2009 生技產業白皮書 -...
TRANSCRIPT
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2009
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98 7
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1995
2004
(BTC)2008 BTC
2009
2008 BTC
TFDA
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2009
98 7
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21
1980
1995
2009
2008
2,010 2007 5% 2004~2008
8%
2000~2008 1,157
2001 200
2008 250
2009 5 23
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2009 2
1 2
98 7
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2008
2008336200736.4%6IPO
2008251,3301.25752008
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20082,01020075%79010%1%1,1846771,4352,768
200727020082502009236130.612008391128440.982007400.0310%20081985.09
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(value chain)TFDA
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2
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Abstract
Applications of biotechnology are widely found in various areas, ranging
from pharmaceuticals and health care to agriculture, food, energy,
chemistry, biological resources, and environmental protection, hence
biotechnology has already become part of human life. As the human
longevity and living quality improves, human beings are increasingly
dependent upon biotechnology products and it is anticipated that
biotechnology will bring tremendous business opportunities in the future.
Therefore, many countries have placed the biotechnology industry on
their top list when promoting the next-generation mainstream industries.
Although the global financial crisis sent the world's economies into a
rapid downturn in the second half of 2008, pharmaceuticals, transgenic
crops, and other biotech products have not suffered as much as other
consumer-oriented products have. The biotech industry is still in its
growth phase, and the size of the industry is continually expanding. The
one impact on the industry has been a reduced ability to raise capital, an
impact which has hit publicly traded companies the hardest. In 2008 the
world's publicly traded biotech companies raised US$33.6 billion, a
decrease of 36.4% compared to 2007, and only six biotech firms held
initial public offerings in 2008. Although privately held firms were not
hit as hard as the publicly traded firms, they also suffered from shift of
venture capitalists investment targets.
Currently biopharmaceuticals are the largest sector of the biotech
industry, and have become the main driving force of biotech industry as
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biopharmaceutical market continuing expansion. At the same time the
number of countries planting genetically modified crops is increasing
annually. By 2008, 25 countries and 13.3 million farmers had already
planted transgenic crops on 125 million hectares of land, valuing a total
of US$7.5 billion. As crude oil prices rose, biofuels became a hot topic in
2008. But long before the price hikes, many countries have treated
biofuel as one of the strategic measures to combating the greenhouse
effect, actively developing new generation of biofuel technology aimed
at increasing biofuel production while simultaneously preventing biofuel
production from competing with crops intended for human use.
The advanced countries of Europe and the Americas is the major market
of biotech products and serve as home to the world's leading biotech &
pharmaceutical firms. Based on the free market competition mechanism,
these governments have enacted a transparent set of regulations and
guidelines that allow biotech firms to follow and compete fairly. These
governments only invest in cutting-edge, high-risk biotech products that
the industry would otherwise have little interest developing,
by .supporting research institutes to perform R&D projects, providing
grants, or encouraging technology transfer and spin-off when the critical
technologies are developed, so that the biotech industry can grow to
reach its full potential. Asian countries are likewise strengthening their
biotech research capabilities and the governments use their existing
market niches and various measures to boost biotech industry, including
utilizing strong government leadership to develop niche technologies,
encouraging non-biotech big conglomerates to invest in biotech
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industries, and providing incentives to attract foreign capital establishing
research and manufacturing centers within their borders. They also
clearly define their target markets for exports. Currently Singapore,
Korea, and India have been the most successful at developing their
biotech industries, and these countries have shown substantial growth in
biotech industry in recent years.
In 2008 Taiwan's biotech industry had total sales of NT$201 billion, an
increase of only 5% over 2007. Medical devices sales were NT$79
billion, the largest portion of total sales. Emerging biotech companies
showed the fastest growth, growing at a rate of 10%. Pharmaceutical
production showed a growth rate of only 1%. The industry is made up of
1,184 firms. Exports totaled NT$67.7 billion while imports totaled
NT$143.5 billion. Domestic biotech demand reached NT$276.8 billion.
Although investment in Taiwan's biotech industry reaches its historical
high of NT$27 billion in 2007 after promulgation of the Act for the
Development of Biotech and New Pharmaceuticals Industry, the
investment drops slightly to NT$25 billion in 2008 owing to banks
tightened lending policies and companies conservative investment
strategies triggered by global financial crisis. By February, 2009 the
National Development Fund, Executive Yuan had approved investment in
36 domestic and overseas biotech investment projects, encompassing a
total of NT$13.061 billion in approved investment. Currently there are
totally 39 biotech companies that are either publicly listed or traded
over-the-counter in Taiwan, including 11 publicly listed companies and
28 over-the-counter (OTC) companies, and total 2008 sales of these
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biotech firms came in at NT$44.098 billion, a 10% increase over 2007's
NT$40.003 billion. There are also 19 companies registered ready for
OTC stock market, these firms had combined total sales of NT$8.509
billion.
Taiwan's biotech industry is still in its development phase in comparison
with advanced countries. Although many Taiwanese biotech firms have
achieved R&D results or have developed core biotech technologies, they
lack the corporate culture and structure to protect their intellectual
property and have not established comprehensive intellectual property
rights and patent strategies, leaving Taiwan unable to realize its full
competitive potential in the global market. Only a continued government
policy of promoting and encouraging biotech development, including the
guidance and financial support necessary for Taiwan's biotech
pharmaceutical industry to establish its own intellectual property rights,
will allow Taiwan's biotech firms to increase their international
competitiveness.
Taiwan's formal educational system is able to produce a sufficient pool of
biotech talent to meet overall industry needs. The government should
promote more direct industry experience, facilitate academic-research
institute-enterprise collaboration and share limited resources, as well as
encourage innovation activities. Only if biotechnology talents are
motivated to engage in innovative research, resulting in a large-scale
increase in new innovating biotech firms, will Taiwan be able to provide
a smooth path to employment for aspiring biotech workers and increase
the utilization of the nation's biotech talent pool.
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In comparison with the Asian nations most successful at developing their
biotech industries, the size of Taiwan's biotech industry is not
particularly significant. The growth of Taiwan's biotechnology market is
far behind that of Asia's top biotech nations. The key reason for this is
that Taiwan's support for biotech development has focused funding on
the development efforts of research institutions without simultaneously
supporting the R&D efforts of industry. From the inception of its biotech
development program to this date Taiwan has not been able to create a
high-value biotech product with the market success necessary to
accelerate the growth in value of Taiwan's biotech industry. The second
reason is that the size of Taiwan's domestic market pales in comparison
to the markets of Europe, Japan, and the Americas. Nor does Taiwan
have the large domestic market to support its development of export
products that India has. Add to this that Taiwan's industry is focused on
the domestic market and has not yet become a part of the international
supply chain and the growth in Taiwan's biotechnology exports is
understandably slow.
In the future Taiwan's biotech industry needs to increase the scale of
every phase of its operation and needs to enhance cooperation and
linkage between all levels of the industry in order to create a smooth path
from lab research to commercialization of products. For those
commercialization oriented R&D projects, the government should focus
on their core value of industrial technologies, integrate academia,
research institute and industrys resources, study and explore their
intellectual property potential, as well as carry out patent valuation. Once
the potential products are identified, resources should be actively focused
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on these projects and assistance should be offered. Regarding medicines,
which require a long development period, the screening of drug
candidates needs to be increased and potential drug candidates need to be
brought into pre-clinical trials more quickly. Additionally private and
government funds should be injected into the research and development
process, after which private companies will utilize the research results to
create commercial products. This process will lead to the establishment
of new biotech companies which create original products.
As biopharmaceuticals are the primary driving force of biotech market,
Taiwan should create a plan to ensure a supply of the requisite
biopharmaceuticals at the earliest possible opportunity. The nation
should undertake the training of the personnel necessary for large scale
production of Biological product in order to meet the needs of the
biotech industry's growth. And, as the laws regulating biotechnology
differ from nation to nation, Taiwan should increase its efforts to
research the approval process for biotech medicines in target countries.
Taiwanese firms should also merge or cooperate with biotech
pharmaceutical distributors in their target markets. In this way Taiwan
can both comply with the import requirements of target nations and
utilize their already existing distribution networks to expand Taiwanese
biotech pharmaceutical exports and increase Taiwan's share of the global
biotech medicine market.
Looking forward, The Executive Yuan's Biotechnology takeoff package
intends to strengthen the industrial value chain & pre clini cal
development in the commercialization process, establish a biotechnology
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venture capital fund, promote an integrated incubation mechanism, and
create the Taiwan Food and Drug Administration (TFDA) so as to bring
Taiwans medical device and pharmaceutical related regulatory
environment to international standards. The plan further calls for
increasing the scale of Taiwan's biotechnology industry through direct
investment, with the goal of enabling Taiwan to develop biotech
pharmaceutical products that can be marketed globally. This achievement
would be a great stride toward the goal of establishing Taiwan as an
important Asia Pacific biotechnology development, trading, and
production center.
The different countries mentioned in this white paper each have their
own differing definitions of the biotechnology industry. In the advanced
countries of Europe and the Americas biotechnology primarily refers to
the emerging field of genetic engineering. In Asia the definition of
biotechnology is slightly broader. As the development of pharmaceuticals
and medical equipment are deeply linked to the development of
biotechnology, and given the needs of Taiwan's biotech industry at this
stage of promotion and development, Taiwan includes both the
pharmaceutical and medical devices industries as well as the newly
emerging biotech fields within its definition of the biotech industry.
The first section of this paper gives a simple definition of biotechnology
and described its key features and scope. The second section describes
the current global state of biotech development and details the means by
which different countries are promoting their biotech industries. The
third section details the current state of biotechnology in Taiwan. The
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fourth section describes Taiwan's biotech industry development policies
and strategies, with primary attention given to those policies and
strategies designed to promote the biotech industry. This section further
examines and analyzes the biotech development strategies of other
countries. The fifth section details the significant achievements of each
government department in promoting Taiwan's biotech industry. The
sixth and seventh sections are devoted to key biotech issues.
The primary differences between this year's white paper and last year's
are found in the second section, The Current State of Global
Biotechnology Development, and in the third section, The Current State
of Taiwan's Biotechnology Development. In the second section, the list of
major biotech countries is divided into two sections, leading biotech
nations and emerging biotech nations. Brazil has been added to the list of
leading biotech nations while Australia and New Zealand have been
added to the list of emerging biotech nations. Looking at the
development strategies of these countries can give Taiwan clues for
promoting its biotech industry. The third section has added information
on biotechnology patents, including an exploration of the current state of
biotech patents in Taiwan as well as a look at possible future directions
for intellectual property development. The key issues of 2008 include,
The Cross Straits Biotech Competition/Cooperation Strategy and Success
Plan and The Influence of the Financial Crisis on Taiwan's Biotech
Industry, Impact and Opportunities. We hope that the suggestions in this
paper will assist Taiwan's biotech industry in charting its future direction
and formulating its future strategies.
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List of Abbreviation and Full Name
ADR Adverse Drug Reaction
ANZBPF The Australia New Zealand Biotechnology Partnership Fund
APEC Asia-Pacific Economic Cooperation
BBSRC Biotechnology and Biological Sciences Research Council
BIO Biotechnology Industry Association
BMBF Bundesministerium fr Bildung und Forschung
BIPP Biotechnology Industry Partnership Programme
BIRAP Biotechnology Industry Research Assistance Programme
BYES Biotechnology Young Entrepreneurs Scheme
CBS Canadian Biotechnology Strategy
CFI Canadian Foundation for Innovation
CGMP Current Good Manufacturing Practices
CHF Congestive Heart Failure
CIHR Canadian Institutes for Health Research
CMC Chemistry, Manufacturing, and Control
CMO Contract Manufacturing Organization
CODEHOP COnsensus-DEgenerate Hybrid Oligonucleotide Primer
CRC Canada Research Chairs Program
CRO Contract Research Organization
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CRT Cardiac Resynchronization Therapy
CSO Contract Sales Organization
CTNBio The National Technical Commission on Biotechnology
CTS Commercialisation Training Scheme
DES Drug Eluting Stents
DMF Drug Master File
DNA Deoxyribonucleic Acid
EMEA European Medicines Agency
EPO Erythropoietin
EPSRC Engineering and Physical Sciences Research Council
FDA Food and Drug Administration
G-CSF Granulocyte Colony Stimulating Factor
GCP Good Clinical Practice
GDP Gross Domestic Product
GLP () Good Laboratory Practice
GMP Good Manufacturing Practice
HGP Human Genome Project
HEOR Health Economics Outcomes Research
IBAB Institute of Bioinformatics and Applied Biotechnology,
IHTSDO International Health Terminology Standards Development Organisation
IMS Intercontinental Medical Statistics
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IND Investigational New Drug Application
iPS induced pluripotent stem cell
ISAAA International Service for the Acquisition of Agri-Biotech Application
IVD In Vitro Diagnostics Device
KRIBB Korean Research Institute Of Bioscience and Biotechnology
MAD Mutual Acceptance of Data
MRC Medical Research Council
NDA New Drug Application
NBP National Biotechnology Policy
NBP National Biotechnology Plan
NBS National Biotechnology Strategy
NIH National Institutes of Health
OCS Office of the Chief Scientist
OECD Organization for Economic Co-operation and Development
OIE The World Organization for Animal Health
OSDD Open Source Drug Discovery
OTC Over the Counter
PIC/S The Pharmaceutical Inspection Cooperation Scheme
PhRMA the Pharmaceutical Research and Manufacturers of America
PLA Poly Lactic Acid
PSUR Periodic Safety Update Report
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QSD Quality System Document
REMS Risk Evaluation and Mitigation Strategy
SAE Severe Adverse Event
SBIR Small Business Innovation Research
SMART Small Firms Merit Award for Research and Technology
SMO Site Management Organization
SPF Specific Pathogen Free
SRB Strategic Review Board
SRC Strategic Research Clusters
STTR Small Business Technology Transfer
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(J. D. Watson)(F. Crick)(deoxyribonucleic acid, DNA)
1973 (H. Boyer) (S. Cohen)DNADNA
Genentech(1976)(Human Insulin)
71990(Human Genome Project, HGP)
DNA
(mRNA)
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30 (Organisation for Economic Co-operation and Development, OECD)2005
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()
()
() () ()
() () () ()
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20092
(p r e d i c t i v e m e d i c i n e )
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1980
2008
2008 652 (Food and Drug Administration, FDA) 24
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2008 55 670 24 144 1.25 75
2008 83 2007 153 6 2008 53
()
1
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3,118 40%2008 2,475 5.8% 15.3% 12.6% 2-1
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2-1 2008 %
2008 2008 2007 2003~2008
3,118 1.4 4.4 5.7 2,475 5.8 7.1 6.4 766 2.1 4.2 2.7 ()
908 15.3 15.0 13.7
465 12.6 12.8 12.7 7,731 4.8 6.6 6.6 2008
IMS, 2009.
2008 Lipitor Zyprexa Lipitor 136 2 Plavix 86 16.9% 3 Nexium2008 78 2-2
2-2 2008 %
2008 Lipitor(Pfizer) 136.55 -0.9 Plavix(Sanofi-Aventis/BMS) 86.34 16.9 Nexium(AstraZeneca) 78.42 7.8 Seretide(GlaxoSmithKline) 77.03 7.0 Enbrel(Amgen/Wyeth) 57.03 5.6 Seroguel(AstraZeneca) 54.04 14.9 Zyprexa(Lilly) 50.23 -1.8 Remicade(Johnson&Johnson) 49.35 14.0 Singulair(Merck) 46.73 3.1 Lovenox (Sanofi-Aventis) 44.35 8.9
IMS, 2009.
Oncologics
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Lipid regulators2008 481 Lipid regulators2008 338 312 3 Respiratory agents 2-3
2-3 2008 %
2008 2007~2008
Oncologics 481.89 11.3
Lipid regulators 338.49 -2.3
Respiratory agents 312.71 5.7
Antidiabetics 272.67 9.6
Acid pump inhibitors 265.25 0.6
Angiotensin II antagonists 228.75 12.6
Antipsychotics 228.53 8.0
Antidepressants 203.36 0.6
Anti-epileptics 169.12 9.7
Autoimmune agents 159.33 16.9
IMS, 2009.
(the Pharmaceutical Research and Manufacturers of America, PhRMA) Burrill 2008 652 2007 20 2008 2,900 750 312 150 109 91
2008 FDA 21 3 4
-
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40% CXCR4 Plerixafor Eltrombopag Romiplostim2008 J&J, Wyeth, GSK, Sanofi-Aventis, Pfizer 5
10 UCB Eisai 2 Genzyme, Watson, GE, Cephalon, Baxter, Ferring
Pfizer 2008 3 26 Lipitor Pfizer 25% 2010 3
Roche Pfizer Aurobindo Pfizer Greenstone Sanofi-Aventis 15% Laboratorios Kendrick Eli Lilly ImClone Millennium
2007
2007 9 12
-
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33 14
2
Biocentury 2008 870 11.6% 12%
47% 30 2008 28 5 10 2020 2,000
2008 279 12.6% 2013 504 22008 175 2013 268 3 2008 159 2016 213 181 15.4%2013 369
3
IMS 2008 780 3.6%
2008 2008 2012 1,390
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84% 330 42%2.7% 10.2% 16.9% 12.5% 10.5% Teva 11% Sandoz 9% Mylan 8% 10 47%
Teva 4 Barr Teva Barr Teva Actavis 99% Pfizer
Watson Teva 17 Daiichi Ranbaxy
4
(Bioequivalency, BE)
1,000~4,000 3~4 100~200 12~18
-
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FDA follow-on biologicsbio-similar(biogenerics)
1982 1 20 2013~2015 200 2006 50% 2-1
(Granulocyte Colony Stimulating Factor, G-CSF) 4
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-
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2006
2-1
IMS, 2007.
Sandoz Omnitrope Roche Mircera 2006 2007 FDA FDA
(European Medicines Agency, EMEA) 2006 Sandoz Omnitrope 11 3 Sandoz 3 Sandoz Genotropin , Humatrope, Eprex Neupogen BioPartners, Medice, Teva 2-4
-
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Omnitrope Somatropin Sandoz Genotropin 12/04/2006Valtropin Somatropin BioPartners Humatrope 24/04/2006Abseamed epoetin alfa Medice Eprex 28/082007 Binocrit epoetin alfa Sandoz Eprex 28/08/2007epoetin alfa Hexal epoetin alfa Hexal Eprex 28/08/2007Retacrit epoetin alfa Hospira Eprex 18/12/2007Silapo epoetin alfa STADA Eprex 18/12/2007Ratiograstim Filgrastim Ratiopharm Neupogen 16/09/2008Biograstim Filgrastim CT Arzneimittel Neupogen 16/09/2008Tevagrastim Filgrastim Teva Neupogen 16/09/2008Zarzio Filgrastim Sandoz Neupogen 13/02/20092009
2017 GDP 20%
2010 20
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4.64%
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2-2 Espicom, 2008
2008
2-3
32.3% X X (Opacifying preparations)(Suture) 22.4%
20.2% 20.0%(MRI)(Scintigraphic apparatus)(UV/IR apparatus)
-
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22.4%
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1
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-
23
Resynchronization Therapy, CRT) (Global Markets Direct)2007 57.5 2006 Abbott XIENCE 7.2%2012 81.5
2007 39 2012 87.6 2,200 (Congestive Heart Failure, CHF)
2
2007 2.46 2003 1.94 25%2025 3.8 4,3004,200 2008 2,400 8%5,700
3(Lab Based Diagnostics Tests)Hb A1C (gel electrophoresis)(cation exchange chromatography)(affinity chromatography)
(Self-monitoring Glucose Meters)
(Point of Care(POC) Diabetes Diagnostics)Hb A1C
-
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Frost & Sullivan 2006 0.6 2006~2013CAGR 3%
2006 2.08 2006~2013 CAGR 9%POC 2006 3.05 2006~2013 CAGR 7%
3.(orthopaedic)
(orthopaedic) (artificial joints) (orthobiologics)(spinal non-fusion devices)2008 122 9% 2012 174 45%
2008 54 9.3% 2012 75 100 5
2008 5.51 2012 7.92 15%
-
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4.
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-
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(Elastography) 4D
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GE Healthcare SoneSite Siemens Philips
(Texas Instruments)(National Semiconductor)
-
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6
Kalorama 2007 419 2007~2012 6% 2012 563 15% 2012 32 2007 32 2012 54
2005 18 75% 2007 16 86% 14%Roche 20%Siemens Abbott 12%
(Molecular diagnostics)(point of care tests)
(DNA, RNA, cDNA)
(High incidence rates)
(POCT)
-
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(component libraries)(algorithms)
()
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(Contract Research Organization, CRO)
(Health Economics Outcomes Research, HEOR) CRO CRO
Business Insight 2008 1,100 CRO 180 2007 14% 2009~2013 14%2013 CRO 350 CRO 48% 29% CRO
Quintiles CRO 2007 27
-
29
16.9%Covance 15 9.7% 2 CRO 2 CRO 10 CRO CRO 56.1%
CRO Covance Eli Lilly Icon Eli Lilly Eli Lilly PPD Merck 5 Merck Recipharm AstraZeneca AstraZeneca 1~2
CRO CRO Quintiles (Global Central Laboratories)
Apollo 1 PPD CRO Cogenics Oncology 1~4
CRO CRO CRO NYSE
2
(Contract Manufacturing Organization, CMO)
-
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2008 204 16.5% 2012 CMO 310 CMO 128 2010 123 2015 106
GMP FDA 75 FDA 50% CMO
CMO
CMO 2008 Dr. Reddy BASF CMO Jubilant Organosys Draxis Piramal Ahmedabad 2009 2 GMP Dishman CMO
()
(International Service for The Acquisition of Agri-Biotech Application, ISAAA) 1996
2008 75 1.25 2007 9%(stacked traits) 41%2008 1.66 15%
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55 25 50%
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63% 15%
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2008 1,330 10% 90%
31% 39% 250 220
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2008
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29% 870 350
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Omega-3 3 BCC Research 2007 1,173 2008 1,239 7.4%2013 1,767
2007 33% 2 2007 384 2013 713 10.8% 3.8%2013 488 2-4
2013 3
2-4 2007~2013 BCC, 2008.
()
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567
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2007
390
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5%()() 3 ()()
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FDA
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2008
2007 622 520 83.6% 16.4%2
61 60%
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5 19 11
(The Food and Agriculture Organization of the United Nations, FAO)2017 1,512 1,268
2-5 2017 243
2-6
United States Brazil EU China India Other
2-5 2005~2017 OECDFAO, 2008.
-
35
2-6 2005~2017 OECDFAO, 2008.
()
2008
2008 2007 528 2008 336 192 36.4% 2004 2-5
2-5 2003~2008
2003 2004 2005 2006 2007 2008 (IPO) 0.5 2.6 1.9 2.0 2.9 0.1 3.9 3.3 4.8 5.6 4.4 1.9 (PIPEs) 2.2 2.8 2.7 4.6 4.7 3.1 9.1 8.8 6.1 11.8 11.6 3.2 4.0 5.2 5.4 5.5 6.8 5.3 partnership 8.9 10.9 17.3 19.8 22.4 20.0 37.5 33.6 38.2 49.3 52.8 33.6 BioCentury, Burrill & Company, 2009.
EU BrazilUnited States Indonesia Other Malaysia
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36
IPOPIPEs 2008 83 2007 153 32 2003 2008 IPO 6 3 1 IPO
2008 53 2007 15 22.1%
24 2006
(Biotechnology Industry Organization, BIO) 45% 180 1 120 6 360 36
()
2008
Ernst & Young 2008 2007 798 776 4,000 20 2-6 2008 4,717 303
2008 896 5.7%
-
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2008 2007 317 2007 27 2008 14
2-6 2005~2008
2005 2006 2007 2008
64,213 78,354 84,782 89,648 20,934 29,860 31,806 31,745 -4,039 -7,382 -2,694 -1,443 146,010 195,640 204,930 200,760 673 743 798 776 4,263 4,460 4,414 4,717 Ernst & Young, 2009.
Takeda Millennium Eli Lilly Imclone Invitrogen Applied Biosystem Amgen 2008 661 2007 652 1.4% 15 11.7% 12.8 2-7 2008 4 2008 1,754 252
2008 165 2007 27%Actelion, Elan, Eurofins Scientific, Meda, Qiagen Shire
-
38
2008 1,836 4.9 16 2008 7
2008 769 155 2008 50 25%
2007 600 2008 1,400
2-7 2007~2008
2007 2008 2007 2008 2007 2008
65,200 66,127 12,920 16,515 3,970 4,965 25,800 25,270 4,603 5,171 488 601 -300 417 -1,666 -702 -6 -14 145,300 128,200 47,720 49,060 15,530
386 371 181 178 149 155 1,116 1,383 1,563 1,658 615 614 1,502 1,754 1,744 1,836 764 769
: Ernst & Young, 2009.
-
39
2
()
1
1976
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2013 328 1,100
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1 FDA 1 1 CGMP IND 1
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FDA Risk Evaluation and Mitigation Strategy, REMS
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2
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Canada Research Chairs Program, CRC
550 80% 100 17 (16 )12.3%2007
780 (733 ) GDP 6.4% 100
2 2007 340 30 3 2
5
-
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2009 (Industrial Research Assistance Program)
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2008
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-
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2005 3.75 (5.50 ) 2008 6.3 (9.25 )
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CSK 2011
6
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-
52
1990 2001 112 2002
2007 181 75%
GDP 3%
2007 2007~2010 (The Action Plan of Science, Technology and Innovation for National Development 2007~2010)
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10 2007~2016 100 (46.51 ) 60%
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-
53
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2008 4,000 1,860 2008 1 2%2008 7 B3 3% 4.2 12.6
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2008 3
2008 (The National Technical Commission on Biotechnology, CTNBio)Monsanto YieldGard Syngenta Bt 11 Bayer LibertyLink
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Forbes 2008 74
Cook Medical, Alcon, GSK, Genzyme, Vistakon, Zimmer, TevaAbiomed Pfizer CRO PPD
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2006 3,300 (4,845 ) 2008 4,600 (6,754)2 39%
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2007~2012 1.75 (2.56 ) 7 10 (14.68 ) 2 7,500 (1.10 ) 1 Fountain 2 Seroba Kernel
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56
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20% 2009 25% GDP
2
1999 2000 (National Biotechnology Strategy)
Kelvin Hopper and Lyndal Thorburn 2001 190 2007 427 5,700 12,000 49%16%13% 35 2007 73 65
-
57
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1,000 (847 )(Researchers in Business)
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2008 222 (2,015 ) 2018 700 (6,352 ) 18% 2018 9,000
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IMD 2007 GDP 4.7% 1
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2020 2 (2,629 ) GDP 4% 10 100 (13.14) 8 500 (65.72 )
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Biospectrumindia 2008 10 471.2 (10.03 ) 39%
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2017 20%
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6
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9 B60-B68 748 889 3.8% 1072 4.8%
10 2 G04-G08,(G06F ) 415 553 2.4% 572 2.6%
11 A61-A63,(A61K A61P )
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13 B01-B09 340 367 1.6% 441 2.0%
14 C07, (C07K ) 478 432 1.9% 428 1.9%
15 C09-C11 340 365 1.6% 400 1.8%
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20 A61K35/66-35/76,38,39, 47/42,48,49/14,49/16,51/08,51/10
367 292 1.3% 323 1.4%
2007
20 ()() 5 2005~2007
10 2007 20
-
108
20
20 (Patent Cooperation Treaty, PCT)
2003~2005 3-12
3-12 20PCT
IPC
2003
2004
2005
2005%
2005%PCT
10 A61-A63,(A61K A61P ) 638 714 550 2.65% 2.20%
11 C07, (C07K ) 626 822 478 2.30% 2.70%
12 C08 750 1087 458 2.20%
14 C01-C05, C30 467 621 376 1.81%
15
A61K35/66-35/76,38,39, 47/42,48,49/14,49/16,51/08,51/10
340 489 367 1.77% 5.90%
17 C09-C11 419 627 340 1.64%
19 251 380 334 1.61% 1.70%
2009
20 PCT
PCT 2005 PCT 2005 1.77% PCT 5.9% 3-10 3-11
-
109
2008 3
2008 utility patents 5
2008
7 ExactechC BEL-CATC701
DCB-WH1 ( WH-1) 2
2008 39 11 28 19 39
21 21 2007~2008
-
110
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1 1736 158 16 18 34 2 1729 100 3 1 4 3 4124 63 2 4 6 4 1716 55 3 0 3 5 1781 48 4 2 6 6 4126 46 1 17 18 7 4736 42 2 1 3 8 1733 37 2 8 10 8 4129 37 0 3 3 9 4116 33 0 2 2 9 3373 33 4 1 5 10 1565 31 2 3 5 10 1799 31 1 7 8 11 4105 30 1 0 1 12 4121 25 1 0 1 13 4106 22 0 3 3 14 1720 17 0 0 0 15 4131 16 0 0 0 16 3164 15 0 0 0 17 3218 14 0 1 1 17 1795 14 2 0 0
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112
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2008 () 53,283 2007 52,496 3-14 21,240 2007 20,229 5% 4,541 21%
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2007 2008 2007 2008 2007 2008 2007 2008 51 63 274 355 1,111 1,150 1,436 1,568 3 3 35 37 21 58 59 98 39 34 651 588 1,311 1,645 2,001 2,267 23 25 125 154 93 94 241 273 22 28 110 131 141 130 273 289 2 6 92 83 40 69 134 158 0 0 0 7 34 34 34 41
140 159 1,287 1,355 2,751 3,180 4,178 4,694 31 17 207 211 462 489 700 717 11 8 49 52 76 76 136 136
42 25 256 263 538 565 836 853 340 343 3,436 3,636 13,522 13,000 17,298 16,979 167 152 2,271 2,394 7,389 7,388 9,827 9,934 106 129 1,059 1,106 3,244 3,128 4,409 4,363 0 0 46 55 37 36 83 91 7 12 125 149 352 372 484 533 ( ) 14 24 127 119 25 0 166 143
634 660 7,064 7,459 24,569 23,924 32,267 32,043 14 7 73 76 266 288 353 371 4 2 65 101 352 365 421 468 6 9 104 100 265 216 375 325 4 11 43 39 109 106 156 156 15 20 233 237 1,387 1,488 1,635 1,745 8 8 34 36 90 86 132 130 0 0 17 11 34 44 51 55 4 3 43 49 237 190 284 242 4 7 114 100 275 339 393 446
59 67 726 749 3,015 3,122 3,800 3,938 10 12 103 108 199 221 312 341
135 148 506 539 1,368 1,328 2,009 2,015 8 6 21 18 0 0 29 24 47 45 291 310 1,269 1,213 1,607 1,568 0 0 39 22 0 0 39 22 6 2 98 102 1,262 1,321 1,366 1,425 3 8 175 225 3,416 3,614 3,594 3,847 5 15 203 216 1,535 1,563 1,743 1,794 11 9 115 129 549 572 675 710 7 0 32 6 0 0 39 6
222 233 1,480 1,567 9,399 9,611 11,101 11,411 0 0 2 3 0 0 2 3 1,107 1,156 10,918 11,504 40,471 40,623 52,496 53,283
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-
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2008 2009~2011 700~900
-
115
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-
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202 25
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(
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18 226 2008 97 3,068 7 7
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-
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125
( )
11982
2002 21984
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41984 1 *
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-
126
101995 8 1997 8 1999 3 2001 10 2003 3
111996 1
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141997 2001 2002 2004 (Strategic Review Board, SRB)
151997 3 2002 2 2005 4 3
161997 12 1998 2002 200 2005 2010
171998 1 2002 2 2006 3 2006 8
181998 7
(GCP) 191999 1
-
127
2006
201999 GMP CGMP
211999 2003 2
222000
232001 5
242001
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262002 5 2008
(2002~2007 ) 272002 2 282002 292003 1
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302003 2
-
128
312003 3 2008 3
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452006 10 2015
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472007 3 ( )
482007 5
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2007 7 4
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135
2009 5 23
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2009 15%( 25%)
-
201
( DNA SNP )
EGFR Typing Iressa Tarceva (EGFR)(NSCLC) NSCLC NSCLC EGFR NSCLC EFGR EGFR typing EGFR typing PCR
()
50% 30% 40%
2007 8 30
-
202
()
/
/
1
2
3
4
-
203
5
()
1 (SOP)
2
3
4 (TFDA SFDA)
5 ITIS ()
6
7 Class II b
-
204
8
9 (NDA regulation)
()
10
-
207
:
2007Bear Stearns2
Lehman Brothers
-
208
-
2008
()
(Global Insight Inc.)(International Monetary Fund, IMF)(World Bank)200820092009-1.3%~0.9%IMF3.8%
7-1
-
209
7-1 2008~2010
(%)
2008 2009 2010 2.3 -1.2 2.3
0.9 -2.6 1.2
5.7 2.0 4.7 (2009.2)
5.9 1.6 3.5
3.2 -1.3 1.9
0.9 -3.8 0.0 IMF (2009.4)
6.1 1.6 4.0
2.5 0.9 3.0
1.3 -0.1 2.0
(2008.12) 6.3 4.5 6.1
World Overview, Global Insight Inc., February 14, 2009 ; World Economic Outlook
Update, IMF, April 22, 2009; Global Economic Prospects, World Bank, December 9,
2008.
()
20080.4%20071.6%1.6%2.2%7-1
-
210
7-1 2008
Global Insight Inc., 2009.01.
2008 14.9%12 7.2%15 5.2%116.3%
20081,10020095,000
()
IMF200820077.2%20083.3%2009-11.0%198220100.6%20081.8%13.5%0.4%-12.1%20086.0%2009-6.4%
-16
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-10
-8
-6
-4
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0
2
4
6
1 2 3 4 5 6 7 8 9 10 11 12
(%
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-
211
200810.9%2009-8.8%7-2
7-2 2006~2010
2006 2007 2008 2009 2010
9.2 7.2 3.3 -11.0 0.6
8.5 6.1 1.8 -13.5 0.5
10.9 9.5 6.0 -6.4 1.2
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13.2 14.0 10.9 -8.8 0.6
2009 2010
IMF , 2009.04.
()
2008292007GDP50%73.062.163,100
()
-
212
1
Ernst & Young20084,717200730320087768962020067-2TakedaMillenniumEli LillyImcloneInvitrogenApplied Biosystem200814
7-2 2004~2008 Ernst & Young, 2009.
2
82.2%20045
%
-
213
7-3
7-3 2002~2008 IMS, 2008.12.
()
3
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800 700 600
500 400
300 200
100 0
25
20
15
10
5
0
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5
-
214
1
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7-4 OECD, 2008; WHO, 2008; IMS, 2008.12.
2
()
-
215
3
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12/3
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07
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8
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4/7/
2008
4/21
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8
5/5/
2008
5/19
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8
6/2/
2008
6/16
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8
6/30
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8
7/14
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8
7/28
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8/11
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8
8/25
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8
9/8/
2008
9/22
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8
10/6
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0 /20
08
11/3
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9 /20
08
D J IAN A S D A QB u r r il l S e le c t
7-5 2008 Burrill Select
Burrill & Company, 2009.
2
2007 528 2008
-
216
336 36.4% 2004 7-6
IPOPIPEs 2008 83 2007 153 2008 6 IPO 1 2002 32 2007 27.59%
2008 306 53 2007 327 68 22.1%
24 2006
7-6 2003~2008 BioCentury, Burrill & Company, 2009.
3
IMS200893
-
217
7%~12%
2009(Pharmaceutical Price Regulation Scheme, PPRS)5%3%~4%10%OTC3%~4%
1~2%
1%~3%
1%2009~20118,500
7-7
-
218
7-7 IMS, 2008
()
1
63% 30% 70~90%
-
219
2
IMS2008~20123~6%9,6207-8
5%~16%
7-8 2012 IMS, 2008.
-
220
()
1%20082,01020075%20072,62120082,7685.6%20080.12%0.29%
99%20081267733048.74%2122007155200813520
2008188.562007182.613.26%20127-3
2008 50% 14
90% 5
-
221
100
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6 2008 6 FDA 5.7 2008 20% 2008
2008
86.81% 77.87% 40% 20.39 10.81% 10
2007 2008
2007
-
222
7-3 2007~2008
(%) 2007 2008 2007 2008
233,128 241,618 83.10 86.81 622,796 736,194 77.57 77.87 221,972 234,629 30.12 31.08 72,082 84,457 25.68 27.58 279,502 369,754 16.04 19.46 4,805 2,094 34.94 10.20 213,347 176,281 6.82 5.57 47,687 87,970 2.67 4.51 5,282 4,371 3.38 2.87 52,303 61,176 1.87 2.34 58,837 23,763 4.04 1.59 5,094 7,401 0.90 1.29 10,421 9,096 0.40 0.30 0 112 0.00 0.11 0 103 0.00 0.02 248 0 1.17 0.00 0 0 0.00 0.00 0 0 0.00 0.00 0 0 0.00 0.00
0 0 0.00 0.00 980,892 1,453,878 67.77 74.16
0 0 0.00 0.00 236,942 220,766 99.93 99.73 1,143,155 1,052,987 98.19 99.07 3,694,951 3,926,073 98.28 98.35 1,587,795 943,497 97.76 97.16 1,096,807 1,155,523 97.34 97.10 1,537,875 1,474,523 96.44 95.16 395,178 485,640 91.83 95.04 1,229,779 1,403,529 93.27 93.49 2,018,527 1,739,781 88.27 84.80 561,032 699,842 67.36 72.83 1,235,947 1,475,875 71.20 70.19 339,672 440,435 61.99 67.26 29,370 35,494 72.87 60.49 345,131 308,147 54.71 50.34 123 612 0.00 0.00 0 0 0.00 0.00
0 0 0.00 0.00
2009
-
223
()
3
200850%870%20%58.69%
30%
-
224
9
2008
2008
2008
2009
-
225
7-4 2007~2008 %
/ * 2007 2008 2007 2008 2007 2008 2008 2009
33.15 34.06 3.44 2.94 22.28 22.63 0.04 0.04 34.14 34.77 0.91 1.66 7.62 8.44 1.39 1.90 68.81 67.85 12.30 11.28 11.81 15.92 2.39 2.60 36.41 41.41 11.07 9.86 14.69 21.14 0.07 0.27 58.82 56.16 7.65 9.80 18.16 12.09 2.90 4.54 51.12 47.94 6.57 6.02 18.76 18.13 3.84 -0.73 78.51 75.55 8.19 8.97 14.84 17.14 2.59 1.17 51.38 48.20 4.95 6.30 18.30 16.14 3.03 NA 74.63 64.29 15.59 14.27 21.98 9.10 2.40 1.83 25.03 26.22 1.56 1.84 3.75 4.83 0.96 0.86 43.14 41.25 7.89 7.74 10.67 8.56 2.47 2.97 33.66 32.52 5.88 6.59 8.05 5.73 0.82 0.87 74.82 74.37 0.03 0.05 4.14 11.30 0.33 -0.04 38.46 19.48 19.05 45.20 -48.82 -121.86 6.76 5.56 10.41 8.69 342.44 547.74 -477.01 -702.57 0.75 -7.01 25.69 27.07 7.98 6.81 1.43 0.44 0.23 0.72 24.22 24.46 5.62 6.38 10.74 8.70 0.63 0.61 44.87 45.05 1.23 0.49 3.34 0.23 4.80 1.56 45.39 44.68 7.54 9.45 5.11 2.79 0.28 0.09
45.61 25.78 329.36 87.34 -729.56 -187.49 0.36 -0.46 20.33 17.58 1.79 1.43 8.92 8.76 0.68 0.70
37.88 39.21 1.34 6.37 12.09 14.35 1.73 1.15 58.14 55.68 1.19 0.94 36.83 33.73 9.64 9.98 27.27 23.66 1.33 1.74 17.23 11.59 5.70 4.48 49.75 43.23 4.57 4.85 39.27 30.54 3.85 8.23 22.64 21.89 0.00 0.00 6.44 6.50 5.59 -0.43 30.50 35.32 4.48 4.53 10.36 16.16 1.73 1.97 28.92 33.24 1.80 0.00 13.15 18.45 4.98 2.24 26.40 29.60 4.28 4.72 10.66 13.17 1.36 1.56 53.51 50.77 5.03 11.01 33.86 19.24 1.10 0.73 31.98 28.99 8.98 8.77 14.26 11.86 2.57 3.11 34.79 28.79 2.64 4.30 28.47 17.27 3.42 5.54 43.01 42.60 7.59 8.76 8.68 7.10 1.85 1.54 71.52 72.96 87.30 48.11 -70.14 -19.44 1.45 NA 7.44 28.97 0.00 0.00 -30.21 -477.78 -2.31 3.75 45.08 44.74 0.21 0.00 18.44 -5.38 4.73 4.09 16.91 17.21 2.98 4.70 5.41 -0.35 0.82 0.64 17.69 11.52 4.21 4.45 6.30 -0.92 0.36 0.64
47.04 48.17 8.93 8.80 4.95 0.12 0.90 1.03
2009
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