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.
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.
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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.
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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.
KEY MARKET SEGMENT
The global IVD quality control products market is segmented based on product type, application, end user, manufacturer type, and geography.
BY PRODUCT TYPE
- 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
- Molecular Diagnostics
BY END USER
- Clinical Laboratories
- Research and Academic Institutes
BY MANUFACTURER TYPE
- Instrument Manufacturer Controls
- Independent Manufacturer Controls
- Third-party Controls
- Instrument Manufacturer Controls