A recent report suggests that the market for paediatric and adolescent vaccines is set to grow four-fold over the next decade, spearheaded by Wyeth's Prevnar as the first blockbuster vaccine.
The Datamonitor report cites the success of Prevnar, the first vaccine approved for the prevention of pneumococcal disease in infants, as evidence that high-priced vaccines targeting teens and infants are likely to become increasingly prominent in pharma pipelines.
Prevnar commanded global sales of $1.9bn in 2006, and although expensive at almost $320 for the four-dose regime, the report authors say "its high price has been accepted by governments due to the vaccine's good cost-benefit profile.
"Wyeth's pricing strategy has paved the way for increasing tolerance of high product prices in the paediatric vaccines sector."
In 2006 paediatric and adolescent vaccines in the seven major markets were worth approximately $4.3bn, but thanks to new high-price vaccines promising significant health benefits, Datamonitor expects this figure to increase substantially, hitting over $16bn by 2016.
Recent events support the Datamonitor predictions, with Merck's human papilloma virus (HPV) vaccine Gardasil garnering huge public attention and putting pressure on health authorities to make the shot available to teenage girls.
GlaxoSmithKline's (GSK) competing vaccine, Cervarix, was also approved in September, and though both products are pricey, vaccination against HPV has been recommended across the US and Europe.
Indeed, on October 26 , the UK's Department of Health announced that HPV vaccination was to be made part of the national immunisation programme for 12-13 year old girls from September 2008, with a two year catch up campaign to start the following year to cover girls up to 18 years.
As a result of the high profile these cancer vaccines have gained in the public consciousness, along with the "exciting opportunity to vaccinate against cancer," Datamonitor sees a huge commercial opportunity for HPV vaccines.
The report predicts annual cohort sales of $1.4bn in teenage girls in the seven major markets of France, Germany, Italy, Spain and the UK by 2016, along with the potential of a cumulative catch-up opportunity for girls aged 13-26 that could add a further $17bn.
While HPV is currently taking centre stage in terms of awareness of high price vaccines, Prevnar (approved in the US in 2000) was the first vaccine with true blockbuster status, and has prompted the development of other high valent candidates to protect a broader range of S. pneumoniae serotypes.
With Wyeth and GSK are both working on such vaccines due to enter the market from 2009, Datamonitor expects the total value of the infant market for pneumococcal vaccines to increase to $2.3bn by 2016 across the US, Japan and the EU 'big five' of France, Germany, Italy, Spain and the UK.
As well as the opportunities apparent in the HPV and pneumococcal vaccine sectors, the report also highlights meningitis as a potential high growth area, with Gardasil and Cervarix paving the way for adolescent indications and targeting a large population with notoriously low immunisation rates.
A particularly lucrative opportunity would be the development of a vaccine against infections with N. meningitides B, according to the report authors, with an estimated $1.9bn in annual cohort sales and $10.7bn in catch-up sales until 2016.
However, the report highlights the fact that not all high-price vaccines will necessarily see the enviable uptake of Prevnar or Gardasil, and that it is crucial that manufacturers appreciate that the key to success lies in a product's introduction into national immunisation schedules.
As such, medical need for the vaccination is clearly a central criterion, and according to Datamonitor forms part of the explanation as to why Merck and GSK's rotavirus vaccines have seen relatively limited uptake.
With quick and efficacious treatments for rotavirus diarrhoea in infants already available, health authorities see little need to introduce such costly vaccines. As such, the report authors expect total annual sales of rotavirus vaccines to remain limited to around $1bn by 2016, driven largely by the US - the one nation among the seven major markets to have recommended rotavirus vaccination in infants.
"The new premium-priced vaccines multiply the costs of infant vaccination and pose a significant challenge for budget-constrained healthcare authorities and providers," report author Hedwig Kresse says.
"Vaccine manufacturers need to focus on real medical needs as well as on improving public education in order to ensure commercial success for their products."