Rethinking Latin America’s Role in Clinical Development

For most biotechnology companies, Latin America is not a strategic priority. That is usually understandable.

The United States remains the world's largest biopharmaceutical market. Western Europe combines world-class academic research, mature clinical research infrastructure, established regulatory systems, and large commercial markets. Central and Eastern Europe has long been valued for experienced investigators and efficient patient recruitment. China, Japan, and other Asia-Pacific countries are becoming increasingly important sources of scientific innovation, clinical research, and commercial growth.

Against that backdrop, Latin America can look peripheral. The region has fragmented markets, reimbursement challenges, pricing pressure, regulatory variability, operational complexity, and post-trial access questions.

That is not wrong. But it may be incomplete.

This isn't an argument for suddenly making Latin America a strategic priority.

It's a narrower question: are there aspects of the region that biotech leaders might be overlooking because they're evaluating it primarily through a commercial lens?

Why this question matters now

Drug development has never been more scientifically sophisticated or more operationally complex. Trials are more expensive. Patient enrollment remains a leading cause of delay.

Precision medicine is raising expectations for the evidence needed to support new therapies, while regulators, clinicians, and patients increasingly expect that evidence to reflect the populations who will ultimately receive them.

That expectation is becoming more relevant in the United States. Today, about one in five Americans and one in four U.S. children are Hispanic. As those younger generations age, the patients who receive new therapies will become increasingly diverse.

Earlier this year, I wrote about why the underrepresentation of Hispanic patients in U.S. clinical trials affects more than diversity. It influences the generalizability of evidence, commercial forecasting, and ultimately patient care.

Writing that article left me with a different question.

If future patient populations are changing, should we also reconsider how and where we generate clinical evidence?

To be clear, improving Hispanic participation in U.S. clinical trials remains essential. Nothing in this article argues otherwise.

The question is whether geography might also be one part of a broader evidence-generation strategy.

Latin America is not one scientific ecosystem

One of the biggest mistakes is treating Latin America as a single scientific landscape.

That's a little like evaluating U.S. biotechnology without distinguishing between Boston, San Diego, and Research Triangle Park. Scientific capability isn't distributed evenly across regions; it clusters in ecosystems. Latin America is no different. Research activity and clinical expertise are concentrated in hubs such as São Paulo-Campinas, Mexico City, Buenos Aires, Santiago, and Bogotá, each with different institutional strengths, research capabilities, and clinical experience.

Nature Index data for 2023 puts some shape around this: Brazil leads the region in scientific output, followed by Mexico, Argentina, Chile, and Colombia. Nature Index is not a measure of biotech investment or commercial strength; it tracks contributions to a selected group of high-impact journals. But that limitation is also the point. Even when looking at only one narrow indicator of scientific activity, the region is not a blank slate.

Development decisions are not made at the level of “Latin America.” They are made country by country, institution by institution, investigator by investigator.

Treating the region as a single opportunity, or a single risk, misses the distinction entirely.

Clinical Research Capacity Is Stronger Than Many Assume

Another persistent assumption is that Latin America lacks sophisticated clinical research capability. That assumption is too broad.

In practice, several countries have participated extensively in multinational trials across oncology, immunology, infectious diseases, cardiovascular diseases, and rare diseases. In some therapeutic areas, sponsors are not starting from zero. They are working with investigators and institutions that have years of experience with global protocols, CROs, ethics review, data quality expectations, and regulatory requirements.

That does not mean capacity is uniform. It is not. Site readiness, timelines, infrastructure, recruitment performance, and post-trial access considerations vary widely across countries and institutions.

But variability is not the same as absence.

The region also has a broader scientific base. UNESCO data, reported by the World Bank, show that Latin America still trails higher-income regions in researchers per million inhabitants. At the same time, the region has an established base of trained scientific personnel, with universities producing more than 80% of its scientific publications while training the next generation of researchers.

That matters because clinical research capacity is not only about whether a country can enroll patients into a trial today. It is also about whether the scientific, institutional, and human infrastructure exists to support more complex research over time.

Regulatory Assumptions Need Updating

Regulatory variability remains one of the real challenges in Latin America. Approval timelines, documentation requirements, ethics review processes, and implementation can differ substantially by country.

But some of the assumptions sponsors carry about the region are increasingly dated.

Mexico recently announced regulatory reforms intended to simplify aspects of the clinical research approval process, including digital submission pathways and a digital single-window platform for selected regulatory procedures. While it is too early to assess their long-term impact, these changes suggest an effort to modernize parts of the country's clinical research ecosystem.

Uruguay is also strengthening its life sciences ecosystem through research institutions, biotech companies, and public-private innovation efforts, with Uruguay XXI describing biotechnology as an emerging sector attracting increasing investment interest.

Brazil has also introduced significant reforms to its clinical research framework, including a new Clinical Research Law and updated ANVISA regulations designed to modernize clinical trial oversight, expand the use of regulatory reliance, and improve review efficiency.

None of this makes the region low-risk.

It does make it harder to rely on old assumptions about slow approvals, limited infrastructure, or weak research capacity without asking whether those assumptions still apply in a specific country, institution, or therapeutic area.

Capacity is built, not assumed

Countries that are consistently selected for multinational trials did not get there by accident.

They built regulatory systems, investigator networks, ethics review capacity, digital infrastructure, and operating models that sponsors could trust. That work required coordination across government, academia, healthcare institutions, CROs, industry, and patient organizations.

Countries that remain outside routine sponsor consideration will need to build that same foundation if they want to participate more fully in global clinical research.

That responsibility does not rest with governments alone. Sponsors influence which ecosystems develop. CROs influence where operational muscle gets built. Academic institutions influence the quality of the investigator base. Patient organizations influence whether research is trusted, understood, and accessible.

Seen that way, strengthening clinical research capacity is not only about attracting more trials. It is about building more durable scientific and healthcare systems over time.

A Different Lens on Evidence Generation

To be clear, this is not an argument for replacing established clinical trial regions with Latin America. For many programs, other regions may remain better suited for speed, operational predictability, and recruitment efficiency.

The point is different.

If clinical development increasingly requires evidence that reflects the patients who will ultimately receive a therapy, then the question is not only: Where can we run this efficiently? It is also: Where can we generate evidence that is both rigorous and relevant to the patients we hope to serve?

Those priorities are not the same. But they do not have to be in conflict. And some parts of LATAM may be the answer.

The Lens Depends on the Sponsor

Not every sponsor is asking the same question.

A venture-backed biotech running its first global study may reasonably be asking: where can we finish this trial before we run out of cash?

Large pharmaceutical companies, with broader infrastructure and larger portfolios, often have more room to optimize across scientific, regulatory, and commercial objectives simultaneously.

Those priorities are not the same. But they do not have to be in conflict. The question is whether selected countries, institutions, and investigator networks in Latin America can help sponsors achieve both.

For some programs, established trial regions may remain better suited for speed, operational predictability, and recruitment efficiency. For others, selected countries and investigator networks in Latin America may help generate evidence that is both rigorous and more relevant to future patient populations.

The question is not whether Latin America should replace established clinical trial regions.

The question is whether parts of Latin America deserve a more precise role in evidence-generation strategy.

The question I'm left with

I do not think the data says Latin America is the answer.

I think it says the old framework of using commercial priority as a proxy for scientific and clinical relevance may be too blunt.

For decades, global development has been optimized around speed, cost, and execution. Those priorities are not going away. They should not. A trial that cannot enroll, execute, or meet regulatory expectations does not become more valuable because it is geographically inclusive.

But as patient populations diversify and precision medicine advances, the better question may no longer be only where we can run a trial most efficiently.

It may also be where we can generate the strongest evidence for the patients we hope to serve while still running the study well.

That answer will not be regional. It will be country-specific, institution-specific, investigator-specific, and program-specific.

Which means Latin America should not be treated as a shortcut, a symbol, or a single strategy.

It should be evaluated with more precision than that.

I'd love to hear how others in Clinical Development, Medical Affairs, Regulatory Affairs, and R&D are thinking about this. Is your organization revisiting its assumptions about where evidence gets generated, or are the traditional frameworks still serving you well?

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