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Pandemic flu threat question remains unanswered |
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20 Aug 2007 |
The rapidly growing influenza vaccine market is set to reach a value of $5 billion in 2016, driven by the increasing awareness of the disease and the overarching pandemic threat. However, several challenges remain, such as limited manufacturing capacity, uncertainty about actual demand and long planning cycles, making the sector a risky field for vaccine manufacturers.
Although only a few human cases of the avian influenza virus H5N1 have been reported to date, experts believe that this virus could cause a severe flu pandemic if it acquires the ability to be transmitted directly between humans. In the absence of drugs to efficaciously treat influenza more than 48 hours after the infection, prophylactic vaccines are the method of choice for controlling the disease.
Driven by the increasing awareness towards influenza, governments, particularly the US, have expanded their national influenza vaccination recommendations over the past few years. As a result, the seasonal influenza vaccine market, worth approximately $2.2 billion in 2006, is growing rapidly, at least doubling in size by 2016.
Major risks for manufacturers
Despite the strong growth, the seasonal influenza market remains challenging for pharmaceutical companies, as the composition of the vaccine has to be changed every year in order to include the currently circulating virus strains. This leaves manufacturers with a very short time frame in which to produce the entire yearly vaccine supply.
In addition, despite the broad vaccination recommendations, the actual yearly public demand varies widely, as it is influenced by several factors such as the weather, severity of the flu season and personal risk perception. This renders the market highly unpredictable and poses an annually recurring risk of commercial failure on manufacturers.
A central concern with regards to influenza vaccines is manufacturing capacity. Currently, the global production capacity stands at 350 million doses of seasonal influenza vaccine, which is only sufficient to supply a small fraction of the recommended population with a flu shot. Although most manufacturers are expanding their facilities, aiming for a total capacity of over 600 million doses by 2010, even this number would be far from satisfactory in the case of a severe flu pandemic.
Current pandemic vaccine efficacy unclear
Supported by large amounts of government funding, vaccine manufacturers have recently embarked on the development of vaccines against the impending flu pandemic. Sanofi Pasteur, the market leader in the flu vaccine sector, was the first company to receive approval for an H5N1 vaccine in the US in April 2007, followed by Novartis's pandemic candidate Focetria in Europe in May 2007. However, as the detailed antigenic properties of a future pandemic virus will remain unknown until the pandemic strikes, the real efficacy of developed H5N1 vaccines remains uncertain. In the best-case scenario, a degree of cross-protection against the pandemic virus will be achieved upon vaccination with currently available vaccines, giving manufacturers time to isolate the actual pandemic virus and develop a targeted vaccine. In the worst-case, the pandemic virus will have a novel antigenic pattern and no cross-protection will occur.
New manufacturing technologies
Using current chicken-egg-based manufacturing techniques, the production of influenza vaccines takes several months, constituting a crucial delay in a pandemic scenario. In order to shorten the time needed to produce the vaccines, a key focus in influenza vaccine research is the development of faster and more flexible manufacturing techniques, for example in mammalian cell-culture systems. Accordingly, the EU approval of Novartis's cell-based seasonal vaccine Optaflu in June 2006 constitutes a key milestone for the future development of the flu vaccines market.
The influenza vaccine market is growing rapidly, driven by the increasing awareness of the disease and the overarching pandemic threat. New technologies will render supply and demand more flexible and timely, however, although significant progress has been made recently, the challenge of an avian flu pandemic remains, at best, only partially addressed.
Related research:
- Infections - Influenza Drug Pipeline Report
- Pipeline and Commercial Insight: Influenza Vaccines - Pandemic threat revitalizes the sector
- Pipeline and Commercial Insight: Pediatric and Adolescent Vaccines
- Novartis: PharmaVitae Profile
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