Revised FDA guidelines make the regulatory environment challenging In December 2008, the FDA announced that the companies developing diabetes drugs will be required to conduct longer and larger studies to avoid any "unacceptable" cardiovascular risk. Companies are now required to conduct meta analyses for cardiovascular safety in the Phase II and III trials and rule out the possibility of an increased cardiovascular disease risk by 80% or more. Inhaled insulin still a distant reality Insulin therapy takes up the biggest share of diabetes treatment and has been an area of extensive research. While several different purer forms of insulin have emerged over a period of time, nasally administered insulin is still a distant reality. Inhaled insulin may aid compliance, leading to superior long term outcomes. Pfizer/Nektar's Exubera was the first to be launched inhaled insulin but it had a troubled launch and was subsequently discontinued in October 2007. The only inhaled insulin which is still under development is Technosphere, being developed by Mannkind/Afresa. This insulin uses a technology that facilitates absorption of proteins and peptides through the pulmonary route.

Use this report to:

Which companies were the leading players in the diabetes therapy area in 2008? How have recent major launches from the key market players performed? Which companies will become the key players in the diabetes market over the period 2009-14? Which products will be impacted by generic competitors over the period 2009-14?

Companies Mentioned:

Boehringer Ingelheim Eli Lilly GSK Merck & Co. Novo Nordisk Sanofi-aventis and Takeda

Source: Business Insights