In Vitro Diagnostics (IVD) Quality Control Market is anticipated to reach USD 1.13 billion by 2024. The rising number of certified clinical laboratories requires quality control (QC) services to maintain their standards, associated with the increasing acceptance of third party providers of quality control services, to ensure the accurate and reproducible test results, and better outcomes which is anticipated to drive the growth.
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The key driving factors responsible for the growth of In Vitro
Diagnostics (IVD) Quality Control market :
For the establishment of definite
standards of quality, the internal Quality Control (QC) programs and the
external QAS (Quality Assurance Schemes) is very important to ensure validity
and reliability of the test results obtained by the IVD devices. These programs
are essential in confirming the delivery of patient diagnostic outcomes, which
are reliable and without errors, such as misdiagnosis because of device-related
errors, which can impact the health of the patient.
The regulation of these In vitro
diagnostics devices are controlled by the respective regulatory bodies, which
includes the U.S. FDA (Food and Drug Administration), the International Medical
Device Regulators Forum (IMDRF), the European Commission, the Australian
Therapeutic Goods Administration (TGA), the Eurasian Economic Union (EEU) and
the Brazilian National Health Surveillance Agency (ANVISA).
The currently undergoing,
extensive R&D related activities beside the introduction of new laws with
the aim of improving the efficacy and safety levels of the IVD services are
anticipated to drive market growth. For example, in September 2012, a new
regulation for IVD devices was published by the European Commission targeted to
enhance the transparency, safety and the traceability without constraining
innovation. These new regulatory inclusions are anticipated to drive the market
growth.
Type Insights
On the type basis, the IVD
quality control market is categorized into quality assurance services quality
control (QC), and data management. The QC schemes are appropriate to
plasma-based, whole blood-based and serum-based products. In 2016, QC market
was one of the largest segments because of the rapidly developing IVD
technologies and the existence of numerous internal QC programs for the
different features of the IVD device-based procedures of testing
Application Insights
There are numerous applications
of the IVDs, which includes haematology, immunology, coagulation, clinical
chemistry, molecular diagnostics and microbiology. Amongst these all, molecular
diagnostics is anticipated to be the fastest growing market segment with 4.88%
CAGR. The frequent usage of the technologies in the molecular diagnostics, such
as gene expression and PCR, high accuracy and specificity are some of the
responsible factors associated with its high growth.
End-use Insights
The hospitals market segment was
valued the largest market segment of over 46.0% in 2016 owing to the high
application of IVD tests in hospitals and the necessity of obedience with the
IVD directives for the product traceability. The home care market segment is
anticipated to observe a lucrative progression owing to the persistent increase
in the usage devices for point-of-care testing. The rise in adoption of
microchip technology which is used to handle fluids in IVD equipment, as well
as the enhanced production processes and the miniaturization technology are
creating efficient point-of-care devices, which are very less susceptible to
errors.
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