OBJECTIVES: Targeted therapies have a growing place within the therapeutic landscape and represent an innovative sector. Companion diagnostics (CD) are complementary to targeted therapies; however there is an unbalanced environment between both technologies with limited incentive measures to support the development of diagnostic tests. The aim of this analysis was to review and compare the existing processes in Europe and North America, and see how CD benefits could be rewarded.  METHODS: An analysis was performed of the healthcare systems in France, the United Kingdom, Germany and the United-States. Advantages and disadvantages of country-specific pricing and reimbursement policies were highlighted. A literature review was then conducted to identify the benefits related to CD and potential processes to capture these benefits. Searches were run on electronic databases (i.e. MEDLINE and MEDLINE In-Process) and were supplemented by hand searches to ensure that most relevant publications were included. RESULTS: The analysis of healthcare systems showed a lack of incentive measures to support the development and market access of CD. Benefits associated with CD can be grouped into two categories: the health benefits (e.g. prediction of the patient’s response) and the economic benefits (e.g. cost-saving due to decrease in the delay of response). To reward these benefits, several potential strategies were identified (e.g. intellectual property, reform of commissions) and the most reported one being the value-based pricing approach.  CONCLUSIONS: Value-based pricing approaches were widely reported to reward the benefits associated with CD. Moreover, a European Directive focusing on medical devices is currently in development, with the clarification of CD’s status expected. However, there is a gap between institutional and scientific timelines given that scientific research is already going a step further with the high-throughput DNA sequencing which would need to be rewarded as well.