Molecular Quality Control Market to Grow with a CAGR of 6.68% through 2029

Growing emphasis on laboratory accreditation and quality assurance and a supportive regulatory environment are the major drivers for the Global Molecular Quality Control Market.

According to TechSci Research report, “Molecular Quality Control Market – Global Industry Size, Share, Trends, Competition Forecast & Opportunities, 2029F”, the Global  Molecular Quality Control Market was valued at USD 0.27 billion in 2023 and will see a steady growth in the forecast period at a CAGR of 6.68% through 2029. The favorable market trend for Molecular Quality Control can be attributed to heightened awareness among individuals. Accreditation bodies and regulatory agencies, such as the Clinical Laboratory Improvement Amendments (CLIA) in the United States and the International Organization for Standardization (ISO), impose stringent quality control requirements on clinical laboratories conducting molecular testing. Compliance with these standards necessitates robust quality control measures, including the utilization of quality control materials to verify test accuracy, precision, and reliability.

Quality control measures are vital for ensuring the accuracy and reliability of molecular diagnostic tests utilized in patient diagnosis, treatment selection, and disease monitoring. Accurate test results play a crucial role in guiding clinical decision-making, optimizing patient care, and enhancing patient outcomes. Quality control materials assist laboratories in identifying and rectifying errors or variations in test performance, thus ensuring the integrity and dependability of test results. These materials contribute to improved laboratory performance by identifying and mitigating sources of variability, bias, and error in molecular testing processes. They enable laboratories to monitor assay performance over time, detect trends or deviations from expected results, and implement corrective actions to uphold test accuracy and consistency.

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Procuring molecular quality control materials, which include certified reference materials, controls, and proficiency testing samples, can pose a financial challenge, especially for laboratories with limited resources. The expenses associated with these materials augment the overall operational costs of laboratories, affecting their capacity to invest in comprehensive quality assurance initiatives. Laboratories engaged in molecular diagnostics often necessitate substantial quantities of quality control materials to validate assay performance, ensure instrument accuracy, and engage in proficiency testing activities. The heightened demand for these materials, driven by the frequent and voluminous testing requirements, exacerbates cost pressures on laboratories, particularly those with extensive testing volumes. Given the finite nature of resources, healthcare organizations and laboratories must prioritize spending on critical operational needs such as personnel, equipment, reagents, and consumables. Budgetary constraints may constrain the allocation of funds for quality control materials, potentially compromising the integrity and accuracy of test outcomes by compromising quality assurance standards.

The Global Molecular Quality Control Market is segmented into Product, Analyte Type, Application, End-User, regional distribution, and company.

Based on its Analyte Type, Single-analyte controls emerged as the dominating segment in 2023. Single-analyte controls serve as quality control materials in molecular diagnostics, employed to oversee the accuracy and performance of assays directed at a particular analyte or molecular marker. In contrast to multiplexed controls, which encompass multiple analytes in a single sample, single-analyte controls are tailored to authenticate the performance of assays focused on individual targets. These controls are formulated to replicate the target analyte of interest within the molecular diagnostic assay, which could encompass a specific nucleic acid sequence, genetic marker, protein, or small molecule correlated with a distinct disease, condition, or biological process. Single-analyte controls are integrated into assay validation, routine testing, and quality control procedures to evaluate the precision, accuracy, and consistency of test outcomes. Laboratories incorporate single-analyte controls into each assay run to ascertain assay performance, identify systematic errors, and ensure reliable detection of the target analyte.

Based on region, North America is anticipated to project the rapid growth in the market. North America enjoys substantial investments in research and development, along with collaborations among academia, industry, and government bodies. These partnerships foster innovation and propel the advancement of sophisticated molecular technologies like next-generation sequencing, digital PCR, and multiplexed assays, necessitating thorough quality control protocols. With a strong healthcare infrastructure, rigorous regulatory scrutiny, elevated disease prevalence, and a culture of innovation, North America emerges as a frontrunner in the Global Molecular Quality Control Market. Regions such as Europe and Asia-Pacific are also experiencing noteworthy expansion and acceptance of molecular quality control solutions, underscoring the market's global reach.

Major companies operating in Global Molecular Quality Control Market are:

• F. Hoffmann-La Roche Ltd.
• Danaher Corporation
• Bio-Rad Laboratories, Inc.
• Anchor Molecular Inc. 
• Thermo Fisher Scientific, Inc.
• Randox Laboratories Ltd.
• Abbott Laboratories Inc. 
• Fortress Diagnostics Ltd 
• Ortho-Clinical Diagnostics, Inc.
• Sun Diagnostics, LLC.

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“The Molecular Quality Control Market is witnessing strong expansion, driven by several factors. These include the growing uptake of molecular diagnostics, increased emphasis on laboratory accreditation and quality assurance, advancements in multiplexed assays, and the demand for precise testing in precision medicine and personalized healthcare. It is essential to improve the accessibility, affordability, and scalability of quality control solutions to meet the rising demand for molecular diagnostics across clinical, research, and public health domains globally”, said Mr. Karan Chechi, Research Director of TechSci Research, a research-based management consulting firm.

“Molecular Quality Control Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Independent Controls and Instrument-Specific Controls), By Analyte Type (Single-Analyte Controls and Multi-Analyte Controls), By Application (Infectious Disease Diagnostics, Oncology Testing, Genetic Testing, and Others), By End-User (Diagnostic Laboratories, Hospitals, IVD Manufacturers & Contract Research Organizations, Academic & Research Institutes, and Others), By Region, and By Competition, 2019-2029F”, has evaluated the future growth potential of Global Molecular Quality Control Market and provides statistics & information on market size, structure and future market growth. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Global Molecular Quality Control Market.

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