Pharmaceuticals Update: Recent Regulations & Innovations in Latin America
By Guillaume Corpart
With all the emphasis on artificial intelligence and device advancements in recent years, it’s easy to lose sight of another major player in the healthcare marketplace — pharmaceuticals. But whether it’s innovations, the increasing availability of generic drugs, or regulatory changes to the markets, pharmaceuticals still play a significant role in the healthcare markets of not only Latin America but around the world.
With that in mind, it’s a good time to look at some of the most recent changes related to pharmaceuticals within the Latin American healthcare market, and how these changes might impact your business moving forward. Here, we’ll take a closer look at new regulations, new medications, and how it’s all impacting the global supply chain.
The Impact of Regulatory Changes
With the wide variety of disparate markets and varying regulations, one common complaint about Latin America is the difficulty for pharmaceutical manufacturers to navigate them all in order to do business in the region. Luckily, 2025 looks like it might be one of improvements for Latin American pharmaceutical regulations. Across the region, many countries are making efforts to speed up and streamline the process of pharmaceutical approvals. This should result in a better environment for companies trying to bring drugs to those markets.
In Brazil, for example, the Brazilian Health Regulatory Agency, ANVISA, began implementing a new resolution on January 21 to simplify the process of introducing biological products, including vaccines, radiopharmaceuticals and generic drugs. It also makes corrections, new indications, withdrawals and other processes around pharmaceuticals easier to navigate. To be eligible for this simplified process, companies must have at least one other drug or biological product already approved in the Brazilian market.
Other markets in Latin America, including the Dominican Republic and Colombia, have announced similar measures in recent months. In July 2024, Argentina announced several related measures to ease restrictions on pharmaceuticals, including measures to allow more generic drugs to enter the marketplace, easing barriers on the opening of new pharmacies, and allowing the sales of over-the-counter medications in businesses other than pharmacies.
Mexico has undergone similar efforts to promote clinical research and enhance access to generic and biosimilar medicines. Interestingly, Mexico’s efforts appear to be targeting not only local access, but also the availability of these medications in markets such as the United States. What this means for pharmaceutical manufacturers is potentially more friendly and open markets for new or generic versions of drugs in the years ahead.
The Rise of Generic Drugs in the Marketplace
Reading through those regulatory changes, it’s probably no surprise that biosimilars and generic drugs are on the rise in Latin America. As specialty medications have grown more expensive, the availability of more affordable generic alternatives has become critical for many people in the region who need them. The easing of regulatory restrictions in countries such as Brazil, Argentina, Colombia and more has made it easier to bring these drugs to market.
Generic drugs were already a core component of the Latin American healthcare market, with generics making up almost half of all Latin American pharmacy drug sales between 2015 and 2019. This upward trend is expected to continue in the years ahead, particularly with the easing of restrictions in the market. Take a look at the table below for projected increases in the upcoming years.
Latin American Generic & Biosimilar Sales
- Percent of all drug pharmacy sales made up by generics from 2015-2019: 45%
- Value of the LatAm biosimilars market in 2018: $517m
- Projected value of the LatAm biosimilars market in 2025: $3.9b
- Compound annual growth rate (CAGR) of the biosimilars market from 2018-2025: 33%
- Worldwide biosimilars market projection for 2032: $893b
How Local Pharma Impacts the Global Supply Chain
As you can see from the table above, market forecasters are projecting nothing short of an explosion in generic and biosimilar sales in the years ahead. The projection is so large, in fact, that it could fundamentally change the role of smaller, local pharmaceutical companies in the overall marketplace, both in Latin America and globally.
Though major multinational companies own the most significant portion of the market share in Latin America, there are also almost 2,000 smaller pharmaceutical companies in the region. Couple this fact with the easing of restrictions on producing generic and biosimilar drugs in many regions across Latin America, and these smaller local companies are well-positioned to produce and sell generics and biosimilars in the region and beyond.
Across the region, you’re already beginning to see efforts to expand the production and availability of these drugs. In Brazil and Colombia, for example, initiatives are underway for local companies to begin producing generic, publicly available versions of popular drugs.
Key Takeaways for Health Care Companies
With the easing of restrictions and the efforts to improve access to generic and biosimilar drugs across the Latin American region, pharmaceutical manufacturers are well-positioned to take advantage of these regulatory and market changes in the months and years ahead.
If you’re a major multinational pharmaceutical company with a large market presence in the region, then you should continue to see growth due to the streamlined process that many countries are implementing to get drugs reviewed, approved and added to the marketplace. One interesting challenge for these larger manufacturers in the coming years may stem from increased competition, as more generic drugs and biosimilars from smaller manufacturers enter the market. Larger companies can stay ahead of the curve by staying agile and continuing to push for innovation in the pharmaceutical sector.
For smaller and regional pharmaceutical companies whose focus is primarily generic drugs or biosimilars, the recent regulatory changes should be nothing but good news for your bottom line. The market is open to these medications coming to market across Latin America, with fewer roadblocks to approval and access than ever before.
Next Steps
Contact GHI to learn more about healthcare trends and their potential impact on the pharmaceutical industry in Latin America. Our team of researchers can provide the analysis you need to gain valuable insights to support strategic decision-making in your industry.
