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.
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.
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.
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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.
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, the analyst 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
- Europe
- Asia-Pacific
- Latin America
- MEA
Why You Should Buy This Report
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
Report Deliverables
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. mRNA Quality Monitoring Market Variables, Trends & Scope
Chapter 4. mRNA Quality Monitoring Market: Product & Service Estimates & Trend Analysis
Chapter 5. mRNA Quality Monitoring Market: Technology Estimates & Trend Analysis
Chapter 6. mRNA Quality Monitoring Market: End Use Estimates & Trend Analysis
Chapter 7. mRNA Quality Monitoring Market: Regional Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The companies profiled in this mRNA Quality Monitoring market report include:- Revvity, Inc.
- Agilent Technologies, Inc.
- Bio-Rad Laboratories, Inc.
- Merck KGaA
- Waters Corporation
- Creative Diagnostics
- GenScript
- TriLink BioTechnologies (Maravai LifeSciences)
- Creative Biolabs
- Vazyme International LLC
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 100 |
| Published | October 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 1.28 Billion |
| Forecasted Market Value ( USD | $ 2.33 Billion |
| Compound Annual Growth Rate | 6.9% |
| Regions Covered | Global |
| No. of Companies Mentioned | 11 |
