Global Molecular Quality Controls Market Size study & Forecast, by Product (Independent Control, Instrument Specific Control (PCR, DNA Sequencing)), Application (Infectious Disease Diagnostics), Analyte Type, End User (Hospitals, Diagnostic Lab) and Regio

The Global Molecular Quality Controls Market, valued at approximately USD 2.27 billion in 2024, is poised to expand at a CAGR of 6.60% during the forecast period 2025–2035. Molecular quality controls play a pivotal role in ensuring the reliability, precision, and standardization of molecular diagnostic tests. They act as critical benchmarks for laboratories to verify instrument performance, reagent integrity, and procedural accuracy—elements that are vital in clinical decision-making. This market’s growth is being underpinned by the increasing demand for accurate infectious disease diagnostics, the rise in molecular testing volumes, and the ongoing shift towards personalized medicine. Heightened awareness regarding early and precise disease detection has accelerated the adoption of these controls, with healthcare systems prioritizing diagnostic accuracy to improve patient outcomes.

The escalating global burden of infectious diseases, coupled with the rapid pace of technological innovations in PCR and DNA sequencing platforms, has intensified the need for robust molecular quality control solutions. Advances in automation, multiplex assay capabilities, and integrated diagnostic workflows have not only increased testing throughput but also amplified the necessity for rigorous quality assurance. The market is also benefiting from the expansion of molecular diagnostics into decentralized testing environments, such as point-of-care and near-patient settings, where maintaining accuracy is paramount. However, the high cost of advanced quality control products and limited accessibility in emerging economies could temper growth to some extent, particularly in resource-constrained healthcare systems.

Geographically, North America currently commands the largest share of the market, buoyed by a well-established diagnostic infrastructure, stringent regulatory requirements, and the presence of leading molecular diagnostic companies. The U.S., in particular, has seen significant investment in advanced infectious disease testing capabilities, driving sustained demand for quality control materials. Europe follows closely, propelled by supportive healthcare policies, rising adoption of precision medicine, and heightened laboratory accreditation standards. Meanwhile, the Asia Pacific region is forecasted to witness the fastest growth, fueled by expanding healthcare infrastructure, rising investments in molecular diagnostic labs in countries such as China and India, and increasing awareness of early disease detection. Latin America and the Middle East & Africa are also showing promising potential, backed by improvements in public health systems and gradual modernization of laboratory facilities.

Major market players included in this report are:
• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• LGC Limited
• ZeptoMetrix Corporation
• Abbott Laboratories
• SeraCare Life Sciences Inc.
• Randox Laboratories Ltd.
• Roche Diagnostics
• Siemens Healthineers AG
• QuidelOrtho Corporation
• Qnostics Ltd.
• Microbiologics, Inc.
• Genomic Health, Inc.
• Grifols S.A.
• Precision Biomonitoring Inc.

Global Molecular Quality Controls Market Report Scope:
• Historical Data – 2023, 2024
• Base Year for Estimation – 2024
• Forecast period – 2025-2035
• Report Coverage – Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
• Regional Scope – North America; Europe; Asia Pacific; Latin America; Middle East & Africa

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within the countries involved in the study. The report also provides detailed information about crucial aspects, such as driving factors and challenges, which will define the future growth of the market. Additionally, it incorporates potential opportunities in micro-markets for stakeholders to invest, along with a detailed analysis of the competitive landscape and product offerings of key players.

The detailed segments and sub-segments of the market are explained below:

By Product:
• Independent Control
• Instrument Specific Control (PCR, DNA Sequencing)

By Application:
• Infectious Disease Diagnostics

By Analyte Type:
• [Multiple analyte categories as per industry classification]

By End User:
• Hospitals
• Diagnostic Lab

By Region:

North America
• U.S.
• Canada

Europe
• UK
• Germany
• France
• Spain
• Italy
• Rest of Europe (ROE)

Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• Rest of Asia Pacific (RoAPAC)

Latin America
• Brazil
• Mexico

Middle East & Africa
• UAE
• Saudi Arabia
• South Africa
• Rest of Middle East & Africa

Key Takeaways:
• Market Estimates & Forecast for 10 years from 2025 to 2035.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with Country level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand side and supply side analysis of the market.

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