Smaller companies could carve out a sizeable niche in future influenza vaccines space

New entrants, as well as smaller companies, will expand the use of cell culture-based manufacturing methods to increase their presence.

The company’s report states that Sanofi, GlaxoSmithKline (GSK), AstraZeneca/MedImmune, Novartis, and CSL Limited/Sequris have provided the majority of commercially available vaccines over the last decade. Smaller companies, such as Mylan, have entered the competitive landscape, but have so far been unable to acquire a significant market share across the seven major pharmaceutical markets (7MM) - US, France, Germany, Italy, Spain, the UK, and Japan.

Christopher J. Pace, GlobalData’s Director of Infectious Diseases, explains: “2015 brought about changes in the influenza vaccines space, as Novartis fully retreated from the market by selling its vaccine portfolio to CSL Limited, leaving only four established companies to compete for the majority of market share in the 7MM.

“AstraZeneca, for example, has tried to remain competitive by continuing to market FluMist as a premium product, focusing on the benefits of a nasal spray over existing standard intramuscular injectable vaccines. However, the recent decision by the US Centers for Disease Control and Prevention to recommend against the use of FluMist will significantly alter the pediatric seasonal influenza vaccine market, leaving current or future players to exploit the drug’s potential marginalization.”

With Flucelvax and Fluad, CSL/Seqirus is the only Big Pharma player with a marketed quadrivalent cell culture-based vaccine and an adjuvanted seasonal influenza vaccine, both of which are posited as offering superior efficacy over standard vaccines. GSK also has a strong presence in the global seasonal influenza vaccines market with its flagship product, Fluarix Tetra, which is directly competing with the leading franchise, Sanofi’s Fluzone Quadrivalent in the US and Vaxigrip in Europe.

Pace concludes: “During the forecast period, GlobalData believes that smaller current players such as Protein Sciences Corporation and Mitsubishi Tanabe Pharma, and new entrants such as Novavax, will expand the use of cell culture-based manufacturing methods in order to increase their presence in the seasonal influenza vaccines market.

“Quadrivalent cell culture-based seasonal influenza vaccines are likely to capture at least 25% of market share in the 7MM by 2025, although it is unlikely that Sanofi, CSL Limited/Seqirus, and GSK will lose their market leadership.”