Report

United States Influenza Vaccine Market size was valued at USD 2.51 billion in 2022 which is expected to reach USD 3.63 billion in 2030 with a CAGR of 4.73% for the forecast period between 2023 and 2030. The drivers fueling the growth of the United States influenza vaccine market include the high prevalence of influenza, the increasing geriatric population, increasing awareness of vaccines, government initiatives towards immunization programs, newly developed vaccines, and technological advancements. Each year, influenza in the United States accounts for 140,000 to 710,000 hospitalizations and 12,000 to 52,000 fatalities. The elderly, pregnant mothers, small children, and those with underlying medical conditions are the groups that are highly susceptible to the flu.
Various stakeholders, such as government agencies, healthcare facilities, and research facilities, are equally contributing to the market. The government actively encourages influenza vaccination through public health campaigns, legislative changes, and educational initiatives. The United States market is experiencing heavy investments from the government and various private pharmaceutical and biotech companies.
The US government has introduced programs like "Healthy People 2030" that seek to vaccinate people for preventing infectious diseases. Vaccination is crucial for the health of infants and children, as it shields them from illnesses such as hepatitis, measles, influenza, and pertussis. While the majority of children receive the recommended vaccinations, certain communities in the United States have insufficient vaccination rates, leaving them vulnerable to potential outbreaks.
Increasing Prevalence of Influenza
Influenza exerts a substantial influence on public health in the United States annually. Although the prevalence of influenza fluctuates from one season to another, it remains a significant and ongoing concern. The 2022 flu season was the most severe in the last 13 years. It deviated from its usual pattern, occurring approximately six weeks earlier than expected, with an unusually high number of cases than expected. Typically, the flu season takes place from October to May, reaching its peak in December and January. The prevalence of influenza is closely monitored by the Centers for Disease Control and Prevention (CDC) using surveillance systems that track and analyze data from healthcare providers, laboratories and various other sources. CDC estimates that, from October 1, 2022, to April 30, 2023, there have been 27-54 million cases, 12-26 million medical vis its, and 19,000 to 58,000 deaths.
Technological Advancements
The United States influenza vaccine market has witnessed several technological advancements aimed at improving the effectiveness, accessibility, and convenience of influenza vaccines. Some notable advancements include cell-based vaccine production, recombinant DNA technology, vaccine delivery methods, vaccine monitoring & surveillance. Recombinant DNA technology has enabled the development of novel influenza vaccines. These vaccines are produced by inserting specific genes from the influenza virus into host cells, which then produce viral proteins that stimulate an immune response. Recombinant vaccines offer the advantage of not requiring egg-based production and can be rapidly manufactured. mRNA vaccines offer several advantages over traditional vaccine approaches. Firstly, their production process is highly flexible and can be rapidly scaled up. mRNA vaccines do not require the use of live virus, making them safer to produce and eliminating the risk of causing the disease they protect against.
In September 2022, Pfizer, a renowned global biopharmaceutical company, commenced a phase 3 clinical trial for a single-dose mRNA-based influenza vaccine. Utilizing only the genetic informa tion of the viruses, mRNA vaccines can be manufactured with greater speed and flexibility, offering potential enhancements in strain matching and the effectiveness of existing flu vaccines.
Government Initiatives
The United States government is taking several initiatives to ensure the widespread availability and administration of influenza vaccines. The objective of these endeavors is to safeguard public health and reduce the consequences of seasonal flu epidemics. Some of the notable initiatives being taken by governments are vaccine production, distribution, surveillance & monitoring, vaccination programs, R&D and public awareness campaigns. National Influenza Vaccine Modernization Strategy (NIVMS), 2020-203 0, offers a vision for the influenza vaccine in the United States as instructed by the Executive Order (EO) 13887 on modernizing influenza vaccines to promote public health and wellness. It outlines a vision for United States' influenza vaccine enterprise to be more efficient at minimizing the effects of seasonal and pandemic influenza viruses by being extremely responsive, agile, resilient, and scalable.
Three major objectives serve as the foundation for this vision: to strengthen and diversify the development, production, and supply chain for influenza vaccines, to support creative strategies and the application of new technology for the detection, prevention, and treatment of influenza and increase accessibility of influenza vaccine and coverage across all populations.
Recombinant Vaccines Offers Clinical Advantages over Egg-Based Vaccines
Recombinant vaccines are being preferred over egg-based vaccines due to several advantages they offer. Firstly, egg-based vaccine production has limitations in scalability and speed. Traditional egg-based methods involve growing the virus in chicken eggs, which can be time-consuming and limit production capacity. In contrast, recombinant vaccines are produced using genetically modified host cells or organisms, allowing for a more efficient and scalable manufacturing process. Secondly, egg-based vaccines can encounter issues with egg allergies or viral adaptation. Some individuals may have allergic reactions to egg proteins, making egg-based vaccines unsuitable for them. Recombinant vaccine technology allows for rapid adaptation to new strains and emerging pathogens. In the case of influenza, which undergoes frequent genetic changes, recombinant vaccines can be readily updated by inserting the relevant genes into the host cells or organisms.
For the 2022-2023 flu season, Sanofi Pasteur Inc. has made available Flublok Quadr ivalent, a recombinant flu vaccine. It is recommended for active immunization against influenza illness caused by both type B and influenza A subtype viruses, and it is suitable for individuals aged 18 years and older.
Intramuscular Injections has Dominant Market Share
Intramuscular vaccines are generally preferred over nasal spray vaccines for several reasons such as efficacy, broad application, vaccine stability, vaccine coverage, and safety considerations. Intramuscular vaccines can be used in a wide range of populations, including infants, children, adults, and older adults. They are suitable for individuals with various health conditions and immune system statuses. In contrast, nasal spray vaccines may have limitations in terms of age restrictions and suitability for individuals with certain medical conditions. Intramuscular vaccines have a well-established safety profile. They have been used for decades and are routinely administered in healthcare settings worldwide. The injection site reactions associated with intramuscular vaccines, such as temporary pain or swelling, are generally mild and transient. Nasal spray vaccines, on the other hand, can cause nasal discomfort, runny nose, or mild respiratory symptoms, which may be less preferable for some individuals. While nasal spray vaccines, such as those used for influenza, offer the advantage of needle-free administration and potential mucosal immune response, intramuscular vaccines remain the preferred choice in many situations due to their proven efficacy, broad applicability, stability, vaccine coverage, and established safety record. The selection of the most appropriate vaccine administration route depends on factors such as the specific disease, the target population, vaccine characteristics, and individual preferences.
For instance, Fluzone (2022-2023 formula), developed by Sanofi Paste ur Inc., a French multinational pharmaceutical company, is a high dose quadrivalent vaccine that can be administered intramuscularly to individuals of all ages, including high-risk groups.
Impact of COVID-19
The COVID-19 pandemic has had a significant impact on the United States influenza vaccine market. One notable effect is the increased awareness and demand for vaccinations, including the influenza vaccine, as people became more concerned about their health and immune system. This heightened awareness has led to a greater emphasis on influenza vaccination campaigns and public health initiatives. However, the pandemic has also posed challenges in terms of vaccine distribution and access, with the focus primarily on COVID-19 vaccine distribution, leading to logistical hurdles and potential strain on resources. Additionally, the implementation of public health measures and behavioural changes, such as social distancing and mask-wearing, has inadvertently contributed to a reduction in influenza transmission.
While positive from a public health perspective, this reduction has made it challenging to accurately assess the need for and demand for influenza vaccines. Nevertheless, the COVID-19 pandemic has spurred innovation and advancements in vaccine research and development, which could potentially influence the future development of influenza vaccines, leading to improved effectiveness and adaptability. Overall, the COVID-19 pandemic has highlighted the interconnectedness between different vaccine markets and underscored the importance of a comprehensive and adaptable approach to public health immunization programs.
Key Players Landscape and Outlook
Pharmaceutical companies are actively pursuing mergers, acquisitions, joint ventures, and extensive collaborations in the field of influenza vaccine manufacturing. Key market players aim to integrate their COVID-19 vaccines with annual flu shots. Executives representing vaccine manufacturers anticipate a gradual transformation of the COVID-19 vaccine market to resemble the dynamics observed in the flu vaccine industry.
Pfizer Inc. and BioNTech SE made significant progress in November 2022 by developing a combined vaccine candidate that utilizes mRNA technology for both influenza and COVID-19. The aim was to create a single vaccine that can effectively target both respiratory diseases. A Phase 1 trial was initiated, and the first participant received a dose to assess the safety, tolerability, and immune response generated by the combination vaccine. The vaccine utilized nucleoside-modified RNA (modRNA) technology.