Oral Vaccine Market Report 2025

The oral vaccine market size has grown rapidly in recent years. It will grow from $3.59 billion in 2024 to $3.95 billion in 2025 at a compound annual growth rate (CAGR) of 10.1%. The growth in the historic period can be credited to rising investments in vaccine research and development, supportive regulatory frameworks for oral vaccine trials, increasing global travel and tourism, the need for large-scale immunization during outbreaks, and the expansion of cold chain infrastructure.

The oral vaccine market size is expected to see strong growth in the next few years. It will grow to $5.74 billion in 2029 at a compound annual growth rate (CAGR) of 9.8%. The growth in the forecast period can be attributed to the rising global burden of infectious diseases, increasing demand for needle-free vaccine administration, higher acceptance among pediatric patients, improved patient adherence, and expansion of government immunization programs. Major trends in this period include the emergence of novel oral vaccine technologies, advancements in oral drug delivery methods, public-private sector collaborations, development of oral vaccines targeting non-traditional diseases, and innovations in encapsulation and formulation techniques.

The increasing prevalence of infectious diseases is expected to drive growth in the oral vaccine market in the coming years. Infectious diseases are caused by harmful microorganisms - such as bacteria, viruses, fungi, or parasites that can be transmitted between individuals or via the environment. Their rise is largely attributed to increased global travel, which facilitates the rapid movement of people and pathogens across borders, accelerating the spread of infections worldwide. Oral vaccines play a key role in combating infectious diseases by stimulating mucosal immunity in the gut, a primary entry point for many pathogens, providing effective protection at the site of infection. For example, according to the Health Security Agency, a UK-based government department, reported tuberculosis (TB) cases in England increased by 11% in 2023 compared to 2022. Consequently, the rising prevalence of infectious diseases is boosting the oral vaccine market.

Companies in the oral vaccine market are developing innovative solutions, such as second-generation oral pill vaccines, to improve immune responses and simplify administration. These pill-based vaccines are designed to enhance immunogenicity, broaden protection, and enable mass immunization without the need for needles or cold-chain storage. For instance, in March 2025, Vaxart Inc., a U.S.-based biotechnology company, initiated a Phase 1 clinical trial for its second-generation oral norovirus vaccine delivered in pill form. The trial aims to evaluate improved immune responses and safety features, addressing the global demand for accessible and effective norovirus immunization. The pill format eliminates barriers associated with injectable vaccines and supports rapid, large-scale distribution during outbreaks.

In March 2024, the International Vaccine Institute (IVI), a South Korea-based nonprofit focused on global vaccine development, partnered with Biological E. Limited to manufacture a simplified oral cholera vaccine (OCV-S) for India and international markets. Through this collaboration, IVI will provide technical expertise and support for clinical development and regulatory approvals, enabling cost-effective oral cholera vaccine production. Technology transfer is scheduled to be completed by 2025 to help meet the growing global demand driven by increasing cholera outbreaks. Biological E. Limited is an India-based oral vaccine manufacturer.

Major players in the oral vaccine market are Pfizer Inc., Johnson & Johnson, Merck & Co., Sanofi SA, AstraZeneca Plc, Novartis AG, GlaxoSmithKline Plc, Sinovac Biotech Ltd., Panacea Biotec Ltd., Emergent BioSolutions Inc., Zydus Lifesciences, Serum Institute of India Pvt. Ltd., Bharat Biotech Ltd., Adimmune, Haffkine Biopharmaceutical Co. Ltd., Changchun BCHT Biotechnology Co., BIBCOL, Medigen Vaccine Biologics Corp., BlueWillow Biologics Inc., BioNet Asia Co. Ltd., and Innovax.

North America was the largest region in the oral vaccine market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in oral vaccine market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the oral vaccine market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

An oral vaccine is a form of immunization delivered through the mouth, usually as a liquid, tablet, or capsule, to trigger an immune response against targeted pathogens. It functions by introducing antigens via the gastrointestinal tract, allowing the immune system to recognize and respond to them effectively.

The primary types of oral vaccines include live attenuated vaccines, inactivated vaccines, subunit vaccines, and others. Live attenuated vaccines contain weakened forms of pathogens designed to elicit a strong immune response without causing the disease. These vaccines are used for diseases such as polio, tuberculosis, rabies, influenza, cholera, and more, and are administered by end users including hospitals, clinics, government health agencies, and other healthcare organizations.

The oral vaccine market research report is one of a series of new reports that provides oral vaccine market statistics, including oral vaccine industry global market size, regional shares, competitors with a oral vaccine market share, detailed oral vaccine market segments, market trends and opportunities, and any further data you may need to thrive in the oral vaccine industry. This oral vaccine market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The oral vaccine market consists of sales of oral booster doses, oral vaccine delivery systems, vaccine stabilizers, and mucosal immunology research tools. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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