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Last Updated: January 5, 2025

FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT Drug Profile


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Summary for Tradename: FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT Derived from Patent Text Search

These patents were obtained by searching patent claims

FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Fluzone and Its Variants

Overview of Fluzone and Its Variants

Fluzone, developed by Sanofi Pasteur, is a series of influenza vaccines designed to protect against various strains of the influenza virus. The portfolio includes Fluzone, Fluzone High-Dose Quadrivalent, Fluzone Intradermal, and Fluzone Quadrivalent, each targeting different demographics and offering unique benefits.

Market Size and Growth

The global influenza vaccine market, which includes Fluzone and its variants, is projected to grow significantly. By 2032, the market is expected to reach $17.77 billion from $8.55 billion in 2024, with a CAGR of 9.6% during the forecast period[1].

Regional Market Dynamics

North America

North America is anticipated to hold the highest market share in the influenza vaccine market. This is driven by increased awareness regarding immunization benefits, expanded vaccination coverage, and the availability of effective vaccines like Fluzone High-Dose Quadrivalent[1].

Europe

Europe holds the second leading position, primarily due to the expansion of vaccination coverage for high-risk populations, leading 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, driven by government initiatives, rising population, and increasing demand for effective vaccines in countries like China and India[1].

Latin America and Middle East & Africa

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

Product-Specific Market Dynamics

Fluzone High-Dose Quadrivalent

This vaccine is specifically designed for adults 65 years of age and older. It has demonstrated superior efficacy in preventing laboratory-confirmed influenza illness and reducing flu-related complications compared to standard-dose vaccines. For instance, Fluzone High-Dose Quadrivalent showed an 18% reduction in cardiorespiratory hospitalizations and a 28% decrease in pneumonia hospitalizations in a meta-analysis involving approximately 34 million people[3].

Fluzone Quadrivalent

This vaccine protects against four flu strains and is available for individuals of various age groups. It is part of the broader Fluzone portfolio and benefits from the overall growth in the influenza vaccine market.

Fluzone Intradermal

Introduced during the 2011-2012 influenza season, Fluzone Intradermal is designed for adults 18-64 years of age. It uses a unique microinjection system to deliver the vaccine intradermally, which can boost confidence in influenza vaccination due to its less invasive method[5].

Financial Performance and Projections

Revenue and Sales

The financial performance of Fluzone and its variants is closely tied to the overall influenza vaccine market. Sanofi, the manufacturer, benefits from the growing demand for influenza vaccines. In 2023, the global influenza vaccine market value stood at $7.97 billion, and it is projected to reach $17.77 billion by 2032[1].

Market Share and Competition

Sanofi, along with other major players like GlaxoSmithKline plc and CSL Limited (Seqirus), dominates the influenza vaccine market. The competitive landscape is driven by the effectiveness of the vaccines, government recommendations, and market penetration in various regions[1].

Technological Advancements and Pipeline Candidates

Manufacturing Process

Technological advancements in the manufacturing process of influenza vaccines, including the use of recombinant technology as seen in Flublok Quadrivalent, are driving market growth. These advancements improve the efficacy and production efficiency of the vaccines[3].

Regulatory Approvals

Regulatory approvals and recommendations play a crucial role in the market dynamics. For example, the CDC's preferential recommendation for Fluzone High-Dose Quadrivalent for adults 65 and older has significantly boosted its adoption[3].

Challenges and Opportunities

Seasonality and Demand

The influenza vaccine market is highly seasonal, with demand peaking during the flu season. This seasonality can lead to fluctuations in revenue and production capacity. However, it also presents opportunities for companies to prepare and capitalize on the annual demand surge[2].

Side Effects and Efficacy

While Fluzone and its variants have shown superior efficacy, they also come with side effects such as pain, redness, and swelling at the injection site. Managing these side effects and continuously improving vaccine efficacy are key challenges and opportunities for growth[3].

Key Players and Market Leadership

Sanofi, the manufacturer of Fluzone, is one of the top players in the influenza vaccine market. The company's market leadership is supported by its extensive portfolio of vaccines, strong research and development capabilities, and significant market penetration[1].

Financial Trajectory for Sanofi

Sanofi's financial performance is influenced by the sales of its influenza vaccines, among other products. The company's revenue from vaccines like Fluzone is expected to contribute to its overall growth. Here are some key financial metrics:

  • Revenue Growth: The global influenza vaccine market's growth is expected to drive Sanofi's revenue from these products.
  • Market Share: Sanofi's market share in the influenza vaccine segment is significant, and the company is expected to maintain its leadership position.
  • Research and Development: Continuous investment in R&D is crucial for maintaining and improving vaccine efficacy, which in turn supports the financial trajectory of the company.

Key Takeaways

  • The global influenza vaccine market is projected to grow significantly, driven by increasing awareness, government initiatives, and technological advancements.
  • Fluzone High-Dose Quadrivalent has demonstrated superior efficacy in preventing flu-related complications in older adults.
  • Sanofi, along with other major players, dominates the market and is expected to continue its leadership.
  • Seasonality and side effects are key challenges, but they also present opportunities for growth and improvement.
  • Regulatory approvals and recommendations are critical for market dynamics.

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 is expected to register the highest CAGR in the influenza vaccine market?

The Asia Pacific region is expected to register a higher CAGR during the forecast period[1].

What are the key benefits of Fluzone High-Dose Quadrivalent?

Fluzone High-Dose Quadrivalent has demonstrated superior efficacy in preventing laboratory-confirmed influenza illness and reducing flu-related complications in adults 65 years of age and older[3].

Who are the major players in the influenza vaccine market?

Sanofi, GlaxoSmithKline plc, and CSL Limited (Seqirus) are the top players in the market[1].

What are the common side effects of Fluzone High-Dose Quadrivalent?

Common side effects include pain, redness, and swelling at the injection site, muscle aches, headache, and general discomfort[3].

Sources

  1. Fortune Business Insights: Influenza Vaccine Market Size | Growth Analysis Report [2032]
  2. Moderna: Moderna Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Business Updates
  3. PR Newswire: Sanofi higher dose flu vaccines preferentially recommended for adults 65 in CDC Morbidity and Mortality Weekly Report
  4. Grand View Research: Biologics Market Size, Share & Growth Analysis Report, 2030
  5. PubMed: FluzoneĀ® Intradermal Quadrivalent Influenza Vaccine

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