Influenza is contagious respiratory disease that is caused by influenza viruses and can lead to hospitalization and even death in certain severe cases. Influenza virus infect the respiratory tract (nose, throat, and lungs) in humans. Seasonal influenza detected year-round and the virus is most common during the influenza season especially in fall and winter months. Moreover, the exact timing and duration of influenza season varies, however influenza activity often begins in winter months. At various geographical regions, influenza infection exist at a low level throughout the year, however its shows seasonal increase typically during the winter months. A seasonal influenza flu vaccine aids in reducing the risk of getting infected with seasonal flu and prevent its spreading throughout the year.
The 2017–2018 recommendations by the Advisory Committee on Immunization Practices (ACIP) mentions routine annual influenza vaccination for everyone aged 6 months and older with either inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV). A high variability and broad host specificity of influenza viruses are the major causes of repeated influenza infections. Moreover, virus neutralizing antibodies induced by various vaccines are strain specific, which leads to vaccinations being updated each year. To tackle this issue, various government and private research organizations are engaged in developing novel vaccines to increase efficacy of these vaccines.
Seasonal Influenza Vaccines Market – Drivers
Increasing incidence of seasonal influenza infection in various geographies is expected to be a major driving factor for growth of global seasonal influenza vaccines market. Rising pandemic events of influenza virus and their severity attributed to the genetic diversity of influenza virus is also another factor aiding in growth of the market. According to the World Health Organization (WHO), 2015, around 233 million outpatient visits, 5.2 million hospital admissions, and 7.4 million deaths are expected if a pandemic case were to occur, globally. Also, the Centers for Medicare & Medicaid Services (CMS) provides reimbursement covering 100% of the costs of one seasonal influenza virus vaccinations per influenza season, and it also covers the seasonal influenza virus vaccinations. Thus, favorable reimbursement is also expected to positively affect adoption rates of seasonal influenza vaccines, thus propelling the market growth.
In addition to this, according to the Indian Journal of Medical Research, June 2016, the influenza A (H1N1) pdm09 outbreak in India caused 30,000 laboratory confirmed cases with over 1,700 deaths from 2009 to 2015. The World Health Organization (WHO): GISRS (Global Influenza Surveillance and Response System) laboratories from 2 April 2018 to 15 April 2018; tested over 137,071 specimens from various National Influenza centers (NIC) and other national influenza laboratories of 113 countries. Among these collected specimens, 21,639 were positive for influenza viruses, including 12,034 (55.6%) were typed as influenza A and 9,605 (44.4%) as influenza B. According to the data published in European Centre for Disease Prevention and Control (ECDC), in February 2018, around 44,000 people die annually of respiratory diseases associated with seasonal influenza in the European Region, out of a total of up to 6, 50, 000 global deaths, annually.
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Collaborative efforts of various government bodies such as U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) with the private sector has led to development of improved influenza vaccines in the U.S. This in turn, has improved influenza pandemic preparedness in the country. Also, National Institute of Allergy and Infectious Disease (NIAID) is engaged in developing new strategic plan to develop novel, safe and effective universal influenza vaccine.
Various government agencies in the U.S. are focusing on collaborations, in order to increase the supply of influenza vaccines. For instance, in September 2016, Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) partnered with the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), to support development of new and better influenza vaccines, as a part of inter-agency government effort in the U.S. Furthermore, in April 2018, Bill & Melinda Gates Foundation released US$ 12 million grant for Universal Influenza Vaccines Development. The grant is intended to bring innovative ideas to treat influenza pandemic infection. Growing initiatives by government and private organizations in the U.S. is expected to drive growth of the seasonal influenza vaccines market.
Moreover, influenza flu vaccination enables to reduce the risk of flu-associated hospitalization among adult and pediatric patients. For instance, according to the Centers for Disease Control and Prevention, 2015, flu vaccinations prevented around 1.9 million flu illnesses, 966,000 flu-associated medical visits, and around 67,000 flu-associated hospitalizations, representing 6.5% lowering of disease burden in the U.S.
Seasonal influenza virus infections could cause significant mortality and morbidity, worldwide. Moreover, current influenza virus vaccines are an effective countermeasure against influenza infection. However, increasing intergenic variability among various influenza virus strains has led to increasing demand for developing influenza vaccines compatible to all types of influenza virus. For instance, National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), in February 2018, announced that they are focusing on developing new strategic plan to create safe and effective universal influenza vaccine. NIAID is engaged in developing an influenza vaccine for all age groups against multiple influenza strains, including those which can cause pandemic. Moreover, in June 2017, Seqirus produced cell-based influenza vaccine at commercial scale, using a candidate vaccine virus (CVVs) that has been isolated and grown in cells, rather than in eggs derived virus CVVs. The use of cell-derived CVVs shows the increased potential over the egg-derived CVVs. This has helped in increasing output in the production of cell-based influenza vaccines.
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Seasonal Influenza Vaccines Market – Restraint
However, high cost of manufacturing and complexity of production process, due to inherent variability of the viral strains are the major factors hindering growth of the seasonal influenza vaccines market. Production of seasonal influenza vaccines is difficult, owing to the slow egg-based manufacturing process, which is currently in use.
Seasonal Influenza Vaccines Market – Regional Analysis
Geographically, global seasonal influenza vaccines market is segmented into North America, Latin America, Europe, Middle East, Asia Pacific, and Africa. North America holds the dominant position in seasonal influenza vaccines market, owing to increasing research and development studies by key market players, to develop novel influenza vaccines and increasing burden of seasonal influenza infection in the region. For instance, according to the data published in Centers for Disease Control and Prevention (CDC), in October 2016, there were around 140,000 to 710,000 influenza related hospitalizations and 12,000 to 56,000 influenza related deaths registered, since 2010. Asia Pacific is expected to witness fastest growth over the forecast period. This is due to large patient pool and increasing focus of key market players to expand in this geography. For instance, according to the World Health Organization (WHO), in 2015, there were an estimated 4.74 million new cases of tuberculosis registered and around 8, 00,000 people died due to the tuberculosis and TB and HIV co-infection (TB-HIV) in the South-East Asia region. In addition, an expected approval of both Daiichi Sankyo’s VN-100 and MEDI3250 in 2017, in the Japanese market, is projected to drive seasonal influenza vaccines market in Asia Pacific region.
Seasonal Influenza Vaccines Market – Competitor
Some of the key players in the seasonal influenza vaccines market includes Sanofi S.A., CSL Limited, GlaxoSmithKline Plc., and Medimmune, LLC. Key players in the market are involved in strategic mergers and acquisitions, to cater to increasing demand for these vaccines. For instance, in August 2017, Sanofi Pasteur acquired Protein Sciences Corporation, thus adding Flublok products to its portfolio — the only FDA approved recombinant protein-based influenza vaccine. With the acquisition, Sanofi expanded its influenza vaccine portfolio and its presence in the global vaccines market.
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