As per the report titled as “In Vitro Diagnostics (IVD) Quality Control Market–Global Opportunity Analysis and Industry Forecast (2017-2022)”, the global IVD quality controls market will grow at a CAGR of 3.8% during the forecast period to reach USD 1,065.3 million by 2022. The global In Vitro Diagnostics Quality Controls Market is driven by the increasing number of accredited clinical laboratories, growing demand for external quality assessment (EQA) support, and increasing mandates from regulatory & accreditation bodies on the use of quality controls. However, additional costs burden associated with quality controls on laboratories, unfavorable reimbursement scenario for IVD tests, and lack of mandatory regulations for clinical laboratory accreditation in many emerging countries is expected to restrain the growth of this market to a certain extent.
The global IVD quality controls market is majorly segmented by product type, application, end user, manufacturer type, and geography. Based on product type, the IVD quality controls market is majorly segmented into quality controls, data management software, and external quality assurance services. Quality Controls segment held the largest share in the global IVD quality controls market in 2016, owing to the increasing adoption of control materials with high stability to check the accuracy & precession of laboratory testing process and IVD tests results.
Based on application, the IVD quality controls market is majorly segmented into clinical chemistry, hematology, immunoassay, molecular diagnostics, microbiology, coagulation/hemostasis, and others. The immunoassay segment accounted for the largest share of the global IVD quality controls market in 2016 and is also expected to continue its dominance during the forecast period. The large share of this segment is attributed to the higher adoption of high sensitive and cost-effective immunoassay tests for the diagnosis of increasing infectious diseases and relatively increased demand for multi-analyte immunoassay controls to ensure the accuracy & reliability of immunoassay test menus.
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On the basis of end user, the In Vitro Diagnostics Quality Controls Market is majorly segmented into hospitals, clinical/ reference laboratories, research & academic institutes, and others. Hospitals segment held the largest share in the global IVD quality controls market in 2016. The largest share of this segment is mainly attributed to the large share of diagnostics tests performed in the hospital attached laboratories and relatively higher demand for quality controls in these healthcare settings to ensure the accuracy and reliability of IVD test results of the patients.
Based on manufacturer type, the IVD quality controls market is majorly segmented into IVD instrument manufacturers and third party quality control manufacturers.Third party quality control manufacturers commanded the largest share in the global IVD quality controls market in 2016. The largest share of this segment is attributed to the increasing demand for multi-analyte third party controls to obtain an unbiased opinion on the analytical performance of the laboratory.
Based on geography, this market is majorly segmented into six regions: North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa. North America holds the major share in the global IVD quality controls market, followed by Europe and Asia-Pacific region.The major share of North America is mainly attributed to the rising number of accredited laboratories, stringent rules and regulations on quality assurance in the region, higher adoption of innovative multi-analyte third party controls and related products & services, and well-established healthcare system & distribution channels in the U.S. However, Asia-Pacific region is projected to show lucrative growth potential for the In Vitro Diagnostics Quality Controls Market during the analysis period, owing to the significantly growing IVD industry in the region with rising demand for early diagnosis from large patient population in Asia, rising number of accredited laboratories, increasing number of hospitals and clinical pathologies, increasing healthcare spending, and improving healthcare infrastructure in the region.
The major players operating in the global In Vitro Diagnostics Quality Controls Market are Randox Laboratories Ltd. (U.K.), Thermo Fisher Scientific Inc. (U.S.), Bio-Rad Laboratories Inc. (U.S.), Technopath Clinical Diagnostics (Ireland), SeraCare Life Sciences Inc. (U.S.), Merck KGaA (Germany), Maine Molecular Quality Controls, Inc. (U.S.), Sero AS (Norway), Eurotrol B.V. (The Netherlands), Omega Diagnostic Group PLC (U.K.), Fortress Diagnostic Limited (U.K.), Sun Diagnostics, LLC. (U.S.), Siemens AG (Germany), Abbott Laboratories (U.S.), F. Hoffmann-La Roche Ltd. (Switzerland), Helena Biosciences Europe (U.K.), Danaher Corporation (U.S.), Ortho Clinical Diagnostics (U.S.), ZeptoMetrix Corporation (U.S.), and Becton, Dickinson and Company (U.S.).
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