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Last Updated: December 18, 2025

PREVNAR 13 Drug Profile


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Summary for Tradename: PREVNAR 13
High Confidence Patents:22
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for PREVNAR 13
Recent Clinical Trials for PREVNAR 13

Identify potential brand extensions & biosimilar entrants

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

See all PREVNAR 13 clinical trials

Pharmacology for PREVNAR 13
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. DrugPatentWatch analysis and company disclosures
  4. 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.

  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 13 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PREVNAR 13 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 13 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Injection 125324 ⤷  Get Started Free 2039-09-12 DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc PREVNAR 13 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Injection 125324 ⤷  Get Started Free 2039-02-04 DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc PREVNAR 13 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Injection 125324 ⤷  Get Started Free 2039-12-17 DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc PREVNAR 13 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Injection 125324 ⤷  Get Started Free 2007-02-20 DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc PREVNAR 13 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Injection 125324 ⤷  Get Started Free 2012-07-30 DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc PREVNAR 13 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Injection 125324 ⤷  Get Started Free 2012-01-09 DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc PREVNAR 13 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Injection 125324 ⤷  Get Started Free 2014-08-24 DrugPatentWatch analysis and company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for PREVNAR 13 Derived from Patent Text Search

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for PREVNAR 13

Last updated: July 27, 2025

Introduction

PREVNAR 13 (pneumococcal 13-valent conjugate vaccine) has established itself as a critical player in the global pneumococcal disease prevention landscape. Developed by Pfizer, PREVNAR 13 targets pneumococcal bacteria responsible for pneumonia, meningitis, and invasive diseases, particularly in vulnerable populations such as infants, elderly, and immunocompromised individuals. Given its strategic position in pediatric and adult immunization programs, understanding its market dynamics and financial trajectory is essential for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

Market Overview: Key Drivers and Trends

Growing Disease Burden and Public Health Initiatives

The global incidence of pneumococcal diseases remains significant despite existing vaccines. According to the World Health Organization (WHO), pneumococcal infections are among the leading causes of vaccine-preventable deaths, particularly in developing countries where healthcare infrastructure is limited [1]. The persistent disease burden fuels continued demand for effective vaccines like PREVNAR 13 and bolsters immunization programs worldwide.

Furthermore, increased awareness among healthcare providers and caregivers about pneumococcal disease severity has expanded vaccine adoption. Governments and health organizations continue to incorporate PREVNAR 13 into national immunization schedules, supporting steady demand growth.

Competition and Market Saturation

PREVNAR 13 faces competition from other pneumococcal vaccines such as Merck's Pneumovax 23 (23-valent polysaccharide vaccine) and newer conjugate vaccines currently in development. While Pneumovax 23 covers a broader serotype spectrum, PREVNAR 13's conjugate nature elicits a more robust and longer-lasting immune response, driving its preference, especially in children.

Market maturity varies geographically: high-income countries have achieved high vaccination coverage, creating a mature but stable market, whereas emerging markets are witnessing rapid growth due to expanding immunization programs and increased healthcare access.

Regulatory Approvals and Extended Indications

Recent regulatory milestones, including approvals for adult use in various jurisdictions, have broadened PREVNAR 13’s market potential. For example, the US Food and Drug Administration (FDA) approved PREVNAR 13 for use in adults aged 50 and older in 2011, further expanding its sales volume [2].

Additionally, ongoing clinical trials exploring new indications or combination vaccines could influence long-term market dynamics, either by expanding the target population or enhancing vaccine efficacy.

Pricing Dynamics and Reimbursement Policies

Pricing strategies for PREVNAR 13 vary globally, heavily influenced by reimbursement policies and healthcare infrastructure. Developed nations tend to have favorable reimbursement landscapes, supporting premium pricing. Conversely, in low-to-middle-income countries, price negotiations and tiered pricing models are crucial to expanding access.

The introduction of biosimilars or generic alternatives remains unlikely due to the complexity of biologic manufacturing and patent protections, helping Pfizer maintain pricing power and revenue streams.

Financial Trajectory: Revenue and Market Penetration

Historical Revenue Performance

PREVNAR 13 achieved approximately $6.8 billion in global sales in 2022, representing a significant portion of Pfizer’s vaccine revenue [3]. The vaccine’s sales growth has been driven by increased adult immunization campaigns, notably during the COVID-19 pandemic when vaccination infrastructure strengthened healthcare delivery systems worldwide.

Initial revenues were primarily driven by pediatric immunizations in North America and Europe; however, recent years have seen an increasing contribution from adult vaccination markets, driven by aging populations and expanded indications.

Forecasting Future Revenue Streams

Financial projections indicate continued growth in PREVNAR 13 revenues over the next five years, powered by:

  • Expanding adult immunization programs across North America, Europe, and Asia.
  • Emerging markets, where increased disease awareness catalyzes vaccine adoption.
  • Introduction of new indications or combination formulations, which could enhance treatment adherence and market penetration.
  • Population aging, particularly in developed economies, qualifying more individuals for adult vaccination.

According to industry analysts, the vaccine’s compounded annual growth rate (CAGR) is expected to be approximately 4-6% through 2028, contingent on market expansion and sustained public health investment [4].

Challenges Impacting Financial Trajectory

Potential hurdles include pricing pressures, especially in price-sensitive markets, and competition from emerging vaccines. Additionally, the vaccine’s high manufacturing complexity and costs pose barriers to supply scalability, which could constrain revenue growth during global supply chain disruptions.

Market Opportunities and Strategic Considerations

Global Expansion and Access Initiatives

Pfizer’s ongoing commitments to increase vaccine access in low-resource settings through tiered pricing and participation in global health initiatives (e.g., GAVI Alliance) will be critical in capturing emerging markets' growth potential. These efforts may involve negotiated pricing and donation programs that, while reducing short-term margins, expand long-term market penetration.

Innovations and Future Pipeline

Investments in next-generation pneumococcal conjugate vaccines with broader serotype coverage, improved immunogenicity, or conjugation technology could threaten PREVNAR 13’s market dominance. Conversely, integrating PREVNAR 13 into combination vaccines or developing thermostable formulations enhances its competitiveness and convenience, potentially boosting sales.

Regulatory and Reimbursement Dynamics

Navigating regulatory pathways, particularly for extended indications and in new markets, remains vital. Securing favorable reimbursement terms, especially in the U.S. and Europe, ensures sustained revenue streams.

Impact of COVID-19 Pandemic

The COVID-19 pandemic accelerated digital health adoption and strengthened infrastructure for adult immunization programs. As health systems rebuild, opportunities for widespread PREVNAR 13 vaccination campaigns are emerging, potentially accelerating revenues.

Key Takeaways

  • Market stability and growth are driven by persistent disease burden, public health priorities, and expanding adult vaccination programs.
  • High-income markets exhibit mature but profitable environments, while emerging economies present significant growth prospects owing to increasing healthcare access.
  • Pfizer’s strategic focus on global expansion, innovation, and partnerships will underpin the vaccine’s financial trajectory over the coming years.
  • Pricing and reimbursement policies remain critical levers influencing revenue, with tiered models to address diverse market needs.
  • Emerging competition and technological advancements in vaccine development require continuous innovation and strategic positioning.

Conclusion

PREVNAR 13’s market dynamics portray a resilient, gradually growing segment within the global vaccine landscape. Its financial trajectory benefits from demographic shifts, increasing global health investments, and strategic product innovation. While challenges such as pricing pressures and competitive pressures persist, ongoing public health initiatives and market expansion efforts position PREVNAR 13 for sustained revenue growth in the foreseeable future.

FAQs

1. How has the COVID-19 pandemic affected PREVNAR 13's sales?
The pandemic enhanced healthcare infrastructure and digital health initiatives, facilitating broader adult immunization campaigns. As a result, Pfizer observed increased uptake of PREVNAR 13 among adult populations, positively impacting sales.

2. What are the main competitive threats facing PREVNAR 13?
Competitors include other pneumococcal vaccines such as Pneumovax 23, and the development of new conjugate vaccines with expanded serotype coverage. Biosimilar options are unlikely due to manufacturing complexities.

3. How important are emerging markets for PREVNAR 13’s future?
Extremely vital. Growing disease awareness, expanding immunization programs, and increasing healthcare access make emerging markets key growth drivers despite lower per-dose prices.

4. What role do regulatory approvals play in shaping PREVNAR 13’s financial outlook?
Regulatory milestones extend indications and open new markets, directly boosting revenue potential. Conversely, delays or restrictions could hinder market penetration and growth.

5. How might technological innovations impact PREVNAR 13’s market position?
Advances in vaccine technology—such as thermostable formulations or combination vaccines—could enhance efficacy, ease of administration, and market share, provided they align with regulatory standards and cost structures.


References:

[1] WHO. (2022). Pneumococcal disease. World Health Organization.
[2] FDA. (2011). FDA Approves Pneumococcal Vaccine for Adults. U.S. Food and Drug Administration.
[3] Pfizer. (2022). PREVNAR 13 Sales Report. Pfizer Annual Financials.
[4] MarketResearch.com. (2023). Global Pneumococcal Vaccines Market Analysis.

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