INDIAN GENERICS FIRMS ADAPT STRATEGY FOR JAPANESE MARKET

Leading Indian generics makers Ranbaxy and Lupin are to enter the Japanese market through product tie-ups with local manufacturers, indicating that the potentially lucrative market retains significant entry barriers. Although Japan's generics sales were worth some US$5.88bn in 2004, this total is equivalent to just 6.4% of the country's entire drug market.

The sharing of responsibilities between Lupin and local partner Kyowa is telling, with the Indian firm set to undertake product development and the Japanese company handling clinical studies, regulatory submissions and marketing. Meanwhile, in contrast, Ranbaxy is planning to launch key products in its high-tech generic portfolio under a joint label with partner Nihon Pharmaceutical Industry.

The alliances reflect diversification among Japanese producers as the sector becomes increasingly dominated by large research-based firms. In terms of Indian companies' objectives, the market's attractions are obvious. However, their entry to the Japanese market has been anticipated for some time, and industry sources continue to complain that the marketplace remains somewhat "restricted."

Apart from regulatory barriers, which the government is attempting to resolve by offering incentives to prescribers and producers, generics firms are also battling negative public perceptions. Nevertheless, the generics market's potential has left many manufacturers undeterred. Several Japanese generics makers are already increasing capacity, as both consumers and the authorities become increasingly conscious of the real cost of medicines.