According to Global Health Intelligence, the Latin American pharmaceutical landscape is undergoing significant transformations, thanks to updates in regulatory reforms, a surge in generic drug availability, and an evolving role in the global supply chain.
Regulatory Reforms
In recent years, several Latin American countries have implemented measures to streamline pharmaceutical approvals, Global Health Intelligence gives the following examples:
Brazil: On January 21, 2025, the Brazilian Health Regulatory Agency (ANVISA) introduced a resolution to simplify the approval process for biological products, including vaccines, radiopharmaceuticals, and generic drugs. Companies with at least one approved product in Brazil can now benefit from this expedited pathway.
Argentina: In July 2024, Argentina enacted policies to facilitate the entry of generic drugs, relaxed restrictions on opening new pharmacies, and permitted the sale of over-the-counter medications outside traditional pharmacy settings.
Mexico: Efforts have been directed toward promoting clinical research and enhancing access to generic and biosimilar medicines, aiming to benefit both local and international markets, including the United States.
Additionally, Fitch Solutions, says there is plans for the establishment of the Latin American Medicines Agency which seeks to harmonize drug regulations across the region, and will draw parallels to the European Medicines Agency. This initiative aims to elevate regulatory standards and foster cross-border collaboration, benefiting domestic drug manufacturers and stimulating pharmaceutical market growth.
Proliferation of Generic Drugs
Global Health Intelligence also says that the easing of regulatory barriers has contributed to a notable increase in generic and biosimilar drugs:
Between 2015 and 2019, generics accounted for approximately 45% of all pharmacy drug sales in Latin America.
The biosimilars market, valued at $517 million in 2018, is projected to reach $3.9 billion by 2025, reflecting a compound annual growth rate of 33%.
This trend underscores a regional shift toward more affordable medication options, driven by both regulatory support and market demand.
Impact on the Global Supply Chain
Global Health Intelligence also outlines how the burgeoning generic drug market is reshaping Latin America's role in the global pharmaceutical supply chain:
The region hosts nearly 2,000 smaller pharmaceutical companies poised to produce and distribute generics and biosimilars locally and internationally.
Initiatives in countries like Brazil and Colombia aim to bolster local production of generic drugs, enhancing self-sufficiency and reducing dependency on imports.
These developments suggest that Latin America is emerging as a significant contributor to the global pharmaceutical industry, with the potential to influence drug availability and pricing worldwide.
Strategic Implications for British Healthcare Companies
For multinational pharmaceutical corporations, streamlined regulatory approval processes present opportunities for faster market entry. However, the influx of generics introduces competitive pressures, necessitating a focus on innovation and agility.
Conversely, regional and smaller pharmaceutical firms stand to gain from reduced regulatory hurdles, enabling them to expand their market presence and contribute to a more diversified pharmaceutical landscape.
In summary, Latin America's pharmaceutical sector is experiencing a dynamic evolution, marked by regulatory harmonization, increased generic drug production, and a more integrated role in the global supply chain. British companies are well positioned to take advantage of these transformation and by joining forces with local firms there is great opportunities for export growth.
According to the International Trade Centre, it is forecasted British companies could be exporting an additional USD$27bn worth of pharmaceutical products and about USD$14bn for medical devices across the world.
Sources: Global Health Intelligence, Fitch Solutions, ITC/Export potential
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