mRNA Quality Monitoring Market Size, Share & Trends Analysis Report By Product & Service, By Technology (Electrophoresis, LC-MS, PCR Techniques), By End Use, By Region, And Segment Forecasts, 2025 - 2033
Description
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.
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:
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.
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
Table of Contents
100 Pages
- Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Market Definitions
- 1.2.1. Product & Service Segment
- 1.2.2. Technology Segment
- 1.2.3. End Use Segment
- 1.3. Information Analysis
- 1.3.1. Market formulation & data visualization
- 1.4. Data Validation & Publishing
- 1.5. Information Procurement
- 1.5.1. Primary Research
- 1.6. Information or Data Analysis
- 1.7. Market Formulation & Validation
- 1.8. Market Model
- 1.9. Total Market: CAGR Calculation
- 1.10. Objectives
- 1.10.1. Objective 1
- 1.10.2. Objective 2
- Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Snapshot
- 2.3. Competitive Insights Landscape
- Chapter 3. mRNA Quality Monitoring Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook.
- 3.2. Market Dynamics
- 3.2.1. Market driver analysis
- 3.2.1.1. Rising Demand for mRNA-Based Therapeutics and Vaccines
- 3.2.1.2. Regulatory Focus on Product Safety and Consistency
- 3.2.2. Market restraint analysis
- 3.2.2.1. High Cost of Quality Monitoring Systems
- 3.2.2.2. Technical Complexity and Skilled Workforce Requirement
- 3.3. MRNA quality monitoring market Analysis Tools
- 3.3.1. Industry Analysis – Porter’s
- 3.3.2. PESTEL Analysis
- Chapter 4. mRNA Quality Monitoring Market: Product & Service Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. Global mRNA Quality Monitoring Market Product & Service Movement Analysis
- 4.3. Global mRNA Quality Monitoring Market Size & Trend Analysis, by Product & Service, 2021 to 2033 (USD Million)
- 4.4. Kits/Assays & Reagents
- 4.4.1. Kits/Assays & reagents market estimates and forecasts 2021 to 2033 (USD Million)
- 4.5. Instruments & Software
- 4.5.1. Instruments & software market estimates and forecasts 2021 to 2033 (USD Million)
- 4.6. QC Testing Services
- 4.6.1. QC testing services market estimates and forecasts 2021 to 2033 (USD Million)
- Chapter 5. mRNA Quality Monitoring Market: Technology Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. Global mRNA Quality Monitoring Market Technology Movement Analysis
- 5.3. Global mRNA Quality Monitoring Market Size & Trend Analysis, by Technology, 2021 to 2033 (USD Million)
- 5.4. LC-MS
- 5.4.1. LC-MS market estimates and forecasts 2021 to 2033 (USD Million)
- 5.5. Electrophoresis
- 5.5.1. Electrophoresis market estimates and forecasts 2021 to 2033 (USD Million)
- 5.6. ELISA
- 5.6.1. ELISA market estimates and forecasts 2021 to 2033 (USD Million)
- 5.7. PCR Techniques
- 5.7.1. PCR techniques market estimates and forecasts 2021 to 2033 (USD Million)
- 5.8. Other Technologies
- 5.8.1. Other technologies market estimates and forecasts 2021 to 2033 (USD Million)
- Chapter 6. mRNA Quality Monitoring Market: End Use Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. Global mRNA Quality Monitoring Market End Use Movement Analysis
- 6.3. Global mRNA Quality Monitoring Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
- 6.4. Biopharmaceutical & Biotechnology Companies
- 6.4.1. Biopharmaceutical & biotechnology companies market estimates and forecasts 2021 to 2033 (USD Million)
- 6.5. CDMOs, CROs & Analytical Labs
- 6.5.1. CDMOs, CROs & analytical labs market estimates and forecasts 2021 to 2033 (USD Million)
- 6.6. Academic & Research Institutes/Centers
- 6.6.1. Academic & research institutes/centers market estimates and forecasts 2021 to 2033 (USD Million)
- Chapter 7. mRNA Quality Monitoring Market: Regional Estimates & Trend Analysis
- 7.1. Regional Market Share Analysis, 2024 & 2033
- 7.2. Regional Market Dashboard
- 7.3. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
- 7.4. North America
- 7.4.1. U.S.
- 7.4.1.1. Key country dynamics
- 7.4.1.2. Competitive scenario
- 7.4.1.3. Regulatory Framework
- 7.4.1.4. U.S. market estimates and forecasts 2021 to 2033 (USD Million)
- 7.4.2. Canada
- 7.4.2.1. Key country dynamics
- 7.4.2.2. Competitive scenario
- 7.4.2.3. Regulatory Framework
- 7.4.2.4. Canada market estimates and forecasts 2021 to 2033 (USD Million)
- 7.4.3. Mexico
- 7.4.3.1. Key country dynamics
- 7.4.3.2. Competitive scenario
- 7.4.3.3. Regulatory Framework
- 7.4.3.4. Mexico market estimates and forecasts 2021 to 2033 (USD Million)
- 7.5. Europe
- 7.5.1. UK
- 7.5.1.1. Key country dynamics
- 7.5.1.2. Competitive scenario
- 7.5.1.3. Regulatory Framework
- 7.5.1.4. UK market estimates and forecasts 2021 to 2033 (USD Million)
- 7.5.2. Germany
- 7.5.2.1. Key country dynamics
- 7.5.2.2. Competitive scenario
- 7.5.2.3. Regulatory Framework
- 7.5.2.4. Germany market estimates and forecasts 2021 to 2033 (USD Million)
- 7.5.3. France
- 7.5.3.1. Key country dynamics
- 7.5.3.2. Competitive scenario
- 7.5.3.3. Regulatory Framework
- 7.5.3.4. France market estimates and forecasts 2021 to 2033 (USD Million)
- 7.5.4. Italy
- 7.5.4.1. Key country dynamics
- 7.5.4.2. Competitive scenario
- 7.5.4.3. Regulatory Framework
- 7.5.4.4. Italy market estimates and forecasts 2021 to 2033 (USD Million)
- 7.5.5. Spain
- 7.5.5.1. Key country dynamics
- 7.5.5.2. Competitive scenario
- 7.5.5.3. Regulatory Framework
- 7.5.5.4. Spain market estimates and forecasts 2021 to 2033 (USD Million)
- 7.5.6. Norway
- 7.5.6.1. Key country dynamics
- 7.5.6.2. Competitive scenario
- 7.5.6.3. Regulatory Framework
- 7.5.6.4. Norway market estimates and forecasts 2021 to 2033 (USD Million)
- 7.5.7. Sweden
- 7.5.7.1. Key country dynamics
- 7.5.7.2. Competitive scenario
- 7.5.7.3. Regulatory Framework
- 7.5.7.4. Sweden market estimates and forecasts 2021 to 2033 (USD Million)
- 7.5.8. Denmark
- 7.5.8.1. Key country dynamics
- 7.5.8.2. Competitive scenario
- 7.5.8.3. Regulatory Framework
- 7.5.8.4. Denmark market estimates and forecasts 2021 to 2033 (USD Million)
- 7.6. Asia Pacific
- 7.6.1. Japan
- 7.6.1.1. Key country dynamics
- 7.6.1.2. Competitive scenario
- 7.6.1.3. Regulatory Framework
- 7.6.1.4. Japan market estimates and forecasts 2021 to 2033 (USD Million)
- 7.6.2. China
- 7.6.2.1. Key country dynamics
- 7.6.2.2. Competitive scenario
- 7.6.2.3. Regulatory Framework
- 7.6.2.4. China market estimates and forecasts 2021 to 2033 (USD Million)
- 7.6.3. India
- 7.6.3.1. Key country dynamics
- 7.6.3.2. Competitive scenario
- 7.6.3.3. Regulatory Framework
- 7.6.3.4. India market estimates and forecasts 2021 to 2033 (USD Million)
- 7.6.4. Australia
- 7.6.4.1. Key country dynamics
- 7.6.4.2. Competitive scenario
- 7.6.4.3. Regulatory Framework
- 7.6.4.4. Australia market estimates and forecasts 2021 to 2033 (USD Million)
- 7.6.5. South Korea
- 7.6.5.1. Key country dynamics
- 7.6.5.2. Competitive scenario
- 7.6.5.3. Regulatory Framework
- 7.6.5.4. South Korea market estimates and forecasts 2021 to 2033 (USD Million)
- 7.6.6. Thailand
- 7.6.6.1. Key country dynamics
- 7.6.6.2. Competitive scenario
- 7.6.6.3. Regulatory Framework
- 7.6.6.4. Thailand market estimates and forecasts 2021 to 2033 (USD Million)
- 7.7. Latin America
- 7.7.1. Brazil
- 7.7.1.1. Key country dynamics
- 7.7.1.2. Competitive scenario
- 7.7.1.3. Regulatory Framework
- 7.7.1.4. Brazil market estimates and forecasts 2021 to 2033 (USD Million)
- 7.7.2. Argentina
- 7.7.2.1. Key country dynamics
- 7.7.2.2. Competitive scenario
- 7.7.2.3. Regulatory Framework
- 7.7.2.4. Argentina market estimates and forecasts 2021 to 2033 (USD Million)
- 7.8. MEA
- 7.8.1. South Africa
- 7.8.1.1. Key country dynamics
- 7.8.1.2. Competitive scenario
- 7.8.1.3. Regulatory Framework
- 7.8.1.4. South Africa market estimates and forecasts 2021 to 2033 (USD Million)
- 7.8.2. Saudi Arabia
- 7.8.2.1. Key country dynamics
- 7.8.2.2. Competitive scenario
- 7.8.2.3. Regulatory Framework
- 7.8.2.4. Saudi Arabia market estimates and forecasts 2021 to 2033 (USD Million)
- 7.8.3. UAE
- 7.8.3.1. Key country dynamics
- 7.8.3.2. Competitive scenario
- 7.8.3.3. Regulatory Framework
- 7.8.3.4. UAE market estimates and forecasts 2021 to 2033 (USD Million)
- 7.8.4. Kuwait
- 7.8.4.1. Key country dynamics
- 7.8.4.2. Competitive scenario
- 7.8.4.3. Regulatory Framework
- 7.8.4.4. Kuwait market estimates and forecasts 2021 to 2033 (USD Million)
- Chapter 8. Competitive Landscape
- 8.1. Company/Competition Categorization
- 8.2. Strategy Mapping
- 8.3. Company Market Position Analysis, 2024
- 8.4. Company Profiles/Listing
- 8.4.1. Revvity, Inc.
- 8.4.1.1. Company overview
- 8.4.1.2. Financial performance
- 8.4.1.3. Product/Service benchmarking
- 8.4.1.4. Strategic initiatives
- 8.4.2. Agilent Technologies, Inc.
- 8.4.2.1. Company overview
- 8.4.2.2. Financial performance
- 8.4.2.3. Product/Service benchmarking
- 8.4.2.4. Strategic initiatives
- 8.4.3. Bio-Rad Laboratories, Inc.
- 8.4.3.1. Company overview
- 8.4.3.2. Financial performance
- 8.4.3.3. Product/Service benchmarking
- 8.4.3.4. Strategic initiatives
- 8.4.4. Merck KGaA
- 8.4.4.1. Company overview
- 8.4.4.2. Financial performance
- 8.4.4.3. Product/Service benchmarking
- 8.4.4.4. Strategic initiatives
- 8.4.5. Waters Corporation
- 8.4.5.1. Company overview
- 8.4.5.2. Financial performance
- 8.4.5.3. Product/Service benchmarking
- 8.4.5.4. Strategic initiatives
- 8.4.6. Creative Diagnostics
- 8.4.6.1. Company overview
- 8.4.6.2. Financial performance
- 8.4.6.3. Product/Service benchmarking
- 8.4.6.4. Strategic initiatives
- 8.4.7. GenScript
- 8.4.7.1. Company overview
- 8.4.7.2. Financial performance
- 8.4.7.3. Product/Service benchmarking
- 8.4.7.4. Strategic initiatives
- 8.4.8. TriLink BioTechnologies (Maravai LifeSciences)
- 8.4.8.1. Company overview
- 8.4.8.2. Financial performance
- 8.4.8.3. Product/Service benchmarking
- 8.4.8.4. Strategic initiatives
- 8.4.9. Creative Biolabs
- 8.4.9.1. Company overview
- 8.4.9.2. Financial performance
- 8.4.9.3. Product/Service benchmarking
- 8.4.9.4. Strategic initiatives
- 8.4.10. Vazyme International LLC
- 8.4.10.1. Company overview
- 8.4.10.2. Financial performance
- 8.4.10.3. Product/Service benchmarking
- 8.4.10.4. Strategic initiatives
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