OBJECTIVES: Given the increasing cost and complexity of executing clinical trials and deriving statistically significant clinical endpoints, payers and decision makers are increasingly looking towards surrogate endpoints for guidance in decision-making.  Examples include progression free survival as a surrogate for overall survival for oncology products and blood pressure as a surrogate for a variety of cardiovascular endpoints.  The purpose of this research is to evaluate the need for surrogate endpoints in healthcare decision-making in Asia. METHODS: A literature review and several telephone interviews were conducted with payers and clinicians to evaluate the current landscape of surrogate endpoints and their use in clinical decision-making in Asia.  Pharmacoeconomic and regulatory guidelines were evaluated from China, South Korea, and Japan, to determine if there was any explicit statement regarding the acceptability of surrogates, the cost-effectiveness of their use, or other types of health economic modelling used to convert surrogates to hard endpoints. RESULTS: The majority of guidelines in markets evaluated mention the use of surrogate endpoints in some capacity; however, no guidelines contained an explicit statement about the acceptability of a surrogate endpoint in lieu of an established clinical endpoint.  Payers acknowledge the importance of surrogate endpoints, but note that there needs to be further research into the potential impact of substituting these endpoints in pharmacoeconomic and regulatory decision-making. CONCLUSIONS: The application and acceptance of surrogate endpoints in Asia is still in its infancy, which is analogous to the use of these endpoints in Europe and the United States.  Further research is necessary to establish statistically significant surrogate endpoints, which would help ensure that advantageous clinical products are brought to market in a timelier manner and reduce the overall cost of clinical trials to healthcare systems.