全球 IVD 品质控制市场规模、份额、成长分析（按产品和服务、应用、製造商类型）- 2024-2031 年产业预测

2022年，全球IVD品质控制市场规模为11.0亿美元，预计将从2023年的11.1亿美元成长到2031年的15亿美元，在预测期间（2024-2031年）复合年增长率为4.10%。

全球 IVD 品质控制市场正在经历大幅增长，其推动因素包括临床实验室发挥的关键作用、老年人口的不断扩大、对外部品质评估倡议的需求增加、发达地区床边护理仪器的使用率增加、以及第三方品质控制措施的激增。此外，传染病、爱滋病毒和癌症的发生率不断上升，需要先进的诊断和严格的品质监控，进一步促进了市场的扩张。例如，联合国爱滋病毒和爱滋病联合规划署的资料显示，2019年，约2450万爱滋病毒患者接受了抗逆转录病毒治疗，这强调了快速诊断解决方案和强大的品质保证机制的必要性。然而，挑战依然存在，包括实验室品质控制的额外负担、IVD 测试的不利报销条件以及许多新兴经济体缺乏临床实验室认证的强制性监管框架。

目录

执行摘要

• 市场概况
• 命运之轮

研究方法论

• 资讯采购
• 二手和主要资料来源
• 市场规模估计
• 市场假设与限制

母公司市场分析

• 市场概况
• 市场规模
• 市场动态
  • 司机
  • 机会
  • 限制
  • 挑战

主要市场洞察

• 技术分析
• 定价分析
• 供应链分析
• 价值链分析
• 市场生态系统
• 智慧财产权分析
• 贸易分析
• 启动分析
• 原料分析
• 创新矩阵
• 管道产品分析
• 总体经济指标
• 顶级投资分析
• 成功的关键因素
• 竞争程度

市场动态与展望

• 市场动态
  • 司机
  • 机会
  • 限制
  • 挑战
• 监管环境
• 波特分析
• 对未来颠覆的特别见解

按产品和服务分類的全球 IVD 品质控制市场

• 市场概况
• 品质控制产品
• 资料管理解决方案
• 品质保证服务。

全球 IVD 品质控制市场（按应用）

• 市场概况
• 临床化学
• 免疫化学/免疫测定
• 血液学
• 分子诊断
• 凝血和止血
• 微生物学
• 和别的

按製造商类型分類的全球 IVD 品质控制市场

• 市场概况
• 第三方控制厂商
• 和原始设备製造商

全球 IVD 品质控制市场规模（按地区）

• 市场概况
• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 欧洲其他地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 巴西
  • 拉丁美洲其他地区
• 中东和非洲 (MEA)
  • 海湾合作委员会国家
  • 南非
  • MEA 的其余部分

竞争格局

• 前 5 名玩家比较
• 2023 年关键参与者的市场定位
• 主要市场参与者所采取的策略
• 最佳制胜策略
• 近期市集活动
• 主要公司市占率 (%), 2023

主要公司简介

• Bio-Rad Laboratories
• Abbott Laboratories
• Siemens Healthineers
• Thermo Fisher Scientific
• Roche Diagnostics
• Randox Laboratories
• Bio-Techne Corporation
• Ortho Clinical Diagnostics
• Streck
• Sysmex Corporation
• Technopath Clinical Diagnostics
• Helena Biosciences
• SeraCare Life Sciences
• Quidel Corporation
• ZeptoMetrix Corporation
• Merck KGaA
• Seracare Life Sciences
• Fortress Diagnostics
• Maine Molecular Quality Controls
• LGC Group

Global IVD Quality Control Market size was valued at USD 1.10 billion in 2022 and is poised to grow from USD 1.11 billion in 2023 to USD 1.5 billion by 2031, growing at a CAGR of 4.10% during the forecast period (2024-2031).

The global IVD quality control market is experiencing substantial growth, driven by factors such as the pivotal role played by clinical laboratories, the expanding geriatric demographic, heightened demand for external quality assessment initiatives, increased uptake of point-of-care instruments in developed regions, and the surge in third-party quality control measures. Furthermore, the escalating incidence of infectious diseases, HIV, and cancers necessitating advanced diagnostics and rigorous quality monitoring further bolster market expansion. For instance, data from the Joint United Nations Program on HIV and AIDS reveal that in 2019, approximately 24.5 million HIV patients received antiretroviral therapy, emphasizing the need for swift diagnostic solutions and robust quality assurance mechanisms. However, challenges persist, including the added burdens placed on laboratories for quality control, unfavorable reimbursement conditions for IVD tests, and the absence of mandatory regulatory frameworks for clinical laboratory accreditation in numerous emerging economies.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global IVD Quality Control Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global IVD Quality Control Market Segmental Analysis

Global In Vitro Diagnostics (IVD) Quality Control market is segmented into product and service, application, manufacturer type, end user, and region. Based on product and service, the IVD Quality Control Market is segmented into quality control products, data management solutions, and quality assurance services. In terms of application, the global market is classified into clinical chemistry, immunochemistry/immunoassay, hematology, molecular diagnostics, coagulation and hemostasis, microbiology, and others. With respect to categorization by manufacturer type, the global IVD Quality Control Market is divided into third-party control manufacturers, and original equipment manufacturers. Based on end users, the global IVD Quality Control Market is segmented into hospitals, home care settings, clinical laboratories, and academic and research institutes.

Drivers of the Global IVD Quality Control Market

The surge in the prevalence of diverse diseases has led to a rise in the demand for laboratory tests, prompting an expansion in both public and commercial laboratory facilities. The swift spread of COVID-19 since December 2019 further intensified the need for diagnostic testing, prompting governmental bodies to establish supplementary laboratories to bolster testing capacity, consequently fueling market growth.

Restraints in the Global IVD Quality Control Market

Establishing quality control (QC) procedures in hospital settings requires both financial investment and specialized knowledge. Clinical laboratories dealing with low volume QC procedures often find the adoption of such protocols financially burdensome. This challenge is compounded by budgetary limitations in many healthcare facilities and labs, leading to a reduced uptake of QC procedures.

Market Trends of the Global IVD Quality Control Market

As diseases become more widespread, medical device companies are increasingly prioritizing the advancement of technologically sophisticated diagnostic tools. Hospitals and laboratories are increasingly favoring point-of-care testing devices to obtain precise real-time data, leading to a surge in demand for such devices and driving market growth.

Table of Contents

Executive Summary

• Market Overview
• Wheel of Fortune

Research Methodology

• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Parent Market Analysis

• Market Overview
• Market Size
• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges

Key Market Insights

• Technology Analysis
• Pricing Analysis
• Supply Chain Analysis
• Value Chain Analysis
• Ecosystem of the Market
• IP Analysis
• Trade Analysis
• Startup Analysis
• Raw Material Analysis
• Innovation Matrix
• Pipeline Product Analysis
• Macroeconomic Indicators
• Top Investment Analysis
• Key Success Factor
• Degree of Competition

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Regulatory Landscape
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers
• Skyquest Special Insights on Future Disruptions
  • Political Impact
  • Economic Impact
  • Social Impact
  • Technical Impact
  • Environmental Impact
  • Legal Impact

Global IVD Quality Control Market by Product and Service

• Market Overview
• Quality control products
• data management solutions
• and quality assurance services.

Global IVD Quality Control Market by Application

• Market Overview
• Clinical Chemistry
• immunochemistry/immunoassay
• hematology
• molecular diagnostics
• coagulation and hemostasis
• microbiology
• and others

Global IVD Quality Control Market by Manufacturer type

• Market Overview
• Third-party control manufacturers
• and original equipment manufacturers

Global IVD Quality Control Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Top Winning Strategies
  • By Development
  • By Company
  • By Year
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• Bio-Rad Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Abbott Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Siemens Healthineers
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Roche Diagnostics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Randox Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Techne Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Ortho Clinical Diagnostics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Streck
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sysmex Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Technopath Clinical Diagnostics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Helena Biosciences
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SeraCare Life Sciences
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Quidel Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ZeptoMetrix Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck KGaA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Seracare Life Sciences
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fortress Diagnostics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Maine Molecular Quality Controls
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LGC Group
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments