Read the Conversation
Conversation highlights:
- Generational Transformation Driving Professionalization: Family-owned laboratories are evolving into more structured, professionally managed organizations with stronger governance, reinvestment, and long-term vision.
- From Domestic Focus to Global Expansion: Mexican laboratories are actively pursuing international markets, strengthening regional integration, and positioning themselves within the North American supply chain.
- Supply Chain Resilience and API Integration: Reinforcing domestic production, API capabilities, and nearshoring strategies has become central to competitiveness and strategic autonomy.
- Digitalization and AI as Competitive Imperatives: Laboratories are advancing structured digital transformation initiatives to enhance regulatory processes, commercial forecasting, operations, and supply chain efficiency.
- Regulatory Modernization as a Strategic Priority: Stronger dialogue with authorities and the digital transformation of regulatory agencies are essential to accelerating access, improving standardization, and sustaining industry growth.
EF: What two great achievements do you think the Life Science ecosystem achieved in Mexico in the last ten years, and what one thing do you think we should accomplish in the next four years?
JV: Over the past decade, Mexico’s life sciences ecosystem has evolved more than in previous generations. A key driver has been the generational transition in family-owned laboratories. Many have moved to professional leadership, becoming more sophisticated in administration, strategic vision, equipment, and reinvestment. This shift has reinforced governance and long-term strategy.
Another major change is a more outward-looking perspective. For years, the industry was focused mainly on the domestic market. The COVID-19 pandemic exposed the need for stronger supply chain resilience, greater API production in Mexico, and deeper North American integration. Laboratories are now exploring international markets more actively and working to integrate products produced across the region.
Digital transformation is also reshaping the sector. Several companies are advancing significant AI initiatives to make product development more predictable across commercial, operational, and supply chain areas, helping them anticipate where the market is heading.
Looking ahead, a crucial factor is the constructive dialogue with the government at all levels. We have built a solid relationship with COFEPRIS and other authorities, who recognize that the health sector is a shared responsibility with those who produce and distribute medicines. This engagement, combined with the agency’s own digital transformation, is key to resolving backlogs and improving regulatory predictability.
In the coming years, consolidation through mergers and acquisitions is likely to accelerate. Generational change, regulatory complexity, and strategic expansion will demand adaptation. With a clear direction, that adaptation becomes easier, and clarity, alignment, and sustained collaboration will shape the industry’s next phase.
EF: As Mexican laboratories reinvest and expand internationally, how can the industry strengthen its integration within North America and turn current momentum into long-term competitiveness?
JV: We must carefully assess current developments while keeping a long-term perspective. It is unwise to react to every episode of uncertainty around trade or tariffs, especially when building new production capacity abroad takes years. Mexico should instead deepen its role as a complementary partner within North America.
The United States has increasingly focused on patented, highly sophisticated medicines, leaving space for generics and biosimilars. This opens a clear opportunity for regional integration: importing selected APIs from the US or Canada, producing finished products in Mexico, and reintegrating them into the North American market.
Through AMELAF, we support laboratories in moving beyond manufacturing excellence toward international commercialization. Many companies know how to produce medicines, but few have experience navigating foreign regulatory frameworks and forging strategic partnerships. Here, coordination is essential.
International players are clearly interested in sourcing competitive molecules from Mexico. Despite tight pricing in generics, Mexican laboratories remain highly competitive. The opportunity is real. It will require time, discipline, and deeper regional integration, but by moving in that direction, Mexico can consolidate its position as a reliable pharmaceutical hub for North America.
EF: How do you advise your members to adapt to digitization? What is the appetite and the reception of local laboratories to engage in digitization?
JV: We are approaching digitization in a structured way. Within AMELAF, we have created a dedicated group focused on digitalization and are working with an external technology company to identify practical opportunities for Mexican laboratories. Their experience in large-scale digital and cybersecurity systems gives us a solid foundation, but our focus is specific: what works for local, family-owned companies is not the same as what works for big pharma.
We are defining a core set of AI tools that can serve as a common starting point. From there, each laboratory can develop what best fits its needs. One of the clearest opportunities is in commercial decision-making, where many choices are still based on partial information and individual judgment. With AI, companies can better anticipate market behavior and improve planning across operations and the supply chain.
In parallel, we are coordinating with government authorities, particularly on regulatory issues and the supply of medicines to the public sector. Digitization cannot advance in isolation; it must be aligned with regulatory processes, which is why sustained dialogue with COFEPRIS is essential.
A major challenge is creating effective communication between IT teams and regulatory affairs professionals. Technology alone is not enough. The quality of the information feeding these systems is critical: weak inputs produce weak outputs. This is about strengthening validation processes and securing reliable data.
There is also a generational dimension. Younger leaders are more open to these initiatives and understand the need to adapt. Some older generations are more cautious, but the direction of change is clear. Transformation will move quickly, and laboratories must be present and aware of the scale of the challenge.
If we succeed in building a workable model in Mexico, it can be replicated across Latin America. Whether a laboratory has thousands of employees or only a few hundred, the core challenge is the same: adapting to a new digital environment without losing operational discipline.
EF: Do you have anything else you would like to add that was not asked?
JV: When I began at AMELAF, I understood that regulatory matters were important. Every year, I realize they are even more important. Regulatory agencies play a dual role. First, they protect the safety and health of the population. Second, they can accelerate access to new medicines, including advanced therapies and biosimilars that are far more effective than older products. For companies, regulatory approvals represent a significant investment and one of the most complex parts of the business.
COFEPRIS must continue improving its systems, strengthening digitalization, and expanding cooperation and mutual recognition with other agencies. Greater standardization and global alignment are essential in a globalized industry.
The larger challenge is that many decision-makers do not fully understand the strategic importance of regulatory agencies. Their work is highly technical, and that makes it difficult to communicate its real impact to political leaders who allocate budgets and shape policy. If the role of regulators were better understood, they would likely receive more resources and institutional support.
For Mexico to strengthen its pharmaceutical ecosystem, regulatory capacity must be seen not as a bureaucratic function, but as a pillar of national development, competitiveness, and public health.
