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
Merck Sharp & Dohme Corp.	Phase 4
Johns Hopkins Bloomberg School of Public Health	Phase 4
Baskent University	Phase 1/Phase 2

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. General 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 Company Disclosures

No patents found based on company disclosures

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

No patents found based on company disclosures

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

Introduction to Rotavirus and the Vaccine

Rotavirus is a highly contagious virus that causes severe gastroenteritis, leading to symptoms such as watery diarrhea, vomiting, fever, and abdominal pain, particularly in infants and young children. The live, oral rotavirus vaccine is a crucial tool in preventing these infections and has been widely adopted globally.

Market Size and Growth

The oral rotavirus vaccine market is experiencing significant growth, with a projected Compound Annual Growth Rate (CAGR) of 12.8% from 2020 to 2027. This growth is driven by the cost-effectiveness and efficiency of oral rotavirus vaccines, which eliminate the need for disposable needles and are more suitable for mass vaccination programs[1].

Key Growth Factors

Several factors contribute to the market's expansion:

• Cost-Effectiveness: Oral rotavirus vaccines are highly cost-effective, especially in low-income countries where they significantly reduce the economic burden of treating rotavirus infections. Studies have shown that the cost per Disability-Adjusted Life Year (DALY) averted is often less than the country's GDP per capita, making the vaccine highly cost-effective[2][5].
• Efficiency of Administration: The oral administration of these vaccines simplifies the vaccination process, making it more feasible for large-scale vaccination programs.
• Rising Prevalence and Awareness: The increasing awareness of rotavirus infections and the benefits of vaccination have fueled demand for these vaccines.
• Government Funding and Support: Increased government funding and support for vaccination programs also boost market growth[1].

Market Segmentation

The global oral rotavirus vaccine market is segmented based on several criteria:

By Product

• Rotarix: Developed by GlaxoSmithKline, this vaccine is indicated for the prevention of rotavirus gastroenteritis and holds a significant market share due to its relative affordability and two-dose regimen[1][3].
• RotaTeq: Developed by Merck & Co., this vaccine requires a three-dose regimen and is also widely used.
• Rotavac: Produced by Bharat Biotech, this vaccine is known for its lower price point, making it more accessible to low- and middle-income countries[3].
• Rotavin-M1 and Lanzhou Lamb: Other notable products in the market.

By Application

• Hospital: Vaccinations administered in hospital settings.
• Vaccination Station: Low-cost mobile vaccination clinics.
• Others: Including community health centers and private clinics[1].

By Age Group

• Pediatric: The primary target group, with the first dose typically administered at six weeks of age and all doses completed before the child is eight months old[1].

By Geography

• North America: A significant market due to high healthcare standards and awareness.
• Europe: Another major market with strong healthcare infrastructure.
• Asia Pacific: Expected to witness the highest CAGR due to the rising prevalence of rotavirus infections in this region[1].

Economic Costs and Benefits

The economic impact of rotavirus vaccination is substantial:

• Cost Savings: Studies have shown that rotavirus vaccination programs lead to significant cost savings by reducing the number of hospitalizations, outpatient visits, and overall treatment costs associated with rotavirus infections[2][5].
• DALYs Averted: The cost-effectiveness of rotavirus vaccines is often measured by the number of DALYs averted. In many countries, the cost per DALY averted is well below the GDP per capita, indicating high cost-effectiveness[2][5].

Challenges and Constraints

Despite the benefits, several challenges affect the market:

• Production Delays and Contamination Risks: Delays in production and the risk of vaccine contamination if not properly stored can hinder market growth[1].
• Low Efficacy in High-Mortality Settings: The efficacy of rotavirus vaccines is lower and wanes more rapidly in high-mortality settings, although they still provide significant protection[4].
• Healthcare Infrastructure: In some countries, especially low- and middle-income countries, the lack of adequate healthcare infrastructure and strategic preventive measures can impede vaccine implementation[3].

Cost-Effectiveness Analysis

Numerous studies have demonstrated the cost-effectiveness of rotavirus vaccination:

• Global Perspective: Across various countries, rotavirus vaccination has been found to be highly cost-effective, even when considering the full market prices for the vaccines[2][5].
• Country-Specific Data: In countries like Afghanistan, Pakistan, and India, the cost per DALY averted is significantly lower than the GDP per capita, highlighting the economic value of these vaccines[2].

Impact on Public Health

The introduction of rotavirus vaccines has had a profound impact on public health:

• Reduction in Rotavirus Cases: Countries that have introduced rotavirus vaccines have seen a significant reduction in rotavirus-related hospitalizations and deaths[4][5].
• Economic Benefits: Beyond the health benefits, the economic savings from reduced healthcare costs and lost wages due to caregiver absenteeism are substantial[2].

Future Outlook

The future of the oral rotavirus vaccine market looks promising:

• Increasing Accessibility: New vaccine products and decreasing prices are expected to improve affordability for low- and middle-income countries[3][5].
• Expanding Market: The market is expected to expand as more countries implement rotavirus vaccination programs, driven by growing awareness and government support[1].

Key Takeaways

• The oral rotavirus vaccine market is growing rapidly due to its cost-effectiveness and efficiency.
• The market is segmented by product, application, age group, and geography.
• Despite challenges, the economic and health benefits of rotavirus vaccination are significant.
• The future outlook is positive, with increasing accessibility and expanding markets.

Frequently Asked Questions

Q: What is the primary growth factor for the oral rotavirus vaccine market? A: The primary growth factor is the cost-effectiveness and efficiency of administration, which makes these vaccines suitable for mass vaccination programs.

Q: Which regions are expected to witness the highest CAGR in the oral rotavirus vaccine market? A: The Asia Pacific region is expected to witness the highest CAGR due to the rising prevalence of rotavirus infections.

Q: How cost-effective are rotavirus vaccines in low-income countries? A: Rotavirus vaccines are highly cost-effective in low-income countries, with the cost per DALY averted often being a fraction of the country's GDP per capita.

Q: What are the main challenges facing the implementation of rotavirus vaccines? A: Challenges include production delays, contamination risks, low efficacy in high-mortality settings, and inadequate healthcare infrastructure.

Q: How have new vaccine products impacted the market? A: New vaccine products, such as Rotavac and Rotasiil, have made rotavirus vaccines more affordable for low- and middle-income countries, improving market accessibility.

Cited Sources

1. Verified Market Research - Oral Rotavirus Vaccine Market Size, Trends, Opportunities & Forecast
2. Johns Hopkins Bloomberg School of Public Health - Economic Costs of Rotavirus Disease and the Value of Vaccines
3. MDPI - Overview of the Development, Impacts, and Challenges of Live-Attenuated Oral Rotavirus Vaccines
4. The Lancet - Efficacy of live oral rotavirus vaccines by duration of follow-up
5. The Lancet Global Health - Re-evaluating the potential impact and cost-effectiveness of rotavirus vaccination in countries eligible for Gavi support

Last updated: 2024-12-18