Molecular Quality Control Market Size, Growth Drivers and Global Forecast 2035 | At a Thriving CAGR of 6.6%

WiseGuy Reports, Oct. 2025 (Press Release) – The Molecular Quality Control Market Global Outlook:

Global Molecular Quality Control Market Growth Analysis and Trends Report Application (Clinical Diagnostics, Biotechnology, Pharmaceuticals, Environmental Testing), By Product Type (Reagents, Controls, Assays, Instruments), By End Use (Hospitals, Diagnostic Laboratories, Research Institutions, Pharmaceutical Companies), By Technique (Polymerase Chain Reaction, Next-Generation Sequencing, Microarray, Sequencing) and By Regions - Global Industry Forecast 2025 to 2035

Molecular Quality Control Market Overview

Molecular Quality Control Market: Driving Accuracy and Reliability in Modern Diagnostics

The Molecular Quality Control Market is evolving rapidly as the global healthcare landscape demands greater precision and reliability in diagnostic testing. With a market size valued at USD 2.48 billion in 2024, the sector is projected to reach USD 2.64 billion in 2025, and further expand to USD 5.0 billion by 2035, reflecting a CAGR of 6.6% from 2025 to 2035. The growth is driven by increasing adoption of molecular diagnostic techniques, stringent quality assurance requirements, and rising research activities in genomic testing and infectious disease detection.

Market Overview

The Molecular Quality Control Market plays a critical role in ensuring the reliability and accuracy of molecular diagnostic results. As healthcare providers and laboratories increasingly rely on molecular diagnostics for detecting genetic, infectious, and oncological conditions, the need for standardized quality control systems has intensified. Key players such as BioMerieux, LGC Limited, BioRad Laboratories, Ortho Clinical Diagnostics, Thermo Fisher Scientific, and Abbott Laboratories are investing heavily in developing high-quality control materials that support precision testing and regulatory compliance.

Growing emphasis on personalized medicine is one of the major market drivers. With therapies becoming more patient-specific, the need for high-quality molecular testing grows to ensure reliable outcomes. Additionally, technological advancements in PCR, NGS, and molecular assay platforms have expanded the scope of molecular quality control applications across clinical, research, and pharmaceutical laboratories.

Market Dynamics

Several key factors are propelling the growth of the Molecular Quality Control Market:

• Growing demand for personalized medicine to enhance treatment accuracy and patient outcomes.
• Advancements in molecular testing technologies, including real-time PCR and sequencing tools.
• Increasing prevalence of infectious diseases and genetic disorders necessitating quality control in diagnostics.
• Stringent regulatory standards for diagnostic validation and laboratory accreditation.
• Rising R&D activities to develop innovative molecular testing kits and control materials.

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Market Segmentation

The Molecular Quality Control Market is segmented based on application, product type, end-use, technique, and region.

• By Application: Infectious disease diagnostics, oncology testing, genetic testing, and others.
• By Product Type: Independent quality controls, instrument-specific controls, and multiplexed controls.
• By End Use: Hospitals, diagnostic laboratories, academic research centers, and biotechnology companies.
• By Technique: Polymerase chain reaction (PCR), next-generation sequencing (NGS), microarrays, and others.

These segments collectively highlight the increasing integration of molecular quality control in advanced diagnostic workflows, ensuring data reliability and consistent results across multiple test platforms.

Regional Analysis

Geographically, the market spans North America, Europe, Asia-Pacific (APAC), South America, and the Middle East & Africa (MEA).

• North America dominates the global market due to high adoption of molecular diagnostics, strong presence of key manufacturers, and robust regulatory frameworks.
• Europe follows closely, driven by the expansion of molecular laboratories and increased demand for compliance with EU diagnostic standards.
• APAC is witnessing the fastest growth due to rising healthcare infrastructure, increasing diagnostic investments, and growing prevalence of infectious diseases in China, India, and Japan.
• South America and MEA regions are also emerging, supported by healthcare modernization and enhanced focus on laboratory quality assurance.

Competitive Landscape

Leading companies are pursuing strategic partnerships, acquisitions, and product launches to strengthen their global footprint. For instance, Thermo Fisher Scientific and Roche Diagnostics continue to enhance molecular control portfolios with innovative technologies. Merck KGaA, Danaher Corporation, and Mindray Medical International are expanding their presence in the APAC market through collaborations and regulatory approvals. The competition emphasizes product reliability, ease of integration, and compliance with international standards such as ISO 15189.

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Key Market Opportunities

• Expansion of regulatory compliance requirements in diagnostics.
• Growth in diagnostics and testing services globally.
• Rising focus on laboratory accreditation standards.
• Ongoing advancements in molecular testing technologies enabling more accurate results.
• Growing demand for personalized and precision medicine.

Future Outlook

The Molecular Quality Control Market is poised for robust expansion over the next decade. The forecast period from 2025 to 2035 anticipates continuous innovation in molecular diagnostics, driven by automation, AI integration, and real-time monitoring technologies. These advancements will further enhance diagnostic precision, reduce error margins, and improve clinical decision-making. Additionally, emerging economies are expected to offer lucrative opportunities as healthcare providers invest in high-quality laboratory systems and compliance frameworks.

Conclusion

In summary, the Molecular Quality Control Market is an essential component of modern diagnostics, ensuring precision, reliability, and compliance in molecular testing. With rapid advancements in genomics, increasing disease prevalence, and strict regulatory oversight, the market is expected to experience substantial growth.

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➼ In-depth analysis of the Molecular Quality Control Market on the global and regional levels.

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➼ Segmentation on the basis of type, application, geography, and others.

➼ Historical and future market research in terms of size, share growth, volume, and sales.

➼ Major changes and assessment in market dynamics and developments.

➼ Emerging key segments and regions

➼ Key business strategies by major market players and their key methods

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