According to latest report, the U.S. vaccine market size is calculated at 33.29 billion in 2025 and is projected to surpass USD 59.77 billion by 2034 with a remarkable CAGR of 6.72% from 2025 to 2034.
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U.S. Vaccine Market Report Highlights
- By type, the mRNA type segment dominated the U.S. vaccine market with a share of 30.12% in 2025.
- By type, the subunit vaccines segment is expected to be the fastest-growing region during the forecast period.
- By route of administration, the parenteral administration is highly preferred for administering vaccines, and the segment dominated the segment market with a share of 81.11% in 2025.
- By route of administration, the oral administration is expected to grow steadily over the forecast period.
- By disease indication, the viral diseases segment dominated the U.S. vaccine market with a share of 58.79% in 2025.
- By disease indication, the market for bacterial disease is expected to grow at the fastest CAGR during the forecast period.
- By age, the adult age group segment accounted for the highest share of the U.S. vaccine market with a of 51.25% in 2025.
- By age, the pediatric age group segment is expected to be the fastest-growing segment during the forecast period.
- By distribution channel, the government suppliers dominated the market in 2025 with a share of 50.19%.
- By distribution channel, the Hospital & retail pharmacies supply channel is estimated to be the fastest-growing distribution channel in the U.S. vaccine market.
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Pandemic preparedness & biodefense are estimated to drive the growth of the U.S. vaccine market over the forecast period. The rising adoption of inorganic growth strategies, like acquisition and merger, by the key players operating in the market to develop vaccines has also been estimated to drive the market's growth.
Rising disease prevalence of infectious diseases has been estimated to drive the growth of the U.S. vaccine market. Increasing cases of infectious diseases (e.g., influenza, hepatitis, HPV, pneumonia) drive vaccine demand. Emerging threats like COVID-19 and monkeypox create new market opportunities. For instance, in January 2025, according to the data published by the World Health Organization, based on respiratory virus surveillance data that countries have submitted to the World Health Organization (WHO) as of January 11, 2025, the global influenza positivity rate for epidemiological week (EW) 1 of 2025 was 22.05%, which is 2.8% higher than EW 52 of 2024. Since the end of 2024, there has been a significant level of influenza virus activity in the Northern Hemisphere, with a trend toward an increase in some North American countries (mostly due to the finding of A(HIN1) pdm09 in addition to A(H3N2)).
Government initiatives & funding for vaccination have increased the demand for the vaccines, which has been estimated to drive the market's growth. Immunization programs by WHO, CDC, and national governments encourage widespread vaccine adoption. Subsidies and funding for R&D, especially for diseases like malaria and tuberculosis. The U.S. government allocates substantial funds to vaccine research, development, and distribution through the CDC, NIH, and BARDA agencies. Programs such as Operation Warp Speed (during COVID-19) demonstrated how government funding can accelerate vaccine production and distribution. The Vaccines for Children (VFC) program provides free vaccines to eligible children, boosting demand and ensuring high coverage. Government-led initiatives, such as National Immunization Awareness Month, help educate the public about vaccine benefits, increasing uptake. Efforts to combat vaccine hesitancy (e.g., through the COVID-19 Vaccination Communication Campaign) have strengthened trust. The COVID-19 pandemic showed how emergency funding enables rapid vaccine development and deployment. The Strategic National Stockpile (SNS) ensures vaccine availability for influenza, RSV, and monkeypox outbreaks. The Advisory Committee on Immunization Practices (ACIP) frequently updates recommendations, expanding the vaccine market to new age groups and conditions (e.g., RSV and shingles vaccines for older adults). For instance, in January 2025, Moderna (MRNA.O) received US$590 million from the U.S. government to further research its bird flu vaccine as the nation intensifies its attempts to combat the rising number of human cases. In addition, the U.S. Department of Health and Human Services (HHS) granted US$176 million in 2024 to finish the testing and late-stage development of a pre-pandemic mRNA-based vaccine against the H5N1 avian influenza.
Rising technological advancements for vaccine development have driven the growth of the U.S. vaccine market over the forecast period. mRNA technology (e.g., Pfizer-BioNTech & Moderna COVID-19 vaccines) has revolutionized the industry. The development of thermostable and needle-free vaccines improves accessibility. For instance, in January 2025, Novavax, a biotechnology company based in the U.S., introduced a bold new business expansion plan to optimize the effects of state-of-the-art technologies. The company is committed to establishing strategic alliances for our Matrix-MTM adjuvant and our early and late-stage research and development (R&D) resources to promote vaccine innovation that safeguards public health. The aging population and chronic diseases support the market's growth. Older people are more vulnerable to diseases, increasing the demand for flu, pneumonia, and shingles vaccines. Patients with chronic conditions (diabetes, cancer) require stronger immunization support.
Biopharmaceutical investments & partnerships are estimated to drive the growth of the U.S. vaccine market in the future. Collaborations between biotech firms, universities, and pharmaceutical giants speed up innovation. Expanding manufacturing capabilities in emerging markets reduces costs and increases supply. Regulatory support & fast-track approvals for vaccines are estimated to drive the growth of the U.S. vaccine market. Emergency Use Authorizations (EUA) and accelerated approvals during crises boost market growth. Ongoing clinical trials exploring new vaccine applications (e.g., cancer, HIV, Alzheimer’s). The U.S. Food Drug Administration’s priority review, breakthrough therapy designation, and fast-track approvals accelerate vaccine development. Emergency Use Authorizations (EUAs) allow rapid deployment during health crises (e.g., COVID-19 vaccines). The Orphan Drug Act & Priority Review Vouchers provide financial and regulatory incentives for companies to develop vaccines for rare diseases. The 21st Century Cures Act supports faster innovation and approval processes. Rigorous FDA safety and efficacy standards ensure public trust, leading to higher vaccination rates. Post-market surveillance (e.g., VAERS and VSD) helps monitor vaccine safety and builds credibility.
The PREP Act (Public Readiness and Emergency Preparedness Act) provides legal immunity to vaccine manufacturers during public health emergencies, reducing financial risk. U.S. regulatory agencies collaborate with international bodies (e.g., WHO, EMA) to align standards, making it easier for U.S. vaccines to reach global markets. For instance, in July 2024, a new project was established to help manufacturers in low- and middle-income nations create and make human avian influenza (H5N1) messenger RNA (mRNA) vaccine candidates more accessible. This initiative will be spearheaded by the Argentinean company Sinergium Biotech, utilizing the Medicines Patent Pool (MPP) mRNA Technology Transfer Program and the World Health Organization (WHO).
U.S. Vaccine Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2026 |
USD 35.52 billion |
|
Revenue forecast in 2034 |
USD 59.77 billion |
|
Growth rate |
CAGR of 6.72% from 2026 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2019 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million and CAGR from 2025 to 2034 |
|
Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
|
Segment coverage |
Type, route of administration, disease indication, age group, distribution channel |
|
Companies profiled |
Serum Institute of India Pvt. Ltd.; Seqirus; Sanofi; GSK Plc.; Merck & Co. Inc.; Pfizer Inc.; Moderna Inc.; Sinovac; BioNTech SE; AstraZeneca. |
|
Annual Subscription |
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Market Trends
• Leadership Changes and Industry Implications: The confirmation of Robert F. Kennedy Jr. as Secretary of the Department of Health and Human Services has elicited mixed reactions. While some are optimistic about potential regulatory efficiencies, concerns arise from his controversial views on vaccines, which could impact vaccine development and investment.
• Technological Advancements: Artificial Intelligence is pivotal in transforming the vaccine market by accelerating development, optimizing manufacturing, and enhancing distribution. This integration is expected to drive significant market growth between 2025 and 2029.
• Strategic Investments: Investment firms are actively influencing vaccine companies' strategies. For instance, Deep Track Capital has initiated a proxy fight at Dynavax Technologies, advocating for a focus on their hepatitis B vaccine, Heplisav, and a halt to new acquisitions.
Artificial Intelligence Role in vaccine Market
Artificial Intelligence (AI) transforms the vaccine market by accelerating research, optimizing manufacturing, enhancing distribution, and improving public confidence. By analyzing vast biological datasets, AI-driven drug discovery identifies potential vaccine candidates faster than traditional methods. Machine learning models predict protein structures and virus mutations, improving vaccine efficacy (e.g., AI-powered mRNA vaccine development for COVID-19). AI helps identify the best patient populations for clinical trials, reducing recruitment time and costs. Predictive analytics improve trial success rates by forecasting potential side effects and efficacy. AI-driven automation and predictive maintenance reduce production downtime and ensure consistent quality. Smart algorithms optimize supply chain logistics, preventing shortages and reducing waste.
AI automates regulatory documentation, making the FDA approval process faster and more efficient. AI-powered real-world data analysis supports faster Emergency Use Authorizations (EUAs) decision-making. AI-driven demand forecasting ensures vaccines reach high-priority regions efficiently. Blockchain + AI enhances traceability, reducing counterfeit vaccines and ensuring quality control. AI analyzes genetic and demographic data to develop customized vaccines for specific populations, increasing effectiveness. mRNA technology + AI enables rapid adaptation for new virus variants. AI integration is revolutionizing the U.S. vaccine market by speeding development, improving supply chains, reducing costs, and boosting public trust. As AI continues to evolve, it will play an even greater role in making vaccines safer, more effective, and widely accessible.
Segment Insights
Type Insights
The Recombinant/conjugate/Subunit segment held a dominant presence in the U.S. vaccine market in 2024. These vaccines use specific antigens (proteins or polysaccharides) rather than live or whole-inactivated pathogens, reducing the risk of adverse reactions, especially in immunocompromised individuals. The recombinant HPV vaccine (Gardasil 9) has a high safety record and adoption. Conjugate vaccines (e.g., pneumococcal conjugate vaccine, PCV13) link antigens to carrier proteins, enhancing immune response, especially in young children. Adjuvants (e.g., aluminum salts in Hepatitis B vaccines) boost immune memory. CDC and ACIP recommendations for routine immunization schedules drive demand. Example: PCV13 and MenACWY (meningococcal conjugate vaccine) are mandatory for school entry. Recombinant and conjugate vaccines offer protection against multiple strains. Example: Gardasil 9 protects against nine HPV strains, reducing cervical cancer risks. Increased cases of pneumonia, meningitis, and HPV-related cancers push adoption. Recombinant DNA technology enables rapid vaccine development (e.g., Novavax COVID-19). Conjugation techniques improve response in infants who do not respond well to polysaccharide vaccines. Major U.S. pharmaceutical companies (e.g., Pfizer, Merck, GSK) favor these technologies due to strong patent protection and profitability.
The viral vector segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034. Viral vectors mimic natural infections, triggering humoral (antibody-based) and cellular (T-cell) immunity. Example: The AstraZeneca (ChAdOx1) and Johnson & Johnson (Ad26.COV2.S) COVID-19 vaccines provide durable protection. Unlike recombinant or subunit vaccines, viral vector vaccines naturally stimulate the immune system without requiring an additional adjuvant. Once a viral vector platform is established, it can be quickly adapted to new diseases. Example: Ebola virus vaccine (rVSV-ZEBOV) was rapidly developed using the vesicular stomatitis virus (VSV) vector. Viral vector technology enables rapid responses to outbreaks. Example: COVID-19 vaccines based on adenovirus vectors were among the first to be approved. Some viral vector vaccines (e.g., J&J’s COVID-19 vaccine) can be stored at normal refrigeration temperatures (2-8°C), making distribution easier in low-resource settings.
Route of Administration Insights
The parenteral segment dominated the market. Parenteral vaccines (intramuscular or subcutaneous) directly deliver antigens into the bloodstream or muscle, triggering a robust systemic immune response. Many vaccines, like mRNA COVID-19 (Pfizer, Moderna) and pneumococcal conjugate (PCV13), require injection for optimal efficacy. Most inactivated, conjugate, recombinant, and subunit vaccines are designed for injection. Example: Hepatitis B, DTaP, HPV, and meningococcal vaccines are all administered parenterally. Parenteral administration often leads to longer-lasting immunity than mucosal (oral/intranasal) vaccines. Example: Injectable polio vaccine (IPV) provides better long-term immunity than oral polio vaccine (OPV). Many vaccines in routine childhood and adult immunization schedules are injectable. Example: CDC and WHO guidelines recommend parenteral administration for most essential vaccines. Parenteral vaccines are easier to standardize and store than oral or intranasal forms. Example: Due to their effectiveness and stability, COVID-19 mass vaccination relied heavily on injectable vaccines. Pharmaceutical companies favor parenteral vaccines due to stronger clinical trial data, established manufacturing processes, and predictable regulatory approvals. Example: Pfizer, GSK, Moderna, and Merck primarily produce injectable vaccines.
The oral segment is anticipated to grow with the highest CAGR in the market during the studied years. Oral vaccines eliminate needle-related pain, fear, and risks (e.g., needle-stick injuries cross-contamination). Example: Rotavirus (RotaTeq, Rotarix) and oral polio vaccine (OPV) are widely accepted due to ease of use. No need for trained healthcare professionals to administer oral vaccines, making them ideal for large-scale immunization campaigns. Oral vaccines trigger local immune responses (IgA) in the gut and respiratory tract, crucial for infections that enter through mucosal surfaces. New oral vaccines, such as heat-stable formulations, can reduce cold chain dependence. Scientists are developing oral mRNA and DNA-based vaccines, which could revolutionize immunization strategies. The oral vaccine market is expanding rapidly due to its needle-free delivery, ease of administration, improved mucosal immunity, and advancing technology. While parenteral vaccines remain dominant, the future of oral vaccines is promising, especially for pandemic preparedness and developing regions.
Disease Indication Insights
The virus disease segment led the market. Unlike bacterial infections, which can often be treated with antibiotics, many viral diseases have limited or no effective antiviral drugs. HIV, hepatitis B, and influenza rely heavily on vaccines for prevention. Viruses spread rapidly and globally, increasing the vaccine demand to control outbreaks. Vaccines provide long-lasting protection against viral infections, reducing the need for ongoing treatments. National vaccination programs prioritize viral diseases due to their public health impact. Example: Childhood vaccines (MMR, polio, hepatitis B) and flu vaccines are part of routine immunization schedules. Major pharmaceutical companies and governments invest heavily in viral vaccine development due to public health needs. Viral vaccines are often produced using cell culture, egg-based, or recombinant DNA technology, allowing for rapid scale-up and global distribution. Viral diseases require mass vaccination due to high transmission, lack of treatments, and public health impact. Governments and pharmaceutical companies prioritize large-scale vaccine manufacturing to prevent outbreaks and control global health threats.
The bacterial diseases segment is projected to expand rapidly in the market in the coming years. Infants and young children have underdeveloped immune systems, making them more susceptible to bacterial diseases. Governments mandate pediatric vaccination through national immunization schedules to prevent outbreaks. Increased awareness about immunization and its role in protecting pregnant women and newborns has driven demand.
Age Group Insights
The pediatric segment registered its dominance over the market. Vaccinating children prevents the spread of disease and protects the entire community. Programs like Vaccines for Children (VFC) in the U.S. heavily fund pediatric vaccines. Many vaccines are mandatory for school entry, increasing demand. Paediatric vaccines are needed worldwide, leading to high production volumes and stockpiling by governments. For example, Gavi, the WHO, and UNICEF procure millions of pediatric vaccine doses annually for global immunization efforts.
The adult segment is anticipated to grow with the highest CAGR in the market during the studied years. The rising number of elderly individuals (65+) has increased the demand for vaccines that protect against age-related diseases like pneumonia, shingles, and flu. Example: Pneumococcal vaccines (Prevnar 20, Pneumovax 23) and shingles vaccine (Shingrix) are widely used in older adults. More adults are recognizing the benefits of vaccination for long-term health. Example: Workplace vaccination programs and pharmacist-administered vaccines (flu, COVID-19, HPV) are increasing uptake. Government agencies like CDC, WHO, and ACIP have expanded vaccine recommendations for adults, boosting demand. Example: HPV vaccines (Gardasil 9) were initially for younger individuals but are now approved up to age 45. Increased global travel and workplace vaccination mandates fuel the need for adult immunization. Example: Hepatitis A, yellow fever, and meningococcal vaccines are essential for travelers.
Distribution Channel Insights
The hospital and retail pharmacies segment dominated the market in 2024. Retail pharmacies (CVS, Walgreens, Walmart) offer walk-in vaccinations, making getting immunized easier without scheduling a doctor's appointment. Hospitals serve as primary immunization centers, especially for newborns, elderly patients, and those with chronic conditions. The Centers for Disease Control and Prevention and state health departments have expanded pharmacists' authority to administer vaccines, increasing retail pharmacy vaccinations. Example: During COVID-19, retail pharmacies played a major role in vaccine distribution. Medicare, Medicaid, and private insurers cover most vaccines administered at hospitals and pharmacies, making them the preferred choice for immunization. Example: The Inflation Reduction Act (2023) eliminated Medicare Part D vaccine copays, boosting pharmacy adult vaccinations. Hospitals and pharmacies have better storage and distribution systems, ensuring they can handle large-scale vaccine administration efficiently. Example: Flu, COVID-19, and shingles vaccines are stocked in high volumes at pharmacies due to seasonal demand. Adults prefer getting vaccines at pharmacies for convenience, while hospitals provide travel vaccines, hepatitis, and pneumonia shots for at-risk populations. Example: Retail pharmacies saw a major rise in shingles (Shingrix) and HPV (Gardasil 9) vaccinations.
The government suppliers segment is anticipated to grow with the highest CAGR in the market during the studied years. Governments run national vaccination programs to protect populations from infectious diseases. Example: The Vaccines for Children (VFC) program in the U.S. provides free vaccines to millions of children annually. Governments stockpile vaccines and invest in pandemic preparedness. Example: The U.S. government’s Operation Warp Speed facilitated rapid COVID-19 vaccine production and distribution. Increased public health funding is boosting government bulk purchases of vaccines. Example: The Centers for Disease Control and Prevention and WHO procure millions of doses annually for influenza, polio, and COVID-19. Governments supply vaccines for global health initiatives through organizations like Gavi and the United Nations Children's Fund. Example: The U.S. government distributes polio, measles, and malaria vaccine in low-income countries. Government-backed vaccination programs increase public trust and compliance, boosting vaccine uptake. Example: State-mandated childhood vaccinations for school entry drive high coverage rates. The government supplier segment is expanding due to large-scale immunization programs, pandemic preparedness, increased funding, global vaccine initiatives, and strong public-private partnerships. This trend will continue as governments play a central role in disease prevention and outbreak response.
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Some of the prominent players in the U.S. Vaccine market include:
• Serum Institute of India Pvt. Ltd.
• Seqirus
• Sanofi
• GSK Plc.
• Merck & Co., Inc.
• Pfizer Inc.
• Moderna Inc.
• Sinovac
• BioNTech SE
• AstraZeneca
Recent Developments:
• In February 2025, GSK plc. declared that Penmenvy has been approved by the US Food and Drug Administration (FDA) for use in people between the ages of 10 and 25. The vaccine combines the antigenic components of GSK's well-known meningococcal vaccines, Bexsero and Menveo. It targets the five major serogroups of Neisseria meningitidis that frequently cause invasive meningococcal disease. The regulatory application L was backed by positive results from a phase III trial. According to the safety statistics, the vaccine's safety profile aligns with GSK's authorized meningococcal vaccines.
• In August 2024, the Food and Drug Administration authorized the use of new mRNA COVID-19 vaccines (2024-2025 formula) to receive authorization (EUA) to the Omicron variation KP.2 is represented by a monovalent (single) component, the SARS-CoV-2 strain. The COVID-19 mRNA vaccines have been modified to include this formula, which will better defend against currently circulating variations and against COVID-19's severe effects, such as hospitalization and death.
U.S. Vaccine 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. Vaccine Market
By Type Scope
• Subunit Vaccines
o Recombinant vaccines
o Conjugate Vaccines
o Toxoid vaccines
• Inactivated
• Live Attenuated
• mRNA vaccines
• Viral vector vaccines
By Route of Administration Scope
• Oral
• Parenteral
• Nasal
By Disease Indication Scope
• Viral Diseases
o Hepatitis
o Influenza
o HPV
o MMR
o Rotavirus
o Herpes Zoster
o Covid-19
o Others
• Bacterial Vaccines
o Meningococcal Diseases
o Pneumococcal diseases
o DPT
o Others
• Cancer Vaccines
• Allergy Vaccines
By Age Scope
• Pediatric
• Adult
By Distribution Channel Scope
• Hospital & Retail Pharmacies
• Government Suppliers
• Others
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