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市场调查报告书
商品编码
1618310

IVD 品质控制市场机会、成长动力、产业趋势分析与预测 2024 - 2032

IVD Quality Control Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2024 - 2032
出版日期: | 出版商: Global Market Insights Inc. | 英文 160 Pages | 商品交期: 2-3个工作天内

价格
简介目录

2023 年，全球 IVD 品质控制市场价值为 13 亿美元，预计未来几年复合年增长率为 4.2%。这种增长主要是由于诊断技术的进步、对精确诊断测试的需求不断增加、对即时检测的兴趣不断增加以及严格的监管要求所推动的。此外，新兴市场不断增长的医疗支出和先进诊断工具的普及进一步促进了市场的扩张。随着医疗保健产业的不断发展，对指导医疗决策的精确诊断的需求不断增加，从而推动了对确保诊断测试的准确性和可靠性的品质控制系统的需求。

全球慢性病和传染病的增加也推动了对持续、准确诊断的需求。 IVD 品质控制涉及验证在受控实验室环境中进行的测试的准确性、精密度和一致性的过程。这些测试通常是对血液、尿液或组织等样本进行，对于确保诊断设备提供可靠的结果至关重要。这对于准确诊断、治疗和患者护理至关重要。

市场按类型细分，2023 年品质控制领域处于领先地位，占 8.596 亿美元。品质控制在监测诊断测试的性能并确保其符合既定标准方面发挥关键作用。这对于维护患者安全、实现监管合规性以及确保诊断实验室的可靠性至关重要。按产品类型划分，受体外诊断程序支出增加的推动，控制细分市场在 2023 年占据最大市场份额，达到 50.6%。

市场范围
开始年份 2023年
预测年份 2024-2032
起始值 13亿美元
预测值 19亿美元
复合年增长率 4.2%

控製材料的技术进步预计将推动该领域的成长。在应用方面，免疫分析领域将在 2023 年引领市场，由于其在早期疾病检测中的重要性，预计将以 4.4% 的复合年增长率成长。从地理上看，北美在 2023 年占据市场主导地位，营收为 4.932 亿美元。该地区的领先地位归功于不断增长的老年人口、不断增长的诊断测试需求以及先进的医疗基础设施。

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加
      • 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
  • 定价分析
  • 波特的分析
  • PESTEL分析

第 4 章：竞争格局

  • 介绍
  • 公司市占率分析
  • 主要市场参与者的竞争分析
  • 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
    • 实验室资讯管理系统（LIMS）
    • 独立软体
  • 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
  • 校准验证器
  • 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
  • 免疫分析
  • 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
  • 其他最终用途

第 10 章：市场估计与预测：按地区划分，2021 - 2032 年

  • 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
  • 亚太地区
    • 中国
    • 日本
    • 印度
    • 澳洲
    • 韩国
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
  • 中东和非洲
    • 南非
    • 沙乌地阿拉伯
    • 阿联酋

第 11 章：公司简介

  • Abbott
  • Agilent Technologies
  • Becton, Dickinson and Company
  • Bio-Rad Laboratories
  • Bio-Techne Corporation
  • Danaher Corporation
  • F. Hoffmann-La Roche
  • Helena Laboratories Corporation
  • Hologic
  • Merck
  • QIAGEN
  • QuidelOrtho Corporation
  • Randox Laboratories
  • Siemens Healthineers
  • Sysmex Corporation
  • Technopath Manufacturing
  • Thermo Fisher Scientific
简介目录
Product Code: 9695

The Global IVD Quality Control Market was valued at USD 1.3 billion in 2023 and is expected to grow at a CAGR of 4.2% over the coming years. This growth is primarily fueled by the advancements in diagnostic technologies, escalating demand for precise diagnostic testing, rising interest in point-of-care testing, and strict regulatory requirements. Additionally, growing healthcare expenditure and improved access to advanced diagnostic tools in emerging markets are further contributing to the market's expansion. As the healthcare industry continues to evolve, the need for precise diagnostics to guide medical decisions is rising, driving the demand for quality control systems that ensure the accuracy and reliability of diagnostic tests.

The global rise in chronic and infectious diseases is also pushing the need for continuous and accurate diagnostics. IVD quality control involves processes that validate the accuracy, precision, and consistency of tests performed in controlled laboratory settings. These tests, typically conducted on samples such as blood, urine, or tissue, are crucial in ensuring that diagnostic devices provide reliable results. This is essential for accurate diagnosis, treatment, and patient care.

The market is segmented by type, with the quality control segment leading in 2023, accounting for USD 859.6 million. Quality control plays a critical role in monitoring the performance of diagnostic tests and ensuring they meet established standards. This is essential for maintaining patient safety, achieving regulatory compliance, and ensuring the reliability of diagnostic laboratories. By product type, the control segment held the largest market share in 2023 at 50.6%, driven by increasing expenditure on in vitro diagnostic procedures.

Market Scope
Start Year2023
Forecast Year2024-2032
Start Value$1.3 Billion
Forecast Value$1.9 Billion
CAGR4.2%

Technological advancements in control materials are expected to drive growth in this segment. In terms of application, the immunoassay segment led the market in 2023 and is expected to grow at a CAGR of 4.4% due to its importance in early disease detection. Geographically, North America dominated the market in 2023, with revenue of USD 493.2 million. The region's leadership is attributed to a growing elderly population, rising demand for diagnostic testing, and advanced healthcare infrastructure.As diagnostic needs increase, so does the demand for IVD quality control products.

Table of Contents

Chapter 1 Methodology & Scope

  • 1.1 Market scope & definition
  • 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 Technology landscape
  • 3.5 Regulatory landscape
  • 3.6 Pricing analysis
  • 3.7 Porter's analysis
  • 3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

  • 4.1 Introduction
  • 4.2 Company market share analysis
  • 4.3 Competitive analysis of major market players
  • 4.4 Competitive positioning matrix
  • 4.5 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
    • 5.3.1 Laboratory information management systems (LIMS)
    • 5.3.2 Standalone software
  • 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 Calibration verifiers
  • 6.5 Other products

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

  • 7.1 Key trends
  • 7.2 Immunoassay
  • 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 Instrument 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 Use

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
  • 10.4 Asia Pacific
    • 10.4.1 China
    • 10.4.2 Japan
    • 10.4.3 India
    • 10.4.4 Australia
    • 10.4.5 South Korea
  • 10.5 Latin America
    • 10.5.1 Brazil
    • 10.5.2 Mexico
    • 10.5.3 Argentina
  • 10.6 Middle East and Africa
    • 10.6.1 South Africa
    • 10.6.2 Saudi Arabia
    • 10.6.3 UAE

Chapter 11 Company Profiles

  • 11.1 Abbott
  • 11.2 Agilent Technologies
  • 11.3 Becton, Dickinson and Company
  • 11.4 Bio-Rad Laboratories
  • 11.5 Bio-Techne Corporation
  • 11.6 Danaher Corporation
  • 11.7 F. Hoffmann-La Roche
  • 11.8 Helena Laboratories Corporation
  • 11.9 Hologic
  • 11.10 Merck
  • 11.11 QIAGEN
  • 11.12 QuidelOrtho Corporation
  • 11.13 Randox Laboratories
  • 11.14 Siemens Healthineers
  • 11.15 Sysmex Corporation
  • 11.16 Technopath Manufacturing
  • 11.17 Thermo Fisher Scientific