Reckoning with a new pharma landscape: the CPHI Americas Roundtable Round-Up

As part of our CPHI Americas conference sessions, we held a closed roundtable bringing together top pharmaceutical industry experts and thought leaders to discuss the most pertinent issues and trends surrounding the whole of the American pharmaceutical value chain. Our discussion spanned such topics as AI and its regulatory landscape in pharma, outsourcing trends and challenges, and the market potential of Latin America, diving deep into a stimulating exchange of ideas and perspectives.

CPHI Americas, held May 21-23 2025 at the Pennsylvania Convention Center in Philadelphia, US, brought together pharmaceutical professionals and experts from across the supply chain for 3 days of collaboration and innovation. Not only was this the show’s first time trading under its new name to fully encompass the whole of the Americas region, this year was also the first year to host a closed roundtable of pharmaceutical thought leaders for a safe and conducive environment to exchange new perspectives, challenges, and potential solutions.

Mapping the pharma battleground

The climate in Philadelphia was charged not only with bouts of rain, but also with the looming uncertainty surrounding the US administration’s stance on trade disputes, including the pharmaceutical industry.

Participants expressed uncertainty regarding tariffs and questioned whether US manufacturing could maintain necessary efficiency and performance standards. Industry leaders warned that regulatory uncertainties and funding challenges might drive pharmaceutical innovation overseas, particularly to China, despite the fact that few Chinese-approved bioproducts have received FDA approval. While drug discovery advances rapidly through AI applications, clinical development remains a significant bottleneck, with experts emphasising the need for accelerated processes that keep patients central.

During the conference, the Trump administration issued an executive order directing HHS to align US pharmaceutical pricing with the lowest prices in OECD countries for brand products without generic competitors, prompting fears about reduced innovation investment. The roundtable experts concluded that domestic manufacturing remains viable only if costs can be effectively managed, noting that while large pharmaceutical companies can absorb increased costs, smaller biotechs and generic manufacturers would be disproportionately affected by reshoring efforts. They specifically highlighted that commodity generic manufacturing would be particularly difficult to relocate to America given the sector's cost structures and current supply chain.

Latin America taking centre-stage

Industry experts noted that the LATAM region, while growing rapidly, faces substantial hurdles in developing efficient systems for innovative pharmaceutical products, with concerns that such infrastructure might remain unavailable for at least 5 years due to prohibitive costs.

The Latin American pharmaceutical market shows varying therapeutic focus areas by country. Mexico demonstrates high demand for oncological products, yet insulin and GLP-1 medications like semaglutide dominate sales. Despite significant need, approximately 60-70% of cancer patients across Latin America lack treatment access due to government constraints and budget cuts. From a country-by-country top-down overview, Mexico's health budget was reduced by half between 2018 and 2024, severely limiting treatment capacity.

Argentina has also emerged as a regional manufacturing leader with stronger production capabilities through companies like Chemo and MapScience, while most Latin American countries struggle with limited domestic capacity. This creates a situation where companies must choose between investing in government supply contracts or focusing on exports to more profitable markets like the United States.

Regulatory challenges further complicate the landscape, with Mexico's drug regulator COFEPRIS implementing stricter requirements for comparability studies. This threatens the registration status of approximately 90% of currently approved products, as many manufacturers have not invested in improving their documentation despite generating billions in revenue. Latin American innovation faces persistent obstacles in knowledge transfer and quality control despite having companies capable of producing both biosimilars and generics.

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To read the full report and explore other topics such as harmonising AI regulations in pharma and how partnerships are developing regionally and abroad, download the full report here or below.