Influenza vaccine, adjuvanted - Biologic Drug Details

Summary for influenza vaccine, adjuvanted

Tradenames:	2
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for influenza vaccine, adjuvanted

Recent Clinical Trials for influenza vaccine, adjuvanted

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Taiwan University Hospital	NA
Seqirus	Phase 2
Seqirus	Phase 2/Phase 3

See all influenza vaccine, adjuvanted clinical trials

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, adjuvanted Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for influenza vaccine, adjuvanted 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
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510		2026-07-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510		2037-11-17	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510		2037-02-24	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510		2039-01-17	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for influenza vaccine, adjuvanted 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
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510		2036-06-24	Patent claims search
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510		2031-10-21	Patent claims search
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510		2036-06-24	Patent claims search
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510		2031-10-21	Patent claims search

International Patents for influenza vaccine, adjuvanted

Country	Patent Number	Estimated Expiration
European Patent Office	1877119
Hungary	E027239
Russian Federation	2401134
Denmark	1909870

Supplementary Protection Certificates for influenza vaccine, adjuvanted

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122017000040	Germany		PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
CA 2017 00026	Denmark		PRODUCT NAME: CERTIFIKAT; REG. NO/DATE:
300880	Netherlands		PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
132017000073676	Italy		PRODUCT NAME: INSULINA ASPART A RAPIDA AZIONE(FIASP); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1160, 20170111

Market Dynamics and Financial Trajectory for the Biologic Influenza Vaccine: Adjuvanted

Last updated: August 5, 2025

Introduction

The global influenza vaccine market continues to evolve amidst advancements in vaccine technology, shifting epidemiological patterns, and the rising demand for more effective immunizations. Among these, the adjuvanted influenza vaccine stands out, with its combination of innovative vaccine formulation and enhanced immune response, particularly for vulnerable populations. This article analyzes the market dynamics and financial trajectory of adjuvanted influenza vaccines, emphasizing recent trends, key drivers, challenges, and future prospects.

Market Overview

Influenza remains a significant public health challenge, causing seasonal epidemics resulting in substantial morbidity, mortality, and economic burden worldwide. The global influenza vaccine market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.3% from 2023 to 2030 [1]. The surge in vaccine innovations, including adjuvants designed to stimulate superior and durable immune responses, is fueling growth.

Adjuvanted influenza vaccines constitute a niche within the broader vaccine market, leveraging adjuvants like MF59, AS03, and CpG 1018, which enhance immunogenicity, especially among elderly and high-risk groups. Notably, adjuvanted formulations have seen increased approval and deployment in both seasonal and pandemic contexts, underpinning their growing market share.

Key Market Drivers

1. Rising Demand for Enhanced Vaccine Efficacy

Traditional influenza vaccines exhibit variable efficacy, influenced by antigenic drift and population heterogeneity. The inclusion of adjuvants addresses these limitations by augmenting immune responses, leading to broader and more durable protection. The elderly and immunocompromised are particularly vulnerable, and adjuvanted vaccines offer a viable solution. The COVID-19 pandemic further underscored the importance of vaccine efficacy, accelerating adoption of adju ABC technologies to improve immune responses.

2. Regulatory Approvals and Government Initiatives

Regulatory bodies such as the FDA and EMA have approved several adjuvanted formulations, including GSK’s Shingrix (though for herpes zoster, highlighting crossover technology) and influenza-specific adjuvants like AS03 used in pandemic vaccines (e.g., Pandemrix). Governments are increasingly investing in adjuvanted vaccines, especially for pandemic preparedness, which bolsters market growth through procurement commitments and funding.

3. Aging Population and Targeted Vaccination

The global demographic shift towards an aging population is a pivotal factor. The World Health Organization estimates that by 2050, individuals aged 60 and above will constitute over 20% of the global population, significantly increasing demand for effective influenza vaccines among seniors. Adjuvanted vaccines, proven to elicit better immune responses in older adults, are thus prioritized in immunization programs.

4. Pandemic Preparedness and Response

The COVID-19 pandemic catalyzed investment in novel vaccine platforms, including adjuvants, which are now integral in pandemic preparedness strategies. The development of universal or broadly protective influenza vaccines utilizing adjuvants is gaining momentum, promising to stabilize and expand the market.

Market Challenges

1. High Development and Manufacturing Costs

Adjuvanted vaccines involve complex manufacturing processes and rigorous clinical testing. The costs associated with adjuvant development, stability studies, and regulatory approval are substantial, potentially limiting market entry for smaller players.

2. Regulatory Hurdles and Safety Concerns

Despite proven benefits, adjuvants have faced scrutiny owing to safety concerns, notably with the 2009 H1N1 pandemic vaccine Pandemrix and its association with narcolepsy. Regulatory agencies demand comprehensive safety data, extending approval timelines and increasing costs.

3. Competition from Non-Adjuvanted and mRNA Vaccines

The rapid development of mRNA vaccines and other novel platforms poses competitive challenges. While mRNA vaccines have demonstrated high efficacy, their adaptability for annual influenza strains remains under evaluation. Adjuvanted vaccines must demonstrate comparable or superior efficacy to retain market relevance.

4. Market Penetration and Accessibility

In low- and middle-income countries (LMICs), vaccine access remains constrained by infrastructure, affordability, and distribution logistics. Incorporating adjuvanted vaccines into national immunization programs requires strategic affordability solutions and partnerships.

Financial Trajectory and Market Potential

The financial outlook for adjuvanted influenza vaccines remains optimistic, driven by ongoing innovation, expanding indications, and supportive policy frameworks. The market is projected to reach USD 8.4 billion by 2030 [1], with a CAGR surpassing 7%. Key factors influencing this trajectory include:

• Product Pipeline Expansion: Several pharmaceutical companies, including GSK, Seqirus, and Sanofi, are investing in adjuvanted vaccine pipelines with enhanced formulations targeting broader age groups and pandemic threats.

• Government and Public Sector Procurement: Governments' commitments to pandemic preparedness projects forecasted increases in vaccine procurement volumes, providing stable revenue streams for vaccine manufacturers.

• Private Sector Expansion: Increased corporate investments in vaccine R&D and public confidence in vaccination strategies bolster sales channels.

• Pricing Strategies: Higher price points for adjuvanted vaccines are justified by their superior efficacy and safety profiles, although pricing negotiations remain sensitive in LMIC markets.

Competitive Landscape

Major players include GSK, Seqirus (a subsidiary of CSL Limited), Sanofi Pasteur, and Valneva, each with distinct adjuvant technologies:

• GSK: Leader with MF59 adjuvant, used in Fluad, capturing substantial market share, especially in older adults.

• Seqirus: Pioneered AS03 adjuvant technology, utilized in pandemic and seasonal vaccines.

• Sanofi Pasteur: Focuses on novel adjuvant formulations and combination vaccine platforms.

Emerging biotech companies are also developing next-generation adjuvants promising improved safety, efficacy, or ease of manufacturing.

Future Outlook and Innovation Trajectories

The future of adjuvanted influenza vaccines hinges on:

• Next-Generation Adjuvants: Development of safer, more potent adjuvants capable of enabling universal influenza vaccines.

• Broader Age Group Coverage: Extending indications to pediatric populations and immunocompromised individuals.

• Combination Vaccines: Integrating influenza vaccines with other immunizations for broader protection.

• Digital and Data-Driven Approaches: Leveraging genomics and predictive analytics to optimize vaccine strain selection, improving adjuvant design efficacy.

• Global Access Initiatives: Public-private partnerships aimed at making adjuvanted vaccines affordable and accessible in underserved regions.

Conclusion

The market dynamics for adjuvanted influenza vaccines are characterized by strong growth prospects driven by technological innovation, demographic shifts, and heightened pandemic awareness. Although challenges related to regulatory hurdles and costs persist, ongoing R&D investments and strategic public health initiatives are expected to accelerate market expansion. The financial trajectory points towards a doubling of market value by 2030, contingent upon successful product pipelines and global adoption.

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Key Takeaways

• The adjuvanted influenza vaccine market is poised for robust growth, projected to reach USD 8.4 billion by 2030, bolstered by the need for more effective immunization strategies.

• Demographic trends and pandemic preparedness efforts significantly drive demand, especially among elderly and vulnerable populations.

• Investment in innovative adjuvant technologies and regulatory approvals are central to market expansion, with major players competing through novel formulations.

• Challenges such as high costs, safety concerns, and market access barriers require strategic management to ensure sustained growth.

• Future trends include development of universal vaccines, combination formulations, and leveraging digital tools for personalized vaccine design.

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FAQs

1. What are the primary adjuvants used in influenza vaccines?
Main adjuvants include MF59 (GSK), AS03 (Seqirus), and CpG 1018 (Dynavax), each enhancing immune responses through different mechanisms.

2. How does adjuvanted influenza vaccine efficacy compare to non-adjuvanted formulations?
Adjuvanted vaccines generally induce stronger and more durable immune responses, particularly in older adults and immunocompromised populations, leading to improved effectiveness against circulating strains.

3. What are the regulatory considerations for adjuvanted influenza vaccines?
Regulatory agencies require extensive safety and efficacy data, with particular attention to adverse immune responses. Past concerns like narcolepsy linked to some adjuvanted vaccines have prompted rigorous safety review.

4. Which regions represent the fastest-growing markets for adjuvanted influenza vaccines?
North America and Europe lead in adoption due to mature healthcare infrastructure, but Asia-Pacific shows significant growth potential driven by aging populations and immunization programs.

5. Are adjuvanted influenza vaccines suitable for pandemic preparedness?
Yes. They are integral in pandemic response strategies due to their ability to elicit rapid and broad immune responses, potentially enabling early deployment of effective vaccines.

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References

[1] Market Research Future. "Influenza Vaccine Market Analysis & Forecast to 2030," 2023.