{"id":41002,"date":"2026-02-13T10:33:52","date_gmt":"2026-02-13T10:33:52","guid":{"rendered":"https:\/\/www.globalresearch.co.kr\/insight\/cell-and-gene-therapy-contract-development-and-manufacturing-organization-market-mordor\/"},"modified":"2026-03-27T23:47:00","modified_gmt":"2026-03-27T14:47:00","slug":"cell-and-gene-therapy-contract-development-and-manufacturing-organization-market-mordor","status":"publish","type":"post","link":"https:\/\/www.globalresearch.co.kr\/insight\/cell-and-gene-therapy-contract-development-and-manufacturing-organization-market-mordor\/","title":{"rendered":"\uc138\uacc4\uc758 \uc138\ud3ec \uc720\uc804\uc790 \uce58\ub8cc \uc704\ud0c1\uac1c\ubc1c\uc0dd\uc0b0\uae30\uad00 \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc810\uc720\uc728 \ubd84\uc11d \u2013 \uc131\uc7a5 \ub3d9\ud5a5 \ubc0f \uc804\ub9dd (2026-2031\ub144)"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/www.globalresearch.co.kr\/insight\/wp-content\/uploads\/2026\/02\/cell-and-gene-therapy-contract-development-and-manufacturing-organization-market-1752428483170-major-players.webp\" alt=\"Chart\" class=\"aligncenter size-full\" \/><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/www.globalresearch.co.kr\/insight\/wp-content\/uploads\/2026\/02\/cell-and-gene-therapy-contract-development-and-manufacturing-organization-market-size-image-1768488754029.webp\" alt=\"Chart\" class=\"aligncenter size-full\" \/><\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-0\">1. \uc11c\ub860<\/p>\n<ul>\n<li class=\"toc-level-2\">1.1 \uc5f0\uad6c \uac00\uc815 \ubc0f \uc2dc\uc7a5 \uc815\uc758<\/li>\n<li class=\"toc-level-2\">1.2 \uc5f0\uad6c \ubc94\uc704<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-1\">2. \uc5f0\uad6c \ubc29\ubc95\ub860<\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-2\">3. \uc694\uc57d<\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-3\">4. \uc2dc\uc7a5 \ud604\ud669<\/p>\n<ul>\n<li class=\"toc-level-2\">4.1 \uc2dc\uc7a5 \uac1c\uc694<\/li>\n<li class=\"toc-level-2\">4.2 \uc2dc\uc7a5 \ub3d9\uc778\n<ul>\n<li class=\"toc-level-3\">4.2.1 CGT \uc784\uc0c1 \ud30c\uc774\ud504\ub77c\uc778 \uc99d\uac00<\/li>\n<li class=\"toc-level-3\">4.2.2 \uc720\uc804 \uc9c8\ud658 \ubc0f \uc554 \uc720\ubcd1\ub960 \uc99d\uac00<\/li>\n<li class=\"toc-level-3\">4.2.3 VC \ubc0f \ube45\ud30c\ub9c8 \uc790\uae08 \uc870\ub2ec \uae09\uc99d<\/li>\n<li class=\"toc-level-3\">4.2.4 \uc18c\uaddc\ubaa8 CGT \uac1c\ubc1c\uc0ac\uc758 \uc544\uc6c3\uc18c\uc2f1 \uc120\ud638<\/li>\n<li class=\"toc-level-3\">4.2.5 \ub300\ub7c9 \ubc30\uce58 CDMO \uc5ed\ub7c9\uc774 \ud544\uc694\ud55c \ub3d9\uc885 &#8216;\uae30\uc131\ud488&#8217; \ud50c\ub7ab\ud3fc<\/li>\n<li class=\"toc-level-3\">4.2.6 \uae00\ub85c\ubc8c CMC \uc11c\ub958 \uc870\ud654(FDA-EMA-PMDA)\ub85c \ub2e4\uc9c0\uc5ed \ucd9c\uc2dc \ub2e8\ucd95<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">4.3 \uc2dc\uc7a5 \uc81c\uc57d\n<ul>\n<li class=\"toc-level-3\">4.3.1 \ub300\uaddc\ubaa8 AAV \uc0dd\uc0b0\uc744 \uc704\ud55c \uc81c\ud55c\ub41c \uace0\ucc98\ub9ac\ub7c9 \ubd84\uc11d<\/li>\n<li class=\"toc-level-3\">4.3.2 \ubcf5\uc7a1\ud558\uace0 \uc218\uc791\uc5c5 \uc9d1\uc57d\uc801\uc778 \uc81c\uc870 \ubc0f \uaddc\uc81c \uc7a5\uc560\ubb3c<\/li>\n<li class=\"toc-level-3\">4.3.3 GMP \ub4f1\uae09 \ud50c\ub77c\uc2a4\ubbf8\ub4dc \ubc0f \ubc14\uc774\ub7ec\uc2a4 \uc6d0\ub8cc \ubd80\uc871<\/li>\n<li class=\"toc-level-3\">4.3.4 \ucf54\ub85c\ub09819 \uc774\ud6c4 CDMO \uacfc\uc789 \uc0dd\uc0b0 \ub2a5\ub825\uc73c\ub85c \uc778\ud55c \ub9c8\uc9c4 \uc555\ubc15<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">4.4 \uacf5\uae09\ub9dd \ubd84\uc11d<\/li>\n<li class=\"toc-level-2\">4.5 \uaddc\uc81c \ud658\uacbd<\/li>\n<li class=\"toc-level-2\">4.6 \uae30\uc220 \uc804\ub9dd<\/li>\n<li class=\"toc-level-2\">4.7 \ud3ec\ud130\uc758 5\uac00\uc9c0 \uacbd\uc7c1 \uc694\uc778 \ubd84\uc11d\n<ul>\n<li class=\"toc-level-3\">4.7.1 \uacf5\uae09\uc5c5\uccb4\uc758 \uad50\uc12d\ub825<\/li>\n<li class=\"toc-level-3\">4.7.2 \uad6c\ub9e4\uc790\uc758 \uad50\uc12d\ub825<\/li>\n<li class=\"toc-level-3\">4.7.3 \uc2e0\uaddc \uc9c4\uc785\uc790\uc758 \uc704\ud611<\/li>\n<li class=\"toc-level-3\">4.7.4 \ub300\uccb4\uc7ac\uc758 \uc704\ud611<\/li>\n<li class=\"toc-level-3\">4.7.5 \uc0b0\uc5c5 \ub0b4 \uacbd\uc7c1<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-4\">5. \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc131\uc7a5 \uc608\uce21 (\uac00\uce58)<\/p>\n<ul>\n<li class=\"toc-level-2\">5.1 \uc81c\ud488\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.1.1 \uc138\ud3ec \uce58\ub8cc<\/li>\n<li class=\"toc-level-4\">5.1.1.1 \uc904\uae30\uc138\ud3ec \uae30\ubc18<\/li>\n<li class=\"toc-level-4\">5.1.1.2 \ube44\uc904\uae30\uc138\ud3ec \uae30\ubc18<\/li>\n<li class=\"toc-level-4\">5.1.1.3 \uae30\ud0c0 \uc138\ud3ec \uce58\ub8cc<\/li>\n<li class=\"toc-level-3\">5.1.2 \uc720\uc804\uc790 \uce58\ub8cc<\/li>\n<li class=\"toc-level-4\">5.1.2.1 \ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130<\/li>\n<li class=\"toc-level-4\">5.1.2.2 \ube44\ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">5.2 \ub2e8\uacc4\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.2.1 \uc804\uc784\uc0c1<\/li>\n<li class=\"toc-level-3\">5.2.2 \uc784\uc0c1<\/li>\n<li class=\"toc-level-3\">5.2.3 \uc0c1\uc5c5<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">5.3 \uc11c\ube44\uc2a4 \uc720\ud615\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.3.1 \uacf5\uc815 \uac1c\ubc1c<\/li>\n<li class=\"toc-level-3\">5.3.2 GMP \uc81c\uc870<\/li>\n<li class=\"toc-level-3\">5.3.3 \ubd84\uc11d \ud14c\uc2a4\ud2b8 \/ \ud488\uc9c8 \uad00\ub9ac<\/li>\n<li class=\"toc-level-3\">5.3.4 \ucda9\uc804-\ub9c8\uac10 &amp; \ud3ec\uc7a5<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">5.4 \uc9c0\uc5ed\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.4.1 \ubd81\ubbf8<\/li>\n<li class=\"toc-level-4\">5.4.1.1 \ubbf8\uad6d<\/li>\n<li class=\"toc-level-4\">5.4.1.2 \uce90\ub098\ub2e4<\/li>\n<li class=\"toc-level-4\">5.4.1.3 \uba55\uc2dc\ucf54<\/li>\n<li class=\"toc-level-3\">5.4.2 \uc720\ub7fd<\/li>\n<li class=\"toc-level-4\">5.4.2.1 \ub3c5\uc77c<\/li>\n<li class=\"toc-level-4\">5.4.2.2 \uc601\uad6d<\/li>\n<li class=\"toc-level-4\">5.4.2.3 \ud504\ub791\uc2a4<\/li>\n<li class=\"toc-level-4\">5.4.2.4 \uc774\ud0c8\ub9ac\uc544<\/li>\n<li class=\"toc-level-4\">5.4.2.5 \uc2a4\ud398\uc778<\/li>\n<li class=\"toc-level-4\">5.4.2.6 \uae30\ud0c0 \uc720\ub7fd<\/li>\n<li class=\"toc-level-3\">5.4.3 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591<\/li>\n<li class=\"toc-level-4\">5.4.3.1 \uc911\uad6d<\/li>\n<li class=\"toc-level-4\">5.4.3.2 \uc77c\ubcf8<\/li>\n<li class=\"toc-level-4\">5.4.3.3 \uc778\ub3c4<\/li>\n<li class=\"toc-level-4\">5.4.3.4 \ub300\ud55c\ubbfc\uad6d<\/li>\n<li class=\"toc-level-4\">5.4.3.5 \ud638\uc8fc<\/li>\n<li class=\"toc-level-4\">5.4.3.6 \uae30\ud0c0 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591<\/li>\n<li class=\"toc-level-3\">5.4.4 \uc911\ub3d9 &amp; \uc544\ud504\ub9ac\uce74<\/li>\n<li class=\"toc-level-4\">5.4.4.1 GCC<\/li>\n<li class=\"toc-level-4\">5.4.4.2 \ub0a8\uc544\ud504\ub9ac\uce74<\/li>\n<li class=\"toc-level-4\">5.4.4.3 \uae30\ud0c0 \uc911\ub3d9 &amp; \uc544\ud504\ub9ac\uce74<\/li>\n<li class=\"toc-level-3\">5.4.5 \ub0a8\ubbf8<\/li>\n<li class=\"toc-level-4\">5.4.5.1 \ube0c\ub77c\uc9c8<\/li>\n<li class=\"toc-level-4\">5.4.5.2 \uc544\ub974\ud5e8\ud2f0\ub098<\/li>\n<li class=\"toc-level-4\">5.4.5.3 \uae30\ud0c0 \ub0a8\ubbf8<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-5\">6. \uacbd\uc7c1 \ud658\uacbd<\/p>\n<ul>\n<li class=\"toc-level-2\">6.1 \uc2dc\uc7a5 \uc9d1\uc911\ub3c4<\/li>\n<li class=\"toc-level-2\">6.2 \uc2dc\uc7a5 \uc810\uc720\uc728 \ubd84\uc11d<\/li>\n<li class=\"toc-level-2\">6.3 \uae30\uc5c5 \ud504\ub85c\ud544 (\uae00\ub85c\ubc8c \uac1c\uc694, \uc2dc\uc7a5 \uac1c\uc694, \ud575\uc2ec \ubd80\ubb38, \uc7ac\ubb34, \uc804\ub7b5 \uc815\ubcf4, \uc2dc\uc7a5 \uc21c\uc704\/\uc810\uc720\uc728, \uc81c\ud488 &amp; \uc11c\ube44\uc2a4, \ucd5c\uadfc \uac1c\ubc1c \ud3ec\ud568)\n<ul>\n<li class=\"toc-level-3\">6.3.1 \ub860\uc790 \uadf8\ub8f9<\/li>\n<li class=\"toc-level-3\">6.3.2 \uce74\ud0c8\ub80c\ud2b8 Inc<\/li>\n<li class=\"toc-level-3\">6.3.3 \uc368\ubaa8 \ud53c\uc154 \uc0ac\uc774\uc5b8\ud2f0\ud53d (\ud30c\ud14c\uc628)<\/li>\n<li class=\"toc-level-3\">6.3.4 \uc6b0\uc2dc \uc5b4\ub4dc\ubc34\uc2a4\ub4dc \ud14c\ub77c\ud53c\uc2a4<\/li>\n<li class=\"toc-level-3\">6.3.5 \uc0bc\uc131\ubc14\uc774\uc624\ub85c\uc9c1\uc2a4<\/li>\n<li class=\"toc-level-3\">6.3.6 AGC \ubc14\uc774\uc624\ub85c\uc9c1\uc2a4<\/li>\n<li class=\"toc-level-3\">6.3.7 \ucc30\uc2a4 \ub9ac\ubc84 \ub7a9\uc2a4 (\ucf54\uadf8\ub124\uc774\ud2b8)<\/li>\n<li class=\"toc-level-3\">6.3.8 \ub808\uc2dc\ud31c AB<\/li>\n<li class=\"toc-level-3\">6.3.9 \ud6c4\uc9c0\ud544\ub984 \ub2e4\uc774\uc624\uc2e0\uc2a4 \ubc14\uc774\uc624\ud14c\ud06c\ub180\ub85c\uc9c0\uc2a4<\/li>\n<li class=\"toc-level-3\">6.3.10 \ubbf8\ub098\ub9ac\uc2a4 \uc7ac\uc0dd \uc758\ud559<\/li>\n<li class=\"toc-level-3\">6.3.11 PCI \ud30c\ub9c8 \uc11c\ube44\uc2a4<\/li>\n<li class=\"toc-level-3\">6.3.12 \uc54c\ub9e5 \uadf8\ub8f9<\/li>\n<li class=\"toc-level-3\">6.3.13 \ud654\uc774\uc790 \uc13c\ud130\uc6d0<\/li>\n<li class=\"toc-level-3\">6.3.14 KBI \ubc14\uc774\uc624\ud30c\ub9c8<\/li>\n<li class=\"toc-level-3\">6.3.15 \ubc14\uc774\uc624\uc13c\ud2b8\ub9ad<\/li>\n<li class=\"toc-level-3\">6.3.16 \uc5d8\ub9ac\ubca0\uc774\ud2b8\ubc14\uc774\uc624<\/li>\n<li class=\"toc-level-3\">6.3.17 \uc774\ud3ec\uc2a4\ucf00\uc2dc<\/li>\n<li class=\"toc-level-3\">6.3.18 \uc81c\ub124\uc820<\/li>\n<li class=\"toc-level-3\">6.3.19 3P \ubc14\uc774\uc624\ud30c\ub9c8\uc288\ud2f0\uceec\uc2a4<\/li>\n<li class=\"toc-level-3\">6.3.20 \uc625\uc2a4\ud3ec\ub4dc \ubc14\uc774\uc624\uba54\ub514\uce74<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-6\">7. \uc2dc\uc7a5 \uae30\ud68c &amp; \ubbf8\ub798 \uc804\ub9dd<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c \uc704\ud0c1\uac1c\ubc1c\uc0dd\uc0b0(CDMO) \uc2dc\uc7a5\uc740 2026\ub144\ubd80\ud130 2031\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 16.08%\uc758 \ub192\uc740 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud558\uba70, 2025\ub144 37.1\uc5b5 \ub2ec\ub7ec\uc5d0\uc11c 2031\ub144 90.8\uc5b5 \ub2ec\ub7ec \uaddc\ubaa8\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub429\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uac00\ud30c\ub978 \uc131\uc7a5\uc138\ub294 2,000\uac1c \uc774\uc0c1\uc758 \uc784\uc0c1 \ubc0f \uc804\uc784\uc0c1 \ud504\ub85c\uc81d\ud2b8\ub85c \uad6c\uc131\ub41c \uac15\ub825\ud55c \ud30c\uc774\ud504\ub77c\uc778\uacfc \uc5f0\uac04 10~20\uac74\uc758 \uc2b9\uc778\uc744 \uc608\uc0c1\ud558\ub294 \uaddc\uc81c \ud658\uacbd\uc5d0 \uae30\uc778\ud569\ub2c8\ub2e4.<\/p>\n<p>\uc774\uc5d0 \ub530\ub77c CDMO \uae30\uc5c5\ub4e4\uc740 2024\ub144 \uc774\ud6c4 100\uc5b5 \ub2ec\ub7ec \uc774\uc0c1\uc758 \ud22c\uc790\ub97c \ubc1c\ud45c\ud558\uba70 \uc0dd\uc0b0 \ub2a5\ub825 \uacbd\uc7c1\uc5d0 \ub3cc\uc785\ud588\uc2b5\ub2c8\ub2e4. \ud2b9\ud788 \uc0bc\uc131\ubc14\uc774\uc624\ub85c\uc9c1\uc2a4\ub294 2025\ub144\uae4c\uc9c0 784,000L, \ub860\uc790\ub294 12\uc5b5 \ub2ec\ub7ec\ub97c \ud22c\uc790\ud558\uc5ec \ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130 \uc0dd\uc0b0\uc744 \uc704\ud55c 330,000L \uaddc\ubaa8\uc758 \uc2dc\uc124\uc744 \ud655\ubcf4\ud588\uc2b5\ub2c8\ub2e4. \ub178\ubcf4 \ud640\ub529\uc2a4\uc758 \uce74\ud0c8\ub80c\ud2b8 165\uc5b5 \ub2ec\ub7ec \uc778\uc218\ub294 \uc218\uc9c1 \ud1b5\ud569\uc758 \ub9e4\ub825\uc744 \ubd80\uac01\ud558\uba70 \ucd94\uac00\uc801\uc778 \ud569\ubcd1 \uac00\ub2a5\uc131\uc744 \uc2dc\uc0ac\ud569\ub2c8\ub2e4. \ud32c\ub370\ubbf9 \uc774\ud6c4 \uc77c\ubd80 \uacf5\uc7a5\uc758 \uac00\ub3d9\ub960\uc774 70% \ubbf8\ub9cc\uc73c\ub85c \ub5a8\uc5b4\uc9c0\uba74\uc11c, CDMO\ub4e4\uc740 \uace0\ub9c8\uc9c4\uc758 \ubd84\uc11d \ubc0f \uacf5\uc815 \uac1c\ubc1c \uc11c\ube44\uc2a4 \ucd94\uac00\ub97c \ud1b5\ud574 \uc218\uc775\uc131 \ud655\ubcf4\uc5d0 \ub098\uc11c\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc8fc\uc694 \ubcf4\uace0\uc11c \uc694\uc57d:<br \/>\n*   \uc81c\ud488\ubcc4: \uc138\ud3ec \uce58\ub8cc\uc81c\uac00 2025\ub144 \uc2dc\uc7a5 \uc810\uc720\uc728 69.98%\ub97c \ucc28\uc9c0\ud588\uc73c\uba70, \uc720\uc804\uc790 \uce58\ub8cc\uc81c\ub294 2031\ub144\uae4c\uc9c0 16.85%\uc758 \uac00\uc7a5 \ube60\ub978 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\uc744 \ubcf4\uc77c \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<br \/>\n*   \uac1c\ubc1c \ub2e8\uacc4\ubcc4: \uc804\uc784\uc0c1 \ubc0f R&#038;D \ud65c\ub3d9\uc774 2025\ub144 \ub9e4\ucd9c\uc758 70.25%\ub97c \ucc28\uc9c0\ud588\uc73c\uba70, \uc0c1\uc5c5\ud654 \uc81c\uc870\ub294 14.92%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \uc131\uc7a5\ud560 \uac83\uc785\ub2c8\ub2e4.<br \/>\n*   \uc11c\ube44\uc2a4 \uc720\ud615\ubcc4: \uc704\ud0c1 \uc81c\uc870\uac00 2025\ub144 \uc2dc\uc7a5\uc758 35.20%\ub97c \ucc28\uc9c0\ud588\uace0, GMP \uc81c\uc870\ub294 2031\ub144\uae4c\uc9c0 13.05%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\uc774 \uc804\ub9dd\ub429\ub2c8\ub2e4.<br \/>\n*   \uc9c0\uc5ed\ubcc4: \ubd81\ubbf8\uac00 2025\ub144 43.75%\uc758 \uc810\uc720\uc728\ub85c \uc2dc\uc7a5\uc744 \uc120\ub3c4\ud588\uc73c\uba70, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc774 16.12%\ub85c \uac00\uc7a5 \ube60\ub978 \uc131\uc7a5\uc774 \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<p>\uae00\ub85c\ubc8c \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c CDMO \uc2dc\uc7a5 \ub3d9\ud5a5 \ubc0f \ud1b5\ucc30\ub825<\/p>\n<p>\uc131\uc7a5 \ub3d9\ub825:<br \/>\n*   \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c \uc784\uc0c1 \ud30c\uc774\ud504\ub77c\uc778 \uc99d\uac00: 2,000\uac1c \uc774\uc0c1\uc758 \ud65c\uc131 \ud504\ub85c\uadf8\ub7a8\uc774 \uac1c\ubc1c \uc911\uc774\uba70, \ubbf8\uad6d FDA\ub294 \uce58\ub8cc \uc81c\ud488 \uc0ac\ubb34\uc2e4\uc744 \uc2e0\uc124\ud558\uc5ec 2025\ub144\uae4c\uc9c0 \ub9e4\ub144 \ub450 \uc790\ub9bf\uc218 \uc2b9\uc778\uc744 \uc608\uc0c1\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uac01 \ud6c4\ubcf4 \ubb3c\uc9c8\uc740 \ub9de\ucda4\ud615 \ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130 \ub610\ub294 \uc138\ud3ec \ud655\uc7a5 \uc6cc\ud06c\ud50c\ub85c\uc6b0\ub97c \uc694\uad6c\ud558\uba70, \uc774\ub294 \ub300\ubd80\ubd84\uc758 \uc2a4\ud3f0\uc11c\uac00 \ub0b4\ubd80\uc801\uc73c\ub85c \ubd80\uc871\ud55c \uc804\ubb38\uc131\uc785\ub2c8\ub2e4. \ubd81\ubbf8\uc640 \uc720\ub7fd\uc774 \uc784\uc0c1 \uc2dc\ud5d8\uc758 80%\ub97c \ucc28\uc9c0\ud558\uc5ec \ud604\uc9c0 \uc2dc\uc124\uc5d0 \ubd80\ub2f4\uc744 \uc8fc\uace0 \ud504\ub9ac\ubbf8\uc5c4 \uac00\uaca9 \ucc45\uc815\uc744 \uac00\ub2a5\ud558\uac8c \ud569\ub2c8\ub2e4.<br \/>\n*   \uc720\uc804 \uc9c8\ud658 \ubc0f \uc554 \uc720\ubcd1\ub960 \uc99d\uac00: \uc57d 4\uc5b5 \uba85\uc758 \ud658\uc790\uac00 \uc720\uc804 \uc9c8\ud658\uc744 \uc553\uace0 \uc788\uc73c\uba70, \uc804 \uc138\uacc4 \uc554 \ubc1c\ubcd1\ub960\uc740 \ub9e4\ub144 2~3% \uc99d\uac00\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc815\ubc00 \uc758\ud559\uc758 \ubc1c\uc804\uc740 \ubca1\ud130 \uae30\ubc18 \uc811\uadfc \ubc29\uc2dd\uc744 \uc0ac\uc6a9\ud558\uc5ec \uc774\uc804\uc5d0 \uce58\ub8cc \ubd88\uac00\ub2a5\ud588\ub358 \ud45c\uc801\uc744 \uacf5\ub7b5\ud560 \uc218 \uc788\uac8c \ud588\uc2b5\ub2c8\ub2e4. CAR-T \uce58\ub8cc\uc81c\ub294 \ud604\uc7ac 40\ub9cc~50\ub9cc \ub2ec\ub7ec\uc758 \uc815\uac00\ub97c \ud615\uc131\ud558\uba70, \uc77c\ud68c\uc131 \uac1c\uc785\uc5d0 \ub300\ud55c \uc9c0\ubd88 \uc758\uc0ac\ub97c \ubcf4\uc5ec\uc90d\ub2c8\ub2e4. \ub300\uaddc\ubaa8 \ubc30\uce58 \uacf5\uae09\uc774 \uac00\ub2a5\ud55c CDMO\ub294 \uc801\uc751\uc99d \uaddc\ubaa8\uac00 \ud655\ub300\ub428\uc5d0 \ub530\ub77c \uac00\uc7a5 \ud070 \ud61c\ud0dd\uc744 \ubc1b\uc744 \uac83\uc785\ub2c8\ub2e4.<br \/>\n*   VC \ubc0f \ube45\ud30c\ub9c8 \uc790\uae08 \uc870\ub2ec \uae09\uc99d: 2024\ub144 \ubc14\uc774\uc624 \uc81c\uc57d \ud68c\uc0ac\uc640 \ubca4\ucc98 \ud380\ub4dc\ub294 CGT \uac70\ub798\uc5d0 150\uc5b5 \ub2ec\ub7ec \uc774\uc0c1\uc744 \ud22c\uc790\ud588\uc2b5\ub2c8\ub2e4. \ub178\ubcf4 \ud640\ub529\uc2a4\uc758 \uce74\ud0c8\ub80c\ud2b8 165\uc5b5 \ub2ec\ub7ec \uc778\uc218\ub294 \uc0dd\uc0b0 \ub2a5\ub825 \ud655\ubcf4\ub97c \uc704\ud55c \uc804\ub7b5\uc801 \uc758\ub3c4\ub97c \uac15\uc870\ud569\ub2c8\ub2e4. \uc790\ubcf8 \uc720\uc785\uc740 \ubc1c\uacac\ubd80\ud130 1\uc0c1\uae4c\uc9c0\uc758 \uc2dc\uac04\uc744 \ub2e8\ucd95\uc2dc\ucf1c \uacf5\uc815 \uac1c\ubc1c \ubc0f GMP \ubc30\uce58\uc5d0 \ub300\ud55c \uc8fc\ubb38 \uc99d\uac00\ub85c \uc774\uc5b4\uc9d1\ub2c8\ub2e4.<br \/>\n*   \uc18c\uaddc\ubaa8 CGT \uac1c\ubc1c\uc0ac\uc758 \uc544\uc6c3\uc18c\uc2f1 \uc120\ud638: \uc804\uc6a9 \ubca1\ud130 \ub610\ub294 \uc138\ud3ec \ucc98\ub9ac \uc2dc\uc124\uc744 \uad6c\ucd95\ud558\ub294 \ub370\ub294 5\ucc9c\ub9cc~1\uc5b5 \ub2ec\ub7ec\uac00 \uc18c\uc694\ub418\uba70 18~24\uac1c\uc6d4\uc774 \uac78\ub9b4 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub530\ub77c\uc11c \uc2a4\ud0c0\ud2b8\uc5c5\uc740 \uacf5\uc815 \ucd5c\uc801\ud654, \ucda9\uc804-\ub9c8\uac10, \ubd84\uc11d \ud14c\uc2a4\ud2b8\uc640 \uac19\uc740 \ud65c\ub3d9\uc744 \uc544\uc6c3\uc18c\uc2f1\ud558\uba70, \ub300\uae30\uc5c5\uc870\ucc28\ub3c4 \uacf5\uc7a5 \uac00\ub3d9 \uc911\ub2e8\uc744 \ud53c\ud558\uae30 \uc704\ud574 \uc678\ubd80 \uc2ac\ub86f\uc744 \uc608\uc57d\ud558\uc5ec \uc704\ud5d8\uc744 \ud5e4\uc9c0\ud569\ub2c8\ub2e4.<br \/>\n*   \ub3d9\uc885 &#8220;\uae30\uc131\ud488&#8221; \ud50c\ub7ab\ud3fc\uc758 \ub300\uaddc\ubaa8 \ubc30\uce58 CDMO \uc6a9\ub7c9 \ud544\uc694\uc131: \ub3d9\uc885 \uc138\ud3ec \uce58\ub8cc\uc81c\ub294 \ub300\uaddc\ubaa8 \ubc30\uce58 \uc0dd\uc0b0\uc774 \ud544\uc694\ud558\uba70, \uc774\ub294 CDMO\uc758 \uc6a9\ub7c9 \ud655\ub300\ub97c \ucd09\uc9c4\ud569\ub2c8\ub2e4.<br \/>\n*   \uae00\ub85c\ubc8c CMC \uc11c\ub958 \uc870\ud654: FDA-EMA-PMDA \uac04\uc758 \uae00\ub85c\ubc8c CMC \uc11c\ub958 \uc870\ud654\ub294 \ub2e4\uc9c0\uc5ed \ucd9c\uc2dc \uae30\uac04\uc744 \ub2e8\ucd95\uc2dc\ucf1c \uc2dc\uc7a5 \uc131\uc7a5\uc5d0 \uae30\uc5ec\ud569\ub2c8\ub2e4.<\/p>\n<p>\uc81c\uc57d \uc694\uc778:<br \/>\n*   \ub300\uaddc\ubaa8 AAV \uc0dd\uc0b0\uc744 \uc704\ud55c \uace0\ucc98\ub9ac\ub7c9 \ubd84\uc11d\uc758 \ud55c\uacc4: \uc644\uc804\ud55c AAV \ub85c\ud2b8 \ucd9c\uc2dc\uc5d0 \ucd5c\ub300 4\uc8fc\uac00 \uc18c\uc694\ub418\uba70, \uc774\ub294 \uc8fc\ub85c \ucea1\uc2dc\ub4dc \ube44\uc728 \ubd84\uc11d \ubc0f \uac8c\ub188 \ubb34\uacb0\uc131 \ud14c\uc2a4\ud2b8 \ub54c\ubb38\uc785\ub2c8\ub2e4. \ub290\ub9b0 \ubd84\uc11d \ucc98\ub9ac \uc2dc\uac04\uc740 \ucea0\ud398\uc778 \ucc98\ub9ac\ub7c9\uc744 \uc81c\ud55c\ud558\uace0 \uc7ac\uace0 \ube44\uc6a9\uc744 \uc99d\uac00\uc2dc\ud0b5\ub2c8\ub2e4.<br \/>\n*   \ubcf5\uc7a1\ud558\uace0 \uc218\ub3d9 \uc9d1\uc57d\uc801\uc778 \uc81c\uc870 \ubc0f \uaddc\uc81c \uc7a5\uc560\ubb3c: \ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130 \uc815\uc81c \ubc0f \uc138\ud3ec \ucc98\ub9ac \ub2e8\uacc4\ub294 \uc5ec\uc804\ud788 \uc791\uc5c5\uc790 \uac1c\uc785\uc5d0 \uc758\uc874\ud558\uba70, \uc774\ub294 COGS(\ub9e4\ucd9c\uc6d0\uac00)\uc758 40~60%\ub97c \ucc28\uc9c0\ud569\ub2c8\ub2e4. \uc218\ub3d9 \ud65c\ub3d9\uc740 \ubc30\uce58 \uc2e4\ud328 \uc704\ud5d8\uc744 \ub192\uc774\uace0 \uc2a4\ucf00\uc77c\uc5c5\uc744 \ubcf5\uc7a1\ud558\uac8c \ub9cc\ub4ed\ub2c8\ub2e4.<br \/>\n*   GMP \ub4f1\uae09 \ud50c\ub77c\uc2a4\ubbf8\ub4dc \ubc0f \ubc14\uc774\ub7ec\uc2a4 \uc6d0\uc790\uc7ac \ubd80\uc871: \uae00\ub85c\ubc8c \uacf5\uae09\ub9dd\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\uba70, \ud2b9\ud788 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc5d0\uc11c \uc2ec\uac01\ud569\ub2c8\ub2e4.<br \/>\n*   \ucf54\ub85c\ub09819 \uc774\ud6c4 CDMO \uacfc\uc789 \uc0dd\uc0b0 \ub2a5\ub825\uc73c\ub85c \uc778\ud55c \ub9c8\uc9c4 \uc555\ubc15: \ubd81\ubbf8\uc640 \uc720\ub7fd\uc5d0\uc11c \uc8fc\ub85c \ubc1c\uc0dd\ud558\uba70, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc5d0\ub294 \uc81c\ud55c\uc801\uc778 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4.<\/p>\n<p>\uc138\uadf8\uba3c\ud2b8 \ubd84\uc11d<\/p>\n<p>*   \uc81c\ud488\ubcc4: \uc138\ud3ec \uce58\ub8cc\uc81c \uc9c0\ubc30\ub825 \uc18d \uc720\uc804\uc790 \uce58\ub8cc\uc81c \uac00\uc18d\ud654<br \/>\n    \uc138\ud3ec \uce58\ub8cc\uc81c\ub294 6\uac1c\uc758 \uc0c1\uc5c5\uc6a9 CAR-T \uc81c\ud488\uacfc \ud655\uc7a5\ub418\ub294 \ub3d9\uc885 \ud30c\uc774\ud504\ub77c\uc778\uc5d0 \ud798\uc785\uc5b4 2025\ub144 \uc2dc\uc7a5\uc758 69.98%\ub97c \ucc28\uc9c0\ud588\uc2b5\ub2c8\ub2e4. \uc904\uae30\uc138\ud3ec \ud50c\ub7ab\ud3fc\uc740 \ud655\ub9bd\ub41c \ud655\uc7a5, \ub3d9\uacb0 \ubcf4\uc874 \ubc0f QC \uc6cc\ud06c\ud50c\ub85c\uc6b0\ub85c \uc778\ud574 \uc138\ud3ec \uce58\ub8cc\uc81c\uc5d0\uc11c \uac00\uc7a5 \ud070 \ube44\uc911\uc744 \ucc28\uc9c0\ud569\ub2c8\ub2e4. \uc720\uc804\uc790 \uce58\ub8cc\uc81c\ub294 \ub354 \uc791\uc740 \uae30\ubc18\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0 2031\ub144\uae4c\uc9c0 16.85%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud558\uba70 \ube60\ub974\uac8c \uaca9\ucc28\ub97c \uc881\ud790 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130, \ud2b9\ud788 AAV\ub294 \uc548\uc804\uc131\uacfc \uc870\uc9c1 \uce5c\ud654\uc131 \uc774\uc810\uc73c\ub85c \uc778\ud574 \uac00\uaca9 \uacb0\uc815\ub825\uc744 \uc720\uc9c0\ud569\ub2c8\ub2e4. \ube44\ubc14\uc774\ub7ec\uc2a4 \ubc29\uc2dd(\uc9c0\uc9c8 \ub098\ub178 \uc785\uc790, \ubbf8\ub2c8\uc11c\ud074 DNA)\uc740 \ubc14\uc774\ub7ec\uc2a4 \uc2dc\uc2a4\ud15c\uc5d0 \ub0b4\uc7ac\ub41c \uba74\uc5ed\uc6d0\uc131 \ubc0f \uc2a4\ucf00\uc77c\ub9c1 \ubb38\uc81c\ub97c \uc6b0\ud68c\ud560 \uc218 \uc788\uc5b4 \uc790\ubcf8\uc744 \uc720\uce58\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ub3d9\uc885 \uc138\ud3ec \uce58\ub8cc\uc81c\uc758 \ubc30\uce58 \uaddc\ubaa8\ub294 5\ubc30 \uc99d\uac00\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\uba70, 2,000L \ud3d0\uc1c4\ud615 \ubc14\uc774\uc624\ub9ac\uc561\ud130 \ubc0f \uc790\ub3d9 \uba78\uade0 \uc6a9\uc811 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc218\uc694\ub97c \ucd09\uc9c4\ud569\ub2c8\ub2e4.<\/p>\n<p>*   \uac1c\ubc1c \ub2e8\uacc4\ubcc4: \uc804\uc784\uc0c1 \ubb3c\ub7c9 \ub300\ube44 \uc0c1\uc5c5\ud654 \uac00\uce58 \ubd80\uac01<br \/>\n    \uc804\uc784\uc0c1 \ubc0f R&#038;D \ud504\ub85c\uc81d\ud2b8\ub294 \ub300\ubd80\ubd84\uc758 \ud30c\uc774\ud504\ub77c\uc778 \uc790\uc0b0\uc774 \ubc1c\uacac \ub610\ub294 IND(\uc784\uc0c1\uc2dc\ud5d8\uacc4\ud68d) \uc2b9\uc778 \ub2e8\uacc4\uc5d0 \uba38\ubb3c\ub7ec \uc788\uae30 \ub54c\ubb38\uc5d0 2025\ub144 \uc2dc\uc7a5\uc758 70.25%\ub97c \ucc28\uc9c0\ud588\uc2b5\ub2c8\ub2e4. \ubb3c\ub7c9\uc740 \uc801\uc9c0\ub9cc, \uc81c\ud55c\ub41c \uacbd\uc7c1\uacfc \uacc4\uc57d\uc5d0 \ud3ec\ud568\ub41c \uace0\ubd80\uac00\uac00\uce58 \ucee8\uc124\ud305\uc73c\ub85c \uc778\ud574 \ub9c8\uc9c4\uc740 40% \uc774\uc0c1\uc785\ub2c8\ub2e4. \uc0c1\uc5c5\ud654 \uc81c\uc870\ub294 2025\ub144 \ubb3c\ub7c9\uc758 9.35%\uc5d0 \ubd88\uacfc\ud558\uc9c0\ub9cc, 2031\ub144\uae4c\uc9c0 14.92%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud558\ub294 \ubd80\ubb38\uc785\ub2c8\ub2e4. \uc0c1\uc5c5 \uc0dd\uc0b0\uc740 \uc885\uc885 5\ub144 \uc7a5\uae30 \uacc4\uc57d\uc744 \ud1b5\ud574 CDMO\uac00 \uc790\ubcf8 \ud22c\uc790\ub97c \uc0c1\uac01\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub418\uc9c0\ub9cc, \uac15\ud654\ub41c \uaddc\uc81c \uac10\ub3c5\uacfc \ubc30\uce58 \ucc45\uc784\uc5d0 \ub178\ucd9c\ub418\ub294 \ubcf4\uc99d \uc870\ud56d\uc73c\ub85c \uc778\ud574 \uc704\ud5d8\ub3c4 \ub530\ub985\ub2c8\ub2e4.<\/p>\n<p>*   \uc11c\ube44\uc2a4 \uc720\ud615\ubcc4: GMP \uc81c\uc870\uac00 \uc131\uc7a5 \ub9ac\ub354\ub85c \ubd80\uc0c1<br \/>\n    \uc704\ud0c1 \uc81c\uc870\ub294 \uc784\uc0c1 \ubc0f \uc0c1\uc5c5 \ubc30\uce58 \uc0dd\uc0b0\uc744 \ubaa8\ub450 \ud3ec\ud568\ud558\uc5ec 2025\ub144 \uc2dc\uc7a5\uc758 35.20%\ub97c \ucc28\uc9c0\ud588\uc2b5\ub2c8\ub2e4. GMP \uc81c\uc870 \ub9e4\ucd9c\uc740 \uac80\uc99d\ub418\uace0 \uc7ac\ud604 \uac00\ub2a5\ud55c \ub85c\ud2b8\ub97c \uc694\uad6c\ud558\ub294 3\uc0c1 \uc5f0\uad6c\uc758 \uc99d\uac00\uc5d0 \ud798\uc785\uc5b4 2031\ub144\uae4c\uc9c0 13.05%\uc758 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\ub85c \uc131\uc7a5\ud558\uace0 \uc788\uc73c\uba70, \uae00\ub85c\ubc8c \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc744 \uac16\ucd98 CDMO\uac00 \uac00\uc7a5 \ud070 \ud61c\ud0dd\uc744 \ubc1b\uc2b5\ub2c8\ub2e4. \uacf5\uc815 \uac1c\ubc1c \uacc4\uc57d\uc740 \ud3c9\uade0 18~24\uac1c\uc6d4\ub85c \uc9c0\uc18d\ub418\uba70, \ud5a5\ud6c4 GMP \uacc4\uc57d\uc744 \uc704\ud55c \uc720\uc785 \uacbd\ub85c\ub97c \ub9cc\ub4ed\ub2c8\ub2e4. \ubd84\uc11d \uc11c\ube44\uc2a4\ub294 \uc774\uc81c \ud575\uc2ec\uc801\uc778 \uc694\uc18c\uac00 \ub418\uace0 \uc788\uc73c\uba70, CDMO\uac00 \uc18d\ub3c4\ub97c \uc704\ud574 \ubca1\ud130 \uac8c\ub188 \uc5ed\uac00 \ubd84\uc11d, \ud6a8\ub2a5 \ud14c\uc2a4\ud2b8 \ubc0f \ucd9c\uc2dc \ubd84\uc11d\uc744 \uc790\uccb4\uc801\uc73c\ub85c \ud655\uc7a5\ud568\uc5d0 \ub530\ub77c \uc2dc\uc7a5 \uc810\uc720\uc728\uc740 \uc99d\uac00\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc9c0\uc5ed \ubd84\uc11d<\/p>\n<p>*   \ubd81\ubbf8: \ubd81\ubbf8\ub294 FDA\uc758 \uba85\ud655\ud55c \uacbd\ub85c, \uc2a4\ud0c0\ud2b8\uc5c5\uc758 \ubc00\uc9d1, \ucd08\uae30 \uc784\uc0c1 \uc5f0\uad6c\ub97c \uc9c0\uc6d0\ud558\ub824\ub294 \ud22c\uc790\uc790 \uae30\ubc18\uc5d0 \ud798\uc785\uc5b4 2025\ub144 \uc804 \uc138\uacc4 \ub9e4\ucd9c\uc758 43.75%\ub97c \ucc3d\ucd9c\ud588\uc2b5\ub2c8\ub2e4. \ubbf8\uad6d\ub9cc \ud574\ub3c4 \ud65c\uc131 \uc784\uc0c1 \uc2dc\ud5d8\uc758 60% \uc774\uc0c1\uc744 \uc8fc\ucd5c\ud558\uc5ec Thermo Fisher\uac00 \ud504\ub9b0\uc2a4\ud134 \ud655\uc7a5\uc5d0 4\uc5b5 7,500\ub9cc \ub2ec\ub7ec\ub97c \ud22c\uc790\ud558\uace0 \uc0bc\uc131\ubc14\uc774\uc624\ub85c\uc9c1\uc2a4\uac00 \uc804\ub7b5\uc801 \ud30c\ud2b8\ub108\uc2ed\uc744 \ud1b5\ud574 \uc0dd\uc0b0 \ub2a5\ub825\uc744 \ud560\ub2f9\ud558\ub3c4\ub85d \ud588\uc2b5\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uc774 \uc9c0\uc5ed\uc758 \ub192\uc740 \ube44\uc6a9 \uae30\ubc18\uacfc \uc219\ub828\ub41c \ub178\ub3d9\ub825 \ubd80\uc871\uc740 \ub0a9\ud488 \uc2dc\uac04\uc744 \ub298\ub9bd\ub2c8\ub2e4.<br \/>\n*   \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591: \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591\uc740 2031\ub144\uae4c\uc9c0 16.12%\uc758 \uac00\uc7a5 \ube60\ub978 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud558\uba70 \uc5ed\uc0ac\uc801\uc778 \uc9c0\ubc30\ub825\uc5d0 \ub3c4\uc804\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc911\uad6d \uad6d\uac00\ubc1c\uc804\uac1c\ud601\uc704\uc6d0\ud68c\ub294 \uc5ec\ub7ec \uc0b0\uc5c5 \ub2e8\uc9c0\uc5d0 \uc790\uae08\uc744 \uc9c0\uc6d0\ud588\uc73c\uba70, WuXi Biologics\ub294 \uc2f1\uac00\ud3ec\ub974\uc640 \ubbf8\uad6d\uc5d0 \uc0dd\uc0b0 \ub2a5\ub825\uc744 \ucd94\uac00\ud558\ub294 \ub3d9\uc2dc\uc5d0 \uc6b0\uc2dc \ucea0\ud37c\uc2a4\ub97c \ud655\uc7a5\ud588\uc2b5\ub2c8\ub2e4. \uc77c\ubcf8 PMDA\ub294 \ubbf8\uad6d \ud601\uc2e0 \uce58\ub8cc\uc81c \uc9c0\uc815\uacfc \uc720\uc0ac\ud55c \ud328\uc2a4\ud2b8 \ud2b8\ub799\uc744 \ub9cc\ub4e4\uc5b4 \ud3c9\uade0 \uac80\ud1a0 \uc2dc\uac04\uc744 4\uac1c\uc6d4 \ub2e8\ucd95\ud588\uc2b5\ub2c8\ub2e4. \ud55c\uad6d\uc758 \ub86f\ub370\ubc14\uc774\uc624\ub85c\uc9c1\uc2a4\ub294 \uc778\ucc9c\uc5d0 40\ub9ccL \uaddc\ubaa8\uc758 \uacf5\uc7a5\uc744 \uc704\ud574 33\uc5b5 \ub2ec\ub7ec\ub97c \ud560\ub2f9\ud558\uc5ec \uc9c0\uc5ed \uc218\uc694\ub97c \ud655\ubcf4\ud558\ub824\ub294 \uc758\uc9c0\ub97c \ubcf4\uc5ec\uc8fc\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \uc720\ub7fd: \uc720\ub7fd\uc740 \uc131\uc219\ud588\uc9c0\ub9cc \ub354\ub518 \uc131\uc7a5\uc138\ub97c \uc720\uc9c0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. EMA\uc758 \uc911\uc559 \uc9d1\uc911\uc2dd \uc2b9\uc778 \uc2dc\uc2a4\ud15c\uc740 \uc608\uce21 \uac00\ub2a5\uc131\uc744 \uc81c\uacf5\ud558\uc9c0\ub9cc, \uc0c1\uc774\ud55c \uad6d\uac00\ubcc4 GMP \uac80\uc0ac \ubc0f \ub192\uc740 \uc5d0\ub108\uc9c0 \ube44\uc6a9\uc740 \ubbfc\ucca9\uc131\uc744 \uc800\ud574\ud569\ub2c8\ub2e4. \ub860\uc790\uc758 \ube44\uc2a4\ud504 \ucea0\ud37c\uc2a4\uc640 AGC \ubc14\uc774\uc624\ub85c\uc9c1\uc2a4\uc758 \ud558\uc774\ub378\ubca0\ub974\ud06c \uc2dc\uc124\uc740 \uac00\uaca9\ubcf4\ub2e4 \uc2e4\uc801\uc744 \uc911\uc2dc\ud558\ub294 \ud504\ub85c\uc81d\ud2b8\ub97c \uacc4\uc18d \uc720\uce58\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uacbd\uc7c1 \ud658\uacbd<br \/>\n\ub860\uc790, \uc0bc\uc131\ubc14\uc774\uc624\ub85c\uc9c1\uc2a4, \uc368\ubaa8 \ud53c\uc154, \uce74\ud0c8\ub80c\ud2b8(\uc778\uc218 \ud6c4), \ucc30\uc2a4 \ub9ac\ubc84 \ub4f1 \uc0c1\uc704 5\uac1c \uacf5\uae09\uc5c5\uccb4\ub294 2024\ub144 \ub9e4\ucd9c\uc758 \uc0c1\ub2f9 \ubd80\ubd84\uc744 \ucc28\uc9c0\ud588\uc73c\uba70, \uadf8 \uc678\uc5d0 \ud2c8\uc0c8 \uc2dc\uc7a5\uc744 \uacf5\ub7b5\ud558\ub294 \uc218\ub9ce\uc740 \uc18c\uaddc\ubaa8 \uacf5\uae09\uc5c5\uccb4\ub4e4\uc774 \uc874\uc7ac\ud569\ub2c8\ub2e4. \uc774\ub4e4 \ub300\uae30\uc5c5\uc740 \uac00\ub3d9\ub960 \ubcc0\ub3d9\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0 \ub9c8\uc9c4\uc744 \uc720\uc9c0\ud558\uae30 \uc704\ud574 \uc77c\ud68c\uc6a9 \ubc18\uc751\uae30 \ud31c, \ub514\uc9c0\ud138 \ud2b8\uc708, AI \uae30\ubc18 \ud3b8\ucc28 \uc608\uce21\uc5d0 \ud22c\uc790\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc911\uacac \uc804\ubb38 \uae30\uc5c5\ub4e4\uc740 \ud2c8\uc0c8\uc2dc\uc7a5\uc744 \uac1c\ucc99\ud558\uace0 \uc788\uc73c\uba70, Cellares(CellShuttle) \ubc0f Ori Biotech(IRO)\uc640 \uac19\uc740 \ud601\uc2e0 \uae30\uc5c5\ub4e4\uc740 \ubaa8\ub4c8\ud615 \ud3d0\uc1c4 \uc2dc\uc2a4\ud15c \ud558\ub4dc\uc6e8\uc5b4\ub97c\uac1c\ubc1c\ud558\uc5ec \uc2dc\uc7a5\uc5d0 \uc0c8\ub85c\uc6b4 \uc194\ub8e8\uc158\uc744 \uc81c\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>CDMO \uc2dc\uc7a5\uc758 \ubbf8\ub798 \uc804\ub9dd<br \/>\nCDMO \uc2dc\uc7a5\uc740 \ub2e8\uae30\uc801\uc778 \uc5ed\ud48d\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0 \uc7a5\uae30\uc801\uc73c\ub85c\ub294 \uacac\uace0\ud55c \uc131\uc7a5\uc744 \uc774\uc5b4\uac08 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \ud2b9\ud788 \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c(CGT), mRNA \ubc31\uc2e0, \ud56d\uccb4-\uc57d\ubb3c \uc811\ud569\uccb4(ADC)\uc640 \uac19\uc740 \uace0\ubd80\uac00\uac00\uce58 \ubc14\uc774\uc624\uc758\uc57d\ud488 \ubd84\uc57c\uc758 \uc131\uc7a5\uc774 CDMO \uc218\uc694\ub97c \uacac\uc778\ud560 \uac83\uc785\ub2c8\ub2e4. \ub610\ud55c, \ubc14\uc774\uc624\uc758\uc57d\ud488 \uac1c\ubc1c\uc758 \ubcf5\uc7a1\uc131 \uc99d\uac00\uc640 \uaddc\uc81c \ud658\uacbd\uc758 \ubcc0\ud654\ub294 \uc804\ubb38\uc131\uc744 \uac16\ucd98 CDMO\uc758 \uc911\uc694\uc131\uc744 \ub354\uc6b1 \ubd80\uac01\uc2dc\ud0ac \uac83\uc785\ub2c8\ub2e4. CDMO \uae30\uc5c5\ub4e4\uc740 \uae30\uc220 \ud601\uc2e0, \uc0dd\uc0b0 \ub2a5\ub825 \ud655\uc7a5, \uadf8\ub9ac\uace0 \uc804\ub7b5\uc801 \ud30c\ud2b8\ub108\uc2ed\uc744 \ud1b5\ud574 \uc774\ub7ec\ud55c \ubcc0\ud654\uc5d0 \ub300\uc751\ud558\uace0 \uc2dc\uc7a5\uc5d0\uc11c\uc758 \uacbd\uc7c1 \uc6b0\uc704\ub97c \ud655\ubcf4\ud574\uc57c \ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p>\uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c \uc704\ud0c1\uac1c\ubc1c\uc0dd\uc0b0(CDMO) \uc2dc\uc7a5 \ubcf4\uace0\uc11c\ub294 \ud574\ub2f9 \uc2dc\uc7a5\uc758 \uc815\uc758, \ubc94\uc704, \uc5f0\uad6c \ubc29\ubc95\ub860, \uc2dc\uc7a5 \ud658\uacbd, \uaddc\ubaa8 \ubc0f \uc131\uc7a5 \uc608\uce21, \uacbd\uc7c1 \uad6c\ub3c4, \uadf8\ub9ac\uace0 \ubbf8\ub798 \uc804\ub9dd\uc744 \ud3ec\uad04\uc801\uc73c\ub85c \ub2e4\ub8e8\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubcf8 \ubcf4\uace0\uc11c\uc5d0\uc11c \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c CDMO \uc11c\ube44\uc2a4\ub294 \uc9c8\ubcd1 \uce58\ub8cc\ub97c \uc704\ud55c \uc0b4\uc544\uc788\ub294 \uc138\ud3ec \ub610\ub294 \uc720\uc804 \ubb3c\uc9c8\uc744 \ud65c\uc6a9\ud558\ub294 \uce58\ub8cc\ubc95\uc758 \uac1c\ubc1c, \uc0dd\uc0b0 \ubc0f \ud14c\uc2a4\ud2b8\ub97c \uc9c0\uc6d0\ud558\ub294 \uc804\ubb38 \uc11c\ube44\uc2a4\ub97c \uc758\ubbf8\ud569\ub2c8\ub2e4. \uc2dc\uc7a5\uc740 \uc81c\ud488(\uc138\ud3ec \uce58\ub8cc\uc81c, \uc720\uc804\uc790 \uce58\ub8cc\uc81c), \uac1c\ubc1c \ub2e8\uacc4(\uc804\uc784\uc0c1, \uc784\uc0c1, \uc0c1\uc5c5\ud654), \uc11c\ube44\uc2a4 \uc720\ud615(\uacf5\uc815 \uac1c\ubc1c, GMP \uc81c\uc870, \ubd84\uc11d \ud14c\uc2a4\ud2b8\/QC, \ucda9\uc804 \ubc0f \ud3ec\uc7a5), \uadf8\ub9ac\uace0 \uc9c0\uc5ed(\ubd81\ubbf8, \uc720\ub7fd, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591, \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74, \ub0a8\ubbf8)\ubcc4\ub85c \uc138\ubd84\ud654\ub418\uc5b4 \ubd84\uc11d\ub429\ub2c8\ub2e4. \ud2b9\ud788, \uc138\ud3ec \uce58\ub8cc\uc81c\ub294 \uc904\uae30\uc138\ud3ec \uae30\ubc18 \ubc0f \ube44\uc904\uae30\uc138\ud3ec \uae30\ubc18 \ub4f1\uc73c\ub85c, \uc720\uc804\uc790 \uce58\ub8cc\uc81c\ub294 \ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130 \ubc0f \ube44\ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130\ub85c \ub354 \uc138\ubd84\ud654\ub418\uba70, \uc804 \uc138\uacc4 17\uac1c \uc8fc\uc694 \uad6d\uac00\uc758 \uc2dc\uc7a5 \uaddc\ubaa8\uc640 \ub3d9\ud5a5\uc744 \ud3ec\ud568\ud569\ub2c8\ub2e4.<\/p>\n<p>\uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc131\uc7a5 \uc608\uce21\uc5d0 \ub530\ub974\uba74, \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c CDMO \uc2dc\uc7a5\uc740 2026\ub144 43.1\uc5b5 \ub2ec\ub7ec \uaddc\ubaa8\uc5d0\uc11c 2031\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 16.08%\uc758 \ub192\uc740 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud558\uba70 90.8\uc5b5 \ub2ec\ub7ec\uc5d0 \uc774\ub97c \uac83\uc73c\ub85c \uc804\ub9dd\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc8fc\uc694 \uc2dc\uc7a5 \uc131\uc7a5 \ub3d9\ub825\uc73c\ub85c\ub294 \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c(CGT) \uc784\uc0c1 \ud30c\uc774\ud504\ub77c\uc778\uc758 \uc9c0\uc18d\uc801\uc778 \uc99d\uac00, \uc720\uc804 \uc9c8\ud658 \ubc0f \uc554 \uc720\ubcd1\ub960 \uc0c1\uc2b9, \ubca4\ucc98\uce90\ud53c\ud0c8(VC) \ubc0f \ub300\ud615 \uc81c\uc57d\uc0ac\uc758 \ud22c\uc790 \ud655\ub300\uac00 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c, \uc18c\uaddc\ubaa8 CGT \uac1c\ubc1c\uc0ac\ub4e4\uc758 \uc544\uc6c3\uc18c\uc2f1 \uc120\ud638 \uacbd\ud5a5, \ub300\ub7c9 \uc0dd\uc0b0 \uc5ed\ub7c9\uc774 \ud544\uc694\ud55c \ub3d9\uc885\uc720\ub798(Allogeneic) &#8216;\uae30\uc131\ud488(Off-The-Shelf)&#8217; \ud50c\ub7ab\ud3fc\uc758 \ubd80\uc0c1, \uadf8\ub9ac\uace0 FDA-EMA-PMDA \uac04 CMC \uc11c\ub958 \uc870\ud654(Harmonisation)\ub97c \ud1b5\ud55c \ub2e4\uc9c0\uc5ed \ucd9c\uc2dc \uae30\uac04 \ub2e8\ucd95 \ub4f1\uc774 \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uacac\uc778\ud558\ub294 \ud575\uc2ec \uc694\uc778\uc73c\ub85c \uc791\uc6a9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubc18\uba74, \ub300\uaddc\ubaa8 AAV \uc0dd\uc0b0\uc744 \uc704\ud55c \uace0\ucc98\ub9ac\ub7c9 \ubd84\uc11d\uc758 \uc81c\ud55c, \ubcf5\uc7a1\ud558\uace0 \uc218\uc791\uc5c5 \uc758\uc874\uc801\uc778 \uc81c\uc870 \uacf5\uc815 \ubc0f \uaddc\uc81c \uc7a5\ubcbd, GMP \ub4f1\uae09 \ud50c\ub77c\uc2a4\ubbf8\ub4dc \ubc0f \ubc14\uc774\ub7ec\uc2a4 \uc6d0\uc790\uc7ac \ubd80\uc871\uc740 \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uc800\ud574\ud558\ub294 \uc694\uc778\uc73c\ub85c \uc9c0\ubaa9\ub429\ub2c8\ub2e4. \ub354\ubd88\uc5b4, \ucf54\ub85c\ub09819 \ud32c\ub370\ubbf9 \uc774\ud6c4 CDMO \uacf5\uae09 \uacfc\uc789\uc73c\ub85c \uc778\ud55c \ub9c8\uc9c4 \uc555\ubc15\ub3c4 \ub3c4\uc804 \uacfc\uc81c\ub85c \uc5b8\uae09\ub429\ub2c8\ub2e4.<\/p>\n<p>\ubcf4\uace0\uc11c\uc758 \uc8fc\uc694 \ubd84\uc11d \uacb0\uacfc\uc5d0 \ub530\ub974\uba74, 2025\ub144 \uae30\uc900 \uc138\ud3ec \uce58\ub8cc\uc81c\uac00 \uc2b9\uc778\ub41c CAR-T \uc81c\ud488\uacfc \uc2ec\uce35\uc801\uc778 \ub3d9\uc885\uc720\ub798 \ud30c\uc774\ud504\ub77c\uc778\uc5d0 \ud798\uc785\uc5b4 69.98%\uc758 \uac00\uc7a5 \ud070 \uc218\uc775 \ube44\uc911\uc744 \ucc28\uc9c0\ud558\uba70 \uc2dc\uc7a5\uc744 \uc8fc\ub3c4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc9c0\uc5ed\ubcc4\ub85c\ub294 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc774 \uc911\uad6d, \uc77c\ubcf8, \ud55c\uad6d\uc758 \uc0dd\uc0b0 \ub2a5\ub825 \ud22c\uc790\uc5d0 \ud798\uc785\uc5b4 2031\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 16.12%\ub85c \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<p>CDMO\ub4e4\uc740 \uc218\uc791\uc5c5 \uacf5\uc815\uc774 \ube44\uc6a9\uc758 \ucd5c\ub300 60%\ub97c \ucc28\uc9c0\ud558\uace0 \uc2e4\ud328 \uc704\ud5d8\uc744 \ub192\uc774\ub294 \uc810\uc744 \uace0\ub824\ud558\uc5ec, \uc7ac\ud604\uc131\uc744 \uac1c\uc120\ud558\uace0 \ucc98\ub9ac \uc2dc\uac04\uc744 \ub2e8\ucd95\ud558\uae30 \uc704\ud574 \uc790\ub3d9\ud654\uc5d0 \uc801\uadf9\uc801\uc73c\ub85c \ud22c\uc790\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc0b0\uc5c5 \ud1b5\ud569 \uce21\uba74\uc5d0\uc11c\ub294 Novo Holdings\uc758 Catalent \uc778\uc218\uc640 \uac19\uc740 \ub300\uaddc\ubaa8 \uac70\ub798\uac00 \uacf5\uae09\uc5c5\uccb4 \ud480\uc744 \ucd95\uc18c\uc2dc\ucf1c \ub0a8\uc544\uc788\ub294 \ub3c5\ub9bd \uae30\uc5c5\ub4e4\uc5d0\uac8c \ub354 \ud070 \uac00\uaca9 \ud611\uc0c1\ub825\uc744 \ubd80\uc5ec\ud558\uace0 \uc788\uc73c\uba70, \uc2a4\ud3f0\uc11c\ub4e4\uc740 \ub2e4\ub144 \uacc4\uc57d\uc744 \ud1b5\ud55c \uc0dd\uc0b0 \ub2a5\ub825 \ud655\ubcf4\ub97c \ucd94\uc9c4\ud558\ub294 \uacbd\ud5a5\uc744 \ubcf4\uc785\ub2c8\ub2e4. \uc120\ub3c4 CDMO\ub4e4\uc740 \ud1b5\ud569\ub41c \ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130 \ubc0f \uc138\ud3ec \ucc98\ub9ac \uc2a4\uc704\ud2b8, \uace0\uae09 \ubd84\uc11d \uae30\ub2a5, \uadf8\ub9ac\uace0 \uae00\ub85c\ubc8c \uaddc\uc81c \uc804\ubb38\uc131\uc744 \ud1b5\ud574 IND(\uc784\uc0c1\uc2dc\ud5d8\uacc4\ud68d)\ubd80\ud130 \uc0c1\uc5c5 \ucd9c\uc2dc\uae4c\uc9c0 \uc804\ubc18\uc801\uc778 \ud504\ub85c\uadf8\ub7a8\uc744 \ucc98\ub9ac\ud560 \uc218 \uc788\ub294 \ucc28\ubcc4\ud654\ub41c \uc5ed\ub7c9\uc744 \uc81c\uacf5\ud558\uba70 \uacbd\uc7c1 \uc6b0\uc704\ub97c \ud655\ubcf4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uacbd\uc7c1 \ud658\uacbd \ubd84\uc11d\uc740 \uc2dc\uc7a5 \uc9d1\uc911\ub3c4, \uc2dc\uc7a5 \uc810\uc720\uc728 \ubd84\uc11d, \uadf8\ub9ac\uace0 Lonza Group, Catalent Inc, Thermo Fisher Scientific (Patheon), WuXi Advanced Therapies, Samsung Biologics \ub4f1 \uc8fc\uc694 20\uac1c \uae30\uc5c5\uc758 \uc0c1\uc138 \ud504\ub85c\ud544(\uc0ac\uc5c5 \uac1c\uc694, \uc7ac\ubb34, \uc81c\ud488 \ubc0f \uc804\ub7b5, \ucd5c\uadfc \uac1c\ubc1c \uc0ac\ud56d \ud3ec\ud568)\uc744 \uc81c\uacf5\ud558\uc5ec \uc2dc\uc7a5 \ucc38\uc5ec\uc790\ub4e4\uc758 \uc804\ub7b5 \uc218\ub9bd\uc5d0 \uc911\uc694\ud55c \uc815\ubcf4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-41002","post","type-post","status-publish","format-standard","hentry","category-market-reports"],"_links":{"self":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts\/41002"}],"collection":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/comments?post=41002"}],"version-history":[{"count":0,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts\/41002\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/media?parent=41002"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/categories?post=41002"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/tags?post=41002"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}