Mexico has long been considered a relatively appealing destination for clinical trials and, in recent years, has participated in more than one percent of global drug development research, generating an economic outflow of over 240 million dollars per annum in the process. Indeed, most of the major biopharma multinationals now lay claim to well-established in-country clinical trial footprints and continue to invest vigorously into this space.
“Over the past decade, Johnson & Johnson’s involvement in clinical trials within Mexico has risen markedly, with increased resources allocated year on year,” confirms Jorge Luis Caridad, the company’s managing director for Innovative Medicine who notes that his organization has, “over the previous five-year period, enrolled well over 2,000 local patients suffering from life-threatening conditions ranging from cancers and multiple myeloma to rare diseases.”
For many market insiders, Mexico’s primary asset as a host for clinical trials relates to the sheer size and breadth of its patient pool. “With its 130 million-strong population, epidemiological profile, and evolving demographics, Mexico presents a wide sweep of health conditions creating fertile conditions for improving the applicability of trial outcomes,” explains Arturo Rodriguez Jacob, founder and CEO of the CRO, Infinite Clinical Research.
“Scientifically, this country benefits from an incredible diversity of genetics, with unique populations such as the Mennonites in the north and indigenous groups in Oaxaca and Jalisco, offering valuable insights into rare diseases,” elaborates Nicolas Linares, general manager for Mexico and Central America at Ultragenyx Pharmaceutical, a biotech dedicated to the discovery and development of therapies for ultra-rare disease.
This is particularly opportune at a moment when precision medicine is increasingly in vogue and treatments are becoming ever more personalized and tailored to a patient’s genomic and proteomic makeup. “Historically, clinical research tended to be rather limited in scope, often focusing on a narrow demographic. However, with the emergence of biological medicines – such as advanced cell and gene therapies – innovative drug developers and regulatory bodies alike now wish to prioritize the inclusion of diverse populations in studies, incorporating data from various ethnic and genetic backgrounds which is particularly advantageous for Mexico with its rich ethno-cultural heritage,” opines Cecilia Moreno, senior director at PPD™, the clinical research arm of Thermo Fisher. Little wonder, then, that Mexico has already cemented itself as something of a regional leader in oncology trials – especially immunotherapies and other targeted treatments.
Naturally, the most common trials conducted tend to be in those therapeutic areas where the country exhibits pronounced disease prevalence, notably obesity and associated categories such diabetes and cardiovascular ailments. “In global studies for key molecules in diabetes and obesity, Mexico nowadays frequently accounts for up to 40 percent of our sample and has become thoroughly invaluable for advancing that part of our drug development pipeline,” acknowledges Karla Alcazar, SVP and president for LatAm at Eli Lilly, which currently ranks as the largest single investor in clinical trials in the country.
Novo Nordisk, meanwhile, has “expended over 600 million Mexican pesos on in-country trials within a period of only three to four years,” according to VP and General Manager Valney Suzuki. Currently the company is partnering with over 30 local scientific centers on R&D projects illustrating the oversized relevance of the Mexican market to the Danish diabetes-focused specialty player, and its drug discovery operations.
Smooth Enrolment
Ease of enrolment plays a role too in the sheer pulling power of the market. “Mexicans might not possess a culture of participating in clinical trials per se, but they certainly do trust and obey their doctors who are responsible for explaining them the treatments. So long as the physician is convinced that the study has more benefits than risks, then it becomes relatively easy to invite and enlist the patient volumes that you require for a successful study,” reasons Rodriguez Jacob.
The same can be said for the country’s patient retention rates. “Once studies are underway, Mexico’s real strength lies in the perseverance and staying power of the patient cohorts. Because most Mexican patients retain such strong and enduring relationships with their physicians, their likelihood of remaining engaged throughout the duration of the trial is significantly higher than in many alternative markets,” recounts Cecilia Moreno. “With many modern-day trials now spanning multiple years, maintaining elevated levels of participant involvement starts to become a decisive factor as ultimately it impacts the validity and integrity of the data compiled,” she adds.
Meanwhile the country’s favourable population distribution also affords a certain competitive edge. “Thanks to the preponderance of major conurbations such as Distrito Federal, Queretaro, Monterrey and Guadalajara, clinical sites can speedily enrol high volumes of patients compared to clinical trial-saturated countries, where individual sites may only manage to recruit a handful of participants. This concentration of subjects enables researchers to conduct large-scale studies with fewer sites, substantially increasing efficiency and lowering cost,” notes Moreno.
Such attributes are, at the same time, bolstered by a strong supporting infrastructure and bountiful ensemble of trained investigators. “Mexico possesses robust regulatory bodies, well-structured committees, and an abundance of medical facilities staffed with experienced and educated clinicians, creating the right sort of enabling environment necessary to develop high-quality research at cost-effective price points,” observes Rodriguez Jacob. Indeed, Mexico’s regulatory framework led by COFEPRIS, a member of the International Council for Harmonization (ICH), remains well-aligned with international standards, while the country boasts world-class institutions such as the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) and the Instituto Nacional de Cancerología (INCAN) among numerous others.
Besides, it’s not only the quantity of studies that is on the rise, but also the quality and general level of sophistication. “In 2024, we conducted no fewer than 68 trials in the country, from which three comprised phase I studies,” recounts Roche Pharma General Manager Monica Palomanes. “That means that Mexico has now joined the exclusive club of countries with the human expertise and infrastructural capabilities to handle the early stages of trials and all the scientific complexity that this entails,” she explains.
Opportunity Loss
Nonetheless, some local commentators believe that Mexico has the potential to perform much better. They point out that, while the country might already rank as the second most prolific market for clinical trials within Latin America, it still manages barely half the volume of studies that rival megamarket Brazil churns out annually.
“Frankly, the untapped potential is enormous, and with the right adjustments, Mexico could easily itself into a world-renowned, global hub for clinical R&D and innovation,” argues Larry Rubin, Executive Director of the Mexican Association of Pharmaceutical Research Industries (AMIIF) representing more than 60 of the country’s research-based pharmaceutical companies. “Here, in Mexico, our members right now invest a mere USD 300 million locally in R&D annually compared to the USD 141 billion they plough into clinical research globally each year so the scope for raising the Mexican share of pie is gigantic,” he continues.
For a start, Rubin thinks Mexico should be capitalizing much more on its geographic proximity to the world’s most lucrative pharma market and trailblazer of medical innovation, the United States. “With a full 12 percent of the American population having Mexican ethnicity, understanding Mexican patients is critical for the US market. Meanwhile, Mexico’s nearness and price differential for comparative quality renders it a no-brainer for any American originator drug developer needing to conduct large-scale, multi-centre clinical trials,” he contends.
“Mexico possesses all the fundamental ingredients necessary to become a genuine international clinical trials powerhouse,” agrees Johnson and Johnson’s Jorge Luis Caridad. “However, several important challenges must first be addressed to properly unlock this potential and sharpen the market’s competitiveness,” he insists.
The first and foremost, Mexico must move to correct its sluggish approval timeframes. “While certain other Latin American countries can approve clinical trial protocols within 45 days, Mexico’s process can easily take as long as six months,” bemoans Luis Caridad. “Presently, we risk losing trial sites to markets like Argentina and Guatemala simply because our processes aren’t as agile as they need to be,” agrees Ultragenyx’s Nicolas Linares.
“The name of the game is speed. Historically, Mexico used to be fairly well-regarded in this area. However, years of tinkering around with the regulatory apparatus has introduced an element of unpredictability into the approval process that unsettles business, and in many instances has entailed significant delays to being able to start or conclude trials,” recalls Rodrigo Ruiz Mingramm, general manager Mexico & LatAm at Stendhal Pharma, which partners with foreign multinational biopharma that lack their own presence across Latin America.
“The root of the problem is not necessarily a single bottleneck, but rather the cumulative complexity and opacity of the regulatory process. For example, transitioning from a clinical trial to product approval and access remains challenging with no clear pathway for undertaking this transition. To attract in big-ticket investment on a sustained basis, drug developers are going to want to see not just prompt approval of the protocols, but much greater consistency and transparency on the part of the regulatory authorities,” he argues.
Infinite Clinical Research’s Arturo Rodriguez Jacob very much concurs. “When we talk about rendering the approval and licensing processes more efficient, it’s not about compromising on quality, but about identifying formulas that could make us more competitive as a host country. The authorities really need to start benchmarking themselves against rival markets in terms of response times and reaction speeds. This implies establishing the responsibilities of each of the participants in the process and avoiding the duplication of reviews or procedures that have already been carried out,” he advises. “A good starting point would be to differentiate between protocols that have already been approved by other regulatory agencies and give them an expedited process that would lessen the burden of the Mexican authority’s workload,” he suggests.
Rodriguez Jacob points out that, after all, something akin to this was very successfully introduced for fast-track covid-19 vaccine development during the global pandemic. “COFEPRIS created expedited pathways to complete the revision of the protocols and secure approval within just 30 days. Moreover, CROs and research sites demonstrated that they could work at this kind of tempo with very high patient densities all the while maintaining good clinical practice (GCP) and the upmost quality standards,” he recalls.
“Aside from simplifying and streamlining the approval pathway, the authorities would also do well to incorporate a clear and predictable legal framework that protects the intellectual property generated from these trials,” thinks Johnson and Johnson’s Luis Caridad. “The United States-Mexico-Canada Agreement (USMCA), known as TMEC within Mexico, provides an opportunity to reinforce these protection mechanisms for instance by including provisions that allow for the extension of patents to cover delays caused by regulatory agencies,” he adds.
Thankfully moves are already afoot to implement changes. In early 2024, COFEPRIS launched a Digital Platform for Research and Clinical Trials (Digipris), which strives to eliminate the need for in-person appointments and physical documents, innovating the regulatory process. The platform makes it possible to carry out procedures online, directly and without intermediaries.
“This is a noticeable step forward which brings Mexico’s evaluation apparatus into line with other regulatory agencies that have long embraced digitalization,” explains Cecilia Moreno. “Digipris functions as a one-stop-platform that can be used to process requests for new protocols and changes in those already authorized, as well as to review applications determine their status,” she notes.
Multiplier Effect
Enacting such reforms could potentially reap a big dividend for the national economy. According to AMIIF calculations every additional peso invested in clinical research generates some 1.67 in revenue in return. “If we can only manage to turn Mexico into internationally competitive clinical trials hub it will also create numerous jobs. For every job created in this industry, four additional jobs are generated, and the investment in clinical trials is ongoing, unlike one-time investments in manufacturing plants,” counsels Rubin.
Moreover, aside from that economic spill over, doing so could unlock substantial cascade benefits in both the public health and life science arenas. “The more the country can promote clinical research, the more opportunities open up for patients benefit from early access to novel treatments, which indirectly reduces the social burden of these patients and can lead them to back into the workforce,” reasons Francisco Chavez, VP and general manager for Latin America at Thermo Fisher Scientific.
“Meanwhile, in-country clinical trials serve to not only advance medical knowledge, but also to ensure that the very latest innovations are properly integrated into healthcare practices by enabling exposure of clinicians and physicians to the latest developments in their fields and reducing the gap between cutting-edge technology and its practical application,” he affirms.
So as to maximize these benefits, some multinational biopharma are making an explicit effort to engage more with public hospitals when conducting their in-country trials. Presently, most studies tend to be carried out in private hospitals and clinics because of the additional challenges in the implementation of the protocol when dealing with the state sector. For example, in some instances, the legal framework governing public hospitals does not allow for receiving payments for services provided in the protocol if they come from private parties,” observes Rodriguez Jacob.
Despite this, certain firms like Roche have been attempting to buck the trend. “A unique feature of our approach in Mexico is our commitment to including public hospitals in every clinical trial that we undertake,” reveals Monica Palomanes. “While it is indeed true that this is a market where the inclusion of public sites in clinical research has historically been more challenging than in other countries, we nonetheless see this commitment as an essential mechanism for spreading knowledge, elevating standards, and training a new generation of local researchers,” she asserts.
Moreover, rumours abound that a new agreement between the AMIIF and the IMSS to collaborate on trials and the gathering of real-world evidence is in the works. “If confirmed, this would mark a significant development. Gaining access to a large institution with around 50 to 60 million people for running clinical trials would be truly exceptional,” muses Oswaldo Bernal, general manager at BMS.
“Looking ahead I am quietly confident. The willingness of institutions like COFEPRIS and IMSS to collaborate and form partnerships reflects a broader trend of working together to improve patient outcomes, and by joining forces on the issue of clinical research, a healthier and more prosperous Mexico should be within our grasp,” he concludes.
