As a result, an elaborated business plan including detailed market analysis was generated. It could be shown that there is a large clinical need for a test like ChemoPredict. Moreover, there is a large market for the test with a target population of 212,361 patients and a total addressable market of €170 million in Europe per year. No competitive test could be found on the market. The existing customer basis of Sividon’s current product EndoPredict® will facilitate market entry of the ChemoPredict test. The commercialization strategy will start with the key opinion leaders to get included into clinical guidelines and is accompanied by discussions with the health insurances. Costs for the clinical validation trials and for product development were calculated and the estimated revenues reveal that ChemoPredict offers an attractive business opportunity. Moreover, regulatory issues with focus on possible changes in the European IVDD were evaluated and the clinical validation as well as product development strategy as well as a development plan were generated.