07/15/2025 | Angelica Weise

https://futurodasaude.com.br/nova-era-de-pesquisas-clinicas/ 

Attractiveness points include regulatory and professional development of research centers, support reports

Brazil meets the conditions to be signed as a relevant pole in the conduct of global clinical trials. Genetic diversity, custo-effective operations, robust hospital infrastructure and advances in regulation are among the competitive advantages that mark the new era of clinical research in Brazil, placing the country off the radar of international researchers. This is an unpublished report by L.E.K. Consulting.

The analysis is supported by the fact that clinical research is mapped in the country: about 2% of the two global clinical trials conducted around the world involve Brazilian centers - about 300 per year. In the last five years (2019-2024), the majority (72%) of these multinational researches have been concentrated in phases 3 and 4 (69%), as the two studies are more advanced. Part of them is the oncology area (28%), followed by infectious diseases (22%).

The data also show that the operating costs of two oncology clinical studies conducted in Brazil are 65% lower compared to the United States. Second report, this factor, combined with the quality of work force and the structure of Brazilian institutions, is attractive for optimizing resources.

For analysts, this combination of elements opens the way for a turn in the sector in the country. "Brazil will not be the largest market in the world, but it can occupy the space it fits, with important growth in the coming years," says Rafael Freixo, director of L.E.K. Consulting.

Isso means expanding activity in a global market that moves US$70 billion per year, second or second. For Freixo, the regulatory advance, the entry of new players and the formation of specialized networks opens a path of opportunity for Brazil.

Opportunity for clinical trials
Second report by L.E.K. Consulting, the genetic diversity of the Brazilian population can be a differential for the attraction of clinical studies. "More than 90% of global clinical trials are still carried out in predominantly white populations, which limits the understanding of the effects of medications in diverse genetic groups," says Danilo Simões, consultant at L.E.K.

Nesse context, or country can occupy a relevant position to expand genetic representation in research. "The racial diversity of the country is an attraction that is still underutilized, but has enormous value in making treatments more precise and inclusive," emphasizes Simões.

Another highlight of the story is the infrastructure installed in the country, made up of laboratories, hospitals and healthcare networks, which can help expand clinical studies in different regions. "We have highly motivated researchers, but it is still necessary to scale up and accelerate the conduct of studies," Rafael Freixo confirms.

According to the document, currently nearly half of two clinical trials conducted in Brazil are concentrated in private institutions. Rafael Freixo cites as examples the Einstein and Sírio-Libanês hospitals, which are heavily invested in research. In addition to generating recipes, this strategy strengthens the positioning of these institutions as reference centers in areas such as oncology and cardiology, he explains.

Despite two advances, Freixo highlights that there is a consensus in this sector: the sustainable growth of clinical research in Brazil depends on greater integration with SUS and with public universities. Second, this articulation can expand the volume of studies, guarantee diversity and non-recruitment of participants, and promote more equity and access. Furthermore, he cites the formation of integrated networks of research centers as a strategic step to strengthen the national scientific ecosystem and the impact of scientific production in the country.

The regulatory advance
Um passage given this direction was the approval of Law nº 14,874, of 2024, which instituted the Legal Framework for clinical research with human beings in Brazil. The new legislation created the National System of Ethics in Research and has the objective of giving more agility to the ethical and regulatory procedures.Secondly, to simplify the approval processes for ethics committees, “it has significantly reduced the time required to initiate clinical trials.”

Ainda, aponta a decentralização das aprovações para comitês locais como uma melhora, em contraposição à centralização do processo. This is important because the delay in the approval of two ethics committees and other bureaucratic processes can lead to studies migrating to markets with more time-consuming processes.

"We're moving in the right direction. Simplification can accelerate studies and stimulate a new investment cycle," explains consultant Danilo Simões. Analysts expect that additional reforms regarding the provision of medicines to study participants will accelerate Brazil's attractiveness in the global pharmaceutical market.

The Expansion of the New Era of Clinical Research
According to the report, the market is operating more maturely abroad. In countries like the United States and Germany, specialized companies manage networks of clinical centers by therapeutic area, with efficient recruitment, data management, and scalability. "Brazil can follow the path of Eastern Europe, which has become an alternative to the United States for offering genetic diversity and lower costs, as long as it can overcome its structural barriers," Simões points out.

Among the obstacles cited by analysts are the lack of standardization in processes and the low operational maturity of some research centers. In this regard, professionalization of the sector is key to the expansion of clinical trials in Brazil, according to Freixo: "It should attract more investment and improve the quality of research."

The private sector is also tending to professionalize and expand its presence through the formation of clinical research networks. According to analysts, this movement is already a reality abroad: institutions have been acquiring centers and consolidating specialized networks, focused on reducing costs and gaining scale to accelerate patient recruitment. They project that this will also happen in Brazil.

Another challenge is the lack of financial incentives and mechanisms to encourage patient participation in clinical trials. "Abroad, there are remuneration systems that encourage patient participation in research, something that still doesn't exist here, which makes the market less attractive for some studies," explains Simões.

This limitation makes it especially difficult to include patients with rare diseases or when the study is the only available therapeutic alternative. Even so, early access to innovative treatments, often before their regulatory approval, serves as a strong clinical incentive.

For analysts, clinical research should be viewed as a strategy for growth and institutional strengthening. In addition to generating revenue with low investment, it improves the quality of care, positions hospitals as centers of excellence, and connects these institutions to global science. "Participating in a study can mean access to treatments not yet available through the SUS (Brazilian Unified Health System) or the private sector, bringing direct benefits to the patient," says Freixo.

Despite the obstacles, there is optimism regarding this new scenario. "We haven't yet reached our full potential, but the trend is clear: the market will grow, networks will consolidate, and professionalization will continue to increase," Simões predicts. "We are facing a new era for clinical research in the country," he concludes.