In-Vitro Diagnostics (IVD) Quality Control

IVD quality controls are tests used to authenticate the consistency of IVD testing system to confirm precision of test findings and assess the influence of factors such as environmental conditions and operator’s performance on test results. Key recent developments: in June 2019, Illumina, Inc. announced the launch of VeriSeq NIPT Solution v2, a CE-IVD; next-generation sequencing (NGS)-based approach to noninvasive prenatal testing (NIPT), delivers the most comprehensive view of the fetal genome compared to other CE-IVD NIPT products.

Factors including increasing prevalence of chronic diseases, launch of new clinical laboratories, stringent mandates, as well as rising need of early diagnostics by patients drive the growth of In-Vitro Diagnostics (IVD) Quality Control market.  Increasing incidence of public-private laboratories which are undergoing laboratory accreditation procedure even boosts up the growth of this particular market. For instance: In August 2018, Abbott Laboratories introduced Alinity, its state-of-the-art, harmonized family of systems for clinical diagnostics, to the US market indicating high demand for the systems’ advanced capabilities and potential to provide savings and increased efficiencies for labs, clinicians, and hospitals.

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Further key findings from the report suggest:

  • The American Clinical Laboratory Association (ACLA) states that more than 7.5 billion lab tests are performed in U.S. annually and 80% of clinical decisions are taken after lab testing
  • In December 2018, BioMérieux announced its culture bottles BACT/ALERT® BPA and BPN have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for quality control testing of leukocyte-reduced apheresis platelet (LRAP) units with the BACT/ALERT® VIRTUO® fully automated blood culture system
  • In-Vitro Diagnostics (IVD) Quality Control Market is fastest growing at a CAGR of 3% in Asia Pacific owing to rising incidence of IVD tests in developing countries such as India and China due to upsurge in number of clinical laboratories, global awareness among patients
  • FDA is encouraging convergence of regulatory systems for medical devices, which is anticipated to boost trade, while protecting public health through regulatory means
  • Data Management Solutions segment is accounted to be the second-leading segment which is valued at USD 155.6 million because it gives access to LIS and easy for managing test results of patients and even popular due to dependable laboratory outcomes
  • Europe is the second largest region with a CAGR of 4.0% due to acceptance of point of care diagnostics across Europe especially in regions in UK, Denmark, Poland and Slovenia
  • Home Care segment is the fastest growing at a CAGR of 5.3% because they are providing PoC instruments which give ease of convenience for the patient who requires everyday testing and further reduces hospital visits
  • Immunochemistry segment has dominated the market in 2018 with a market share over 30% and is expected to continue the same during the forecasted period due to the demand for high sensitivity test and even rise in communicable and chronic diseases
  • North America is expected to account for the 44% of the global In-Vitro Diagnostics (IVD) Quality Control Market million owing to presence of many diagnostic laboratories and even production of technologically advanced multianalyte controls
  • Some of the key players are Agilent Diagnostics, Abbott Diagnostics, Becton, Dickson and Company, Bio-Rad Laboratories, Inc., and ThermoFisher Scientific
  • The Japan was the major shareholder in the Asia-Pacific market in 2015 with around half of market share.

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For the purpose of the study, this Reports and Data has segmented the Global In-Vitro Diagnostics (IVD) Quality Control Market on the basis of product type, manufacturer type, design, application, end user and the regional outlook:

Product Type (Revenue, USD Million; 2016–2026)

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

Manufacturer Type (Revenue, USD Million; 2016–2026)

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

Application (Revenue, USD Million; 2016–2026)

  • Clinical Chemistry
  • Immunochemistry
  • Haematology
  • Molecular Diagnostics
  • Coagulation/Haemostasis
  • Microbiology
  • Others

End User (Revenue, USD Million; 2016–2026)

  • Hospitals
  • Clinical Laboratories
  • Home Care
  • Others

Regional Outlook: (Revenue, USD Million; 2016–2026)

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

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