U.S. mRNA Synthesis Raw Materials Market Size, Share & Trends Analysis Report, By Type (Capping Agents, Nucleotides, Plasmid DNA), By Application (Vaccine, Therapeutics), By End-use, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The U.S. mRNA synthesis raw materials market size was estimated at USD 842.7 million in 2023 and is expected to grow at a CAGR of 2.93% from 2024 to 2030. This is attributed to the growing academic & industrial interest in mRNA technology, increasing funding for mRNA research, and raising awareness of the advantages of mRNA-based vaccines. Moreover, the increasing therapeutic applications of RNA technology are anticipated to provide significant demand for mRNA synthesis raw materials over the forecast period.

The COVID-19 pandemic has spurred the rapid adoption of mRNA technology, mainly through mRNA vaccines. Government agencies, research institutions, and pharmaceutical companies are prioritizing the development of efficient COVID-19 detection methods. mRNA vaccines, represented by mRNA-1273 developed by the National Institute of Allergy and Infectious Diseases (NIAID) and Moderna, Inc., have proven highly effective, receiving emergency use authorization from the U.S. FDA in December 2020. This has led to a significant increase in mRNA vaccine usage during the pandemic.

Moreover, RNA centers have been established at numerous institutions to promote therapeutic uses for RNA, particularly In Vitro Transcribed (IVT) mRNA. These facilities include the Yale Center for RNA Science and Medicine, the RNA Institute at the University at Albany, the State University of New York, and the RNA Therapeutic Institute at the University of Massachusetts in the U.S. In addition, university spin-off businesses funded by significant venture capital infusions (such as Argos Medicines, Factor Bioscience, CureVac, Ethris, BioNTech, Moderna, eTheRNA, and Onkaido) have advanced the preclinical and clinical development of mRNA-based therapeutics.

Furthermore, mRNA vaccines direct the cells to produce proteins, driving the demand for mRNA-based vaccines due to the growing awareness among individuals. This, in turn, increases the demand for and surges in adopting mRNA vaccines among patient populations and biotech companies. For instance, in March 2022, a Phase 1 clinical trial was initiated by The National Institutes of Health's NIAID to evaluate three potential HIV vaccines using an mRNA platform.

Market Concentration & Characteristics

The market growth stage is high, and the pace of the market growth is accelerating. This growth stage reflects increasing demand for mRNA-based therapeutics and vaccines, driven by their effectiveness, versatility, and potential applications across various medical fields. Factors such as technological advancements, supportive regulatory frameworks, and strategic collaborations are fueling the growth of the market. Thus, continuous development and collaboration are propelling the expansion of the U.S. mRNA synthesis raw materials industry, which is further expected to grow significantly over the period.

In the market, collaboration activities are a high level of engagement within the industry. These collaborations facilitate technology transfer, expedite research and development efforts, and promote the commercialization of mRNA-based products. Biopharmaceutical companies, research institutions, and raw material suppliers are actively partnering to leverage expertise, share knowledge, and accelerate innovation in mRNA technology. For instance, in February 2023, Life Edit Therapeutics Inc. and Moderna Inc. signed a collaboration agreement to discover and develop mRNA gene-editing therapies.

The U.S. has the most stringent standards for mRNA approval in the world. The FDA is the regulatory body solely responsible for the commercialization of mRNA-based therapeutics or vaccines. The FDA enforces laws enacted by the U.S. Congress and regulations established by the agency to protect consumers' safety and health. However, mRNA is regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) and is not yet categorized as a regenerative medicine advanced therapy.

The industry currently exhibits a high level of product expansion. The rising demand for mRNA-based therapeutics and vaccines is propelling the growth of the market. Moreover, technological advancements have enhanced production efficiency and quality, while substantial investments and strategic collaborations have bolstered manufacturing capacity and innovation. For instance, in December 2022, Merck KGaA announced the launch of SP6 RNA Polymerase for the synthesis of mRNA for stringent vaccine and therapeutics manufacturing markets.

Type Insights

Capping agents held the largest revenue market share of 41.02% in 2023 and is expected to grow at the highest CAGR over the forecast period. Capping and tailing are crucial stages in the development of mRNA for use in functional studies. These procedures reduce the translational difficulty and avoid degradation in eukaryotes. Capping agents act as binding molecules or stabilizers to prevent steric hindrance or aggregation. For instance, in September 2022, TriLink BioTechnologies, a manufacturer of raw materials, expanded its GMP-grade product line by offering N1-Methyl-Pseudouridine-5’-Triphosphate (N1meΨTP), an improved Nucleoside-Triphosphate (NTP) necessary for mRNA production. Thus, the increase in the development and launch of novel raw materials to be used in mRNA synthesis is expected to drive market growth.

The nucleotide segment is expected to register a significant CAGR over the forecast period. Nucleotide analogs with unique characteristics would be used as powerful drugs like mRNA-based therapeutics to fight a variety of pathogens or cellular probes. Thus, increasing use of nucleotides in mRNA therapies and drug discovery propelled the market growth.

End-use Insights

Biopharmaceutical & pharmaceutical companies dominated the segment with a market share of 49.56% in 2023 and is anticipated to grow at the highest CAGR over the forecast period. This is attributed to the increasing demand for the development of new therapeutics due to significant expansions in the pharmaceutical industry pipeline. For instance, according to a study published by Informa in April 2022, there were 46 drugs in the pipeline from Moderna, followed by 29 from BioNTech, 19 from CureVac, 11 from Sanofi, 10 from Pfizer, 5 and 4 from GSK and AstraZeneca, respectively.

The CROs & CMOs segment is expected to grow at a significant CAGR over the forecast period. This fast growth is due to vaccine developers entering into strategic agreements with contract service providers to meet the urgent global demand for mRNA-based vaccines, which led to a sharp increase in the outsourcing industry. In addition, some of the leading outsourcing companies are increasing their finances to strengthen their mRNA synthesis infrastructure and support segment growth. For instance, in June 2022, Vernal Biosciences finished its USD 21 million financing to incorporate its mRNA manufacturing solutions completely.

Application Insights

Vaccine production dominated the segment with a revenue market share of 83.86% in 2023 and is anticipated to grow at the highest CAGR over the forecast period. This is attributed to the high demand for mRNA vaccines during the COVID-19 pandemic and increased research on mRNA vaccine candidates for several diseases. Moreover, robust product pipelines and a rise in research activities are also supplementing market growth.

The therapeutics segment is expected to grow at a significant CAGR over the forecast period. Rising expenditures by key market players for the production of novel and effective mRNA therapeutics are expected to boost market growth over the forecast years. Moreover, the development and production of mRNA for therapeutic applications are relatively easy, scalable, and incredibly rapid. Due to this, the demand to produce mRNA therapeutics to combat future pandemics has increased gradually over the forecast years.

Key U.S. mRNA Synthesis Raw Materials Company Insights

The market players operating in the market are adopting product approval to increase their reach and improve the availability of their products in diverse geographical areas, along with expansion as a strategy to enhance production/research activities. In addition, several market players are acquiring smaller players to strengthen their market position. This strategy enables companies to increase their capabilities, expand their product portfolios, and improve their competencies.

Recent Developments

• In May 2023, Touchlight completed the redevelopment and expansion of its GMP manufacturing facility in the UK. This move tripled the unit's capacity, which is anticipated to increase the global supply of DNA plasmids for various genetic medicines.

• In July 2023, Applied DNA Sciences, Inc. announced the launch of Linea IVT platform evaluation kits to minimize impurities and lower production expenses for mRNA therapies, such as the COVID-19 vaccines.

• In September 2023, Charles River Laboratories and INADcure collaborated to manufacture gene therapy. The company’s CDMO expertise would enable the production of high-quality plasmids to support Phase I/II clinical trials for Infantile Neuroaxonal Dystrophy.

• In October 2023, Sartorius announced the acquisition of Polyplus, a French company, for a total of 2.4 billion euros (USD 2.6 billion). This acquisition is expected to provide Sartorius with enhanced expertise in nucleic acid delivery, including transfection reagents and plasmid DNA design, which are essential for manufacturing viral vectors for the development of cell and gene therapies.

U.S. mRNA Synthesis Raw Materials Market Report Scope

U.S. mRNA Synthesis Raw Materials Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. mRNA synthesis raw materials market report based on type, application, and end-use:

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Capping Agents

  • Nucleotides

  • Plasmid DNA

  • Enzymes

    • Polymerase

    • RNase Inhibitor

    • DNase

    • Others

  • Others

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Vaccine Production

  • Therapeutics Production

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Biopharmaceutical & Pharmaceutical Companies

  • CROs & CMOs

  • Academic & Research Institutes