Pandemic flu threat question
remains unanswered
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: LSA Therapy reports
Pipeline and Commercial Insight: Influenza Vaccines - Pandemic threat
revitalizes the sector
Pipeline and Commercial Insight: Pediatric and Adolescent Vaccines
