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The U.S. influenza vaccine market size was worth USD 3.77 billion in 2022 and is projected to grow at a CAGR of 9.3% during the forecast period.
The rising burden of influenza (flu) cases in the U.S. is one of the predominant factors raising the demand for influenza vaccines. According to the preliminary data published by the Centers for Disease Control and Prevention (CDC), the estimated number of flu cases in the U.S. was around 9.0 million in 2022.
Furthermore, rising government initiatives to launch influenza vaccination programs for expanding vaccination coverage to manage the rising cases of seasonal flu are propelling the U.S. influenza vaccine market growth. Moreover, in September 2019, the U.S. government issued Executive Order (EO) 13887: Modernizing Influenza Vaccines to support the improvement of flu vaccines. Such initiatives by the government are bolstering the growth of the market. The market witnessed significant growth during the pandemic due to the rising uptake of influenza vaccines amid the COVID-19 crisis.
Shifting Focus of Manufacturers to Increase Production Capabilities of Advanced Flu Vaccine
The market is witnessing a gradual shift in preference from trivalent influenza (flu) vaccines toward quadrivalent vaccines. The quadrivalent vaccine is designed to protect against four different strains of flu and is more efficient than the trivalent vaccine. Thus, due to the additional coverage of four flu virus strains, healthcare professionals recommend quadrivalent influenza vaccines to patients.
Further, to cater to the rising demand for quadrivalent vaccines, the manufacturers are increasing their production capabilities in the country.
For instance, in June 2021, the U.S. Center for Biologics Evaluation and Research approved Sanofi's establishment of an additional influenza manufacturing facility. Through this newly completed facility, the company aimed to expand the production and distribution of Fluzone, a high-dose quadrivalent vaccine, for the year 2021-2022.
Rising R&D investments and Increasing Product Launches to Drive the Adoption
The growing initiatives by the key players to increase R&D activities to develop advanced flu vaccines and seek their approval is expected to promote market growth in the upcoming years. Additionally, the researchers are currently trying to develop mRNA-based vaccines with better speed and more precision when compared to conventional vaccines.
For instance, Pfizer commenced a phase 3 study of an mRNA-based vaccine intended for influenza to evaluate the safety and efficacy of the vaccine.
Moreover, the rising vaccination program by the government and companies to increase vaccination coverage is also expected to drive the market in the coming years.
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The number of influenza cases in the U.S. during 2019-2020 was around 36.0 million, out of which only 390,000 were hospitalized.
Longer Manufacturing Timeline for Vaccines Coupled with Stringent Approval Guidelines to Impede the Market Growth
Vaccine production is a complex process that generally takes 10-15 years. Meeting regulatory requirements, such as clinical efficacy, safety, and quality, requires lengthy timelines for vaccine development. Furthermore, in the U.S., the vaccine products, after receiving marketing authorization, must undergo additional studies to evaluate the effectiveness, safety, and potential side effects.
For instance, according to an article published by the American Academy of Family Physicians in 2020, the flu vaccine is 50% effective against influenza B viruses and 37% effective against influenza A.
The Center for Biologics Evaluation and Research (CBER) regulates vaccine products in the U.S. The organization requires the company to follow processes such as IND filings, Biological License Application (BLA) filings, 510k filings, and others. Such labeling and filing stretch the timeline. Further, different labeling requirements add complexity to conducting clinical studies. Thus, stringent regulatory requirements and the longer duration for conducting clinical trials are anticipated to impede market growth.
Based on type, the market is segmented into inactivated and live attenuated.
The inactivated segment held a larger share in 2022, owing to the increased safety of these vaccines compared to live attenuated vaccines. Live attenuated vaccines are reported to undergo replication and have an increased possibility of reversion to virulent forms.
However, the higher efficiency of live attenuated vaccines and the reduced number of vaccination shots required compared to inactivated vaccines are a few factors contributing to the segment's growth during the forecast period.
Based on valency, the market is segmented into trivalent and quadrivalent.
The quadrivalent segment held a larger share in 2022, owing to increasing production of quadrivalent vaccines due to increased demand. Quadrivalent vaccine contains two influenza B antigens, making it more effective than trivalent vaccines. Also, the launch of quadrivalent vaccines in the country is increasing their adoption.
For instance, according to the CDC data related to influenza (flu) vaccine supply for the year 2022-203, approximately 173.5 million to 183.5 million doses of vaccine for influenza will be supplied, and 100% of these vaccines will be quadrivalent type, and about 20% of total vaccine produced will be cell-based influenza vaccines.
Based on age group, the market is segmented into pediatric and adults.
Influenza cases are more prevalent among older people aged 65 years and above. Thus, the rising older population in the country is expected to increase the demand for vaccines to manage influenza.
According to the Administration for Community Living, the population aged 65 years and above is expected to reach 94.7 million in 2060.
On the other hand, the pediatric segment is anticipated to grow significantly due to rising recommendations of influenza vaccination for children and infants, launch of new products, and others.
Based on distribution channel, the market is segmented into hospital & retail pharmacies, government suppliers, and others.
The hospital & retail pharmacies segment held the largest share in 2022 due to increased hospitalization of patients suffering from influenza.
For instance, according to the CDC 2022 estimates, the number of influenza-related hospitalizations increased to 390,000 in 2019-2020 from 380,000 in 2018-2019.
Government suppliers are anticipated to grow significantly during the forecast period due to increased government vaccination programs.
In terms of the competitive landscape, the market depicts the presence of well-established companies. Sanofi dominated the U.S. influenza vaccine market share in 2022. The dominance is due to various market expansion strategies adopted by the company. The company received various approvals for the flu vaccine, increased manufacturing capacity, and contributed to its revenue growth.
For instance, in July 2022, the U.S. FDA approved the licensure request to Sanofi for flu vaccine approval for the upcoming 2022-2023 flu season.
Other key players, such as Pfizer, CSL Limited, GlaxoSmithKline plc, and AstraZeneca, have significant market share in the U.S. market. Rising investment in research & development, increasing collaboration with the government to raise awareness, and others improve their brand presence.
For instance, in June 2022, CSL Sequris completed the fill-finish manufacturing facility to produce flu vaccine.
The U.S. influenza vaccine market research report provides a detailed analysis of the market. It focuses on key aspects such as an overview of technological advancements, prevalence of influenza in the U.S., and influenza vaccination rate. Additionally, it includes an overview of the pricing analysis, pipeline analysis, new product launches, key industry developments such as mergers, partnerships, & acquisitions, and the impact of COVID-19 on the market. Besides this, the report also offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the U.S. market in recent years.
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CAGR of 9.3% from 2023 to 2030
Value (USD Billion)
By Age Group
By Distribution Channel
Fortune Business Insights says the U.S. market was worth USD 3.77 billion in 2022.
The market is expected to exhibit a CAGR of 9.3% during the forecast period (2023-2030).
By age group, the adults segment accounts for a considerable proportion of the market.
Sanofi, Pfizer, GlaxoSmithKline plc, and CSL Limited (Seqirus) are the top players in the market.
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