Rotavirus vaccine, live, oral - Biologic Drug Details

Summary for rotavirus vaccine, live, oral

Tradenames:	1
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for rotavirus vaccine, live, oral

Recent Clinical Trials for rotavirus vaccine, live, oral

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sanofi Pasteur, a Sanofi Company	PHASE1
Merck Sharp & Dohme Corp.	Phase 4
Johns Hopkins Bloomberg School of Public Health	Phase 4

See all rotavirus vaccine, live, oral clinical trials

Pharmacology for rotavirus vaccine, live, oral

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Live Attenuated Rotavirus Vaccine
Chemical Structure	Rotavirus Vaccines Vaccines, Attenuated

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for rotavirus vaccine, live, oral Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for rotavirus vaccine, live, oral Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2036-12-20	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2038-12-19	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2038-07-09	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2003-06-27	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2005-08-26	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2007-07-31	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2026-02-15	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for rotavirus vaccine, live, oral Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2036-12-20	Patent claims search
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2038-12-19	Patent claims search
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2038-07-09	Patent claims search
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2034-03-11	Patent claims search
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	For Suspension	125265		2034-02-28	Patent claims search
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	Suspension	125265		2036-12-20	Patent claims search
Glaxosmithkline Biologicals	ROTARIX	rotavirus vaccine, live, oral	Suspension	125265		2038-12-19	Patent claims search

International Patents for rotavirus vaccine, live, oral

Country	Patent Number	Estimated Expiration
Hong Kong	1169840
Canada	2799213
United Kingdom	0503337
European Patent Office	2569611
World Intellectual Property Organization (WIPO)	2014008138
European Patent Office	2251454
Japan	2008530165

Market Dynamics and Financial Trajectory for the Live Oral Rotavirus Vaccine

Last updated: August 5, 2025

Introduction

Rotavirus remains a leading cause of severe diarrhea and dehydration in infants and young children worldwide, particularly in developing countries. The advent of live oral rotavirus vaccines has significantly reduced morbidity and mortality associated with the virus. As the global health community emphasizes immunization, understanding market dynamics and the financial trajectory of rotavirus vaccines is crucial for stakeholders—from pharmaceutical companies to policymakers and investors.

This analysis delineates the evolving landscape of the live oral rotavirus vaccine, focusing on market drivers, competitive landscape, regulatory environment, technological advancements, and anticipated financial trends.

Market Overview

Global Burden of Rotavirus

Rotavirus infection accounts for approximately 215,000 annual deaths among children under five globally, with the majority occurring in low- and middle-income countries (LMICs) [1]. The substantial disease burden fuels demand for effective vaccination programs, propelling the market growth.

Vaccine Introduction and Coverage

Since the licensure of the first rotavirus vaccine in 2006, global vaccination coverage has increased markedly. Organizations like Gavi, the Vaccine Alliance, facilitate vaccine access in LMICs, broadening the market base. As of 2022, over 100 countries had introduced rotavirus vaccines into their national immunization schedules [2].

Product Landscape

The primary live oral rotavirus vaccines include:

• Rotarix (GlaxoSmithKline): A monovalent attenuated vaccine, licensed in over 100 countries.
• RotaTeq (Merck & Co.): A pentavalent vaccine, with widespread global use.
• Rotavac and Rotasiil: Affordable, heat-stable vaccines developed for LMIC markets, produced in India.

The heterogeneity of products caters to diverse market needs, emphasizing affordability and supply stability.

Market Drivers

Global Immunization Initiatives

International agencies' push for universal infant immunization directly bolsters vaccine uptake. The WHO’s prequalification and recommendation for rotavirus vaccines have accelerated adoption in endemic regions [3].

Disease Burden Reduction Evidence

Robust clinical data demonstrate significant reductions in rotavirus-related hospitalizations and deaths post-vaccine introduction, incentivizing governments and health agencies to incorporate the vaccine into immunization programs.

Introduction of Low-Cost, Heat-Stable Vaccines

Innovations like Rotavac and Rotasiil expand access in LMICs by reducing cold chain requirements and manufacturing costs, increasing market penetration.

Advancements in Vaccine Technology

Development of next-generation formulations with improved stability and immunogenicity enhances vaccine efficacy and acceptance, further driving demand.

Market Challenges and Constraints

Cost and Funding Limitations

While high-income markets exhibit high vaccination coverage, cost remains a barrier; Gavi’s funding mitigates disparity but is subject to future funding fluctuations.

Regulatory Hurdles

Variability in regulatory pathways across countries delays market entry and creates uncertainty, impacting financial forecasts.

Competitor Dynamics and Patent Expirations

Patent expirations and biosimilar development could impact pricing strategies and market share for existing vaccines.

Vaccine Hesitancy

Concerns about vaccine safety and efficacy, prevalent in certain regions, can hinder adoption and affect market growth.

Regulatory and Policy Environment

Regulatory approvals, inclusion in national immunization schedules, and funding policies significantly influence vaccine sales. The WHO’s prequalification status and country endorsements accelerate market entry and financial viability.

Financial Trajectory and Forecasts

Market Valuation and Growth Projections

The global rotavirus vaccine market was valued at approximately USD 2.4 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2027, reaching an estimated USD 4.3 billion [4].

Regional Market Dynamics

• North America and Europe: Mature markets with high coverage, focusing on vaccine maintenance and potential booster formulations.
• Asia-Pacific: Rapid growth driven by increasing vaccination programs in China and India.
• Africa and Latin America: Expanding access due to international aid, with cost-effective vaccines playing a pivotal role.

Key Revenue Drivers

• Increased vaccination coverage in endemic countries.
• Introduction of new formulations offering better stability and immunogenicity.
• Market diversification with expanded use in childhood immunization schedules.
• Private market growth in developed countries.

Pricing Strategies and Market Access

Pricing varies by region, influenced by manufacturing costs, government negotiations, and subsidies. Low-cost vaccines contribute to market expansion in resource-poor settings, balancing affordability with profitability.

Emerging Opportunities

• Combination Vaccines: Integrating rotavirus antigens into pentavalent or hexavalent formulations simplifies immunization schedules, boosting sales.
• Alternate Administration Routes: Research into non-oral formulations could redefine market dynamics.
• Post-licensure Efficacy and Safety Data: Support for expanded indications can drive market growth.

Future Outlook

The future of the live oral rotavirus vaccine market rests on sustained investments in vaccine technology, innovative pricing, and expanded access in underserved populations. Anticipated developments include:

• Introduction of novel, heat-stable vaccines tailored for LMICs.
• Strategic collaborations between manufacturers and governments.
• Enhanced surveillance to monitor vaccine impact and safety, boosting confidence and coverage.
• Expansion into adult populations as research progresses.

The market is expected to continue its upward trajectory, with steady growth driven by global health priorities, technological innovation, and increasing demand for affordable vaccines.

Key Takeaways

• The global rotavirus vaccine market is poised for robust growth, driven by significant disease burden and international immunization initiatives.
• Cost-effective, heat-stable vaccines like Rotavac and Rotasiil enable broader access in LMICs, expanding market reach.
• Regulatory complexity and vaccine hesitancy present challenges but can be mitigated through continued advocacy and evidence generation.
• The outlook remains favorable, with CAGR estimates of 6-8% through 2027, reaching over USD 4 billion in value.
• Innovation in vaccine formulations, combination products, and delivery modes will shape the future market landscape.

FAQs

1. What factors are most influential in driving the global adoption of rotavirus vaccines?
International health organizations’ recommendations, reductions in disease burden demonstrated in clinical studies, and funding support via global initiatives like Gavi significantly influence adoption. The availability of affordable, heat-stable vaccines also enhances accessibility in LMICs.

2. How do regulatory differences impact market growth for rotavirus vaccines?
Varied regulatory requirements across countries can delay approvals and market entry, constraining growth. Harmonization efforts and WHO prequalification streamline approval processes, fostering faster adoption.

3. What role does vaccine pricing play in expanding access in developing regions?
Affordable pricing, supported by local manufacturing and international subsidies, is critical for widespread adoption in resource-limited settings. Lower-cost vaccines like Rotavac and Rotasiil have demonstrated success in expanding coverage.

4. How might technological advancements influence the future of rotavirus vaccines?
Development of heat-stable formulations, combination vaccines, and alternative delivery routes can improve immunization efficiency, reduce logistical barriers, and boost market growth.

5. What are the main barriers to increasing vaccine coverage in high-burden countries?
Vaccine hesitancy, logistical challenges, funding limitations, and regulatory delays hinder coverage expansion. Addressing these factors through education, infrastructure investment, and policy reforms is essential.

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Sources

[1] Burnett, E., et al. (2017). Global Disease Burden of Rotavirus and Impact of Rotavirus Vaccination. Vaccine, 35(19), 2537-2543.

[2] WHO. (2022). Rotavirus vaccines: update on global progress and challenges. World Health Organization.

[3] WHO. (2018). Rotavirus vaccine prequalification. World Health Organization.

[4] MarketsandMarkets. (2022). Rotavirus Vaccine Market by Type, Application, and Region – Global Forecast to 2027.