The convenience of non-invasive insulin delivery methods is set to overcome their high cost and concerns about safety and efficacy, with the greatest beneficiary being the European inhaled insulin market which is predicted to swell from $49.3m (€38.5m) in 2006 to $611.7m in 2012, according to two new market reports from Frost & Sullivan.
While the oral anti-diabetic market is in its mature phase, nascent non-invasive insulin delivery technologies, and inhaled insulin devices in particular, are set to stimulate growth in the European insulin market, pushing it from $2.8bn in 2005 to $4.6bn in 2012.
Although inhaled insulin, like oral insulin, is typically costlier than standard insulin vials and cartridges, its convenience will prevail over reimbursement limitations according to Frost & Sullivan.
Already, Pfizer's and Nektar's Exubera has become the first inhaled insulin to enter the market, while Novo Nordisk is pursuing final clinical studies on AerX with plans to launch it by 2008.
"As the European markets are driven by the convenience factor, companies will need to analyse dosing accuracy, bioavailability and the device size," said Sylvia Miriyam Findlay, a Frost & Sullivan Research Analyst.
"This novel drug delivery method will have to demonstrate its advantages in terms of safety and accuracy relative to current insulin injections."
Indeed, the inhaled insulin market faces concerns over the long-term safety and efficacy of using the pulmonary insulin delivery method.
Occurrences of pulmonary fibrosis during clinical trials and the incidence of side effects are restraining the uptake of inhaled insulin.
Manufacturers of inhaled insulin devices will need to focus on the long-term safety and convenience aspects of their products, with the incorporation of newer techniques in inhaler devices set to enhance convenience, the reports suggest.
Moreover, due to high production costs, inhaled insulins are likely to be priced three to five times higher than conventional ones.
This price premium will challenge manufacturers, although the price factor will be balanced out by its greater convenience.
Traditionally, insulin has been injected under the skin with a needle and syringe. Until the late 1990s, Becton Dickinson (BD) dominated the insulin delivery systems industry, commanding 63 per cent of the market with its syringes.
However, the arrival of new insulin pens pulled the rug out from BD, as the popularity of these pens grew throughout the world, particularly in Europe. Now in some countries, 70-90 per cent of all insulin is delivered by pen.
"Technological advancements in the field of drug delivery have propelled scientists to research new and more convenient forms of insulin delivery," said Findlay.
"The subsequent emergence of newer methods of insulin delivery including inhaled insulin, oral insulin, transdermal insulin will eventually expand the insulin market."
With reimbursement for insulin devices and novel forms of insulin still uncertain, the penetration of inhaled insulin delivery forms across the European Union will constitute a difficult task, but prospects look good for those manufacturers that can sufficiently address the concerns of patients, the reports stress.