Unlocking Brazil’s Clinical Trial Opportunity: A Strategic Roadmap for Healthcare Leaders

Clinical trials are essential for validating the safety, efficacy, and optimal dosing of new drugs, serving as a crucial step in bringing innovative therapies to market. Despite their critical role, clinical trials are inherently complex, lengthy, and resource-intensive processes. On average, developing a new drug takes more than a decade and costs over USD 2 billion per successfully approved medication. Moreover, the success rates from Phase I trials to regulatory approval typically range from only 5% to 15%, highlighting the significant challenges and risks involved in pharmaceutical research and development (R&D).

The global clinical research market currently exceeds USD 70 billion annually and is poised for continued growth. This growth is driven largely by increasing complexity and specialization within drug development. As the availability of straightforward, widely applicable drug targets diminishes, pharmaceutical companies are focusing on breakthrough innovations and advanced therapeutic approaches, such as gene and cell therapies. These cuttingedge therapies often target complex conditions and rare diseases, requiring sophisticated technologies and methodologies. Additionally, the specific and narrow patient populations associated with these advanced treatments make patient recruitment more challenging and extend trial timelines. Heightened regulatory scrutiny and increasingly intricate trial designs further contribute to escalating costs and longer development durations.

As the cost of drug development continues to rise, global pharmaceutical companies are increasingly seeking more cost-efficient markets for clinical trials. Brazilian healthcare institutions are well-positioned to capitalize on this shift by identifying and activating their distinct capabilities to gain relevance in the expanding clinical research industry.

Brazil’s untapped potential in clinical trials

Brazil participates in approximately 300 clinical trials annually, representing only about 2% of global clinical trial activity (Figure 1). Most trials conducted in Brazil are multinational and concentrated in late-stage development phases (Phase III and IV), primarily focusing on therapeutic areas of high relevance such as oncology and infectious diseases (Figure 2).

Brazil presents unique competitive advantages that position it strongly for increased participation in global clinical trials:

• Rich genetic diversity: Brazil’s population has been shaped by centuries of immigration, resulting in a rich blend of Indigenous, African, European, and Asian ancestries. This genetic diversity creates a highly heterogeneous population, making Brazil an exceptionally valuable setting for clinical research. Distinct disease patterns, such as a high prevalence of hypertension (approximately 45% of adults), underline the country’s suitability for cardiovascular trials. Additionally, the significant incidence of obesity, affecting about 30% of adults—nearly double the global average—emphasizes Brazil’s potential for metabolic and endocrine research. These distinct health profiles, influenced by genetics and lifestyle, position Brazil as an essential hub for trials with global applicability.
• Cost-effective trial operations: Brazil offers a substantial cost advantage for clinical trials compared to leading markets such as the U.S., U.K., and Germany. Particularly in oncology—the most heavily funded therapeutic area globally—trial costs in Brazil are approximately 65% lower than in the United States, making the country strategically valuable for pharmaceutical sponsors. Combined with a highly skilled medical workforce and centralized infrastructure, Brazil provides an attractive balance between quality and cost efficiency, enabling sponsors to optimize their investment returns without compromising trial quality (Figure 3).
• Highly skilled labor: Over the past two decades, the number of physicians in Brazil has grown at an annual rate of roughly 4%. Increased accessibility to medical education programs and greater availability of financial support have broadened entry into medical professions, resulting in a larger and more diverse pool of medical talent. Concurrently, residency entrance exams have become more selective, ensuring a highly qualified and skilled medical workforce capable of meeting rigorous international standards required for clinical trial execution.
• Regulatory framework advancements: Recent regulatory developments, especially Law #14.874/2024, have significantly streamlined ethical approval processes in Brazil, greatly reducing trial initiation timelines. The decentralization of ethical approval to local committees within healthcare institutions represents a substantial improvement over the historically centralized and cumbersome processes. Additional anticipated reforms regarding medication provision for trial participants are expected to further increase Brazil’s attractiveness to global pharmaceutical companies. These regulatory enhancements set the stage for accelerated growth and heightened international competitiveness in Brazil’s clinical trial sector.

Local healthcare institutions can accelerate clinical trials in Brazil

As global sponsors increasingly seek cost-effective, high-quality clinical research environments, local healthcare institutions in Brazil are in a strong position to lead. Their proximity to patients, integration within care delivery, and reputation among physicians give them a strategic edge in clinical trial execution. Yet, to fully capture this opportunity, institutions must evolve from passive research participants to proactive research enablers.

Clinical trial activities are often performed by a range of players (Figure 4). Trial sponsors oversee the overall trial and may handle high-level functions such as regulatory submissions and site selection, but often outsource day-to-day management to CROs, who typically manage the operations, ensuring compliance, and conducting site monitoring and coordination to keep the trial running smoothly. Clinical Trial Site Operators (e.g., Site Management Organizations - SMOs, Integrated Research Organizations - IROs), are contracted by CROs or sponsors to manage individual sites or networks. Clinical Trial Sites are usually owned or managed within a network, with operations tailored to the therapeutic expertise of their principal investigators.

Brazilian institutions primarily operate as clinical research sites, delivering trial services such as patient recruitment, treatment administration, and follow-up. Some have expanded into broader roles akin to Contract Research Organizations (CROs), though differentiation against global CROs remains limited. However, when acting as site operators, Brazilian institutions can offer distinctive advantages across the clinical trial value chain.

Participating in clinical trials as research sites creates substantial upside for local healthcare organizations:

• Revenue diversification through monetizing research infrastructure and patient access.
• Enhanced outcomes by providing patients access to advanced treatments before commercial availability.
• Institutional visibility as research-active centers attract both talent and partnership interest.
• Reduced costs by leveraging investigational drugs to offset treatment expenses.

Despite these advantages, Brazil’s research landscape remains fragmented (Figure 5). Around 50% of trials are concentrated in reference private hospitals, with the remainder split across academic centers, medical practices, and dedicated clinical trial centers. This fragmentation leads to inefficiencies, variability in quality, and lower sponsor confidence. 

In contrast, the clinical research landscape in the United States is shifting toward consolidated site networks, replacing traditional individual site models. Scaled site operators provide greater efficiency, centralized trial management, enhanced patient recruitment capabilities, and strengthened relationships with sponsors, positioning themselves as preferred partners. This shift toward consolidation, often driven by private equity investments, is a potential strategic direction for Brazil, where scalability could become a significant competitive advantage.

Brazil has a window to adopt this model and reshape its research infrastructure. Institutions that lead this transformation will not only capture greater sponsor interest but also shape the standards for Brazil’s clinical research future.

Winning in Brazil’s clinical research surge requires sharp choices

Brazilian healthcare institutions interested in scaling their participation in clinical research must make deliberate, strategic choices. A clear roadmap can help guide their evolution from isolated sites into integrated research leaders:

1. Define your positioning: Make deliberate choices about the institution’s role in the clinical research ecosystem (Figure 6). Should it focus solely on site operations, evolve into a networked research center, or develop into a full-service clinical trial partner? This decision should be guided by where the institution can generate the most value based on patient access, infrastructure readiness, and alignment with priority therapeutic areas.
2. Design your partnership model: Success in clinical trials depends on building relationships with CROs, sponsors, and peer institutions. Healthcare leaders should define which activities to retain in-house (e.g., recruitment, patient care) and where to partner (e.g., regulatory submissions, data management). Long-term collaborations, exclusivity arrangements, or shared infrastructure models can help improve sponsor confidence and drive trial volume.
3. Build to scale: Configure operations to support scalability and professionalization. This includes investing in infrastructure, standardizing processes across sites (if operating a network), enhancing governance, and tracking performance through defined KPIs. Institutions should also consider the potential of consolidation – either growing their own networks or joining larger site operators to increase competitiveness.

The institutions that take clear, structured steps now—by defining their role, establishing the right partnerships, and scaling effectively—will shape the next phase of Brazil’s clinical research ecosystem. Those who lead will not only capture market growth but also help position Brazil as a global reference in clinical trials.

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