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, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 0.34 Billion
CAGR (2026-2031)	6.99%
Fastest Growing Segment	Oncology Testing
Largest Market	North America
Market Size (2031)	USD 0.51 Billion

Market Overview

The Global Molecular Quality Control Market will grow from USD 0.34 Billion in 2025 to USD 0.51 Billion by 2031 at a 6.99% CAGR. Molecular quality controls serve as essential benchmarks, utilizing biological or synthetic materials to verify the precision of nucleic acid testing assays and ensure the validity of clinical diagnostics. The market’s expansion is fundamentally supported by the rigorous enforcement of laboratory accreditation standards, such as ISO 15189, which necessitate consistent proficiency testing, alongside the rising volume of genetic and infectious disease testing that requires validated control measures.

Despite these drivers, the high acquisition costs of third-party controls and the logistical strictures of cold-chain management present a notable challenge to broader market penetration in developing regions. Operational data reflects the industry's response to growing testing complexity; according to the College of American Pathologists, in 2024, the organization launched 18 new proficiency testing programs to address the evolving needs of clinical laboratories.

Key Market Drivers

Technological advancements in molecular diagnostics, particularly the proliferation of Next-Generation Sequencing and multiplex assays, are significantly propelling the demand for advanced quality control solutions. As laboratories adopt high-throughput platforms to analyze complex genetic markers, the requirement for multi-analyte controls that can validate extensive genomic panels has intensified. This shift ensures the accuracy of sensitive assays used in oncology and hereditary disease screening. Reflecting this surge in advanced genomic infrastructure, according to Illumina, February 2024, in the 'Form 10-K Fiscal Year 2023', the company reported shipping 352 NovaSeq X instruments during the fiscal year, thereby expanding the footprint of high-complexity testing that necessitates stringent quality assurance protocols.

The rising prevalence of infectious diseases acts as a parallel catalyst, necessitating high-volume molecular testing and the rigorous verification of diagnostic accuracy. The global emphasis on rapid pathogen detection has shifted clinical workflows toward molecular methods, which demand continuous proficiency testing to maintain regulatory compliance and patient safety. For instance, according to the World Health Organization, November 2023, in the 'Global Tuberculosis Report 2023', the global uptake of molecular diagnostics reached a new high where 47% of people diagnosed with tuberculosis were initially tested with a WHO-recommended rapid molecular diagnostic test. To support the operational scale of such diagnostic manufacturers, according to Bio-Rad Laboratories, in 2024, the Clinical Diagnostics segment achieved annual net sales of approximately $1.53 billion, underscoring the substantial market valuation attributed to diagnostic assurance and testing support.

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Key Market Challenges

The high acquisition expense associated with third-party molecular quality controls constitutes a significant barrier to market expansion, particularly within budget-constrained environments. Clinical laboratories in emerging economies often operate with finite financial resources, making the procurement of premium, independent control materials difficult to justify against other operational necessities. Consequently, these facilities may reduce the frequency of quality control procedures or rely on less rigorous in-house alternatives, which directly diminishes the revenue potential for commercial control manufacturers and undermines the standardization of diagnostic results globally.

Furthermore, the stringent logistical requirements for maintaining cold-chain integrity during transport and storage exacerbate these financial pressures. Molecular controls frequently require consistent preservation at sub-zero temperatures to maintain stability, a condition that is often compromised in regions with unreliable infrastructure. This logistical fragility leads to product spoilage and increased waste, further deterring adoption in non-centralized settings. The impact of such operational strains is evident in recent industry shifts. According to the Association for Diagnostics & Laboratory Medicine, in 2024, survey data revealed that 48% of laboratories planned to discontinue certain testing services due to the intensifying burden of resource limitations and compliance costs. This contraction in testing volumes directly limits the addressable market for molecular quality control products.

Key Market Trends

The increasing adoption of independent third-party quality controls is reshaping the market as clinical laboratories prioritize unbiased assessment tools over kit-included controls to meet rigorous accreditation standards. This shift is driven by the need to minimize lot-to-lot variability and ensure that diagnostic platforms maintain consistent accuracy across different reagent batches, a critical requirement for ISO 15189 compliance. Laboratories are aggressively integrating these independent materials to isolate systematic errors that manufacturer-supplied controls might mask due to optimized matrix compatibility. Operational performance underscores this demand; according to Bio-Rad Laboratories, October 2024, in the 'Third-Quarter 2024 Financial Results', the Clinical Diagnostics segment reported net sales of $388.8 million, with growth primarily attributed to the rising global demand for quality control products.

Concurrently, the industry is witnessing a significant transition towards multi-analyte and multiplexed control panels, designed to streamline workflow efficiency in high-volume testing environments. As diagnostic manufacturers consolidate multiple targets into single syndromic panels—particularly for respiratory and gastrointestinal pathogens—laboratories require consolidated control materials that can validate all targets simultaneously, thereby reducing the time and consumable costs associated with running single-analyte controls. This consolidation supports the operational scalability of modern diagnostic hubs. Reflecting the market's robust activity in this sector, according to Revvity, November 2024, in the 'Financial Results for the Third Quarter of 2024', the Diagnostics segment generated revenue of $383 million, representing a 6% increase driven by the continued uptake of specialized immunodiagnostic and molecular solutions.

Segmental Insights

The oncology testing segment represents the fastest-growing category within the global molecular quality control market, primarily due to the increasing adoption of precision medicine. As healthcare providers rely more heavily on genetic analysis to determine specific cancer treatments, laboratories must ensure the absolute accuracy of these complex diagnostic tests. This demand is further amplified by stringent regulatory guidelines from authorities like the U.S. Food and Drug Administration, which mandate rigorous validation of test results. Consequently, the critical need to minimize errors and ensure patient safety drives the rising consumption of quality control products dedicated to cancer diagnostics.

Regional Insights

North America leads the Global Molecular Quality Control Market, driven by an established healthcare infrastructure and the widespread adoption of molecular diagnostics. This dominance is largely attributed to strict regulatory mandates requiring rigorous assay validation to ensure patient safety. Laboratories maintain compliance with the US Food and Drug Administration (FDA) regulations and Clinical Laboratory Improvement Amendments (CLIA) standards, which necessitates the routine use of independent quality controls. Furthermore, the substantial presence of major industry manufacturers within the United States and Canada facilitates product accessibility, cementing the region's position as the primary market globally.

Recent Developments

• In June 2025, ZeptoMetrix announced the launch of the NATtrol Influenza A H5N1 Quantitative Stock to assist laboratories during avian influenza outbreaks. This molecular quality control product utilized a specialized technology to encapsulate RNA within phage-like particles, simulating the characteristics of a true clinical specimen. This design enabled laboratories to validate the complete testing workflow, including extraction and amplification, while avoiding the risks associated with live virus samples. The development provided a robust tool for healthcare facilities to verify assay performance and ensure accurate detection of emerging respiratory viral strains.
• In November 2024, Microbiologics acquired SensID, a manufacturer specializing in reference materials and quality controls for molecular diagnostics, particularly in oncology. This strategic transaction integrated SensID’s expertise in precision medicine with the acquiring company's established background in infectious disease controls. The collaboration allowed the organization to broaden its range of quality control offerings for diagnostic technology developers and clinical laboratories. By combining these resources, the company aimed to enhance the availability of precise molecular controls required for validating advanced diagnostic tests and improving patient care standards globally.
• In September 2024, LGC Clinical Diagnostics expanded its molecular quality control portfolio with the launch of the Seraseq DPYD DNA Mutation Mix. This reference material was specifically designed to assist clinical laboratories in developing and validating pharmacogenomic assays that detect mutations in the DPYD gene. The product aimed to support personalized medicine by enabling the accurate identification of cancer patients who might experience severe toxicity from specific chemotherapy treatments. This release marked a strategic entry into the pharmacogenomics market, offering a consistent and reliable control solution for Next Generation Sequencing and other molecular testing platforms.
• In February 2024, Bio-Rad Laboratories released new molecular quality control solutions specifically addressing the needs of the cell and gene therapy sector. The company introduced the Vericheck ddPCR Replication Competent Lentivirus Kit and the Replication Competent AAV Kit to support precise quantification in therapeutic manufacturing. These products were developed to detect replication-competent viruses, which is a critical safety requirement for biological drug production. By utilizing digital PCR technology, these kits provided a standardized method for biopharmaceutical laboratories to validate their processes and ensure that viral vector-based therapies met stringent regulatory safety standards.

Key Market Players

• 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

By Product	By Analyte Type	By Application	By End-User	By Region
Independent Controls and Instrument-Specific Controls	Single-Analyte Controls and Multi-Analyte Controls	Infectious Disease Diagnostics Oncology Testing Genetic Testing and Others	Diagnostic Laboratories Hospitals IVD Manufacturers & Contract Research Organizations Academic & Research Institutes and Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Molecular Quality Control Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Molecular Quality Control Market, By Product:

• Independent Controls and Instrument-Specific Controls

• Molecular Quality Control Market, By Analyte Type:

• Single-Analyte Controls and Multi-Analyte Controls

• Molecular Quality Control Market, By Application:

• Infectious Disease Diagnostics
• Oncology Testing
• Genetic Testing
• and Others

• Molecular Quality Control Market, By End-User:

• Diagnostic Laboratories
• Hospitals
• IVD Manufacturers & Contract Research Organizations
• Academic & Research Institutes
• and Others

• Molecular Quality Control Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE