2005 5 16 1
1 3 2 GMP 5 3 8 4 13 5 CRO 14 6 17 7 18 8 22 9 23 10 27 11 31 12 32 2
TOP 1 5 16 45 45 20 21 DNA 25 3
4 42 5 3000 2008 16 25 20 90 IP 4
40 TOP 2 GMP 1982 GMP 2000 1340 2001 5
2 60% 79 GMP GMP 800 1500 3000 1200 21 1.8 5 2.2 5000 1000 30 GMP 250 193 GMP 80 2004 40 GMP 1600 GMP 6
9 GMP 1.9 3.6 GMP 1 1 5 9 5000 2004 4.15 1.2 21.7 50 91 GMP 70 30 GMP GMP GMP GMP 7
GMP GMP GMP TOP 3 7 1 2005 5 8
22 2005 7 1 2005 2000 2005 3 3 2005 9
2005 5 2000 200 2005 2 50 6 4 50 3 1 2 2 2005 2005 2005 10
2005 7 1 525 975 7 1 2005 7 1 2006 12 31 2005 ( ) 7 1 525 975 11
2005 60% 2005 2000 3 3 12
TOP 4 13
TOP 5 CRO Contract Research Organization CRO CRO CRO CRO FDA CRO 14
CRO FDA FDA CRO CRO FDA 1997 Covance CRO FDA CRO CRO CRO Quintiles FDA CRO 2004 FDA CRO CRO 15
1~2 FDA CRO FDA CRO CRO CRO CRO FDA CRO CRO CRO CRO CRO CRO 16
TOP 6 1998 15 2000 ( ) 15% 20% 30% 50% 90 42 17
50%-70% ( ) : TOP 7 180, 3 18
2000 7 4 3 8 4 19
20
5000 GDP 1000 21
TOP 8 (API) Newprot Strategms JeanHoffman Hoffman Hatch-Wax-man Hatch-Wax-man 1984 (ANDA) 4 I- (Paragraph I- certifications) I 22
( FDA ) ANDA Hoffman " " (Dr Reddy s) (Ivax) ( ) (cipla) 2000 12 TOP 9 2004 1 23
11548 35.7% 5934 35.4% 3% 40% 50% 90% 2003 80 65% 20% 10% 2004 100 50% ( ) 1999 118 24
1 3 2005~2006 3.7% 5 1 1 6 ~7 90% 25
6 7 8 ( ) 26
10 180 10 40 100 1000 TOP 10 generics multisource drugs 2007 35 820 27
IMS 2002 2005 CAGR 13% CAGR 9% 2003 290 2004 20% 348 2002 2005 15% 12% 2003 22% 2004 170 50% EGA 2009 75% 210 40 50 10% 45% APIs 2002 80 2007 150 APIs 70% 75% 2002 60 2007 100 2500 APIs 200 4000 1500 80 40 5000 60 8000 40 300 20 1990 783 97.4% 1985 2001 1193 147 87.6%% 28
12 8 Process chemistry Delivery systems 10 3 10 3 150000 60000 5000 NCEs 1976 1.25 2001 8.00 5 4 5000 20% 2001 120.8 2003 460 2005 1200 10% 15% 30% APIs 2010 29
80% DMF FDA cgmp EDMF / COS 30
TOP 11 FDA 11 FDA 2004 9 FDA 177 9.8% 53 29.9% 22 12.4% 2004 10 FDA 146 8.4% 18 12.3% 31 21.2% 2004 11 FDA 177 11 41 23.2% 35 19.8% 3 48 31
FDA FDA TOP 12 GSK GSK 0.3% 32
2006 50 62 30%~70% 16% 33