IVD 品质控制市场，按类型、产品、应用、製造商类型、最终用途 - 全球预测

在慢性病和遗传性疾病盛行率上升的推动下，IVD 品质控制市场规模在 2024 年至 2032 年期间复合年增长率将达到 5.7%。据世界卫生组织称，非传染性疾病（NCD）每年导致 4,100 万人死亡，占全球死亡人数的 74%。这些情况通常需要持续监测和精确诊断，需要严格的品质控制措施以确保测试准确性和病人安全。对早期疾病检测和预防性医疗保健的日益重视正在刺激先进的品质控制解决方案的开发，这些解决方案可以支持广泛的诊断测试

诊断技术的创新，包括新一代定序、高通量筛选和自动化测试系统，正在提高诊断程序的准确性和效率。这些进步可以更精确地检测疾病和状况，进而改善患者的治疗效果。将尖端技术融入品质控制流程以及实验室中自动化系统的持续采用，进一步推动了市场的扩张

IVD（体外诊断）品质控制产业根据类型、产品、应用、製造商类型、最终用途和地区进行分类。

到 2032 年，资料管理解决方案领域将快速成长，因为这些解决方案包含旨在管理、分析和保护大量诊断资料的各种技术和平台。透过提供即时监控和全面的资料分析，这些解决方案有助于改善决策并确保遵守品质标准。有效资料管理系统的实施使医疗保健提供者和诊断实验室能够更准确地处理复杂的资料集，从而提高诊断结果的整体品质。

在遗传性疾病、传染病和癌症日益普及的推动下，到 2032 年，分子诊断领域将出现可观的成长。这些测试需要严格的品质控制措施以确保其准确性和可靠性。随着分子诊断领域随着新技术创新不断发展，强调在测试过程中保持高品质标准将推动市场成长。

在医疗保健基础设施快速进步、医学研究投资增加以及对提高诊断准确性的日益关注的推动下，亚太地区 IVD 品质控制行业将在 2024 年至 2032 年取得显着收益。中国、印度和日本等国家在采用先进诊断技术和品质控制措施方面处于领先地位。这些国家的慢性病盛行率不断上升，医疗保健产业不断扩大，导致对高品质诊断解决方案的需求不断增长。

目录

第 1 章：方法与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业影响力
  • 成长动力
    • 对准确诊断测试的需求不断增长
    • 诊断技术的进步
    • 对现场检测的需求不断增长
    • 严格的监管要求
  • 产业陷阱与挑战
    • IVD品质控制服务成本高
    • 有限的报销政策
• 成长潜力分析
• 技术景观
• 监管环境
• 波特的分析
• PESTEL分析

第 4 章：竞争格局

• 介绍
• 公司市占率分析
• 竞争定位矩阵
• 战略展望矩阵

第 5 章：市场估计与预测：按类型，2021 - 2032

• 主要趋势
• 品质管制
  • 基于血清/血浆的对照
  • 基于全血的对照
  • 基于尿液的控制
  • 其他品质控制
• 资料管理解决方案
• 品质保证服务

第 6 章：市场估计与预测：按产品分类，2021 - 2032 年

• 主要趋势
• 控制
  • 总蛋白
  • 白蛋白
  • 血中尿素氮
  • 尿酸
  • 肌酸酐
  • 钠
  • 钾
  • 氯化物
  • 钙
  • 镁
  • 天门冬胺酸转氨酶
  • 肌酸激酶
  • γ谷氨酰转移酶
  • 总胆红素
  • 其他控制
• 校准器
• 其他产品

第 7 章：市场估计与预测：按应用分类，2021 - 2032

• 主要趋势
• 免疫化学
• 临床化学
  • 电解质和矿物质
  • 肾功能
  • 肝功能
  • 蛋白质和酵素
  • 心臟标记物
  • 其他临床化学应用
• 分子诊断
  • 核酸扩增测试
  • DNA定序
  • 基因检测
  • 其他分子诊断应用
• 微生物学
• 血液学
• 凝血和止血
• 其他应用

第 8 章：市场估计与预测：按製造商类型，2021 - 2032 年

• 主要趋势
• 第三方控制
  • 独立控制
  • 仪器特定控制
• 原始设备製造商控制

第 9 章：市场估计与预测：按最终用途，2021 - 2032 年

• 主要趋势
• 医院
• 临床实验室
• 学术及研究机构
• 其他最终用户

第 10 章：市场估计与预测：按地区，2021 - 2032

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
  • 欧洲其他地区
• 亚太地区
  • 日本
  • 中国
  • 印度
  • 澳洲
  • 韩国
  • 亚太地区其他地区
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
  • 拉丁美洲其他地区
• 中东和非洲
  • 沙乌地阿拉伯
  • 南非
  • 阿联酋
  • 中东和非洲其他地区

第 11 章：公司简介

• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Becton, Dickinson and Company
• BIO-TECHNE CORPORATION
• CINVEN LIMITED
• Danaher Corporation
• F. Hoffmann-La Roche Ltd.
• Hologic, Inc.
• Helena Laboratories Corporation
• Merck KGaA
• QIAGEN N.V.
• QuidelOrtho Corporation
• Randox Laboratories Ltd
• Sysmex Corporation
• Siemens Healthineers AG
• Thermo Fisher Scientific, Inc.

The IVD Quality Control Market size will record 5.7% CAGR during 2024-2032, driven by the rising prevalence of chronic diseases and genetic disorders. According to WHO, noncommunicable diseases (NCDs) account for 41 million deaths annually, representing 74% of all global deaths. These conditions often require ongoing monitoring and precise diagnosis, necessitating stringent quality control measures to ensure test accuracy and patient safety. The growing emphasis on early disease detection and preventive healthcare is spurring the development of advanced quality control solutions that can support a wide range of diagnostic tests

Innovations in diagnostic technologies, including next-generation sequencing, high-throughput screening, and automated testing systems, are enhancing the accuracy and efficiency of diagnostic procedures. These advancements enable more precise detection of diseases and conditions, leading to better patient outcomes. The integration of cutting-edge technologies into quality control processes and the rising adoption of automated systems in laboratories are further fueling market expansion

The IVD (in-vitro diagnostics) quality control industry is classified based on type, product, application, manufacturer type, end-use, and region.

The data management solutions segment will grow rapidly through 2032, as these solutions encompass various technologies and platforms designed to manage, analyze, and secure large volumes of diagnostic data. By offering real-time monitoring and comprehensive data analytics, these solutions facilitate improved decision-making and ensure adherence to quality standards. The implementation of effective data management systems enables healthcare providers and diagnostic labs to handle complex data sets with greater accuracy, thereby enhancing the overall quality of diagnostic outcomes.

The molecular diagnostics segment will witness decent growth through 2032, driven by the growing prevalence of genetic disorders, infectious diseases, and cancer. These tests require rigorous quality control measures to ensure their accuracy and reliability. As the field of molecular diagnostics continues to evolve with new technological innovations, the emphasis on maintaining high-quality standards in testing processes will drive the market growth.

Asia Pacific IVD quality control industry will register significant gains over 2024-2032, driven by rapid advancements in healthcare infrastructure, increasing investments in medical research, and a rising focus on improving diagnostic accuracy. Countries such as China, India, and Japan are leading the way in adopting advanced diagnostic technologies and quality control measures. The growing prevalence of chronic diseases and the expanding healthcare sector in these countries are contributing to the rising demand for high-quality diagnostic solutions.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing demand for accurate diagnostic testing
    • 3.2.1.2 Advancements in diagnostic technologies
    • 3.2.1.3 Rising demand for point-of-care testing
    • 3.2.1.4 Stringent regulatory requirements
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 High cost of IVD quality control services
    • 3.2.2.2 Limited reimbursement policies
• 3.3 Growth potential analysis
• 3.4 Technological landscape
• 3.5 Regulatory landscape
• 3.6 Porter's analysis
• 3.7 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Competitive positioning matrix
• 4.4 Strategy outlook matrix

Chapter 5 Market Estimates and Forecast, By Type, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Quality control
  • 5.2.1 Serum/plasma-based controls
  • 5.2.2 Whole blood-based controls
  • 5.2.3 Urine-based controls
  • 5.2.4 Other quality controls
• 5.3 Data management solutions
• 5.4 Quality assurance services

Chapter 6 Market Estimates and Forecast, By Product, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Control
  • 6.2.1 Total protein
  • 6.2.2 Albumin
  • 6.2.3 Blood urea nitrogen
  • 6.2.4 Uric acid
  • 6.2.5 Creatinine
  • 6.2.6 Sodium
  • 6.2.7 Potassium
  • 6.2.8 Chloride
  • 6.2.9 Calcium
  • 6.2.10 Magnesium
  • 6.2.11 Aspartate transaminase
  • 6.2.12 Creatine kinase
  • 6.2.13 Gamma glutamyl transferase
  • 6.2.14 Total bilirubin
  • 6.2.15 Other controls
• 6.3 Calibrators
• 6.4 Other products

Chapter 7 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Immunochemistry
• 7.3 Clinical chemistry
  • 7.3.1 Electrolytes and minerals
  • 7.3.2 Renal function
  • 7.3.3 Liver function
  • 7.3.4 Proteins and enzymes
  • 7.3.5 Cardiac markers
  • 7.3.6 Other clinical chemistry applications
• 7.4 Molecular diagnostics
  • 7.4.1 Nucleic acid amplification tests
  • 7.4.2 DNA sequencing
  • 7.4.3 Genetic testing
  • 7.4.4 Other molecular diagnostic applications
• 7.5 Microbiology
• 7.6 Hematology
• 7.7 Coagulation and hemostasis
• 7.8 Other applications

Chapter 8 Market Estimates and Forecast, By Manufacturer Type, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 Third-party controls
  • 8.2.1 Independent controls
  • 8.2.2 Instruments specific controls
• 8.3 Original equipment manufacturer controls

Chapter 9 Market Estimates and Forecast, By End-use, 2021 - 2032 ($ Mn)

• 9.1 Key trends
• 9.2 Hospitals
• 9.3 Clinical laboratories
• 9.4 Academic and research institutes
• 9.5 Other end-users

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 10.1 Key trends
• 10.2 North America
  • 10.2.1 U.S.
  • 10.2.2 Canada
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 France
  • 10.3.4 Spain
  • 10.3.5 Italy
  • 10.3.6 Netherlands
  • 10.3.7 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 South Korea
  • 10.4.6 Rest of Asia Pacific
• 10.5 Latin America
  • 10.5.1 Brazil
  • 10.5.2 Mexico
  • 10.5.3 Argentina
  • 10.5.4 Rest of Latin America
• 10.6 Middle East and Africa
  • 10.6.1 Saudi Arabia
  • 10.6.2 South Africa
  • 10.6.3 UAE
  • 10.6.4 Rest of Middle East and Africa

Chapter 11 Company Profiles

• 11.1 Abbott Laboratories
• 11.2 Bio-Rad Laboratories, Inc.
• 11.3 Becton, Dickinson and Company
• 11.4 BIO-TECHNE CORPORATION
• 11.5 CINVEN LIMITED
• 11.6 Danaher Corporation
• 11.7 F. Hoffmann-La Roche Ltd.
• 11.8 Hologic, Inc.
• 11.9 Helena Laboratories Corporation
• 11.10 Merck KGaA
• 11.11 QIAGEN N.V.
• 11.12 QuidelOrtho Corporation
• 11.13 Randox Laboratories Ltd
• 11.14 Sysmex Corporation
• 11.15 Siemens Healthineers AG
• 11.16 Thermo Fisher Scientific, Inc.