U.S. mRNA Therapeutics Market Size to Reach USD 12,300 Million By 2034

According to Statifacts, the U.S. mRNA therapeutics market size was valued at USD 5,150 million in 2024, and is anticipated to reach around USD 12,300 million by 2034. It is expanding at a CAGR of 9.1% between 2025 and 2034.

U.S. mRNA Therapeutics Market Size 2025 to 2034

U.S. mRNA Therapeutics Market Report Highlights

•  The infectious disease applications segment dominated the U.S. mRNA therapeutics market in 2024.

•  The oncology application segment is expected to grow fastest during the forecast period.

•  The prophylactic type segment dominated the market with the highest share in 2024.

•  The therapeutics type segment is expected to grow fastest during the forecast period.

•  The hospitals & clinics end-use segment dominated the U.S. mRNA therapeutics market with the highest share in 2024.

•  The other end-use segment is expected to have significant growth during the forecast period.

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The versatile approach of mRNA, the increasing prevalence of chronic diseases, and technological advancements have driven the market growth.

The mRNA therapeutics market is rapidly expanding and represents a groundbreaking domain focused on employing messenger RNA (mRNA) to both treat and prevent various diseases. mRNA serves as a critical carrier of genetic information, transmitting instructions from DNA to the protein synthesis machinery within cells. By leveraging this biological mechanism, mRNA therapeutics can guide cells to produce specific proteins that elicit therapeutic benefits, offering a wide range of applications. This innovative approach is exceptionally adaptable, allowing for the development of several medical solutions, including personalized cancer treatments, protein replacement therapies for genetic disorders, and vaccines for infectious diseases. Recent technological advancements in mRNA delivery systems and manufacturing processes are significantly improving the efficacy and accessibility of these treatments.

As the incidence of chronic diseases, infectious diseases, and cancers continues to rise globally, the demand for innovative therapeutic strategies, such as mRNA therapies, is on the upswing. Notably, mRNA vaccines have gained substantial attention for their effectiveness in preventing infectious diseases, demonstrating the platform's potential. Moreover, mRNA can be utilized to mobilize the immune system to target and destroy cancer cells, creating new avenues for cancer immunotherapy. The versatility of mRNA therapies also extends to the correction of genetic disorders by compensating for faulty genes, providing a novel avenue for treatment.

The integration of artificial intelligence (AI) plays a transformative role in this field. Advanced algorithms can meticulously analyze vast datasets of biological information to pinpoint promising targets for mRNA therapies, thereby accelerating the drug discovery process. AI techniques can also design more stable and efficient mRNA sequences, optimizing protein production while minimizing the risk of unwanted immune responses. Furthermore, predictive models powered by AI can assess the effectiveness and safety of mRNA therapies even before they reach clinical trials, substantially reducing the likelihood of developmental failures and conserving valuable time and resources. AI is not limited to sequence design; it also enhances the formulation of lipid nanoparticles (LNPs) that facilitate the delivery of mRNA into cells, ensuring a more targeted and efficient therapeutic effect. Additionally, AI-driven optimizations can streamline the manufacturing process for mRNA therapies, leading to improved efficiency and cost-effectiveness, which ultimately supports broader patient access to these revolutionary treatments.

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U.S. mRNA Therapeutics Market Report Scope

Report Attribute

Details

Market size value in 2025

USD 5,620 Million

Revenue forecast in 2034

USD 12,300 Million

Growth rate

CAGR of 9.1% from 2025 to 2034

Actual data

2018 - 2024

Forecast period

2025 - 2034

Quantitative units

Revenue in USD million/billion and CAGR from 2024 to 2034

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

By Type, By Application, and By End User

Key companies profiled

GSK plc., BioNTech SE, CureVac N.V., Sangamo Therapeutics, Inc., Translate Bio, Inc., Moderna, Inc., Argos Therapeutics Inc., Arcturus Therapeutics, AstraZeneca plc., Pfizer Inc., CRISPR Therapeutics AG and Others.

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope

Annual Subscription; Pricing and purchase options

Avail customized purchase options to meet your exact research needs. Explore purchase options

 

U.S. mRNA Therapeutics Market Trends

•  Emerging Fields in mRNA Technology- While mRNA vaccines, such as those developed for COVID-19, have demonstrated remarkable success, the application of this technology is rapidly evolving beyond infectious diseases. Researchers are increasingly focusing on the development of mRNA therapies for various conditions, including cancer, genetic disorders, and rare diseases. A noteworthy advancement in this realm is the emergence of small interfering RNA (siRNA), a next-generation mRNA technology that enhances protein expression levels while requiring lower dosages. This advancement has significant implications for improving the efficacy and safety profiles of mRNA therapies, ultimately promising to reduce manufacturing costs associated with mRNA products.

•  Emergence of Circular RNA- Another groundbreaking technology making waves in the field is circular RNA (circRNA). Unlike traditional linear mRNA, circRNA offers increased stability and prolonged protein expression, making it an attractive option for therapeutic applications that necessitate sustained protein production. This characteristic could be particularly useful in treating chronic conditions where ongoing protein synthesis is critical. Furthermore, advancements in delivery systems, such as lipid nanoparticles (LNPs), are vital for ensuring that mRNA reaches its intended target cells effectively. Researchers are diligently working on developing more targeted and efficient delivery mechanisms to enhance the safety and overall efficiency of mRNA therapies.

•  Development and Production Optimization- As the global demand for mRNA therapies continues to escalate, there is an intensifying emphasis on optimizing manufacturing processes and scaling up production capabilities. Companies are investing substantial resources into establishing new production facilities and adopting state-of-the-art technologies to meet the rising demand for mRNA-based treatments. Additionally, researchers are exploring the synergistic potential of combining mRNA therapies with established treatments such as immunotherapy and chemotherapy. This integrative approach aims to improve patient outcomes by harnessing the strengths of multiple therapeutic modalities.

•  Collaboration and Investment Landscape- The market for mRNA therapeutics is attracting significant investment from both public and private sectors, highlighting the growing confidence in the future of this innovative field. There is also a notable trend of collaboration between biotech companies and academic research institutions, fostering an environment conducive to accelerating the development of new mRNA therapies. These partnerships aim to streamline research efforts and enhance knowledge sharing, ultimately leading to faster breakthroughs.

•  Focus on Personalized Medicine - One of the most transformative aspects of mRNA technology lies in its potential to facilitate personalized medicine. By enabling therapies tailored to the specific genetic and molecular profiles of individual patients, mRNA technology can revolutionize treatment paradigms. This approach could lead to the development of more effective and targeted therapies, enhancing treatment success rates and improving overall health outcomes for patients with diverse medical conditions.

•  Integration of Artificial Intelligence- Artificial intelligence (AI) can seamlessly integrate data from a wide array of sources, including advanced imaging data, comprehensive clinical records, and detailed genomic information. This integration offers a more holistic view of a patient's health status. Cutting-edge algorithms are now employed to automate the analysis of intricate disease patterns, significantly diminishing the time and labor that were traditionally necessary for manual evaluations.

U.S. mRNA Therapeutics Market Segment Insights

 Application Insights

In the U.S. mRNA therapeutics market, the infectious disease segment is currently the largest contributor, largely driven by the substantial demand for COVID-19 therapies. The surge in interest surrounding messenger RNA-based vaccines has also spurred market dynamics, with a notable increase in the number of mRNA candidates undergoing clinical trials targeting various infectious diseases. This trend is expected to substantially enhance market growth throughout the projected period.

On the other hand, the oncology segment is anticipated to exhibit the most rapid growth in the coming years. The remarkable promise demonstrated by mRNA technology in cancer treatment is noteworthy; ongoing clinical trials are investigating the applications of mRNA vaccines and therapies across different cancer types. A prime example includes personalized mRNA cancer vaccines designed to invigorate the immune system's ability to identify and destroy cancer cells, thereby offering a tailored approach to cancer therapy.

Type Insights

In terms of application type, the prophylactic segment currently dominates the U.S. mRNA therapeutics market. COVID-19-related products significantly contribute to the bulk of revenues generated in this segment. Furthermore, vaccines addressing other viral illnesses, such as influenza and respiratory syncytial virus (RSV), are projected to play a crucial role in expanding this segment in the upcoming years. Leading pharmaceutical companies are actively engaged in clinical trials and the advancement of RNA vaccines targeting a range of conditions, including COVID-19, influenza, HIV, and various other viral infections, all aimed at enhancing their market presence and achieving significant revenue growth.

Conversely, the therapeutics segment is expected to experience the highest growth rate, propelled by escalating investments from major market players who are focused on innovating new and effective RNA-based therapies. This increasing expenditure is anticipated to bolster the overall market landscape over the forecast period.

End-use Insights

The hospitals and clinics segment holds the dominant position in this market, accounting for the largest share of revenue, and is projected to see the fastest growth rate. The extensive utilization of messenger RNA-based vaccines and therapies to manage chronic diseases is expected to significantly propel the market for personalized pharmaceuticals. Additionally, the growth of this segment is expected to be further supported by the rising number of patients seeking medical care at hospitals and clinics. The integration of therapeutic advances is revolutionizing the healthcare landscape, characterized by remarkable innovations in areas such as mRNA technology, delivery systems, and drug discovery. These advancements are not only broadening the horizon for new therapeutics but also enhancing existing methods of delivery systems and treatment modalities. Through enhanced diagnostic capabilities, mRNA technology is fundamentally transforming how diseases are diagnosed and treated, leading to improved patient outcomes.

The 'other' segment, which encompasses specialty pharmacies, is also predicted to witness considerable growth. Specialty pharmacies play an essential role in the distribution and administration of mRNA vaccines, owing to the distinct storage and handling requirements these innovative vaccines necessitate. This aspect is crucial for ensuring the vaccines’ efficacy and safety, thus underpinning the segment's anticipated growth trajectory in the competitive landscape of mRNA therapeutics.

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U.S. mRNA Therapeutics Market Top Key Companies:

•  GSK plc.

•  BioNTech SE

•  CureVac N.V.

•  Sangamo Therapeutics, Inc.

•  Translate Bio, Inc.

•  Moderna, Inc.

•  Argos Therapeutics Inc.

•  Arcturus Therapeutics

•  AstraZeneca plc.

•  Pfizer Inc.

•  CRISPR Therapeutics AG

U.S. mRNA Therapeutics Market Recent Developments

In May 2024, a newly developed cancer vaccine, the Epstein–Barr virus-related mRNA therapeutic cancer vaccine was approved by the US Food and Drug Administration (FDA).

•  In September 2023, Moderna, Inc. expanded its messenger ribonucleic acid research across oncology, respiratory, and rare diseases. This initiative was anticipated to fuel the company’s revenue

•  In August 2023, CureVac announced the commencement of dosing for the initial participant in a Phase 2 study. This study focuses on modified COVID-19 mRNA vaccine candidates developed through a collaboration with GSK Plc

•  In January 2023, BioNTech SE entered a strategic collaboration with the UK government to supply personalized messenger RNA cancer immunotherapies for up to 10,000 patients by 2030. This initiative positively impacted the company’s revenue

•  In January 2023, BioNTech SE completed the acquisition of InstaDeep Ltd. This initiative was anticipated to strengthen BioNTech’s AI-powdered drug discovery, design, and development

U.S. mRNA Therapeutics Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the global U.S. mRNA Therapeutics Market

By Type

•  Therapeutic Vaccines

•  Prophylactic Vaccines

By Application

•  Oncology

•  Rare Genetic Diseases

•   Infectious Diseases

•  Others

By End-use

•  Research Organizations

•  Hospitals & Clinics

•  Others

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