Overview
The global mRNA synthesis and manufacturing market is expected to grow at a CAGR of ~6% during the forecast period. Growing demand for mRNA-based vaccines and therapeutics, increasing cases of infectious and chronic diseases, rapid advancements in lipid nanoparticle (LNP) delivery systems, emergence of AI-driven platforms for mRNA design and synthesis, and expansion of contract development and manufacturing organizations (CDMOs) are key factors driving market growth. However, challenges such as stability and storage issues associated with mRNA products continue to hinder market expansion.
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Market Definition
The mRNA synthesis and manufacturing market forms a critical segment of the biopharmaceutical industry, focusing on the production of messenger RNA molecules used in vaccines and therapeutics. The process encompasses plasmid preparation, in vitro transcription (IVT), mRNA purification, and formulation, often leveraging lipid nanoparticles (LNPs) for efficient delivery. Key market components include enzymes, reagents, templates, delivery systems, synthesis tools, raw materials, analytical instruments, production platforms, and fill-finish technologies that collectively ensure scalable, high-quality mRNA production.
Rising Demand for mRNA-based Vaccines and Therapeutics Drives Market Expansion
The global success of mRNA-based COVID-19 vaccines has fueled strong interest in mRNA technology across diverse applications. As per WHO, more than 13 billion COVID-19 vaccine doses had been administered worldwide by October 2024, showcasing the scalability and responsiveness of mRNA platforms. Biopharma companies are now heavily investing in mRNA therapeutics targeting infectious diseases, cancer, and rare genetic disorders. This surging demand is increasing the need for high-quality raw materials, advanced synthesis systems, and large-scale, flexible production infrastructure. Expanding clinical trials and regulatory approvals for mRNA-based therapies are further propelling market growth.
Growth in Personalized Cancer Immunotherapy Drives Innovation in mRNA Manufacturing
The growing adoption of cancer immunotherapy and personalized mRNA-based oncology vaccines is unlocking new growth avenues in the mRNA manufacturing space. Unlike traditional therapies, mRNA cancer vaccines are designed to target tumor-specific antigens, enhancing treatment precision and minimizing off-target effects. Their personalized nature demands agile, high-quality, and efficient synthesis capabilities—fueling innovation in manufacturing automation, real-time quality control, and platform scalability.
Recent Developments in the mRNA Synthesis and Manufacturing Market
The industry is witnessing rapid advancements in mRNA production technologies, facility expansion, and novel therapeutic pipelines. Companies are strengthening collaborations and infrastructure to accelerate next-generation therapies. In April 2025, CureVac received FDA clearance to begin a Phase 1 trial of its mRNA-based precision immunotherapy for squamous non-small cell lung cancer. In November 2024, SyVento Biotech, supported by Cytiva, launched Poland’s first mRNA FlexFactory—a 7,000 m² facility aimed at commercial-scale production. In May 2024, GenScript introduced a self-amplifying RNA synthesis service to enhance potency and efficiency for vaccine, gene, and immunotherapy applications.
Market Drivers
Growing number of clinical trials targeting rare and genetic disorders
Rising demand for mRNA-based vaccines and therapeutics
Advancements in targeted delivery technologies such as lipid nanoparticles
Increasing prevalence of chronic and infectious diseases
Rising R&D investments by biotech and pharma companies
Attractive Opportunities
Integration of AI and machine learning in mRNA design
Growing demand for personalized mRNA-based oncology vaccines
Rising outsourcing to CDMOs for large-scale, flexible manufacturing
Expansion into emerging markets
Competitive Landscape Analysis
The global mRNA synthesis and manufacturing market is characterized by the presence of established and emerging players such as Lonza Group AG, Wuxi Biologics (Cayman) Inc., Merck KGaA, Thermo Fisher Scientific Inc., GenScript Biotech Corporation, Sartorius AG, Takara Bio Inc., Danaher Corporation, Promega Corporation, New England Biolabs, Inc., and Telesis Bio Inc. Leading strategies include new product launches, strategic collaborations, and geographical expansion to enhance market positioning and technological capabilities.
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About Medi-Tech Insights
Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services in the areas of market assessments, due diligence, competitive intelligence, market sizing and forecasting, pricing analysis & go-to-market strategy. Our methodology includes rigorous secondary research combined with deep-dive interviews with industry-leading CXO, VPs, and key demand/supply side decision-makers.
