Medical Devices

In Vitro Diagnostics (IVD) Quality Control Product Market by Product Type (Quality Controls (Whole Blood-based Controls, Serum/Plasma-based Controls, Urine-based Controls, Other IVD Quality Controls), Data Management Software, and Quality Assurance Services), by Application (Clinical Chemistry, Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis, Microbiology, and Others), by End User (Hospitals, Clinical Laboratories, Research & Academic Institutes, and Others), by Manufacturer Type [Instrument Manufacturer Controls and Independent Manufacturer Controls (Third-party Controls and Instrument Manufacturer Controls)] - Global Opportunity Analysis and Industry Forecast, 2014-2022

  • ALL797431
  • 170 Pages
  • December 2016
  • Medical Devices

In-vitro diagnostics (IVD) quality controls (QC) are liquid or lyophilized samples or materials, which are used by laboratories to check the testing process to ensure reliability and accuracy of testing results. The regulatory bodies and accredited bodies insist on using quality controls for every test performed in laboratories. However, laboratories use quality controls for testing products when reagent batches are changed, analyzers/instruments are serviced, or test results seem incorrect.

The global IVD quality control products market was valued at $823 million in 2015, and is expected to reach $1,052 million by 2022, registering a CAGR of 3.5% from 2016 to 2022. The market is driven by factors such as increase in adoption of third party quality control products, upsurge in the number of laboratories and diagnostic centers worldwide, and stringent norms for using controls. However, poor reimbursement framework and lack of regulations on the use of controls in the emerging economies are projected to hamper the market growth during the analysis period.

The global IVD quality controls products market is segmented based on product type into quality controls, IVD quality control data management software, and IVD quality assurance services. In 2015, the quality controls segment accounted for the largest share in the global market, and is estimated to grow at the fastest CAGR of 3.7% during the analysis period. The market growth is attributed to upsurge in demand for third-party quality control products and services.

The IVD quality controls market is segmented based on application into clinical chemistry, immunochemistry, hematology, molecular diagnostics, coagulation, microbiology, and others. The molecular biology diagnostics segment is estimated to grow at the fastest CAGR of 5.3% during the analysis period. The end users of the market are hospitals, clinical laboratories, research & academic institutes, and others. The hospitals segment held the largest share in the global IVD quality control products market in 2015.

Based on manufacturer type, the market is segment into instrument manufacturer controls and independent manufacturer controls including third party controls and instrument specific controls. The independent manufacturer controls segment dominated the market in 2015, and is estimated to grow at the fastest CAGR during the forecast period, owing to the increase in demand for third party controls.

The global IVD quality control market is segmented on the basis of region into North America, Europe, Asia-Pacific, and LAMEA regions. North America dominated the global market in 2015 due to stringent mandates on the use of third party IVD quality control products by regulatory authorities. The Asia-Pacific and LAMEA regions are expected to provide lucrative opportunities to market players in the near future. Asia-Pacific is expected to be the fastest growing region by 2022, registering a CAGR of 4.9% during the forecast period.


  • In-depth analysis of the market is based on market estimations of key segments for the period of 2014‐2022.
  • Comprehensive analyses of market dynamics, such as drivers, restraints, and opportunities impacting the market growth are provided in the report.
  • Exhaustive analysis of the market segments helps in understanding the prospects of IVD quality control products and variants in the future.
  • Competitive intelligence of leading manufacturers and distributors of IVD quality control products market helps in understanding the competitive scenario of geographies.
  • The profiles and strategies of key market players are provided in the report to understand the competitive outlook of the global market.


The global IVD quality control products market is segmented based on product type, application, end user, manufacturer type, and geography.


  • Quality Controls
  • Whole Blood-based Controls
  • Serum/Plasma-based Controls
  • Urine-based Controls
  • Other IVD Quality Controls
  • Data Management Software
  • Quality Assurance Services


  • Clinical Chemistry
  • Immunochemistry
  • Hematology
  • Molecular Diagnostics
  • Coagulation/Hemostasis
  • Microbiology
  • Others


  • Hospitals
  • Clinical Laboratories
  • Research and Academic Institutes
  • Others


  • Instrument Manufacturer Controls
  • Independent Manufacturer Controls
  • Third-party Controls
  • Instrument Manufacturer Controls


  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • Japan
    • China
    • India
    • Rest of Asia-Pacific
    • Latin America
    • Middle East
    • Africa


  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific, Inc.
  • Randox Laboratories Ltd.
  • Roche Diagnostics
  • Abbott Diagnostics
  • Helena Laboratories
  • Seracare Life Sciences, Inc.
  • Technopath Clinical Diagnostics
  • Sun Diagnostics, LLC.

The other players in the industry (profiles not included in the report) include

  • Zeptometrix Corporation
  • Sysmex Corporation
  • Fortress Diagnostics
  • Meril Life Sciences Pvt. Ltd.
  • Multiplicom N.V.
  • Future Diagnostics Solutions B.V.
  • Surmodics, Inc.
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