Japan Laments Clinical Trials Decline

Sources within Japan's research-based pharmaceuticals sector have highlighted that the country's clinical trials market appears to be in decline, faced with growing regional competition. Asian rivals South Korea, Taiwan and Singapore are increasingly securing a larger slice of key drug development activity.

Clearly, the drivers of this growth are not simply economic. Taking one example, the recent finding that UK drugmaker AstraZeneca's oncology drug Iressa is effective in Asians has shown multinational drug firms that epidemiological factors necessitate a clinical trials base in the region. Asia's abundance of lower-cost R&D locations, and wide genetic disparities between potential trial volunteers, has also led to an expansion in multi-centre trials across the wider region.

South Korea appears set to become an important competitor in this field. In 2000, the government permitted multi-centre trials, and the country is now expected to host about 100 trials this year, up from just five prior to liberalisation. The government plans to open 15 testing centres by 2008.

Taiwan also hopes to conduct about 45 trials in 2005, but the wider R&D sector is expanding rapidly amid heavy investment in biotech. The Taiwanese government claims that local firms invested some TWD10.5bn (US$307.02mn) in biotech in the first seven months of 2004.

Nevertheless, the strongest competitive challenge to Japanese drug development has been posed by Singapore, which opened a new 2,000-employee biotech park known as Biopolis last year. The country is already a major Asian manufacturing hub for multinationals, with US firms now especially prominent in clinical trial activity.

Meanwhile, the prospects for Japanese clinical studies look gloomy. The country's Pharmaceutical Manufacturers' Association (PMA) estimates that the number of trials requested in 2000 was one-third of 1993 levels. Unwieldy application procedures and a rigorous inspection regime are widely blamed for this decline.

However, there are signs that large domestic companies have other priorities. While there were five new Japanese-developed drugs with sales over US$500mn in 1997 - worth a total US$7.3bn - this total reached 17 in 2003, with sales of US$23bn. The growing focus of Japanese firms on sales in overseas markets is confirmed by the fact that new drugs first marketed overseas soared to 43.2% of the total by 2000.