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Regulatory Focus™ > News Articles > Overview of Orphan Drugs in Japan

Overview of Orphan Drugs in Japan

Posted 01 January 2011 | By Priya Jambhekar 

Approximately 5,000 to 8,000 distinct rare diseases, which affect 6-10% of the world's population at some point in life, have been identified. However, because discovery and development of new molecules is generally very lengthy (10 years on average), very costly (millions to billions of dollars) and highly risky, pharmaceutical companies historically have been unwilling to develop medicines for such diseases due to their small projected sales. More than 30 years ago, it became apparent that incentives were necessary to encourage development of medicines for rare diseases.1 Without these legislative incentives, many lifesaving new drugs might not have not been developed, produced and marketed.2


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