Competition in International Generic Drug Markets

Background
While expensive new medicines draw considerable policy attention, older and more affordable generic drugs play a pivotal role in global drug utilization.

Objective
This study compares the small molecule generic drug markets across high-income countries with similar pharmaceutical regulations to assess market competitiveness.

Methods
This repeated cross-sectional study analyzed generic drug market data from the MIDAS database (IQVIA) for fiscal years 2010–2022, including all prescription drugs across formulations and sectors. Market competitiveness was assessed by examining the number of manufacturers selling 25+ generics per country and the share of off-patent products dominated by a single manufacturer.

Results
Between 2010 and 2022, the number of generic manufacturers selling 25 or more products increased in 10 of 13 countries, with the largest relative growth in the US (74%) and Australia (79%). Despite this growth, most off-patent drugs remained dominated by a single company, with over 70% of such products in monopoly markets in 8 of 13 countries by 2022, except for notable reductions in Sweden and the US.


Conclusion
There were significant international variations in generic market competitiveness, with the US and Germany showing the most competitive markets, while smaller countries were less competitive. Despite increased generic manufacturers since 2010, high market concentration persisted across all countries in 2022, raising concerns about the impact on drug shortages. Strengthening competition through policies that incentivize new manufacturers and deter market dominance could help improve access to medicines and mitigate supply disruptions.

Citation
Gaudette É, Rizzardo S, Pothier KR, Tadrous M. (2024). Competition in International Generic Drug Markets. JAMA Health Forum.

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Date Released: October 11, 2024

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