The global molecular quality controls market was valued at USD 164.0 million in 2021 and it is anticipated to grow up to USD 311.4 million by 2031, at a CAGR of 6.6% during the forecast period.
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Molecular quality control refers to the testing and reporting of any irregularity in diagnostic products, which can affect decisions regarding approval of the product for use in laboratories. Molecular laboratories use thorough QC (quality control) procedures to supervise the testing for both systematic as well as random errors and detect immediate shifts in data and abnormalities in long-term trends. Early detection of potential anomalies is crucial for laboratories, as it helps them implement a timely response and avoid negative impacts on patient data.
Market Trends and Drivers
Increasing number of accredited clinical laboratories is anticipated to propel the market growth. Globally, the number of laboratory tests being conducted has increased owing to the rising burden of various diseases worldwide. To meet this demand, the number of laboratories in public as well as the private sector is increasing. In most countries, it is mandatory for clinical laboratories to secure accreditation from regulatory bodies such as the International Organization for Standardization (ISO) 15189:2012 and other similar standards to perform diagnostic tests. During the accreditation process, the respective authorities evaluate the quality system and competence of a laboratory based on specific standards. For instance, in 2020, the number of total laboratory entities registered for CLIA accreditation increased to 286,396 as compared to 259,967 in 2017. Also, in 2018, 15,353 laboratories received CLIA accreditation by several accreditation organizations (Source: CLIA UPDATE – January 2020).
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Major Players in the Global Molecular Quality Controls Market
The key players in the 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), and Seegene Inc. (South Korea) among others.
COVID-19 Impact
The onset of the novel coronavirus outbreak has created unprecedented disruptions across the globe. While this disruptive force has created upheavals for many industrial sectors, the molecular quality controls market could flourish significantly during the pandemic, as clinical laboratories and diagnostic manufacturers make efforts to address the growing demand for testing solutions, which are considered essential aspects of COVID-19 disease management. To that end, ZeptoMetrix announced the addition of another important molecular quality control to its vast Infectious Disease NATtrol™ Quality Controls line. Dubbed the SARS-CoV-2 Variant Panel, the solution includes four individual, separate vials of each of the variants, Alpha, Beta, Gamma, and Delta. Developments such as these could contribute to the growing demand for molecular quality control solutions over the foreseeable future.
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Global Molecular Quality Controls Market Segmentation
By Product Type
- Independent
- Instrument Specific
By Analyte Type
- Single Analyte
- Multi-Analyte
By Application
- Oncology
- Infectious Disease
- Blood Screening
- Genetic Testing
- Others
By End-Use
- Clinical and Research Laboratories
- Blood Centers
- Hospitals
- IVD Manufacturers
- Academic & Research Institutes
- Others
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