Mexico’s clinical research sector is quietly becoming one of the most attractive destinations for global pharmaceutical companies. The numbers don’t lie. Mexico is the second largest clinical trial market in Latin America with a population of 130 million, whose documented genetic diversity is highly relevant for sponsors developing precision medicine and targeted therapies . The country has committed to ramping up its annual investment in clinical research from $200 million to $2 billion by 2030, a trajectory that mirrors the increasing alignment of national health priorities with global development timelines.
What makes Mexico especially interesting is the evolution of its regulation. In 2021, Mexico’s regulatory standards were aligned with international norms as the ICH group was joined by COFEPRIS. Since then the government has taken major steps to fast track the approval process for clinical trials. In March 2025, COFEPRIS issued an agreement allowing “Reliance” practices, acknowledging protocol approvals from four major international agencies: FDA, EMA, MHRA and Health Canada. This reduces duplicate reviews and speeds up trial start-up timelines. In September 2025, COFEPRIS adopted 16 ICH efficacy guidelines on trial design, safety and reporting. In November 2025 they deepened cooperation with CONBIOÉTICA to improve control of clinical trials, aligning procedures with international standards such as WHO GBT methodology and ICH Good Clinical Practice guidelines.
These regulatory improvements are already making a difference. “Mexico is always a top-five country for the highest-enrolling countries in pivotal clinical studies in oncology and other indications, with the quality of local sites and the depth of relationships built by CROs operating in the country. But there are challenges. “Currently Mexico participates in about 1% of the clinical trials performed globally, which means an economic income of around $200 million per year. Industry leaders estimate that ongoing regulatory improvements and strategic government commitment could boost Mexico’s participation by 0.5% annually, creating more than $1 billion in annual revenue within a decade.
Here are the top five clinical research organizations leading this transformation.
1. PSI CRO
In May 2026, PSI CRO made a significant advancement by opening a dedicated office in Mexico City. With more than ten years of experience working in Mexico, the office, located at Av. Insurgentes Sur 1458, Actipan, Benito Juárez, provides sponsors with direct access to a local team of multidisciplinary experts who have local expertise on the ground.
The thing that matters about PSI’s expansion is its history. “Mexico has always ranked in the top five for PSI’s key studies in oncology and other indications in terms of enrollment. This performance reflects the quality of local sites and the strength of the relationships developed over more than a decade of clinical trial work in the country.
PSI is a global full-service CRO specializing in pivotal Phase 2 and Phase 3 clinical trials in multiple therapeutic areas, including oncology, hematology, gastroenterology, immunology, infectious diseases and neuroscience. In 2025, PSI celebrated its 30th anniversary as the only fully independent and privately held mid-sized CRO, with more than 3,300 employees in 58 countries.
Partnering with a PSI CRO: Who Sponsors running complex multi-site and cross-border studies, particularly in oncology and immunology, who need predictable timelines, faster patient enrollment and reliable data quality in Latin America’s second largest clinical trial market.
Official Website: https://psi-cro.com
2. AXIS Mexico
AXIS Mexico has been supporting sponsors since 2011, conducting over 400 studies over the past decade and helping major pharmaceutical companies register products in Mexico and across Latin America.
AXIS has a different infrastructure than the others. The company has two Clinical Pharmacology Units with more than 330 beds for large bioequivalence studies. The four state-of-the-art LC-MS/MS systems provide reliable, high-quality bioanalytical data. Most notably, AXIS is the only CRO in Mexico authorized to conduct studies with controlled substances, which gives it a unique competitive advantage .
The company is recognized by COFEPRIS and ISP Chile as a trusted partner for bioequivalence and clinical research in the region. Their team of over 70 dedicated professionals bring deep expertise in clinical development and regulatory compliance, ensuring accurate results that meet global and regional standards.
Who should work with AXIS Mexico? Sponsors requiring large-scale bioequivalence studies, particularly in the generic drug space and companies needing specialized capabilities for controlled substance trials.
Official Website: https://axisclinicalsusa.com
3. Infinite Clinical Research
Infinite Clinical Research has transformed from a regulatory services provider into a global CRO over the past decade. The company was founded by Arturo Rodriguez Jacob, who has over 20 years of experience in the Mexican clinical research industry.
What makes Infinite unique is that they’re a full-service shop. They continue to grow in regulatory affairs, where they have a strong clinical operations group and their team of seasoned industry veterans have deep expertise in the field. This enables them to provide full-service support to clients in areas such as regulatory processes, clinical operations, foreign trade and pharmacovigilance .
The company’s changes are part of a larger shift in the Mexican CRO landscape. “There’s been a change in the leadership of clinical research, with younger people taking decision-making positions,” Rodriguez said. Infinite has adapted and redefined its objectives to fit this changing industry dynamic .
Who should partner with Infinite Clinical Research? Sponsors are searching for a partner with deep regulatory expertise and strong clinical operations capabilities, particularly those needing help navigating the regulatory environment in Mexico and import/export processes.
Official Website: https://weareinfinite.mx/
4. Parexel
Parexel began building clinical research infrastructure in Latin America in 2002 as part of its global network, tapping into the region’s educated workforce, improved regulatory landscape and financial resilience.
Claudia Yvette Cravioto Guzman, Sr. Director, FSP Clinical Operations, Mexico and General Manager of Business Administration, oversees the company’s operations in Mexico. Parexel has the highest retention rates in the region versus competitors, which the company says is driven by strong relationships built through close collaboration with clinical research teams, training and career development pathways.
Parexel’s success in Mexico is part of a broader Latin America strategy. The Latin America Clinical Trials market is projected to reach USD 3.23 billion by 2029, growing at a CAGR of 8.2% during the forecast period 2024-2029. Brazil had 10,000 clinical studies registered as of April 2024, with Mexico close behind at about 5,000. The company has successfully leveraged functional service provider (FSP) delivery models, thanks to Mexico’s favorable time zone proximity to the US and its growing pool of English-speaking talent.
Who should work with Parexel? Biopharma companies adopting functional service provider (FSP) delivery models need access to skilled talent, strong collaborative communication and quick project turnaround times, particularly for cross-border studies.
Official Website: https://www.parexel.com
5. Accelerated Clinical Research
Based in Mexico City’s Hipódromo neighborhood, Accelerated Clinical Research is one of the established Contract Research Organizations operating in Mexico’s clinical research landscape.
Cost-effectiveness, a large and diverse patient population and a significant number of skilled researchers are some of the reasons why Mexico is attractive for clinical research. Information about the service portfolio and therapeutic specialties of Accelerated Clinical Research is somewhat limited in the available sources; however, since the company is based in Mexico City, it is located in the heart of the country’s clinical research activity.
Who should work with Accelerated Clinical Research? Sponsors looking for an established local CRO partner with experience navigating Mexico’s clinical trial landscape and regulatory environment.
Official Website: https://acresearch.net/
Why Mexico’s CRO Sector Matters Now
Mexico’s clinical research industry is at a crossroads. The country’s unique set of advantages that make it a hub for clinical trials include geographic proximity to the United States, a population of 130 million with documented genetic diversity, experienced medical professionals, well-equipped medical facilities and cost-effectiveness.
The regulatory environment is becoming more and more favorable. COFEPRIS’ The government’s commitment to attracting clinical research investment is evidenced by its adherence to Reliance practices, adoption of ICH guidelines and intensified cooperation with CONBIOÉTICA. These reforms are in line with Plan México, a national strategy to boost competitiveness through investment in clinical research to promote scientific, economic and health development.
But there are challenges. The time to get a clinical trial approved is back to 90+ days, a competitive disadvantage after the expedited processes of the pandemic era. As Arturo Rodriguez pointed out, “Mexico already has facilities, doctors, personnel specialized in clinical research and universities to generate new resources; however, we are not competitive due to administrative and regulatory delays.”
The companies profiled here show the strength and diversity of Mexico’s CRO sector, from global leaders such as PSI and Parexel to established local players like AXIS, Infinite Clinical Research and Accelerated Clinical Research. They are working together to make Mexico a leading clinical research destination.
FAQ
What is a Contract Research Organization (CRO) and what do they do in Mexico?
A CRO provides research services to pharmaceutical, biotechnology and medical device companies on a contractual basis. CROs in Mexico provide services such as clinical trial management, regulatory affairs, data management, biostatistics, medical monitoring, pharmacovigilance and bioequivalence studies.
Why is Mexico an attractive destination for clinical trials?
Mexico offers a large and diverse patient population of 130 million, geographic proximity to the United States for efficient coordination, experienced medical professionals, well-equipped medical facilities, cost-effectiveness compared to the US and Europe and an improving regulatory environment aligned with ICH standards.
What regulatory changes have improved Mexico’s clinical trial environment?
Key reforms include Mexico joining the ICH Group in 2021, COFEPRIS implementing “Reliance” practices in March 2025 to recognize foreign regulatory approvals (FDA, EMA, MHRA and Health Canada), adoption of 16 ICH efficacy guidelines in September 2025 and strengthened collaboration with CONBIOÉTICA for protocol review and oversight.
Which CRO has the largest presence in Mexico?
PSI CRO recently opened a dedicated Mexico City office in May 2026, expanding on more than a decade of clinical trial work in the country. AXIS Mexico started operations in 2011 and has successfully completed over 400 studies. Parexel has been in Latin America since 2002.
What is the size of Mexico’s clinical research market?
Currently Mexico takes part in approximately 1% of the clinical studies conducted worldwide, which represents an economic influx of about $200 million dollars per year. The government has promised to increase investment to $2 billion by 2030. The clinical trials market in Latin America is expected to grow at a compound annual growth rate (CAGR) of 8.4% to reach a value of $3.23 billion by the year 2029.
What makes AXIS Mexico unique among CROs in Mexico?
AXIS Mexico is the only CRO in Mexico authorized to perform studies with controlled substances. They have two Clinical Pharmacology Units with more than 330 beds for bioequivalence studies and have conducted more than 400 studies in the past decade.
What are the main challenges facing clinical research in Mexico?
Key challenges include regulatory approval times that have returned to 90 days or more after pandemic-era expedited processes, the need for greater systematization of processes and competition from other clinical trial destinations. Mexico participates in only 1% of global studies despite having strong fundamentals.
Which therapeutic areas see the most clinical research in Mexico?
“Mexico has strong capabilities in a range of therapeutic areas such as oncology, infectious disease, gastroenterology, immunology, neurology and rare diseases. The country has been one of the five highest-enrolling countries in key oncology studies.
How are public hospitals involved in clinical research in Mexico?
Most clinical trials now take place in private hospitals where procedures are more streamlined and authorization is quicker. Public hospitals such as IMSS have long legal processes and complex structures that sometimes prevent them from receiving payments from private parties for protocol services.
What is the outlook for Mexico’s CRO market?
The outlook is promising. Mexico is poised for strong growth due to regulatory reforms, government commitment through Plan Mexico and the country’s inherent advantages. With steady 0.5% annual growth in global study participation, industry leaders estimate that Mexico could produce upwards of $1 billion in annual clinical research revenue within a decade.
