This study aims to cover the regulatory outlook and the diagnostics and drug approval process in the US, Europe, India, China, Japan and Brazil. Comparative analysis enables competitors to understand various regulatory hurdles and to position their products in pipeline better and plan for costs. Comparative analysis also enables an understanding of which geographies are hard to penetrate. Understanding regional barriers and the timeline taken for the evaluation process will help IVD and pharmaceutical companies choose an appropriate partner for their companion diagnostic product development.