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Influenza vaccine market dynamics
The market for seasonal influenza vaccines, sized at US$2.8 billion in 2008–2009 across the seven major markets (United States, Japan, France, Germany, Italy, Spain and UK), has had a strong compound annual growth rate of 12.6% since 2005–2006 (Ref. 1). In recent years, the sector has benefited considerably from an increase in disease awareness and funding, triggered by the threat of an influenza pandemic. However, owing to increasing competition and market commoditization, maintaining this strong growth momentum will be a key challenge in the future. The cautious stance of regulators towards new technologies inhibits successful product differentiation, particularly in the crucial US market. Improved vaccines for the elderly, alongside faster and more flexible manufacturing technologies, are the key unmet needs.
Challenges of the market
The influenza vaccines market is a challenging sector for several reasons. Besides requiring annual updates, seasonal influenza vaccines have to be produced and shipped within a short time frame of 6 months. Manufacturing delays and reduced output can result in losses of revenue and market share. Additionally, the demand for seasonal influenza vaccines is variable and often unpredictable, being influenced by factors such as the weather, the timing and severity of the influenza season, vaccine availability and public awareness of vaccination. These factors make production planning difficult. The pandemic influenza vaccines business is even more unpredictable and depends almost exclusively on government stockpiling and supply contracts.
A re-emerging focus for vaccine players
Historically, the influenza vaccine landscape has undergone marked fluctuations, particularly in the United States. The country remains the single largest market for seasonal influenza vaccines, accounting for 40% of overall sales across the seven major markets in 2008–2009 (Ref. 1). In the 1970s, at least ten US firms were marketing seasonal influenza vaccines. As a consequence of stricter FDA regulations and poor returns on investment compared with other pharmaceutical sectors, only three companies remained in the market in 2002: Wyeth, Aventis Pasteur (now Sanofi Pasteur) and PowderJect (now Novartis). In 2003, Wyeth ceased production of its own vaccines to concentrate on marketing MedImmune's (now part of AstraZeneca) FluMist, but decided to leave the flu space altogether in 2004.
Two factors prompted a change in US policy: the emerging threat of a pandemic caused by the H5N1 avian influenza strain since 2004 and a perceived vaccine supply shortage in 2004–2005 following disruptions at Chiron's (previously PowderJect's) manufacturing facility. The US government subsequently began to invest heavily into establishing US-based influenza vaccine production capacity, aiming to decrease the country's dependence on vaccine imports from few, mostly European, manufacturers. Furthermore, the US provided an additional growth stimulus by sequentially expanding recommendations on seasonal influenza vaccination to include more than 85% of the country's population by 2009 (Ref. 2). This combination of 'push' and 'pull' incentives transformed the sector's commercial potential, attracting numerous vaccine developers to build and expand their influenza portfolios in the United States. Following the market entry of GlaxoSmithKline (GSK) in 2005 and CSL in 2007, the number of vaccine suppliers for the US market has increased to five in 2009, with Sanofi Pasteur as the market leader (Fig. 1).
However, as the demand for seasonal influenza vaccination in the general population has failed to meet the expectations of suppliers, oversupply of these vaccines in the United States has become a growing problem during the past influenza seasons (Fig. 2).
This has triggered a growing commoditization of influenza vaccines. Prices, which increased from below $2 per dose in the late 1990s to $12 per dose at the peak of the business in 2007, have fallen over the past 2 years to reach a new low of $8.60 on average in 2009 (Ref. 3). To reverse this price decline, reduce the commodity nature of influenza immunizations and improve their market shares, vaccine developers are turning to new technologies that could offer product differentiation.
Developments in adjuvant technology
