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• 2011-2020³â °£ ÀÓ»ó1»ó ´Ü°èÀÇ Èĺ¸¹°ÁúÀÌ ÃÖÁ¾ ¹Ì±¹ FDA Çã°¡¸¦ ȹµæÇÏ°í ½ÃÀå¿¡ Ãâ½ÃµÈ È®·ü(LOA)Àº 7.9%
• ÀǾàÇ° °³¹ß ½Ã ÀÓ»ó2»ó ´Ü°è°¡ °¡Àå Å« À庮À¸·Î, ÀÓ»ó2»ó Èĺ¸¹°ÁúÀÇ 28.9%¸¸ÀÌ ´ÙÀ½ °³¹ß ´Ü°è·Î ÀÌÇà(transition)µÊ
• 14°³ÀÇ ÁÖ¿ä Áúȯ±º Áß Ç÷¾×(hematology) Ä¡·áÁ¦ÀÇ LOA 23.9%·Î °¡Àå ³ô¾Ò°í(23.9%), ºñ´¢±â(urology) LOA 3.6%·Î °¡Àå LOA°¡ ³·À½
• ¸é¿ªÇ×¾ÏÄ¡·áÁ¦(immuno-oncology) LOA´Â 12.4%·Î Àüü Ç×¾ÏÁ¦(LOA 5.3%) ´ëºñ Çã°¡°¡´É¼ºÀÌ ³ô°Ô ³ªÅ¸³²
• Èñ±ÍÁúȯġ·áÁ¦´Â Àü¹ÝÀûÀÎ LOA°¡ 17.0%·Î ƯÈ÷ ³ô¾ÒÀ½
• ¸¸¼º, ³ôÀº À¯º´·üÀÇ Áúȯ Ä¡·áÁ¦ÀÇ Àü¹ÝÀûÀÎ LOA 5.9%·Î Çã°¡ °¡´É¼ºÀÌ ³·Àº ÆíÀ» ±â·ÏÇÔ
• ÀǾàÇ°ÀÇ ¾ç»ó(modalities)¿¡¼ »ý¹°ÇÐÀûÀ¸·Î º¹ÀâÇÒ¼ö·Ï ÀϹÝÀûÀ¸·Î LOA°¡ ´õ ³ôÀ½ (¿¹: CAR-T, RNAiÀÇ LOA°¡ °¢°¢ 17.3%, 13.5%·Î °¡Àå ³ôÀº ¼öÄ¡¸¦ ±â·Ï)
• ÀÓ»ó½ÃÇè¿¡ Âü¿©Çϴ ȯÀÚ¸¦ ¹ÙÀÌ¿À¸¶Ä¿ ÅëÇØ ¹Ì¸® ¼±º°ÇÏ´Â °æ¿ì, ÀÓ»ó 1»ó ´Ü°è¿¡¼ LOA 2¹è Áõ°¡(15.9%) ¹× ÀÓ»ó2»ó ´ÙÀ½´Ü°è ÁøÇà ¼º°ø·ü ¾à 50%(one-in-two)ÀÓ
• ÀÓ»ó ´Ü°è ¼º°ø(phase success)¿¡ °¡Àå ¸¹Àº ¿µÇâÀ» ¹ÌÄ¡´Â ¿ä¼Ò´Â ÀûÀÀÁõ(disease indication), Ç¥Àû(target), ¾ç»ó(modality) ¹× ½Å¾à¿©ºÎ(drug novelty)ÀÓ
• Æò±ÕÀûÀ¸·Î, ÀÓ»ó1»ó¿¡¼ Ç°¸ñÇã°¡±îÁö 10.5³â ¼Ò¿äµÊ. LOA°¡ Æò±Õ ÀÌ»óÀÎ Áúȯ±ºÀÌ ÂªÀº °³¹ß ŸÀÓ¶óÀÎÀ» °¡Áö´Â °æÇâÀÌ ÀÖÀ½
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2021.02_BIO+Informa+QLS_Clinical Development Success Rates and Contributing Factors 2011-2020.pdf