(MENAFN- Market Press Release) December 2, 2025 12:56 am - The Self-Amplifying RNA Synthesis market, valued at USD 107.8 million in 2024, is expected to register revenue CAGR of 20.3%. Request free copy of this report:

December 02, 2025- Rising demand for next-generation RNA vaccines and therapeutics is a major factor driving revenue growth in the self-amplifying RNA (saRNA) synthesis market. In recent years, saRNA has become a transformative platform in molecular biology and medicine. Originating from alphavirus genomes, saRNA preserves the non-structural elements needed for replication while replacing structural genes with a target antigen. This allows intracellular RNA amplification, enabling stronger antigen expression with smaller doses compared to conventional mRNA vaccines.

In May 2024, GenScript Biotech Corporation, a global leader in life-science research tools, expanded its IVT RNA synthesis offerings to include self-amplifying RNA. This advancement further enhances GenScript's leadership in IVT RNA technologies and provides researchers a powerful new format for vaccine development, cancer immunotherapy, and gene or cell therapy applications.

Despite encouraging results in preclinical and early clinical studies, saRNA vaccines face significant regulatory hurdles before broad commercialization. These challenges include stringent requirements for manufacturing consistency, quality control, and approval pathways. Regulatory authorities such as the FDA and EMA demand robust, reproducible production processes to ensure safety and effectiveness. Scaling saRNA manufacturing in cell-based systems must consistently yield high-quality RNA while minimizing impurities and degradation.

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Segments market overview and growth Insights
Based on synthesis method, the self-amplifying RNA synthesis market is segmented into In-vitro Transcription (IVT)-based synthesis, cell-free enzymatic synthesis, and chemical synthesis & hybrid methods. In-vitro Transcription (IVT)-based synthesis networks segment contributed the largest revenue share in 2024. Like conventional mRNA, synthetic saRNA is produced using in vitro transcription (IVT). However, because saRNA molecules are considerably longer, standard IVT methods may result in low yields or reduced transcript quality. SaRNA is also more immunogenic than typical mRNA. The IVT process can produce full-length RNA from a plasmid DNA template, which can then be delivered either unformulated or in nanoparticle form if structural genes are supplied in trans.

Regional market overview and growth insights
North America held the largest market share in 2024. Overall, market growth is primarily fueled by rising demand for advanced RNA therapeutics and breakthroughs in IVT processes and enzyme engineering. The region has emerged as a global center for RNA research and therapeutic innovation, supported by major investments in mRNA and saRNA platforms, as well as state-of-the-art manufacturing capabilities. Additionally, the presence of established and emerging companies with access to high-quality enzymes and reagents is accelerating growth. In January 2025, MalarVx, Inc., a clinical-stage vaccine developer, licensed HDT Bio's proprietary self-amplifying replicon RNA (repRNA) and lipid nanoparticle technology for malaria vaccine development.

Competitive Landscape and Key Competitors
The self-amplifying RNA synthesis market is characterized by a fragmented structure, with many competitors holding a significant share of the market. List of major players included in the self-amplifying RNA synthesis market report are:

oGenScript Biotech Corporation
oOZ Biosciences
oAldevron LLC
oBOC Sciences
oTriLink BioTechnologies
oZiphius NV
oVirogin
oArcturus Therapeutics, Inc.
oImmorna (Hangzhou) Biotechnology Co., Ltd.
oVaxEquity Ltd.
oCroyez Bioscience Co., Ltd.
oReplicate Bioscience

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Major strategic developments by leading competitors
Replicate Bioscience: In August 2025, Replicate Bioscience, a clinical-stage company advancing self-replicating RNA (srRNA) technologies for infectious diseases and immunology, entered a multi-year research partnership with Novo Nordisk. The collaboration combines Novo Nordisk's deep therapeutic expertise with Replicate's srRNA platform to create new treatment options for obesity, type 2 diabetes, and other cardiometabolic disorders.

Strand Medicines: In August 2025, Strand Medicines, a leader in next-gen mRNA therapeutics, announced a USD 153 million Series B funding round. The investment will accelerate development of its pipeline, including STX-001, a programmable mRNA therapy designed to express interleukin-12 (IL-12) directly within the tumor microenvironment.

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Navistrat Analytics has segmented the self-amplifying RNA synthesis market based on type, synthesis method, application, end-use, and region:
.Type Outlook (Revenue, USD Million; 2022-2032)
oInstruments & Equipment
oReagent Kits & Consumables
oSoftware
oServices

.Synthesis Method Outlook (Revenue, USD Million; 2022-2032)
oIn-vitro Transcription (IVT)-based Synthesis
oCell-free Enzymatic Synthesis
oChemical Synthesis & Hybrid Methods

.Application Outlook (Revenue, USD Million; 2022-2032)
oVaccine Development
oTherapeutics
oGene Editing & Cell Therapy
oResearch

.End-Use Outlook (Revenue, USD Million; 2022-2032)
oPharmaceutical & Biotechnology Companies
oAcademic & Research Institutes
oContract Development & Manufacturing Organizations (CDMOs)
oDiagnostic Laboratories

.Regional Outlook (Revenue, USD Million; 2022-2032)
oNorth Benelux
g Countries
h of Europe

oAsia Pacific
a Japan
d Oceania
f Countries
g of APAC

oLatin Brazil
b of LATAM

oMiddle East & Africa
a Countries
b Turkey
e of MEA

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