Influenza virus vaccine - Biologic Drug Details

Summary for influenza virus vaccine

Tradenames:	3
High Confidence Patents:	0
Applicants:	3
BLAs:	4
Suppliers: see list	2
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
National Taiwan University Hospital	NA
Tsinghua University	NA
Second Affiliated Hospital of Bengbu Medical College	NA

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	10,406,209	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
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	11,696,956	2038-12-19	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	8,496,944	2028-11-03	DrugPatentWatch analysis and company disclosures
Seqirus Inc.	AGRIFLU	influenza virus vaccine	Injection	125297	8,834,898	2031-12-16	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
Japan	4252061
Poland	377338
World Intellectual Property Organization (WIPO)	2005016949
Argentina	113966
Russian Federation	2333223
Japan	2009082133

Market Dynamics and Financial Trajectory for the Biologic Drug: Influenza Virus Vaccine

Last updated: July 28, 2025

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Introduction

Influenza virus vaccines, classified as biologic drugs, represent a cornerstone in infectious disease prevention worldwide. As the global health landscape evolves—marked by pandemic threats, vaccine innovation, and changing consumer demands—the market dynamics for influenza vaccines are experiencing significant shifts. This analysis explores these dynamics, focusing on factors influencing market growth, revenue trajectories, and strategic investment opportunities.

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Global Market Overview

The influenza vaccine market is projected to reach approximately USD 8 billion by 2027, growing at a compound annual growth rate (CAGR) of 7-9% from 2023 to 2027 [1]. This growth is driven by heightened awareness of influenza’s societal burden, expanded immunization programs, and advances in vaccine technology. The biologic nature of these vaccines entails complex manufacturing processes and regulatory pathways, influencing their supply chain and market supply-demand dynamics.

Market Drivers

1. Rising Global Burden of Influenza

Annual seasonal influenza epidemics result in an estimated 3-5 million severe cases and approximately 290,000-650,000 respiratory deaths worldwide [2]. The persistent health toll underscores the need for widespread vaccination, propelling demand, especially in vulnerable populations such as the elderly, children, and immunocompromised individuals.

2. Technological Innovations

Recent biotechnological advancements—such as recombinant DNA technology, mRNA platforms, and adjuvant formulations—have enhanced vaccine efficacy and safety profiles. mRNA-based influenza vaccines, exemplified by Moderna’s mRNA flu candidate, promise faster development timelines and better strain coverage, disrupting traditional manufacturing cycles [3].

3. Pandemic Preparedness and Supply Chain Resilience

The COVID-19 pandemic elevated awareness of vaccine infrastructure and accelerated investments in biologic manufacturing. Governments and organizations are diversifying their stockpiles, which positively impacts influenza vaccine procurement and deployment strategies.

4. Expansion of Vaccination Programs

Many countries, notably in North America and Europe, have integrated influenza vaccination into national immunization schedules. Efforts to target high-risk groups and incorporate adult and pediatric immunization campaigns are fueling market expansion.

5. Policy and Reimbursement Landscape

Regulatory agencies such as the FDA and EMA have become more receptive to innovative biologics, streamlining approval processes. Additionally, reimbursement policies favor vaccination programs, supporting market stability and growth [4].

Market Challenges

1. Manufacturing Complexities

Biologic vaccines demand sophisticated production facilities, cold chain logistics, and stringent quality control. These factors impose high entry barriers and limit rapid scaling during outbreaks.

2. Strain Predictability and Efficacy

The antigenic drift of influenza viruses hampers vaccine effectiveness, which varies annually and can undermine confidence and uptake.

3. Competition from Alternative Vaccines

Emerging technologies like universal flu vaccines aim to provide broad and durable protection, challenging traditional seasonal vaccines and potentially disrupting revenue streams.

Financial Trajectory and Revenue Forecasts

The revenue generated from influenza biologics hinges on several factors:

• Vaccine Adoption Rates: Increased vaccination coverage, particularly among high-risk and pediatric populations, correlates with revenue growth.
• Innovative Vaccine Launches: Entry of new platforms, such as mRNA-based vaccines, can boost sales and introduce premium pricing.
• Pandemic and Non-Pandemic Demand: During severe seasons or pandemic scenarios, demand surges, impacting revenue variabilities.
• Pricing and Reimbursement Policies: Payor coverage and government procurement strategies influence gross margins.

Major pharmaceutical players—including Sanofi Pasteur, GlaxoSmithKline (GSK), Seqirus, and emerging biotech firms—generate annual revenues ranging from USD 1 billion to USD 3 billion from influenza vaccines [5]. The integration of personalized and platform-based approaches is expected to enhance future profit margins, with some estimates projecting a compounded annual growth rate (CAGR) of 8% over the next five years.

Strategic Investment and Market Opportunities

Investors should monitor:

• Innovation Pipelines: The progression of universal and mRNA influenza vaccines offers significant upside.
• Regulatory Advances: Expedited approval pathways for novel biologics accelerate market entry.
• Partnerships and Collaborations: Cross-sector alliances facilitate technology sharing and market expansion.
• Emerging Market Penetration: Expanding into Asia-Pacific and African regions presents growth opportunities due to increasing healthcare expenditures and immunization awareness.

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Regulatory and Competitive Landscape

Regulatory agencies prioritize safety, which influences trial designs, approval timelines, and post-market surveillance for biologic influenza vaccines. Market entrants benefit from accelerated approval pathways (e.g., FDA’s Fast Track, EMA’s PRIME scheme) when demonstrating significant advantages over existing options.

The competitive landscape is characterized by patent protections, licensing agreements, and strategic alliances. Despite the dominance of established players, biotech firms focusing on mRNA and universal vaccine platforms are poised for substantial market share gains.

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Conclusion

The influenza virus vaccine market is poised for sustained growth driven by technological innovations, increased vaccination coverage, and evolving pandemic preparedness strategies. While challenges exist—particularly regarding manufacturing complexity and vaccine efficacy—opportunities abound for innovative biologics and platform technologies to redefine market trajectories. Stakeholders aligning with emerging trends and investing in regenerative biologic solutions will likely maximize ROI.

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Key Takeaways

• The global influenza biologic market is projected to grow at a CAGR of approximately 8% through 2027, driven by technological innovation and policy support.
• Advances in mRNA and recombinant platform technologies will disrupt traditional vaccine manufacturing and market dynamics.
• High vaccine efficacy and broadened immunization programs underpin steady revenue growth, supported by public-private sector collaborations.
• Challenges include manufacturing complexities, efficacy variability, and competition from universal vaccine candidates.
• Strategic investments in innovation, regulatory agility, and emerging markets will be critical for maximizing long-term financial gains.

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FAQs

Q1: How will mRNA technology influence the influenza vaccine market?
A1: mRNA platforms enable rapid development, higher strain coverage, and potentially better efficacy. As these vaccines move through clinical trials, they are expected to capture market share, offering premium pricing and expanding the market’s technological horizon.

Q2: What role do government policies play in shaping the influenza vaccine market?
A2: Policies promoting immunization, funding of vaccine development, and streamlined regulatory pathways accelerate market expansion. Reimbursement schemes also incentivize manufacturers to innovate and supply vaccines broadly.

Q3: Are universal influenza vaccines a threat or an opportunity?
A3: Universal vaccines pose a disruptive threat by potentially reducing the demand for seasonal vaccines. However, they also represent an opportunity for companies to lead in next-generation biologics with broader, longer-lasting protection.

Q4: How do pandemic scenarios impact influenza vaccine revenues?
A4: Pandemics significantly increase demand, elevating revenues temporarily. They also stimulate investments in vaccine infrastructure, which can have long-term benefits for market growth.

Q5: Which regions offer the most significant growth opportunities?
A5: Emerging markets in Asia-Pacific and Africa, driven by rising healthcare spending and immunization initiatives, offer considerable growth potential alongside mature markets in North America and Europe.

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References

[1] Fortune Business Insights, “Influenza Vaccine Market Size, Share & Industry Analysis,” 2022.
[2] World Health Organization, “Influenza (Seasonal)” Factsheet, 2022.
[3] BioSpace, “mRNA Influenza Vaccines: Next-Generation Solutions,” 2023.
[4] U.S. Food and Drug Administration, “Vaccine Regulation and Approval,” 2022.
[5] MarketWatch, “Top Influenza Vaccine Companies and Revenue Analysis,” 2023.