Molecular Quality Control Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Molecular Quality Control Market is projected to expand from USD 0.34 Billion in 2025 to USD 0.51 Billion by 2031, registering a CAGR of 6.99%. Functioning as critical benchmarks, molecular quality controls employ synthetic or biological materials to validate nucleic acid testing precision and confirm the reliability of clinical diagnostics. This growth is primarily underpinned by strict adherence to laboratory accreditation norms, such as ISO 15189, which mandate regular proficiency testing, coupled with the increasing volume of infectious disease and genetic testing that necessitates verified control protocols.

Despite these positive indicators, market penetration in developing areas faces significant hurdles due to the high expense of third-party controls and the logistical difficulties associated with cold-chain management. Operational data highlights the industry's adaptation to increasing testing complexity; for instance, the College of American Pathologists launched 18 new proficiency testing programs in 2024 to meet the shifting requirements of clinical laboratories.

Market Drivers

Advancements in molecular diagnostic technologies, specifically the widespread adoption of Next-Generation Sequencing and multiplex assays, are a major force behind the demand for sophisticated quality control solutions. As laboratories implement high-throughput systems to examine complex genetic markers, there is an intensified need for multi-analyte controls capable of validating extensive genomic panels, ensuring accuracy in hereditary disease screening and oncology. This expansion of advanced genomic infrastructure is evidenced by Illumina's 'Form 10-K Fiscal Year 2023' report from February 2024, which noted the shipment of 352 NovaSeq X instruments, highlighting the broader footprint of high-complexity testing that requires rigorous quality assurance.

Simultaneously, the increasing prevalence of infectious diseases serves as a catalyst, demanding high-volume molecular testing and strict verification of diagnostic precision. The global focus on rapid pathogen detection has reoriented clinical workflows toward molecular techniques, which require ongoing proficiency testing to ensure regulatory compliance and patient safety. For example, the World Health Organization's 'Global Tuberculosis Report 2023', released in November 2023, indicated that molecular diagnostics usage reached a peak, with 47% of initial tuberculosis diagnoses utilizing a WHO-recommended rapid molecular test. Supporting the scale of these operations, Bio-Rad Laboratories reported in 2024 that its Clinical Diagnostics segment achieved approximately $1.53 billion in annual net sales, demonstrating the significant value placed on diagnostic assurance and testing support.

Market Challenges

The substantial cost of acquiring third-party molecular quality controls represents a major obstacle to market growth, especially in resource-limited settings. Clinical laboratories in emerging economies often face financial constraints, making it difficult to justify the purchase of premium, independent control materials amidst other operational needs. As a result, these facilities might decrease the frequency of quality control measures or resort to less stringent in-house options, which reduces revenue opportunities for commercial manufacturers and compromises the global standardization of diagnostic outcomes.

Additionally, the strict logistical demands for maintaining cold-chain integrity during storage and transport intensify these financial burdens. Molecular controls typically require preservation at sub-zero temperatures to remain stable, a requirement often difficult to meet in areas with inconsistent infrastructure. This logistical vulnerability results in product spoilage and increased waste, further discouraging adoption in decentralized locations. The consequences of such operational pressures are highlighted by recent industry trends; according to a 2024 survey by the Association for Diagnostics & Laboratory Medicine, 48% of laboratories intended to stop specific testing services due to the growing weight of compliance costs and resource limitations, thereby shrinking the potential market for molecular quality control products.

Market Trends

The market is being reshaped by the rising utilization of independent third-party quality controls, as clinical laboratories prioritize unbiased assessment tools over kit-included options to satisfy strict accreditation requirements. This transition is motivated by the necessity to reduce lot-to-lot variability and ensure consistent diagnostic accuracy across various reagent batches, which is essential for ISO 15189 compliance. Laboratories are actively adopting these independent materials to identify systematic errors that might be obscured by the optimized matrix compatibility of manufacturer-supplied controls, a demand reflected in Bio-Rad Laboratories' 'Third-Quarter 2024 Financial Results' from October 2024, where the Clinical Diagnostics segment reported $388.8 million in net sales driven largely by global demand for quality control products.

In parallel, the industry is undergoing a notable shift toward multiplexed and multi-analyte control panels aimed at enhancing workflow efficiency in high-volume testing settings. As diagnostic manufacturers combine multiple targets into single syndromic panels - especially for gastrointestinal and respiratory pathogens - laboratories need consolidated control materials capable of validating all targets at once, thereby cutting down on consumable costs and time associated with single-analyte controls. This consolidation bolsters the scalability of modern diagnostic centers, a trend supported by Revvity's 'Financial Results for the Third Quarter of 2024' in November 2024, which showed the Diagnostics segment generating $383 million in revenue, a 6% increase attributed to the continued adoption of specialized molecular and immunodiagnostic solutions.

Key Players Profiled in the Molecular Quality Control Market

• 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

Report Scope

In this report, the Global Molecular Quality Control Market has been segmented into the following categories:

Molecular Quality Control Market, by Product:

• Independent Controls
• Instrument-Specific Controls

Molecular Quality Control Market, by Analyte Type:

• Single-Analyte Controls
• Multi-Analyte Controls

Molecular Quality Control Market, by Application:

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

Molecular Quality Control Market, by End-User:

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

Molecular Quality Control Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Molecular Quality Control Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.