América Latina: "Tierra de promisión" para la Investigación clínica...

Over the past several years, biopharmaceutical companies have increased innovative research and development outside their traditional boundaries with dramatic expansion of clinical drug development into many countries around the world. The reason for this dramatic increase in globalization may be attributed to greater competition observed in the United States and European markets and also to the current challenges with high costs, slow patient recruitment, and greater demand on qualified clinical research professionals. Other reasons may include the rapid economic growth and improvement of regulatory processes in emerging regions, partly driven by wider adoption of ICH guidelines and principles. Sponsors can find many opportunities to develop their products in the nontraditional regions as part of their multinational strategy.

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Like many parts of the developing world, Latin America continues to experience rapid population growth (see Table 1) and the rate is not expected to slow any time soon. A large population in this economically emerging region presents an opportunity and many advantages for drug development. Some advantages include rapid growth of the pharmaceutical market; population concentration in large urban centers such as Mexico City (Mexico), São Paulo and Rio de Janeiro (Brazil), and Buenos Aires (Argentina); population heterogeneity; two official languages spoken in the entire region; and English language proficiency of most investigators in the region.²


Based on data derived from seven of the largest markets in Latin America—Argentina, Brazil, Chile, Colombia, Mexico, Peru, and Venezuela (see Figure 1)—the pharmaceutical market was worth about US$ 50 billion in 2008 with a projection of US$ 80 billion in 2013. In light of the increasing global competitiveness, biopharmaceutical companies located in the major ICH regions have been conducting an increasing number of clinical trials in Latin America in the recent years as part of their global market expansion strategy (see Table 2 and Figure 2).

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Conclusion
The increasing number of clinical trials in Latin America reflects trends in global biopharmaceutical market expansion. To stay competitive, the industry is exporting their innovation outside of their traditional boundaries and has increased collaboration efforts. The perception that new drugs will cure diseases and ameliorate many others has encouraged people to participate in clinical trials with the hope these investments will bring therapies that can help alleviate unmet medical needs in their nations.



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