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In Vitro Diagnostics (IVD) Quality Controls: Global Market

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    Report

  • 138 Pages
  • June 2022
  • Region: Global
  • BCC Research
  • ID: 5625104

Report Scope



The current report provides detailed information regarding the in vitro diagnostics quality controls market. This report highlights the current and future market potential of in vitro diagnostics controls and a detailed analysis of the drivers and challenges in the market. The report also covers market projections to 2027 and market rank for key market players. It also covers the competitive environment and regulatory scenario. The report details the market share of IVD controls based on test type, products and services, manufacturer, application and end user.

Based on test type, the market is segmented into immunoassays, clinical chemistry, hematology and hemostasis, molecular diagnostics, microbiology and others. Based on products and services, controls are categorized into quality control products, data management solutions, and quality assurance services. Based on manufacturer, the market is segmented into third-party controls and OEM controls. Based on end users, the market is segmented into hospitals, diagnostic laboratories and academic institutions.

The report includes the company profiles of the key players with detailed information about their business segments, financials, product portfolios and recent developments. The report also includes impact of the COVID-19 pandemic on this market.

By geography, the market has been segregated into North America, Europe, Asia-Pacific and the Rest of the world. The North America region includes the U.S., Canada and Mexico. Europe includes Germany, U.K., Italy and Rest of Europe. Asia-Pacific includes China, India, Japan and the Rest of Asia-Pacific.

For market estimates, data has been provided for the 2020 as the historic year, 2021 as the base year and forecast for 2027.

Report Includes

  • 26 data tables and 24 additional tables
  • An overview of the global market for in vitro diagnostics (IVD) quality controls market
  • Estimation of the market size and analyses of global market trends, with data from 2021, estimates for 2022 with projections of compound annual growth rates (CAGRs) through 2027
  • Highlights of the market potential for in vitro diagnostics (IVD) quality controls market, based on test type, manufacturer, products and services, end user, and region
  • Identification of market drivers, restraints and other forces impacting the global market and evaluation of current market size and forecast
  • Coverage of regulatory landscape, product recalls, pipeline products, and discussion on future perspective, strategies, and developments of the industry
  • Market share analysis of the key companies of the industry and coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies and a relevant patent analysis
  • Company profiles of major players, including Abbott Laboratories, Bio-Rad Laboratories Inc., LGC Ltd., Siemens Healthineers AG, and ThermoFisher Scientific Inc.

Table of Contents

Chapter 1 Introduction
  • Study Goals and Objectives
  • Reasons for Doing this Study
  • Scope of this Report
  • Methodology
  • Geographic Breakdown
  • Analyst's Credentials
  • Custom Research
  • Related Research Reports
Chapter 2 Summary and Highlights
  • Highlights of the Market for Ivd Quality Controls
Chapter 3 Market Background and Technology
  • Overview
  • Characteristics of Quality Control Materials
Chapter 4 Market Dynamics
  • Market Drivers
  • Growing Demand for Third-Party Controls
  • Increasing Focus on Internal Quality Control in Point-Of-Care Tests
  • Rising Aging Population and Global Incidence of Chronic Diseases
  • Market Challenges
  • Matrix Effects With Qc Materials
  • Lack of Well-Defined Standards for Molecular Qc Tests
  • Packaging Challenges
  • Stringent Regulatory Framework
Chapter 5 Market Breakdown by Test Type
  • Global Market for in Vitro Diagnostic (Ivd) Quality Controls
  • Market Analysis
  • Immunodiagnostic Quality Controls
  • Clinical Chemistry Quality Controls
  • Molecular Diagnostic Quality Controls
  • Market Size and Forecast
  • Hematology and Hemostasis Quality Controls
  • Market Size and Forecast
  • Microbiology Quality Controls
  • Market Size and Forecast
  • Other Quality Controls
  • Market Size and Forecast
Chapter 6 Market Breakdown by Type of Manufacturer
  • Global Market for Ivd Quality Controls by Type of Manufacturer
  • Third-Party Controls
  • Oem Controls
Chapter 7 Market Breakdown by Product and Service
  • Global Market for Ivd Quality Controls by Product and Service
  • Ivd Quality Control Products
  • Global Market for Ivd Quality Control Products Based on Product Type
  • Serum/Plasma-Based Quality Controls
  • Whole Blood-Based Quality Controls
  • Urine Based Quality Controls
  • Other Quality Controls
  • Data Management Services
  • Quality Assurance Services
Chapter 8 Market Breakdown by End-user
  • Global Market for Ivd Quality Controls by End-user
  • Diagnostic Laboratories
  • Hospitals and Clinics
  • Point-Of-Care Centers
  • Research Institutions
  • Others
Chapter 9 Market Breakdown by Region
  • Global Market for Ivd Quality Controls by Region
  • North America
  • United States
  • Canada
  • Mexico
  • Europe
  • Germany
  • United Kingdom
  • France
  • Rest of Europe
  • Asia-Pacific
  • China
  • Australia
  • Japan
  • Rest of Asia-Pacific
  • Rest of the World
Chapter 10 Regulatory Scenario
  • Ivd Regulations in North America
  • United States
  • Canada
  • Mexico
  • Ivd Regulations in Europe
  • Ivd Regulations in Asia-Pacific
  • Japan
  • China
  • India
  • Australia and New Zealand
  • Malaysia
  • Singapore
  • Ivd Regulations in Row (Latin America, Africa and Middle East)
  • Brazil
  • Israel
  • Saudi Arabia
  • South Africa
Chapter 11 Impact of the Covid-19 Pandemic
  • Impact of Covid-19 on the Ivd Quality Controls Market
  • Increased Demand for Molecular and Immunoassay Assay Quality Controls
  • Decreased Demand for Routine Diagnostic Testing
  • Delays in the Implementation of Regulations
  • Shortage of Raw Materials
Chapter 12 Competitive Landscape
  • Overview
  • Recent Developments of Key Market Players
  • Growth Strategies
Chapter 13 Company Profiles
  • Abbott Laboratories
  • Becton, Dickinson & Co.
  • Biomérieux Sa
  • Bio-Rad Laboratories Inc.
  • Bio-Techne Corp.
  • Danaher
  • Ekf Diagnostics Holdings plc
  • Lgc Ltd.
  • Microbiologics Inc.
  • Mindray Medical International Ltd.
  • Qnostics Ltd.
  • Quidel Corp.
  • Randox Laboratories Ltd.
  • Roche Diagnostics Corp.
  • Sero As
  • Siemens Healthineers AG
  • Sysmex
  • Thermofisher Scientific Inc.
  • Zeptometrix LLC
List of Tables
Summary Table: Global Market for IVD Quality Controls, by Test Type, Through 2027
Table 1: Comparison Between Third-Party Controls and Original Equipment Manufacturer Controls
Table 2: Global Market for IVD Quality Controls, by Test Type, Through 2027
Table 3: Global Market for Immunodiagnostic Quality Controls, by Region, Through 2027
Table 4: Global Market for Clinical Chemistry Quality Controls, by Region, Through 2027
Table 5: Global Market for Molecular Diagnostic Quality Controls, by Region, Through 2027
Table 6: Global Market for Hematology Quality Controls, by Region, Through 2027
Table 7: Global Market for Microbiology Quality Controls, by Region, Through 2027
Table 8: Global Market for Other Types of Quality Controls, by Region, Through 2027
Table 9: Global Market for IVD Quality Controls, by Type of Manufacturer, Through 2027
Table 10: Global Market for Third-Party Controls, by Region, Through 2027
Table 11: Global Market for OEM Controls, by Region, Through 2027
Table 12: Global Market for IVD Quality Controls, by Product and Service, Through 2027
Table 13: Global Market for IVD Quality Control Products, by Region, Through 2027
Table 14: Global Market for IVD Quality Control Products, by Product Type, Through 2027
Table 15: Comparison Between Dipper and Dropper Style Urinalysis Quality Controls
Table 16: Global Market for Data Management Services of IVD Quality Controls, by Region, Through 2027
Table 17: Global Market for Quality Assurance Services of IVD Quality Controls, by Region, Through 2027
Table 18: Global Market for IVD Quality Controls, by End User, Through 2027
Table 19: Global Market for IVD Quality Controls Used in Diagnostic Laboratories, by Region, Through 2027
Table 20: Global Market for IVD Quality Controls Used in Hospitals and Clinics, by Region, Through 2027
Table 21: Global Market for IVD Quality Controls Used in Point-of-Care Centers, by Region, Through 2027
Table 22: Global Market for IVD Quality Controls Used in Research Institutions, by Region, Through 2027
Table 23: Global Market for IVD Quality Controls Used by Other End Users, by Region, Through 2027
Table 24: Global Market for IVD Quality Controls, by Region, Through 2027
Table 25: North American Market for IVD Quality Controls, by Country, Through 2027
Table 26: European Market for IVD Quality Controls, by Country, Through 2027
Table 27: Asia-Pacific Market for IVD Quality Controls, by Country, Through 2027
Table 28: Becton, Dickinson, and Co.: Product Portfolio
Table 29: Becton, Dickinson, and Co.: Key Developments
Table 30: Bio-Rad Laboratories Inc.: Products Portfolio
Table 31: Bio-Rad Laboratories Inc.: Recent Developments
Table 32: Bio-Techne Corp.: Product Portfolio
Table 33: EKF Diagnostics Holdings PLC: Product Portfolio
Table 34: EKF Diagnostics Holdings plc: Key Developments
Table 35: LGC Ltd.: Key Developments
Table 36: Microbiologics Inc.: Product Portfolio
Table 37: Mindray Medical International Ltd.: Product Portfolio
Table 38: Qnostics Ltd.: Product Portfolio
Table 39: Quidel Corp.: Product Portfolio
Table 40: Quidel Corp.: Key Developments
Table 41: Randox Laboratories Ltd.: Product Portfolio
Table 42: Roche Diagnostics Corp.: Key Developments
Table 43: Sero AS: Product Portfolio
Table 44: Siemens Healthineers: Key Developments
Table 45: Sysmex: Key Developments
Table 46: ThermoFisher Scientific Inc.: Product Portfolio
Table 47: ThermoFisher Scientific Inc.: Key Developments
Table 48: ZeptoMetrix LLC: Product Portfolio
Table 49: ZeptoMetrix LLC: Key Developments
List of Figures
Summary Figure: Global Market for IVD Quality Controls, by Test Type, 2020-2027
Figure 1: Global Market Shares of IVD Quality Controls, by Test Type, 2021
Figure 2: Global Market for Immunodiagnostic Quality Controls, by Region, 2020-2027
Figure 3: Global Market Shares of Immunodiagnostic Quality Controls, by Region, 2021
Figure 4: Global Market for Clinical Chemistry Quality Controls, by Region, 2020-2027
Figure 5: Global Market Shares of Clinical Chemistry Quality Controls, by Region, 2021
Figure 6: Global Market for Molecular Diagnostic Quality Controls, by Region, 2020-2027
Figure 7: Global Market Shares of Molecular Diagnostic Quality Controls, by Region, 2021
Figure 8: Global Market for Hematology Quality Controls, by Region, 2020-2027
Figure 9: Global Market Shares of Hematology Quality Controls, by Region, 2021
Figure 10: Global Market for Microbiology Quality Controls, by Region, 2020-2027
Figure 11: Global Market Shares of Microbiology Quality Controls, by Region, 2021
Figure 12: Global Market for Other Types of Quality Controls, by Region, 2020-2027
Figure 13: Global Market Shares of Types of Other Quality Controls, by Region, 2021
Figure 14: Global Market Shares of IVD Quality Controls, by Type of Manufacturer, 2021
Figure 15: Global Market for Third-Party Quality Controls, 2020-2027
Figure 16: Global Market for OEM Controls, 2020-2027
Figure 17: Global Market Shares of IVD Quality Controls, by Product and Service, 2021
Figure 18: Global Market for IVD Quality Control Products, 2020-2027
Figure 19: Global Market Shares of IVD Quality Control Products, by Product Type, 2021
Figure 20: Global Market for Serum/Plasma Based Quality Controls, 2020-2027
Figure 21: Global Market for Whole Blood-Based Quality Controls, 2020-2027
Figure 22: Global Market for Urine-Based Quality Controls, 2020-2027
Figure 23: Global Market for Other Types of Product Quality Controls, 2020-2027
Figure 24: Global Market for Data Management Services of IVD Quality Controls, 2020-2027
Figure 25: Global Market for Quality Assurance Services of IVD Quality Controls, 2020-2027
Figure 26: Global Market Shares of IVD Quality Controls, by End User, 2021
Figure 27: Global Market for IVD Quality Controls, by End User, 2020-2027
Figure 28: Global Market for IVD Quality Controls Used in Diagnostics Laboratories, 2021-2027
Figure 29: Global Market for IVD Quality Controls Used in Hospitals and Clinics, 2020-2027
Figure 30: Global Market for IVD Quality Controls Used in Point-of-Care Centers, 2020-2027
Figure 31: Global Market for IVD Quality Controls Used in Research Institutions, 2020-2027
Figure 32: Global Market for IVD Quality Controls Used by Other End Users, 2021-2027
Figure 33: Global Market Shares of IVD Quality Controls, by Region, 2021
Figure 34: North American Market Shares of IVD Quality Controls, by Country, 2021
Figure 35: U.S. Market for IVD Quality Controls, 2020-2027
Figure 36: Canadian Market for IVD Quality Controls, 2020-2027
Figure 37: Mexican Market for IVD Quality Controls, 2020-2027
Figure 38: European Market Shares of IVD Quality Controls, by Country, 2021
Figure 39: German Market for IVD Quality Controls, 2020-2027
Figure 40: U.K. Market for IVD Quality Controls, 2020-2027
Figure 41: French Market for IVD Quality Controls, 2020-2027
Figure 42: Rest of the European Market for IVD Quality Controls, 2020-2027
Figure 43: Asia-Pacific Market Shares of IVD Quality Controls, by Country, 2021
Figure 44: Chinese Market for IVD Quality Controls, 2020-2027
Figure 45: Australian Market for IVD Quality Controls, 2020-2027
Figure 46: Japanese Market for IVD Quality Controls, 2020-2027
Figure 47: Rest of Asia-Pacific Market for IVD Quality Controls, 2020-2027
Figure 48: Rest of the World Market for IVD Quality Controls, 2020-2027
Figure 49: Abbott Laboratories: Annual Revenue, 2019-2021
Figure 50: Abbott Laboratories: Market Share, by Business Segment, 2021
Figure 51: Abbott Laboratories: Market Share of Diagnostics Segment, by Region, 2021
Figure 52: Abbott Laboratories: Market Share of Diagnostics Segment, by Business, 2021
Figure 53: Becton, Dickinson and Co.: Annual Revenue, 2019-2021
Figure 54: Becton, Dickinson, and Co.: Market Share, by Region, 2021
Figure 55: Becton, Dickinson, and Co.: Market Share, by Business Segment, 2021
Figure 56: BioMérieux SA, Annual Revenue, 2019-2021
Figure 57: BioMérieux SA: Market Share, by Business Segment, 2021
Figure 58: BioMérieux SA: Market Share, by Region, 2021
Figure 59: Bio-Rad Laboratories Inc.: Annual Revenue, 2019-2021
Figure 60: Bio-Rad Laboratories Inc.: Market Share, by Business Segment, 2021
Figure 61: Bio-Rad Laboratories Inc.: Revenue Share, by Region, 2021
Figure 62: Bio-Techne Corp., Annual Revenue, 2019-2021*
Figure 63: Bio-Techne Corp.: Market Share, by Region/Country, 2021
Figure 64: Bio-Techne Corp.: Market Share, by Segment, 2021
Figure 65: Danaher: Annual Revenue, 2019-2021
Figure 66: Danaher: Market Share of Diagnostics Segment, by Region, 2021
Figure 67: Danaher: Market Share, by Business Segment, 2021
Figure 68: EKF Diagnostics Holdings PLC: Annual Revenue, 2020 and 2021
Figure 69: EKF Diagnostics Holdings PLC: Market Share, by Region, 2021
Figure 70: EKF Diagnostics Holdings PLC: Market Share, by Business Segment, 2021
Figure 71: LGC Ltd.: Annual Revenue, 2019 and 2020*
Figure 72: LGC Ltd.: Market Share, by Region, 2020
Figure 73: LGC Ltd.: Market Share, by Business Segment, 2020
Figure 74: Quidel Corp.: Annual Revenue, 2019-2021
Figure 75: Quidel Corp.: Market Share, by Region, 2021
Figure 76: Quidel Corp.: Market Share, by Business Segment, 2021
Figure 77: Roche Diagnostics Corp.: Annual Revenue, 2020 and 2021
Figure 78: Roche Diagnostics Corp.: Market Share, by Region, 2021
Figure 79: Roche Diagnostics Corp.: Market Share, by Business Segment, 2021
Figure 80: Siemens Healthineers AG: Annual Revenue, 2020 and 2021
Figure 81: Siemens Healthineers: Market Share, by Business Segment, 2021
Figure 82: Siemens Healthineers: Market Share, by Region, 2021
Figure 83: Sysmex: Annual Revenue, 2019-2021
Figure 84: Sysmex: Market Share, by Region/Country, 2021
Figure 85: Sysmex: Revenue Share, by Business Segment, 2021
Figure 86: ThermoFisher Scientific Inc.: Annual Revenue, 2019-2021
Figure 87: ThermoFisher Scientific Inc.: Market Share, by Region, 2021
Figure 88: ThermoFisher Scientific Inc.: Market Share, by Business Segment, 2021
Figure 89: ThermoFisher Scientific Inc.: Market Share, by Product, 2021

Executive Summary

Reasons for Doing This Study:

  • In vitro diagnostic tests performed on biological samples, such as blood, urine, saliva, spinal fluid and DNA, help diagnose various diseases or assess health conditions. The information provided by IVD tests enables healthcare providers to manage several diseases through timely prevention and diagnosis and provide patient-specific treatments.
  • Due to recent rapid technological advances, the range and complexity of diagnostic tests have increased significantly. These rapid innovations have made possible disease detection before the appearance of symptoms and the prediction of beneficial and adverse treatment outcomes. The IVD controls increase the accuracy of the diagnostic tests and ensure the long-term performance monitoring of the testing systems.
  • This research report, “In Vitro Diagnostics (IVD) Quality Controls: Technologies and Global Markets,” will provide a detailed analysis of key factors governing the growth of the IVD quality controls industry, providing strategic insights and recommendations for those looking to expand their markets.

Companies Mentioned

  • Abbott Laboratories
  • Becton, Dickinson & Co.
  • Biomérieux Sa
  • Bio-Rad Laboratories Inc.
  • Bio-Techne Corp.
  • Danaher
  • Ekf Diagnostics Holdings plc
  • Lgc Ltd.
  • Microbiologics Inc.
  • Mindray Medical International Ltd.
  • Qnostics Ltd.
  • Quidel Corp.
  • Randox Laboratories Ltd.
  • Roche Diagnostics Corp.
  • Sero As
  • Siemens Healthineers AG
  • Sysmex
  • Thermofisher Scientific Inc.
  • Zeptometrix LLC

Table Information