More speculation on inhaled insulin market potential

By Emilie Reymond

- Last updated on GMT

Related tags Insulin Diabetes

Innovative, non-invasive new ways of delivering insulin are poised
to transform diabetes management, despite concerns about their
safety and efficacy, according to new research.

According to a new report published by consultants Frost & Sullivan, the diabetic community is expected to support research into new technologies that promote greater compliance and therefore improved disease management.

Accordingly, the revenue potential across Europe of non-invasive insulin, particularly inhaled insulin, will be considerable, said the report, which forecasts that the European inhaled insulin market will generate revenue of $49.3m in 2006 and expects this to reach $611.7m in 2012.

"Compliance is currently a major drawback in current diabetes delivery devices, with several patients suffering from Type II diabetes irregularly following or, in some cases, even discontinuing their insulin therapy due to pain or fear of injections,"​ said Frost & Sullivan Research Analyst Sylvia Miriyam Findlay.

"Through more convenient drug delivery methods, pharmaceutical companies, regulatory bodies and other government institutions can introduce better diabetes care and reduce costs related to diabetic complications caused by poor compliance."

Currently, several new ways of delivering insulin, including oral, transdermal, nanotechnology-based and gene therapy-based ones, are being developed. Efforts are also being made towards developing a vaccine for diabetes, but according to F&S, the most promising mode of delivery currently under research is inhalable insulin.

The number of people with Type II diabetes is expected to reach the 40m mark by 2012 and drug makers have seen a goldmine in alternatives to injectable insulin.

Leading participants in the diabetes medication market are competing to develop newly-formulated insulin drugs. Already, Exubera, developed by Pfizer and Netkar, 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.

However, a recent research was more sceptical over the future of inhalable insulin saying it is unlikely to achieve the blockbuster status the industry had hoped for.

According to a Datamonitor report published in October, the unmet need for these newly-formulated drugs is too low to fuel a multibillion-dollar market - bad news for a number of manufacturers who have long pursued the development of newly-formulated insulin as a potential money-spinner.

According this previous report, the core issue is that, although the new formulation of the drug would remove the need for injections, patients would still have to put up with the usual disadvantages of insulin therapy, including weight gain and the need to adhere to a restrictive meal-dependent administration routine.

Added to that, Datamonitor cardiovascular analyst Daniel Poso cited the effectiveness of other types of diabetic treatments in the pipeline as a big challenge to universal uptake of inhalable insulins.

He also said that the introduction of inhalable insulin products has added a set of further potential side effects to insulin - on top of hypoglycaemia and weight gain: the unknown risk of carcinogenicity and long-term lung damage.

Specifically, there has been concern about the potential effect of insulin, a growth factor, on the pulmonary vasculature, such as pulmonary hypotension and pulmonary oedema.

On this particular point, the F&S report agrees saying that occurrences of pulmonary fibrosis during clinical trials and the incidence of side effects are restraining the uptake of inhaled insulin.

This latest report added that 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.

"As the European markets are driven by the convenience factor, companies will need to analyse dosing accuracy, bioavailability and the device size,"​ says Findlay from F&S.

"This novel drug delivery method will have to demonstrate its advantages in terms of safety and accuracy relative to current insulin injections."

The report concluded saying that it will be up to manufacturers of inhaled insulin devices to prove the safety and convenience of their products.

With many other inhaled insulin products coming into the market in the next few years, we can expect speculation on whether new products like Exubera will be blockbusters or not to continue.

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