The BRIC Countries: Opportunities for Regulated Market Players

From the perspective of active ingredient- and finished-dose manufacturers based in the United States and Europe, players from emerging markets, especially India and China, often seem to pose threats. The availability of low-cost active pharmaceutical ingredients (APIs) from India and China has had a big impact on the Italian and Spanish API manufacturers. Today, 29 India-based groups and 16 China-based groups are considered "established" by Thomson Reuters, meaning that they have many years of experience with supplying a number of APIs to regulated markets such as the US and European Union (see Figure 1). Meanwhile, the emergence of a new crop of backward integrated Indian generic-drug manufacturers has changed the market dynamics in Europe and the US. Both the number of abbreviated new drug application (ANDA) filers and filings from India have increased dramatically over the past 10 years (see Figure 2).