Rotavirus Vaccines Market Size, Share & Industry Analysis, By Type (Live Attenuated and Others), By Product (ROTARIX, RotaTeq, ROTASIIL, ROTOVAC, and Others), By Distribution Channel (Hospital & Retail Pharmacies, Government Suppliers, and Others), and Regional Forecast, 2025-2032

The global rotavirus vaccines market size was valued at USD 5.19 billion in 2024. The market is projected to grow from USD 5.22 billion in 2025 to USD 10.21 billion by 2032, exhibiting a CAGR of 10.1% during the forecast period. North America dominated the rotavirus vaccines market with a market share of 38.53% in 2024. 

Rotavirus is a highly contagious virus that primarily affects the gastrointestinal tract and causes inflammation in the stomach and intestines. It is the common cause of diarrhea and vomiting, particularly in infants. These vaccines are administered orally to protect infants from severe infections. Rotavirus vaccines are typically given as part of the routine immunization schedule for infants.

The rotavirus vaccines market is witnessing significant growth due to the rise in incidence of rotavirus. In the U.S., almost all children are infected with rotavirus before 5 years of age. Additionally, the rise in awareness about rotavirus infections and preventive measures further support the market growth.

• For instance, according to the data published by the Centers for Disease Control and Prevention, in April 2024, more than 4,00,000 rotavirus patients visit the doctor, each year in the U.S., among them 2,00,000 patients visit emergency rooms.

The market is expected to show prominent growth in the future due to the robust pipeline and high R&D investment by major players, such as GSK plc., Merck & Co., Inc., and Serum Institute of India Pvt. Ltd.

MARKET DYNAMICS

MARKET DRIVERS

Growing Implementation of National Immunization Programs Drive Market Growth

The rotavirus vaccine market is driven by a rise in the implementation of National Immunization Programs particularly in Southeast Asia and Europe. These programs are focused on protecting children and pregnant women from life-threatening diseases and infections including rotavirus. The U.S., Germany and France, set the schedule for rotavirus vaccination as a part of routine childhood immunizations. This expansion, coupled with rising awareness of the disease impact and support from international health organizations significantly boost the rotavirus vaccine market growth.

• For instance, according to the data published by the Government of India’s Ministry of Health and Family Welfare, in August 2019, the National Technical Advisory Group on Immunization (NTAGI) recommended the introduction of the rotavirus vaccine in the Universal Immunization Programme (UIP).

MARKET RESTRAINTS

Supply Chain Issues May Hinder Market Growth

Disruptions in the supply chain leading to delays and requirement for use of vaccine substitutes due to the temporary unavailability of few vaccines can negatively impact the market growth. These vaccines require specific transport and storage conditions, which are hard to maintain in resource-limited settings. Such scenarios may lower the vaccine availability, which lowers the product adoption rate and hinders the overall market growth.

• For instance, according to the data published by the UNICEF Supply Division, in October 2024, several countries addressed rotavirus vaccine supply disruptions experienced in 2022 and 2023 by switching to alternative vaccine products. These disruptions were primarily due to reduced supply from a specific manufacturer, GSK, through UNICEF.

MARKET OPPORTUNITIES

Expanding Vaccination Coverage Expected to Boost Market Growth in Future

The vaccination coverage is expected to rise due to factors such as a rise in awareness, new rotavirus vaccine introduction, and the cost-effectiveness of rotavirus vaccination programs. Expanding vaccination coverage, especially in developing countries such as India, China, and others, is expected to provide growth opportunities in the future. Additionally, several countries are including vaccines for rotavirus into their national immunization schedules, which further increases vaccination coverage rates. Moreover, a rise in government initiatives is also expected to support the market growth in upcoming years.

• For instance, in October 2024, in the Expanded Programme on Immunization, Chad launched three vital new vaccines. These vaccines are against rotavirus diarrhea, malaria, and pneumococcal infections.

MARKET CHALLENGES

Rise in Safety Concerns May Pose a Significant Market Challenge

The rotavirus vaccines are crucial in preventing severe gastroenteritis in children, however, the potential safety concerns, such as intussusception, may hinder the market growth. Additionally, the negative community discussion about the vaccine safety issues can significantly influence public perception and trust in vaccines, impacting overall market growth.

• For instance, according to the data published by the Centers for Disease Control and Prevention in December 2024, studies show that rotavirus vaccination caused a slight increase in the risk of intussusception, a type of bowel blockage.

ROTAVIRUS VACCINES MARKET TRENDS

Innovative Novel Vaccine Formulations is a Prominent Market Trend

Currently, oral administration is the only route of administration for rotavirus vaccines. Despite being a convenient and easy-to-administer route, it has low bioavailability. Drugs are disrupted in the stomach due to several enzymes or breakdown during first-pass metabolism in the liver. These factors reduce the bioavailability of rotavirus vaccine. To overcome these problems, patients need novel vaccine formulations, including patches. Thus, rise in R&D activities and key players’ involvement is a prominent market trend.

• For instance, in June 2025, Emory University and Micron Biomedical announced the first clinical trial of CC24, a novel rotavirus vaccine with dissolvable microarray technology. This is the first clinical evaluation of any vaccine delivered via patch.

Additionally, the ongoing research on vaccines for rotavirus by key market players, such as the development of vaccines for the parenteral route of administration, further promotes the rotavirus vaccines market growth.

• For instance, according to the data published by the National Center for Biotechnology Information in August 2021, some of the rotavirus vaccines that are under development, which are designed for parenteral administration. These advanced parenteral vaccine candidates are 2 subunit vaccines.

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Segmentation Analysis

By Type

Increased Availability, Approvals, and Long-lasting Response Drive Live Attenuated Segment

On the basis of type, the market is classified into live attenuated and others.

The live attenuated vaccine type accounted for the leading global rotavirus vaccines market share in 2024. This growth is due to the rise in R&D activities and clinical trials by key market players. The live attenuated type of vaccine shows a strong and long-lasting immune response, supporting the market growth. For instance, the U.S. FDA has approved ROTARIX and RotaTeq, both are live attenuated types of vaccines.

• In March 2024, Sinovac Biotech Ltd. initiated a phase 1 clinical trial for the reassortant rotavirus vaccine, which is a live attenuated, oral vaccine.

The others segment include subunit types of vaccines for rotavirus, and these vaccines are under development. The trivalent P2-VP8 candidate by SK chemicals is in phase 3 and it is the most advanced pipeline product for the subunit type of vaccine. This growing pipeline of products is anticipated to boost the segment’s growth in future.

By Product

Availability and Inclusion in National Immunization Programs Boosts Growth of RotaTeq Segment

Based on product, the market is segmented into ROTARIX, RotaTeq, ROTASIIL, ROTOVAC, and others.

The RotaTeq segment held a leading market share during the forecast period. This dominance is attributed to its high efficacy, especially against severe rotavirus gastroenteritis. RotaTeq is a pentavalent vaccine and protects against five different types of rotavirus strains. Additionally, it is included in national immunization programs. Since the inclusion, there is a significant reduction in rotavirus-related hospitalizations and deaths, which shows its wide availability and high efficacy.

• For instance, according to the data published by the Centers for Disease Control and Prevention, in March 2021, RotaTeq vaccine showed 98% protection against severe rotavirus gastroenteritis in large clinical trials.

The ROTARIX segment held a significant share of the market in 2024. The growth of the segment is attributed to its advantages including high potency. This vaccine has received approval in major regions, such as North America, Europe, Asia Pacific, and others.

By Distribution Channel

Increase in Focus on Public Health Boosts the Growth of Government Suppliers

Based on distribution channel, the market is segmented into hospital & retail pharmaciess, government suppliers, and others.

The government suppliers segment held the highest share of the market in 2024. The segment is primarily growing through national immunization programs, such as India's Universal Immunization Programme (UIP). UIP makes these vaccines available to children at free of cost. This significantly increases vaccine coverage and reduces the financial burden on families. Different factors, such as public health initiatives, equitable access, among others, also support the segment’s growth.

• For instance, according to the data published by the UNICEF Supply Division, in October 2024, UNICEF purchased 329 million rotavirus vaccines for Gavi-supported countries and 2.0% for middle-income countries (MICs).

The hospital & retail pharmacies segment held a significant share of the market due to the rise in cases of rotavirus, which has resulted in high patient flow in hospitals.

Rotavirus Vaccines Market Regional Outlook

By geography, the market is categorized into North America, Europe, Asia Pacific, and Latin America, and the Middle East & Africa.

North America

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North America dominated the market growth and generated revenues of USD 2.0 billion in 2024. The presence of advanced healthcare infrastructure, such as innovative supply chain and cold chain management, is expected to drive the market growth in this region. Additionally, higher vaccination rate, robust research and development capabilities, with a high demand for new solutions also support the market growth.

The U.S. market held the largest share of the North American region in 2024. The dominance of the U.S. is due to the rise in the number of cases of rotavirus. This high incidence of rotavirus results in a rise in vaccination rate, which supports the region’s growth. Additionally, government initiatives, product approvals and recommendations, and favorable reimbursement policies boost the market growth in the U.S.

• For instance, according to data published by the Centers for Disease Control and Prevention, in July 2024 two vaccines were approved in the U.S., these vaccines are safe and operative for infants and recommended by the CDC.

Europe

Europe held a significant share of the market in 2024. The growth of the region is due to the rising cases of rotavirus infection. Since 2006, the European government has approved ROTARIX and RotaTeq vaccines to control the rise in cases.

• For instance, according to the data published by the National Center for biotechnology information, in November 2022, rotavirus gastroenteritis leads to approximately 75,000–150,000 hospitalizations in Europe annually.

Asia Pacific

Asia Pacific held a substantial share and is the fastest-growing region of the market. The demand for rotavirus preventive vaccines rises due to a surge in the pediatric population in this region. Additionally, government initiatives and support drives the regional market growth. The rise in cases of rotavirus infection in this region also drives the market growth.

• For instance, according to the data published by the National Center for Biotechnology Information, in May 2020, as per the 2008-2018 rotavirus surveillance data, 40.8% of all diarrheal disease in children in Southeast Asia were caused by rotavirus infection.

Latin America and the Middle East & Africa

Latin America and the Middle East & Africa are expected to have a considerable share of the market in the near future. The rise in disease burden and increase in government initiatives drive regional growth. Additionally, government suppliers, such as Gavi and UNICEF, support this region's growth by providing rotavirus vaccines at a low price.

COMPETITIVE LANDSCAPE

Key Industry Players

New Product Development by Key Companies Resulted in their Dominating Position

The global rotavirus vaccines market is concentrated with companies such as GSK plc., Merck & Co., Inc., and Serum Institute of India Pvt. Ltd., accounting for a significant market share. The GSK plc. held a significant share of the market. The company's dominance is due to its key distribution strategy and strong vaccine portfolio. In developing nations, GSK plc., implemented a successful distribution strategy by partnering with organizations such as Gavi, the Vaccine Alliance, to provide affordable access to Rotarix. Additionally, high research and development activities as well as product approvals also support the company's growth.

• For instance, in November 2022, GSK plc. received the U.S. FDA approval for the new liquid presentation of ROTARIX vaccine, which contains live, human attenuated rotavirus strain.

Merck & Co., Inc. held a notable share in 2024. The growth is attributed to the wide adoption of its live oral pentavalent rotavirus vaccine, RotaTeq. The company actively worked to expand the reach of its rotavirus vaccine, including entering into the Chinese market.

Furthermore, Serum Institute of India Pvt. Ltd., Sanofi, Bharat Biotech, and SINOVAC are among other major key players in the market. These key players are focusing on the development of vaccines for rotavirus and have significant investments in the research & development of innovative products that have supported the companies’ growing share.

LIST OF KEY ROTAVIRUS VACCINES COMPANIES PROFILED

• GSK plc. (U.K.)
• Merck & Co. Inc. (U.S.)
• Serum Institute of India Pvt. Ltd. (India)
• Sanofi (France)
• Bharat Biotech (India)
• SINOVAC (China)

KEY INDUSTRY DEVELOPMENTS

• January 2024: SINOVAC received approval for the clinical trial of the reassortant rotavirus vaccine from the China National Medical Products Administration (NMPA).
• May 2021: The Wistar Institute in the U.S. is celebrating the 15th anniversary of the commercialization and approval of a rotavirus vaccine.
• March 2021: GSK plc. and UNICEF committed to supply rotavirus vaccine, Rotarix, at a low price through the Humanitarian Mechanism for civil society organizations and Gavi-supported immunization programmes.
• January 2020: Serum Institute of India launched a new variant of Rotasiil, a World Health Organization prequalified rotavirus vaccine, for the prevention of rotavirus.
• November 2018: Merck & Co. Inc. ended their long-term agreement to supply rotavirus vaccines to West Africa and started supplying RotaTeq vaccine to China.

REPORT COVERAGE

The global rotavirus vaccines market analysis provides market size & forecast by all the segments included in the report. It includes details on the market dynamics and market trends expected to drive the market in the forecast period. It offers information on key regions/countries, key industry developments, new product launches, details on partnerships, and mergers & acquisitions in key countries. The report covers a detailed competitive landscape with information on the market share and profiles of key players.

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Report Scope & Segmentation