Diabetes mellitus is a chronic, multisystem disease that requires careful lifelong management and presently remains incurable.

In 2010 it is estimated that 285 million people worldwide have diabetes mellitus and this figure is predicted to rise to over 438 million in the next 20 years. Improvements in the management of diabetes mellitus have significantly decreased the number of deaths as a direct result of the disease, so much so that vascular complications have now become the leading cause of morbidity and mortality among diabetics.

Diabetic retinopathy is the most frequent vascular complication of diabetes and DME is the sight-threatening manifestation of diabetic retinopathy. DME is the leading cause of adult blindness in developed countries.

This epidemic of diabetes with vascular complications coupled with an aging population and worldwide urbanisation is creating a huge medical burden on individuals and society.

Approximately 20-25% of patients with diabetes will have DME threatening their vision, with an additional 2 million new cases diagnosed annually.  Given the market size and substantial unmet clinical need, it is thought that a safe and effective treatment for DME could have multi-billion dollar annual sales revenue potential.

Market Drivers

In the absence of safe, effective treatments for DME, pharmaceutical sales for its management are relatively low, comprising predominantly off-label VEGF inhibitor use. However, in the next few years the pharmaceutical sales for the treatment of retinal disorders are projected to expand rapidly driven by the formal launch of VEGF inhibitors for DME as well as other new treatments.

This will establish the DME market as an important growth area for pharmaceutical companies.