The Japan-based Astellas, after Russia in 1992, China in 1994, and India in 2008, finally laid the last "BRIC" in its emerging markets house in 2009. Devaney Baccarin, the manager who has been there since day one, doesn't mince words when talking about the reasoning behind the entry decision. "The answer is simple: great market potential. Brazil is the largest market in Latin America. Most of pharmaceutical markets in developed countries are quite stable and mature, increasing no more than 1% to 3% per year, while the Brazilian pharmaceutical market is increasing by double digits per year," Baccarin notes. The company, whose raison d'être is to be a global category leader in areas such as urology, transplant, infectious diseases, and oncology, did face hurdles. "One was overcoming regulatory challenges and the other was how to attract talented people," Baccarin says. "Brazil is very interesting in terms of market potential, but our regulatory regime is very challenging. Therefore the main barriers to surpass are to have registration, prepare for launching, and consolidate the team."
On the former point, Baccarin is quick to come to the government's defense, and hopeful: "I believe there is a strong interest in improvements, because ANVISA knows how important it is for new companies to have a good regulatory environment. In the first year Astellas suffered through delays, and new products were not approved as planned until the end of the first fiscal year. We continue to have bureaucratic issues regarding importation. We believe some improvements are possible for more investments in clinical research, for example."