The radiopharmaceutical industry stands at a critical inflection point. Radioligand Therapy (RLT), a groundbreaking approach to cancer treatment that combines targeted radiation with precision medicine, represents a $6.8 billion market projected to reach $14 billion by 2034. Yet despite this explosive growth potential and validated commercial success stories like Novartis's blockbuster Pluvicto® and Lutathera®, the industry faces a paradoxical crisis: severe infrastructure bottlenecks are constraining patient access and stifling innovation at the very moment when scientific breakthroughs are accelerating.
This infrastructure crisis creates a unique challenge for medical device companies. While RLTs are regulated as drugs by the FDA, they require medical device-like infrastructure, including specialized imaging equipment, lead-lined facilities, and sophisticated radiation detection systems. The convergence of pharmaceutical and medical device requirements has created unprecedented operational complexity that traditional clinical trial destinations struggle to accommodate.
Enter Latin America—a region that has quietly positioned itself as an unexpected solution to these challenges. Through a combination of streamlined regulatory frameworks, established nuclear medicine infrastructure, and cost-effective operations, countries like Brazil, Mexico, and Colombia are emerging as strategic destinations for RLT clinical trials. This transformation offers medical device companies a pathway to overcome the infrastructure constraints plaguing the industry while accelerating development timelines and reducing costs.
The rapid growth of the RLT sector has exposed fundamental infrastructure limitations that threaten to derail the industry's momentum. Currently, there are 121 active RLT clinical trials globally, with 68 companies developing radioligand therapies. However, this surge in development activity has collided with a severely constrained clinical infrastructure, creating what industry experts call the "Infrastructure Paradox".
The challenges begin with site activation, where the timeline for bringing a clinical site online for RLT trials can stretch to 4-6 months or longer. Unlike traditional oncology trials, RLT sites must navigate a complex web of requirements:
Licensing Complexity: Sites must obtain radioactive materials licenses from nuclear regulatory bodies, a process that varies significantly by isotope. For alpha-emitting isotopes like Actinium-225, trace impurities can trigger requirements for Decommissioning Financial Assurance—a substantial financial liability that many institutions are unwilling to assume.
Infrastructure Requirements: RLT trials demand specialized facilities including:
Personnel Shortages: Each site requires a multidisciplinary team including Authorized User physicians, medical physicists, radiopharmacists, and specialized nuclear medicine technologists. The demand for these professionals now exceeds supply by a factor of 5:1 for senior positions.
The physics of radioactive decay imposes brutal constraints on the entire clinical operation. With half-lives measured in hours or days, RLT products are "melting ice cubes" that must be manufactured, quality tested, shipped, and administered within extremely tight timeframes. This creates cascading challenges:
In the United States, estimates suggest only 70-280 specialized centers are equipped to handle RLT trials. This severe shortage creates:
While the industry grapples with these constraints in traditional markets, Latin America has emerged as a compelling alternative. The region combines several unique advantages that directly address the infrastructure challenges plaguing RLT development.
Latin American countries have implemented groundbreaking regulatory reforms that dramatically accelerate clinical trial timelines:
Brazil's Transformation: Law 14.874/24 and RDC 837/2023 have revolutionized Brazil's clinical trial landscape. Approval timelines for RLT trials now range from 60-90 days, compared to 180-270 days in other regions. The law eliminates duplicate ethics reviews and creates clear pathways for international sponsors.
Regional Harmonization: Countries across Latin America are adopting harmonized approaches to radiopharmaceutical regulation, reducing complexity for multi-country trials. Colombia has streamlined its approval process to 90-120 days, while Mexico maintains predictable 120-150 day timelines.
Contrary to common perceptions, Latin America possesses robust nuclear medicine capabilities that rival many developed markets:
Imaging Infrastructure:
Professional Expertise: The region has a well-developed nuclear medicine specialty with thousands of trained professionals. Brazil alone has over 3,000 board-certified nuclear medicine physicians, while Mexico and Argentina maintain strong training programs producing qualified specialists annually.
Financial considerations make Latin America particularly attractive for RLT trials:
Operational Savings: Clinical trial costs in Latin America are typically 25-35% lower than in the United States or Europe. For RLT trials, these savings are amplified by:
Faster Recruitment: Latin American sites typically achieve patient recruitment 15-20% faster than North American sites, with retention rates 10-15% above global averages. For RLT trials where timing is critical, this acceleration provides substantial value.
Latin America's location offers unique benefits for RLT clinical operations:
Proximity to US Markets: Direct flights connect major Latin American cities to US radiopharmaceutical production hubs. São Paulo to Miami requires only 8-9 hours, enabling same-day delivery of time-sensitive radiopharmaceuticals.
Time Zone Alignment: Similar time zones facilitate real-time coordination between sponsors, production facilities, and clinical sites—critical for managing the tight timelines imposed by radioactive decay.
Brazil leads Latin America in RLT trial readiness:
Regulatory Framework:
Infrastructure Advantages:
Success Stories: Instituto de Pesquisas Energéticas e Nucleares (IPEN) in São Paulo has conducted multiple successful RLT trials, demonstrating the country's capabilities in managing complex radiopharmaceutical studies.
Mexico offers unique advantages for US-based sponsors:
Strategic Location: Border proximity enables efficient radiopharmaceutical logistics
Regulatory Efficiency: COFEPRIS has established specific pathways for radiopharmaceutical trials
Infrastructure:
Colombia is rapidly developing its RLT capabilities:
Regulatory Innovation: INVIMA has implemented expedited review processes for innovative therapies
Infrastructure Growth: Recent investments in nuclear medicine facilities in Bogotá and Medellín
Cost Advantages: Among the most cost-effective locations in Latin America while maintaining international quality standards
Argentina combines strong scientific expertise with practical advantages:
Research Excellence: Home to internationally recognized nuclear medicine research centers
Regulatory Experience: ANMAT has extensive experience with radiopharmaceutical trials
Infrastructure: Well-developed nuclear medicine capabilities, particularly in Buenos Aires
Latin American countries have developed sophisticated approaches to managing the unique logistics of RLT trials:
Import/Export Efficiency: Streamlined customs processes for radioactive materials, with dedicated lanes for time-sensitive shipments. Brazil's ANVISA has established 24-hour clearance protocols for clinical trial radiopharmaceuticals.
Regional Production Networks: Strategic partnerships between local radiopharmacies and international CDMOs ensure reliable supply chains. Countries like Brazil and Mexico maintain GMP-certified facilities capable of final product preparation and quality control.
Latin American sites demonstrate strong compliance with international standards:
GCP Adherence: Consistent track record of meeting FDA and EMA inspection standards
Radiation Safety: Comprehensive radiation protection programs meeting or exceeding international guidelines
Data Quality: Electronic data capture systems and centralized monitoring ensure high-quality data generation
Forward-thinking sponsors are establishing long-term partnerships in Latin America:
Hub-and-Spoke Models: Major centers in São Paulo, Mexico City, and Buenos Aires serve as hubs, with satellite sites extending geographic reach
Training Programs: Investment in site personnel development ensures sustainable expertise
Technology Integration: Implementation of remote monitoring and digital health tools optimizes trial efficiency
Prioritize Established Centers: Begin with sites that have existing nuclear medicine infrastructure and RLT experience. Leading institutions include:
Evaluate Regional Capabilities: Consider multi-country approaches to leverage each nation's strengths while diversifying risk.
Early Engagement: Initiate regulatory discussions 6-12 months before trial initiation
Harmonized Protocols: Design protocols that meet both local and FDA/EMA requirements
Local Expertise: Partner with regulatory consultants familiar with radiopharmaceutical requirements
Integrated Service Providers: Select CROs with specific RLT experience in Latin America
Academic Collaborations: Leverage relationships with leading research institutions
Government Support: Explore incentive programs for clinical research investment
Diversified Supply Chains: Establish multiple isotope supply routes to ensure reliability
Contingency Planning: Develop protocols for managing weather, logistics, or regulatory delays
Insurance Considerations: Ensure comprehensive coverage for radiopharmaceutical-specific risks
Artificial Intelligence Integration: Latin American sites are adopting AI-powered imaging analysis and dosimetry calculations, enhancing trial efficiency and data quality.
Expanded Isotope Capabilities: Investment in new cyclotrons and production facilities will support next-generation alpha-emitting isotopes.
Regional Clinical Networks: Collaborative networks between countries are streamlining multi-national trial execution.
Government Initiatives: Countries are recognizing clinical trials as economic drivers, implementing supportive policies and infrastructure investments.
Private Sector Growth: International CDMOs and CROs are establishing regional presence, building dedicated RLT capabilities.
Academic Partnerships: Universities are expanding nuclear medicine training programs to address workforce needs.
The convergence of RLT's explosive growth with severe infrastructure constraints in traditional markets has created a strategic imperative for geographic diversification. Latin America's unique combination of streamlined regulations, established nuclear medicine infrastructure, cost-effectiveness, and operational excellence positions the region as an ideal solution to the industry's most pressing challenges.
For medical device companies navigating the complex landscape of RLT development, Latin America offers more than just an alternative—it provides a competitive advantage. The region's capabilities enable faster trial execution, broader patient access, and reduced operational complexity while maintaining the highest quality standards.
As the RLT market continues its trajectory toward $14 billion by 2034, success will belong to companies that recognize and leverage Latin America's strategic advantages. The infrastructure crisis that constrains the industry in traditional markets becomes an opportunity for those willing to embrace new geographic strategies.
The question is no longer whether to consider Latin America for RLT trials, but how quickly companies can establish their presence in this rapidly evolving landscape. With regulatory frameworks in place, infrastructure ready, and expertise available, Latin America stands ready to accelerate the next generation of radioligand therapies from concept to clinic to commercial success.
For more information about conducting RLT clinical trials in Latin America, visit bioaccess or contact our team of regional experts who can guide you through the strategic planning and execution of your radiopharmaceutical development program.