Few people are aware of just how powerful a force Europe is in the R&D of vaccines. This is important given the fact that
the earlier part of this decade saw the number of pharmaceutical companies making vaccines steadily decrease and those still
active scaling back their R&D efforts. While this trend could be partially explained because of industry consolidation, the
main reason for the decline was commercial factors, with some companies feeling that the R&D expense for vaccines was not
being sufficiently offset by revenue gained in the marketplace. Indeed, vaccine sales tended to fall well below the level
of revenue being brought in from major pharma products; in 2005, for example, it was calculated that among the top four pharma
companies making vaccines, these products accounted for less than 6% of total revenue.1 Another worry for vaccine manufacturers was the impact of safety concerns and product liability lawsuits. As an example
of how serious a risk this is, a 1986 lawsuit stating that pertussis vaccine caused paralysis in a child resulted in the jury
awarding $1.1 million, which worked out at more than half of the entire market for pertussis vaccine at the time!1
Although growth for certain segments of the vaccine market has been affected by under utilisation of available vaccines (e.g.,
for measles), the vaccine market, as a whole, is now entering a period of expansion. During the past 5 years, overt measures
to encourage vaccine manufacturers has helped give a boost to the sector, largely thanks to government interest in preparing
for influenza pandemics and combating bioterrorism. Other specific measures have also been taken to make life easier for the
industry; for example, in the US, the risk assumed by vaccine developers has been eased through the Vaccine Injury Compensation
Programme, a national fund that compensates families whose children are injured by vaccines.
Market growth is expected to occur primarily because of the introduction of new vaccines against diseases for which no vaccine
currently exists or as second-generation products to replace existing vaccines.2 It has recently been predicted in the US media that vaccine sales would double from $19 billion in 2009 to $39 billion in
2013.3 In particular, cancer vaccines are expected to be a major driver of future market growth because of the promise they have
already shown for preventing disease, as well as the receptiveness of the market for dealing with cancer using this approach.
In the UK, for example, uptake rates of the cervical cancer vaccine were around 80% between 2009 and 2010, leading to predictions
that cases could be cut by around 63% by 2025.4
Recently, there has been considerable media attention concerning Dendreon's (WA,USA) innovative prostate cancer vaccine Provenge,
which was launched in the US in April 2010. Between June and July, sales more than doubled to $5.2 million, but the company's
manufacturing is reported to be struggling to keep up with demand.5–7 One of the problems with Provenge is that, unlike other drugs, eligible patients must have their cells shipped to a laboratory
where a customised immune therapy is prepared, which takes about a month. Prior to FDA approval, the company had been hesitant
to expand manufacturing in case of a negative opinion, but is now under pressure from patients to boost production. The company
is expected to reach full manufacturing capacity by early 2011.
Within the current market, the most successful vaccine product is Pfizer's Prevnar 7, which protects against seven strains
of streptococcus pneumoniae.8 In 2009, Prevnar 7 had global sales close to $3 billion, which put it among the company's top products. Pfizer is now developing
Prevnar 13, which protects against 13 strains of the bacterium. The vaccine is already approved in Europe and the US for infants
and children, but the company is running trials with the aim of expanding into the adult population.9 If this approach is successful, it could add an extra $1.5 billion in annual product sales.
However, Pfizer may well be facing competition in this area from GSK's Synflorix, which was approved in Europe in 2009. In
the same year, GSK also signed a 10year $1.5 billion agreement with the Brazilian government for supply of the vaccine,10 although the company has not yet made a decision about launching it in the US.
The author says...