For the U.S., local licensee Acacia estimates that currently more than 40 million procedural sedations are performed annually. The growth of the procedural sedation market in the U.S. has been driven for many years by the increase in medical procedures involving procedural sedations, such as colonoscopies, as well as by an increasing general demand for screening. According to Acacia, approximately 25 million colonoscopies and endoscopies are performed annually in the United States. Acacia states that more than 80% of colonoscopies and endoscopies are performed in the presence of personnel trained in anesthesia. The wholesale acquisition cost (WAC) price is reported by Acacia to be USD 39 per dose. Overall, the total market in procedural sedation is more than USD 1.5 billion per year, according to Acacia.
In Europe, based on its own projections for procedural sedation, PAION currently estimates an annual peak sales potential of approx. EUR 50 million to approx. EUR 60 million. In contrast to the U.S. market which has a large freestanding ambulatory surgery healthcare infrastructure, procedural sedation in Europe is mainly a hospital-based activity where anesthesiologists have the overall responsibility for the sedation of patients. Important users, however, are also e.g. gastroenterologists. This entails a high potential for synergies with the planned commercialization of remimazolam for use in general anesthesia. In addition, the area of day surgery is also growing in Europe, so that PAION expects a steady growth of procedural sedation procedures in Europe as well. One driver of this development is the establishment and further spread of colorectal cancer screening (diagnostic colonoscopies).