Media release from GlobalData

LONDON, UK (GlobalData), 16 August 2012 - Reports of swine flu infections have begun to circulate within the media once again. Since July 2011, the incidence of swine flu cases has increased, especially in individuals who were in direct contact with pigs. The strain of influenza is a H3N2 variant, otherwise known as the H3N2v, which includes the M gene from the human influenza A (H1N1) strain from the 2009 pandemic. Centre for disease control and prevention (CDC) press releases state that the current incidence of infection, while growing, was not a cause for concern due to the mild nature of the infections. The CDC has also issued a guide for appropriate action by individuals who may come in contact with pigs, such as people raising pigs, or even those that attend fairs with animals present.

With the low severity of the symptoms and the contained spread of the virus thus far, the CDC has emphasized that these infections are not reflective of a pandemic. To date, there have only been two hospitalizations associated with this rise in swine flu infections, with no reports of any associated deaths. The CDC has adopted a decentralized method of H3N2v confirmation to streamline the process while still maintaining necessary checks. Under the revised guidelines, state-run laboratories will determine the nature of the infection, prior to CDC involvement. Positive samples would then be sent to the CDC for further genetic screening.

The recommended treatment for all those infected with this variant of influenza remains the FDA-approved antiviral treatments Tamiflu (oseltamivir) and Relenza (zanamivir), which are generally prescribed to work against seasonal influenza infections. Despite being deemed a non-pandemic situation, the threat of severity is not considered equal among all patient groups. The CDC has deemed that individuals within at-risk groups, such as the elderly (aged 65 and above), children younger than the age of 5, immunocompromised individuals, and pregnant women are at exceptionally high risk of developing influenza-induced complications.

These at-risk or high-risk groups have been overlooked by most vaccine manufacturers in their quest to garner a larger share of the seasonal and pandemic flu market. Currently, within the US, companies such as Sanofi, GlaxoSmithKline, Novartis, AstraZeneca and Merck dominate the seasonal flu market. The bulk of new innovation has dealt with increasing the scalability and ease of the manufacturing process, with a large focus on decreasing the use of inactivated virus vaccines or weakened live viruses, as seen with vaccines such has FluMist (Influenza vaccine live, intranasal), which is a live attenuated influenza virus-based vaccine (LAIV). Even new entrants into this market compete against one another to gain access to the largest market segment, i.e., the healthy population.

Sanofi, the clear market leader of influenza vaccines in the US, would appear to be the only company driven to answer the needs of all existing market segments. Sanofi's Fluzone (influenza virus vaccine) has been introduced across the world in a variety of flavors to not only provide a cohesive marketing mix targeting all segments, but also to reassert its place at the head of the pack. Since introducing a standard version of Fluzone, Sanofi has engineered newer formulations to tackle at-risk groups such as the elderly (Fluzone High-Dose) and young children (Fluzone Pediatric Dose). Sanofi has also developed a new form of vaccine administration by introducing a version of Fluzone that utilizes intradermal administration over the standard intramuscular method.

As the market continues to diversify technologically, the stratification of the market segments will leave more and more individuals within the high-risk groups untreated. Currently, vaccines such as the FluMist, popular in the media for their innovative intranasal delivery, are contraindicated for individuals who fall into these at-risk groups, leaving scores of people virtually unprotected against a potentially deadly infection. It begs the question how a company like AstraZeneca plans to maintain its 10-11% share of the market without tackling these obvious unmet needs. While these patients can be treated with antiviral therapeutics, extended use of these therapeutics has in turn resulted in a new market to treat antiviral-resistant influenza strains.

Sanofi has diversified its seasonal vaccine portfolio in order to maintain, or even increase, its substantial share of the United States seasonal influenza vaccine market (~40% in 2011). Instead of following Sanofi's lead, other companies, such as Crucell Holland BV seem to believe that the generation of a "universal vaccine" is a more lucrative endeavor. A vaccine with efficacy against seasonal and pandemic influenza viruses would likely obtain substantial market share, but the dynamic nature of influenza, which undergoes seasonal variation, makes a universal vaccine a risky proposition. In this prophylactic driven market, vaccine companies will have to assess whether innovation to develop new and more efficient influenza vaccines will answer the concerns that arise without comprehensive coverage in affected populations.