Overcoming Clinical Challenges in BRIC Markets - Brazil

Figure 1A: While many still tout the benefits for conducting clinical trials in emerging markets, data from Cortellis finds that drug development in most of the BRIC (Brazil, Russia, India and China) countries is on the decline. Sponsors are largely pulling back or out completely due to increasingly complex regulatory guidelines, corruption, patent challenges, losses to generics, and import/export delays.

Figure 1C: For clinical trials reported in the BRIC countries by phase, Russia and China feature the highest number of unreported phases. Russia edges out the remaining countries on Phase III trials.

Figure 2A: Although improving, Brazil’s regulatory approval process for clinical trials still remains the lengthiest in Latin America and can take anywhere from five to 12 months. ANVISA, the national health surveillance agency for Brazil, operates much like the FDA. The country’s compassionate use program, approved in August 2013, guarantees free orphan drug supply to those who have participated in a Phase III trial and benefitted from the drug. Because the patient population for a rare disease is limited by nature, the sponsor’s Brazilian market for the respective orphan drug may be entirely comprised of its successful Phase III trial patients, negating any profit they may make in the country.

Figure 2B: Overall, trials have declined in Brazil since 2011, however, local companies are filling the gaps, as well as university and government trials. Novartis remains a key player in the country, along with Roche and AstraZeneca. Pfizer, Sanofi, and GSK have decreased their presence.

SOURCE: Thomson Reuters Cortellis Competitive Intelligence

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