Diabetes mellitus is a chronic metabolic disorder that results due to a failure of the body to produce the hormone insulin and/or an inability of the body to respond adequately to circulating insulin. Type 1 diabetes, previously referred to as insulin-dependent diabetes mellitus (IDDM), occurs most commonly in children or young adults and constitutes 5-10% of the diagnosed diabetes patient population. Type 2 diabetes, previously known as adult-onset diabetes or non-insulin-dependent diabetes mellitus (NIDDM), accounts for 90-95% of diagnosed diabetes cases globally and typically develops in middle-aged adults. The 2008 prevalence of diabetes mellitus, together in the seven major markets, was 8.5% with Germany having the highest prevalence rate at 11.8%. But the disease has been growing at epidemic proportions, a fact that has driven extensive R&D in this therapy area.
The global diabetes market was worth $27.3bn in 2008 and was led by insulin analogs which captured 45.0% of the market followed by glitazones that captured a share of 22.8%. US is the largest diabetes market globally with sales of $12.9b in 2008 and a market share of 47.6%. However the highest growth in sales y-o-y was exhibited by several early emerging economies such as UAE at 59.7%.
Scope of this report
Epidemiological analysis of the therapy area and forecast prevalence over the period 2009-14 .
Forecasts and analysis of the key products in the diabetes market over the period 2009-14 spread across the major classes of treatments.
Overview of key events in the global diabetes market that have impacted treatment trends and sales potential.
Strategic and growth analysis of leading pharmaceutical corporations based on sales focus by drug class, currently marketed products and R&D product portfolios.
Key findings from this report
Biguanides, mainly comprised of metformin, are the core first line therapy in diabetes care. These drugs have been used in diabetes therapy for over a decade. Some of their advantages include, efficacy, low cost, extensive experience, lack of incidences of hypoglycemia and weight neutrality. Metformin lost patent protection in 2002 and the class is now much genericized and has been ceding market share to other therapies.
Insulin captured the largest market share (45%) among available diabetes treatments and is likely to dominate the market in the forecast period. However, though insulin analogs have become well established in the market, inhaled insulin is yet to make its mark.
Significant R&D has been observed in the pre-insulin market leading to the development of several novel and safer therapies. The comparative performance of these therapies, such as the DPP-IV inhibitors and GLP-1 analogs would shape the diabetes market landscape through 2014 and in the long term.
Key issues
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?
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