Introduction to PREVNAR 13
PREVNAR 13, a 13-valent pneumococcal conjugate vaccine, is a crucial tool in the prevention of invasive diseases caused by specific serotypes of Streptococcus pneumoniae. Developed and manufactured by Pfizer, this vaccine is approved for use in children aged 6 weeks through 5 years and adults aged 18 years and older[3][5].
Clinical Trials Overview
The safety and efficacy of PREVNAR 13 have been extensively evaluated through multiple clinical trials.
Pediatric Indications
- The vaccine was tested in 13 clinical trials involving 4,729 infants and toddlers who received at least one dose of PREVNAR 13. These trials assessed the safety, tolerability, and immunogenicity of the vaccine. The vaccination schedule included doses at 6 weeks, 4 months, 6 months, and a booster dose at 12-15 months of age[4].
- The trials showed that PREVNAR 13 had a similar safety profile to the control vaccine, with comparable rates of serious adverse events and solicited local and systemic adverse reactions[4].
Comparative Studies
- Studies comparing PREVNAR 13 to other vaccines, such as PREVENAR 13 vs. PREVENAR 20, have been conducted to evaluate the immunogenicity and safety of these vaccines. For example, Pfizer's Phase 3 clinical trial program for the pediatric indication of 20vPnC (PREVENAR 20) included comparisons with PREVENAR 13 to assess the tolerability, safety, and immunogenicity of the new vaccine[1].
Market Analysis
Current Market Size and Share
- As of 2023, the global pneumococcal vaccine market size was estimated at USD 8.07 billion, with PREVNAR 13 leading the market with the highest revenue share. This dominance is attributed to its widespread adoption and efficiency in preventing pneumococcal diseases[3].
Market Segments
- The pneumococcal vaccine market is segmented by vaccine type, product type, and distribution channel. Among these, the pneumococcal conjugate vaccine (PCV) segment, which includes PREVNAR 13, accounted for 89% of the overall market share in 2017 and is expected to retain its dominance through 2025[2].
- The PREVNAR 13 segment specifically captured 79.1% of the market share in 2017 and is projected to grow at a CAGR of 5.1% from 2018 to 2025[2].
Revenue and Growth
- In 2019, Pfizer reported a global revenue of USD 5,847 million from PREVNAR 13, indicating strong market performance. The vaccine segment observed an operational growth of 12% internationally in 2019, driven by increasing use in children and government purchases[5].
- The market is expected to continue growing, with the global pneumococcal vaccine market projected to reach USD 10.21 billion by 2025, growing at a CAGR of 5% from 2018 to 2025[2].
Projections and Future Outlook
Market Growth Drivers
- The increasing use of pneumococcal vaccines in children, coupled with government initiatives and partnerships with organizations like Gavi, the Vaccine Alliance, are expected to drive market growth. Rising research and development funding is also anticipated to expand the pneumococcal vaccine market[5].
Competitive Landscape
- While PREVNAR 13 dominates the market, other vaccines like Synflorix and Pneumovax 23 also play significant roles. The introduction of new vaccines, such as Pfizer's 20-valent pneumococcal conjugate vaccine (20vPnC), may alter market dynamics but is expected to complement rather than replace PREVNAR 13 in the short term[1][2].
Patent Expiration and Impact
- Pfizer's patent for PREVNAR 13 is set to expire in 2026, which could lead to the entry of generic competitors. However, the brand's established reputation and ongoing research and development are likely to maintain its market position even after patent expiration[3].
Distribution and Access
Distribution Channels
- The distribution of PREVNAR 13 is facilitated through various channels, including distribution partner companies, non-governmental organizations, and government authorities. The private sector segment is expected to lead the market through 2025, indicating a strong commercial presence[2].
Global Access
- PREVNAR 13 is widely available globally, with significant sales in both developed and developing countries. The vaccine's inclusion in immunization programs and its association with global health initiatives have enhanced its accessibility[5].
Key Takeaways
- PREVNAR 13 is a highly effective and widely used pneumococcal conjugate vaccine with a strong safety profile.
- The vaccine dominates the pneumococcal vaccine market, capturing a significant market share.
- Market growth is driven by increasing use in children, government purchases, and partnerships with global health organizations.
- The vaccine's patent expiration in 2026 may introduce generic competition, but Pfizer's ongoing research and brand reputation are expected to maintain its market position.
- The global pneumococcal vaccine market is projected to continue growing, reaching USD 10.21 billion by 2025.
FAQs
Q: What is PREVNAR 13 used for?
A: PREVNAR 13 is used for the active immunization against invasive diseases caused by specific serotypes of Streptococcus pneumoniae in children aged 6 weeks through 5 years and adults aged 18 years and older[3].
Q: How safe is PREVNAR 13?
A: PREVNAR 13 has been evaluated in multiple clinical trials and has shown a similar safety profile to control vaccines, with comparable rates of serious adverse events and solicited local and systemic adverse reactions[4].
Q: What is the current market size of the pneumococcal vaccine market?
A: As of 2023, the global pneumococcal vaccine market size was estimated at USD 8.07 billion, with PREVNAR 13 leading the market[3].
Q: What are the key drivers of the pneumococcal vaccine market growth?
A: The key drivers include increasing use in children, government purchases, and partnerships with global health organizations like Gavi, the Vaccine Alliance[5].
Q: When does the patent for PREVNAR 13 expire?
A: The patent for PREVNAR 13 is set to expire in 2026[3].
Sources
- Pfizer Receives Positive CHMP Opinion for its 20-Valent Pneumococcal Conjugate Vaccine - Pfizer
- Pneumonia Vaccines Market to Reach $10.21 Bn, Globally, by 2025 - PR Newswire
- Pneumococcal Vaccine Market Size And Share Report, 2030 - Grand View Research
- Package Insert - Prevnar 13 - FDA
- Global Pneumococcal Vaccine Market Size & Share, Growth Report 2037 - Research Nester
