Ultra-rapid formulations of the currently marketed rapid-acting insulin analogs have the clear potential to radically change the insulin market over the next five years, according to a director with research and consulting firm GlobalData.

Valentina Gburcik, Ph.D., GlobalData’s Director of Cardiovascular & Metabolic Disorders, states that the use of long-acting insulin analogs may decrease as rapid- and ultra-rapid-acting analogs gradually take over the type 1 diabetes market.

Gburcik explains: “A substantial and ongoing rise in insulin pump usage over recent years, alongside the rapid development of a closed-loop system, or artificial pancreas, strengthens the need for insulins that act even faster than the currently marketed rapid-acting analogs.

“An artificial pancreas, which combines continuous glucose monitoring, a control algorithm and an insulin pump device, will likely become reality over the next few years. Ultra-rapid-acting formulations will also help with developing artificial pancreas systems, as their fast reaction time could allow the pumps’ algorithms to dose insulin in real time.”

The director notes that a number of these formulations are currently in development and may profit from the increasing pump therapy use, as they better match the physiological profile of prandial insulin.

Gburcik says: “Novo Nordisk’s FIAsp (NN-1218) is an ultra-rapid-acting formulation of NovoLog/NovoRapid (insulin aspart), which aims to continue NovoLog’s legacy and protect the franchise from generic erosion to biosimilars, as the drug’s patent expires throughout 2014 and 2015.

“In addition, biotech companies Adocia, Biodel, and Halozyme Therapeutics are developing similar formulations that will likely reach the market over the next few years, due to the short duration of the pharmacokinetic/pharmacodynamic clinical studies that are necessary for these drugs.”

The director adds that while Adocia’s BioChaperon insulin lispro is the most developed of the three biotech offerings, the company will have to either raise more capital or enter into licensing or collaboration agreements with experienced and well-funded players to compete in the insulin market.