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
Centers for Disease Control and Prevention	Phase 4
Children's Hospital Medical Center, Cincinnati	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. 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, 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 Company Disclosures

No patents found based on company disclosures

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

No patents found based on company disclosures

The Rotavirus Vaccine Market: Dynamics and Financial Trajectory

Introduction to Rotavirus Vaccines

Rotavirus vaccines are a crucial component of global health initiatives, particularly in preventing severe diarrhea and dehydration in infants and children. These vaccines, such as Rotarix, RotaTeq, and Rotavac, have been widely adopted and are continuing to evolve to meet the needs of diverse populations.

Market Size and Growth Projections

The global rotavirus vaccine market is experiencing significant growth. As of 2023, the market was valued at USD 10,819.1 million and is projected to reach USD 26,012.1 million by 2032, with a compound annual growth rate (CAGR) of 10.3%[1].

Regional Market Dynamics

• North America: This region currently leads the rotavirus vaccine market due to its robust healthcare infrastructure and the presence of major pharmaceutical companies. The strong base of healthcare facilities and ongoing research activities contribute to its dominance[1][5].
• Asia-Pacific: This region is expected to witness rapid growth due to increasing government initiatives, growing research activities, and a large population pool. The demand for quality healthcare in this region is also driving market expansion[1][5].

Market Segmentation

• End-Use Category: In 2023, the hospital segment led the market in terms of end-use, highlighting the critical role hospitals play in vaccine administration and public health initiatives[1].
• Vaccine Type: The Rotarix type segment has been a notable revenue driver in the rotavirus vaccine market, largely due to its widespread use and relative affordability compared to other options[1][5].

Key Drivers of Market Growth

• Increased Awareness and Immunization Programs: Greater awareness of the impact of rotavirus infections and expanded immunization programs have significantly boosted the demand for rotavirus vaccines. Support from international health organizations has also played a crucial role in this growth[1].
• Population Growth and Live Births: The increase in the overall population and live births is a key trend driving the rotavirus vaccine market. As more children are born, the demand for these vaccines increases to protect them from severe rotavirus infections[1].

Emerging Trends and Innovations

• Injectable Rotavirus Vaccines: Next-generation rotavirus vaccines, such as injectable vaccines, are in advanced development. These vaccines aim to address key barriers to vaccine uptake and access, including ease of delivery and cost-effectiveness. Combining these vaccines with DTP-containing vaccines is seen as a highly preferred approach by national stakeholders due to its simplicity and lower cost[2].
• New Vaccine Formulations: The prequalification by the World Health Organization (WHO) of new vaccines produced in India has expanded the global availability of rotavirus vaccines. This includes Rotavac and RotaSIIL, which offer relatively lower prices and are expected to improve the global supply and reduce costs[3].

Cost-Effectiveness and Health Impact

• Efficacy and Cost: Studies have shown that the efficacy of current oral rotavirus vaccines (ORVs) varies, particularly in low- and middle-income countries (LMICs). However, even with similar efficacy to current ORVs, injectable next-generation rotavirus vaccines (iNGRVs) can be highly cost-effective, especially when combined with DTP-containing vaccines. These combinations are predicted to prevent an additional 200,000 rotavirus deaths over ten years and save billions of dollars in healthcare costs[2].
• Country-Level Preferences: Local stakeholders prefer vaccines that are easy to deliver and cost-effective. A study by PATH found that national stakeholders and healthcare providers prefer iNGRVs combined with DTP-containing vaccines due to their ease of administration and lower costs[2].

Challenges and Barriers

• Vaccine Cost and Policy: Despite the efficacy and effectiveness of rotavirus vaccines, their implementation is often hindered by high costs, policy barriers, and infrastructure challenges. Many countries, especially in Asia, America, and Europe, have yet to implement these vaccines due to these factors[4].
• Efficacy Variability: The efficacy of rotavirus vaccines can vary significantly between high-income countries (HICs) and low- to middle-income countries (LMICs). This variability poses a challenge in ensuring universal protection against rotavirus infections[4].

Real-World Implications

• Public Health Value Proposition: The development of iNGRVs and their potential combination with other vaccines could significantly enhance public health outcomes. These vaccines are expected to offer a compelling value proposition by reducing the number of rotavirus-related deaths and healthcare costs[2].
• Structured Consultations: Engaging with country-level stakeholders early in the vaccine development process is crucial. This ensures that the vaccines developed meet the needs and preferences of the target populations, thereby increasing their adoption and effectiveness[2].

Financial Trajectory

• Market Value Projections: The global human rotavirus vaccine market is expected to grow from USD 7.20 billion in 2022 to USD 10.36 billion by 2030, with a CAGR of 6.2% during the forecast period[5].
• Pricing Analysis: The prices of rotavirus vaccines vary significantly. For instance, Rotarix is offered at a lower price compared to RotaTeq, especially in GAVI-eligible countries. The introduction of Indian-produced vaccines like Rotavac and RotaSIIL has further reduced the cost, making these vaccines more accessible to a broader population[4].

Key Takeaways

• The rotavirus vaccine market is growing rapidly, driven by increased awareness, expanded immunization programs, and new vaccine formulations.
• Regional dynamics, particularly in North America and the Asia-Pacific, are significant drivers of market growth.
• Emerging trends such as injectable vaccines and combined formulations with DTP-containing vaccines are expected to enhance cost-effectiveness and ease of delivery.
• Despite challenges related to cost and policy, the market is projected to continue growing, with significant public health benefits anticipated.

FAQs

Q: What is the projected growth rate of the rotavirus vaccine market? A: The rotavirus vaccine market is expected to grow at a CAGR of 10.3% from 2024 to 2032[1].

Q: Which region is leading the rotavirus vaccine market? A: North America is currently the leading region in the rotavirus vaccine market, followed by the Asia-Pacific region which is expected to grow rapidly[1][5].

Q: What are the key drivers of the rotavirus vaccine market growth? A: Increased awareness, expanded immunization programs, and population growth are key drivers of the market growth[1].

Q: What are the emerging trends in rotavirus vaccines? A: Next-generation injectable rotavirus vaccines and combined formulations with DTP-containing vaccines are emerging trends aimed at improving cost-effectiveness and ease of delivery[2].

Q: How do the prices of different rotavirus vaccines compare? A: The prices of rotavirus vaccines vary, with Rotarix generally being more affordable than RotaTeq. Indian-produced vaccines like Rotavac and RotaSIIL offer even lower prices, making them more accessible[4].

Sources

1. Acumen Research and Consulting. "Rotavirus Vaccine Market Size, Share, Trends | Forecast 2032."
2. PATH. "Injectable rotavirus vaccines—what value could they bring?"
3. Johns Hopkins Bloomberg School of Public Health. "Current and Upcoming Rotavirus Vaccines."
4. MDPI. "Overview of the Development, Impacts, and Challenges of Live-Attenuated Oral Rotavirus Vaccines."
5. Data Bridge Market Research. "Global Human Rotavirus Vaccine Market Size, Share & Revenue Analysis."