体外诊断 (IVD)：技术与全球市场

全球体外诊断 (IVD) 市场规模预计将从 2024 年的947 亿美元增至 2029 年底的 1,419 亿美元，预测期内的复合年增长率为 8.4%。

免疫化学 IVD 市场预计将从 2024 年的 328 亿美元成长到 2029年终的430 亿美元，预测期内的复合年增长率为 5.5%。 POC IVD 检测市场预计将从 2024 年的 232 亿美元成长到 2029年终的384 亿美元，复合年增长率为 10.6%。

本报告调查了全球体外诊断（IVD）市场，并提供了市场的全面概述、市场影响因素和市场机会的分析、法律制度、新兴技术和技术发展的趋势、市场规模的趋势和预测、各个细分市场和地区的详细分析、竞争格局以及主要企业的概况。

目录

第一章执行摘要

• 市场展望
• 研究范围
• 市场概况

第二章 市场及技术背景

• 体外诊断 (IVD) 技术
• 概述
• IVD 元素的分类
• IVD技术和品管的重要性
• IVD 与生物医学诊断的区别
• 体外诊断（IVD）产业监管
• 各国IVD产品监管

第三章 市场动态

• 概述
• 市场驱动因素
• 老年人口不断增加：对诊断程序的依赖
• 人工智慧与IVD的整合
• 慢性病流行
• 提高就地检验(POCT) 的质量
• 市场限制
• 与技术产品包装相关的挑战
• 运输成本增加和服务问题
• 实验室助理缺乏操作实验室设备和耗材的技能
• 市场机会
• 居家照护检测设备的兴起
• POCT 设备需求
• 对人工智慧和物联网的需求不断增长

第四章 新兴科技与发展

• IVD 市场的新兴技术
• AI
• 旧 IVD 技术已改进
• 液态生物检体
• 自动化体外诊断设备
• IVD 的新发展
• FDA核准
• 个人化医疗需求日益增长
• 实验室自动化和数位健康平台
• IVD 装置可移植性选项
• 癌症诊断居家护理套件
• FDA核准的IVD 装置：支援人工智慧

第五章市场区隔分析

• 细分市场
• 依技术进行市场分析
• 免疫化学
• POC 测试
• 血
• 分子诊断
• 组织诊断
• 临床微生物学
• 市场分析：按应用
• 糖尿病
• 肾
• 血糖值评估与监测 (BGEM)
• 瘤
• 心臟病
• 感染疾病
• 其他的
• 最终用户的市场分析
• 诊断实验室
• 医院和诊所
• 点检中心
• 其他的
• 地理分布
• 市场分析：按地区
• 北美洲
• 欧洲
• 亚太地区
• 拉丁美洲
• 中东和非洲

第六章 竞争讯息

• 全球企业排名分析
• 中国主要IVD企业概况
• 协议、合作与伙伴关係
• IVD 公司和Start-Ups

7. 体外诊断 (IVD) 产业的永续性：ESG 视角

• ESG 在 IVD 製造业的重要性
• IVD 产业的 ESG 实践
• 环境绩效
• 社会绩效
• 管治绩效
• 企业在 ESG 发展中的作用
• ESG风险评估
• BCC 的看法

第 8 章 附录

• 调查方法
• 参考
• 公司简介
• ABBOTT
• BD
• BIOMERIEUX
• BIO-RAD LABORATORIES INC.
• BIO-TECHNE
• BRUKER
• DANAHER CORP.
• EKF DIAGNOSTICS HOLDINGS PLC
• F. HOFFMANN-LA ROCHE LTD.
• HOLOGIC INC.
• JSR CORP.
• QUIDELORTHO CORP.
• SIEMENS HEATHNIEERS AG
• SYSMEX CORP.
• THERMO FISHER SCIENTIFIC INC.

The global market for In Vitro Diagnostics (IVD) is expected to grow from $94.7 billion in 2024 and is projected to reach $141.9 billion by the end of 2029, at a compound annual growth rate (CAGR) of 8.4% during the forecast period of 2024 to 2029.

The immunochemistry IVD market is expected to grow from $32.8 billion in 2024 and is projected to reach $43.0 billion by the end of 2029, at a CAGR of 5.5% during the forecast period of 2024 to 2029.

The POC testing IVD market is expected to grow from $23.2 billion in 2024 and is projected to reach $38.4 billion by the end of 2029, at a CAGR of 10.6% during the forecast period of 2024 to 2029.

Report Scope

This report covers the in vitro diagnostic (IVD) technologies as well as in vitro diagnostic devices used in hospitals and point-of-care (POC) facilities to diagnose diseases. It also details the current and future market potential of in vitro diagnostic technology and includes an analysis of this market's competitive environment. The report covers market drivers, restraints, opportunities, product approvals, regulatory scenario assessments and emerging technologies. It features market projections and estimates of the market shares of key players through 2029.

In this analysis, the in vitro diagnostics market is segmented based on technologies, applications, end users and region. Based on technologies, the market is segmented into the following categories: hematology, immunochemistry, molecular diagnostics, POC testing, clinical microbiology and tissue diagnostics. Based on applications, the in vitro diagnostics market is segmented into these categories: diabetes, nephrology, blood glucose evaluation and monitoring (BGEM), oncology, cardiology, infectious diseases and other applications. The market is segmented based on end users into diagnostic laboratories, hospitals and clinics, point-of-care centers, and other end users.

The global in vitro diagnostics market has been segmented by the following geographical regions: North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. The report features detailed analyses of major countries such as the U.S., Germany, the U.K., Italy, France, Spain, Japan, China, India, Australia and New Zealand (ANZ), Argentina, Brazil, South Africa, Mexico and the GCC countries. Market analysis data is provided for 2023, which serves as the base year, and estimates are given for 2024 and forecast values through 2029.

Report Includes

• 41 data tables and 54 additional tables
• Analysis of global market trends, with data from 2021-2023, estimates for 2024, and projections of compound annual growth rates (CAGRs) through 2029
• Estimates of the size of the market for in vitro diagnostics (IVD) technologies, revenues, and market shares by technology, product, application, end user and region
• Assessment of market dynamics such as drivers, restraints and opportunities
• Discussion of how the rise in the number of respiratory infections, hospital acquired infections (HAIs), and sexually transmitted diseases are creating a constant need for IVD testing in hospitals and laboratories
• Discussion of IVD for neglected infectious diseases, chemistry-based portable analysis and microfluidic platform-based POC tests
• A discussion on ESG challenges and practices in the industry
• Assessment of the competitive landscape, including the market shares of key companies, their product portfolios and financial overviews
• Information on recent mergers, acquisitions, expansions, collaborations, investments, divestments and product launches
• Profiles of the leading companies, including F. Hoffmann-La Roche Ltd., Abbott, Sysmex Corp., Danaher, BD, and Siemens Healthineers AG

Table of Contents

Chapter 1 Executive Summary

• Market Outlook
• Scope of Report
• Market Summary

Chapter 2 Market and Technology Background

• Introduction
• In vitro Diagnostics Technology
• Overview
• Classification of In Vitro Diagnostic Elements
• Importance of In Vitro Diagnostics Technologies and Quality Control
• Difference Between In Vitro and In Vivo Diagnostics
• Regulations in the IVD Industry
• Regulation of IVD Products in Different Countries

Chapter 3 Market Dynamics

• Overview
• Market Drivers
• Rise in Population of Older Adults: Dependence on Diagnosis Procedures
• Integration of Artificial Intelligence in Vitro Diagnostics
• Rising Prevalence of Chronic Diseases
• Improving the Quality of Point-of-Care Testing (POCT)
• Market Restraints
• Challenges Associated with Technologies Product Packaging
• Increases in Shipping Costs or Service Issues
• Laboratory Assistant's Inability to Handle Laboratory Equipment and Consumables
• Market Opportunities
• Rise in Home Care Testing Devices
• Demand for Point-of-Care (POC) Testing Units
• Growing Demand for AI and the Internet of Things

Chapter 4 Emerging Technologies and Developments

• Emerging Technologies in the IVD Market
• Artificial Intelligence
• Modified Old IVD Techniques
• Liquid Biopsy
• Automated In Vitro Diagnostic Devices
• Emerging Developments in In Vitro Diagnostics
• FDA Approval
• Rise in Demand for Personalized Medicine
• Lab Automation and Digital Health Platform
• Portability Option in IVD Devices
• Home Care Kits for Cancer Diagnosis
• FDA Approved In Vitro Diagnostic Devices: AI Enabled

Chapter 5 Market Segmentation Analysis

• Segmentation Breakdown
• Market Analysis by Technology
• Immunochemistry
• POC Testing
• Hematology
• Molecular Diagnostics
• Tissue Diagnostics
• Clinical Microbiology
• Market Analysis by Application
• Diabetes
• Nephrology
• Blood Glucose Evaluation and Monitoring (BGEM)
• Oncology
• Cardiology
• Infectious Diseases
• Other Applications
• Market Analysis by End User
• Diagnostic Laboratory
• Hospitals and Clinics
• Point-of-Care (POC) Centers
• Other End Users
• Geographical Breakdown
• Market Analysis by Region
• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

Chapter 6 Competitive Intelligence

• Introduction
• Global Analysis of Company Market Ranking
• Glimpse of Leading In Vitro Diagnostics (IVD) Companies in China
• Agreements, Collaborations and Partnerships
• bioMerieux Agreements
• Siemens Healthineers and Sysmex Enter into a Global Agreement
• Roche Enters into Agreement with Path AI
• Quidel Corp. Signs Agreement to Acquire Ortho Clinical Diagnostics
• In Vitro Diagnostics Companies and Start-Ups in 2021-2023
• Diagopreutic Private Limited
• Diatherax
• IPLEXMED
• Magnify Bioscience Inc.

Chapter 7 Sustainability in the In Vitro Diagnostics Industry: An ESG Perspective

• Importance of ESG in In Vitro Diagnostics Manufacturing Industry
• ESG Practices in the In Vitro Diagnostics Industry
• Environmental Performance
• Social Performance
• Governance Performance
• Company Role in ESG Development
• ESG Risk Ratings
• BCC Research Viewpoint

Chapter 8 Appendix

• Research Methodology
• References
• Company Profiles
• ABBOTT
• BD
• BIOMERIEUX
• BIO-RAD LABORATORIES INC.
• BIO-TECHNE
• BRUKER
• DANAHER CORP.
• EKF DIAGNOSTICS HOLDINGS PLC
• F. HOFFMANN-LA ROCHE LTD.
• HOLOGIC INC.
• JSR CORP.
• QUIDELORTHO CORP.
• SIEMENS HEATHNIEERS AG
• SYSMEX CORP.
• THERMO FISHER SCIENTIFIC INC.

List of Tables

• Summary Table : Global Market for In Vitro Diagnostics, by Technology, Through 2029
• Table 1 : Approved FDA In Vitro Diagnostics Devices, 2021-2024
• Table 2 : Differences Between In Vitro and In Vivo Diagnostics
• Table 3 : FDA Approval of Artificial Intelligence and Machine Learning-Enabled Medical Devices, 2024
• Table 4 : Global Market for In Vitro Diagnostics, by Technology, Through 2029
• Table 5 : Global Market for In Vitro Diagnostics in Immunochemistry, by Region, Through 2029
• Table 6 : Global Market for In Vitro Diagnostics in POC Testing, by Region, Through 2029
• Table 7 : Summary of Electrochemiluminescence POCT Devices with Their Analytic Performance
• Table 8 : Global Market for In Vitro Diagnostics in Hematology, by Region, Through 2029
• Table 9 : Global Market for In Vitro Diagnostics in Molecular Diagnostics, by Region, Through 2029
• Table 10 : Global Market for In Vitro Diagnostics in Tissue Diagnostics, by Region, Through 2029
• Table 11 : Global Market for In Vitro Diagnostics in Clinical Microbiology, by Region, Through 2029
• Table 12 : Global Market for In Vitro Diagnostics, by Application, Through 2029
• Table 13 : Global Market for Diabetes in In Vitro Diagnostics, by Region, Through 2029
• Table 14 : Global Market for Nephrology in In Vitro Diagnostics, by Region, Through 2029
• Table 15 : Global Market for BGEM in In Vitro Diagnostics, by Region, Through 2029
• Table 16 : Global Market for Oncology in In Vitro Diagnostics, by Region, Through 2029
• Table 17 : Global Market for Cardiology in In Vitro Diagnostics, by Region, Through 2029
• Table 18 : Global Market for Infectious Diseases in In Vitro Diagnostics, by Region, Through 2029
• Table 19 : Global Market for Other Applications in In Vitro Diagnostics, by Region, Through 2029
• Table 20 : Global Market for In Vitro Diagnostics, by End User, Through 2029
• Table 21 : Global Market for In Vitro Diagnostics for Diagnostic Laboratory, by Region, Through 2029
• Table 22 : Global Market for In Vitro Diagnostics for Hospitals and Clinics, by Region, Through 2029
• Table 23 : Global Market for In Vitro Diagnostics for Point-of-Care Centers, by Region, Through 2029
• Table 24 : Global Market for In Vitro Diagnostics for Other End Users, by Region, Through 2029
• Table 25 : Global Market for In Vitro Diagnostics, by Region, Through 2029
• Table 26 : North American Market for In Vitro Diagnostics, by Country, Through 2029
• Table 27 : European Market for In Vitro Diagnostics, by Country, Through 2029
• Table 28 : Asia-Pacific Market for In Vitro Diagnostics, by Country, Through 2029
• Table 29 : Latin American Market for In Vitro Diagnostics, by Sub-Region, Through 2029
• Table 30 : Total Imports of Medical Equipment into Brazil, 2021 and 2022
• Table 31 : Middle Eastern and African Market for In Vitro Diagnostics Technology, by Sub-Region, Through 2029
• Table 32 : bioMerieux Agreements
• Table 33 : ESG Practices: Environmental Performance
• Table 34 : ESG Practices: Social Performance
• Table 35 : ESG Practices: Governance Performance
• Table 36 : Creating an Attractive Workplace: Social Performance
• Table 37 : ESG Rankings for Leading In Vitro Diagnostics Companies, 2023 and 2024*
• Table 38 : Abbott: Company Snapshot
• Table 39 : Abbott: Financial Performance, FY 2022 and 2023
• Table 40 : Abbott: Product Portfolio
• Table 41 : Abbott: News/Key Developments, 2022-2024
• Table 42 : BD: Company Snapshot
• Table 43 : BD: Financial Performance, FY 2022 and 2023
• Table 44 : BD: Product Portfolio
• Table 45 : BD: News/Key Developments, 2022-2024
• Table 46 : BIOMERIEUX: Company Snapshot
• Table 47 : BIOMERIEUX: Financial Performance, FY 2022 and 2023
• Table 48 : BIOMERIEUX: Product Portfolio
• Table 49 : BIOMERIEUX: News/Key Developments, 2023 and 2024
• Table 50 : Bio-Rad Laboratories Inc.: Company Snapshot
• Table 51 : Bio-Rad Laboratories Inc.: Financial Performance, FY 2022 and 2023
• Table 52 : Bio-Rad Laboratories Inc.: Product Portfolio
• Table 53 : Bio-Rad Laboratories Inc.: News/Key Developments, 2021-2024
• Table 54 : Bio-Techne: Company Snapshot
• Table 55 : Bio-Techne: Financial Performance, FY 2022 and 2023
• Table 56 : Bio-Techne: Product Portfolio
• Table 57 : Bio-Techne: News/Key Developments, 2022 and 2023
• Table 58 : Bruker: Company Snapshot
• Table 59 : Bruker: Financial Performance, FY 2022 and 2023
• Table 60 : Bruker: Product Portfolio
• Table 61 : Bruker: News/Key Developments, 2021-2024
• Table 62 : Danaher Corp.: Company Snapshot
• Table 63 : Danaher Corp.: Financial Performance, FY 2022 and 2023
• Table 64 : Danaher Corp.: Product Portfolio
• Table 65 : Danaher Corp.: News/Key Developments, 2021-2023
• Table 66 : EKF Diagnostics Holdings plc.: Company Snapshot
• Table 67 : EKF Diagnostics Holdings plc.: Financial Performance, FY 2022 and 2023
• Table 68 : EKF Diagnostics Holdings plc.: Product Portfolio
• Table 69 : EKF Diagnostics Holdings plc.: News/Key Developments, 2022-2024
• Table 70 : F. Hoffmann-La Roche Ltd.: Company Snapshot
• Table 71 : F. Hoffmann-La Roche Ltd.: Financial Performance, FY 2022 and 2023
• Table 72 : F. Hoffmann-La Roche Ltd.: Product Portfolio
• Table 73 : F. Hoffmann-La Roche Ltd.: News/Key Developments, 2022-2024
• Table 74 : Hologic Inc.: Company Snapshot
• Table 75 : Hologic Inc.: Financial Performance, FY 2022 and 2023
• Table 76 : Hologic Inc.: Product Portfolio
• Table 77 : Hologic Inc.: News/Key Developments, 2022-2024
• Table 78 : JSR Corp.: Company Snapshot
• Table 79 : JSR Corp.: Financial Performance, FY 2022 and 2023
• Table 80 : JSR Corp.: Product Portfolio
• Table 81 : JSR Corp.: News/Key Developments, 2024
• Table 82 : QuidelOrtho Corp.: Company Snapshot
• Table 83 : QuidelOrtho Corp.: Financial Performance, FY 2022 and 2023
• Table 84 : QuidelOrtho Corp.: Product Portfolio
• Table 85 : QuidelOrtho Corp.: News/Key Developments, 2021-2024
• Table 86 : Siemens Healthineers AG: Company Snapshot
• Table 87 : Siemens Healthineers AG: Financial Performance, FY 2022 and 2023
• Table 88 : Siemens Healthineers AG: Product Portfolio
• Table 89 : Siemens Healthineers AG: News/Key Developments, 2021-2024
• Table 90 : Sysmex Corp.: Company Snapshot
• Table 91 : Sysmex Corp.: Financial Performance, FY 2022 and 2023
• Table 92 : Sysmex Corp.: Product Portfolio
• Table 93 : Sysmex Corp.: News/Key Developments, 2022 and 2023
• Table 94 : Thermo Fisher Scientific Inc.: Company Snapshot
• Table 95 : Thermo Fisher Scientific Inc.: Financial Performance, FY 2022 and 2023
• Table 96 : Thermo Fisher Scientific Inc.: Product Portfolio
• Table 97 : Thermo Fisher Scientific Inc.: News/Key Developments, 2022 and 2023

List of Figures

• Summary Figure : Global Market Shares of In Vitro Diagnostics, by Technology, 2023
• Figure 1 : Snapshot of Market Dynamics
• Figure 2 : Older Adults Using Technology to Manage Chronic Health Issues in the U.S., by Age Group, 2024
• Figure 3 : Percentage of People Aged 50+ Using Digital Services in the U.S., 2024
• Figure 4 : Breakdown of Global Elderly Population (Aged 65+ Years), by Select Countries, 2022
• Figure 5 : Emerging AI Applications in In Vitro Diagnostics
• Figure 6 : Global Market Shares of In Vitro Diagnostics, by Technology, 2023
• Figure 7 : Global Market Shares of In Vitro Diagnostics, by Application, 2023
• Figure 8 : Snapshot of IVD Tests in Oncology
• Figure 9 : Global Market Shares of In Vitro Diagnostics, by End User, 2023
• Figure 10 : Global Market Shares of In Vitro Diagnostics, by Region, 2023
• Figure 11 : North American Market Shares of In Vitro Diagnostics, by Technology, 2023
• Figure 12 : North American Market Shares of In Vitro Diagnostics, by Application, 2023
• Figure 13 : North American Market Shares of In Vitro Diagnostics, by End User, 2023
• Figure 14 : North American Market Shares of In Vitro Diagnostics, by Country, 2023
• Figure 15 : European Market Shares of In Vitro Diagnostics, by Technology, 2023
• Figure 16 : European Market Shares of In Vitro Diagnostics, by Application, 2023
• Figure 17 : European Market Shares of In Vitro Diagnostics, by End User, 2023
• Figure 18 : European Market Shares of In Vitro Diagnostics, by Sub-Region , 2023
• Figure 19 : Asia-Pacific Market Shares of In Vitro Diagnostics, by Technology, 2023
• Figure 20 : Asia-Pacific Market Shares of In Vitro Diagnostics, by Application, 2023
• Figure 21 : Asia-Pacific Market Shares of In Vitro Diagnostics, by End User, 2023
• Figure 22 : Asia-Pacific Market Shares of In Vitro Diagnostics, by Country, 2023
• Figure 23 : Latin American Market Shares of In Vitro Diagnostics, by Technology, 2023
• Figure 24 : Latin American Market Shares of In Vitro Diagnostics, by Application, 2023
• Figure 25 : Latin American Market Shares of In Vitro Diagnostics, by End User, 2023
• Figure 26 : Latin American Market Shares of In Vitro Diagnostics, by Sub-Region, 2023
• Figure 27 : Middle Eastern and African Market Shares of In Vitro Diagnostics, by Technology, 2023
• Figure 28 : Middle Eastern and African Market Shares of In Vitro Diagnostics, by Application, 2023
• Figure 29 : Middle Eastern and African Market Shares of In Vitro Diagnostics, by End User, 2023
• Figure 30 : Middle Eastern and African Market Shares of In Vitro Diagnostics, by Sub-Region, 2023
• Figure 31 : Rankings of Leading Companies in Global In Vitro Diagnostics Market, 2023
• Figure 32 : Snapshot: Key ESG Trends in the In Vitro Diagnostics Industry
• Figure 33 : Abbott: Revenue Shares, by Business Unit, FY 2023
• Figure 34 : Abbott: Revenue Shares, by Country/Region, FY 2023
• Figure 35 : BD: Revenue Shares, by Business Unit, FY 2023
• Figure 36 : BD: Revenue Shares, by Country/Region, FY 2023
• Figure 37 : BIOMERIEUX: Revenue Shares, by Business Unit, FY 2023
• Figure 38 : BIOMERIEUX: Revenue Shares, by Country/Region, FY 2023
• Figure 39 : Bio-Rad Laboratories Inc.: Revenue Shares, by Business Unit, FY 2023
• Figure 40 : Bio-Rad Laboratories Inc.: Revenue Shares, by Country/Region, FY 2023
• Figure 41 : Bio-Techne: Revenue Shares, by Business Unit, FY 2023
• Figure 42 : Bio-Techne: Revenue Shares, by Country/Region, FY 2023
• Figure 43 : Bruker: Revenue Shares, by Business Unit, FY 2023
• Figure 44 : Bruker: Revenue Shares, by Country/Region, FY 2023
• Figure 45 : Danaher Corp.: Revenue Shares, by Business Unit, FY 2023
• Figure 46 : Danaher Corp.: Revenue Shares, by Country/Region, FY 2023
• Figure 47 : EKF Diagnostics Holdings plc.: Revenue Shares, by Business Unit, FY 2023
• Figure 48 : EKF Diagnostics Holdings plc.: Revenue Shares, by Country/Region, FY 2023
• Figure 49 : F. Hoffmann-La Roche Ltd.: Revenue Shares, by Business Unit, FY 2023
• Figure 50 : F. Hoffmann-La Roche Ltd.: Revenue Shares, by Country/Region, FY 2023
• Figure 51 : Hologic Inc.: Revenue Shares, by Business Unit, FY 2023
• Figure 52 : Hologic Inc.: Revenue Shares, by Country/Region, FY 2023
• Figure 53 : JSR Corp.: Revenue Shares, by Business Unit, FY 2023
• Figure 54 : JSR Corp.: Revenue Shares, by Country/Region, FY 2023
• Figure 55 : QuidelOrtho Corp.: Revenue Shares, by Business Unit, FY 2023
• Figure 56 : QuidelOrtho Corp.: Revenue Shares, by Country/Region, FY 2023
• Figure 57 : Siemens Healthineers AG: Revenue Shares, by Business Unit, FY 2023
• Figure 58 : Siemens Healthineers AG: Revenue Shares, by Country/Region, FY 2023
• Figure 59 : Sysmex Corp.: Revenue Shares, by Business Unit, FY 2023
• Figure 60 : Sysmex Corp.: Revenue Shares, by Country/Region, FY 2023
• Figure 61 : Thermo Fisher Scientific Inc.: Revenue Shares, by Business Unit, FY 2023
• Figure 62 : Thermo Fisher Scientific Inc.: Revenue Shares, by Country/Region, FY 2023