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Last Updated: December 26, 2024

PREVNAR 20 Drug Profile


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Summary for Tradename: PREVNAR 20
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for PREVNAR 20
Recent Clinical Trials for PREVNAR 20

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Mark LoebPhase 4
CelgenePhase 2
Aduro Biotech, Inc.Phase 2

See all PREVNAR 20 clinical trials

Pharmacology for PREVNAR 20
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 PREVNAR 20 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PREVNAR 20 Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for PREVNAR 20 Derived from Patent Text Search

No patents found based on company disclosures

PREVNAR 20 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PREVNAR 20

Introduction

PREVNAR 20, a 20-valent pneumococcal conjugate vaccine developed by Pfizer, has been a significant player in the global pneumococcal vaccine market. Here, we delve into the market dynamics and financial trajectory of this biologic drug.

Market Size and Growth

The global pneumococcal vaccine market, which includes PREVNAR 20, was estimated at USD 8.07 billion in 2023 and is projected to grow at a CAGR of 6.21% from 2024 to 2030[1].

Product Overview

PREVNAR 20 is designed to protect against invasive pneumococcal disease (IPD) and pneumococcal pneumonia. It includes capsular polysaccharide conjugates for 20 serotypes, building on the 13 serotypes covered by its predecessor, Prevnar 13. This vaccine is approved for use in infants and children aged 6 weeks to 17 years and for preventing otitis media in infants aged 6 weeks to 5 years[1][4].

Regulatory Approvals and Recommendations

In April 2023, PREVNAR 20 received FDA approval for its expanded indications. Additionally, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended PREVNAR 20 for all adults aged 50 and older, pending final approval by the CDC and the Department of Health and Human Services[1][4].

Market Share and Competition

PREVNAR 20, along with Prevnar 13, dominates the pneumococcal vaccine market. Prevnar 13 led the market with the highest revenue share in 2023. The competitive landscape is intense, with other pharmaceutical companies like Merck & Co., Inc. and Sanofi and SK bioscience developing their own advanced pneumococcal vaccines. For instance, Sanofi and SK bioscience are progressing with their 21-valent conjugate vaccine candidate, which could offer broader serotype coverage than current vaccines[1].

Geographical Performance

The North American market, particularly the U.S., is a significant contributor to the global pneumococcal vaccine market, accounting for a 75.4% share in 2023. Government health agencies and the presence of leading pharmaceutical companies in this region drive market demand and innovation[1].

Financial Performance

In the first quarter of 2024, Pfizer reported that the Prevnar family (including Prevnar 20 and Prevnar 13) saw a 7% operational increase globally, primarily driven by the pediatric indication in the U.S.[2].

For the full year 2023, Pfizer's revenues from the Prevnar family were down 7% operationally, mainly due to lower sales in emerging markets. However, excluding the impact of COVID-19-related products like Comirnaty and Paxlovid, Pfizer's non-COVID operational revenue grew 7% in 2023, with the Prevnar family contributing to this growth[5].

Future Outlook and Financial Guidance

Pfizer is on track to deliver significant cost savings and operational revenue growth. For 2024, Pfizer reaffirmed its revenue guidance of $58.5 to $61.5 billion and raised its adjusted diluted EPS guidance to $2.15 to $2.35. The company expects operational revenue growth of 8% to 10% excluding contributions from Comirnaty and Paxlovid, driven in part by the performance of the Prevnar family[2][5].

Impact of Regulatory Recommendations

The ACIP recommendation for PREVNAR 20 for adults aged 50 and older is expected to significantly boost its market share. This recommendation could lead to millions of newly eligible U.S. adults receiving the vaccine, thereby increasing demand and revenue[4].

Competitive Landscape and Innovation

The pneumococcal vaccine market is highly competitive, with continuous innovation driving growth. The development and approval of novel vaccines, such as Sanofi and SK bioscience's 21-valent conjugate vaccine candidate, will continue to shape the market. Pfizer's PREVNAR 20, with its expanded serotype coverage, remains a key player in this competitive landscape[1].

Challenges and Opportunities

Despite the positive outlook, there are challenges such as patent expirations and competition from new entrants. Pfizer's patent for Prevnar 13 is set to expire in 2026, which could impact future revenues. However, the approval and recommendation of PREVNAR 20 for broader age groups and indications present significant opportunities for growth[1][4].

Key Statistics and Quotes

  • Market Growth: The global pneumococcal vaccine market is projected to grow at a CAGR of 6.21% from 2024 to 2030[1].
  • Revenue Impact: In the U.S., the 20 serotypes contained in PREVNAR 20 are estimated to cause over 2,000 deaths and more than 65,000 cases of invasive pneumococcal disease annually in adults aged 50 to 64[4].
  • Regulatory Approval: "Vaccination with PREVNAR 20 helps prevent serotype 4 disease, which incidence has been rising in certain populations in the western U.S."[4].

Key Takeaways

  • PREVNAR 20 is a dominant player in the pneumococcal vaccine market with significant growth potential.
  • Regulatory approvals and recommendations, such as the ACIP recommendation for adults aged 50 and older, are crucial for market expansion.
  • The North American market, particularly the U.S., drives a substantial portion of the global market demand.
  • Continuous innovation and competition from other pharmaceutical companies shape the market dynamics.
  • Pfizer's financial guidance indicates strong operational revenue growth driven by the Prevnar family.

FAQs

Q: What is PREVNAR 20, and how does it differ from Prevnar 13? A: PREVNAR 20 is a 20-valent pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for 20 serotypes, whereas Prevnar 13 covers 13 serotypes. PREVNAR 20 offers broader serotype coverage.

Q: What are the key regulatory approvals for PREVNAR 20? A: PREVNAR 20 received FDA approval in April 2023 and was recommended by the ACIP for adults aged 50 and older, pending final approval by the CDC and the Department of Health and Human Services.

Q: How does the North American market influence the global pneumococcal vaccine market? A: The North American market, particularly the U.S., accounts for a significant share of the global market, driven by government health agencies and the presence of leading pharmaceutical companies.

Q: What are the financial projections for Pfizer's Prevnar family in 2024? A: Pfizer expects operational revenue growth of 8% to 10% excluding contributions from Comirnaty and Paxlovid, with the Prevnar family contributing to this growth.

Q: How does competition impact the market for PREVNAR 20? A: The market is highly competitive, with other companies like Sanofi and SK bioscience developing advanced pneumococcal vaccines. Continuous innovation and new entrants shape the competitive landscape.

Cited Sources

  1. Grand View Research: Pneumococcal Vaccine Market Size And Share Report, 2030
  2. BioSpace: Pfizer Reports First-Quarter 2024 Results
  3. Sanofi: Press Release Q4 2023 English
  4. Pfizer: Advisory Committee on Immunization Practices Recommends PREVNAR 20
  5. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Financial Guidance

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