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mRNA Synthesis & Manufacturing Market

The market for mRNA Synthesis & Manufacturing was estimated at $2.3 billion in 2025; it is anticipated to increase to $3.2 billion by 2030, with projections indicating growth to around $4.3 billion by 2035.

Report ID:DS1804001
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Biotechnology
mRNA Synthesis & Manufacturing
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Report Summary
Market Data
Methodology
Table of Contents

Global mRNA Synthesis & Manufacturing Market Outlook

Revenue, 2025

$2.3B

Forecast, 2035

$4.3B

CAGR, 2026 - 2035

6.2%

The mRNA Synthesis & Manufacturing industry revenue is expected to be around $2.3 billion in 2026 and expected to showcase growth with 6.2% CAGR between 2026 and 2035. Industry demand for the manufacturing of mRNA is driven by pharmaceutical and biotechnology companies and contract research organizations , with this particular end user base accounting for nearly 80% of industry need. They are expanding pipelines for both vaccines and mRNA therapy. Growing investment in rapid response vaccine platforms and in next generation RNA based drugs is leading to an increased requirement for GMP compliant mRNA manufacturing. Personalised cancer treatments are another region seeing significant investment. Companies are increasingly turning to specialized mRNA Synthesis and Manufacturing contract development and manufacturing services as they look to strengthen their product pipelines and research.

Capable of carrying out the entire process from design through large scale manufacture, mRNA Synthesis and Manufacturing provides a service which includes the custom chemical synthesis of mRNA, the development of suitable manufacturing processes and large scale mRNA vaccine production. This encompasses in vitro transcription, purification and formulation. Template design is the first step in the process, followed by transcription and finally purification and formulation. The unmodified mRNA products brought in revenue of $1.55 billion in 2025. This of mRNA product is widely used for the production of vaccines for infectious diseases, and also for the creation of cancer treatments and gene therapy. Advances in lipid nanoparticle formulation, plus continuous and modular manufacturing techniques and the increasing adoption of flexible facilities that can manufacture a variety of products are resulting in growing need for mRNA synthesis and production services.

mRNA Synthesis & Manufacturing market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
mRNA Synthesis & Manufacturing Market Outlook

Market Key Insights

  • The Mrna Synthesis & Manufacturing market is projected to grow from $2.3 billion in 2025 to $4.3 billion in 2035. This represents a CAGR of 6.2%, reflecting rising demand across Vaccines, Cancer Immunotherapy, and Gene Editing.

  • Key industry players are Lonza, Maravai LifeSciences and Danaher who are working to establish their respective positions in this sector.

  • The US and Germany will be the biggest markets in terms of size for the mRNA Synthesis and Manufacturing market. The CAGR for these countries is predicted to be 4% to 6% from 2025 to 2030.

  • The highest growth rates of between 7.1% and 8.6% are expected to occur in the emerging markets of South Korea, Brazil and India.

  • Precision medicine is likely to have a greater impact on the markets value chain in both the US and Germany than in other regions. By 2030, its influence could add $95 million to the value of the mRNA synthesis and manufacturing industry.

  • Between 2025 and 2035 the mRNA Synthesis and Manufacturing industry is due to increase by $1.9 billion. The vaccines and protein replacement therapeutics region is forecast to see increased market share.

  • With

    expanding mrna therapeutic pipeline and advancements in manufacturing process automation, and

    Rising Outsourcing to Specialized GMP mRNA Manufacturing Partners, Mrna Synthesis and Manufacturing market to expand 82% between 2025 and 2035.

mrna synthesis & manufacturing market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
mRNA Synthesis & Manufacturing - Country Share Analysis

Opportunities in the mRNA Synthesis & Manufacturing

In Europe the centres focused on rare diseases are increasingly using mRNA synthesis and manufacturing equipment to develop news of gene therapies. There is also growing demand for high fidelity enzymes, modified nucleotides and speciality analytical chemicals suited to high value, low volume clinical diagnostics. Collaboration between medical academics, pharmaceutical innovators and firms which manufacture on a Good Manufacturing Practice basis speed up the translation. The fastest growth rate in Europe will be in consumables used in ex vivo gene edited cell therapies. These consumables need to meet high standards and are used regularly which results in repeat custom and revenue.

Growth Opportunities in North America and Europe

North America's mRNA synthesis and manufacturing industry is driven mainly by pharmaceutical and biotechnology companies. It is these firms which drive demand for RNA therapeutics and mRNA vaccines, whether for clinical or commercial scale. Key region's of expansion include the mRNA based contract manufacturing service, which encompasses both GMP grade and integrated mRNA platforms. The mRNA platforms involve multiple processes such as synthesis, enzymatic capping, purification and encapsulation into nanoparticles. In the rapidly evolving mRNA sector, companies are vying with one another. This includes vertically integrated big pharmaceuticals and biotechnology companies, specialist contract development and manufacturing organisations and also newer platform entities. This competition has driven companies to differentiate themselves by focusing on high yield processes, and on modular production facilities, as well as rapid technology transfer. Key drivers in this region are plentiful venture capital, quick clinical trials, a robust intellectual property framework and a growing pipeline of biotechnology products, including vaccines for diseases and gene editing programmes. This all suggests investment in mRNA manufacturing technologies which can be scaled up and digitalised quality control systems, as well as long term supply deals with biopharmaceutical companies.
Across Europe it is research institutions which are at the forefront of the development of RNA synthesis and manufacture. These institutions lead in innovation in this region and are the first to adopt new RNA medicines. Traditional drug manufacturers also feature prominently in the RNA synthesis and manufacture industry. Key opportunities lie in collaborative platforms which allow early GMP grade to research grade mRNA production, have standardised process development toolkits and flexible small scale manufacturing for consortia based projects and investigator initiated clinical trials. In the market, a mix of regional contract development and manufacturing organisations, public private partnerships and RNA specialists is present. Differentiation in the market occurs due to regulatory expertise, the companies ability to adhere to stringent quality standards and their capacity to manufacture on a large scale academic breakthroughs. A supportive environment will be necessary for investment in this region, driven by the presence of sustained public funding for translational research, supportive regulatory frameworks and cross border collaboration. This environment will be conducive to the establishment of decentralised mRNA Synthesis and Manufacturing sites, technology transfer services for hospitals and research institutes and the provision of niche capabilities in complex formulations and LNP enabled delivery systems.

Market Dynamics and Supply Chain

01

Driver: Expanding mRNA Therapeutic Pipeline and Advancements in Manufacturing Process Automation

The growing clinical pipeline of mRNA based vaccines and therapeutics is also a major growth driver for mRNA synthesis and manufacturing. Beyond infectious diseases, developers are also rapidly advancing programs in oncology, rare diseases, and gene therapies, increasing demand for scalable and flexible mRNA production. Simultaneously, advancements in automated in vitro transcription, purification technologies, and closed system manufacturing are also improving yield consistency and reducing batch variability. Innovations such as enzymatic capping efficiency improvements and microfluidic lipid nanoparticle formulation are also lowering production timelines. These combined factors are also enabling faster transition from clinical to commercial scale, attracting pharmaceutical investment and strengthening long term market expansion.
Biopharmaceutical companies are also increasingly outsourcing mRNA synthesis and manufacturing to specialized CDMOs to reduce capital expenditure and accelerate development timelines. CDMOs offer regulatory compliant facilities, validated production platforms, and experienced quality management systems. This trend is also particularly strong among small and mid sized biotech firms lacking internal manufacturing expertise. As clinical pipelines expand, demand for flexible batch sizes and rapid scale up capabilities continues to grow, directly boosting revenue opportunities for contract manufacturers focused on mRNA technologies.
02

Restraint: High Production Costs and Complex Quality Control Requirements Limiting Commercial Scalability

mRNA synthesis and manufacturing involves expensive raw materials, specialized enzymes, and stringent GMP compliance, significantly increasing production costs. Complex quality control processes such as impurity profiling and stability testing add further financial burden. These factors raise final therapy pricing, limiting adoption in cost sensitive healthcare systems. High operational costs also constrain smaller developers, slowing clinical progress and reducing overall market demand.
03

Opportunity: US oncology demand boosting premium mRNA Synthesis & Manufacturing for personalized cancer vaccines and Asia-Pacific preparedness programs expanding mRNA Synthesis & Manufacturing for rapid infectious disease vaccines

US oncologys pipelines are creating an increasing demand for high purity mRNA synthesis and manufacturing capabilities particularly for personalised neoantigen personalised cancer vaccines. Ever more biopharmaceuticals are turning to specialist contract development and manufacturing organisations to carry out their complex mRNA synthesis, and the associated GMP manufacturing, in collaboration with them. These CDMOs can provide services that include process automation, quality control analysis and the encapsulation of mRNA in nanoparticles. World consumption of consumables is projected to grow from $1.55 billion in the year 2025 to $2.14 billion by 2030. This rise in global consumables revenue has accentuated the use of single use bioreactors. The most rapidly increasing region will be in US clinical grade mRNA therapies for bespoke vaccine regimens for solid tumours.
Across the Asia Pacific region, frameworks for post pandemic preparedness are promoting long term contracts for the large scale mRNA synthesis and manufacturing which can be used in making quick response vaccines for various infectious diseases. By 2030, governments and health authorities worldwide are expected to fund the construction of manufacturing sites for mRNA vaccines that can be expanded or reduced as needed. This could increase the global market for medical equipment from $0.79 billion in 2025 to $1.03 billion by 2030. A platform based approach to mRNA therapeutics possesses advantages in the flexibility of batch sizes, the resilience of the cold chain, and the robustness of quality control analysis. Strong growth will come from Asia Pacific government backed vaccine facilities making stockpiles of multi purpose respiratory vaccines.
04

Challenge: Cold Chain Storage Constraints and Limited Long Term Stability of mRNA Products

The inherent instability of mRNA requires ultra low temperature storage and specialized logistics infrastructure. This limitation restricts global distribution, particularly in emerging markets with underdeveloped cold chain networks. Storage challenges increase operational costs for manufacturers and healthcare providers, reducing commercial reach. As a result, market expansion remains uneven across regions, impacting overall revenue growth and delaying broader adoption of mRNA based therapeutics.

Supply Chain Landscape

1

Raw Materials Supply

New England BiolabsMaravai LifeSciencesGenScript
2

mRNA Synthesis & Manufacturing

LonzaGenScriptDanaher Corporation
3

Lipid Nanoparticle Formulation

LonzaDanaher CorporationMaravai LifeSciences
4

Therapeutic Applications

Vaccine developmentmRNA therapeuticsRare disease treatment
mRNA Synthesis & Manufacturing - Supply Chain

Use Cases of mRNA Synthesis & Manufacturing in Vaccines & Cancer Immunotherapy

Vaccines : Vaccines represent the most mature application of the mRNA synthesis and manufacturing market, primarily utilizing in vitro transcribed mRNA produced at GMP scale. This mRNA is engineered with optimized capping, poly A tails, and nucleoside modifications to enhance stability and immunogenic response. The platform enables rapid antigen design and scalable production, offering speed advantages over conventional vaccines. Leading players such as Moderna, BioNTech, and CureVac dominate this segment through strong IP portfolios, advanced lipid nanoparticle delivery expertise, and vertically integrated manufacturing capabilities.
Cancer Immunotherapy : Cancer immunotherapy increasingly relies on personalized and neoantigen based mRNA synthesis manufactured in small batch, high precision GMP facilities. This application mainly uses sequence customized mRNA encoding fcelspecific antigens to stimulate targeted immune responses. The key advantage lies in adaptability to patient specific tumor profiles and faster development timelines. BioNTech and Moderna lead this space, supported by robust clinical pipelines, while companies like Gritstone Bio and CureVac strengthen innovation through oncology focused mRNA platforms.
Gene Editing : Gene editing applications predominantly use high purity mRNA encoding gene editing tools such as CRISPR Cas9 or base editors. The mRNA synthesis process emphasizes high fidelity transcription and minimized immunogenicity to ensure transient expression and reduced off target effects. This approach enables safer delivery compared to viral vectors. Thermo Fisher Scientific, Aldevron, and TriLink BioTechnologies are key suppliers, leveraging strong enzymatic synthesis expertise, scalable production infrastructure, and established partnerships with gene therapy developers.
Rare Diseases : Rare disease treatments utilize mRNA synthesis and manufacturing for protein replacement and genetic correction therapies, often produced in smaller volumes under stringent quality control. The application benefits from rapid development cycles and the ability to address previously undruggable genetic disorders. Modified mRNA with enhanced stability is commonly used to ensure sufficient protein expression. Moderna and BioNTech hold strong positions through rare disease focused pipelines, while CDMOs such as Lonza support commercialization by offering flexible GMP manufacturing capabilities.

Recent Developments

Recent developments in the mRNA synthesis & manufacturing sector show dynamic growth in modular, automated biopharmaceutical production platforms, expansion of CDMO capacity, and stronger raw material supply chains as firms like Thermo Fisher and BioNTech scale integrated IVT transcription and LNP encapsulation for vaccines and therapeutics. The trend toward predictive manufacturing with AI analytics enhances yield and quality forecasting, while legal and IP disputes underscore competitive pressures. These shifts highlight broader demand for GMP-grade mRNA production across vaccines, oncology, and rare disease pipelines.

October 2025 : TriLink BioTechnologies (Maravai LifeSciences) launched its first comprehensive mRNA synthesis kit featuring advanced CleanCap capping technology, expanding its product portfolio for research and academic use globally.
May 2025 : TriLink BioTechnologies introduced a new suite of CleanCap analogs optimized for improved mRNA capping efficiency and yield in therapeutic applications, bolstering its position in raw materials for GMP mRNA manufacturing.
February 2025 : Danaher Corporation (via Cytiva) completed an expansion of its Marlborough, Massachusetts facility to add capacity for high-purity enzymes and nucleotides critical for mRNA synthesis, supporting increased demand from biopharma customers.

Impact of Industry Transitions on the mRNA Synthesis & Manufacturing Market

As a core segment of the Biotechnology industry, the mRNA Synthesis & Manufacturing market develops in line with broader industry shifts. Over recent years, transitions such as Precision Medicine and Integration of End to End mRNA Platforms have redefined priorities across the Biotechnology sector, influencing how the mRNA Synthesis & Manufacturing market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Precision Medicine

This trend towards precision medicine is having a profound effect on the manufacture of mRNA in particular in fields like oncology where the new, highly tailored treatments are increasingly the standard treatment. By 2030, this shift is expected to unlock $95 million in revenue for the industry, with the United States and Germany emerging as major production hubs in the mRNA supply chain, from clinical trials to commercial manufacturing. The increasing focus on mRNA treatments for cancer, where the genetic code of an individuals cells is altered, necessitates more efficient ways of producing these genetic tools. This has led to a demand for more flexible systems that can produce genetic material quickly in large quantities. The enhanced capacity will facilitate greater collaboration between innovators, contract manufacturers and suppliers, reduce the time to market and ultimately increase the importance of mRNA Synthesis and Manufacturing within the field of precision medicine.
02

Integration of End to End mRNA Platforms

An important transition is the integration of end to end mRNA platforms covering synthesis, formulation, and fill finish under one operational framework. Companies are moving toward vertically integrated models to improve speed, quality control, and regulatory compliance. This transition is reshaping CDMO partnerships and reducing reliance on fragmented supply chains. It is also impacting lipid nanoparticle suppliers and raw material manufacturers, driving closer collaboration across the mRNA ecosystem.