In the not-too-distant future we could see diabetes, the seventh leading cause of death in the U.S., treated with a vaccine. Several vaccine candidates are in the pipeline, creating a possible $2.4 billion market for diabetes vaccine products by 2020, according to healthcare market research publisher Kalorama Information, who recently published a survey of emerging vaccine products titled: "What's Next in Vaccines? HIV, Malaria, Rabies, MRSA, and 30 Other Vaccine Targets in the 2010-2020 Pipeline."

Type I diabetes currently afflicts 35,000 people in the U.S. and about 700,000 people worldwide each year. Type II diabetes affects more than 16 million Americans and over 200 million people worldwide.

Currently, other than a humanized anti-CD3 antibody with considerable side effects, there is no other means to reverse new-onset type 1 diabetes. People with type II diabetes must control their blood sugar levels with diet and exercise, and approximately 78% also take prescription medications to help control their diabetes. However, they remain at risk for a large number of associated conditions including foot ulcers, heart disease, kidney failure, and various skin conditions.

"Diabetes is a debilitating disease and a growing problem as waistlines continue to expand," said Bruce Carlson, publisher of Kalorama Information. "This is a desirable market for any drug maker, and it's not surprising that the pipeline is full."

There are at least seven diabetes vaccine candidates in development. Most are in Phase I testing and address type 1 diabetes. But one being developed by the Swedish company Diamyd Medical is currently in a global Phase III trial, which includes 640 children and adolescents newly diagnosed with type 1 diabetes. The purpose of the Phase III trial is to confirm and evaluate the ability of the Diamyd vaccine to arrest or slow the autoimmune destruction of the body's insulin-producing cells, thereby preserving the body's own ability to produce insulin. Initial analysis of data from the Phase II trial showed that patients treated with the Diamyd vaccine early after diagnosis have a clearly better diabetes status compared to the corresponding placebo group, 4 years after the injections.

Kalorama predicts a $100 million market from diabetes vaccines by 2012 as the first product currently in Phase III trials enters the market, with growth amounting to $2.4 billion by 2020 as other products reach market.

Kalorama Information's "What's Next in Vaccines? HIV, Malaria, Rabies, MRSA, and 30 Other Vaccine Targets in the 2010-2020 Pipeline" forecasts emerging vaccine markets through 2020, previews the product pipeline and details the major players in the industry. It is available here.

Kalorama Information