mRNA Quality Monitoring Market (2025 - 2033) Size, Share & Trends Analysis Report By Product & Service, By Technology (Electrophoresis, LC-MS, PCR Techniques), By End Use, By Region, And Segment Forecasts

mRNA Quality Monitoring Market Summary

The global mRNA quality monitoring market size was estimated at USD 1.28 billion in 2024 and is projected to reach USD 2.33 billion by 2033, growing at a CAGR of 6.93% from 2025 to 2033. Growing adoption of mRNA-based therapeutics and vaccines drives demand for robust quality monitoring to ensure product safety, efficacy, and regulatory compliance. Furthermore, advancements in analytical technologies (LC-MS, electrophoresis, qPCR) and rising outsourcing to CDMOs/CROs further accelerate market growth.

Surge in mRNA-Based Therapeutics & Vaccines

Biopharma firms have greatly expanded their pipelines beyond infectious diseases as a result of the success of COVID-19 vaccines, which has brought mRNA into the public eye. By significantly expanding the scale and complexity of production, Moderna, BioNTech, and CureVac are developing mRNA therapies for protein replacement, rare diseases, and oncology. In order to comply with GMP and regulatory requirements, more batches must go through thorough quality monitoring, which covers integrity, purity, capping efficiency, and residual contaminants.

Globally, large capacity investments support this trend. To increase vaccine production, BioNTech is setting up modular mRNA manufacturing units (BioNTainers) in Rwanda and has constructed a new plasmid DNA manufacturing facility in Marburg, Germany.  In a similar way, Moderna established a commercial mRNA plant in Melbourne, Australia, that can generate up to 100 million doses per year. The mRNA quality monitoring industry is driven by the need for sophisticated analytical tools like LC-MS, electrophoresis, and PCR because every facility needs to conduct thorough QC testing at several stages, from raw material verification to the release of the finished product.

Technology Innovation & Outsourcing Trends

Rapid advancements in digital and analytical technologies are revolutionizing the monitoring of mRNA quality. The detailed structural characterization of mRNA is now possible thanks to the increased sensitivity and quicker run times of next-generation LC-MS systems. In addition, capillary electrophoresis based on microfluidics enables high-throughput integrity analysis using small sample volumes. For accurate quantification and sequence verification, next-generation sequencing (NGS) and digital PCR (dPCR) are also combined. In order to scale mRNA manufacturing from clinical to commercial production, these developments are increasing the automation, standardization, and reproducibility of QC workflows.

In parallel, many small- and mid-sized biotech firms are increasingly outsourcing QC activities to CDMOs, CROs, and specialized analytical labs. Outsourcing allows these companies to avoid high upfront investments in instruments and regulatory compliance infrastructure, while still accessing state-of-the-art technology and expertise. This trend is expanding the addressable market for QC service providers, driving collaborations and strategic partnerships, and fueling growth across both product and service segments of the mRNA quality monitoring industry.

Market Concentration & Characteristics

The mRNA Quality Monitoring industry is highly innovation-driven, with rapid advancements in analytical technologies such as high-resolution LC-MS, microfluidics-based capillary electrophoresis, digital PCR, and AI-powered data analysis. Players are focused on developing automation-ready, high-throughput solutions to handle growing mRNA production volumes and complex characterization requirements. Innovation is also evident in kits and reagents tailored for mRNA integrity, capping efficiency, and dsRNA detection, enabling faster, standardized workflows.

M&A activity in this space is moderate but strategically significant, with larger life science tool providers and CROs acquiring niche technology developers or QC service providers to expand their mRNA analytics portfolios. For example, acquisitions often target companies with proprietary sequencing or bioinformatics platforms, enhancing integrated solutions for mRNA QC. This consolidation trend is strengthening end-to-end service offerings and helping major players secure a competitive edge in supporting biopharma’s RNA therapeutics pipeline.

Regulations play a critical role, as mRNA products must meet stringent quality, safety, and efficacy standards set by the FDA, EMA, and ICH. Guidance around identity testing, impurity profiling, potency assays, and GMP compliance directly shapes the design of QC workflows. As regulatory frameworks for RNA therapeutics evolve, companies are investing heavily in validated, compliant analytical methods and adopting automation to minimize human error and ensure data integrity, making regulatory influence a major growth driver.

Service providers, including CDMOs, CROs, and analytical labs, are rapidly expanding their offerings to include specialized mRNA characterization services such as NGS-based sequence verification, capping efficiency assays, and dsRNA quantification. Many are building GMP-compliant labs and scaling capacity to handle commercial production volumes. This expansion is especially attractive for small- and mid-sized biotech firms seeking to accelerate development timelines while minimizing infrastructure costs.

Regional expansion is a key characteristic of the industry, as companies seek to establish QC and manufacturing capabilities closer to major biopharma hubs. Asia Pacific (notably Singapore, China, and India) is seeing growing investment in local mRNA production and analytics capacity, while Africa is emerging with initiatives like BioNTech’s modular BioNTainer facilities in Rwanda. This geographic diversification supports faster regulatory approvals, strengthens supply chain resilience, and boosts demand for QC technologies and services worldwide.

Product & Service Insights

The kits/assays & reagents segment dominated the market, with the largest revenue share of 52.04% in 2024. These products enable rapid and reproducible testing for critical quality attributes such as mRNA integrity, capping efficiency, and residual impurities, reducing assay development time and regulatory risk. The growing adoption of mRNA therapeutics beyond COVID-19 vaccines, in oncology, infectious diseases, and rare genetic disorders, further drives the need for high-throughput, automation-compatible kits that can support clinical and commercial manufacturing scales.

The QC testing services segment is expected to grow at the fastest CAGR from 2025 to 2033. This rapid growth is being driven by the increasing tendency of biopharma and biotech companies, especially small and mid-sized firms, to outsource analytical testing to specialized CROs, CDMOs, and GMP-compliant labs. Outsourcing helps reduce capital expenditure on expensive instruments like LC-MS and digital PCR systems, while providing access to cutting-edge expertise and validated methods for mRNA integrity, potency, and impurity testing. As mRNA pipelines expand and regulatory scrutiny tightens, the demand for reliable, high-throughput, and compliant QC testing services is skyrocketing, making this segment a key growth driver for the mRNA quality monitoring industry.

Technology Insights

The electrophoresis segment led the mRNA quality monitoring market in 2024, accounting for the largest revenue share of 33.42%. It offers an efficient, precise, and cost-effective way to evaluate mRNA's purity, size distribution, and integrity. In development and GMP QC settings, capillary and gel-based electrophoresis techniques are frequently employed to identify degradation, truncated transcripts, or contaminants that may affect the effectiveness of treatment. The need for automated, high-throughput electrophoresis systems and readily available consumables that produce reliable, repeatable results is growing along with the scale of mRNA manufacturing, making this technology a vital component of effective and compliant QC workflows.

The LC-MS segment is expected to grow at the fastest CAGR over the forecast period, driven by its high-resolution analysis of mRNA molecules, including sequence verification, detection of chemical modifications, and impurity profiling. Its ability to provide detailed structural and molecular information makes it essential for regulatory-compliant release testing and characterization of complex mRNA therapeutics. The need for sophisticated LC-MS equipment, software, and related consumables is increasing as mRNA production scales and pipelines develop across vaccines and innovative treatments, establishing this technology as a vital component of premium QC workflows.

End Use Insights

Based on end use, the biopharmaceutical & biotechnology companies segment led the market with the largest revenue share of 55.79% in 2024. These companies require comprehensive QC solutions to ensure the integrity, purity, and potency of every batch, meeting stringent regulatory standards for clinical and commercial production. As mRNA pipelines expand into oncology, infectious diseases, and rare genetic disorders, in-house QC labs increasingly invest in advanced instruments, kits, and assays, as well as automated and high-throughput workflows, making this end-use segment the largest and most consistent contributor to market growth.

The CDMOs, CROs & analytical labs segment is projected to grow at the fastest CAGR during the forecast period. These service providers offer access to state-of-the-art instruments, validated assays, and regulatory-compliant workflows without requiring heavy capital investment from clients. As the demand for mRNA therapeutics and vaccines grows, the reliance on contract testing and analytical services is increasing, fueling market expansion and encouraging providers to broaden their service portfolios and geographic reach.

Regional Insights

North America dominated the mRNA quality monitoring industry with the largest revenue share of 36.54% in 2024, driven by the high concentration of leading mRNA developers such as Moderna and BioNTech’s U.S. operations. Strong R&D infrastructure, well-established GMP manufacturing facilities, and supportive regulatory frameworks encourage early adoption of advanced QC technologies, including LC-MS, electrophoresis, and digital PCR, making the region a consistent growth engine for the market.

U.S. mRNA Quality Monitoring Market Trends

The U.S. dominates North America due to the presence of major mRNA therapeutics and vaccine manufacturers. High investment in mRNA R&D, combined with regulatory pressure from the FDA to ensure product safety and efficacy, is fueling demand for robust quality monitoring systems and services. In addition, strong venture capital funding supports smaller biotech firms, further expanding market adoption.

Europe mRNA Quality Monitoring Market Trends

Europe’s mRNA quality monitoring market is growing rapidly due to increasing investments from pharmaceutical giants and biotech startups across Germany, France, and Switzerland. The region emphasizes compliance with EMA guidelines, GMP manufacturing, and high-quality analytical standards, driving widespread adoption of QC assays, instruments, and outsourcing services.

The UK market is expanding with a strong focus on innovation in mRNA therapeutics and vaccines, supported by government funding and partnerships between biotech firms and academic institutions. Regulatory alignment with EMA standards ensures rigorous QC processes, boosting demand for electrophoresis, LC-MS, PCR-based assays, and QC testing services.

Germany is a major European hub for biopharma and biotech, home to advanced mRNA manufacturing facilities and analytical labs. Investments in both in-house QC and outsourced services, along with strong adherence to EMA and national GMP guidelines, are driving the demand for high-throughput and automated quality monitoring solutions.

Asia Pacific mRNA Quality Monitoring Market Trends

The mRNA quality monitoring market in Asia Pacific is anticipated to witness the fastest CAGR of 9.05% throughout the forecast period. Asia Pacific is a high-growth market for mRNA quality monitoring, fueled by increasing biotech investments in countries like China, Japan, Singapore, and India. Governments are promoting local mRNA manufacturing capabilities, while rising outsourcing to regional CDMOs and CROs accelerates adoption of advanced QC technologies.

China’s expanding biotech and vaccine sector is a key driver, with domestic mRNA vaccine developers scaling production to meet local and regional demand. Regulatory encouragement, investment in GMP-compliant facilities, and growing adoption of advanced analytical tools are boosting the mRNA quality monitoring market.

Japan’s mRNA market growth is supported by government-backed initiatives for next-generation vaccines and therapeutics. Domestic companies and research institutes are increasingly investing in QC infrastructure and high-throughput analytical systems to ensure compliance with stringent PMDA standards. Moreover, Japan’s aging population and rising prevalence of chronic diseases are accelerating the development of novel cell-based treatments, further boosting the market growth.

MEA mRNA Quality Monitoring Market Trends

The Middle East is emerging as a growth region, driven by initiatives to develop local mRNA manufacturing capabilities and strengthen healthcare infrastructure. Investment in GMP-compliant facilities, partnerships with global biopharma companies, and adoption of outsourced QC services are key factors driving market expansion.

Kuwait’s nascent mRNA sector is primarily supported by government-backed health initiatives and partnerships with international biotech firms. Early-stage adoption of mRNA QC workflows, including outsourcing to regional labs and CDMOs, is laying the foundation for future growth in instruments, assays, and QC testing services.

Key mRNA Quality Monitoring Company Insights

Revvity, Inc. supports the mRNA quality monitoring market with integrated RNA-specific tools such as its Signals One platform, benefiting from growing demand for standardized, high-throughput assays while facing pressure to innovate. Agilent Technologies offers advanced instruments such as Femto Pulse, LC-MS, and automated electrophoresis systems, gaining from regulatory-driven QC needs but needing continual R&D to maintain leadership. Bio-Rad Laboratories provides ddPCR-based solutions across development and GMP QC, supporting precision quantification while navigating fluctuations in diagnostic demand and rising competition.

Merck KGaA delivers end-to-end mRNA services with GMP-grade manufacturing sites and strategic collaborations, capitalizing on global mRNA expansion but impacted by regulatory scrutiny and high operational costs. Collectively, these companies are driving innovation, expanding services, and shaping the rapidly growing mRNA quality monitoring market.

Recent Developments

• In July 2025, Sartorius Stedim Biotech and Sensible Biotechnologies partnered to scale up Sensible’s unique cell-based mRNA design and manufacturing platform.

• In February 2025, Aldevron and InDevR formed a partnership to evaluate and validate chip-based technology aimed at assessing mRNA capping efficiency. This collaboration focused on leveraging InDevR’s specialized analytical platform to streamline and enhance the accuracy of capping measurements, supporting Aldevron’s efforts in mRNA quality control and production optimization.

mRNA Quality Monitoring Market Report Scope

Global mRNA Quality Monitoring Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For the purpose of this report, Grand View Research has segmented the global mRNA quality monitoring market on the basis of product & service, technology, end use, and region:

• Product & Service Outlook (Revenue, USD Million, 2021 - 2033)

  • Kits/Assays & Reagents 

  • Instruments & Software

  • QC Testing Services

• Technology Outlook (Revenue, USD Million, 2021 - 2033)

  • LC-MS 

  • Electrophoresis

  • ELISA 

  • PCR Techniques

  • Other Technologies

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Biopharmaceutical & Biotechnology Companies 

  • CDMOs, CROs & Analytical Labs 

  • Academic & Research Institutes/Centers

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait