Influenza vaccine - Biologic Drug Details

Summary for influenza vaccine

Tradenames:	5
High Confidence Patents:	0
Applicants:	6
BLAs:	7
Suppliers: see list	7

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 influenza vaccine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for influenza vaccine 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
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127		2036-05-09	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127		2028-04-15	DrugPatentWatch analysis and company disclosures
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163		2033-10-25	DrugPatentWatch analysis and company disclosures
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163		2042-06-23	DrugPatentWatch analysis and company disclosures
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163		2034-04-28	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for influenza vaccine 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
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127		2036-10-12	Patent claims search
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127		2034-01-23	Patent claims search
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127		2034-09-23	Patent claims search
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127		2032-10-01	Patent claims search
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127		2035-08-03	Patent claims search

International Patents for influenza vaccine

Country	Patent Number	Estimated Expiration
Philippines	12014502544
World Intellectual Property Organization (WIPO)	2007052155
Spain	2378471
United Kingdom	0609902
Canada	2634885

Supplementary Protection Certificates for influenza vaccine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C20240033	Finland
SPC/GB20/045	United Kingdom		PRODUCT NAME: INFLUENZA VIRUS HAEMAGGLUTININ, INACTIVATED, OF THE FOLLOWING STRAINS PREPARED IN CELL CULTURES: B/XXXXX-LIKE STRAIN B/XXXXX-LIKE STRAIN; REGISTERED: UK EU/1/18/1326/001(NI) 20181212; UK PLGB 47991/0003 20181212
CA 2024 00037	Denmark		PRODUCT NAME: INFLUENZA A VIRUS H5 HAEMAGGLUTININ OVERFLADEANTIGEN, INAKTIVERET, FREMSTILLET I CELLEKULTURER; REG. NO/DATE: EU/1/24/1806, EU/1/24/1807 20240422
122020000047	Germany		PRODUCT NAME: INFLUENZAVIRUS-HAEMAGGLUTININ, INAKTIVIERT, DER FOLGENDEN STAEMME HERGESTELLT IN ZELLKULTUR: B/XXXXX - AEHNLICHER STAMM B/XXXXX - AEHNLICHER STAMM; REGISTRATION NO/DATE: EU/1/18/1326 20181212
122024000055	Germany		PRODUCT NAME: INFLUENZA-A-VIRUS-H5-HAEMAGGLUTININ-OBERFLAECHENANTIGEN, INAKTIVIERT, HERGESTELLT IN ZELLKULTUREN; REGISTRATION NO/DATE: EU/1/24/1806 20240419

Market Dynamics and Financial Trajectory of Influenza Vaccine Biologics: An In-Depth Analysis

Last updated: July 29, 2025

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Introduction

The influenza vaccine segment within the biologic pharmaceuticals market stands as a critical sector in global public health, driven by seasonal demand, pandemic preparedness, and advances in vaccine technology. As a biologic product, influenza vaccines represent a complex, highly regulated product class characterized by substantial R&D investments, manufacturing intricacies, and evolving market dynamics influenced by epidemiological patterns, technological innovation, and policy frameworks. This article delineates the current market landscape, examines key determinants shaping its future, and evaluates financial trajectories anticipated over the coming decade.

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Market Overview

The global influenza vaccine market was valued at approximately USD 7.4 billion in 2022 and is projected to reach USD 12.4 billion by 2030, registering a Compound Annual Growth Rate (CAGR) of around 7.0% during 2023–2030 [1]. This growth is propelled by increasing influenza incidence, expanding immunization programs, technological advancements, and heightened awareness of vaccine efficacy.

Major Market Players

Global leading vaccine manufacturers include Sanofi Pasteur, GlaxoSmithKline (GSK), Seqirus (a CSL company), AstraZeneca, and local/regional players such as China National Pharmaceutical Group and Serum Institute of India. These entities dominate supply, leverage extensive R&D pipelines, and benefit from strategic partnerships and licensing agreements.

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Market Drivers

Several factors underpin the expanding demand for influenza vaccines:

1. Rising Disease Burden: Seasonal outbreaks worldwide and pandemic threats accentuate the need for effective influenza immunization, especially among vulnerable groups such as the elderly, children, and immunocompromised individuals [2].

2. Immunization Policies and Programs: Governments worldwide increasingly endorse universal vaccination policies, supported by public health initiatives. Notably, the WHO recommends annual immunizations for high-risk groups, forming a significant demand driver [3].

3. Technological Innovations: Next-generation vaccines, including recombinant, adjuvanted, and mRNA-based platforms, promise enhanced immunogenicity and broader strain coverage, potentially increasing vaccination rates and market competitiveness.

4. Pandemic Preparedness: The COVID-19 pandemic bolstered investment and interest in influenza vaccine technology, with a focus on rapid response and scalable manufacturing processes.

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Market Challenges

Despite optimistic growth prospects, several challenges temper the market outlook:

• Vaccine Efficacy Variability: Influenza vaccine effectiveness fluctuates annually due to virus mutation, impacting public confidence and vaccination uptake.

• Manufacturing Complexity: Biologics production entails sophisticated cell culture or egg-based systems, high costs, and stringent regulatory compliance, constraining capacity expansion.

• Antigenic Drift and Shift: Continuous viral evolution necessitates annual reformulation, increasing R&D costs and extending time to market.

• Vaccine Hesitancy: Misinformation and safety concerns diminish vaccination rates in certain demographics.

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Technological Evolution and Future Trends

The future trajectory of influenza biologics hinges on technological advances:

• Universal Influenza Vaccines: Research into vaccines targeting conserved viral regions aims for broad, long-lasting protection, reducing the need for annual reformulation [4]. Companies like Moderna and Vaxxinity are actively pursuing mRNA and peptide-based universal vaccines, which could revolutionize the market.

• Recombinant and Cell-based Vaccines: These platforms eliminate egg-adapted mutations, offering higher yields and potentially improved efficacy, with increased acceptance in regions banning egg-based manufacturing.

• Adjuvanted Vaccines: Designed to boost immune response with smaller doses, adjuvants improve efficacy among the elderly and immunocompromised, opening new market segments.

• Digital and Data-Driven Manufacturing: Integration of AI, automation, and real-time analytics enhance production efficiency and vaccine supply chain management.

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Financial Trajectory and Investment Outlook

The influenza vaccine market exhibits robust investment potential, driven by high global demand and innovations:

• Revenue Growth: Projected to grow at a CAGR of approximately 7.0%, reaching USD 12.4 billion by 2030 [1].

• R&D Expenditure: Major players allocate substantial budgets—Sanofi invested over USD 400 million in influenza vaccine R&D in 2022—to maintain technological edge.

• Pricing Dynamics: High manufacturing costs influence vaccine pricing, though increased competition, especially from newer entrants and biosimilar-like products, may moderate prices.

• Market Entry Barriers: Stringent regulatory pathways and manufacturing complexities restrict new entrants, favoring established players but requiring significant capital investment.

• Public Sector Impact: Government procurement contracts and immunization programs secure predictable revenue streams, incentivizing continuous innovation and supply continuity.

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Regulatory Environment

Stringent regulatory standards by agencies such as the FDA, EMA, and WHO shape market pathways. Recent approvals of novel platforms—mRNA-based influenza vaccines—demonstrate a shift toward expedited pathways and adaptive licensing, potentially accelerating product commercialization and influencing financial outcomes.

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Market Outlook and Strategic Implications

The influenza biologics market is poised for steady expansion, bolstered by innovative vaccine platforms and expanded immunization initiatives. Companies focusing on universal vaccines and leveraging mRNA technology could capture substantial market share, reconfiguring traditional competitive dynamics. Strategic alliances, licensing agreements, and capacity investments remain critical to capitalize on upcoming opportunities.

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Key Challenges and Risks

• Vaccine efficacy inconsistency may deter public uptake, impacting sales.

• Manufacturing constraints and supply chain disruptions pose risks to product availability.

• Regulatory uncertainties Surrounding novel platforms could delay commercialization.

• Evolving epidemiological patterns necessitate adaptive R&D to stay relevant.

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Conclusion

The biologic influenza vaccine market is experiencing a transformative phase characterized by technological innovation, expanding demand, and strategic investments. While face-paced advancements and policy support foster growth, challenges such as efficacy variability and manufacturing hurdles necessitate proactive management. Stakeholders focusing on next-generation vaccines, efficient manufacturing, and adaptive regulatory strategies are positioned to harness the market’s full potential, ensuring sustained financial success.

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Key Takeaways

• The influenza vaccine biologics market is forecasted to grow at a CAGR of approximately 7% through 2030, driven by increased disease burden and technological innovation.
• Next-generation platforms, including universal, mRNA, and recombinant vaccines, are poised to reshape the competitive landscape.
• Manufacturing complexity and efficacy variability remain critical challenges; investment in scalable and adaptable production methods is essential.
• Strategic alliances and rapid regulatory pathways will be crucial for market entrants aiming to capitalize on emerging technologies.
• Public health policies and pandemic preparedness drive long-term demand, securing the financial outlook for established and emerging players alike.

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FAQs

1. What are the primary drivers fueling growth in the influenza vaccine biologics market?
Increasing global influenza incidence, expanded immunization policies, technological advances (such as universal and mRNA vaccines), and heightened pandemic preparedness efforts drive market growth.

2. How might next-generation influenza vaccines influence market dynamics?
Universal and mRNA-based influenza vaccines offer broader, longer-lasting protection, reducing formulation frequency and manufacturing costs, thereby potentially expanding market size and encouraging new entrants.

3. What are major challenges faced by manufacturers of influenza biologics?
Key challenges include variable vaccine efficacy due to viral mutation, high manufacturing complexity, regulatory hurdles for novel platforms, and vaccine hesitancy impacting demand.

4. What role does regulation play in shaping the influenza biologic market?
Stringent regulatory standards influence product approval timelines and quality requirements. Accelerated pathways for innovative platforms like mRNA vaccines may, however, expedite market entry.

5. How significant is public health policy in influencing vaccine market revenues?
Government immunization initiatives and procurement contracts secure stable demand, incentivize R&D investment, and can drive market expansion across diverse regions.

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References

[1] MarketWatch, “Influenza Vaccine Market Size, Share & Trends Analysis Report,” 2023.
[2] World Health Organization, “Influenza Fact Sheet,” 2022.
[3] WHO Strategic Advisory Group of Experts (SAGE), “Seasonal Influenza Vaccines: Recommendations,” 2022.
[4] Moderna, “Universal Influenza Vaccine Program,” 2022.