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市场调查报告书
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1965879

心臟生物标记市场－全球产业规模、份额、趋势、机会、预测：按类型、应用、地区和竞争格局划分，2021-2031年

Cardiac Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type, By Application, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 180 Pages | 商品交期: 2-3个工作天内

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简介目录

全球心臟生物标记市场预计将从 2025 年的 184.1 亿美元成长到 2031 年的 292.3 亿美元，复合年增长率为 8.01%。

这些生物标记由心臟压力期间释放到血液中的可测量酵素和蛋白质组成，是诊断心肌梗塞等疾病的重要指标。该市场的成长主要受心血管疾病发病率上升以及紧急情况下快速准确诊断的迫切需求的驱动。大量疾病负担数据凸显了这项需求。根据美国心臟协会 (AHA) 估计，到 2024 年，约有 1.269 亿美国成年人将患有某种形式的心血管疾病，如此高的盛行率需要进行广泛的诊断检测，从而持续推动市场收入成长。

市场概览
预测期 2027-2031
市场规模：2025年 184.1亿美元
市场规模：2031年 292.3亿美元
复合年增长率：2026-2031年 8.01%
成长最快的细分市场 BillionP 和 NT-proBillionP
最大的市场 北美洲

然而，阻碍市场发展的一大障碍是新型诊断检测套组严格的监管核准流程。製造商必须遵守复杂的合规标准，并经历漫长的检验阶段以证明其临床效用，这增加了研发成本并延迟了产品上市。此外，国际医疗保健体系对新兴生物标记的报销覆盖范围不均，也会阻碍其商业性应用，并削弱新供应商检测方案的财务永续性。

市场驱动因素

全球心血管疾病盛行率的不断上升是心臟生物标记市场的主要驱动力，从而持续推高了对诊断检测的需求。随着心臟衰竭和心肌梗塞等疾病发病率的增加，医疗机构越来越依赖高灵敏度的生物标记进行有效的风险分层和快速分流。日益加重的疾病负担直接导致临床和医院环境中检测量的增加，因此需要建立完善的诊断基础设施。根据美国疾病管制与预防中心 (CDC) 于 2025 年 6 月发布的《关键统计快报》，2024 年美国心臟相关死亡人数将达到 683,037 人，这凸显了精准检测工具对于管理不断增长的患者群体和预防严重后果的迫切需求。

同时，高灵敏度生物标记检测技术的进步正在提高诊断准确性并扩大市场潜力。这些先进的解决方案能够检测到浓度较低的肌钙蛋白，从而比传统方法更早识别心肌损伤，进而推动预防性患者照护的发展。市场对这些创新技术的正面反应已在财务指标中得到体现。根据雅培公司2024年10月发布的2024年第三季财报，更新的诊断系统的普及推动了其全球核心实验室诊断销售额4.5%的内部成长。罗氏公司也强调了这一高容量应用趋势，其报告称，2025财年全球整体总合进行了300亿次诊断测试。

市场挑战

严格的监管核准流程是阻碍全球心臟生物标记市场扩张的一大障碍。製造商必须遵守复杂的合规要求，并经历全面的检验阶段，才能确立新型诊断检测方法的临床效用。这项严苛的审批流程延长了产品上市前的研发週期，并显着增加了营运成本。因此，核准所需的大量时间和资金投入往往阻碍了企业推出创新型生物标记物，减缓了创新步伐，并限制了先进诊断解决方案的应用。

这些监管压力带来的后果在近期行业趋势中得到了清晰的体现，即企业纷纷策略性地退出那些合规要求复杂的市场。根据欧洲医疗技术协会（MedTech Europe）2024年的数据，由于新的监管环境带来的种种困难，选择欧盟作为其首批产品上市主要市场的主要体外诊断试剂製造商的比例下降了40%。这项数据凸显了繁重的监管要求如何迫使企业重新分配资源并推迟产品上市策略。这些阻碍必要诊断工具部署的监管壁垒，极大地限制了收入潜力，并限制了整个产业的商业性成长。

市场趋势

随着临床检查室致力于简化工作流程以应对日益增长的检测工作量，自动化高通量免疫检测系统的兴起正在从根本上改变全球心臟生物标记市场。製造商们不断推出整合免疫诊断和临床化学的平台，最大限度地减少人工操作，并缩短关键心臟检测的周转时间。对先进诊断基础设施的强劲需求反映在近期的市场趋势中。根据罗氏公司2025年1月发布的题为「罗氏公布2024年强劲业绩，销售额增长7%」的新闻稿，该公司诊断部门的基础业务销售额（不计外汇波动的影响）增长了8%，这主要得益于免疫诊断解决方案的持续普及以及cobas质谱系统的实施。

同时，个人化医疗和以价值为导向的心臟照护模式的转变正在重塑市场动态，要求医疗服务提供者实施能够减少不必要资源消耗的诊断通讯协定。利用高精准度生物标记进行快速风险分层，能够帮助医院有效率地筛选出急性心臟疾病事件，进而缓解急诊室的壅塞状况，降低整体医疗成本。近期统计数据也印证了这项提升营运效率的趋势。根据GlobalRPH于2025年10月发表的一篇报导《高敏肌钙蛋白检测：终结不必要的胸痛住院？ 》，高敏肌钙蛋白I检测通讯协定的实施使胸痛相关住院人数以金额为准减少了5.6%。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：全球心臟生物标记市场展望

  • 市场规模及预测
    • 按金额
  • 市占率及预测
    • 按类型（肌钙蛋白、CK-MB、肌红蛋白、BNP 和 NT-proBNP、其他）
    • 依应用领域（急性冠状动脉症候群、心肌梗塞、郁血性心臟衰竭等）
    • 按地区
    • 按公司（2025 年）
  • 市场地图

第六章：北美心臟生物标记市场展望

  • 市场规模及预测
  • 市占率及预测
  • 北美洲：国别分析
    • 我们
    • 加拿大
    • 墨西哥

第七章：欧洲心臟生物标记市场展望

  • 市场规模及预测
  • 市占率及预测
  • 欧洲：国别分析
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙

第八章：亚太地区心臟生物标记市场展望

  • 市场规模及预测
  • 市占率及预测
  • 亚太地区：国别分析
    • 中国
    • 印度
    • 日本
    • 韩国
    • 澳洲

第九章：中东和非洲心臟生物标记市场展望

  • 市场规模及预测
  • 市占率及预测
  • 中东与非洲：国别分析
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 南非

第十章：南美洲心臟生物标记市场展望

  • 市场规模及预测
  • 市占率及预测
  • 南美洲：国别分析
    • 巴西
    • 哥伦比亚
    • 阿根廷

第十一章 市场动态

  • 促进因素
  • 任务

第十二章 市场趋势与发展

  • 併购
  • 产品发布
  • 近期趋势

第十三章 全球心臟生物标记市场：SWOT分析

第十四章：波特五力分析

  • 产业竞争
  • 新进入者的潜力
  • 供应商的议价能力
  • 顾客权力
  • 替代品的威胁

第十五章 竞争格局

  • Abbott Laboratories Inc.
  • QuidelOrtho Corporation
  • Siemens Healthineers AG
  • F. Hoffmann-La Roche Ltd
  • Danaher Corporation
  • Bio-Rad Laboratories, Inc.
  • Randox Laboratories Ltd.
  • Creative Diagnostics
  • Life Diagnostics Inc.
  • BIOMeRIEUX Inc.

第十六章 策略建议

第十七章：关于研究公司及免责声明

简介目录
Product Code: 24326

The Global Cardiac Biomarkers Market is projected to expand from USD 18.41 Billion in 2025 to USD 29.23 Billion by 2031, registering a CAGR of 8.01%. These biomarkers, consisting of measurable enzymes or proteins released into the bloodstream during cardiac stress, function as vital indicators for diagnosing conditions such as myocardial infarction. The market is propelled chiefly by the increasing frequency of cardiovascular disorders and the urgent requirement for precise, rapid diagnostics in emergency scenarios. This necessity is highlighted by significant disease burden data; according to the American Heart Association, approximately 126.9 million adults in the United States were estimated to have a form of cardiovascular disease in 2024, a prevalence that necessitates widespread diagnostic testing and continuously drives market revenue.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 18.41 Billion
Market Size 2031USD 29.23 Billion
CAGR 2026-20318.01%
Fastest Growing SegmentBillionP and NT-proBillionP
Largest MarketNorth America

However, a major obstacle impeding market progression is the rigorous regulatory approval process mandated for new diagnostic assays. Manufacturers face the task of navigating intricate compliance standards and enduring prolonged validation phases to prove clinical utility, which escalates development costs and postpones product launches. Additionally, uneven reimbursement coverage for emerging biomarkers across international healthcare systems can hinder commercial uptake and curtail the financial sustainability of testing solutions for newer providers.

Market Driver

The rising global prevalence of cardiovascular diseases serves as a primary engine for the cardiac biomarkers market, generating consistent demand for diagnostic testing. With the incidence of conditions like heart failure and myocardial infarction increasing, medical providers are relying more heavily on sensitive biomarkers for effective risk stratification and rapid triage. This growing disease burden leads directly to elevated testing volumes in clinical and hospital environments, requiring a strong diagnostic infrastructure. According to the 'Vital Statistics Rapid Release' report by the Centers for Disease Control and Prevention in June 2025, heart disease-related deaths in the United States climbed to 683,037 in 2024, highlighting the essential need for precise tools to manage the expanding patient population and prevent severe outcomes.

Concurrently, technological advancements in high-sensitivity biomarker assays are broadening market potential by improving diagnostic accuracy. These sophisticated solutions enable the detection of cardiac troponin at much lower concentrations, allowing for the identification of myocardial injury significantly earlier than traditional methods, which supports a shift toward proactive patient care. The market's favorable reception of these innovations is evident in financial metrics; according to Abbott's 'Third-Quarter 2024 Results' press release from October 2024, global Core Laboratory Diagnostics sales grew by 4.5 percent organically, fueled by the uptake of updated diagnostic systems. Underscoring this trend of high-volume usage, Roche reported delivering a total of 30 billion diagnostic tests globally during the preceding fiscal year in 2025.

Market Challenge

The exacting regulatory approval process acts as a significant hurdle that directly impedes the expansion of the Global Cardiac Biomarkers Market. Manufacturers are required to maneuver through complex compliance structures and undertake comprehensive validation stages to establish the clinical utility of new diagnostic assays. This intense scrutiny results in extended development schedules and substantially increased operational expenses before a product can reach the commercial stage. Consequently, the substantial investment of time and capital needed to obtain approvals frequently discourages companies from launching innovative biomarkers, thereby slowing the rate of innovation and limiting the introduction of advanced diagnostic solutions.

The consequence of these regulatory pressures is visible in recent industry trends, where there is a strategic withdrawal from markets characterized by complicated compliance mandates. According to MedTech Europe in 2024, the preference for the European Union as the primary region for initial product launches by major in vitro diagnostic manufacturers fell by 40 percent due to difficulties linked to the new regulatory landscape. This data point emphasizes how burdensome regulatory requirements compel firms to reallocate resources and postpone launch strategies. By hindering the rollout of necessary diagnostic tools, these regulatory obstacles effectively limit revenue potential and restrict the sector's broader commercial growth.

Market Trends

The rise of Automated High-Throughput Immunoassay Systems is fundamentally transforming the Global Cardiac Biomarkers Market as clinical labs focus on workflow efficiency to handle growing testing loads. Manufacturers are increasingly releasing integrated platforms that merge immunodiagnostics with clinical chemistry, thereby minimizing manual tasks and accelerating turnaround times for essential cardiac assays. This strong demand for sophisticated diagnostic infrastructure is reflected in recent market performance; according to Roche's January 2025 press release titled 'Roche reports strong 2024 results with 7% sales growth,' the company's Diagnostics Division saw base business sales rise by 8 percent at constant exchange rates, driven by the continued adoption of immunodiagnostic solutions and the launch of the cobas Mass Spec system.

Simultaneously, a movement toward Personalized Medicine and Value-Based Cardiac Care is shaping market dynamics, urging healthcare providers to implement diagnostic protocols that reduce unnecessary resource use. By utilizing high-precision biomarkers for swift risk stratification, hospitals can efficiently rule out acute cardiac events, which helps alleviate emergency department congestion and lowers overall healthcare expenses. This trend toward enhanced operational efficiency is backed by recent statistics; according to a GlobalRPH article from October 2025 titled 'High-Sensitivity Troponin Testing: The End of Unnecessary Chest Pain Admissions?', the adoption of high-sensitivity cardiac troponin I testing protocols led to an absolute reduction of 5.6 percent in hospital admissions related to chest pain.

Key Market Players

  • Abbott Laboratories Inc.
  • QuidelOrtho Corporation
  • Siemens Healthineers AG
  • F. Hoffmann-La Roche Ltd
  • Danaher Corporation
  • Bio-Rad Laboratories, Inc.
  • Randox Laboratories Ltd.
  • Creative Diagnostics
  • Life Diagnostics Inc.
  • BIOMeRIEUX Inc.

Report Scope

In this report, the Global Cardiac Biomarkers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Cardiac Biomarkers Market, By Type

  • Troponin
  • CK-MB
  • Myoglobin
  • BNP and NT-proBNP
  • Others

Cardiac Biomarkers Market, By Application

  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Congestive Heart Failure
  • Others

Cardiac Biomarkers Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cardiac Biomarkers Market.

Available Customizations:

Global Cardiac Biomarkers Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Cardiac Biomarkers Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (Troponin, CK-MB, Myoglobin, BNP and NT-proBNP, Others)
    • 5.2.2. By Application (Acute Coronary Syndrome, Myocardial Infarction, Congestive Heart Failure, Others)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Cardiac Biomarkers Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By Application
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Cardiac Biomarkers Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
        • 6.3.1.2.2. By Application
    • 6.3.2. Canada Cardiac Biomarkers Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
        • 6.3.2.2.2. By Application
    • 6.3.3. Mexico Cardiac Biomarkers Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type
        • 6.3.3.2.2. By Application

7. Europe Cardiac Biomarkers Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By Application
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Cardiac Biomarkers Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
        • 7.3.1.2.2. By Application
    • 7.3.2. France Cardiac Biomarkers Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
        • 7.3.2.2.2. By Application
    • 7.3.3. United Kingdom Cardiac Biomarkers Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
        • 7.3.3.2.2. By Application
    • 7.3.4. Italy Cardiac Biomarkers Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
        • 7.3.4.2.2. By Application
    • 7.3.5. Spain Cardiac Biomarkers Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type
        • 7.3.5.2.2. By Application

8. Asia Pacific Cardiac Biomarkers Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By Application
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Cardiac Biomarkers Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
        • 8.3.1.2.2. By Application
    • 8.3.2. India Cardiac Biomarkers Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
        • 8.3.2.2.2. By Application
    • 8.3.3. Japan Cardiac Biomarkers Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
        • 8.3.3.2.2. By Application
    • 8.3.4. South Korea Cardiac Biomarkers Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Type
        • 8.3.4.2.2. By Application
    • 8.3.5. Australia Cardiac Biomarkers Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Type
        • 8.3.5.2.2. By Application

9. Middle East & Africa Cardiac Biomarkers Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By Application
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Cardiac Biomarkers Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
        • 9.3.1.2.2. By Application
    • 9.3.2. UAE Cardiac Biomarkers Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
        • 9.3.2.2.2. By Application
    • 9.3.3. South Africa Cardiac Biomarkers Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type
        • 9.3.3.2.2. By Application

10. South America Cardiac Biomarkers Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By Application
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Cardiac Biomarkers Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
        • 10.3.1.2.2. By Application
    • 10.3.2. Colombia Cardiac Biomarkers Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
        • 10.3.2.2.2. By Application
    • 10.3.3. Argentina Cardiac Biomarkers Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type
        • 10.3.3.2.2. By Application

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Cardiac Biomarkers Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Abbott Laboratories Inc.
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. QuidelOrtho Corporation
  • 15.3. Siemens Healthineers AG
  • 15.4. F. Hoffmann-La Roche Ltd
  • 15.5. Danaher Corporation
  • 15.6. Bio-Rad Laboratories, Inc.
  • 15.7. Randox Laboratories Ltd.
  • 15.8. Creative Diagnostics
  • 15.9. Life Diagnostics Inc.
  • 15.10. BIOMeRIEUX Inc.

16. Strategic Recommendations

17. About Us & Disclaimer