FLULAVAL Drug Profile

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. General 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 FLULAVAL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FLULAVAL Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for FLULAVAL 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
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	10,004,803	2036-10-12	Patent claims search
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	10,030,231	2034-01-23	Patent claims search
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	10,034,931	2034-09-23	Patent claims search
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	10,047,116	2040-01-30	Patent claims search
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	10,059,925	2035-08-03	Patent claims search
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	10,124,056	2034-08-18	Patent claims search

FLULAVAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Influenza Vaccines: A Focus on FLULAVAL

Introduction

Influenza vaccines, including products like FLULAVAL, are a crucial component of public health strategies to combat seasonal and pandemic influenza. Here, we will delve into the market dynamics and financial trajectory of the influenza vaccine market, with a particular focus on FLULAVAL and similar products.

Global Influenza Vaccine Market Overview

The global influenza vaccine market is experiencing significant growth, driven by increasing awareness of immunization benefits, government initiatives, and technological advancements.

• Market Size and Growth: The global influenza vaccine market was valued at USD 7.97 billion in 2023 and is projected to grow to USD 17.77 billion by 2032, with a CAGR of 9.6% during the forecast period of 2024-2032[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the influenza vaccine market.

Increasing Prevalence of Seasonal Outbreaks

• Seasonal influenza outbreaks result in millions of severe cases and hundreds of thousands of deaths globally each year. This increasing prevalence is a significant driver for the demand of influenza vaccines[1].

Government Initiatives and Immunization Programs

• Governments worldwide are implementing robust immunization programs to shield populations against influenza outbreaks. These initiatives are particularly strong in developing economies, where the adoption of vaccines is on the rise[1].

Technological Advancements

• The launch of novel vaccines, such as the needle-free nasal influenza vaccine by the Serum Institute of India and MyLab, is contributing to market growth. These advancements include improvements in vaccine safety, immunogenicity, and the development of quadrivalent vaccines[1].

Regional Market Dynamics

The market is geographically diverse, with different regions exhibiting unique growth patterns.

North America

• North America holds the highest market share, with a market value of USD 4.28 billion in 2023. The region's strong healthcare infrastructure and high immunization rates among the population are key factors[1].

Europe

• Europe is the second leading region, driven by the expansion of vaccination coverage for high-risk individuals. This has led to higher immunization rates among the European population[1].

Asia Pacific

• The Asia Pacific region is expected to register a higher CAGR during the forecast period. Government initiatives, rising population, and increasing demand for effective vaccines in countries like China and India are driving this growth[1].

Latin America and Middle East & Africa

• These regions are also expected to see significant growth due to rising awareness of the influenza virus, the launch of new vaccines, and increasing government efforts to vaccinate the population[1].

Financial Performance of Key Players

Major pharmaceutical companies are key players in the influenza vaccine market.

GlaxoSmithKline (GSK)

• GSK's vaccine sales, including influenza vaccines, have shown mixed results. While overall vaccine sales were up by 1% in Q2 2024 (excluding COVID-19 solutions), influenza vaccine sales specifically declined by 70% due to seasonal fluctuations[2].

Sanofi

• Sanofi's vaccine sales decreased by 4.8% in Q2 2024, primarily due to the absence of COVID-19 vaccine sales in 2024. However, the company's overall performance was strong, driven by other pharmaceutical products like Dupixent[3].

FLULAVAL and Similar Products

FLULAVAL, an influenza vaccine produced by GSK, is part of the broader market landscape.

Product Overview

• FLULAVAL is a trivalent influenza vaccine designed to protect against three different strains of the influenza virus. It is widely used in various regions and is part of GSK's vaccine portfolio[2].

Market Position

• While specific financial data for FLULAVAL is not separately disclosed, it contributes to GSK's overall vaccine sales. The decline in influenza vaccine sales in Q2 2024 reflects seasonal variations rather than a decline in the product's market position[2].

Technological and Regulatory Environment

The market is influenced by technological advancements and regulatory approvals.

Quadrivalent Vaccines

• Quadrivalent vaccines, which protect against four strains of the influenza virus, are gaining traction. The launch of novel quadrivalent vaccines, such as the needle-free nasal vaccine, is expected to drive market growth[1].

Regulatory Approvals

• Regulatory approvals and filings for new vaccines and vaccine candidates are crucial for market expansion. For example, GSK's filings for new vaccine candidates, such as the meningitis (ABCWY) vaccine, indicate a strong pipeline[2].

Challenges and Opportunities

The market faces several challenges and opportunities.

Challenges

• Seasonal fluctuations in demand and the impact of COVID-19 on vaccine sales are significant challenges. Additionally, competition from generic and biosimilar products can affect market dynamics[2][3].

Opportunities

• Emerging markets, particularly in the Asia Pacific region, offer substantial growth opportunities. Increasing government initiatives and partnerships with local stakeholders are expected to drive demand for influenza vaccines[1][4].

Key Takeaways

• Growing Market: The global influenza vaccine market is projected to grow significantly, driven by increasing prevalence of seasonal outbreaks and government initiatives.
• Regional Growth: North America and Europe are leading regions, while the Asia Pacific is expected to register higher growth rates.
• Technological Advancements: Quadrivalent vaccines and novel delivery methods are driving market growth.
• Financial Performance: Major players like GSK and Sanofi are experiencing mixed results, but overall market growth is positive.
• Challenges and Opportunities: Seasonal fluctuations and competition are challenges, while emerging markets offer significant opportunities.

FAQs

What is the projected growth rate of the global influenza vaccine market?

The global influenza vaccine market is projected to grow at a CAGR of 9.6% from 2024 to 2032[1].

Which region holds the highest market share in the influenza vaccine market?

North America holds the highest market share in the influenza vaccine market[1].

What are the key drivers of the influenza vaccine market growth?

Key drivers include increasing prevalence of seasonal outbreaks, government initiatives, and technological advancements in vaccine development[1].

Which companies are major players in the influenza vaccine market?

Major players include GlaxoSmithKline (GSK), Sanofi, and CSL Limited (Seqirus)[1].

What is the significance of quadrivalent vaccines in the market?

Quadrivalent vaccines protect against four strains of the influenza virus and are expected to drive market growth due to their greater demand and safety properties[1].

Sources

1. Fortune Business Insights: Influenza Vaccine Market Size | Growth Analysis Report [2032]
2. GSK: Q2 2024 Announcement
3. Sanofi: Q2: strong performance with 10% sales growth; 2024 guidance upgraded
4. BioSpace: Influenza Vaccine Market is Forecasted to Worth US$ 22.71 Billion by 2032