OBJECTIVES: The Pharmaceutical Market Restructuring Act (AMNOG) came into action in Germany January 2011 with the aim of containing rising health care expenditure, notably by introducing mandatory benefit assessments and price negotiation for all new innovative pharmaceuticals. The impact of the reform for the pharmaceutical industry is predicted to be at its highest with repercussions beyond the country’s borders, due to Germany’s strategic importance in the European market. This project aimed to identify the challenges and opportunities created for the industry in terms of pricing and market access of innovative pharmaceuticals. METHODS: The impact was measured from three angles by developing hypotheses and testing them thanks to a series of exploratory interviews with pharmaceutical companies and Market access stakeholders.RESULTS: Results obtained project that the impact of the reform for the industry will be very high, increasing the importance of national stakeholders, altering the cost, time and strategy for market access as well as potentially leading to significant price reductions. What do these changes mean for the industry? What are the main challenges and opportunities for companies and how can they best adapt?  Many questions remain to be determined. Yet AMNOG sets the scene for a new Market access process in Germany, for which challenges can be foreseen. The industry will need to acquire new skills to interact with national Market access stakeholders, develop internal efficient processes to compile Benefit Dossiers, adapt the European launch sequence as well as investigate new Market access strategies, for example targeting sub-target population groups to demonstrate higher additional benefit or leveraging Phase IV data. ONCLUSIONS: Industry needs to prepare itself for developing their launch and commercial strategies in Germany as Germany is a key market from revenue, price referencing and credibility perspective