Presentation (CTI)

OBJECTIVES: To assess trends in manufacturer participation in Project Orbis under evolving U.S. most-favored-nation (MFN) drug pricing frameworks.
METHODS: An analysis was conducted evaluating the number of oncology products participating in Project Orbis between 2020 and 2025. Current trends were assessed, including forward-looking considerations for 2026 based on observed patterns and expected completions.
RESULTS: Across major markets, the proportion of regulatory approvals granted by agencies such as the European Medicines Agency (EMA), Swissmedic (Switzerland), H. Canada, MHRA (UK), and PMDA (Japan) relative to U.S. Food and Drug Administration (FDA) approvals has declined over time, while NMPA (China) has remained relatively stable or shown modest growth. In parallel, Project Orbis—an FDA-led initiative designed to accelerate access to oncology therapies across participating countries—also shows a noticeable decline in observed participation in 2025. However, interpretation should remain cautious given the immaturity of recent data.
CONCLUSIONS: The interaction between MFN pricing policies and Project Orbis creates a structural tension in global launch and market access strategies: while Project Orbis accelerates regulatory timelines, MFN frameworks constrain international pricing flexibility. The observed decline in Project Orbis participation aligns with recent U.S. pricing policy developments and may reflect evolving manufacturer behavior, consistent with broader directional trends observed across global regulatory approvals. However, participation in accelerated regulatory pathways may represent a strategic opportunity for countries (eg, Brazil, Singapore) that are not primary U.S. reference markets to enhance access to innovative oncology therapies. Furthermore, even in reference markets, earlier access and revenue generation through accelerated pathways may partially offset increased pricing pressures, particularly in therapeutic areas where speed to market is critical.