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Add to CartHuman Rotavirus Vaccine Market
By Type;
Rotarix, Rotateq, Rotavac, Rotavin-M1, Lanzhou Lamb, and OtherBy Product Type;
Monovalent Rotavirus Vaccines and Pentavalent Rotavirus VaccinesBy End Use;
Hospitals & Clinics, Academic & Research, and OthersBy Route of Administration;
Oral Vaccination and Parenteral VaccinationBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Introduction
Global Human Rotavirus Vaccine Market (USD Million), 2021 - 2031
In the year 2024, the Global Human Rotavirus Vaccine Market was valued at USD 11,329.70 million. The size of this market is expected to increase to USD 21,249.05 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 9.4%.
Human Rotavirus Vaccine Market
*Market size in USD million
CAGR 9.4 %
| Study Period | 2025 - 2031 |
|---|---|
| Base Year | 2024 |
| CAGR (%) | 9.4 % |
| Market Size (2024) | USD 11,329.70 Million |
| Market Size (2031) | USD 21,249.05 Million |
| Market Concentration | Medium |
| Report Pages | 313 |
Major Players
- GlaxoSmithKline plc
- Merck & Co., Inc.
- Bharat Biotech
- Sanofi S.A.
- Lanzhou Institute of Biological Products Co., Ltd.
- Serum Institute of India Pvt. Ltd.
- Biological E. Limited
- Shanghai Institute of Biological Products Co., Ltd.
- Hualan Biological Engineering Inc.
- Instituto Butantan
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Human Rotavirus Vaccine Market
Fragmented - Highly competitive market without dominant players
The global human rotavirus vaccine market is experiencing significant growth driven by the increasing emphasis on childhood immunization programs and the rising awareness of the importance of preventing rotavirus infections. Rotavirus is a leading cause of severe diarrhea and dehydration in infants and young children worldwide, resulting in significant morbidity and mortality, particularly in low- and middle-income countries. In response, governments, healthcare organizations, and international agencies are implementing vaccination campaigns to reduce the burden of rotavirus gastroenteritis and its associated complications. The widespread adoption of rotavirus vaccination as part of routine childhood immunization schedules is driving market expansion, with increasing vaccination coverage contributing to a decline in rotavirus-related hospitalizations and deaths.
Technological advancements in vaccine development and manufacturing are enhancing the efficacy, safety, and accessibility of human rotavirus vaccines. The introduction of live-attenuated oral rotavirus vaccines, such as Rotarix and RotaTeq, has revolutionized rotavirus prevention efforts by providing effective protection against multiple rotavirus strains. These vaccines have undergone rigorous testing and regulatory approval processes, demonstrating their safety and efficacy in large-scale clinical trials. Additionally, innovations in vaccine delivery systems, such as heat-stable formulations and needle-free administration devices, are addressing challenges related to vaccine storage, distribution, and administration in resource-limited settings, thereby facilitating broader vaccine coverage and improving global vaccine access.
Strategic partnerships and collaborations between governments, vaccine manufacturers, and international organizations are driving market growth and expanding access to human rotavirus vaccines in underserved regions. Initiatives such as the Gavi, the Vaccine Alliance, and the Rotavirus Vaccine Program are facilitating the introduction of rotavirus vaccination in low-income countries through subsidized vaccine procurement, technical assistance, and capacity-building efforts. Furthermore, advocacy efforts and public-private partnerships are raising awareness about the benefits of rotavirus vaccination and addressing barriers to vaccine uptake, including vaccine hesitancy and healthcare infrastructure limitations. As these collaborative efforts continue to strengthen, the global human rotavirus vaccine market is expected to witness sustained growth, contributing to the reduction of rotavirus-associated morbidity and mortality worldwide.
Global Human Rotavirus Vaccine Market Recent Developments
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In 2017, the Serum Institute of India Pvt. Ltd. revealed the result of a clinical trial Phase 3 efficacy study of the rotavirus vaccine BRV-PV, ROTASIIL. The study has shown that the vaccine is safe, well tolerated, and provides significant efficacy against severe rotavirus gastroenteritis
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Mexico, a decline of up to 50% in diarrhoeal deaths in children who belong to the age group of fewer than 5 years of age was attributed directly to the use of the vaccine and safeguard their health.
Human Rotavirus Vaccine Market Segment Analysis
In this report, the Human Rotavirus Vaccine Market has been segmented by Type, Product Type, End Use, Route of Administration and Geography.
Human Rotavirus Vaccine Market, Segmentation by Type
The Human Rotavirus Vaccine Market has been segmented by Type into Rotarix, Rotateq, Rotavac, Rotavin-M1, Lanzhou Lamb and Other.
Rotarix
Rotarix is a widely trusted human rotavirus vaccine, capturing nearly 35% of the global market. Its oral administration and high efficacy in preventing severe rotavirus gastroenteritis make it a preferred choice among healthcare providers and parents. The vaccine plays a crucial role in reducing hospitalizations for children under five years old.
Rotateq
Rotateq dominates about 28% of the global rotavirus vaccine market due to its pentavalent design covering multiple virus strains. Supported by strong clinical performance, it is frequently included in national immunization schedules, enhancing access for infants worldwide.
Rotavac
Rotavac contributes roughly 15% to the international market, especially in India. Its affordable pricing and simple storage requirements make it ideal for mass immunization campaigns, ensuring broader coverage for infants at risk of severe rotavirus infections.
Rotavin-M1
Rotavin-M1, primarily utilized in Vietnam, accounts for about 6% of the market. It has shown high safety and effectiveness in regional studies, facilitating its increasing use in Southeast Asian vaccination programs.
Lanzhou Lamb
The Lanzhou Lamb vaccine holds around 5% of the market, with widespread usage in China. Its single-dose schedule reduces logistical challenges while providing strong protection against rotavirus, making it a convenient option for public health initiatives.
Other
Emerging and regional vaccines make up approximately 11% of the global market. These alternatives often feature innovative delivery systems and are tailored to meet the needs of specific populations, expanding access to rotavirus immunization worldwide.
Human Rotavirus Vaccine Market, Segmentation by Product Type
The Human Rotavirus Vaccine Market has been segmented by Product Type into Monovalent Rotavirus Vaccines and Pentavalent Rotavirus Vaccines.
Monovalent Rotavirus Vaccines
Monovalent rotavirus vaccines target a single dominant strain, capturing about 40% of the global market. Known for their excellent safety and effectiveness, they are widely administered in infant immunization programs. These vaccines are particularly beneficial in regions where one rotavirus strain is most prevalent, providing focused and reliable protection.
Pentavalent Rotavirus Vaccines
Pentavalent rotavirus vaccines offer protection against five major rotavirus strains, making up roughly 60% of the market. Their comprehensive coverage makes them a preferred choice in countries with diverse rotavirus prevalence. These vaccines play a critical role in reducing severe gastroenteritis, hospitalizations, and rotavirus-related complications in young children globally.
Human Rotavirus Vaccine Market, Segmentation by End Use
The Human Rotavirus Vaccine Market has been segmented by End Use into Hospitals & Clinics, Academic And Research and Others.
Hospitals & Clinics
Hospitals and clinics represent the largest end-use segment, holding around 65% of the global human rotavirus vaccine market. These facilities are essential for routine pediatric immunizations, ensuring infants receive timely protection. Their role is crucial in reducing severe rotavirus infections and hospitalizations.
Academic And Research
Academic and research institutions account for approximately 20% of the market. They are involved in vaccine development, clinical research, and efficacy studies, contributing to innovation and the improvement of vaccine safety and effectiveness. These efforts support global public health initiatives and informed immunization strategies.
Others
Other end users, making up about 15% of the market, include government programs, NGOs, and community health organizations. They play a key role in mass vaccination campaigns, outreach, and awareness programs, ensuring that rotavirus vaccines reach remote and underserved populations.
Human Rotavirus Vaccine Market, Segmentation by Route of Administration
The Human Rotavirus Vaccine Market has been segmented by Route of Administration into Oral Vaccination and Parenteral Vaccination.
Oral Vaccination
Oral vaccination is the predominant route for human rotavirus immunization, holding about 80% of the global market. Its non-invasive administration, ease of use, and high compliance among infants make it the preferred choice worldwide. Oral vaccines effectively stimulate intestinal immunity, providing strong protection against severe rotavirus gastroenteritis.
Parenteral Vaccination
Parenteral vaccination accounts for approximately 20% of the market and includes injectable formulations of rotavirus vaccines. This route is valuable for specific vaccine types or clinical research studies, offering a robust systemic immune response. Parenteral vaccination serves as an important alternative when oral administration is not feasible.
Human Rotavirus Vaccine Market, Segmentation by Geography
In this report, the Human Rotavirus Vaccine Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Regions and Countries Analyzed in this Report
Human Rotavirus Vaccine Market Share (%), by Geographical Region
North America
North America accounts for about 25% of the global human rotavirus vaccine market, supported by advanced healthcare infrastructure, extensive immunization programs, and high public awareness. Hospitals and clinics actively facilitate routine infant vaccination, helping reduce rotavirus-related illnesses.
Europe
Europe holds nearly 22% of the market, driven by strong government-led immunization programs, clinical research, and vaccine accessibility. These initiatives have effectively lowered hospitalizations and severe rotavirus cases among children across the continent.
Asia Pacific
Asia Pacific is the largest regional market with a 35% share, fueled by high population, expanding healthcare access, and government vaccination initiatives in key countries like India, China, and Indonesia. Both monovalent and pentavalent vaccines are rapidly adopted through national immunization schedules.
Middle East and Africa
Middle East and Africa together contribute about 10% of the global market, with growth driven by increasing healthcare investments, immunization campaigns, and support from international organizations. While distribution challenges exist, vaccination adoption is steadily rising.
Latin America
Latin America accounts for roughly 8% of the market, supported by government programs and NGO-led initiatives to improve access in both urban and rural regions. Focused public health campaigns have increased awareness and coverage of rotavirus vaccination.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Human Rotavirus Vaccine Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers:
- Emphasis on Childhood Immunization Programs
- Rising Awareness of Rotavirus Infections
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Technological Advancements in Vaccine Development-Technological advancements in vaccine development have been instrumental in shaping the landscape of the global human rotavirus vaccine market. Traditional methods of vaccine production have given way to more sophisticated techniques, leading to the development of highly efficacious and safe rotavirus vaccines. Live-attenuated oral vaccines, such as Rotarix and RotaTeq, have emerged as the cornerstone of rotavirus prevention efforts, offering protection against multiple rotavirus strains. These vaccines are developed using advanced biotechnological methods to attenuate the virulence of the virus while retaining its immunogenicity, ensuring robust protection against rotavirus gastroenteritis. Furthermore, advancements in vaccine formulation and delivery systems have addressed critical challenges associated with rotavirus vaccination, particularly in resource-limited settings. Heat-stable formulations have been developed to overcome issues related to vaccine storage and transportation in regions with unreliable cold chain infrastructure. Additionally, innovations in needle-free delivery devices and oral administration techniques have improved vaccine acceptance and accessibility, especially in populations with limited access to healthcare facilities. These technological advancements have expanded the reach of rotavirus vaccination programs, facilitating broader vaccine coverage and contributing to the reduction of rotavirus-related morbidity and mortality globally. Moreover, ongoing research and development efforts are focused on enhancing the efficacy, safety, and affordability of rotavirus vaccines through novel vaccine platforms and manufacturing processes. Novel vaccine candidates, including virus-like particles (VLPs) and recombinant subunit vaccines, are being explored as potential alternatives to live-attenuated vaccines, offering advantages such as improved safety profiles and simplified manufacturing processes. Furthermore, advancements in adjuvant technology and antigen design are aimed at enhancing vaccine immunogenicity and durability of immune responses, potentially leading to the development of next-generation rotavirus vaccines with improved performance characteristics. As technological innovations continue to drive progress in vaccine development, the global human rotavirus vaccine market is poised for further growth and innovation, with the potential to achieve even greater impact in reducing the global burden of rotavirus gastroenteritis.
Restraints:
- Vaccine Hesitancy and Accessibility
- Cost of Vaccination Programs
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Challenges in Distribution and Storage-Challenges in distribution and storage pose significant hurdles to the global human rotavirus vaccine market, particularly in regions with limited healthcare infrastructure and resources. Rotavirus vaccines, primarily administered orally, require cold chain storage to maintain their efficacy and stability. However, maintaining the cold chain throughout the vaccine distribution process, from manufacturing facilities to remote healthcare centers, presents logistical challenges, including the need for reliable refrigeration equipment, trained personnel, and adequate transportation infrastructure. In resource-limited settings, where electricity and refrigeration facilities may be scarce, ensuring the integrity of the cold chain becomes even more challenging, increasing the risk of vaccine degradation and wastage.
The decentralized nature of vaccine distribution systems in many countries exacerbates the challenges of ensuring timely and equitable access to rotavirus vaccines. In fragmented healthcare systems, vaccines may be stored and distributed through multiple channels, including public health facilities, private clinics, and community outreach programs. Coordinating these diverse distribution channels and maintaining consistent vaccine supply chains requires effective collaboration between government agencies, healthcare providers, and vaccine manufacturers. However, logistical inefficiencies, bureaucratic hurdles, and supply chain disruptions can lead to vaccine stockouts, uneven distribution, and delays in vaccine delivery, hindering efforts to achieve high vaccination coverage rates and protect vulnerable populations from rotavirus infections.
The high cost of implementing and maintaining cold chain infrastructure poses financial barriers to vaccine distribution and storage, particularly in low- and middle-income countries. Investments in refrigeration equipment, transportation logistics, and staff training can strain limited healthcare budgets, diverting resources from other essential health services. Additionally, the need for specialized storage facilities and temperature monitoring systems adds to the overall cost of vaccine distribution, further challenging the sustainability of rotavirus vaccination programs. Addressing these challenges in distribution and storage requires coordinated efforts from policymakers, healthcare stakeholders, and international organizations to improve cold chain infrastructure, strengthen supply chain management, and enhance vaccine accessibility in resource-constrained settings.
Opportunities:
- Expansion in Low- and Middle-Income Countries
- Innovations in Vaccine Delivery Systems
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Partnerships for Improved Vaccine Access-Partnerships are playing a vital role in improving access to human rotavirus vaccines globally, particularly in low- and middle-income countries where the burden of rotavirus-related illness is most significant. Collaborations between governments, international organizations, vaccine manufacturers, and philanthropic entities aim to overcome barriers to vaccine access, including affordability, distribution challenges, and healthcare infrastructure limitations. Through strategic partnerships, initiatives such as the Gavi, the Vaccine Alliance, and the Rotavirus Vaccine Program facilitate the procurement, delivery, and implementation of rotavirus vaccination programs in underserved regions. These partnerships leverage collective resources, expertise, and networks to ensure equitable access to vaccines and maximize their impact on reducing rotavirus morbidity and mortality.
Partnerships enable capacity-building efforts to strengthen healthcare systems and vaccination infrastructure in low-resource settings. Training programs for healthcare workers, community outreach initiatives, and investments in cold chain logistics are essential components of collaborative efforts to enhance vaccine delivery and uptake. By empowering local healthcare providers and communities, partnerships foster sustainable solutions for the effective delivery and monitoring of rotavirus vaccination programs. Additionally, partnerships facilitate advocacy and communication campaigns to raise awareness about the benefits of rotavirus vaccination and address vaccine hesitancy, cultural beliefs, and misconceptions surrounding vaccination, further promoting vaccine acceptance and uptake.
Public-private partnerships are driving innovation in vaccine development, delivery systems, and affordability strategies to improve vaccine access. Collaboration between vaccine manufacturers and research institutions enables the development of more affordable vaccine formulations, heat-stable formulations, and novel delivery devices tailored to the needs of resource-limited settings. Furthermore, partnerships with regulatory agencies and procurement mechanisms streamline the regulatory approval process and facilitate bulk purchasing agreements, ensuring timely access to high-quality vaccines at affordable prices. By harnessing the strengths of diverse stakeholders and fostering collaboration across sectors, partnerships are instrumental in expanding access to human rotavirus vaccines and advancing global efforts to reduce the burden of rotavirus-related illness and mortality.
Competitive Landscape Analysis
Key players in Global Human Rotavirus Vaccine Market include:
- GlaxoSmithKline plc
- Merck & Co., Inc.
- Bharat Biotech
- Sanofi S.A.
- Lanzhou Institute of Biological Products Co., Ltd.
- Serum Institute of India Pvt. Ltd.
- Biological E. Limited
- Shanghai Institute of Biological Products Co., Ltd.
- Hualan Biological Engineering Inc.
- Instituto Butantan
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Type
- Market Snapshot, By Product Type
- Market Snapshot, By End Use
- Market Snapshot, By Route of Administration
- Market Snapshot, By Region
- Human Rotavirus Vaccine Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Emphasis on Childhood Immunization Programs
- Rising Awareness of Rotavirus Infections
- Technological Advancements in Vaccine Development
- Restraints
- Vaccine Hesitancy and Accessibility
- Cost of Vaccination Programs
- Challenges in Distribution and Storage
- Opportunities
- Vaccine Hesitancy and Accessibility
- Cost of Vaccination Programs
- Challenges in Distribution and Storage
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Human Rotavirus Vaccine Market, By Type, 2021 - 2031 (USD Million)
- Rotarix
- Rotateq
- Rotavac
- Rotavin-M1
- Lanzhou Lamb
- Other
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Human Rotavirus Vaccine Market, By Product Type, 2021 - 2031 (USD Million)
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Monovalent Rotavirus Vaccines
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Pentavalent Rotavirus Vaccines
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- Human Rotavirus Vaccine Market, By End Use, 2021 - 2031 (USD Million)
- Hospitals & Clinics
- Academic And Research
- Others
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Human Rotavirus Vaccine Market, By Route of Administration, 2021 - 2031 (USD Million)
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Oral Vaccination
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Parenteral Vaccination
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- Human Rotavirus Vaccine Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Human Rotavirus Vaccine Market, By Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- GlaxoSmithKline plc
- Merck & Co., Inc.
- Bharat Biotech
- Sanofi S.A.
- Lanzhou Institute of Biological Products Co., Ltd.
- Serum Institute of India Pvt. Ltd.
- Biological E. Limited
- Shanghai Institute of Biological Products Co., Ltd.
- Hualan Biological Engineering Inc.
- Instituto Butantan
- Company Profiles
- Analyst Views
- Future Outlook of the Market