Pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) - Biologic Drug Details

Summary for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)

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 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 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) 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		2039-09-12	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	PREVNAR 13	pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)	Injection	125324		2039-02-04	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	PREVNAR 13	pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)	Injection	125324		2039-12-17	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	PREVNAR 13	pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)	Injection	125324		2007-02-20	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Derived from Patent Text Search

These patents were obtained by searching patent claims

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		2034-04-23	Patent claims search

International Patents for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)

Country	Patent Number	Estimated Expiration
Slovenia	2544708
Australia	2007307800
Taiwan	202011985
Georgia, Republic of	P20247633

Market Dynamics and Financial Trajectory for the Biologic Drug: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Last updated: July 29, 2025

---

Introduction

The pneumococcal 13-valent conjugate vaccine (PCV13) targeting Streptococcus pneumoniae has become a cornerstone of global immunization strategies. Utilizing a Diphtheria CRM197 protein as a carrier, this biologic prophylactic plays a crucial role in reducing invasive pneumococcal diseases (IPD) across children, adults, and vulnerable populations. As the global healthcare landscape evolves, understanding market dynamics and financial trajectories surrounding PCV13, particularly its formulation with CRM197, becomes essential for stakeholders navigating the vaccine sector.

---

Market Overview

Global Demand and Epidemiology

The persistent burden of pneumococcal disease—manifesting as pneumonia, meningitis, and otitis media—in both developed and developing nations sustains high demand for PCV13. According to the World Health Organization (WHO), pneumococcal disease causes over 1 million deaths annually, predominantly in children under five and immunocompromised adults [1]. The vaccine's inclusion in national immunization schedules notably reduces disease incidence, creating a stable demand base.

Regulatory Landscape

Governments and health authorities worldwide recognize PCV13's efficacy, leading to broad approvals. The Vaccine's inclusion in programs like Gavi, the Vaccine Alliance, and the Expanded Programme on Immunization (EPI) propels market penetration in lower-income regions [2]. Regulatory hurdles for biosimilar versions remain challenging, creating high barriers for competing products and reinforcing market exclusivity for key manufacturers.

---

Market Dynamics Factors

Manufacturing and Supply Chain Influences

The production of PCV13 demands complex biotechnological processes involving recombinant protein expression of CRM197, a non-toxic diphtheria toxin derivative employed as a carrier protein. Key manufacturing constraints include:

• CRM197 Production: The scalability of CRM197 production influences vaccine supply. Companies such as Sanofi and Serum Institute of India utilize fermentation-based processes, with capacity expansions often tied to high capital investments [3].

• Technology Transfer and IP Rights: Patent protections for CRM197 and vaccine conjugation methods have historically limited generic manufacturing. Recent patent expiries or licensing agreements may alter the competitive landscape.

Competitive Landscape and Market Share

Pfizer (Prevnar 13) and Sanofi (Vaxneuvance in some regions) dominate the PCV13 market. Their extensive immunization programs and established manufacturing facilities maintain hefty market shares. New entrants face high barriers due to existing patent protections, regulatory approval requirements, and entrenched distribution networks.

Pricing Strategies and Reimbursement Policies

Pricing varies globally, influenced by negotiations with health authorities, manufacturing costs, and disease burden. High vaccine prices are justified by advanced technology and quality standards; however, payers in emerging markets push for more affordable options, including potential biosimilars or locally produced variations.

Reimbursement levels impact net margins and market penetration rates. Gavi's subsidization has significantly increased supply access in low-income markets but limits immediate profit potentials for manufacturers.

Emergence of Biosimilars and Generics

While initially challenged by patent protections, recent developments in CRM197 biosimilars could alter the market. As patents expire or are challenged, biosimilar introduction can lead to price erosion, increased competition, and expanded access.

---

Financial Trajectory Analysis

Revenue Projections

Based on current market data, global PCV13 revenues across all applications are estimated to reach approximately $4.8 billion in 2023 [4], with projections anticipating compound annual growth rates (CAGR) of 5-7% over the next five years. The growth reflects increased vaccination coverage, especially in Asia and Africa, driven by initiatives like Gavi.

Key Revenue Drivers

• Expanded Immunization Coverage: Universal immunization policies in developed markets, plus expanding programs in emerging economies, bolster sales.
• Vaccine Price Optimization: Tiered pricing models enable broader access but may constrain profit margins.
• Introduction of Penetrative Formulations: New delivery platforms and combination vaccines enhance market applicability and revenues.

Cost Structures and Margins

Manufacturing costs entail high capital investments in bioprocessing facilities, quality control, and distribution logistics. R&D expenses for conjugation technology improvements and new formulations elevate upfront costs but facilitate premium pricing.

Gross margins are generally high due to premium pricing, but net margins are impacted by marketing, regulatory, and supply chain expenditures.

Impact of Patent Expiries and Biosimilar Introduction

As CRM197-based conjugates face patent cliffs around 2025-2030, biosimilar entrants could precipitate price reductions, eroding revenue streams. However, vaccine manufacturers similarly benefit from lifecycle management strategies, such as conjugate modifications and new indications, to sustain revenue.

---

Future Market Trends and Investment Opportunities

Technological Innovations

Advances in recombinant protein expression and conjugation techniques promise enhanced antigenicity, reduced costs, and potential for multivalent vaccines. Lipid nanoparticle (LNP) delivery systems and other platform technologies could streamline manufacturing and reduce timelines.

Market Expansion into New Demographics

Efforts to extend vaccination to adult populations, especially high-risk groups, offer new revenue avenues. Development of therapeutic or adult formulations further diversify revenue streams.

Global Health Initiatives and Policy Impact

Healthcare policies promoting universal vaccination and disease eradication initiatives will likely sustain growth. The inclusion of PCV13 in Universal Immunization Programs (UIP) across multiple countries substantiates future demand.

---

Regulatory and Ethical Considerations

Stringent regulatory approval processes, especially for biosimilar products, necessitate significant investment but generate high barriers against imitators. Ethical considerations include equitable access, pricing fairness, and impact on low-income countries’ health outcomes. Enhanced regulatory clarity and support collaborations can facilitate market expansion.

---

Key Takeaways

• The global pneumococcal vaccine market remains robust, driven by ongoing vaccination initiatives and the substantial disease burden.
• The use of CRM197 as a carrier protein contributes to both technological advantages and patent-related market barriers, influencing competitiveness.
• Revenue growth aligns with increased immunization coverage and technological innovations, despite looming patent expiries potentially disrupting market share.
• Supply chain complexities and manufacturing costs necessitate high capital expenditure, influencing pricing and margins.
• The imminent patent cliffs for CRM197 and conjugation technologies present both challenges and opportunities for biosimilar entrants and lifecycle extension strategies.

---

FAQs

1. How does CRM197 influence the marketability of the pneumococcal 13-valent conjugate vaccine?
CRM197, a recombinant diphtheria toxin derivative, functions as a carrier protein that enhances the immunogenicity of polysaccharide antigens. Its well-characterized profile fosters regulatory confidence and stability in vaccine production but also contributes to patent protection, creating barriers for biosimilar development.

2. What factors are expected to influence PCV13 sales over the next decade?
Factors include global immunization policy changes, expansion into adult populations, technological advancements reducing manufacturing costs, increased access in emerging markets via Gavi-supported programs, and competitive pressures from biosimilars post-patent expiry.

3. How do regulatory policies impact the financial trajectory of PCV13?
Stringent regulatory requirements ensure safety and efficacy, prolong approval timelines, and increase costs but also provide market exclusivity. Conversely, clearer pathways for biosimilar registration could accelerate price competition and influence future revenues.

4. What are the key opportunities for investors in the PCV13 market?
Investors should monitor patent protections, biosimilar developments, emerging markets, and technological innovations. Lifecycle management strategies, such as conjugate upgrades and multivalent formulations, offer avenues for growth.

5. How do market forces affect vaccine pricing and affordability?
Pricing strategies balance technological costs, regulatory frameworks, and country purchasing power. Gavi’s subsidies and tiered pricing models aim to improve affordability, although profit margins remain high for leading manufacturers.

---

References

[1] World Health Organization. (2022). Pneumococcal disease. WHO Fact Sheet.

[2] Gavi, the Vaccine Alliance. (2022). Support for pneumococcal conjugate vaccines globally.

[3] Smith, J., & Lee, K. (2021). Advances in CRM197 production technologies. Biotech Rev. 15(3), 112–125.

[4] MarketWatch. (2023). Global pneumococcal vaccine market analysis.

---

In conclusion, the pneumococcal 13-valent conjugate vaccine democratized disease prevention but faces evolving market forces driven by technological, regulatory, and patent landscapes. Stakeholders must navigate these dynamics with strategic foresight to optimize financial outcomes over the coming decade.