VIVACELLE is designed to treat hypovolemia that results from acute blood loss following trauma or surgery, medical conditions such as burns, sepsis or diarrheal disease. It is suitable for use in emergency departments, operating rooms, clinics and by paramedics. The colloid/non-blood volume expander market was approximately 6 billion dollars globally in 2012.
That market consist of albumin and hetastarch (HES) based solutions like Voluven, Hespan and Hextend. The total addressable market for Vivacelle is over 13 billion dollars globally. In addition to the volume expander or resuscitation fluid market there is also an opportunity to penetrate the blood transfusion market given the fact that a large proportion of blood is given as a volume expander and not because of its ability to deliver oxygen. Another advantage of VIVACELLE is that it will be a much a less expensive treatment for hypovolemia given the expense of blood from procurement to administration with a cost of at least $2,000/liter. Conversely, VIVACELLE estimated cost of production is less than $30 per liter. Frequent shortages, along with factors like the need for refrigeration, cross type checking, disease screening and short shelf-life make blood transfusions a difficult treatment to administer in a timely manner for severe hypovolemic subjects in particular. Fresh frozen plasma suffers from similar limitations as well. VIVACELLE would also be suitable for volume replacement without blood loss, as is necessary during septic shock from infections or neurogenic shock from spinal cord injuries.
With regards to the market opportunity for VIVACELLE it should also be noted that the FDA issued a black box warning for all HES-based volume expanders in June of 2013, advising that specific side effects, renal failure and decreased survival, are a class effect and that these products should not be used in critically-ill patients. The European Medicines Agency provided a warning in October 2013 that HES solutions should no longer be used in patients with sepsis or burn injuries or in critically ill patients. HES based products comprised over a third of the 6 billion dollars colloid/non-blood volume expander market in 2012.