OBJECTIVES: The increasing use of risk-sharing in reimbursement decisions across major markets necessitates that key stakeholders understand the role of this concept in shaping drug development and regulatory decision-making. The objective of this research was to examine global trends in risk-sharing agreements since 1990 to provide a comprehensive understanding of the current and future impact of this fast-evolving concept. METHODS: Primary research was conducted through 50 in-depth 45-minute telephone interviews in native languages. Subjects were carefully selected and represented payers, government agencies and HTA organizations in nine markets (Europe 5, Australia, New Zealand, United States and Canada) to understand their assessment of the role which risk-sharing agreements have – or have not – played in their respective markets, and whether they will do so in the future. This was complemented with secondary research of reimbursement decisions around the world based on a newly created database of risk-sharing agreements around the world. RESULTS: In some countries such as the United Kingdom and Italy, for certain therapeutic areas such as oncology, these agreements almost act as a substitute for the normal reimbursement process, but primary research indicates that this practice faces significant resistance at many layers. Still, many other countries are seeking to understand the potential applicability of risk-shares to their own market. Also, risk-share agreements are being examined for their potential in several other therapeutic areas. Whilst population- and patient-level agreements remain the most popular, we conclude that health outcomes-based arrangements are significantly on the rise, with 27 having been identified through the study in the markets that were studied, the majority of which were signed since 2007. Just over half were signed for oncology therapeutics. CONCLUSIONS: Outcomes-based agreements are becoming an increasingly important consideration to include in pricing models across the traditional development pathway for new molecules.