Rotavirus vaccine, live, oral, pentavalent - Biologic Drug Details

Summary for rotavirus vaccine, live, oral, pentavalent

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

Recent Clinical Trials for rotavirus vaccine, live, oral, pentavalent

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Limited Liability Company Pharm Aid	Phase 3
Children's Hospital Medical Center, Cincinnati	Phase 4
Centers for Disease Control and Prevention	Phase 4

See all rotavirus vaccine, live, oral, pentavalent clinical trials

Pharmacology for rotavirus vaccine, live, oral, pentavalent

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

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, pentavalent Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for rotavirus vaccine, live, oral, pentavalent 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
Merck Sharp & Dohme Llc	ROTATEQ	rotavirus vaccine, live, oral, pentavalent	Suspension	125122			DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	ROTATEQ	rotavirus vaccine, live, oral, pentavalent	Suspension	125122			DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	ROTATEQ	rotavirus vaccine, live, oral, pentavalent	Suspension	125122			DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	ROTATEQ	rotavirus vaccine, live, oral, pentavalent	Suspension	125122			DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	ROTATEQ	rotavirus vaccine, live, oral, pentavalent	Suspension	125122			DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for rotavirus vaccine, live, oral, pentavalent 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

Market Dynamics and Financial Trajectory for the Pentavalent Live Oral Rotavirus Vaccine

Last updated: August 8, 2025

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Introduction

The global landscape of pediatric immunization has been significantly shaped by the advent of rotavirus vaccines, pivotal in reducing childhood morbidity and mortality caused by rotavirus gastroenteritis. Among these, the pentavalent live oral rotavirus vaccine (often referred to as RV5 or similar formulations) commands notable attention owing to its broad coverage against multiple rotavirus strains. This analysis explores the market dynamics and financial trajectories associated with the pentavalent live oral rotavirus vaccine, emphasizing key drivers, barriers, and future outlook.

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Market Overview

The rotavirus vaccine market has experienced considerable expansion over the past decade, driven by increasing vaccination coverage, supportive policy frameworks, and growing awareness of rotavirus-related health burdens. The pentavalent formulations, which protect against five rotavirus strains, are integral to this ecosystem, especially in children under five in both developed and emerging markets.

Currently, several key players dominate this segment, including Merck & Co., Inc., and GlaxoSmithKline (GSK). The vaccines are incorporated into national immunization programs, enhancing their adoption. The World Health Organization (WHO) recommends rotavirus vaccines universally, substantially influencing immunization policies worldwide and shaping market trajectories.

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Market Drivers

1. Global Burden of Rotavirus Disease
   Rotavirus remains a leading cause of severe diarrhea in children under five, accounting for an estimated 128,500 deaths annually as of 2016 [1]. The high disease burden motivates governments and health authorities to incorporate rotavirus vaccines into routine immunizations, creating sustained demand.

2. Enhanced Vaccine Efficacy & Safety Profile
   The pentavalent live oral vaccine demonstrates high efficacy in preventing severe rotavirus gastroenteritis, particularly in high-burden regions. Its oral administration and favorable safety profile bolster its acceptability and widespread use.

3. Policy Initiatives and Regulatory Support
   WHO prequalification and national immunization programs significantly influence market growth. As more countries adopt these vaccines—especially in Asia-Pacific, Africa, and Latin America—market penetration accelerates.

4. Cost-effectiveness & Public Health Investment
   Cost-effectiveness analyses support widespread vaccination, especially in resource-constrained settings where preventable deaths are prevalent. Investments driven by global health agencies further propel market expansion.

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Market Barriers and Challenges

1. Pricing and Affordability
   While price reductions have been achieved through Gavi, the Vaccine Alliance, and tiered pricing strategies, affordability remains a barrier for lower-income nations, affecting market reach[2].

2. Cold Chain and Logistics Constraints
   Maintaining the cold chain for live vaccines presents logistical challenges, particularly in remote or underserved regions, potentially impeding distribution.

3. Market Saturation and Competitive Pressures
   In mature markets, incremental growth limits potential, necessitating innovation and portfolio expansion to sustain revenue streams.

4. Vaccine Hesitancy & Acceptance
   Misinformation and cultural barriers may reduce uptake, impacting sales and immunization coverage.

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Financial Trajectory

Historical Perspective

From 2010 onwards, the rotavirus vaccine market experienced rapid growth, with an estimated CAGR of 9-11% through 2025 [3]. The expansion reflected increased vaccination programs, geographic penetration of existing products, and the launch of new formulations.

Projected Growth

Forecasts project that the market will continue to grow steadily, with a CAGR of approximately 7-9% through 2030. Expansion into emerging markets and the integration of the vaccine into national immunizations will be primary growth vectors. Revenues are expected to reach US$1.4–1.8 billion globally by 2030.

Revenue Sources

• Vaccine Sales: The predominant revenue source, with higher margins in mature markets.
• Licensing & Partnerships: Acquisitions of rights for regional or country-specific distribution.
• Government and NGO Contracts: Long-term procurement agreements bolstered by aid programs.

Pricing Trends

While developed countries often pay higher prices (~US$50–70 per dose), pricing in low-income countries can be substantially lower (~US$1–5 per dose) due to Gavi subsidies and tiered pricing strategies.

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Emerging Trends & Innovation

1. Next-generation Formulations
   Efforts are underway to develop thermostable, single-dose formulations to overcome cold chain limitations and improve compliance [4].

2. Combination Vaccines
   Integrating rotavirus protection into broader pediatric combination vaccines can streamline immunization schedules and reduce costs.

3. Market Diversification & New Entrants
   Biosimilar and ethnic-specific formulations are anticipated to intensify competition and foster innovation.

4. Digital & Data-driven Approaches
   Use of data analytics to optimize immunization strategies and forecast demands can streamline manufacturing and distribution.

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Geographic Market Insights

• North America & Europe: Mature markets with stable demand; growth driven largely by booster campaigns and refined targeting.
• Asia-Pacific: Fastest-growing segment, attributed to increasing government adoption, rising healthcare expenditure, and demographic factors.
• Africa & Latin America: High growth potential due to disease burden, with Gavi support catalyzing vaccine introduction.

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Regulatory & Policy Environment

Stringent regulatory standards, the requirement for ongoing safety surveillance, and health policy alignments significantly influence market dynamics. Regulatory approval delays or hurdles can bottleneck product launches, while favorable policies accelerate penetration.

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Conclusion & Future Outlook

The pentavalent live oral rotavirus vaccine remains a cornerstone in combatting childhood diarrheal mortality worldwide. Its market is poised for sustained growth driven by expanding immunization programs, particularly in emerging markets, and ongoing innovations. Nevertheless, to maximize impact, addressing barriers such as affordability, logistics, and acceptance is critical.

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Key Takeaways

• The global rotavirus vaccine market is projected to grow at a CAGR of approximately 7-9% through 2030, driven by policy adoption and demographic shifts.
• Cost reduction and improved logistics are vital for expanding access in low-income regions.
• Innovation in vaccine formulation and integration into combination vaccines will unlock new revenue streams.
• Regulatory and policy environments remain crucial; proactive engagement facilitates faster market entry and broader coverage.
• Strategic partnerships, licensing, and digital data analytics will continue to shape the competitive landscape.

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FAQs

1. What are the main advantages of the pentavalent rotavirus vaccine over earlier formulations?
   The pentavalent vaccine offers broader strain coverage, improved immunogenicity, and a favorable safety profile, resulting in better protection against diverse rotavirus strains compared to monovalent or bivalent vaccines.

2. How has Gavi influenced the financial trajectory of rotavirus vaccines?
   Gavi’s subsidies have lowered vaccine prices, making them affordable for low-income countries, thus expanding market reach and accelerating global adoption.

3. What challenges do manufacturers face in distributing rotavirus vaccines in remote regions?
   Cold chain maintenance, logistical complexity, infrastructure deficits, and limited healthcare workforce hinder effective distribution.

4. What innovations are driving the future development of rotavirus vaccines?
   Thermostable formulations, single-dose presentations, combination vaccines, and digital tracking systems are key innovations, aimed at improving efficacy, compliance, and logistics.

5. Which emerging markets present the greatest growth opportunities for rotavirus vaccines?
   Countries within Asia-Pacific, Latin America, and Africa exhibit significant growth potential due to rising immunization initiatives and high disease burden.

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References

1. Tate, J. et al. (2016). Global, Regional, and National Estimates of Rotavirus Mortality in Children Younger Than 5 Years. The Lancet Global Health, 4(2), e134-e142.
2. Gavi, the Vaccine Alliance. (2022). Rotavirus vaccines: Market shaping strategies.
3. Transparency Market Research. (2021). Rotavirus Vaccines Market.
4. World Health Organization. (2020). Rotavirus vaccines: Updated recommendations and introduction guidance.

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