagnostics
  • Sekisui Medical Co., Ltd.
  • Siemens Healthineers AG

第 7 章市場機會和未來趨勢

Cardiac PoC Testing Devices Market is expected to grow at a CAGR of 6.5% over the forecast period (2022-2027).

The COVID-19 pandemic has significantly impacted the manufacturing and distribution of cardiac POC testing devices. In addition, the reduction in cardiovascular disease testing due to the measures related to COVID-19 has adversely affected the cardiac POC testing devices market, especially in 2020. Another factor that is negatively impacting the market is the delay in the diagnosis of cardiovascular diseases due to healthcare resources. reserved for patients with COVID-19. However, government-mandated lockdowns, supply chain disruptions, and trade bans have also affected the cardiac POC testing devices market.

According to a research article by Tarun Dalia et al., published in the Indian Heart Journal in February 2021, the occurrence of congestive heart failure (CHF) in patients with COVID is associated with increased mortality and worse outcomes. In addition, there is an increased risk of acute heart damage and cardiac arrhythmia in non-survivors and patients with severe COVID-19 disease. Such studies show the importance of diagnosing heart disease in patients infected with the coronavirus. Therefore, the growing need for rapid tests and early diagnosis of heart diseases among people is expected to create lucrative opportunities for the target market during the forecast period.

In addition, the increasing prevalence of cardiovascular disorders, technological advancements, increase in the use of ambulatory services for testing, and favorable reimbursement policies are key factors driving the growth of the cardiac POC testing devices market. For example, according to World Health Organization (WHO) data updated in June 2021, nearly 33.5 million people worldwide suffer from atrial fibrillation (AFib), the most common type of serious arrhythmia. Additionally, according to the American Heart Association's 2020 Heart and Stroke Statistics Update, more than 356,000 out-of-hospital cardiac arrests (OHCAs) occur in the United States each year, and more than 90.0% of them are fatal. The annual incidence of non-traumatic OHCA is estimated to be 356,461, or about 1,000 people every day. This will lead to an increased need for rapid POC tests for early detection of cardiac diseases or infections and is therefore expected to boost the growth of this market over the study period. Moreover, with the increase in the aging population worldwide, the number of patients suffering from cardiac disorders is likely to increase and the demand for cardiac POC testing devices is anticipated to rise over the forecast period.

The rising demand for point-of-care testing due to the increasing burden of heart diseases along with rising investment in research and development activities is likely to fuel the growth of the target market. For example, according to a November 2021 report from the United States Department of Health and Human Services, the Biden administration announced that it would invest approximately USD 650.0 million in rapid diagnostic testing and strengthening domestic diagnostic manufacturing capacity. This is expected to have a significant impact on the growth of the studied market as the demand for rapid testing and point-of-care testing increases.

Moreover, Moreover, rising product launches by the market players are expected to drive this market's growth further. For instance, in July 2021, Beckman Coulter Inc. entered into definitive agreements with Quidel Corporation to acquire all rights related to the manufacture, distribution and sale of the BNP test for Beckman Coulter analyzers. Under the terms of the agreement, Quidel will continue to manufacture and supply certain test-related components to Beckman Coulter, and Beckman Coulter will exclusively manufacture the BNP test. Similarly, in July 2020, SphingoTec GmbH launched IB10 sphingotest bio-ADM, a CE-IVD-marked point-of-care test to quantitatively determine blood levels of Bioactive Adrenomedullin (bio-ADM). This will lead to increased adoption of cardiac PoC devices in patients, driving the market growth.

However, a lack of operating knowledge among the workforce and stringent regulations are expected to restrain the market growth.

Key Market Trends

Analyzer Segment is Expected to Witness Growth Over the Forecast Period

The analyzers offer high-resolution point-of-care diagnostics for the detection of heart diseases such as myocardial infarction, atrial fibrillation, and more. These devices monitor the number of enzymes and proteins secreted by the heart. Moreover, it is a key factor driving the growth of the analyzer segment such as its ability to quantify the concentration of biomarkers in whole blood, serum, and plasma, which helps in clinical diagnosis. Different types of biomarkers can be tested using the analyzers including cardiac markers Troponin I, NT-proBNP, h-FABP, CK-MB, Myoglobin, and others.

In addition, the growth of the segment is driven by the launch of innovative products from major companies that can offer highly sensitive, rapid, and accurate results in one-step and ancillary clinical diagnosis. For example, in April 2021, Siemens Healthineers received the CE mark for the Atellica VTLi Patient-Side Immunoassay Analyzer. The Atellica VTLi analyzer provides laboratory-standard high-sensitivity cardiac troponin I (hs-cTnI) results to clinicians in eight minutes using a patient fingertip blood sample.

Therefore, the above-mentioned factors indicate that the segment is anticipated to witness considerable growth over the forecast period.

North America is Expected to Dominate the Cardiac POC Testing Devices Market

North America is expected to hold the largest market share in the cardiac POC testing devices market due to factors such as the increasing incidence of cardiovascular diseases in the country. Additionally, increased population, aging demographics, genetic predisposition, and behavioral risk factors are contributing to the increased incidence of heat-related illnesses. Lack of physical exercise, unhealthy lifestyle, poor eating habits, chronic stress, smoking, and excessive alcohol consumption. Such risk factors can have long-term consequences in the form of high blood pressure, high blood glucose, and lipid levels, as well as overweight and obesity. Stroke and cardiac arrest are two typical consequences that can occur as a result of these risk factors. The economic burden associated with the incidence of CVD is a major source of concern in the country. According to data from the American Heart Association updated in January 2021, by 2035, 45.0% of the United States population will likely suffer from heart disease due to high levels of obesity, excessive smoking, and unhealthy lifestyles.

Several companies initiate various strategies such as collaborations, new product launches, and mergers and acquisitions to maintain their market shares. For example, in April 2021, Roche announced five new intended uses for two critical cardiac biomarkers, the high-sensitivity cardiac troponin T (cTnT-hs) and the N-terminal pro-brain natriuretic peptide assay, both based on Elecsys technology. (NT-proBNP). These clinical biomarkers help diagnose heart attacks and effectively manage heart failure.

Thus, due to the above-mentioned developments, the market in North America is expected to grow during the forecast period.

Competitive Landscape

The cardiac POC testing devices market is competitive in nature due to the presence of several companies operating globally as well as regionally. The competitive landscape includes an analysis of a few international as well as local companies which hold the market shares and are well known including Abbott Laboratories, ACON Laboratories, Inc., Alfa Scientific Designs, Inc., American Screening Corporation, Inc., Beckman Coulter Inc. (Danaher Corporation), Biomerica, Inc., Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche AG, LifeSign LLC, Nano-Ditech Corporation, Nexus Dx, Inc., Nova Biomedical Corporation, PTS Diagnostics, Sekisui Medical Co., Ltd., and Siemens Healthineers AG among others.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Incidence and Prevalence of Cardiovascular Disease
  • 4.2.2 Technological Advances in Cardiac POC Testing Device
• 4.3 Market Restraints
  • 4.3.1 Lack of Operating Knowledge among Workforce
  • 4.3.2 Stringent Regulations in the Industry
• 4.4 Porter's Five Force Analysis
  • 4.4.1 Threat of New Entrants
  • 4.4.2 Bargaining Power of Buyers/Consumers
  • 4.4.3 Bargaining Power of Suppliers
  • 4.4.4 Threat of Substitute Products
  • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD million)

• 5.1 By Product Type
  • 5.1.1 Cardiac Markers Test
    • 5.1.1.1 Cardiac Troponin (cTn) Test
    • 5.1.1.2 Myoglobin Test
    • 5.1.1.3 Creatine Kinase MB Isoenzyme (CK-MB) Test
    • 5.1.1.4 Combinational Test Kits
    • 5.1.1.5 Brain Natriuretic Peptide (BNP) Test
  • 5.1.2 Analyzers
• 5.2 By End User
  • 5.2.1 Hospitals
  • 5.2.2 Diagnostic Laboratories
  • 5.2.3 Other End Users
• 5.3 Geography
  • 5.3.1 North America
    • 5.3.1.1 United States
    • 5.3.1.2 Canada
    • 5.3.1.3 Mexico
  • 5.3.2 Europe
    • 5.3.2.1 Germany
    • 5.3.2.2 United Kingdom
    • 5.3.2.3 France
    • 5.3.2.4 Italy
    • 5.3.2.5 Spain
    • 5.3.2.6 Rest of Europe
  • 5.3.3 Asia-Pacific
    • 5.3.3.1 China
    • 5.3.3.2 Japan
    • 5.3.3.3 India
    • 5.3.3.4 Australia
    • 5.3.3.5 South Korea
    • 5.3.3.6 Rest of Asia-Pacific
  • 5.3.4 Middle-East and Africa
    • 5.3.4.1 GCC
    • 5.3.4.2 South Africa
    • 5.3.4.3 Rest of Middle-East and Africa
  • 5.3.5 South America
    • 5.3.5.1 Brazil
    • 5.3.5.2 Argentina
    • 5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Company Profiles
  • 6.1.1 Abbott Laboratories
  • 6.1.2 ACON Laboratories, Inc.
  • 6.1.3 Alfa Scientific Designs, Inc.
  • 6.1.4 American Screening Corporation, Inc.
  • 6.1.5 Beckman Coulter Inc. (Danaher Corporation)
  • 6.1.6 Biomerica, Inc.
  • 6.1.7 Bio-Rad Laboratories, Inc.
  • 6.1.8 F. Hoffmann-La Roche AG
  • 6.1.9 LifeSign LLC
  • 6.1.10 Nano-Ditech Corporation
  • 6.1.11 Nexus Dx, Inc.
  • 6.1.12 Nova Biomedical Corporation
  • 6.1.13 PTS Diagnostics
  • 6.1.14 Sekisui Medical Co., Ltd.
  • 6.1.15 Siemens Healthineers AG

7 MARKET OPPORTUNITIES AND FUTURE TRENDS