全球 IVD 品質控制市場規模、佔有率、成長分析（依產品和服務、應用、製造商類型）- 2024-2031 年產業預測

2022年，全球IVD品質控制市場規模為11.0億美元，預計將從2023年的11.1億美元成長到2031年的15億美元，在預測期間（2024-2031年）複合年成長率為4.10%。

全球 IVD 品質控制市場正在經歷大幅成長，其推動因素包括臨床實驗室發揮的關鍵作用、老年人口的不斷擴大、對外部品質評估舉措的需求增加、已開發地區床邊護理儀器的使用率增加、以及第三方品質控制措施的激增。此外，傳染病、愛滋病毒和癌症的發生率不斷上升，需要先進的診斷和嚴格的品質監控，進一步促進了市場的擴張。例如，聯合國愛滋病毒和愛滋病聯合規劃署的資料顯示，2019年，約2450萬愛滋病毒患者接受了抗逆轉錄病毒治療，這強調了快速診斷解決方案和強大的品質保證機制的必要性。然而，課題依然存在，包括實驗室品質控制的額外負擔、IVD 測試的不利報銷條件以及許多新興經濟體缺乏臨床實驗室認證的強制性監管框架。

目錄

執行摘要

• 市場概況
• 命運之輪

研究方法論

• 資訊採購
• 二手和主要資料來源
• 市場規模估計
• 市場假設與限制

母公司市場分析

• 市場概況
• 市場規模
• 市場動態
  • 促進要素
  • 機會
  • 限制
  • 課題

主要市場洞察

• 技術分析
• 定價分析
• 供應鏈分析
• 價值鏈分析
• 市場生態系統
• 智慧財產權分析
• 貿易分析
• 啟動分析
• 原料分析
• 創新矩陣
• 管道產品分析
• 總體經濟指標
• 頂級投資分析
• 成功的關鍵因素
• 競爭程度

市場動態與展望

• 市場動態
  • 促進要素
  • 機會
  • 限制
  • 課題
• 監管環境
• 波特分析
• 對未來顛覆的特別見解

依產品和服務分類的全球 IVD 品質控制市場

• 市場概況
• 品質控制產品
• 資料管理解決方案
• 品質保證服務。

全球 IVD 品質控制市場（依應用）

• 市場概況
• 臨床化學
• 免疫化學/免疫測定
• 血液學
• 分子診斷
• 凝血和止血
• 微生物學
• 和別的

依製造商類型分類的全球 IVD 品質控制市場

• 市場概況
• 第三方控制廠商
• 和原始設備製造商

全球 IVD 品質控制市場規模（依地區）

• 市場概況
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 歐洲其他地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 亞太其他地區
• 拉丁美洲
  • 巴西
  • 拉丁美洲其他地區
• 中東和非洲 (MEA)
  • 海灣合作理事會國家
  • 南非
  • MEA 的其餘部分

競爭格局

• 前 5 名企業比較
• 2023 年關鍵參與者的市場定位
• 主要市場參與者所採取的策略
• 最佳制勝策略
• 近期市集活動
• 主要公司市佔率 (%), 2023

主要公司簡介

• 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