Key Factors Driving the Growth of the Molecular Quality Controls Market

The molecular quality controls market has been experiencing significant growth in recent years, fueled by several key factors. As advancements in molecular diagnostics and precision medicine continue to gain momentum, the demand for reliable and standardized quality control solutions has surged.

The global molecular quality controls market in terms of revenue was estimated to be worth $0.2 billion in 2023 and is poised to reach $0.3 billion by 2028, growing at a CAGR of 6.6% from 2023 to 2028.

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This article explores the essential factors driving the expansion of the molecular quality controls market and their impact on the healthcare industry.

Advancements in Molecular Diagnostics: The rapid progress in molecular diagnostics has revolutionized the way diseases are diagnosed and treated. Molecular testing techniques, such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and microarrays, have enabled the identification of genetic variations associated with various diseases.

Rising Prevalence of Infectious Diseases and Genetic Disorders: The global burden of infectious diseases and genetic disorders continues to grow, necessitating more efficient and accurate diagnostic tools. Molecular quality controls play a crucial role in validating the performance of diagnostic assays, ensuring the accuracy of test results, and minimizing false positives or false negatives.

Increasing Adoption of Precision Medicine: Precision medicine is an emerging approach that tailors medical treatments to individual patients based on their unique genetic makeup and other molecular characteristics. This personalized approach to healthcare demands high-quality and reliable molecular diagnostics to determine the most effective treatments for patients. Molecular quality controls are vital in this context, as they help maintain the accuracy and consistency of diagnostic results, making them an indispensable component of precision medicine.

Stringent Regulatory Guidelines: The healthcare industry is subject to strict regulatory guidelines, especially concerning the approval and commercialization of diagnostic products. Regulatory authorities worldwide emphasize the importance of using standardized quality control solutions to ensure the accuracy and reliability of diagnostic tests.

Growing Number of Accredited Clinical Laboratories: The number of accredited clinical laboratories has been steadily rising, driven by an increasing demand for accurate and reliable diagnostic services. Accredited labs are required to implement stringent quality control measures to maintain their accreditation status.

Technological Advancements in Quality Control Solutions: Advancements in technology have led to the development of more sophisticated and user-friendly molecular quality control solutions. These products offer greater stability, reproducibility, and ease of use, making them attractive to laboratories seeking efficient quality assurance measures.
The molecular quality controls market is witnessing robust growth due to the convergence of various factors. The increasing adoption of molecular diagnostics, rising prevalence of infectious diseases and genetic disorders, and the demand for precision medicine have all contributed to the market's expansion.

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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.

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.

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