The global IVD quality control market is projected to reach USD 1.4 billion by 2026 from USD 1.1 billion in 2021, at a CAGR of 5.3% during the forecast period. IVD testing plays a significant role in clinical decision-making.
The product & service segment holds the highest share of the total IVD quality control market during the forecast period
Based on product & service, the IVD quality control market is segmented into quality control products, data management solutions, and quality assurance services. The quality control products segment accounted for the largest share of the IVD quality control market in 2020.
The increasing number of accredited laboratories and mandates for the use of quality controls from regulatory bodies to ensure the accuracy of diagnostic test results are driving the growth of the IVD quality control products market.
Serum based controls drive the growth of the quality control products segment during the forecast period
Based on type, the IVD quality control products market is segmented into serum/plasma-based controls, whole blood-based controls, urine-based controls, and others. Serum/plasma-based controls are highly preferred by laboratories; this segment accounted for the largest share of the quality control products market in 2020.
The greater uptake of serum/plasma-based quality controls among laboratories and the wide application areas of these controls for various IVD tests are driving the market growth.
Molecular diagnostics segment accounted for the highest CAGR of the global IVD quality control market
Based on technology, the IVD quality control market is broadly segmented into clinical chemistry, immunochemistry, hematology, coagulation & hemostasis, microbiology, molecular diagnostics, and other technologies. The molecular diagnostics segment has the highest CAGR for the forecast period.
With the increased non-communicable disease burden, molecular diagnostic tests have been used in the field of oncology widely. Technological advancement in the field of molecular diagnostics is another driver for the growth of this industry.
Third-party controls accounted for the highest share for the IVD quality control market
Based on manufacturer, the IVD quality control market is segmented into third-party controls and OEM controls. The third-party controls segment accounted for the largest share of the global IVD quality control market in 2020.
The large share of this segment can be attributed to the increasing use of third-party quality controls across the globe to verify the accuracy and reliability of tests.
Based on end users, hospitals accounted for the highest share of the global IVD quality control market during the forecast period
The key end users of IVD quality controls studied in this report include hospitals, clinical laboratories, research & academic institutes, and other end users. The hospitals segment accounted for the largest share of the IVD quality control market in 2020, owing to the large volume of diagnostic tests carried out in hospitals.
North America is expected to account for the highest share for players operating in the global IVD quality control market
Geographically, the global IVD quality control market studied in this report is divided into five major regions-North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2020, North America accounted for the largest share of the global IVD quality control market, followed by Europe.
The APAC region has the highest CAGR of the global IVD quality control market. The Asia Pacific is considered the most lucrative market for IVD quality controls, owing to the region's large patient population and rising healthcare needs.
Market players are focusing on improving laboratory test quality in emerging APAC countries by working with local government bodies, agencies, and academic societies to offer external QC for standardizing laboratory testing procedures and ensure accuracy.
Key Topics Covered:
2 Research Methodology
3 Executive Summary
4 Premium Insights 4.1 IVD Quality Control Market Overview 4.2 APAC: IVD Quality Control Market, by Technology and Country (2020) 4.3 IVD Quality Control Market: Geographic Mix 4.4 IVD Quality Control Market: Developed vs Developing Markets
5 Market Overview 5.1 Market Dynamics 5.1.1 Market Drivers 184.108.40.206 Increasing number of accredited clinical laboratories 220.127.116.11 Growing adoption of third-party quality controls 18.104.22.168 Rising demand for external quality assessment support 22.214.171.124 Rising geriatric population and subsequent growth in the prevalence of chronic and infectious diseases 126.96.36.199 Increasing adoption of Poc instruments in developed regions 5.1.2 Market Restraints 188.8.131.52 Additional costs and budget constraints in hospitals and laboratories 184.108.40.206 Unfavorable reimbursement scenario for IVD tests 5.1.3 Market Opportunities 220.127.116.11 Rising demand for multi-analyte controls 5.1.4 Market Challenges 18.104.22.168 Stringent product approval process 22.214.171.124 Lack of regulations for clinical laboratory accreditation in several emerging countries 5.2 Industry Trends 5.2.1 Lyophilized/Freeze-Dried Controls 5.2.2 Trends On Analyte Source: Human Vs. Animal Origin 5.2.3 Consolidation of Laboratories 5.3 Value Chain Analysis 5.4 Supply Chain Analysis 5.5 Ecosystem Market Map 5.6 Porter's Five forces Analysis 5.7 Regulatory Analysis 5.8 Impact of COVID-19 On the IVD Quality Control Market 5.9 Patent Analysis 5.9.1 Patent Publication Trends for IVD Quality Controls 5.9.2 Insights: Jurisdiction and Top Applicant Analysis 5.10 Technology Analysis
6 IVD Quality Control Market, by Product and Service 6.1 Introduction 6.2 Quality Control Products 6.2.1 Serum/Plasma-Based Controls 126.96.36.199 Greater stability and accuracy of diagnostic test results to increase the demand for serum/plasma-based controls 6.2.2 Whole Blood-Based Controls 188.8.131.52 Rising need to ensure high-quality clinical test results to drive the whole blood-based controls market 6.2.3 Urine-Based Controls 184.108.40.206 The growing incidence of kidney diseases increase the need for urine-based controls 6.2.4 Other Controls 6.3 Data Management Solutions 6.3.1 Rising Focus On Improving the Analytical Performance of Clinical Laboratories To Support Market Growth 6.4 Quality Assurance Services 6.4.1 Growing Need for Performance Assessment of Clinical Laboratories To Increase the Demand for Quality Assurance Services
7 IVD Quality Control Market, by Technology 7.1 Introduction 7.2 Immunochemistry 7.2.1 Focus On Monitoring the Precision of Immunoassay Tests To Drive the Adoption of Immunoassay Controls 7.3 Clinical Chemistry 7.3.1 Rising Incidence of Lifestyle Diseases To Provide Opportunities for Market Growth 7.4 Molecular Diagnostics 7.4.1 Growing Incidence of Infectious Diseases To Drive the Demand for Molecular Diagnostic Controls 7.5 Microbiology 7.5.1 Increasing Adoption of Automated Clinical Microbiology Testing Instruments To Support Market Growth 7.6 Hematology 7.6.1 Need for Accuracy In Hematological Test Results To Drive Reliance On Hematology Quality Controls 7.7 Coagulation & Hemostasis 7.7.1 Growing Number of Cardiovascular Surgeries To Drive the Need for Coagulation & Hemostasis Testing 7.8 Other Technologies
8 IVD Quality Control Market, by Manufacturer 8.1 Introduction 8.2 Third-Party Controls 8.2.1 Independent Controls 220.127.116.11 Increased preference for independent controls to fuel market growth 8.2.2 Instrument-Specific Controls 18.104.22.168 Usage limitations to subdue market growth rate in favor of independent controls 8.3 Original Equipment Manufacturer Controls 8.3.1 OEM Controls To Witness Lower Adoption As they Are Less Sensitive To Qc-Related Issues
9 IVD Quality Control Market, by End User 9.1 Introduction 9.2 Hospitals 9.2.1 Huge Volume of IVD Procedures Performed In Hospitals To Drive Market Growth 9.3 Clinical Laboratories 9.3.1 Growing Number of Accredited Laboratories To Drive the Market 9.4 Academic and Research Institutes 9.4.1 Rising Focus On Accurate Research Results To Drive Market Growth 9.5 Other End Users
10 IVD Quality Control Market, by Region
11 Competitive Landscape 11.1 Overview 11.2 Key Player Strategies 11.3 Revenue Share Analysis of the Top Market Players 11.4 Market Share Analysis 11.5 Company Evaluation Quadrant 11.5.1 Stars 11.5.2 Emerging Leaders 11.5.3 Pervasive Players 11.5.4 Participants 11.6 R&D Expenditure 11.7 Company Evaluation Quadrant for Start-Ups 11.7.1 Progressive Companies 11.7.2 Dynamic Companies 11.7.3 Starting Blocks 11.7.4 Responsive Companies 11.8 Company Product Footprint 11.9 Geographic Footprint of the Major Players In the IVD Quality Control Market 11.10 Competitive Scenario 11.10.1 Product Launches 11.10.2 Deals 11.10.3 Other Developments
12 Company Profiles 12.1 Key Players 12.1.1 Bio-Rad Laboratories, Inc. 12.1.2 Thermo Fisher Scientific, Inc. 12.1.3 Randox Laboratories Ltd. 12.1.4 LGC Limited 12.1.5 Roche Diagnostics 12.1.6 Abbott Laboratories 12.1.7 Siemens Healthineers 12.1.8 Quidel Corporation 12.1.9 Danaher Corporation 12.1.10 Sysmex Corporation 12.1.11 Ortho Clinical Diagnostics 12.1.12 Bio-Techne Corporation 12.1.13 Seegene Inc. 12.1.14 Qnostics 12.1.15 Microbiologics, Inc. 12.1.16 Zeptometrix Corporation 12.1.17 Fortress Diagnostics 12.1.18 Microbix Biosystems Inc. 12.1.19 Grifols, S.A. 12.1.20 Alpha-Tec Systems, Inc. 12.2 Other Players 12.2.1 Helena Laboratories Corporation 12.2.2 Streck, Inc. 12.2.3 Maine Molecular Quality Controls, Inc. (MMQCI) 12.2.4 Sun Diagnostics, Llc 12.2.5 Sero AS