2015 2007 5 1
2
2015 2007 5 103-0023 3-4-1 5F TEL : 03-5200-2681 FAX : 03-5200-2684 E-mail : sasabayashi-opir@jpma.or.jp URL : http://www.jpma.or.jp/opir/ 3
4
5
6
1
2
3
4
1
2
3
4
5
6
7
8
9
10
11
2013 2014 2014 ADME 2016 2017 DDS 2017 2017 2017 2018 2 2018 2019 DDS 2019 DDS 2019 2019 2019 2019 2019 2019 2020 2020 2021 2021 2023 2023 550 2030 12
0.0 10.0 20.0 30.0 40.0 50.0 60.0 54.0 48.2 38.2 41.2 26.7 29.8 11.1 10.8 14.3 5.8 8.1 1.6 13
No.17 14
15
16
17
18
19
20
35.0 35.0% 29.5% 30.0 28.0% 28.5% 26.1% 27.0% 30.0% 24.5% 25.0 23.3% 25.0% 21.9% 20.2% 19.6% 20.2% 20.6% 20.7% 20.0 20.0% 28.5 29.1 29.8 30.9 30.4 31.3 31.1 31.5 15.0 15.0% 25.8 27.0 23.5 24.4 21.8 10.0 10.0% 5.0 5.0% 6.4 6.6 6.9 6.7 7.3 7.0 6.8 6.0 6.1 6.1 6.5 6.4 6.9 0.0 0.0% 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 21
22
23
100 1 252,222 5.1 2 67,741 6.8 3 31,869 8.5 4 30,297 6.4 5 19,796 2.6 6 19,453-2.2 7 15,141 8.0 8 13,512 7.1 9 11,629 20.4 10 9,098 38.5 11 8,802 12.0 12 7,625 14.6 13 6,972 21.9 14 6,586 4.9 15 6,328 8.6 16 4,700 3.6 17 4,645 7.5 18 4,402 12.5 19 4,316 0.6 20 3,873 7.7 24
25
//SNPs IT SNPs 26
27
28
A A a b B B 29
H2 HMG-CoA ACE NSAID 1900 1950 1960 1970 1980 1990 2000 2010 30
31
200 2002 200 200 2007 2006 32
33
34
35
() 0 50 100 150 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 36
37
etc etc EBM/ etc 38
39
FIM First in Man) Phase ab Phase b, Phase TR CPRFDA NIH( Innovative Medicine Initiative (EU) ADME SNP IT 40
10 600 10.5 500 400 300 11.4 200 100 3.5 0 1999 2000 2001 2002 2003 2004 41
GSK 1 1 R&D 01 02 06 04 07 01-05 03 05 04 07 03 05 03 04 05 02 42
2,699 5.7 2,330 4.9 2,011 4.2 1,771 3.7 1,705 3.6 1,618 3.4 1,614 3.4 1,411 3.0 1,398 2.9 1,305 2.7 1,288 2.7 1,280 2.7 1,090 2.3 1,067 2.2 985 2.1 984 2.1 957 2.0 838 1.8 752 1.6 737 1.6 43
44
45
46
Investment Innovation Return 47
48
49
50
51
60 53 50 40 39 39 35 39 36 30 20 24 15 21 30 27 24 24 23 17 15 21 16 22 20 20 19 23.2 29.5 10 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 96-06 52
130 120 110 100 90 80 70 60 50 40 30 20 10 0 14 11 15 28 29 5 4 5 8 10 17 17 4 7 12 11 9 3 3 6 97 75.2% 32 24.8% 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 1996-2000 66 74.2% 23 25.8% 2001-2005 53
9,000 8,393 8,000 7,000 6,000 5,606 6,351 6,301 5,963 6,897 7,222 5,080 5,000 4,000 4,349 4,257 3,000 2,000 1,000 1,484 1,581 1,904 851 1,492 1,457 926 1,087 1,230 1,169 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 54
55
56
57
58
59
60
61
62
63
64
65
66
6, 000 5,000 4,000 3,000 2,000 1,000 0 5,507 5,621 3,233 3,567 1,576 1,321 1977-80 1981-84 1985-88 1990-92 1994-95 1998-01 67
68
69
70
71
72
10) 16 73
74
75
76
77
78
16) 79
80
DTI Office for the Strategic Coordination of Health Research OSCHR DH MRC NIHR Translational Medicine Funding Board RCUK NHS 81
82
83
N.A. N.A. 84
85
86
87
88
89
90
91
22) 92
93
94
95
96
97
98
99
100
14 12 10 8 6 5.2 3.9 5.2 5.3 6.6 6.2 5.3 4.7 5.3 5.3 4 2 0 n19 n17 n23 n39 n43 n24 n26 n24 n19 n25 101
2004 (n173) 2005 (n62) (n83) (n177) (n99) (n38) (n53) 45 620 (n116) 47 631 41 475 (n33) (n54) (n185) (n95) 52 650 26 384 52 603 58 760 51 632 42 589 40 441 52 605 35 471 0 200 400 600 800 2005558502 2004622635 655 818 410 481 516 506 631 683 665 678 657 702 102
103
0 500 1,000 1,500 2,000 722 327 102 37.5 n34 n131 n32 n64 104
0.18 0.29 0.26 0.27 0.27 0.19 0.21 1 0.24 0.27 0.27 0.23 0.23 0.24 0.27 1 CRO 0.48 0.27 0.16 0.16 0.04 0.17 0.18 1 0.24 0.27 0.24 0.24 0.24 0.24 0.27 1 0.22 0.28 0.25 0.25 0.25 0.21 0.23 1 105
1995100 96 97 98 99 00 01 02 03 04 05 96 97 98 99 00 01 02 03 04 05 106
/ 0 10 20 30 40 10.0 17.0 4.0 4.1 n443 n492 n562 n195 n556 n403 Phase1 Phase2 Phase3 9.1 10.0 2004 (n29/n19) (n91/n26) (n95/n30) (n87/n19) (n163/n43) (n300/n13) 2005 (n48/n5) (n110/n19) (n29/n7) (n63/n9) (n192/n6) (n116/n0) 4.1 4.8 4.5 5.9 5.6 6.5 6.8 7.5 5.7 6.6 4.0 5.4 4.4 5.3 5.4 4.2 6.9 3.5 7.8 10.1 10.4 10.9 17.0 0 5 10 15 20 20047.95 20058.67 107
108
17) 109
1.0% 0.5% 1.2% 63.8% 84.7% 1. 2.1 3. 61.6% 93.4% 26.9% 10.5% 6.2% 0.4% 14.8% 28.1% 7.7% 0.5% 25.7% 10.8% 61.2% 62.3% N1032 N196 N509 1. 3. N1036 2.1 37.6% 1.2% N196 N510 110
<12 >12 <6 >6 111
( 21.2 11.0 16.6 12.1 16.0 12.9 n69 n96 n47 n66 n56 n78 n39 n71 n44 n106 n47 n76 18.6 13.0 17.4 13.0 22.7 10.2 n69 n96 n47 n66 n56 n78 n39 n71 n44 n106 n47 n76 12 12 112
0 10 20 30 22.0 4.5 19.6 2.5 12.7 2.2 12.2 2.5 12.8 2.6 18.2 2.8 2000 2001 2002 2003 2004 2005 2000 2001 2002 2003 2004 2005 - (1)- - 1.7 1.7 4.7 1.4 8.0 2.0 4.2 1.3 3.0 2.0 -(1) - 14.3 2.7 113
FDA MHRA EMEA 197 2,200 693 900 1,100 400 360 114
115
() 14 12 10 8 6 4 2 0 6.6 2.2 n87 n125 n35 n38 (-) (-) 5.3 1.8 116
0 20 40 60 80 100 100.0 5.6 94.4 7.1 7.1 85.7 5.1 2.6 23.1 69.2 11.8 5.9 47.1 35.3 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 n11 n18 n14 n39 n34 n36 n33 n35 n33 n11 5.6 8.3 47.2 38.9 9.1 51.5 39.4 2.9 5.7 31.4 60.0 3.0 12.1 51.5 33.3 18.2 54.5 27.3 117
118
CRC DM n344 n345 n344 n326 n344 n307 n344 n307 1 0 24) 119
() () () IRB IRB ( n344 n339 n227 n337 n337 -- --, 120
60 53 50 40 39 39 35 39 36 30 20 24 15 21 30 27 24 24 23 17 15 21 16 19 20 20 22 23.2 29.5 10 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 96-06 121
100% 86.0 90% 80% 70% 3929.160% 50% 40% 30% 20% 10% 8160.4 64.5 0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 122
100% 90% 80% 70% 2000 NME04 NME0004 1NME01 NME0104 2b01 2aNME03 20052bNME04 NME00 NME00 00 NME03 NME05 03 05 60% 50% 40% 30% B C NME00 NME02 NME00 NME01 NME02 NME03 04 20% 10% NME01 03 05 NME05 03 0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 123
86 47 34 5 300 250 200 150 100 50 0-50 -100 124
88 47 34 300 250 200 150 3 100 50 0-50 -100 125
100% 1%(2) 4%(6) 2%(3) 3%(4) 3%(4) 4%(6) 5%(7) 16%(24) 25%(37) 80% 60% 57%(85) 62%(93) 71%(106) 45%(67) 40% 72%(108) 20% 0% 38%(57) 24%(36) 33%(50) 23%(34) 7%(11) 7%(10) 1 24 5 ATC 126
127
80% 5.6 68% 6.7 64% 11.7 64% 17 62% 18.5 57% 19.2 45% 38% 29% 28% 0% 20% 40% 60% 80% 19.2 22.1 25.8 35.1 0 10 20 30 40 128
129
130
131
132
133
134
135
136
% 137
138
1 4.8 7.7 6.4 5.0 4.2 2 4.6 5.3 5.3 4.3 3.0 3 4.3 4.9 3.9 3.3 2.9 4 3.8 4.0 3.2 2.5 2.5 5 2.5 3.3 3.2 2.4 2.3 6 2.5 3.0 3.0 HIV 2.2 2.3 7 2.5 2.5 2.9 2.2 2.2 8 2.3 2.4 2.5 1.9 2.2 9 2.0 2.3 2.1 1.8 2.1 10 1.9 2.0 2.1 1.7 2.0 11 1.7 1.7 2.1 1.7 1.9 12 1.3 1.7 1.9 1.6 1.8 13 1.3 1.6 HIV 1.7 1.6 1.6 14 1.3 1.6 1.7 1.5 1.5 15 1.3 1.5 1.7 1.4 1.5 16 1.3 1.5 1.7 1.4 1.5 17 1.3 1.5 1.5 1.4 1.5 18 1.2 1.4 1.5 1.4 1.4 19 1.2 1.4 1.4 1.3 1.3 20 1.2 1.3 1.4 1.2 1.3 20 44.3 52.6 51.2 41.8 41.0 139
ARB 19 9 5 5 5 0 5 10 15 20 ( 6 5 3 3 3 0 2 4 6 8 10 6 5 5 5 ( 7 0 2 4 6 8 10 ( 82 49 46 36 34 0 10 20 30 40 50 60 70 80 90 ( 8 7 6 5 5 0 2 4 6 8 10 ( 140
7 1 3 2 3 2 1 4 2 3 3 3 5 4 2 3 2 1 2 1 3 2 1 2 3 2 2 1 2 2 1 1 3 1 1 1 2 1 1 1 3 2 1 1 2 1 2 1 1 1 1 2 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 3 1 25 25 25 25 25 141
30.0% 28.5% 25.0% 24.6% 22.7% 20.0% 20.6% 18.1% 20.1% 20.4% 18.1% 17.4% 25 15.0% 10.0% 15.2% 11.5% 6.9% 15.1% 15.1% 10.9% 9.3% 15.2% 12.8% 10.0% 6.4% 13.9% 12.0% 9.8% 7.3% 20 15 10 5 5.0% 4.4% 0.0% 142
16 15 14 13 13 14 12 10 8 8 10 9 9 10 8 6 4 4 5 2 2 2 1 2 0 143
100% 90% 80% 70% 32%23 68%48 46%33 44%36 60% 50% 40% 30% 20% 68%48 32%23 44%36 46%33 10% 0% 1997 2005 1997 2005 144
(n=70 61.4% 18.6% 20.0% (n=70 30.0% 45.7% 24.3% (n=68 38.2% 38.2% 23.5% (n=63 30.2% 41.3% 28.6% (n=64 10.9% 54.7% 34.4% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 100.0% 1994 1995-1999 2000-2005 (n=70 60.0% 20.2% 19.8% (n=70 31.0% 46.2% 22.7% (n=68 33.2% 48.8% 18.0% (n=63 30.0% 40.6% 29.4% (n=64 11.8% 54.2% 34.0% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 100.0% 1994 1995-1999 2000-2005 145
146
147
2000100 130.0 120.0 110.0 100.0 101.4 90.0 80.0 70.0 2000.01 2001.01 2002.01 2003.01 2004.01 2005.01 2006.01 84.0 200611 20016100 130.0 All commodities) Pharmaceutical preparations) 120.0 110.0 100.0 90.0 80.0 70.0 2001.06 2002.06 2003.06 2004.06 2005.06 2006.06 Output of manufactured products) Pharmaceutical preparations) 2000100 130.0 120.0 110.0 100.0 90.0 80.0 70.0 2002.01 2003.01 2004.01 2005.01 2006.01 148
4.00 3.50 3.00 2.50 2.00 1.50 1.00 0.50 0.00 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 20mg 10mg 10mg 10mg 149
2 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 20mg 20mg 20mg 20mg 2.00 1.80 1.60 1.40 1.20 1.00 0.80 0.60 0.40 0.20 0.00 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 20mg 20mg 10mg 10mg 150
3.00 2.50 2.00 1.50 1.00 0.50 0.00 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 20mg 20mg 20mg 300.0 250.0 200.0 150.0 100.0 50.0 0.0 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 10mg 5mg 10mg 5mg 151
70 20042000 19991995 19941990 19891985 19841980 1979 0.0 0.5 1.0 1.5 2.0 2.5 3.0 152
20042000 19991995 19941990 19891985 0.0 0.5 1.0 1.5 2.0 2.5 3.0 153
2005 154
155
156
1,017,921 46,623 167,473 123,663 67,767 112,563 48,737 100.0 4.6 16.5 12.1 6.7 11.1 4.8 1990-2004 14.5 36.5 16.6 13.3 13.7 17.2 21.5 % 35.8 64.6 33.6 27.0 40.0 38.7 34.5 12.5 49.8 13.2 16.1 27.4 11.8 23.5 157
158
159
1997 3 8 15 29 30 2,748 1,708 1,181 857 848 5 7,342 2005 7 16 24 25 26 28 37 38 47 56 60 67 73 91 107 109 111 127 4,394 3,472 2,597 2,583 2,562 2,480 1,957 1,956 1,705 1,469 1,403 1,338 1,238 1,099 949 912 889 744 130 739 148 632 164 552 167 540 22 36,209 65 59 64 62 54 56 53 58 60 65 53 54 43 51 54 41 32 15 47 63 4 160
NEEDS 161
DNA DNA DDS DNA DNA DDS NEC NTT JTB DNA 162
05 97 05 97 97 05 05 05 97 97 05 97 163
2002 2003 2004 2005 2006 200210 200210 200311 20054 20068 20059 20074 200510 200510 HD 200710 164
165
166
167
168
169
NEEDS 170
410 14) 10 2002 2005 2002 2003 2004 2005 2004 171
172
173
174
175
45 40 35 42 41 39 2003 2004 2005 30 25 20 15 20 19 17 15 13 12 10 5 9 10 9 6 6 6 4 3 2 2 2 3 4 4 4 3 3 2 0 176
World Scope World Scope 177
178
179
180
0 14 0 14 19 10 0 29 30 23 2 55 9 9 0 18 13 12 2 71 68 4 27 143 181
182
183
15,000 9 27 500 47 66 11,768 400 430 10,000 300 282 5,000 3,154 200 100 0 0 NIH 184
185
42 BASF IDEC 42 BASF IDEC NPO CED NPO CED 18km 38km 45km 157R&D132 39,00097.3R&D 42 BASF IDEC 42 BASF IDEC NPO CED NPO CED 18km 38km 45km 157R&D132 39,00097.3R&D 186
M & A 187
188
189
190
191
2% 4% 3% 12% 16% 8% 9% 78% 71% 192
193
194
195
US 196
197
NIH CTSA 198
199
M B A M B A 200
201
202
203
1 Novartis 7.66 1 BMW 7.38 1 IBM 7.57 1 General Electric 8.24 2 Johnson & Johnson 7.53 2 Toyota Motor 7.18 2 Apple 7.45 2 Siemens 7.19 3 Roche Group 6.97 3 Honda Motor 6.41 3 Microsoft 7.03 3 Matsushita Electric Industrial 7.03 4 Eli Lilly 6.73 4 Volvo 6.27 4 Xerox 7.03 4 Samsung Electronics 6.79 5 GlaxoSmithKline 6.68 5 Mazda Motor 6.03 5 SAP 6.86 5 Royal Philips Electronics 6.63 6 Amgen 6.62 6 DaimlerChrysler 5.85 6 Canon 6.84 6 Sony 6.49 7 Abbott Laboratories 6.61 7 General Motors 5.60 7 Hewlett-Packard 6.56 7 Hitachi 6.33 8 Wyeth 6.43 8 Nissan Motor 5.31 8 Sun Microsystems 6.24 8 Sharp 6.21 9 Sanofi-Aventis 6.07 9 Ford Motor 5.21 9 Oracle 6.05 9 LG 6.14 10 AstraZeneca 6.00 10 Renault 5.17 10 Dell 6.03 10 Toshiba 6.11 11 Pfizer 6.00 11 Volkswagen 5.09 11 Ricoh 5.63 11 Mitsubishi Electric 5.63 12 Merck 5.88 12 PSA Peugeot Citroen 4.84 12 Fujitsu 5.57 12 Tyco International 5.44 13 Schering-Plough 5.53 13 Hyundai Motor 4.66 13 Seiko Epson 5.42 13 Hon Hai Precision Industry 14 Bristol-Myers Squibb 4.98 14 Suzuki Motor 4.57 14 NEC 5.35 14 Sumitomo Electric Industries 5.39 5.38 15 Fiat 4.38 15 Quanta Computer 5.01 15 Sanyo Electric 4.94 204