Influenza virus vaccine - Biologic Drug Details

Summary for influenza virus vaccine

Tradenames:	3
High Confidence Patents:	0
Applicants:	3
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for influenza virus vaccine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for influenza virus vaccine

Recent Clinical Trials for influenza virus vaccine

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Tongji Hospital	NA
U.S. Food and Drug Administration (FDA)	PHASE4
Centers for Disease Control and Prevention	PHASE4

See all influenza virus vaccine clinical trials

Recent Litigation for influenza virus vaccine

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Melinta Therapeutics, LLC v. Nexus Pharmaceuticals, Inc.	2024-12-13
ACQIS LLC v. Hon Hai Precision Industry Co., Ltd.	2023-04-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10

See all influenza virus vaccine litigation

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 virus vaccine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for influenza virus 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
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	10,143,767	2034-06-12	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	10,213,485	2035-08-27	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	10,369,219	2035-08-04	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	10,406,209	2036-09-26	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	10,772,922	2037-11-03	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	11,452,771	2040-09-15	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for influenza virus 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
Seqirus Vaccines Limited	FLUVIRIN	influenza virus vaccine	Injection	103837	10,047,116	2032-10-01	Patent claims search
Seqirus Vaccines Limited	FLUVIRIN	influenza virus vaccine	Injection	103837	10,124,056	2035-08-18	Patent claims search
Seqirus Vaccines Limited	FLUVIRIN	influenza virus vaccine	Injection	103837	10,130,697	2031-03-23	Patent claims search
Seqirus Vaccines Limited	FLUVIRIN	influenza virus vaccine	Injection	103837	10,149,901	2036-01-27	Patent claims search
Seqirus Vaccines Limited	FLUVIRIN	influenza virus vaccine	Injection	103837	10,195,266	2035-09-14	Patent claims search
Seqirus Vaccines Limited	FLUVIRIN	influenza virus vaccine	Injection	103837	10,369,210	2035-09-18	Patent claims search

International Patents for influenza virus vaccine

Country	Patent Number	Estimated Expiration
China	105579056
Japan	2018126167
European Patent Office	1578936
Japan	2015033388
Norway	20051345
Japan	5566992

Influenza virus vaccine Market Analysis and Financial Projection

Last updated: February 17, 2026

What Are the Key Market Dynamics for the Influenza Virus Vaccine?

The influenza virus vaccine market has experienced consistent growth driven by annual vaccination campaigns, increasing healthcare initiatives, and pandemic preparedness efforts. The market value was estimated at approximately $7.5 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 6.2% from 2022 to 2028, reaching an estimated $11 billion by 2028 (source [1]).

Several factors influence market dynamics:

• Public health policies: Governments around the world mandate seasonal vaccination programs, especially for vulnerable populations, bolstering vaccine demand.
• Vaccine technology: Advances in cell-based and recombinant vaccine platforms improve manufacturing speeds and strain match accuracy, influencing production capacity and supply security.
• Emerging strains: The influenza virus's high mutation rate necessitates annual reformulation, impacting R&D cycles and market stability.
• Pandemic preparedness: Increased investment in influenza vaccines as pandemic mitigation tools affects market size. The COVID-19 pandemic elevated awareness and funding, accelerating innovation and production capacity.

How Do Vaccine Types Affect Market Structure?

The influenza vaccine market comprises several segments, each influencing the overall commercial landscape:

• Inactivated vaccines: Traditional, widely used, accounting for roughly 70% of production around the globe.
• Live attenuated vaccines: Primarily used in pediatric populations, representing approximately 15-20% of the market.
• Recombinant vaccines: Rapidly emerging, particularly in the U.S., with notable players like Seqirus's Flublok, gaining regulatory approval since 2013.
• Cell-based vaccines: Growing segment due to better strain match and reduced egg-adaptation issues; currently about 10% market share.

Innovation in vaccine platforms influences competition and pricing. Recombinant and cell-based vaccines command premium pricing due to their technological advantages.

What Is the Financial Trajectory of Influenza Vaccines?

The market is transitioning from modest annual revenues to more lucrative pathways owing to novel vaccine formats and increased vaccination coverage:

• 2021 revenues: Estimated at $7.5 billion worldwide.
• Growth drivers: Augmented R&D investments, expanded immunization programs, and pandemic-related funding increased production capacity.
• Pricing trends: Traditional inactivated vaccines average $10–$40 per dose; recombinant vaccines often command higher prices, ranging from $50–$70.
• Research investments: Global R&D expenditure exceeds $1 billion annually, with a focus on universal influenza vaccines and mRNA platforms, promising potential shifts in the financial landscape.

Major pharmaceutical firms invest in partnerships to develop next-generation vaccines. For example, Moderna’s mRNA-based influenza vaccine candidate entered phase 1 trials in 2022, aiming for broader and longer-lasting immunity, potentially disrupting traditional revenue models.

How Do Regulatory and Production Factors Shape Market Opportunities?

Regulatory approvals significantly influence the market's growth trajectory:

• Approval timelines: Cell-based vaccines have received expedited approval in the U.S. and Europe, reducing time-to-market.
• Global approval variance: Regulatory requirements differ; emerging markets often experience delays, impacting global revenue flow.

Supply chain constraints, especially during the COVID-19 pandemic, exposed vulnerabilities in traditional egg-based manufacturing. This has prompted a shift towards cell-based and recombinant production methods, impacting cost structures and profit margins.

What Are the Challenges and Opportunities?

Challenges:

• High R&D costs and extensive regulatory requirements slow the development pipeline.
• Vaccine efficacy fluctuates annually, affecting consumer confidence and vaccination rates.
• Strain selection and virus mutation complicate manufacturing.

Opportunities:

• Development of universal influenza vaccines aims to provide multi-year protection, expanding market potential.
• Platform technologies, such as mRNA, could significantly reduce development timelines and costs.
• Growing aging populations and increased vaccine recommendations for chronic illness sufferers expand market base.

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Key Takeaways

• The influenza vaccine market is valued at approximately $7.5 billion (2021) with projected CAGR of 6.2% until 2028.
• Technological advances in recombinant, cell-based, and mRNA platforms influence supply, efficacy, and pricing.
• Pandemic preparedness and policy mandates sustain demand, supporting steady revenue growth.
• Regulatory strategies and manufacturing innovations directly impact market entry and scale.
• Investment in universal vaccines and platform technologies presents both challenges and growth opportunities.

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FAQs

1. What are the dominant types of influenza vaccines?
Inactivated vaccines lead globally, while recombinant and cell-based vaccines are increasing due to technological improvements.

2. How does influenza vaccine efficacy vary annually?
Efficacy can range from 40% to 60% depending on strain match and vaccine formulation, influencing public perception and uptake.

3. What role does technology play in the future market?
Technologies like mRNA and universal vaccine platforms promise to reduce development timelines and improve effectiveness, potentially disrupting current market dynamics.

4. What are key regulatory considerations?
Different regions have varying approval processes; expedited pathways exist but still require substantial clinical data, affecting timelines and costs.

5. Which markets show the highest growth potential?
Emerging markets and developed nations with high vaccination coverage, particularly the U.S. and Europe, offer substantial growth opportunities.

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References

1. MarketWatch, “Influenza Vaccine Market Size, Share & Trends Analysis Report,” 2022.