Molecular Quality Controls Industry Is Expand at a CAGR of 6.6% to Reach USD 311.4 million by 2031 | Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Inc, Randox Laboratories Ltd., LGC Limited

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.

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.

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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).

Market Restraints and Challenges

Additional costs involved in quality control and budget constraints in hospitals and laboratories may impede the market growth. Setting up a QC process in a clinical laboratory requires significant investments. Laboratories also need to maintain dedicated personnel to manage the QC system. Moreover, QC procedures incur similar costs, regardless of the volume of tests performed. Hence, the cost of adopting QC procedures is very high for clinical laboratories working with low volumes of diagnostic tests. This, coupled with budgetary constraints in many hospitals and laboratories in developed and developing economies, is expected to result in the lower adoption of QC practices.

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Global Molecular Quality Controls Market Segmentation
By Product Type

• Independent
• Instrument Specific

By Analyte Type

• Single Analyte
• Multi-Analyte

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.

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