United States Molecular Quality Controls Market to Reach CAGR 10.9% by 2031 | Key Players: Bio‐Rad Laboratories Inc, F. Hoffmann‐La Roche AG, SeraCare Life Sciences Inc, bioMérieux Inc

Market Overview

The global molecular quality controls market is projected to grow at a CAGR of 10.9% during the forecast period 2024-2031, reflecting strong demand for reliable molecular testing and quality assurance solutions. Molecular quality controls are essential for evaluating the performance of molecular assays, including in vitro nucleic acid testing for viral load measurements, pathogen detection, leukocyte reduced apheresis platelet (LRAP) units, and healthcare-associated infections (HAIs) such as pneumonia and urinary tract infections.

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These controls primarily focus on defect detection, quality validation, and assay-kit lot performance monitoring, ensuring accuracy and consistency in molecular diagnostic workflows. They are widely used across clinical and research laboratories, blood diagnostic centers, and in vitro diagnostic (IVD) manufacturers, supporting regulatory compliance, assay standardization, and reliable patient testing outcomes. The growing adoption of molecular diagnostics, rising prevalence of infectious diseases, and increasing focus on laboratory quality assurance are expected to drive significant growth in this market during the forecast period.

Recent Key Developments:

✅ June 2025: Bio‐Rad Laboratories launched the Exact Diagnostics GBS Positive and Negative Run Controls, ready‐to‐use molecular quality controls for Group B Streptococcus molecular assays, enhancing quality assurance in clinical labs.

✅ June 2025: ZeptoMetrix (Antylia Scientific) introduced the NATtrol Influenza A H5N1 Quantitative Stock, providing molecular quality controls to support laboratories during avian influenza outbreaks.

✅ Early 2025: Seracare Life Sciences unveiled a new line of tumor mutation controls for molecular oncology diagnostics, helping laboratories ensure accuracy in mutation detection and cancer profiling assays.

✅ 2024-2025: Microbiologics expanded its portfolio and production capacity for molecular quality controls, broadening offerings for infectious disease reference materials and precision diagnostics.

✅ January 2024: Abbott announced development of liquid biopsy controls for next‐generation sequencing (NGS) experiments, improving accuracy and reliability in cancer diagnostics.

✅ January 2024: Roche Diagnostics launched its AmpliRun Control Set, providing comprehensive molecular quality control standards for qPCR experiments to validate analytical performance and ensure consistent test results.

Key Players:
Bio-Rad Laboratories Inc F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc, bioMerieux Inc, and ZeptoMetrix Corporation, Abbott Laboratories, Thermo Fisher Scientific, Microbiologics Inc, Quidel Corporation and Qnostics Ltd.

Bio‐Rad Laboratories Inc - Offers a wide range of molecular quality control products, including run controls and reference materials for infectious disease and oncology assays.

F. Hoffmann‐La Roche AG - Provides comprehensive molecular quality control solutions such as the AmpliRun Control Set for qPCR and NGS-based applications.

SeraCare Life Sciences Inc - Develops tumor mutation controls and specialized quality control panels for molecular oncology and infectious disease testing.

bioMérieux Inc - Offers molecular controls and reference materials supporting pathogen detection and clinical diagnostics.

ZeptoMetrix Corporation - Provides NATtrol and other molecular control products for viral and bacterial pathogen testing.

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Regional Insights:

North America: 45% (Largest share globally, driven by the presence of leading molecular diagnostic and quality control companies such as Bio‐Rad Laboratories, Thermo Fisher Scientific, Abbott Laboratories, and Quidel Corporation. High adoption of molecular diagnostics in clinical labs, strong regulatory frameworks, and increasing focus on laboratory quality assurance contribute to market growth.)

Europe: 25% (Steady growth, supported by well-established clinical laboratories, growing demand for molecular quality controls in oncology and infectious disease testing, and the presence of key players such as F. Hoffmann‐La Roche AG, SeraCare Life Sciences, and Qnostics Ltd.. Stringent regulatory standards also drive quality control adoption.)

Asia Pacific: 20% (Rapid growth, fueled by expanding molecular diagnostics infrastructure, rising prevalence of infectious and chronic diseases, and increasing investments in laboratory quality management. Companies like ZeptoMetrix Corporation and global IVD suppliers are enhancing regional distribution and partnerships.)

Market Dynamics:

Driver - Increasing Demand for Advanced Diagnostics and Accredited Laboratories:
The global molecular quality controls market is being driven by the growing demand for sensitive and accurate diagnostic tests, rising prevalence of infectious diseases, cancers, and genetic disorders, and the expanding number of accredited clinical laboratories adopting third-party quality controls. Worldwide, the volume of laboratory tests has increased significantly due to the rising burden of diseases, prompting growth in both public and private laboratory infrastructure. Regulatory bodies, such as the International Organization for Standardization (ISO 15189:2012) and other accreditation agencies, require laboratories to maintain robust quality management systems. For example, the total number of laboratory entities registered for CLIA accreditation increased from 259,967 in 2017 to 286,396 in 2020, while 15,353 laboratories received CLIA accreditation in 2018. The increasing number of accredited laboratories is expected to hold the largest market share, driving adoption of molecular quality controls globally.

Restraint:
Despite growing demand, the adoption of molecular quality controls is hampered by high costs and budgetary constraints in hospitals and laboratories. Establishing a quality control (QC) process requires significant investment in equipment, reagents, and dedicated personnel to manage the system. Additionally, QC procedures incur similar costs regardless of test volume, making them particularly expensive for laboratories performing low volumes of diagnostic tests. These financial barriers, coupled with budget limitations in both developed and developing regions, are expected to restrict the wider adoption of molecular quality control practices.

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Market Segmentation:

By Product Type: Independent controls dominate the market, capturing approximately 60% share, due to their wide compatibility with multiple molecular platforms and use in validating assay accuracy across different laboratories. Instrument-specific controls hold the remaining 40%, favored by laboratories using proprietary diagnostic instruments that require tailored quality control solutions.

By Application: Infectious diseases lead with 40% of the market, driven by the high prevalence of viral, bacterial, and other pathogen-related illnesses, requiring stringent molecular testing and quality control. Oncology applications account for 30%, supported by the rising adoption of molecular diagnostics in cancer detection, tumor mutation profiling, and personalized medicine. Genetic testing contributes 20%, reflecting increased demand for carrier screening, prenatal testing, and hereditary disease diagnostics. Others, including research applications and rare disease diagnostics, make up 10% of the market.

By End-user: Clinical laboratories are the primary end-users, holding 55% of the market, as they require consistent quality controls to maintain regulatory compliance and ensure diagnostic accuracy. IVD manufacturers and Contract Research Organizations (CROs) account for 35%, leveraging molecular quality controls to validate new assay kits and ensure batch-to-batch consistency. Others, including academic and research institutions, represent the remaining 10%.

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