FLUCELVAX, FLUCELVAX QUADRIVALENT Drug Profile

Summary for Tradename: FLUCELVAX, FLUCELVAX QUADRIVALENT

High Confidence Patents:	0
Applicants:	1
BLAs:	1

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 FLUCELVAX, FLUCELVAX QUADRIVALENT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FLUCELVAX, FLUCELVAX QUADRIVALENT Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for FLUCELVAX, FLUCELVAX QUADRIVALENT 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.	FLUCELVAX, FLUCELVAX QUADRIVALENT	influenza vaccine	Injection	125408		2036-10-12	Patent claims search
Seqirus Inc.	FLUCELVAX, FLUCELVAX QUADRIVALENT	influenza vaccine	Injection	125408		2034-01-23	Patent claims search
Seqirus Inc.	FLUCELVAX, FLUCELVAX QUADRIVALENT	influenza vaccine	Injection	125408		2034-09-23	Patent claims search
Seqirus Inc.	FLUCELVAX, FLUCELVAX QUADRIVALENT	influenza vaccine	Injection	125408		2035-08-03	Patent claims search

FLUCELVAX, FLUCELVAX QUADRIVALENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FLUCELVAX QUADRIVALENT

Introduction to FLUCELVAX QUADRIVALENT

FLUCELVAX QUADRIVALENT is a significant player in the influenza vaccine market, particularly known for its cell-based production method, which distinguishes it from traditional egg-based vaccines. This vaccine is designed to protect against four different strains of the influenza virus, including two A strains and two B strains.

Market Size and Growth Projections

The global influenza vaccine market, within which FLUCELVAX QUADRIVALENT operates, is projected to experience substantial growth. The market size is expected to increase from $8.55 billion in 2024 to $17.77 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 9.6% during the forecast period[1].

Segmentation and Dominance

The market is segmented based on valency, with the quadrivalent segment dominating due to its broader protection against influenza strains. FLUCELVAX QUADRIVALENT, being a quadrivalent vaccine, benefits from this trend. The quadrivalent segment is expected to record a higher CAGR during the forecast period due to its greater demand and the launch of novel vaccines[1][4].

Regional Market Performance

• North America: This region holds the highest market share, with the U.S. being a significant contributor. The U.S. influenza vaccine market alone was valued at $4.04 billion in 2023 and is projected to grow at a CAGR of 10.2% during the forecast period[4].
• Europe: Europe holds the second leading position, driven by the expansion of vaccination coverage for high-risk populations, leading to higher immunization rates[1].
• Asia Pacific: This region is expected to register a higher CAGR due to increasing government initiatives, rising population, and demand for effective vaccines in countries like China and India[1].

Key Drivers of Market Growth

• Increasing Prevalence of Influenza: The rising burden of influenza cases globally, with 3 to 5 million severe cases and 290,000 to 650,000 deaths annually, drives the demand for effective vaccines[1].
• Government Initiatives: Growing focus on immunization programs, especially in developing economies, and government efforts to increase vaccination coverage are key drivers[1][4].
• Technological Advancements: The shift towards cell-based and recombinant vaccines, such as FLUCELVAX QUADRIVALENT, offers advantages over traditional egg-based vaccines, including faster production times and reduced risks of egg allergies[5].

Competitive Landscape

FLUCELVAX QUADRIVALENT competes in a market dominated by major players such as Sanofi, GlaxoSmithKline plc, and CSL Limited (Seqirus). The competitive landscape is characterized by the launch of novel vaccines and the expansion of production capabilities to meet increasing demand[1][4].

Regulatory and Developmental Milestones

The market forecast for FLUCELVAX QUADRIVALENT includes detailed regulatory milestones and developmental activities. For instance, the U.S. Center for Biologics Evaluation and Research has approved additional manufacturing facilities to support the production of quadrivalent vaccines like FLUCELVAX QUADRIVALENT[4].

Market Forecast Analysis

The market size of FLUCELVAX QUADRIVALENT in the six major markets (the United States, EU4, and the United Kingdom) is forecasted to grow significantly from 2019 to 2032. This growth is supported by extensive research, incremental healthcare spending, and the launch of late-stage emerging therapies[3].

Impact of Quadrivalent Vaccines

The introduction of quadrivalent vaccines has been a significant factor in the market's growth. These vaccines protect against an additional B strain, providing more comprehensive protection against influenza B viruses, which circulate alongside influenza A viruses each year[5].

Public Health Impact

The widespread adoption of quadrivalent vaccines, including FLUCELVAX QUADRIVALENT, has improved vaccination coverage rates and contributed to better management of influenza seasons. This has resulted in a reduction in flu-related complications and hospitalizations, underscoring the importance of broad-spectrum flu protection[5].

Financial Trajectory

The financial trajectory for FLUCELVAX QUADRIVALENT is positive, driven by the growing demand for quadrivalent vaccines and the expanding production capabilities of its manufacturers. Here are some key financial indicators:

• Market Size: The global influenza vaccine market is expected to grow from $8.55 billion in 2024 to $17.77 billion by 2032[1].
• CAGR: The market is projected to grow at a CAGR of 9.6% during the forecast period[1].
• Regional Growth: The U.S. market alone is expected to grow at a CAGR of 10.2% during the forecast period[4].

Challenges and Opportunities

While FLUCELVAX QUADRIVALENT benefits from the growing demand for quadrivalent vaccines, it also faces challenges from emerging therapies and competitive market dynamics. The launch of late-stage emerging therapies in the near future will significantly impact the market, presenting both opportunities and challenges for FLUCELVAX QUADRIVALENT[3].

Key Takeaways

• Growing Market: The global influenza vaccine market is expected to grow significantly, driven by the increasing prevalence of influenza and government initiatives.
• Quadrivalent Dominance: The quadrivalent segment, including FLUCELVAX QUADRIVALENT, dominates the market due to its broader protection against influenza strains.
• Technological Advancements: Cell-based and recombinant vaccines offer advantages over traditional egg-based vaccines.
• Public Health Impact: The adoption of quadrivalent vaccines has improved vaccination coverage and reduced flu-related complications.

Frequently Asked Questions (FAQs)

Q1: 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% during the forecast period from 2024 to 2032[1].

Q2: Why is the quadrivalent segment dominating the influenza vaccine market? The quadrivalent segment dominates due to its broader protection against four different strains of the influenza virus, including two A strains and two B strains, making it more effective than trivalent vaccines[1][4].

Q3: Which regions are expected to drive the growth of the influenza vaccine market? North America, particularly the U.S., and Europe are expected to be significant contributors, while the Asia Pacific region is anticipated to register a higher CAGR due to increasing government initiatives and rising population[1][4].

Q4: What are the key drivers of the market growth for FLUCELVAX QUADRIVALENT? Key drivers include the increasing prevalence of influenza, government initiatives to increase vaccination coverage, and technological advancements in vaccine production[1][4][5].

Q5: How does FLUCELVAX QUADRIVALENT compare to traditional egg-based vaccines? FLUCELVAX QUADRIVALENT, being a cell-based vaccine, offers advantages such as faster production times and reduced risks of egg allergies compared to traditional egg-based vaccines[5].

Cited Sources

1. Fortune Business Insights: Influenza Vaccine Market Size | Growth Analysis Report [2032][1]
2. BioSpace: Influenza Vaccines Market (Vaccine Type, Virus Type) - BioSpace[2]
3. Research and Markets: FLUCELVAX QUADRIVALENT Drug Insight and Market Forecast[3]
4. Fortune Business Insights: U.S. Influenza Vaccine Market Size, Research Report [2032][4]
5. BioSpace: Influenza B Market Size to Reach USD 42.5 Million by 2034[5]