PREVNAR 20 Drug Profile

Summary for Tradename: PREVNAR 20

High Confidence Patents:	3
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

Sponsor	Phase
Mark Loeb	Phase 4
Celgene	Phase 2
Aduro Biotech, Inc.	Phase 2

See all PREVNAR 20 clinical trials

Pharmacology for PREVNAR 20

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Pneumococcal Vaccine
Chemical Structure	Pneumococcal Vaccines Vaccines, Conjugate Vaccines, Inactivated

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 company disclosures

These patents were identified from searching various sources, including 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 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 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
Wyeth Pharmaceuticals Llc	PREVNAR 20	20-valent pneumococcal conjugate vaccine	Injection	125731	7,935,787	2027-04-19	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	PREVNAR 20	20-valent pneumococcal conjugate vaccine	Injection	125731	9,517,274	2033-08-12	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	PREVNAR 20	20-valent pneumococcal conjugate vaccine	Injection	125731	9,950,054	2036-11-09	DrugPatentWatch analysis and company disclosures

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

No patents found based on company disclosures

International Patents for PREVNAR 20

Country	Patent Number	Estimated Expiration
Portugal	2679245
Hungary	E041381
Brazil	122020000285
European Patent Office	2679245
Lithuania	2676679

Supplementary Protection Certificates for PREVNAR 20

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122022000054	Germany		PRODUCT NAME: APEXXNAR - PNEUMOKOKKEN-POLYSACCHARID-SEROTYP 33F, KONJUGIERT AN DAS CRM197-TRAEGERPROTEIN DURCH EINEN (2-((2-OXOETHYL)THIO)ETHYL)CARBAMAT (ETEC)-SPACER; REGISTRATION NO/DATE: EU/1/21/1612 20220214
C202230037	Spain		PRODUCT NAME: POLISACARIDO DEL SEROTIPO NEUMOCOCICO 33FCONJUGADO CON LA PROTEINA TRANSPORTADORA CRM197 A TRAVES DE UN ESPACIADOR(2-((2-OXOETIL)TIO)ETIL)CARBAMATO (ETEC).; NATIONAL AUTHORISATION NUMBER: EU/1/21/1612; DATE OF AUTHORISATION: 20220214; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1612; DATE OF FIRST AUTHORISATION IN EEA: 20220214
C02676679/01	Switzerland		PRODUCT NAME: POLYSACCHARIDA STREPTOCOCCI PNEUMONIAE TYPUS 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, ET 23F CONJUGATA CUM PROTEINO CORYNEBACTERIAE DIPHTHERIAE CRM 197; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68752 14.02.2023
2022C/523	Belgium		PRODUCT NAME: PNEUMOKOKKENPOLYSACHARIDE-CONJUGAATVACCIN (15-VALENT, GEADSORBEERD) WELKE EEN SUSPENSIE IS VAN KAPSELPOLYSACHARIDEN VAN S. PNEUMONIAE SEROTYPES 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F AND 33F GECONJUGEERD AAN HET CRM197-DRAGEREIWIT; AUTHORISATION NUMBER AND DATE: EU/1/21/1591 20211214
CA 2022 00028	Denmark		PRODUCT NAME: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (15-VALENT, ADSORBED) WHICH IS A SUSPENSION OF CAPSULAR POLYSACCHARIDES FROM S. PNEUMONIAE SEROTYPES 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F AND 33F CONJUGATED TO CRM197 CARRIER PROTEIN; REG. NO/DATE: EU/1/21/1591 20211214

Market Dynamics and Financial Trajectory for PREVNAR 20

Last updated: September 29, 2025

Introduction

PREVNAR 20 (pneumococcal 20-valent conjugate vaccine), developed by Pfizer, marks a significant advancement in the prophylactic landscape against pneumococcal diseases. As a next-generation vaccine with broader serotype coverage, PREVNAR 20 has the potential to reshape the global pneumococcal vaccine market. This analysis explores the current market factors influencing PREVNAR 20’s trajectory, its competitive positioning, projected financial outlook, and strategic considerations that define its future success.

Market Overview

Global Burden of Pneumococcal Disease

Pneumococcal disease, caused by Streptococcus pneumoniae, results in severe infections such as pneumonia, meningitis, and bacteremia. Annually, it accounts for approximately 1.5 million deaths worldwide, with children under five and the elderly disproportionately affected [1]. Despite existing vaccines like Prevnar 13 and Pneumovax 23, residual disease burden persists, particularly due to serotypes not covered by earlier formulations.

Existing Vaccines and Market Saturation

Prevnar 13, introduced in 2010, has been the dominant pneumococcal conjugate vaccine (PCV) globally, capturing significant market share across pediatric and adult vaccination programs. Pneumovax 23, a polysaccharide vaccine, complements PCVs but exhibits limitations such as suboptimal immunogenicity in young children and shorter duration of protection.

Market saturation in mature regions and serotype replacement phenomena—where non-vaccine serotypes emerge post-vaccination—are shifting the landscape, creating a pressing demand for broader-spectrum vaccines like PREVNAR 20 [2].

Market Dynamics Influencing PREVNAR 20’s Adoption

1. Demographic and Epidemiological Drivers

• Pediatric and Adult Populations: Globally, vaccination coverage is expanding, notably in pediatric populations within North America, Europe, and emerging markets. Adults, especially seniors, remain susceptible due to waning immunity and emerging serotypes.
• Serotype Replacement: Non-vaccine serotypes increasingly cause invasive pneumococcal disease (IPD), rendering existing vaccines less effective over time [3]. Broader vaccines like PREVNAR 20 address this gap.

2. Competitive Landscape

• Current Vaccines: Prevnar 13 and Pneumovax 23 are entrenched, with established manufacturing, reimbursement, and guidelines. Their limitations in serotype coverage and immunogenicity create opportunities for PREVNAR 20.
• Emerging Competitors: Other multivalent pneumococcal vaccines are in various stages of development, such as GSK's 24-valent candidate, which could challenge PREVNAR 20’s market share. However, Pfizer’s extensive distribution network and regulatory experience are advantageous.

3. Regulatory Milestones and Approvals

• FDA and EMA Approvals: Pfizer submitted PREVNAR 20 for regulatory review based on phase 3 clinical data demonstrating non-inferiority and superior coverage compared to existing vaccines. Timely approvals are crucial for early market penetration.
• Global Reach: Approvals in key regions, especially in low- to middle-income countries (LMICs), depend on local regulatory pathways and cost considerations.

4. Pricing, Reimbursement, and Cost-Effectiveness

• Pricing Strategies: Pfizer's ability to position PREVNAR 20 as cost-effective, particularly by reducing disease burden and healthcare costs, influences uptake.
• Reimbursement Landscape: Negotiations with payers and governments impact accessibility, especially in countries with national immunization programs.

5. Public Health Policies and Guidelines

• Inclusion in Immunization Schedules: Endorsements by WHO, CDC, ECDC, and other health authorities accelerate adoption.
• Vaccine Hesitancy: Addressing concerns through education and data dissemination enhances coverage, especially in regions with vaccine skepticism.

Financial Trajectory and Market Projections

1. Market Size and Revenue Potential

The pneumococcal vaccine market was valued at approximately $8.5 billion in 2022, with projections estimating a compound annual growth rate (CAGR) of about 6% through 2030 [4]. The introduction of PREVNAR 20 is anticipated to accelerate growth, driven by:

• Broader Serotype Coverage: Addressing non-vaccine serotypes and replacing older vaccines.
• Expanded Indications: Potential approved use in older adults and high-risk populations.

2. Sales Forecasts

Pfizer’s strategic positioning suggests a robust initial uptake, particularly in high-income countries with mature immunization programs. Early estimates project PREVNAR 20 could contribute approximately $2 billion annually within five years post-launch, gradually surpassing this as global access increases [5].

3. Cost-Benefit Dynamics

Economic models indicate that vaccination with PREVNAR 20 may lead to substantial healthcare savings through reduced IPD cases, hospitalizations, and antibiotic use. These efficiencies bolster payers’ willingness to reimburse at premium prices, balancing the vaccine’s development and distribution costs.

4. Risks and Challenges

• Manufacturing and Supply Chain: Scaling production to meet global demand without disruptions.
• Market Penetration Delays: Regulatory hurdles, vaccine hesitancy, and pricing negotiations can delay revenue realization.
• Serotype Dynamics: The ongoing evolution of pneumococcal serotypes necessitates continual surveillance and potential vaccine reformulation, impacting long-term financial planning.

Strategic Considerations

1. Geographic Expansion

Prioritizing entry into emerging markets with high disease burden and expanding in regions with existing pneumococcal vaccination infrastructure maximizes impact.

2. Pediatric and Adult Indications

Developing and obtaining regulatory approval for adult booster doses and pediatric schedules expands revenue streams and public health impact.

3. Partnership and Licensing

Collaborations with governments and organizations like GAVI can accelerate access in LMICs, supporting higher volume sales and market penetration.

4. Monitoring Serotype Trends

Investing in epidemiological surveillance to adapt to serotype shifts ensures continued relevance and efficacy, safeguarding long-term market viability.

Key Takeaways

• PREVNAR 20 addresses critical gaps in pneumococcal disease prevention through broader serotype coverage, positioning it favorably in a competitive landscape.
• The vaccine’s successful market entry hinges on timely regulatory approvals, favorable reimbursement policies, and effective global rollout strategies.
• Its potential to generate over $2 billion in annual revenue within five years underscores its financial significance and strategic value.
• Ongoing disease surveillance and adaptability remain essential to sustain its market position amid evolving pneumococcal epidemiology.
• Strategic collaborations, especially in emerging markets, can amplify impact and revenue, reinforcing Pfizer’s leadership in infectious disease prevention.

FAQs

1. How does PREVNAR 20 differ from Prevnar 13?
PREVNAR 20 covers 20 pneumococcal serotypes, including 7 additional types not present in Prevnar 13, offering broader protection, especially against emerging non-vaccine serotypes.

2. What is the current regulatory status of PREVNAR 20?
Pfizer submitted PREVNAR 20 for approval to key agencies such as the FDA and EMA. While approval timelines vary, positive clinical data support expected regulatory clearance in the near term.

3. What are the main challenges in the adoption of PREVNAR 20?
Challenges include regulatory hurdles, pricing negotiations, reimbursement policies, vaccine hesitancy, and competition from other multivalent pneumococcal vaccines.

4. Which markets will be prioritized for PREVNAR 20 rollout?
High-income countries with established immunization infrastructure and high disease burden regions are primary targets, followed by efforts to expand access in LMICs through global health initiatives.

5. How does serotype replacement influence the future of pneumococcal vaccines?
Serotype replacement necessitates updated vaccines with expanded coverage like PREVNAR 20 and ongoing epidemiological monitoring to ensure sustained efficacy and relevance.

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References

[1] WHO. (2022). Pneumococcal disease fact sheet. World Health Organization.
[2] CDC. (2021). Pneumococcal Vaccination: Summary of Recommendations. Centers for Disease Control and Prevention.
[3] Weiser, J.N., et al. (2018). Serotype replacement after pneumococcal vaccines. Journal of Infectious Diseases.
[4] MarketsandMarkets. (2022). Pneumococcal Vaccine Market.
[5] Pfizer Investor Presentation. (2023). Pipeline and Market Strategy for PREVNAR 20.