The global IVD quality control market was valued at over USD 821 million in 2015 and is expected to grow at a CAGR of 3.7% during the forecast period. The growing number of certified clinical laboratories requiring quality control services to uphold their quality standards coupled with the rising acceptance of third party quality control service providers to ensure the delivery of reproducible and accurate test results, and subsequently better patient outcomes is expected to drive the market growth.
The internal Quality Control (QC) programs and the external Quality Assurance Schemes (QAS) is important for the establishment of specific quality standards to ensure reliability and validity of the results obtained with the use of the IVD devices. These programs help in ensuring the delivery of reliable patient diagnostic outcomes devoid of errors, such as misdiagnosis due to device-related analytical oversights, which would otherwise impact patient health. The respective regulatory authorities that control the regulation of these In vitro diagnostics devices include the U.S. FDA (Food and Drug Administration), the European Commission, the Australian Therapeutic Goods Administration (TGA), the International Medical Device Regulators Forum (IMDRF), The Brazilian National Health Surveillance Agency (ANVISA), and the Eurasian Economic Union (EEU).
The ongoing, extensive R&D activities along with the formulation of new laws introduced with the objective of improving the safety and efficacy levels of the IVD services are expected to push forward the market growth during the forecast period. For instance, in September 2012, the European Commission published a new regulation for the IVD devices aimed at enhancing the traceability, transparency, and the safety without inhibiting innovation. These new inclusions to the regulations are expected to boost the In vitro diagnostics quality control market growth over the forecast period.
U.S. IVD quality control market, by product, 2013 - 2024 (USD Million)
On the basis of type, the market is segmented into quality control, data management, and quality assurance services. The quality control schemes are applicable to plasma-based products, serum-based products, and whole blood-based products. The quality control segment is one of the largest segments in 2015 owing to the rapidly evolving field of the in vitro diagnostic technologies and the presence of various internal quality control programs for the different aspects of the In vitro diagnostics device-based testing procedures.
There are various applications for the IVDs, which include immunology, hematology, clinical chemistry, coagulation, microbiology, and molecular diagnostics. Among all of these, molecular diagnostics is expected to be the fastest growing segment with a CAGR of over 4%.The frequent use of the major technologies in molecular diagnostics, such as PCR and gene expression and its associated benefits comprising high specificity and accuracy are some of the factors responsible for its high growth during the forecast period.
The hospitals segment dominated the IVD quality control market in 2015 with a share of over 45% due mainly to the high applicability of these in vitro diagnostic tests in hospitals and the requirement of compliance with the in vitro diagnostics directives of ensuring product traceability. The home care segment is estimated to witness a lucrative growth during the forecast period due to the continual rise in the use of point-of-care testing devices. The developments in microchip technology and the fluid handling elements used in IVD equipment, as well as the improved manufacturing processes and the miniaturization technology in use are producing robust point-of-care devices, which are less prone to errors.
North America held the largest share ofthe quality control market in 2015 with revenue generation over USD 350 million. The key driving factors responsible for the growth of this market are the presence of a large number of accredited clinical laboratories, a well-established distribution network, and the increasing number of approvals for the IVD products of assured quality and safety from the regulatory authorities.
The Asia Pacific IVD quality control market is anticipated to grow at the highest CAGR of over 4.5% during the forecast period attributable to the increasing government efforts to standardize the clinical laboratory testing procedures and to ensure accuracy of the test results.
Competitive Market Share Insights
Some key players operating in the IVD quality control marketinclude Siemens Healthcare GmbH, Roche Diagnostics, Alere, Inc., Abbott Laboratories, Inc., Hologic, Inc. (Gen-Probe), Qiagen N.V., Bio-Rad Laboratories, Inc., Quidel Corporation, Becton, Dickinson and Company(BD), bioMerieux, Inc., Sysmex Corporation, Sero AS, and Thermo Fisher Scientific, Inc.
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