The growth of Molecular Quality Controls Market is primarily driven by factors such as the rising adoption of third-party quality controls, increasing number of accredited clinical laboratories, the rising demand for external quality assessment support, increasing government funding to support genomics projects, increasing demand for personalized medicines and declining costs of sequencing procedures and increasing prevalence of infectious diseases, cancer & genetic diseases.

The molecular quality controls market size is expected to grow from USD 164 million in 2021 to USD 226 million by 2026, at a CAGR of 6.7% during the forecast period. 

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Market Segmentation:

Based on product, the molecular quality control market is segmented into Independent Controls and Instrument Specific Controls. The Independent control segment accounted for the largest share of the market in 2020. The increasing number of accredited laboratories and mandates for the use of quality controls from regulatory bodies to ensure the accuracy of diagnostic test results are driving the growth of the molecular quality control products market.

Based on analyte type, the market is segmented into single-analyte controls and multi-analyte controls. Single-analyte controls dominated the molecular quality controls market in 2020 due to the significant use of singleplex assays in hospitals and the advantages associated with the use of single-analyte controls, such as simple analysis & interpretation and low risk of cross-reactivity.

Based on application, the molecular quality control market is segmented into infectious disease diagnostics, oncology testing, genetic testing, and other applications. The infectious disease diagnostics segment accounted for the largest share of the molecular quality controls market in 2020. The large share of this segment is attributed to the development of advanced assays for infectious diseases, a significant increase in the prevalence of infectious diseases, and the rising awareness about the effective use of molecular diagnostic technologies to control the occurrence and spread of infectious diseases.

The key end users of molecular quality controls studied in this report include diagnostic laboratories, hospitals, IVD Manufacturers and CROs Academic & Research Institutes, and other end users. The Diagnostic Laboratories segment accounted for the largest share of the market in 2020, increasing number of accredited diagnostic laboratories to provide growth opportunities in the coming years.

Regional Analysis:

The molecular quality control market is segmented into five major regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2020, North America was the largest regional market for molecular quality controls due to the developed healthcare system in the US and Canada, the presence of many leading molecular quality control product manufacturers in the region, and the easy accessibility to technologically advanced products in the region.

Recent Developments

• In June 2021, SeraCare partnered with the International Quality Network for Pathology (IQN Path) (Luxembourg) to develop, manufacture, and supply a range of highly characterized cell line genomic DNA and formalin-fixed, paraffin-embedded (FFPE) standards with confirmed low, mid, and high levels of mutational burden within their exome regions
• In May 2021, Bio-Rad entered a global partnership with Roche Diagnostics (Switzerland) to provide its customers access to a complete line of InteliQ products and Unity QC data management solutions along with customer training and support services.
• In 2020, Abbott Laboratories invested USD 2.4 billion in R&D, of which USD 10.80 billion was invested in developing technologically advanced diagnostic products to strengthen its product portfolio.

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Top Key Players:

The prominent players in the molecular quality controls market are F. Hoffmann-La Roche Ltd. (Switzerland), Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific, Inc. (US), Randox Laboratories Ltd. (UK), LGC Limited (UK), Abbott Laboratories (US), Fortress Diagnostics (UK), SERO AS (Norway), Anchor Molecular (US), Ortho-Clinical Diagnostics, Inc. (US), Quidel Corporation (US), Sun Diagnostics, LLC (US), Seegene Inc. (South Korea), ZeptoMetrix, LLC (US), Qnostics (UK), Bio-Techne Corporation (US), Microbiologics, Inc. (US), Microbix Biosystems Inc. (Canada), SpeeDx Pty. Ltd. (Australia), Maine Molecular Quality Controls, Inc. (US), and Grifols, S.A. (Spain).

Conclusion:

In conclusion, the molecular quality controls market is an important segment of the clinical diagnostics industry, focused on providing quality control materials and services for molecular diagnostic testing. The market is driven by the increasing demand for molecular diagnostics in healthcare, as well as the need for reliable and accurate diagnostic testing. The market includes both internal and external quality controls, and a range of molecular quality control materials such as nucleic acid controls, protein controls, and whole cell controls. The major players in the market provide a range of quality control materials and services to clinical laboratories, research institutions, and diagnostic manufacturers around the world. Overall, the molecular quality controls market is expected to continue to grow in the coming years, driven by the increasing demand for molecular diagnostics and the need for reliable and accurate testing.