The global in vitro diagnostics quality control market is expected to reach USD 1.04 billion by 2022, at a CAGR of 3.5% from 2017 to 2022.
Rising demand for multi-analyte controls
Technological advancements have led to the development of a new range of multi-analyte and multi-instrument controls. These innovative controls consolidate multiple instrument-specific controls into a single control, thereby enabling clinical laboratories to cut down costs. In addition, these controls save the time involved in separate QC procedures for each individual analyte.
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Multi-analyte controls are very useful in screening and diagnosis procedures and they can be used with multiple reagents and instruments. Currently, a number of multi-analyte controls are available in the market. Earlier, laboratories had to maintain more than 30 individual controls to run quality control procedures. However, with the evolution of multi-analyte controls, clinical laboratories offer accurate and precise test results using only one or two multi-analytes. For example, the multi-analyte controls available in the market for immunoassay testing help laboratories to perform quality control tests for 50 or more parameters, including cardiac and tumor markers, hormones, therapeutic drugs, kidney function, and vitamins, all within the same serum. In addition, these controls need not be changed with change in reagent lot, and hence support laboratories in long-term quality control monitoring. The increasing preference for these controls from laboratories is thus expected to offer significant growth opportunities for players operating in the IVD quality control market during the forecast period.
Stringent product approval process
Over the past few years, in vitro diagnostic companies have faced difficulties due to an increasingly complex regulatory process. IVD players currently face a number of challenges related to FDA regulations for their products (instruments, reagents, and calibration & controls). For more than 20 years, the FDA has emphasized its regulatory authority over laboratory-developed tests (LDTs) and related products and it has chosen to exercise enforcement discretion over such tests. In recent years, however, the FDA has declared that added oversight of LDTs and related products is needed and that the agency plans to issue a guidance document on this. Assayed and unassayed QC materials are subject to the Quality System Regulation (QSR), 21 Code of Federal Regulations (CFR), Part 820, and labeling regulation 21 CFR 809.10.
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Over the past few years, FDA requirements, particularly with regard to 510(k) notifications, have increased, requiring more data and details than earlier. This change has resulted in unpredictable premarket submission requirements and it is extremely unfavorable for IVD manufacturers that require 510(k) clearance.
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