List of Contents
What is mRNA Vaccines and Therapeutics Market Size?
The global mRNA vaccines and therapeutics market size is was accounted for USD 2.14 billion in 2025 and is expected to reach around USD 21.97 billion by 2034, expanding at a solid CAGR of 29.71% from 2025 to 2034. The applications of mRNAvaccines and therapeutics including mRNA-based gene editing, protein replacement, mRNA-based genetic reprogramming, cancer immunotherapy, and infectious disease vaccines these factors help the growth of the market. The mRNA vaccines and therapeutics market is expanding due to the growing demand for messenger ribonucleic acid-based vaccines and therapeutics, an increasing number of clinical trials, and trending stem cell therapies globally, which are propelling the market growth further.
Market Highlights
- North America dominated the mRNA vaccines and therapeutics market in 2024.
- Asia Pacific is estimated to be the fastest growing during the forecast period of 2025-2034.
- By disease type, the hereditary transthyretin-mediated amyloidosis genetic segment dominated the market in 2024.
- By disease type, the acute hepatic porphyria segment is the fastest growing during the forecast period.
- By route of administration type, the IV infusion segment dominated the market in 2024.
- By route of administration type, the subcutaneous segment is the fastest growing during the forecast period.
- By end-user type, the hospitals and clinics segment dominated the in 2024 and is also expected to be the fastest growing during the forecast period.
Which are the AI Factors Impacting the mRNA Vaccines and Therapeutics Market?
Vaccine development was marked as one of the revolutionary works in the healthcare sector by fighting infectious diseases and reducing mortality rates worldwide. However, the conventional way to develop vaccines is time-consuming, costly, and efficient either. However, AI has promising possibilities and better outcomes for vaccine development by focusing on antigen selection, epitope prediction, and optimization strategies. AI algorithms like machine learning deep learning use genomic data, protein structures, and immune systems interaction to identify antigenic epitopes, assess immunogenicity, and prioritize antigens for experiments. Moreover, AI-based approaches help the rational design of immunogens for optimal safety and efficacy profiles. There are some popular AI tools that play crucial roles in escalating the vaccine discovery and design process, eventually contributing to the development of safe and effective vaccines to combat fatal infectious diseases.
What are the Major Applications of Advanced mRNA Vaccines & Therapeutics?
The mRNA vaccines and therapeutics deliver the mRNA coding for specific proteins or antigens into the cells of a patient either naked or using a delivery vehicle. The mRNA vaccines and therapeutics market deal with research institutes, hospitals, and clinics for various applications including vaccines, cell therapy, gene editing, therapeutic protein replacement, and more, and also for various disease types which include atherosclerotic cardiovascular disease, primary hyperoxaluria type 1, acute hepatic porphyria, and hereditary transthyretin-mediated amyloidosis genetic.
The mRNA vaccines and therapeutics are an innovative biomedical approach used in developing antigen-specific vaccines that may generate adaptive immune responses, triggering both cellular and humoral immunity to improve the body's defense against certain infections. These have the potential to prevent infections and treat diseases and help the growth of the market. These factors help the growth of the market.
mRNA Vaccines and Therapeutics Market Growth Factors
- The mRNA vaccines and therapeutics applications include treatment for cancer and protein replacement and infectious diseases that help the growth of the market.
- The advantages of mRNA vaccines and therapeutics include low cost, safety, efficacy, transfection efficiency, efficacy, and high stability manufacturing processes.
- mRNA vaccines are safer because they do not contain live viruses. These vaccines may be fastly mass produced, tested, and designed. These factors help the growth of the mRNA vaccines and therapeutics market.
- mRNA vaccines have the potential to treat different diseases or different variants of diseases. mRNA vaccines work by activating immune systems by creating antibodies. These factors help the growth of the market.
- mRNA therapeutics applications include vaccines, cell therapy, gene editing, therapeutic protein replacement, and more that help the growth of the market.
mRNA Vaccines and Therapeutics Market Outlook:
- Global Expansion: It is propelled by a rise in major investments, international collaborations, and technological breakthroughs, with expanded applications from infectious diseases to cancer and genetic disorders.
- Major Investor: Moderna company planned to invest nearly $25 billion in R&D from 2024 to 2028 to transform its mRNA medicine scope and signed a $1 billion agreement with Chinese officials for R&D and manufacturing of mRNA medicines.
- Startup Ecosystem: Blank Bio, founded in S2025, is a startup involved in developing foundation models by using artificial intelligence to understand RNA and rigorous applications across the R&D pipeline.
Market Scope
| Report Coverage | Details |
| Market Size in 2025 | USD 2.14 Billion |
| Market Size in 2026 | USD 2.81 Billion |
| Market Size by 2034 | USD 21.97 Billion |
| Market Growth Rate from 2025 to 2034 | CAGR of 29.71% |
| Largest Market | North America |
| Base Year | 2024 |
| Forecast Period | 2025 to 2034 |
| Segments Covered | Disease Type, Route of Administration, End-user Type, and Regions |
| Regions Covered | North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
Market Dynamics
Drivers
Increasing occurrence of infectious and chronic diseases
The increased prevalence of viral infections, HIV (Human Immunodeficiency Virus), influenza, and Ebola helps to the growth of the market. The mRNA vaccines help to produce harmless proteins in the body that look like proteins found on the surface of the virus. Advantages of the use of mRNA vaccines include being quickly mass-produced, tested, and designed. mRNA vaccines are safe because they do not contain live viruses. The applications of mRNA vaccines also include preventing diseases like COVID-19, cancer-like diseases, and other infectious diseases. These factors help the growth of the mRNA vaccines and therapeutics market.
Restraint
Risks of mRNA vaccines and therapeutics
The mRNA vaccines and therapeutics may include increased risks of myocarditis or pericarditis, cancer, autoimmunity, chronic autoinflammation, and DNA damage. The mRNA vaccines contain most of the serious side effects including deaths, anaphylaxis, and antibody-dependent enhancements. The mRNA vaccines also have some other side effects including persistent or severe headaches, fits or seizures or confusion, blurred vision, persistent abdominal pain, leg pain, leg swelling, chest pain, and shortness of breath. Some people have concerns that cause of heart problems due to mRNA vaccines. These factors can restrict the growth of the mRNA vaccines and therapeutics market.
Opportunity
Recent verifications have shown the potential of mRNA vaccines to counteract a large range of cancers and infectious pathogens. The mRNA vaccines are easy, efficacious, and safe to manufacture on a large scale. These properties become necessary when battling against global pandemics in the future. The future applications of mRNA vaccines include cancer therapeutics and vaccines, severe acute respiratory syndrome (SARS), respiratory syncytial virus (RSV), and HIV. Innovation in the development of mRNA-based vaccines against the subtype of influenza viruses. These factors help the growth of the mRNA vaccines and therapeutics market.
Segment Insights
Disease Type Insights
The hereditary transthyretin-mediated amyloidosis genetic segment dominated the mRNA vaccines and therapeutics market in 2023. The mRNA vaccines and therapeutics are highly used for the treatment of hereditary transthyretin-mediated amyloidosis genetic disease. mRNA vaccines and therapeutics are used to instruct body cells to make specific proteins that have essential roles in the body. mRNA normally uses biological processes and our own body to prevent infections and potentially treat diseases. For the treatment of peripheral nerve disease which is caused due to the hereditary transthyretin-mediated amyloidosis genetic disease in adult patients, mRNA vaccines and therapeutics are used. These factors help the growth of the hereditary transthyretin-mediated amyloidosis genetic disease type segment and contribute to the growth of the market.
The acute hepatic porphyria segment is the fastest-growing during the forecast period. mRNA vaccines have properties of swiftest response to a wide range of outbreaks of infectious disease. Acute hepatic porphyria disease is a group of rare inherited diseases due to deficiency in distinct enzymes and the treatment of this type of disease. mRNA vaccines and therapeutics have multiple therapeutic advantages that help to make them ideal for the development of next-generation cancer immunotherapy drugs as compared to other functional biomolecules like recombinant proteins and DNA plasmids. mRNA-based drugs have lower toxicity and higher transfection efficiencies as compared to DNA-based drugs. These factors help the growth of the acute hepatic porphyria disease type segment and contribute to the growth of the mRNA vaccines and therapeutics market.
Route of Administration Type Insights
The IV infusion segment dominated the mRNA vaccines and therapeutics market in 2023. mRNA carriers in vaccines play an essential role in the composition of mRNA, delivery method, mRNA formulation, and effective vaccination. mRNA vaccines may be delivered by using naked mRNA or peptides, polymers, and lipid nanoparticles. IV infusion type route of administration allows direct access to mRNA vaccines to the lymphoid organs and immune cells in the circulatory system leading to improved efficiency of the mRNA vaccines.
The IV infusion is highly used for the administration of mRNA vaccines and therapeutics due to their benefits including high speed, efficacy, and convenience which helps healthcare professionals and patients recover quickly. IV infusion benefits also include control of dose and delivery speed, it ensures that the drug remains in the system for a longer period, promoting better cardiovascular risks, promoting relaxation, and easing anxiety. IV infusion is essential in clinical settings and hospitals. These factors help the growth of the IV infusion route of the type administration segment and contribute to the growth of the market.
The subcutaneous segment is the fastest-growing during the forecast period. The subcutaneous type of route administration is highly used for mRNA vaccines and therapeutics. There are many advantages including the subcutaneous route of administration allows sustained action depot preparation, self-administration is possible because the subcutaneous injections need not penetrate deeply, absorption is slower and it is safer than intramuscular and intravenous routes, and it is the better route of administration especially for the skin infections. These factors help the growth of the subcutaneous route of administration segment and contribute to the growth of the mRNA vaccines and therapeutics market.
End-user Type Insights
The hospitals and clinics segment dominated the mRNA vaccines and therapeutics market in 2023 and is the fastest-growing during the forecast period. As compared to other vaccines mRNA vaccines have unique advantages including the use of short development time, protein translational machinery of the host, efficient delivery, and versatility. The mRNA vaccines are easy and fast speed for their manufacture. It requires minimum platform change for mRNA manufacturing and development. The mRNA vaccines can safely and rapidly protect patients from infectious diseases.
The key advantages of mRNA therapeutics include rapid manufacturing, ease of design, no risk of genomic integration, lack of requirement for nuclear delivery, transient, potent, rapid, and expression. The mRNA-based vaccines are used for the treatment of a variety of diseases including cerebrovascular diseases, cardiovascular diseases, cancer, metabolic genetic diseases, and infectious diseases. These factors help the growth of the hospitals and clinics segment and contribute to the growth of the market.
Regional Insights
Why did North America Dominate the Market in 2024?
North America dominated the mRNA vaccines and therapeutics market in 2024. In North America, the supportive reimbursement policies and increase in the number of senior populations help to the growth of the market. mRNA vaccines have the potential for the treatment of different diseases and different types of diseases.
Enhancement of FDA Efforts: Fostering the US Market
The U.S. is the leading country for the growth of the market. A lot of the major companies belong to the U.S. which gives a boost to the growth and development of vaccines and therapeutics. Organization like the FDA ensures that the vaccines and treatment options follow all the quality and safety standards which ensure that the vaccines and therapeutics are safe for using on mass level.
- In January 2022, the U.S. Food and Drug Administration (FDA) approved the second mRNA-based COVID-19 vaccine Spikevax which was previously called as Moderna COVID-19 vaccine. This FDA-approved vaccine is marketed as Spikevax for COVID-19 prevention in individuals of 18 years age and above.
Asia Pacific is estimated to be the fastest growing during the forecast period of 2024-2033. The increasing prevalence of chronic diseases leads to a high demand for the growth of the market. India, China, and Japan are the leading countries for the growth of the mRNA vaccines and therapeutics market.
Extensive Government Initiatives: Leveraging the Chinese Market Growth
In the current era, the Chinese government has been boosting technological self-reliance in the biopharmaceutical area through diverse major support, funding, and suitable policies for local mRNA research & development (R&D). Recently, Chengdu Wissin BioTech unveiled an mRNA tumor vaccine, WGC-043 injection, targeting advanced Epstein-Barr virus-positive solid tumors and haematological malignancies, which was approved for Phase I clinical trials in China and the USA in 2024.
Ongoing Advances in Drug Delivery Systems are Driving Europe
Europe is experiencing a notable growth in the mRNA vaccines and therapeutics market. This is primarily powered by persistent innovations in drug delivery systems, especially lipid nanoparticles (LNPs), which accelerate mRNA stability and optimize targeted delivery. In early 2025, Kostaive (zapomeran, developed by Arcturus Therapeutics/CSL) received approval from the European Commission as a foremost self-amplifying mRNA vaccine.
Various Pipeline Progression: Escalating the German Market Development
Specifically, Autogene cevumeran (BNT122) demonstrates longer-term follow-up Phase I/II data for this tailored mRNA cancer vaccine in patients with pancreatic cancer at the AACR 2024 meeting. Also, the recent alliance with Lonza in April 2025 for the development of room-temperature stable, spray-dried formulations of mRNA vaccines evolved for mucosal delivery, particularly for respiratory diseases.
mRNA Vaccines and Therapeutics Market: Value Chain Analysis
- R&D This comprises designing the mRNA sequence, generating a DNA template, performing in vitro transcription (IVT) to develop the mRNA, and then purifying the mRNA.
Key Players: Moderna, BioNTech, Arcturus Therapeutics, etc. - Clinical Trials & Regulatory Approvals Conduction of diverse phases for assessment of safety & efficacy, and finally, different stages are involved in the approval, such as submission, review, and approval.
Key Players: Ente Ospedaliero Ospedali Galliera, Novartis Pharmaceuticals, John Sampson, etc. - Patient Support & Services This basically focuses on robust infrastructure for mass vaccination, with services to provide information and education regarding safety, efficacy, and other side effects, with other patient support and assistance programs.
Key Players: Gennova Biopharmaceuticals, AstraZeneca, Merck, etc.
Key Players in mRNA Vaccines and Therapeutics Market and Their Offerings
- Kernal Biologics Inc- It is mainly involved in the R&D pipeline of mRNA therapeutics for oncology and autoimmune diseases.
- Sanofi- It possesses a devoted Vaccines mRNA Center of Excellence and is working on various vaccine candidates for many infectious diseases.
- Argos Therapeutics Inc- It is actively involved in the development of RNA-based, autologous dendritic cell therapies.
- CureVac SE- It usually produces prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases.
- Ethris GmbH- It has offered a proprietary technology platform (SNIM RNA and SNaP LNP) for establishing next-generation mRNA therapeutics and vaccines.
Recent developments
- On January 10th, 2025, Arcturus Therapeutics Holdings Inc., a commercial messenger RNA medicine company, focused on the development of vaccines for infectious diseases within liver and respiratory disease. The announced self-amplifying mRNA vaccine, also known as LUNAR-H5N1, is used for active immunization to prevent pandemic influenza disease caused by the virus H5N1.
- In January 2025, Esphera Synbio, a well-known pre-clinical stage synthetic biology company, introduced a new project to develop and increase the efficacy of mRNA vaccines by using its proprietary technology to engineer mRNA vaccines.
Segments Covered in the Report
By Disease Type
- Hereditary Transthyretin-mediated Amyloidosis Genetic
- Acute Hepatic Porphyria
- Primary Hyperoxaluria Type 1
- Atherosclerotic Cardiovascular Disease
By Route of Administration
- IV Infusion
- Subcutaneous
By End-user Type
- Research Institutes
- Hospitals and Clinics
By Region
- North America
- Asia Pacific
- Europe
- Latin America
- Middle East & Africa
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