The mRNA synthesis and manufacturing market is projected to reach USD 738.3 million in 2029 from USD 624.4 million in 2024. This market is projected to grow at a CAGR of 3.4% over the forecast period. The primary drivers behind the expansion of this industry are the Growing focus on mRNA-based vaccine development, expanding therapeutic applications of mRNA technology, advancements in mRNA synthesis technology, increased outsourcing for mRNA synthesis and modification, and collaborations among industry players. However, stability, storage, and manufacturing scalability present a challenge to this industry. This is further amplified by the slow patient adoption rate and the complexity of the development of mRNA-based therapy.
In many important respects, artificial intelligence (AI) is transforming the mRNA synthesis and manufacturing sector. First, by scanning large databases to find suitable mRNA sequences for therapeutic usage, artificial intelligence speeds up drug research and development greatly. Developed tools like the LinearDesign AI aim to maximize mRNA sequences, therefore producing vaccines with more antibody responses than conventional techniques. From raw material acquisition to final product packaging, artificial intelligence maximizes several manufacturing steps, thereby lowering costs and raising efficiency. AI-powered predictive maintenance reduces downtime and guarantees manufacturing equipment’s seamless running.
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The market is expanding rapidly due to factors such as the development of mRNA-based vaccines and expanded applications such as cancer immunotherapies. Furthermore, improvements in mRNA synthesis technology, a rise in mRNA synthesis and modification outsourcing, and industry players working together to create mRNA therapies all contribute to the growth of the mRNA synthesis and manufacturing market. Additionally, factors such as advancements in drug delivery technologies, growth in the regenerative medicines market, and increasing government funding and private investments in the mRNA therapeutics market will further provide revenue growth opportunities for the players operating in mRNA synthesis & manufacturing.
Based on product type, the mRNA synthesis and manufacturing products market is divided into two broad categories, consumables and instruments. The consumables segment of the market held the largest market share in 2023, due to the sustained use of consumables such as nucleotides, RNA polymerase, reverse transcriptase, buffer, and reagents that also require frequent repurchases. The consumables segment will be experiencing high growth due to several factors, including an increase in the mRNA therapeutics pipeline and growing investments made to develop mRNA-based therapeutics, advancement in mRNA synthesis technologies, increase in demand for consumables among contract service providers with the growing trend of outsourcing.
Based on service type, the global mRNA synthesis and manufacturing services market has been categorized into four service types: mRNA synthesis, modification, and related activities; purification of mRNA; analytical and characterization services; and scale-up and manufacture activities. In 2023, the mRNA synthesis and modification services captured the highest market share because of the demand for custom and modified mRNA sequences, which are intended to enhance therapeutic candidates for the molecules market. Given the expanding uses of the mRNA technology, researchers and developers are looking for mRNA sequences that can incorporate protein expression enhancement or immune response improvement.
Based on application, the market for mRNA synthesis and manufacturing has been divided into segments including vaccines and cell & gene therapy. The vaccine segment has the dominant share in the market in 2023. The large share of this segment can be supported by the large number of clinical trials of mRNA vaccines for various diseases infectious diseases, cancer and rare genetic disorders. The remarkable success of mRNA-based COVID-19 vaccines has not only proven the efficacy & scalability of mRNA technology but also catalysed interest in targeting other therapy areas, such as cancer and rare diseases.
Based on end user, the mRNA synthesis and manufacturing market has been categorized into pharmaceutical and biotechnology companies, academic and research institutes, and CROs and CDMOs. In 2023, pharmaceutical and biotechnology companies dominated the market for mRNA synthesis and manufacturing. According to the market’s emerging needs, companies are investing to develop next-generation biologics such as mRNA therapeutics. Higher research and development activities of companies to develop mRNA therapeutics and cell and gene therapies have resulted in rising needs for specialized consumables and instruments as well as synthesis, modification, purification, analysis, and characterization services.
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The global mRNA synthesis and manufacturing market is consolidated with the top five players — Thermo Fisher Scientific Inc. (US), Aldevron, LLC. (Danaher Corporation) (US), TriLink BioTechnologies (US), GenScript (US), and Merck KGaA (Germany). Other prominent market players include, New England Biolabs (US), Promega Corporation (US), Sartorius AG (Germany), WuXi Biologics (China), Takara Bio Inc. (Japan), GENEWIZ (Azenta US, Inc.) (US), Lonza (Switzerland), Telesis Bio Inc. (US), Aurigene Pharmaceutical Services Ltd. (Dr. Reddy’s Laboratories Ltd.) (India), ST Pharm (South Korea), AGC Biologics (US).
Thermo Fisher Scientific Inc. (US):
Thermo Fisher Scientific Inc., headquartered in Waltham, Massachusetts, is a leading player in mRNA synthesis and manufacturing, offering a broad range of products and services tailored to this field. The company provides advanced solutions for mRNA synthesis, including custom RNA synthesis services and reagents through its GeneArt platform, which supports the development of mRNA constructs for research, therapeutic, and vaccine applications. Thermo Fisher’s technologies enable efficient in vitro transcription (IVT) and include automated solutions that enhance scalability and production efficiency. Their extensive expertise, quality assurance measures, and global reach position them as a key player in advancing mRNA technology and supporting the development of next-generation therapeutics and vaccines.
Aldevron, LLC. (Danaher Corporation) (US):
Aldevron, established in 1998 and based in Fargo, North Dakota, is a key player in the nucleic acid synthesis industry, particularly known for its expertise in mRNA synthesis and manufacturing. The company is highly regarded for producing high-quality mRNA and plasmid DNA, essential for cutting-edge applications in vaccine development, gene therapy, and other biotechnological innovations. Aldevron’s offerings include custom RNA synthesis and cGMP-compliant mRNA production, ensuring that their products meet the stringent standards required for clinical use. Aldevron’s robust quality control and assurance processes further guarantee the reliability and efficacy of their products. As a global leader in the field, Aldevron has expanded its facilities and technological infrastructure to meet growing demand, establishing a significant presence in the biopharmaceutical sector. Their collaborations with biotechnology firms, pharmaceutical companies, and research institutions underscore their pivotal role in advancing mRNA technology and supporting the development of next-generation therapies and vaccines.
TriLink BioTechnologies (US):
TriLink BioTechnologies, a subsidiary of Maravai LifeSciences based in San Diego, California, is a key player in mRNA synthesis and manufacturing. The company excels in providing high-quality nucleic acid products and services, with a strong focus on mRNA technology. TriLink offers comprehensive mRNA synthesis services, including the production of custom mRNA and chemically modified mRNA, which enhances stability and translation efficiency — crucial for effective therapeutic and vaccine development. Utilizing advanced in vitro transcription technologies, TriLink ensures high yield and purity in their mRNA products.
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