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In Vitro Diagnostics (IVD) Quality Controls: Global Market

June 2022 | 138 pages | ID: I438F9FC42A1EN
BCC Research

US$ 5,500.00

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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.
CHAPTER 1 INTRODUCTION

Study Goals and Objectives
Reasons for Doing This Study
Scope of This Report
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC 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.
BIOM?RIEUX 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: BioM?rieux SA, Annual Revenue, 2019-2021
Figure 57: BioM?rieux SA: Market Share, by Business Segment, 2021
Figure 58: BioM?rieux 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


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