Visiongain has released its new mRNA Contract Manufacturing Market Report 202-2026, forecasting that the global market will reach US$13.52bn by 2036 from US$4.62bn in 2026.

The market is forecast to expand at a compound annual growth rate (CAGR) of 11.3% between 2026 and 2036, driven by the diversification of the mRNA pipeline beyond COVID-19 vaccines, growing demand for integrated LNP formulation expertise, and increasing outsourcing by biotechnology and pharmaceutical companies.

Key Market Growth Drivers & Industry Transformations

Increasing Outsourcing by Biotechnology and Pharmaceutical Companies: The technical and regulatory demands of mRNA manufacturing are encouraging biotechnology and pharmaceutical companies to engage specialist CDMOs rather than establish complete production capabilities internally. Manufacturing requires expertise in DNA-template preparation, in-vitro transcription, purification, capping, analytical characterisation and, where applicable, lipid nanoparticle formulation and sterile filling. On 28 September 2026, 4basebio PLC announced it will supply clinical-grade opDNA starting material for a multi-national pharmaceutical innovator’s latest cell therapy programme, with TriLink BioTechnologies selected as CDMO to manufacture the mRNA drug substance using its proprietary CleanCap co-transcriptional capping technology.

Growing Demand for Lipid Nanoparticle Formulation and Delivery Expertise: Effective delivery remains one of the principal technical challenges in developing mRNA vaccines and therapeutics. Lipid nanoparticles have become the leading delivery platform, creating demand for lipid screening, formulation development, encapsulation, process optimisation, particle characterisation and scalable GMP manufacturing. Demand is becoming more technically diverse as developers pursue cancer immunotherapies, protein-replacement treatments, gene-editing applications and regenerative medicines. On 26 August 2026, Artis BioSolutions launched its Genetic Medicines Center of Excellence in Bilbao, Spain, providing an end-to-end platform spanning synthetic DNA, mRNA drug-substance manufacturing, lipid nanoparticle formulation and GMP drug-product manufacturing.

Need for Flexible and Rapid Manufacturing Platforms: The platform-based nature of mRNA technology allows developers to modify nucleotide sequences while retaining several core manufacturing steps. This creates demand for CDMOs that can support rapid process development, technology transfer and clinical-batch production across multiple constructs. Flexible capacity is particularly valuable for emerging infectious diseases, personalised cancer vaccines and programmes requiring frequent sequence changes. Modular facilities, single-use equipment and standardised analytical platforms can shorten project onboarding and reduce changeover times.

Personalised mRNA Cancer Vaccines and Small-Batch Manufacturing: The advancement of personalised cancer vaccines is creating a differentiated opportunity for mRNA contract manufacturers. Unlike conventional vaccines produced in large, standardised batches, these therapies may require patient-specific or small-cohort formulations based on tumour-associated neoantigens. CDMOs will need flexible manufacturing suites, digitalised workflows, robust chain-of-identity controls and analytical methods capable of supporting accelerated batch release. Providers that can standardise the underlying production platform while accommodating sequence-level customisation will be best positioned to capture this opportunity.

What This Means for the mRNA Contract Manufacturing Market

The mRNA contract manufacturing market is entering a period of sustained structural growth as the pipeline diversifies, commercial programmes accumulate, and pharmaceutical and biotechnology companies increasingly rely on specialist CDMOs for integrated end-to-end services. CDMOs that combine technical breadth across the full mRNA manufacturing chain – from plasmid DNA template through LNP formulation and sterile fill-finish – alongside flexible capacity and strong regulatory capabilities are best positioned to capture long-term programme value over the next decade.

Scope of the Visiongain Report

The 300+ page report provides robust quantitative and qualitative analysis across all key facets of the global mRNA contract manufacturing market:

By Development Stage: Preclinical; Clinical; Commercial.

By Service Type: Plasmid DNA Template Development and Manufacturing; mRNA Drug Substance Manufacturing; Formulation and Lipid Nanoparticle Encapsulation; Process Development and Tech Transfer; Fill-Finish and Packaging; Analytical Development; Others.

By End-users: Government and Academic Institutes; Pharmaceutical Companies; Biotech Companies; Others.

By Regional & Country Markets: North America, Europe, Asia Pacific, Latin America, and MEA.

Competitive Landscape

The competitive environment is characterised by specialist mRNA CDMOs, integrated biologics manufacturers expanding into RNA capabilities, and technology platform providers offering proprietary capping and formulation technologies. Companies profiled in the report include:

• AGC Biologics
• BioCina Pty Ltd.
• Biomay AG
• Bio-Synthesis, Inc.
• Catalent, Inc. (Novo Holdings)
• Curia Global, Inc.
• Danaher Corporation (Aldevron)
• Evonik Industries AG
• Kaneka Eurogentec S.A.
• Lonza Group AG
• Recipharm AB
• Samsung Biologics Co., Ltd.
• Thermo Fisher Scientific Inc. (Patheon Pharma Services)
• TriLink BioTechnologies (Maravai LifeSciences)
• Wacker Biotech GmbH

Recent Developments

• 28 Sep 2026 – 4basebio PLC announced it will supply clinical-grade opDNA starting material for a multi-national pharmaceutical innovator’s cell therapy programme, with TriLink BioTechnologies selected as CDMO to manufacture the mRNA drug substance using its proprietary CleanCap co-transcriptional capping technology.

• 26 Aug 2026 – Artis BioSolutions launched its Genetic Medicines Center of Excellence in Bilbao, Spain, providing an end-to-end platform spanning synthetic DNA, mRNA drug-substance manufacturing, lipid nanoparticle formulation and GMP drug-product manufacturing.

• 1 Apr 2026 – CATUG launched its RNA-LNP lyophilisation manufacturing line, designed to deliver stable, efficient and flexible industrial-scale solutions for RNA therapeutics, featuring high-grade aseptic control and integrated automation.

• 29 Jan 2026 – Toshiba announced a business partnership with Ricoh Biosciences and Mediridge to support clinical trials of mRNA medicines in Japan, providing integrated domestic support from mRNA template production through LNP encapsulation. Ricoh Biosciences had manufactured more than 750 mRNA sequences as of February 2025.

Related Reports

• Antibody Drug Conjugates Contract Manufacturing Market 2026-2036
• Biopharmaceuticals Contract Manufacturing Market 2026-2036
• Protein Contract Manufacturing Market 2026-2036
• Peptide Contract Manufacturing Market 2026-2036

About Visiongain

Established in 1998, Visiongain is an independent publisher of analyst-led market intelligence, delivering data-driven research, forecasts, and strategic insight across global industries and emerging markets. Visiongain supports evidence-based decision-making for investment, procurement, and long-term strategic planning.

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