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Status of BioStatus of Bio--industryindustryyyin Koreain Korea
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Global Trend of Bio-industry
“There will be more pressure on drug prices in 2009, from employers and insurers, new generic drugs and p y , g gthe Obama administration possibly requiring discounts on drugs in the Medicare program.
The growing use of biologics and their high price tagThe growing use of biologics and their high price tag will put pressure on US legislators to establish a pathway to allow the FDA to approve generic versionsof such drugs (biosimilars). g ( )
With strong support from the Korean government, Korea’s biotechnology and pharmaceutical industry has been rapidlygrowing from $10 2billion in 2000 to $15 7 billion in 2005growing from $10.2billion in 2000 to $15.7 billion in 2005representing an 18% of annual growth rate. The KoreanGovernment formulated Bio-Vision 2016 in November 2006 to acquire competitive source technologies and expand industrial infrastructure over the next 10 years. As the g p yfuture growth engine industry, the Korean market of biotechnology industry will develop to $23.1 billion in 2010. “
- G. Steven Burrill, ceo of Burrill & Company
1/22
Bi i d t i KOREABio-industry in KOREA
Market Value
Korean pharmaceutical market has been growing fast and expected to grow up to US$16.6 billion by 2010(10% of CAGR).Korean Bio related industry market is fast growing and predicted to reach
No of Employees Market Trade Global Market
Unit : USD Million, (USD 1=KRW1000)
Korean Bio-related industry market is fast growing and predicted to reachUS$6.5 billion by 2010 (20% of CAGR).
Year No. of Firms
Employees(Personnel)
Market Size Production Export Import Trade
BalanceGlobal Market
Share
Pharmaceutical Industry
(includes finished goods
2006781
(Manufacturers: 570)
70,681 13,882 11,473 863 3,272 - 2,409
(includes finished goods & raw materials,
excluding quasi-drugs)CAGR
`01~`06 4.6% 8.7% 10.1% 8.3% 3.1% 15.6% 21.4% 1.8%
2006 79417,316
(R&D – 8,715 (50 3%))
2,745 3,160 1,350 935 415Bio-related
industry
(50.3%))
CAGR`01~`06 12.5% 19.4% 18.7% 17.6% 9.1% 17.9% - 5.2% 2.2%
*S KIET 2007 KHIDI 2007 [2006 Whi P H l h I d ] MKE/ KATS/KIET/BAK [2006 S i i K Bi I d ] 2007*Source : KIET 2007, KHIDI 2007 [2006 White Paper on Health Industry], MKE/ KATS/KIET/BAK [2006 Statistics on Korean Bio Industry] 2007
3/22
Market Value
Korea recorded 1.8% of global market share, but its annual growth rate(’95~’05) is remarkable among OECD
◆ Global Pharmaceutical Market Share– Total Market Size US$607.9 Billion
7.13.6US
Total Health Expenditure Drug Expenditure
47.7%
29.9%
9.3% 5.8
5.8
6.4
6.6
7.1
3
3.4
3.2
4.7
4.3
S i
Mexico
Canada
Australia
Slovakia
KOREAKOREA
8.6%
4.5%
4 1
4.6
4.9
5.4
5.5
3.1
4
2.4
7.6
3
Netherlands
OECD
Austria
Korea
Spain
KOREAKOREA1.8%($14 billons)North America
Europe
Japan 3.1
3.3
3.5
4
4.1
3 2
2.3
2.8
1.8
3.4
France
Swiss
Germany
Norway
Netherlands
Japan
Asia Pacific&Africa (KOREA 1.8%)
Latin America
Source : IMS Health (2006) Source : OECD Health Data 2007 (Unit : %)
0.8
2.92.6
3.2
Japan
Italy
4/22
2009 Governmental R&D Investment in BT
The government plans to invest US$2.1 billion in biotechnology in2009(16.9% of total governmental R&D investment).
16 8% of 16.9% 16.9% of 16.8% of
Governmental
Total R&D
i i
Governmental
Total R&D
investment in
BT 2008investment in
BT 2009
※※R&D Investment in IT : 17.1%R&D Investment in IT : 17.1%→→16.1%(US$1.9billion)16.1%(US$1.9billion)(not considering private sector)
1$=1000KRW, Source : Ministry of Strategy and Finance (2009)
5/22
2009 Governmental R&D Investment in BT
The rate of government investment in biotechnology has been remarkable,comparing other sectors.
RANKSRANKS 20042004 20062006 20082008 20092009
1 IT(21.4%) IT(19.8%) IT(17.1%) BT(17.4%)
2 BT(15.6%) BT(17.4%) BT(16.6%) IT(16.2%)
3 Machines(9.0%) Machines(10.3%) Machines(11.8%) Energy(11.2%)
4 Energy(7.2%) Aero, space,marine(7.4%)
Energy(10.6%) Machines(11.2%)
5 Aero, space, marine(4 7%)
Energy(7.3%) Aero, space, marine(7 9%)
Aero, space, marine(7 8%)marine(4.7%) marine(7.9%) marine(7.8%)
Unit : % total government R&D budgets, Source : Ministry of Strategy and Finance (2009)
* Private investment s are excluded.
6/22
Major pharmaceutical companiesK h ti l i t l i R&D th l b l fi h
Sales R&D Expenditure Sales R&D Expenditure
Korea pharmaceutical companies spent less in R&D than global firms, however
recently recorded 2-digit growth in R&D investments.
NO Name
Sales R&D Expenditure
2008 2007Growth
rate2008 2007
Growth rate
D A 702 571 10 4% 45 40 12 5%
NO Name
Sales R&D Expenditure
2008 2007Growth
rate2008 2007
Growth rate
1 J&J 24,567 24,866 -1.2% 5095 5265 -3.2%1 Dong A 702 571 10.4% 45 40 12.5%
2 Hanmi 558 422 11.4% 57 55 3.6%
2 Pfizer 48,296 48,414 -0.2% 7945 8089 -1.8%
3 GSK 35,183 32,819 7.2% 5318 4807 10.6%
3 Yuhan 596 411 23.7% 34 30 13.3%
4 Green Cross 516 442 16.7% 42 35 20.0%
4 Sanofi-Aventis 38,924 39,607 -1.7% 6459 6406 0.8%
5 Novartis 41,459 38,072 8.9% 7217 6430 12.2%
5 Choongwae 438 385 13.8% 20 18 11.1%6 AstraZeneca 31,601 29,559 6.9% 5179 5162 0.3%
7 Merck 23,850 24,198 -1.4% 4805 4882 -1.6%
6 Jeil 319 305 4.6% 9 8 12.5%
7 Chong KunDang 303 252 20.2% 27 22 22.7%
8 Roche 43,199 43,688 -1.1% 8376 7940 5.5%
9 Wyeth 22 835 22 399 1 9% 3373 3256 3 6%g
8 LGLife Science 282 256 10.2% 60 59 1.7%
9 Wyeth 22,835 22,399 1.9% 3373 3256 3.6%
10 Eli Lilly 20,378 18,633 9.4% 3841 3486 10.2%
7/22 Unit : Million USD, 1$=KRW1000, Source : KFDA 2007
Development of Innovative drug in Korea
14 new drugs were approved by the KFDA (1 by USFDA) since 1999More than 9 new drug candidates have received IND approval from the USFDA
Product Name Indication Company Development Status
FACTIVE Quinolone Antibiotics LG Life Science Market Launched
hGH, IFN-a Growth Deficiency LG Life Science PhaseⅢ
LB8038 Anti-HBV therapeutics LG Life Science PhaseⅡ
Zydena(DA-8159) Erectile Dysfunction Dona A Pharm PhaseⅡ
YKP509 Anti-epilepsy SK Corporation PhaseⅡ
YKP10A Anti-depression SK Corporation PhaseⅡ
PTH Facilitates the formation of bone density Green Cross Corp PhaseⅠ
VM202 Cardiovascular disease Viromed PhaseⅠ
Neu2000 Cerebrovascular disease Neurotech PhaseⅠ
Source : Korea Drug Research Association (2008)
8/22
PatentsP i bi h h i d idl d k d K 2 d i A i■ Patents in biotech have increased rapidly and ranked Korea as 2nd in Asia.
Source: Biotech Policy Research Center 2009
RANK Country # of Patents(‘08)
# 14 KOREA 55Source: Biotech Policy Research Center, 2009
#1 US 2424
#2 JAPAN 399
#3 GERMANY 198
178207
150
200Number of patents
14 World Ranking
#4 CANADA 117
#5 SWISS 72
#6 UK 854750
100Technological strength
145.7
73.3
17
21
Ranking
■ Growth rate of patent registration in Korea is higher than U S
#7 FRANCE 100
: : : Source: Korea Drug Research Association (2007)
0 '94~'97 '98~'01 '02~'0513.9
21
■ Growth rate of patent registration in Korea is higher than U.S.
Source: KIPO 2007 9/22
Number of publications for BT Korean scientists in biotech have rapidly increased the contribution ofresearch papers, particularly to Nature, Cell and Science.
2928
26
CELL
SCIENCE
NATURE
7
2
514
1918
NATURE
Total No.
142 5
4
5
1
35
24
7
4
7
1011
1413
1 1 2 2 3 26
4 4 57
9
1 01 0
32
2 112
34
95 96 97 98 99 00 01 02 03 04 05 06 07
3 Main journals (NSC for Bio) 2 papers95 19 papers07
SCI Expanded(for Bioscience)
933 papers(23rd )95 4,909 papers
(`2005:13th)07Source: MEST, Report of BioVision2016 , 2008
10/22
Clinical TrialsIn 2007, total clinical trials were calculated for 281 cases.
Since 1993, the number of clinical trials has steadily increased in Korea, while
it in Japan decreased.
218
281
250
300
Multinational
108
134110
55
143 136
185
218
100
150
200
250Domestic
Total
5
18 17
46 6195
28 27 3897
75 90
14733
45 55
0
50
2000 2001 2002 2003 2004 2005 2006 2007
International Multi-centered Trials
Source: KFDA (2007.11)
11/22
Manpower of Bio-industry in KoreaKorea has plenty of creative biotech R&D personnel in both quality and
quantity.
US Europe Canada Asia- Pacific Korea
All employees 134,600 47,720 7,330 15,280 17,316
R&D employees 57,878 20,996 3,958 5,348 8,715
Percent 43 44 54 35 50
yBiotechIndustry 11.9% 44.4% 43.6%
OtherIndustries
1.7%
13% 86.3%Industries
PhD MS BS
12/22
fFuture of Korea Bio-industry
New growth engines for Korea since 2008
Establish high-value added new industry through development of
bio-pharmaceuticals, IT fusion medical devices with bio-fund of US$100 million.
Industrial Sectors Industrial Sectors Growth engines(22)Growth engines(22)
Energy, Environment Pollution-free fuel energy, Marine bio fuel, Solar battery, Fuel cell developing system, etc.
Transportation system Green Car, Vessel·Marine system
New IT Semiconductor, Display, Next-generation wireless communication, LED light etc.
Fusion new industryRobot, Material·nano fusionIT fusion system Broadcasting communication fusionFusion new industry IT fusion system, Broadcasting communication, fusion media.
BIO Biological drugs and medical-deviceSoftware Design Healthcare service
Knowledge serviceSoftware, Design, Healthcare serviceCulture contents
14/22
New growth engines for Korea since 2008
FINAL GOAL : “To be ranked among 5 leading countries in a sector of FINAL GOAL : “To be ranked among 5 leading countries in a sector of biotechnology and medical devices in 2018”biotechnology and medical devices in 2018”biotechnology and medical devices in 2018 biotechnology and medical devices in 2018
SectionSection PolicyPolicySectionSection PolicyPolicy
System Improvement
- Ease regulations on Clinical study/Pre clinical studies
and approvalsSystem Improvement pp
- Ease regulations on of listing KOSDAQ
Develop treatment of new concept
R&DDevelop New-generation Implant
Medi-bio diagnostic techinologies
Develop fusion medical devices
Human resource cGMP process, Risk assessment, HR training
15/22
u a esou ce p , , g
Future of Korea Bio-industry
“Quality of Life Oriented Society” with Prosperous “Bio-economy”
VISION 2018
- To achieve the 5th place Globally in BT arenas -
Objectives
Domestic Production of Bio USD 45 billionUSD 6 billion
2018201820082008
Objec es
Domestic Production of Bio
Scientific Publication
Patent Competitiveness
USD 45 billionUSD 6 billion
13TH Place 5th place
14TH Place 5TH Place
Job Creation 3,5000/year 244,000/year
Market Share 1.8 % 7.4 %
Expanding infrastructure forupgrading R&D
The innovative restructuring of the national biotech promotion system
StrategiesStrategies
1 2
Achieving the globalization of bio-industries
The regulatory and legal overhaul andthe enhancement of public acceptance
StrategiesStrategies
3 416/22
Korea’s Latest Technology Lisencsing Korean firms possess relatively sound drug development pipelines and have
successfully licensed out drug candidates
Comp. Purchase Comp. Indication
‘07. 7 Dong-hwa P&G Pharmaceuticals Osteoporosis
‘07. 7 LG Life Science TAKEDA Obesity
‘07. 7 Han-mi iNova Obesity
‘07. 9 Green Cross VABIOTECH Chicken pox
‘07. 11 LG Life Science Gilead Science Liver disease
‘07. 12 Green Cross Abraxsis Bioscience Inc rec. Factor VIII
‘07 12 CTC BIO Di h I t ti l BV Ob it‘07. 12 CTC BIO Disphar International BV Obesity
‘08. 1 SK J & J Epilepsy
‘08. 2 Crystal Genomics Proquest Anemia
Source : Bioindustry Association of Korea, 2008
‘08. 3 Viromed Cordis Myocardial infarction, Angina pectoris
17/22
K Bi h lKorea BiotechnologyIndustry Organizationy g- Your access to success
KoreaBio
HistoryHistory
1982. 1982. Korea Biotechnology Research Association(KBRA) founded1991.111991.11 Bio-industry Association of Korea(BAK) founded y ( )
2000. 72000. 7 Korea Bio-venture Association(KOBIOVEN) founded
2008.112008.11 BAK, KOBIOVEN and KBRA merged into KoreaBio
MissionMission
ToTo becomebecome anan interfaceinterface ofof governmentgovernment andand pharma/biotechpharma/biotech companiescompanies
TT tt KK bibi i d ti d t ii l b ll b l bibi i d ti d t ititToTo representrepresent KoreanKorean biobio--industryindustry inin globalglobal biobio--industryindustry communitycommunity
ToTo serveserve membermember companiescompanies withwith variousvarious supportingsupporting programsprograms
19/22
KoreaBio
Main Business AreaMain Business Area
Industry development and support
International cooperation
Information support and public relations
Policy cooperation and member company support
Training
Establishment of Pangyo Bio Center
20/22
KoreaBio
Supporting CompaniesSupporting Companies
Chong Keun Dang, Han-mi, Dong-A Pharm Co., LG Life Science,Green cross, Choog-wei, Macrogen Inc, Dea-sang, Bo-ryung Pharm,Sam-yang Genex, Dea-woong, Cell trion, Dong-kook, Meditox, Viromed, Medipost, Bioneer… (total 302 companies)
Business ObjectivesBusiness Objectives
ToTo assistassist KoreanKorean governmentgovernment toto executeexecute thethe policypolicy “New“New GrowthGrowth Engine”Engine”
ToTo establishestablish aa BioBio centercenter withwith USUS$$100100 millionmillion ofof fundfund raisingraising
ToTo developdevelop “BIO“BIO KOREA”KOREA” asas aa representativerepresentative biobio--relatedrelated eventevent inin KoreaKorea
21/22
Thank you !y
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