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In Vitro Diagnostics Quality Control Market : Market Size, Trends, Key Players and Forecast

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Rosy Wills
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According to the new market research report "In Vitro Diagnostics Quality Control Market by Source (Plasma, Whole Blood, Urine), Technology (Immunoassay, Hematology, Microbiology, Molecular Diagnostics), Manufacturer (Third-party, OEM), End Users (Hospitals, Lab) - Global Forecast to 2026", published by MarketsandMarkets™, 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.


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The IVD testing plays a significant role in clinical decision-making. 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 Quality Control in IVD Market is primarily driven by the rising number of accredited clinical laboratories, rising geriatric population, rising demand for external quality assessment programs, increasing adoption of and POC instruments in developed regions and increasing adoption of third-party quality controls. The rising 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.


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 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.


Immunochemistry accounted for the highest share of the technology segment 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 immunochemistry segment accounted for the largest share of the market in 2020. The large share of this segment can be attributed to the increasing use of multi-analyte controls to perform immunoassay tests in laboratories. The use of immunoassay tests in clinical laboratories has also increased due to the high sensitivity of these tests over conventional methods.


Third-party controls accounted for the largest share for the IVD quality control market


Based on manufacturer, the In Vitro Diagnostics 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 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


Hospitals accounted for the highest share of the global IVD quality control market


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 market in 2020, owing to the large volume of diagnostic tests carried out in hospitals.


North America is expected to account for the largest share for players operating in the global IVD quality control market


Geographically, the global In Vitro Diagnostics 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 market, 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 market in North America.


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Some of the key players in the In Vitro Diagnostics (IVD) Quality Control Market include Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), and Abbott Laboratories (US). Other prominent payers in the market include Roche Diagnostics (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), Fortress Diagnostics (UK), SERO AS (US), Sysmex Corporation (Japan), Ortho-Clinical Diagnostics (US), Helena Laboratories Corporation (US), Quidel Corporation (US), Sun Diagnostics, LLC (US), Seegene Inc. (South Korea), ZeptoMetrix Corporation (US), Qnostics (UK), Bio-Techne Corporation (US), Microbiologics (US), Microbix Biosystems (Canada), Streck, Inc. (US), Alpha-Tec Systems (US), Maine Molecular Quality Controls, Inc. (US), and Grifols, S.A. (Spain). These players aim to secure higher market shares through strategies such as product launches, expansions, agreements, and acquisitions.


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