The European Medicine Agency’s (EMEA’s) approval of Sandoz’s biosimilar human growth hormone (hGH), Omnitrope, in 2006, has cut the cost of treatment by 25 per cent.
In response, Frost & Sullivan recommends that companies seek to invest in drug delivery technologies to differentiate their products.
Prabakar Sampath, a research analyst at Frost & Sullivan, said: "One of the chief competitive factors for hGH products is the delivery method, which represents an avenue for product differentiation.
“Alternative drug delivery methods could increase the market size by attracting more users, particularly considering that the majority of hGH users are children below the age of fifteen and that hGH injections have to be given daily."
hGH’s biochemical nature means that it is more effective when injected directly into the bloodstream, which many patients dislike as a delivery method.
If a company could provide an effective, needle-free alternative for hGH delivery it could seize a sizeable proportion of the European hGH market. This was valued by Frost & Sullivan at $846.4m in 2007, with a compound annual growth rate (CAGR) of 2.4 per cent from 2007 to 2014.
To create needle-free alternatives Frost & Sullivan recommends that manufacturers form strategic partnerships with drug delivery design companies. These partnerships should focus on the creation of an oral or transdermal delivery system for hGH.
In addition to differentiation through delivery system the report also recommends that manufacturers attempt to get hGH approved for new indications.
Sampath said: “Currently, hGH treatment is approved for only five medical conditions in Europe. Further growth of the European hGH market depends on the EMEA's approval of hGH treatment for new indications such as cachexia and achondroplasia.”
The US Food and Drug Administration (FDA) has already approved hGH for the treatment of cachexia, in addition toseveral conditions that the EMEA is yet to allow.
Frost & Sullivan’s report believes the reluctance of manufacturers to apply for EU marketing approval is due to the EMEA not approving Serostim, Merck-Serono's hGH product for AIDS-related wasting.