In-Vitro Diagnostics (IVD) Quality Control Market USD 84.7 Billion in 2022

The global in vitro diagnostics quality control market size was USD 84.7 Billion in 2020 and is expected to register a CAGR of 19.30% during the forecast period. Steady growth of the global market is attributed to rising prevalence of chronic diseases, such as diabetes and cancer, rising prevalence of cardiovascular diseases (CVDs), growing demand for advanced and rapid diagnostic systems, and escalating demand for third-party IVD quality controls.

In vitro diagnostics quality control refers to assessment of the overall performance of IVD tests for detection of Healthcare-associated Infections (HAIs), such as pneumonia, urinary tract infections, and numerous other medical conditions. These products are widely used to identify defects and maintain the quality of IVD tests. Blood Culture (BCID) control panel and Human Papillomavirus (HPV) control panel are among the most commonly used control and validation panels for in vitro diagnostics. These quality controls validate the safety and efficiency of IVD testing systems and enhance laboratory performance across clinical and research laboratories and blood diagnostic centers. Besides maintaining the accuracy of test findings, IVD quality controls also assess several external factors such as operator’s technical knowhow or unfavorable environmental conditions. These systems conform to ISO 9001 quality standards and regulations and are monitored through government inspections, independent audits, and post-market surveillance. The U.S. Food & Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA), Central Drug Standard Control Organization (CDSCO), Ministry of Health, Labor & Welfare (MHLW), and European Medicines Agency (EMEA) are globally recognized regulatory bodies to monitor the quality and efficacy of IVD devices.

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Global In Vitro Diagnostics Quality Control Market: Dynamics
Dynamics: Multiple-level quality control analysis and identification of critical analytical system issues are expected to bolster growth of this market

Growth of the global market is majorly supported by several advantages associated with in vitro diagnostics quality control. Some of these advantages are sensitive and long-term monitoring of IVD test systems performances, multiple-level quality control analysis, and identification of critical analytical system issues. Moroever, most IVD quality control protocols are compliant with the World Health Organization (WHO) standards. Such factors are expected to boost the growth of the global in vitro diagnostics quality control market in the upcoming years.

Restraints: Lack of technical expertise in quality control and assessment is a major restraining factor for market growth

The global in vitro diagnostics quality control market growth could be hampered to a certain extent due to factors such as lack of technical expertise in quality control and assessment of in vitro diagnostic devices. Quality assessment of in vitro diagnostics can be augmented with expertise in quality control and inspection, inventory control, and risk management. Use of state-of-the-art equipment, compliance with international standards, and understanding of customer requirements are other significant factors that influence quality control of IVD devices. Complex nature of these tasks may restrain the market growth going ahead.

Global In Vitro Diagnostics Quality Control Market: Application Outlook

In terms of application, the global in vitro diagnostics quality control market is segmented into immunochemistry, clinical chemistry, molecular diagnostics, hematology, coagulation & hemostasis, microbiology, and others. The immunochemistry segment, which accounted for the largest share of the global market in 2020, is predicted to register highest growth in revenue over the forecast period. Growing significance of immunochemistry in in vitro diagnostics quality control, enhanced detection of antigens and antibodies, rising prevalence of infectious and autoimmune disorders, and increasing demand for rapid diagnostic methods are the most critical factors propelling the growth of this segment.

Global In Vitro Diagnostics Quality Control Market: Regional Analysis

The global in vitro diagnostics quality control market comprises several leading regions including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The North America in vitro diagnostics quality control market dominates in terms of revenue and is expected to display fastest revenue growth rate over the forecast period. Market growth in this region is accelerated by rapid spread of infectious diseases such as urinary tract infection, increasing patient pool, rising number of accredited clinical laboratories and diagnostic centers, and growing awareness about early disease diagnosis in the region. Presence of advanced healthcare infrastructure globally is another significant factor fueling the North America market growth.

Companies Profiled in the Report:

The global in vitro diagnostics quality control market consists of several market players including Abbott Laboratories Inc., Bio-Rad Laboratories Inc., Thermo Fisher Scientific Inc., Siemens Healthineers, Randox Laboratories Ltd., Technopath Clinical Diagnostics, Fortress Diagnostics, Roche Diagnostics, Bio-Techne Corporation, Danaher Corporation, SeraCare Life Sciences Inc., Ortho-Clinical Diagnostics, Inc., Sysmex Corporation, and Helena Laboratories. These market players have been undertaking various strategic initiatives, such as mergers & acquisitions, collaborations, joint ventures, and new business deals, to strengthen their market positions.

Key Developments:

  • In March 2021, Bio-Rad Laboratories, Inc. expanded partnership with healthcare giant Roche to provide a new range of InteliQ products including barcoded quality control tubes, along with Unity QC data management solutions intended to enhance analytical performance. The new InteliQ products are specifically designed to streamline the QC workflow of a lab, while Unity QC data management solutions help reduce the turnaround time.
  • In May 2020, Technopath Clinical Diagnostics introduced its all-new Multichem ID-COVID-19 quality control solutions. The third-party quality control solutions act as an advanced diagnostic method for COVID-19 antibody testing.
  • In November 2020, leading diagnostics company Devyser received the Medical Device Single Audit Program (MDSAP) certification for successfully completing its quality management system audit. With this esteemed certification, the company looks to enhance its IVD quality assurance standards.

Global In Vitro Diagnostics Quality Control Market Segmentation:

For the purpose of this report, the global in vitro diagnostics quality control market has been segmented based on the product & service type, manufacturer, application, end-user, and region:

In-Vitro Diagnostics (IVD) Quality Control Market Report Scope

Segments covered By Product & Service Type , Manufacture, Application,End-user Regional Outlook

By Product & Service Type         

Quality Control Products

Whole Blood-based Controls

Serum/Plasma-based Controls

Urine-based Controls

Data Management Solutions

Quality Assurance Services

Source-based IVD Quality Controls

By Manufacture              

Third-Party Control Manufacturers

Original Equipment Manufacturers (OEMs)

Instrument-Specific Controls

Independent Controls

By Application 


Coagulation & Hemostasis

Molecular Diagnostics

Clinical Chemistry




By End-user       


Home Care

Clinical Laboratories

Academic & Research Institutes

Contract Research Organizations (CROs)

IVD Manufacturers


Regional scope

North America


Asia Pacific

Latin America

Middle East & Africa

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QYResearch Medical has more than 4000 global well-known customers, covering more than 30 industries including pharmaceuticals, medical technology & devices, healthcare services etc. Company services cover one-stop solution as Data-Analysis-Suggestion-Consulting Implementation. Research regions cover North America, Europe, Latin America, Middle East and Africa, Asia- Pacific.

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