Global In Vitro Diagnostics (IVD) Quality Control Market Projected to Reach USD 1.4 Billion by 2026

The global in vitro diagnostics (IVD) quality control market is projected to grow at a CAGR of 5.3% from USD 1.1 billion in 2021 to USD 1.4 billion by 2026, thanks to the significant role played by IVD testing in clinical decision-making.

These are the latest findings of MarketsandMarkets (Northbrook, IL, USA), a provider of quantified B2B research.


Over the years, IVD quality control products and procedures have become mandatory in accredited clinical or medical laboratories. The applications of IVD quality control products have also widened over the years, with a number of quality controls currently available in the market for clinical chemistry, immunochemistry, hematology, molecular diagnostics, coagulation, and microbiology. To ensure technological competitiveness, companies are continuously launching innovative and advanced quality control products in the market for a variety of applications.

The growth of the IVD quality control market is primarily driven by the rising number of accredited clinical laboratories, increasing geriatric population, growing demand for external quality assessment programs, increasing adoption of POC instruments in the developed regions, and rising adoption of third-party quality controls. The increasing focus on multi-analyte controls is also expected to offer significant growth opportunities for the market in the coming years. The use of quality control products is, however, not mandatory for all clinical laboratories in many countries. The lack of regulations for these products is expected to adversely affect market growth.

Based on product & service, the quality control products segment accounted for the largest share of the IVD quality control market in 2020, mainly due to 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. On the basis of technology, the immunochemistry segment held the largest share of the IVD quality control market in 2020 which can be attributed to the increasing use of multi-analyte controls for performing immunoassay tests in laboratories. The use of immunoassay tests in clinical laboratories has also increased due to the high sensitivity of these tests in comparison to conventional methods.

Based on manufacturer, the third-party controls segment accounted for the largest share of the global IVD quality control market in 2020, led by the increasing use of third-party quality controls across the world to verify the accuracy and reliability of tests. On the basis of end user, 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.

Geographically, North America accounted for the largest share of the global IVD quality control market in 2020, followed by Europe. Recommendations for and approvals of quality control products from the FDA and the College of American Pathologists (CAP) and the presence of well-established distribution channels and leading companies in the US are driving the IVD quality control market in North America.


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