In-Vitro Diagnostics (IVD) Quality Control Market Size to Reach USD 1,325.6 Million in 2028 – Reports and Data

Rising prevalence of cardiovascular diseases and surging demand for third-party IVD quality control products are expected to spur market growth

The global in-vitro diagnostics (IVD) quality control market size is expected to reach USD 1,325.6 million by 2028 at a CAGR of 4.1%, according to a new report by Reports and Data. Steady growth in market revenue is majorly supported by increasing prevalence of cardiovascular diseases (CVDs) and chronic diseases such as cancer and diabetes, rising demand for advanced IVD systems, growing demand for third-party IVD quality controls, and stringent regulatory standards for in-vitro diagnostic quality control products. In-vitro diagnostics quality control products offer various advantages such as long-term performance monitoring of IVD test systems, identification of critical analytical system issues, and multiple-level quality control analysis. Hence, growing demand for IVD quality control products owing to such advantages is a pivotal factor contributing to the growth of this market.

In vitro diagnostics (IVD) quality control refers to the performance analysis of IVD tests that help detect pneumonia, Healthcare-associated Infections (HAIs), urinary tract infections, and various other conditions. Commonly used IVD control and validation panels include Human Papillomavirus (HPV) control panel and Blood Culture (BCID) control panel. IVD quality control ensures the safety and efficacy of in vitro diagnostic systems, besides augmenting laboratory performance and improving the accuracy of test findings. IVD quality control products are conforming to ISO 9001 quality standards. Top regulatory bodies monitoring the quality and efficacy of in vitro diagnostics are the U.S. Food & Drug Administration (FDA), Central Drug Standard Control Organization (CDSCO), Medicines and Healthcare Products Regulatory Agency (MHRA), and European Medicines Agency (EMEA).

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Some Key Highlights in the Report:

  • Based on 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 held the largest revenue share in 2020. The segment is projected to register the highest CAGR over the forecast period due to surging prevalence of infectious and autoimmune disorders, growing adoption of rapid diagnostic methods, and increasing use of in vitro diagnostics quality control in immunochemistry.
  • Among regional markets, the North America in vitro diagnostics quality control market emerged as the most dominant in terms of revenue in 2020. The North America market growth is spurred by rising burden of infectious diseases including the ongoing coronavirus disease, increase in patient pool, growing focus on early disease diagnosis, and increasing applications of in vitro diagnostics quality control products in accredited clinical laboratories and diagnostic centers.
  • The most prominent companies in the global in-vitro diagnostics (IVD) quality control market are 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.
  • In March 2021, Bio-Rad Laboratories, Inc. expanded its partnership with Roche with the introduction of a new range of InteliQ products, which are designed to streamline the quality control workflow of a laboratory. The new product range comprises barcoded quality control tubes and Unity QC data management solutions.

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For the purpose of this report, the global in-vitro diagnostics (IVD) quality control market is segmented on the basis of product & service type, manufacturer, application, end-use, and region:

Product & Service Type Outlook (Revenue, USD Million; 2018-2028)

  • 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

Manufacturer Outlook (Revenue, USD Million; 2018-2028)

  • Third-Party Control Manufacturers
  • Original Equipment Manufacturers (OEMs)
  • Instrument-Specific Controls
  • Independent Controls

Application Outlook (Revenue, USD Million; 2018-2028)

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

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End-use Outlook (Revenue, USD Million; 2018-2028)

  • Hospitals
  • Home Care
  • Clinical Laboratories
  • Academic & Research Institutes
  • Contract Research Organizations (CROs)
  • IVD Manufacturers
  • Others

Regional Outlook (Revenue, USD Million; 2018-2028)

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Rest of the Asia Pacific
  • Latin America
    • Brazil
    • Rest of Latin America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Rest of Middle East & Africa

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