In today's seasonal influenza market, vaccine manufacturers must match supply to a conservatively estimated annual demand; this estimate is typically lower than what is needed, and so it can represent lost profits. The threat of an influenza pandemic presents an unprecedented vaccine manufacturing situation in which scalability, speed, and biosafety would be key issues. An avian flu strain could mean additional biocontainment challenges. Hence, alternative technologies are being developed to address the drawbacks of traditional platforms. The ideal vaccine manufacturing facility would handle multiproduct campaigns and would include a range of production and process platforms. Vaccine manufacturers should consider how to make a good business case for new production and facility concepts.
The seasonal influenza industry of today can be viewed as the result of an imperfect market. Manufacturers match supply to a conservatively estimated demand for seasonal flu vaccines annually; this estimated demand is far lower than what would prevent or reduce related mortalities, and it results in lost economic productivity. Often seen as fickle, this low estimated seasonal influenza demand has not offered vaccine manufacturers the incentives to develop more efficient processes, and as the consequence of an underfunded market, it has resulted in a manufacturing system based on an antiquated process. This situation is now changing. Because it is expected that seasonal flu facilities will be modified to manufacture pandemic vaccines in a time of crisis, manufacturers' ability to deliver is belied by a global capacity shortfall. This shortfall will occur because the market size for a pandemic vaccine is potentially the entire world population. If represented as the "global influenza superset," this market has little or no relationship to current seasonal demand, yet it is wholly dependent on the supplies of "local subsets" of seasonal flu resources. Currently available capacities would be insufficient in a pandemic crisis, and new investments are driven toward building seasonal influenza manufacturing facilities. However, the key issue being raised is whether there is a good economic case for these new facilities, especially in markets with little or no demand for seasonal vaccines.