In Vitro Diagnostics (IVD) Quality Control Market Size, Share, Demand, Growth Rate, Opportunity, Top Manufacturers, Current Trends, Forecast 2025

In Vitro Diagnostics (IVD) Quality Control Market by Source (Serum, Whole Blood, Urine), Application (Immunoassay, Hematology, Microbiology), Type (Independent Controls, Original Equipment Manufacturers), End User (Hospital, Lab) – Global Forecast to 2025

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The global IVD quality control market size is projected to reach USD 1,158 million by 2025 from USD 961 million in 2020, at a CAGR of 3.8% during the forecast period. The market for IVD quality control is primarily driven by the increasing number of accredited clinical laboratories, rising demand for external quality assessment support, and increasing prevalence of chronic and infectious diseases. However, the unfavorable reimbursement scenario for IVD tests will restrain the market growth.

The leading players in this market include Bio-Rad Laboratories Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific Inc. (US), Technopath Clinical Diagnostics (Ireland), Bio-Techne Corporation (US), Fortress Diagnostics (UK), Roche Diagnostics (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), SeraCare Life Sciences Inc. (US), Abbott Laboratories Inc. (US), Sysmex Corporation (Japan), Ortho-Clinical Diagnostics, Inc. (US), and Helena Laboratories (US).

In Vitro Diagnostics (IVD) Quality Control Market is a proficient and comprehensive marketing report that focuses on primary and secondary market drivers, market share, leading segments, and geographical analysis. Nowadays, businesses get highly benefited with the different segments covered in the market research report which makes available better market insights to them with which they can drive the business into the right direction. This market report covers an array of aspects of the market analysis which today’s businesses call for. The In Vitro Diagnostics (IVD) Quality Control Market report is produced with the systematic gathering and analysis of information about individuals or organisations which is conducted through social and opinion research.

“In 2019, the independent controls segment accounted for the largest share of the market.”

On the basis of type, the third-party controls market is segmented into independent controls and instrument-specific controls. Independent controls segment accounted for the largest share of the third-party controls market in 2019. The large share of this segment can be attributed to the fact that these controls are recommended by regulatory bodies to gain unbiased quality inputs and results.

“In 2019, the hospitals segment accounted for the largest share of the market.”

On the basis of end user, the hospitals segment accounted for the largest share of the global IVD quality control market in 2019.The large share of this segment is primarily attributed to the huge volume of IVD procedures being performed in hospitals and increasing focus on offering precise & accurate diagnostic test results.

APAC is projected to witness the highest growth during the forecast period.”

The APAC market is estimated to register the highest CAGR during the forecast period. The growth in this market can be attributed to the region’s large patient population and rising healthcare needs, increasing number of accredited laboratories, and rising prevalence of chronic and infectious diseases.

The breakdown of primary participants was as mentioned below:

  • By Company Type: Tier 1–35%, Tier 2–45%, and Tier 3–20%
  • By Designation: C-level–45%, Director Level–30%, and Others–25%
  • By Region: North America–40%, Europe–30%, Asia Pacific–20%,Latin America–5%, Middle East & Africa–5%

Research Coverage:

The report analyzes the various quality control products and their adoption patterns. It aims at estimating the market size and future growth potential of the IVD quality control market for different segments such as product & service, application, manufacturer, end user,and region. The report also includes an in-depth competitive analysis of the key players in this market, along with their company profiles, product offerings, and recent developments.

Reasons to Buy the Report

The report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which, in turn, would help them garner a greater share. Firms purchasing the report could use one or any combination of the below-mentioned five strategies for strengthening the market.

This report provides insights on the following pointers:

  • Market Penetration: Comprehensive information on the product portfolios offered by the top players in the global IVD quality control market
  • Product Development/Innovation: Detailed insights on the upcoming trends, R&D activities, and product launches in the global IVD quality control market
  • Market Development: Comprehensive information on the lucrative emerging regions by product & service, application, manufacturer, and end user
  • Market Diversification: Exhaustive information about new products, growing geographies, and recent developments in the global IVD quality control market
  • Competitive Assessment: In-depth assessment of market shares, growth strategies, and products of leading players in the global IVD quality control market

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Table of Contents

1 Introduction
1.1 Objectives of the Study
1.2 Market Definition
1.2.1 Inclusions and Exclusions
1.3 Market Scope
1.3.1 Markets Covered
1.3.2 Years Considered for the Study
1.4 Currency
1.5 Limitations
1.6 Stakeholders

2 Research Methodology
2.1 Research Approach
2.1.1 Secondary Data
2.1.1.1 Key Data From Secondary Sources
2.1.2 Primary Data
2.1.2.1 Key Data From Primary Sources
2.1.2.2 Breakdown of Primaries
2.2 Market Size Estimation
2.3 Market Breakdown and Data Triangulation

3 Executive Summary

4 Premium Insights
4.1 IVD Quality Control: Market Overview
4.2 APAC: IVD Quality Control Market, By Technology (2019)
4.3 Geographic Snapshot of the Market
4.4 Regional Mix: Market
4.5 Market: Developing Vs. Developed Markets

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Increasing Number of Accredited Clinical Laboratories
5.2.1.2 Growing Adoption of Third-Party Quality Controls
5.2.1.3 Rising Demand for External Quality Assessment Support
5.2.1.4 Increasing Prevalence of Chronic and Infectious Diseases
5.2.2 Market Restraints
5.2.2.1 Additional Costs and Budget Constraints in Hospitals and Laboratories
5.2.2.2 Unfavorable Reimbursement Scenario for IVD Tests
5.2.3 Market Opportunities
5.2.3.1 Rising Demand for Multi-Analyte Controls
5.2.4 Challenges
5.2.4.1 Stringent Product Approval Process
5.2.4.2 Lack of Regulations for Clinical Laboratory Accreditation in Several Emerging Countries

6 Industry Insights
6.1 Introduction
6.2 Industry Trends
6.2.1 Lyophilize/Freeze-Dried Controls
6.2.2 Trends on Analyte Source: Human Vs. Animal Origin
6.2.3 Consolidation of Laboratories
6.3 Vendor Benchmarking
6.3.1 Product Portfolio Analysis: IVD Quality Control Market
6.4 Regulatory Analysis
6.4.1 North America
6.4.1.1 US
6.4.1.2 Canada
6.4.2 Europe
6.4.3 Asia Pacific
6.4.3.1 Japan
6.4.3.2 China
6.4.3.3 India

7 IVD Quality Control Market, By Product & Service
7.1 Introduction
7.2 Quality Control Products
7.2.1 Serum/Plasma-Based Controls
7.2.1.1 Greater Stability and Accuracy of Diagnostic Test Results Will Increase the Demand for Serum/Plasma-Based Controls
7.2.2 Whole Blood-Based Controls
7.2.2.1 Rising Need to Ensure High-Quality Clinical Test Results is Driving the Market for Whole Blood-Based Controls
7.2.3 Urine-Based Controls
7.2.3.1 Growing Incidence of Kidney Diseases Will Increase the Need for Urine-Based Controls
7.2.4 Other Controls
7.3 Data Management Solutions
7.3.1 Rising Focus on Improving the Analytical Performance of Clinical Laboratories Supports Market Growth
7.4 Quality Assurance Services
7.4.1 Growing Need for Performance Assessment of Clinical Laboratories Will Increase the Demand for Quality Assurance Services

8 IVD Quality Control Market, By Technology
8.1 Introduction
8.2 Immunochemistry
8.2.1 Focus on Monitoring the Precision of Immunoassay Tests is Driving the Adoption of Immunoassay Controls
8.3 Clinical Chemistry
8.3.1 Rising Incidence of Lifestyle Diseases Provides Opportunities for Market Growth
8.4 Molecular Diagnostics
8.4.1 Growing Incidence of Infectious Diseases Will Drive Demand for Molecular Diagnostic Controls
8.5 Microbiology
8.5.1 Increasing Adoption of Automated Clinical Microbiology Testing Instruments is Supporting Market Growth
8.6 Hematology
8.6.1 Need for Accuracy in Hematological Test Results has Driven Reliance on Hematology Quality Controls
8.7 Coagulation & Hemostasis
8.7.1 Growing Number of Cardiovascular Surgeries Will Increase Need for Coagulation & Hemostasis Testing
8.8 Other Technologies

9 IVD Quality Control Market, By Manufacturer
9.1 Introduction
9.2 Third-Party Controls
9.2.1 Independent Controls
9.2.1.1 Increasing Preference for Independent Controls Fuels Market Growth
9.2.2 Instrument-Specific Controls
9.2.2.1 Usage Limitations Have Subdued Market Growth Rate in Favor of Independent Controls
9.3 Original Equipment Manufacturer Controls
9.3.1 OEM Controls are Less-Sensitive to Qc-Related Issues, Which has Resulted in Lower Adoption

10 IVD Quality Control Market, By End User
10.1 Introduction
10.2 Hospitals
10.2.1 Huge Volume of IVD Procedures Performed in Hospitals are Driving Market Growth
10.3 Clinical Laboratories
10.3.1 Growing Number of Accredited Laboratories Will Drive the Market
10.4 Academic and Research Institutes
10.4.1 Rising Focus on Obtaining Accurate Research Findings is Driving Market Growth
10.5 Other End Users

11 IVD Quality Control Market, By Region
11.1 Introduction
11.2 North America
11.2.1 US
11.2.1.1 US is the Largest Market for IVD Quality Control in North America
11.2.2 Canada
11.2.2.1 Government Initiatives to Promote Quality Controls are Expected to Drive Market Growth in Canada
11.3 Europe
11.3.1 Germany
11.3.1.1 Germany is a Major Market for IVD Quality Control Products in Europe
11.3.2 France
11.3.2.1 Increasing Prevalence of Infectious Diseases and Growing Demand for Early Diagnosis is Driving Market Growth
11.3.3 UK
11.3.3.1 Growth in the Country’s Life Science Industry and Increasing Research are Key Factors Driving Market Growth in the UK
11.3.4 Italy
11.3.4.1 Growing Disease Prevalence has Contributed to the Demand for Better and Accurate Disease Diagnosis in Italy
11.3.5 Spain
11.3.5.1 Increasing Demand for Prenatal and Genetic Testing and Rising Focus on Laboratory Consolidation Support Market Growth in Spain
11.3.6 Russia
11.3.6.1 Increasing Incidence of Lifestyle Diseases Will Create a Need for Accurate Diagnosis
11.3.7 Rest of Europe
11.4 Asia Pacific
11.4.1 Japan
11.4.1.1 Japan Held the Largest Share of the Market in the APAC
11.4.2 China
11.4.2.1 Growing Access to Modern Healthcare and Government Support Will Boost Market Growth
11.4.3 India
11.4.3.1 Rising Need to Secure Nabl Accreditation Will Increase the Demand for Quality Controls in India
11.4.4 Australia
11.4.4.1 Rising Burden of Geriatric Population has Resulted in Initiatives to Enhance Access to Healthcare and Improve Infrastructure
11.4.5 South Korea
11.4.5.1 Rising Healthcare Expenditure and the Growing Number of Hospitals are Driving the Growth of the South Korean Market
11.4.6 Rest of Asia Pacific
11.5 Latin America
11.5.1 Brazil
11.5.1.1 Brazil Dominates the Latin American IVD Quality Control Market
11.5.2 Mexico
11.5.2.1 Mexico is Emerging as a Prominent Medical Tourism Hub
11.5.3 Rest of Latin America
11.6 Middle East and Africa
11.6.1 Rising Cancer Incidence has Attracted Stakeholder Attention to Regional Markets in Mea

12 Competitive Landscape
12.1 Overview
12.2 Market Ranking Analysis
12.3 Market Ranking Analysis for External Quality Assessment Services in 2018
12.4 Competitive Leadership Mapping
12.4.1 Visionary Leaders
12.4.2 Innovators
12.4.3 Dynamic Differentiators
12.4.4 Emerging Companies
12.5 Competitive Situation and Trends
12.5.1 Product Launches
12.5.2 Agreements and Partnerships
12.5.3 Expansions

13 Company Profiles
13.1 Bio-Rad Laboratories
13.1.1 Business Overview
13.1.2 Products and Services Offered
13.1.3 Recent Developments
13.1.4 MnM View
13.2 Randox Laboratories
13.2.1 Business Overview
13.2.2 Products and Services Offered
13.2.3 Recent Developments
13.2.4 MnM View
13.3 Thermo Fisher Scientific
13.3.1 Business Overview
13.3.2 Products Offered
13.3.3 Recent Developments
13.3.4 MnM View
13.4 Roche Diagnostics
13.4.1 Business Overview
13.4.2 Products Offered
13.5 Helena Laboratories
13.5.1 Business Overview
13.5.2 Products Offered
13.6 SeraCare Life Sciences
13.6.1 Business Overview
13.6.2 Products Offered
13.7 SERO AS
13.7.1 Business Overview
13.7.2 Products Offered
13.8 Ortho Clinical Diagnostics
13.8.1 Business Overview
13.8.2 Products Offered
13.9 Sun Diagnostics
13.9.1 Business Overview
13.9.2 Products Offered
13.10 Quidel Corporation
13.10.1 Business Overview
13.10.2 Products Offered
13.11 Technopath Clinical Diagnostics
13.11.1 Business Overview
13.11.2 Products Offered
13.11.3 Recent Developments
13.12 Abbott Laboratories
13.12.1 Business Overview
13.12.2 Products Offered
13.13 Danaher Corporation
13.13.1 Business Overview
13.13.2 Products Offered
13.14 Sysmex Corporation
13.14.1 Business Overview
13.14.2 Products Offered
13.15 Siemens Healthineers
13.15.1 Business Overview
13.15.2 Products Offered
13.15.3 Recent Developments
13.16 Fortress Diagnostics
13.16.1 Business Overview
13.16.2 Products Offered
13.16.3 Recent Developments
13.17 Zeptometrix Corporation
13.17.1 Business Overview
13.17.2 Products Offered
13.17.3 Recent Developments
13.18 Qnostics
13.18.1 Business Overview
13.18.2 Products Offered
13.18.3 Recent Developments
13.19 Bio-Techne Corporation
13.19.1 Business Overview
13.19.2 Products Offered
13.19.3 Recent Developments
13.20 Microbiologics
13.20.1 Business Overview
13.20.2 Products Offered
13.20.3 Recent Developments

14 Appendix
14.1 Insights of Industry Experts
14.2 Discussion Guide
14.3 Knowledge Store: Marketsandmarkets’ Subscription Portal
14.4 Available Customizations
14.5 Related Reports
14.6 Author Details

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