Oral Vaccine Market Size, Share and Trends 2024 to 2034

Oral Vaccine Market Size and Forecast 2024 to 2034

The global oral vaccine market size accounted for USD 3.87 billion in 2024 and is expected to exceed around USD 9.62 billion by 2034, growing at a CAGR of 9.54% from 2024 to 2034. The rising demand for oral vaccine market is attributable to the need for safer, easier-to-administrate, and more affordable vaccines than injectable vaccines.

Oral Vaccine Market Key Takeaways

• North America dominated the global oral vaccine market in 2023.
• Europe is projected to host the fastest-growing market in the forecast period.
• By vaccine type, the live attenuated segment contributed the highest market share in 2023.
• By vaccine type, the inactivated vaccines segment is expected to grow at a significant CAGR during the forecast period.
• By application, the infectious diseases segment accounted for the largest market share in 2023.
• By application, the cancer segment is anticipated to grow with the highest CAGR during the forecast period.
• By distribution, the hospital segment contributed the highest market share in 2023.
• By distribution, the clinics segment is projected to grow significantly during the forecast period.
• By end-user, the pediatric segment held the largest market share in 2023.
• By end-user, the adult segment is expected to grow at the fastest CAGR during the projected period.

How is Artificial Intelligence (AI) Changing the Oral Vaccine Market?

The integration of artificial intelligence in the oral vaccine market has the potential to transform the development and distribution. The importance of artificial intelligence has recently been demonstrated during the COVID-19 pandemic. AI-based approaches were used to boost the mRNA vaccine antigen design and perform clinical trials. Moreover, it helps developers to go from a viral sequence to an approved product in less than a year. mRNA technology is creating the way a new vaccine that is quicker and easier to modify. Researchers employed a deep learning algorithm called Linear Design to design COVID-19 vaccines.

Market Overview

Oral vaccines are a gentle and convenient way to take medication and prevent infectious diseases, along with any invasive injections. The oral administration of active ingredients into the body induces the immune response for the ongoing treatments. The popularity of oral vaccines is credited to the ease of administration, zero-invasion, safety, and lower cost compared to injectable vaccines. Another advantage of oral vaccination over injectable vaccines is the simple manufacturing procedures. Additionally, oral vaccination is ideal for individuals with weakened immune systems. Currently, the vaccines available in the market for certain diseases such as Polio-Polio Sabin, cholera-dukoral, Vaxchora, Rotavirus-RotaTeq, Rotarix, Typhoid fever-Vivotif.

• In Guinea, health workers, communities, the government, UNICEF, and partners teamed up and took part in the vaccination campaign to vaccinate each child in the country with the oral vaccine in 2024. 3.2 million children were vaccinated twice against the disease.

Oral Vaccine Market Growth Factors

• Bacillus subtilis spores: According to clinical research, 3 doses of B. Subtilis spores result in a significant elevation of both IgG and IgA antibodies against the spike proteins.
• Nanoparticle-based delivery system: nanotechnology is assisting as a vaccine-delivery vehicle to enhance the stability of antigens and efficacy of immunity production. The widely studied nanoparticles for oral vaccine delivery are liposomes, lipid nanoparticles, dendrimers, and inorganic nanoparticles. This concept is still emerging and holds the potential to revolutionize the oral vaccine market.
• No adverse effects: The advantages of the administration of oral vaccines are that they reduce the risk of infection, there is no requirement for medical personnel, beneficial for people with weakened immune systems, non-invasive and thermal stable. 
• User-friendly administration: The needle-free vaccine administration mitigates the risk of transmitting blood-borne diseases and can be performed by a non-health worker or someone without medical training.

Market Scope

Market Dynamics

Driver

Routine immunization and system strengthening

Routine immunization is a recommended practice for everyone, depending on the age and vaccine history. The misconception people hold is vaccination needs to be taken only in childhood before starting school. However, they are recommended routine vaccines and boosters for adolescents and adults. Having some immunization helps people protect from chronic illness and sometimes death. It also protects against spreading disease among family members, colleagues, friends, classmates, and other communities. This practice has been made a priority for all countries in WHO South-East Asia.

• In November 20204, the Pan American Health Organization (PAHO) re-verified Brazil as free of measles, rubella, and congenital rubella syndrome (CRS)

Restraint

Tolerance of the oral vaccine

The primary challenge behind hindering the oral vaccine market growth is the factor that an oral vaccine must tolerate the extreme environment of the highly acidic stomach, the wide range of pH values throughout the gastrointestinal tract, and the existence of proteolytic enzymes that can decompose proteins without reducing the potency. As there are various types of immune adjuvants used in injectable vaccines to boost the immune response, compared to that, there is a significant lack of mucous adjuvants for oral vaccinations. To settle this problem, novel oral vaccine adjuvants are developed that are safer and can withstand harsh environments.

Opportunity

Government, Industry, and organization development

The government across all nations is expected to establish early, evidence-informed strategic goals and leadership that serves global health interests. By investing in new vaccine technologies, regional research and development, and manufacturing hubs, the government will strengthen market readiness. The industries are anticipated to ensure their activities are aligned with WHO’s guidance, emphasizing research and development, particularly on the WHO-listed priority pathogens and target product profile, clinical trials in low-income countries, and target global policy needs and expedited data submission needed for regulatory approval.

The international organization and partners will be prioritizing the global public health immunization agenda in 2030. Bringing new country-driven initiatives and projects and calling for technology and application of resolutions on market transparency for health products. Strengthening routine immunization systems and services is essential to achieve high coverage and target global and regional disease elimination. Even the top-tier nations with immunization programs have unreached populations that are given special efforts.

Vaccine Type Insights

The live attenuated segment contributed the highest share of the oral vaccine market in 2023. The dominance of this segment is observed due to its popularity of utilizing the weakened or attenuated form of the germ that causes a disease. These vaccines are homogenous to the natural infection. They create a strong and long-lasting immune response. Administering just one or two doses of live vaccines can provide lifetime protection against specific germs or diseases. Live attenuated vaccines are commonly given for diseases such as measles, mumps, rubella (MMR combined), rotavirus, smallpox, chickenpox, and yellow fever.

• In August 2024, Indian Immunological Limited (IIL), a Hyderabad-based vaccine maker, developed a live attenuated, needle-free intranasal booster vaccine against the Sars-Cov-2 virus that causes Covid-10. This development is created in collaboration with Griffith University, Australia.

The inactivated vaccines segment is expected to grow at a significant CAGR in the oral vaccine market during the forecast period. The possibility of higher safety profiles, less reactogenicity, and technical feasibility contribute to the expansion of this segment. The inactivated vaccines contain pathogens that have been killed or inactivated, making them unable to replicate or cause diseases. Generally, they do not offer any immunity protection equivalent to live vaccines. They would require several doses to build immunity against disease. Currently, there are six licensed viral inactivated vaccines with either formaldehyde or BPL.

Application Insights

The infectious diseases segment accounted for the largest share of the oral vaccine market in 2023. The prevention of infectious disease through vaccination starts through the production of the same antibodies that make the real disease. This act helps the body to learn to recognize and fight the invasion of a particular virus or bacteria. The body learns to develop immunity and defend itself. Oral vaccines uncover the gut’s mucosal immune system to antigens.

The cancer segment is anticipated to grow with the highest CAGR in the oral vaccine market during the forecast period. This growth is due to the strategic treatment offered by oral vaccines, which trigger the body’s immune response to defend against cancer. Oral vaccines for cancer treatment are proven to be innovative administration routes to improve patient and medical staff experience and immunological results.

Distribution Insights

The hospital segment contributed the highest share of the oral vaccine market in 2023 due to the hospital-based immunization program held to prevent illnesses. The hospital distribution system (HDS) is responsible for managing the organizing framework and process design to distribute medical resources, healthcare supplies, and pharmaceuticals. The hospital's distribution staff ensures that the essential supplies are delivered to the right wards, clinics, and health centers.

The clinics segment is projected to grow significantly in the oral vaccine market during the forecast period, owing to the supply of vaccines for medical indications and to people who are at occupational risk. The role of the clinical stage is to manage vaccines, including storage, handling, and transportation. They also manage the temperature of the vaccine before, during, and after the clinic. Moreover, the clinical workers observe patients post-vaccination for syncope or allergic reactions, educate patients about vaccines, and provide information related to those.

End-user Insights

The pediatric segment held the largest share of the oral vaccine market in 2023. The dominance of this segment is observed as children are exposed to thousands of germs every day, and it is essential to protect them by helping them build their natural defense system. There are several vaccines routinely recommended for infants and children younger than age 7. All children are made to be vaccinated against polio to avoid new outbreaks, and oral polio vaccines (OPV) are given in the majority of the countries. A healthy child younger than 5 years old with a healthy immune system is recommended to get COVID-19 vaccines, which are authorized by the Academy of Paediatrics (AAP). Additionally, there are two rotavirus vaccines licensed for infants as oral vaccines.

The adult segment is expected to grow at the fastest CAGR in the oral vaccine market during the projected period. The growth of this segment is noticed as vaccination enables adults to stay healthy and create a healthy environment for the surrounding people. Some vaccines are repeated as one grows older, and the vaccines taken in childhood get weaker with time. Commonly given oral vaccines to adults are rotavirus, adenovirus, cholera vaccines, and oral typhoid vaccines. Moreover, vaccines for hepatitis B are recommended for all adults above 50 years of age.

Regional Insights

North America dominated the global oral vaccine market in 2023. The dominance of this region is driven by the robust healthcare facilities and investment made into the research and development of novel vaccines. State laws have established mandatory vaccination for both public and private school children. They have also made healthcare workers and patients/residents of healthcare facilities to be vaccinated. Due to the presence of FDA organizations, the vaccines are safe and effective for their intended use. They provide licensed vaccines from the manufacturing process to assure product quality and consistency.

• In 2023, the U.S. government invested about 31.9 billion for the development, production, and purchase of mRNA vaccines for COVID-19 and for the development of vaccine technology to defeat future pandemics.
• In 2024, the U.S. government is supporting GAVI to increase access to immunization in lower-income countries.

Europe is projected to host the fastest-growing oral vaccine market in the forecast period. The expansion of this region is credited to the collaboration initiative taken by the European region to provide full coverage of vaccination and spread awareness regarding the same. The region aims to foster innovation and value recognition for immunization in Europe. The adult vaccine returns up to 19 times their initial investment to society.  With changing global demographics and healthcare challenges, the adult immunization program is a powerful tool for policymakers to ease this pressure. The government is shifting to a prevention-first mindset to help calm the increased pressure on health services.

Oral Vaccine Market Companies

• Sanofi
• GSK
• IOS
• Takeda Pharmaceuticals
• Soligenix
• Liquidia Technologies
• Elasmogen
• Abivax
• Oravax Medical
• Rapid Dose Therapeutics
• AVRO Life Science
• Prokarium Ltd
• Matinas Biopharma
• ACM Biolabs
• Alcami

Latest Announcements by Industry Leaders

• In December 2024, Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, said, “Building on our immunology expertise and 12 years of robust clinical and real-world data, we aim to continue leading the way in protection against flu and its severe outcomes. Our goal is to develop a combined flu and COVID-19 vaccine that offers simpler scheduling and fewer injections without compromising on the industry-leading levels of efficacy, safety, and tolerability of the standalone vaccines included in our combination vaccine.”
• In November 2024, Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said, “As a leader in meningococcal vaccines, GSK is dedicated to finding innovative solutions that simplify immunization and support vaccine uptake. We remain committed to safeguarding individuals from bacterial meningitis, and we will persist in our efforts to prevent this devastating disease among at-risk populations in the European Union.

Recent Developments

• In August 2024, Bharat Biotech International Ltd, a vaccine maker company launched Hillchol (BBV131), a new single-strain oral cholera vaccine (OCV) developed under license from Hilleman Laboratories (funded by Merck, U.S. and Wellcome Trust, UK). The aim behind this initiative is to mitigate the shortage of OCV that exists globally. Currently, there is a shortage of around 40 million doses annually.
• In December 2024, the Ministry of Public Health and Population teamed up with the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF), and with support from Gavi, the Vaccine Alliance launched a mass oral cholera vaccination campaign. This initiative aims to administer a single dose of OCV to 3.8 million across six governorates- Aden, Abyan, Al-Dhale, Lahj, Marib, and Taiz.

Segments Covered in the Report

By Vaccines Type

• Live Attenuated Vaccines
• Inactivated Vaccines
• Subunit Vaccines
• Others

By Application

• Infectious Diseases
• Cancer
• Others

By Distribution Channel

• Hospital 
• Clinics
• Online Pharmacies
• Others

By End-User

• Pediatrics
• Adults
• Geriatrics

By Geography

• North America
• Asia Pacific
• Europe
• Latin America
• Middle East and Africa