In the present final report a five-years business plan for the commercialization of an innovative diagnostic kit for Sjogren’s syndrome (SjS) is presented.
The kit will enable clinicians to perform a definitive diagnosis of SjS, an autoimmune disease with an high incidence in the general population. The product rely on a disruptive technology based on nanomaterials produced in plants, namely plant virus-based particles, characterised by superior performance in ELISA tests compared to actual diagnostic systems.
We first analysed the market in order to identify target markets and the strategies to be implemented by the company to enter the EU and US markets.
The envisaged strategy that resulted from our analysis is: (1) to enter the domestic Italian market by using sales agents (first year); (2) enter the principal EU markets (UK, Germany, France and Spain) by commercial partnership with target distributors (second year); (3) set-up licensing agreements in the US with diagnostic US companies (third to fifth year).
During the envisaged timeframe we will set-up academic partnership in UK in order to develop a robust clinical evidence of our product.
We defined a pricing strategy based on a cost-plus analysis, resulting in a cost per kit of 300€. Considering the market strategy previously described we predict to reach the break-even point by the second year with revenues in the third year of €3,211,115, in the fourth year of €7,057,000 and in the fifth year of €11,960,218. The definitive company employment structure on the fifth year will rely on the presence of 10 people with different roles.
The product is currently covered by a patent filed in Italy in 2015; our IP strategy is to extend the patent in all EU members, US, Japan, Mexico, Russia, Australia and South Africa.
We analysed the regulation for the diagnostic sector in EU and US and defined the following strategy to comply with it.
For EU commercialization we need to CE label our product after the approval of national health authorities while in US the procedure is more complex and is based on specific product validation by FDA.
Eventually, we identified potential developments of our technology by the application of our innovative platform for the diagnosis of other diseases.
