Transcript 台灣生物醫藥產業發展策略

Perspective of Biomedical Industry in
Taiwan: Challenges and Opportunities
Chien-Jen Chen, Sc.D.
Academician and Distinguished Research Fellow
Academia Cinica
1
IMD World Competitiveness Yearbook
Taiwan Rank in 2005-2009
Item
2005
2006
2007
2008
2009
Overall
performance
11
17
18
13
23
Overall
infrastructure
16
18
21
21
23
Technological
infrastructure
5
4
15
5
11
Scientific
infrastructure
8
5
6
4
8
Source：The World Competitiveness Yearbook 2005-2009, International Institute for Management
Development (IMD). 57 economies were ranked.
2
IMD World Competitiveness Yearbook, 2009
Items
USA
HK
Singapore Switzerland Sweden
Japan
China Taiwan Korea
India
Overall performance
1
2
3
4
6
17
20
23
27
30
1. Economic
performance
1
3
8
13
20
24
2
27
45
12
2. Governmental
efficiency
20
2
1
3
10
40
15
18
36
35
3. Industrial
efficiency
16
1
4
3
6
18
37
22
29
11
4. Infrastructure
1
19
8
4
2
5
32
23
20
57
(1) Fundamental
4
5
2
7
13
15
16
27
23
37
(2) Technology
1
6
2
9
3
16
21
11
14
37
(3) Science
1
24
12
7
5
2
6
8
3
32
(4) Health and
environment
17
21
18
4
1
11
53
39
27
57
(5) Education
19
29
13
4
3
26
49
27
36
57
Source：International Institute for Management Development (IMD) World Competitiveness Yearbook, 2009
57 economies ranked
3
WEF Global Competitiveness Report,
2009-2010
Indices
Overall performance
Switzerland USA
Singapore Sweden Denmark German Japan
Hong
Taiwan
Kong
Korea
China
1
2
3
4
5
7
8
11
12
19
29
Infrastructure
3
28
2
5
4
8
27
6
18
23
36
Efficiency
3
1
2
7
6
14
11
5
17
20
32
Innovation
3
1
10
4
7
5
2
23
8
16
29
Source：WEF (World Economic Forum) Global Competitiveness Report, 2009-2010
133 economies included in 2009 report
4
WB Knowledge-based Economic Development,
2009
Rank
Denmark
Sweden
Finland
USA
Taiwan
Singapore
Japan
Hong
Kong
Israel
Korea
World
1
2
3
9
18
19
20
23
26
29
Asia
-
-
-
-
1
2
3
4
5
6
Source：World Bank, Knowledge-based Economic Development 2009
146 economies are ranked
5
R&D Budget and Manpower in OECD
Countries, 2007
每千就業人口研究人員數(全時約當數, 人年)
20
芬蘭
15
美國
10
新加坡
挪威
澳洲
愛爾蘭
捷克
5
日本
丹麥
台灣
加拿大
俄羅斯
瑞典
法國
英國
德國
奧地利
南韓
瑞士
荷蘭
中國
0
1.00
2.00
3.00
4.00
研發經費佔GDP比率(%)
Source：Main Science and Technology Indicators, 2007/1, OECD.
註：圓圈的面積表示研發經費的多寡，研發經費係以購買力平價折算
6
Number and Rank of Research Papers
in Taiwan, 2004-2008
Indices
2004
2005
2006
2007
2008
13,621
16,721
17,846
18,571
22,509
Rank
18
18
17
16
16
Citations＊
144,466
174,910
203,941
234,766
280,357
Rank
24
24
23
23
22
2.45
2.65
2.81
2.94
3.14
EI papers
10,980
11,661
13,076
16,657
17,124
Rank
11
11
11
9
10
785
1,030
1,226
1,548
2,236
20
18
17
16
15
SCI papers
Average citations＊
SSCI papers
Rank
 world average of citation per SCI paper in 2004~2008 was 4.70。
7
Number of U.S. Utility Patents
2003
2004
2005
2006
2007
2008
Country
NUP
Rank
NUP
Rank
NUP
Rank
NUP
Rank
NUP
Rank
NUP
Rank
USA
87,893
1
84, 271
1
74,637
1
89,823
1
79,526
1
77,051
1
Japan
35,515
2
35,348
2
30,341
2
36,807
2
33,354
2
33,682
2
Germany
11,444
3
10,779
3
9,011
3
10,005
3
9,051
3
8,915
3
Taiwan
5,298
4
5,938
4
5,118
4
6,360
4
6,128
5
6,339
5
Korea
3,944
5
4,428
5
4,352
5
5,908
5
6,295
4
7,519
4
Netherlands
1,325
11
1,273
12
993
12
1,323
11
1,250
11
1,329
10
297
22
404
20
402
18
661
16
772
16
1225
12
China
Source：U.S. Patent and Trademark Office
NUP, Number of Utility Patent
8
Leading Industry/Products in Taiwan, 2008
世界排名第一
(10項)
世界排名第二
(12項)
世界排名第三
(7項)
晶圓代工
IC design
印刷電路板
Mask Rom
DRAM
PU合成皮
IC封裝
WLAN
PTA
IC測試
OLED面板
聚酯絲
TN/STN LCD面板
大型TFT-LCD面板(>10”)
耐隆纖維
PND
中小尺寸TFT-LCD 面板
筆記型電腦
電解銅箔
LED
--胡蘿蔔素
光碟片
玻纖布
電動代步車與電動輪椅
(失能人士用機動車)
IC載板
綠藻
ABS
TPE
主機板
資料來源：經濟部技術處ITIS計畫。不含海外生產
9
Knowledge-based Economy
Globalization and Valueaddition
Biotech
Information and
communication
Electrical/
mechanical
engineering
Agriculture
BC6000
1769
1947
2000
Time and Technology
Source：The Coming Biotech Age, Richard W. Oliver
10
Biotechnology R&D in Taiwan:
A Brief History
• Since 1995, the biotech industry has been recognized as one
of the most important industries in Taiwan.
• It was regarded as one of the “rising star” industries in the
6-year “Two Trillions, Two stars” national development
plan in 2002.
• Recently, the healthcare industry has been identified as a
major target of the “Economic Development Vision for
2015.”
• Biotechnology has become an important sector for
scientific research, technology innovation, and industrial
development in Taiwan, as is the case elsewhere in the
world.
• Its aim is for Taiwan to become a global partner in biotech
innovation and commercialization, and to be the Asian hub
for biotechnology.
11
Biotech Industry in the World, 2006
Companies
Revenue
World
USA
EU
Canada
Asia
Pacific
4,275
1,452
1,621
465
737
735
555
115
32
33
28
23
4
1
0.4
(Billion US$)
R&D
budget
(Billion US$)
Ernst & Young Global Biotechnology Report 2007
12
Biotech Industry in Taiwan, 2006
Emerging biotech
(billion US$)
Medical devices
(billion US$)
US Biotech patents
Preclinical trials
Phase I trials
Phase II trials
Phase III trials
Taiwan DCB ITIS Report 2007
World
160
Taiwan
1.3 (0.8%)
170
2.0 (1.2%)
907
Rank: 15th
17 (1.9%)
580
615
260
2 (0.3%)
1 (0.2%)
2 (0.8%)
13
Current Status of Biotech Industry
in Taiwan, 2006
Revenue*
Export*
Emerging
biotech
1.29
Pharmaceuticals
1.94
Medical
devices
2.06
Total
5.29
0.51 (40%) 0.39 (20%) 0.88 (42%) 1.78 (34%)
Import*
0.56
1.77
1.34
3.67
Domestic
market
demand*
1.33
3.34
2.53
7.20
*Billion US$
Biotechnology and Pharmaceuticals Industry Program Office, MOEA, 2007
14
SWOT Analysis of Biomedical Industry
in Taiwan: Strength
. High-priority industry supported by government
. Well-implemented National health insurance
system
. Excellent clinical research activities in 17 medical
centers and regional hospitals
. Strong electronic and ICT industries
. Excellent scientists and technologists in
biomedical R&D organizations and industries
15
SWOT Analysis of Biomedical Industry
in Taiwan: Weakness
. Lack of integration of basic research and
technological development
. Lack of integration of governmental agencies
. Lack of foreign or local capital investment
. Lack of successful story
. Lack of senior managerial experts
. IPR protection and biosafety regulation needs
improvement
. Small local market and lack of experiences in
international marketing
16
SWOT Analysis of Biomedical Industry
in Taiwan: Opportunity
. Huge market in Asia-Pacific Region
. Trend of individualized medicine
. Global collaboration of high value-added industries
. Rapid development of biomedical R&D service
industries
. Biomedical industry for unique Chinese diseases
. Increasing need in health care of aging population
17
SWOT Analysis of Biomedical Industry
in Taiwan: Threat
. Competition with neighboring Asian countries
. Competition with high-tech products from
developed countries
. Competition with low-cost products from
developing countries
. Competition for Chinese talents and
international investments
18
Biotechnology R&D in Taiwan
Implementation
Type of
Research
Fundamental
Research
Applied
Research
Technology
Development
Governmental
Funding
Agencies
in R&D
Universities &
Governmental
Research Inst.
NSC,
MOE,
DOH
Universities,
Academia Sinica,
etc.
MOEA,
MOTC,
MOD,
COA,
DOH,
EPA,
etc.
Nuclear
Energy
Research
Institute,
ChungShan
Institute of S&T,
etc.
Non-profit
Research
Institutes
ITRI,
NHRI,
NARL,
NSRRC,
etc.
Industries
Public/
Private
Enterprise
Research
Laboratory
19
Biomedical Technology Research Programs
 National Science and Technology Program
 Biotechnology and Pharmaceuticals
 Genomic Medicine
 Nanoscience and Nanotechnolog
 Industrial-Academic Cooperative Researches
 Integrated Program Projects
 Individual Research Projects
20
NTPS for Biotechnology and
Pharmaceuticals
1. To optimize lead compounds obtained from up-stream and
further developed by mid-stream resources. Subsequently
to get INDs from FDA.
2. To translate the protein chips research to clinical use, i.e., to
commercialize protein chip products on the market.
3. To establish the databank for botanical drug (more than
200 kinds). After drug efficacy evaluation, to develop into
new indications and get patents. Eventually to get botanical
INDs from FDA.
These objectives are to develop 2-3 successful investments in
biotechnology and pharmaceuticals.
21
National Science and Technology Programs for
Biotechnology and Pharmaceuticals
Drug Discovery
Preclinical Trial
National Science
Council (NSC)
Ministry of Economic
Affairs (MOEA)
Biotechnology
Chemical
Synthesis
Natural
Products
Clinical Trial
Commercialization
Department of
Health (DOH)
Enterprises
Formulation
NCE
Investigational
Toxicology
New Drug
(IND)
ADME
Pharmacology
MDS Pan Lab
Universities
Research Institutes
R&D Institutes
(DCB, BMEC, PDC
ATIT, INER)
I
Phase II
III
New Drug
Application
(NDA)
Drug
Marketing
Phase IV
Center for Drug
Evaluation
Medical Center
Bio/pharm
Companies
Bio/pharm
Companies
22
NTPS for Genomic Medicine
To capitalize on the knowledge embodied in the
human genome sequence in order to
•Develop Taiwan's visibility and international
competitive edge in bio-medical research
•Act as an initiator for the local bio-medical industry
23
National Research Program for
Genomic Medicine
INNOVATIVE
RESEARCH
CANCER
INFECTIOUS
DISEASES
LIVER
LUNG
ELSI
HIGHLY HERITABLE
DISEASES
Bio-medical
Industry
24
NTPS for Nanoscience & Nanotechnology
Through the establishment of common core facilities
and education programs to achieve academic excellence
in basic research, to create innovative industrial
applications, and to speed up the commercialization of
nanotechnology.
Education programs
Academic Excellence
Industrialization
Nanotechnology
Establishment of Core Facilities
25
Unit:USD
Budget (2004~2008)
Year
2004
Budget
122.4 M
2005
2006
115.0 M
119.7 M
2007
89.7 M
2008
91.1 M
Output & Outcome (2004~2007)
Publication
4,983
Talent
training
5,763
Patent
226
Technology
transfer
5.3 M
Manufacturer
investment
46.9 M
26
R&D and
Industrialization
27
2005-2006 Pharmaceutical Industry in Taiwan
millions US$
Turnover
Export
Demand in
Taiwan
Import
Category
2005
Bulk#
2006
2005
2006
2005
2006
2005
2006
471
1,187
207
174
465
1,358
729
2,371
Chemical Drugs
1,387
761
155
229
1,394
681
2,626
1,213
Chinese Herbal
Medicine*
155
181
10
39
3
213
148
355
2,013
2,129
372
442
1,862
2,252
3,503
3,939
Total
# Bulk of 2006 including human and animal usages.
* Chinese Herbal Medicine of 2006 including herbal medicine preparations and medicinal herbs.
Data from PITDC and Biotechnology Industry in Taiwan, 2006 & 2007
28
Biomedical Engineering Research Laboratories , ITRI (BEL)
29
ITRI Biomedical Engineering R&D
• Biomedical Engineering laboratory
• Medical Electronics and device Technology Center
• Medical Device Research
• Molecular Diagnostic Research
30
Biomedical Engineering Research Laboratories , ITRI (BEL)
31
Mission
The Center's mission is to offer guidance and advice on relevant technology to the domestic pharmaceutical industry; strive to develop key technology for
new products; realize the industrial development of high quality products; and open up the international market. The Center is highly committed to the
development of new Chinese and Western medicines and becoming an international R&D center.
32
33
DCB R&D Programs and Facilities
•
•
•
•
•
•
•
Environmental Biotechnology Program
Pharmaceutical Program
Herbal Medicine Program
Biopharmaceutical Program
GPCR Drug Discovery Facility
Center of Toxicology and Preclinical Sciences
Biopharmaceutical Pilot Plant Facility
34
National Health Research Institutes
• Division of Biotechnology and
Pharmaceutical Research
• Division of Medical Engineering
Research
• Vaccine Research and Development
Center
35
Supervision and Regulation of
Biotechnology Industry
36
Regulation of Drugs and Medical Devices
in Taiwan
■ Regulatory Agencies
★ Taiwan Food and Drug Administration (TFDA)
Bureau of Pharmaceutical Affairs (BPA)
Center for Drug Evaluation (CDE)
★ Committee on Chinese Medicine and Pharmacy (CCMP)
37
Bureau of Pharmaceutical Affairs
38
Center for Drug Evaluation (CDE)
39
http://www.ccmp.gov.tw/en/index.asp
Committee on Chinese Medicine and Pharmacy (CCMP)
Department of Health, Executive Yuan
40
National Centers of Excellence for
Clinical Trial and Clinical Research
•
•
•
•
National Taiwan University Hospital
National Cheng-Kung University Hospital
Tri-Service General Hospital
Taipei Municipal Wan-Fang Hospital
41
Number of New Clinical trials
in Taiwan
2005
2006
Phase I
14
12
Phase II
33
32
Phase III
69
86
Phase IV
4
3
120
133
Total
Taiwan ranks third in “Country Rankings in Clinical Medicine”
in the Asia Pacific, just after Japan and Australia.
42
Chinese Medicine Clinical Trial (I)
22 cases of IND analysis (2001-2005) :

Inherent prescription: 2 cases
 New compound: 12 cases
 Foreign compound: 3 cases
 Patrimonial recipe: 2 cases
 New officinal plant: 1 case
 Partial purified articles in Traditional
Chinese herbal medicine: 2 cases
43
Chinese Medicine Clinical Trial (II)
22 cases of IND analysis (2001-2005) :

Phase I : 1 case
 Phase II : 12 cases
 Phase III : 7 cases
 Pilot study : 2 cases
The first new Chinese medicine license has been
issued under the authorization of the DOH.
44
Laws for Biotechnology Development
• The Basic Law for Science and Technology provides
intellectual property management-related measures to
encourage patent application and technology transfer.
Incentives are also offered to researchers and their
institutions for their engagement in academic-industrial
collaborative R&D.
• A new Act for Development of New Drug Industry, which
aims to facilitate the establishment of new companies
specializing in pharmaceutical R&D, has recently been
passed by the Legislative Yuan (Congress). Incentives given
include tax reduction, participation of government
employees in the biotech industry, etc.
45
Science Parks: Biotech Company Clusters
Lungtan Base (107h)
Hsinchu Biomedical Science Park (38h)
Hsinchu Science-based Industrial
Park (625h)
Ilan Base (101h)
Chunan Base (141h)
Tungluo Base (350h)
Houli Base (255)
Central Science-based
Industrial Park
Taichung Base (413h)
Huwei Base (97h)
Southern Science-based
Industrial Park (1,038h)
Kaohsiung Base (570h)
Kaohsiung Biotechnology Industrial Park
Total area: 3,743 hectares
Hsinchu Science-based Industrial Park: 1,362
hectares (semiconductor and IT industries)
Central Science-based Industrial Park: 765
hectares (nano-based optoelectronics, aerospace
and precision machinery industries)
Southern Science-based Industrial Park: 1,616
hectares (optoelectronics industry)
46
Investment in Biotechnology R&D
• National Development Fund provides
investment and financing to underpin
private sector investment in the biotech
industry.
• Incentives are given to the investment of
venture capitals in biotechnology.
47
Conclusion
Through the above-mentioned integrated
efforts to promote scientific research,
technology innovation and industry
development in biotechnology, Taiwan will be
on its way to becoming a biomedical
technology island and will play an important
role in international biotechnology industry.
48
Thank You!
49
政府在生物醫藥研發扮演的角色

創造適合生物醫藥產業發展的有利環境

發展完善的生物醫藥研發基礎建設

培育及延攬各級生物醫藥研發人才

支持生物醫藥研發的國際合作研究

鼓勵生物醫藥研發成果管理、技術轉移及產
業應用
50
台灣生物醫藥產業發展策略:
強化轉譯研究



加強臨床前動物實驗及臨床一、二期試驗
相關之轉譯研究與組織架構。
建立符合GMP之蛋白質及生物製劑量產設
施，以作為臨床實驗及商業製造之用。
鼓勵現有製造學名藥、原料藥或小分子化
合物中間產物之GMP設施升級，以製造可
供臨床實驗之創新產品。
51
臺灣生物醫藥科技研發體系
執
行
機
負責
推動機關
研究 單位
政府機構 學校及研究機構 財團法人
層次
基礎研究
中央研究院
教 育 部
國 科 會
中央研究
院各所
應用研究
技術發展
經
國
交
農
原
衛
環
濟
防
通
委
能
生
保
部
部
部
會
會
署
署
中 科 院
核 能 所
勞 安 所
政府所設
之各類研
究所
關
企 業 界
各大學
系所
工
研
院
食
品
所
資
策
會
生 技 中 心
國 研 院
同步輻射中心
國
衛 院
等
公民營
企 業
台灣生物醫藥產業發展策略:
改組生技中心




改組生技中心成為「生技醫藥臨床前研發
中心」。
改善組織與薪資結構，禮聘有經驗之執行
長及專業人才。
足夠資金、能力與誘因以主動尋找並承接
國內早期創新研發成果，協助開發至可供
臨床試驗階段，再技轉業界。
提供業界臨床前動物試驗，及臨床試驗用
藥品之量產服務，並由服務及技轉取得現
金與股票等回饋。
53
台灣生物醫藥產業發展策略:
成立生技創投基金


提升「行政院開發基金」投資於生技製藥
的專業能力，或成立專屬生技製藥之創投
基金。
延攬具有國際創投經驗之專家，善用基金，
積極主動尋找、分析早期創新研究成果，
或已接近上市之後期產品之可行性及獲利
性，將初期研發成果落實在產業發展，且
與金融資本市場接軌，形成生技產業聚落。
54
台灣生物醫藥產業發展策略:
整體布局



利用技轉或合作模式取得高階醫療器材及在
初期臨床實驗之新藥的智慧財產權及相關製
造、行銷權益，並建立生產設施。
工研院加強協助研究機構及業界開發高階醫
療器材及精密生醫儀器。
結合中研院、研究型大學、生技中心、國衛
院、卓越臨床實驗中心及業界，共同完成臨
床前及臨床試驗，開發有智慧財產保護的小
分子及生技藥品。
55
台灣生物醫藥產業發展策略:
法規鬆綁




落實「科學技術基本法」，加強人才延攬與
技轉，並鼓勵創業。
調整公教人員及產業專家人員之薪資結構
提升藥品及醫材審查之品及效率。
修訂「生技新藥產業發展條例」施行細則，
使從事新劑型及新用途之藥品及醫療器材，
且須進行臨床試驗者得以適用。
56
台灣生物醫藥產業發展策略:
建立生醫科技園區
園區名稱
園區設施特色
園區經營方向
‧分醫學研究中心區及產業專用區 ‧以臨床醫學為主
新竹生物 兩大區塊(醫學、育成、研究中心 ) ‧轉譯醫學研究與相關產品開發
醫學園區
‧癌症與腦心血管疾病之主題以及生
醫電子影像領域研究
‧園區內包括：國家衛生研究院、 ‧以生物晶片及醫療器材為發展重點
竹南園區 台灣動物科技研究所
‧可配合國衛院及動科所的腫瘤治療
生技聚落
‧ 30單位生物科技標準廠房
與胚胎研究
‧人工植入物及手術工具
‧與「金屬工業研究中心」合作
高雄園區 ‧醫療儀器
‧結合南部地區既有金屬產業聚落如
醫療器材 ‧醫療用機器人及輔具
金屬製造﹑加工﹑鑄造﹑模具等，設
專區
置14公頃專區，發展生技醫療器材產
業
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台灣生技醫藥產業發展的願景




全球生技醫藥產業研發及商業化不可或缺之重要環節
具特色之亞太生技醫藥產業發展樞紐：
亞洲多發性疾病研發及臨床中心
生技及藥物重要量產基地
醫療工程應用及產製中心
亞洲生技醫藥創業投資重鎮
未來五年生技產業營業額年平均成長25%，帶動1,500
億元投資
十年內成立500家生技公司，促成成功投資案例
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敬請指教！
藥物法規發展趨勢:生技學名藥
• 1990-2005年，美國核准新藥(NME)總數達449個，
其中27個是生技藥品(NBE)；EMEA核准127個新
藥中有44個是生技藥品。近10年生技藥品快速成
長。
• 2005年全球生技藥品的銷售額達530億美元。
• 2005～2010年多項生技藥品專利到期，將創造近
200億美元的市場。
• 生技學名藥未來市場快速擴大，歐盟與亞太區域
國家正研擬相關法規，國內目前尚未有相關規範
可供產業依循。
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亞洲新興生技產業的共同現況
• 以製造或低成本為政策思維
– 政府扮演主導推動的角色
– 許多新興的小型公司，技術及基礎建構尚
發展中
– 缺乏具有商業化潛力的技術成果
– 智財保護與法規國際化是最大的挑戰
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亞洲新興生技產業的發展利基
• 委託研究與生產(CRO、CMO)
– 成本、專業品質
• 專利過期的藥物
– 學名藥(Generics)=>廣大人口市場、價格/成本
– 生技學名藥(Biosimilar) =>高技術層次(智財權保護)、
高資本投資(cGMP plant)、法規障礙
• 跨領域生醫工程
– 醫療器材、生物材料、生技檢測儀器、生物資訊等
• 傳統草藥
– 科學化醫藥研究
– 功能性保健品、植物性新藥
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台灣新興生技產業已漸成型
• 200家至少30年歷史的GMP學名藥藥廠，主要競爭
台灣40%藥品市場。
• 國際藥廠及代理商在台約40家，競爭台灣另60%藥
品市場。
• 300家的新興生技公司，與製藥相關約佔30%，大多
成立5-6年尚在研發階段。
• 2005年國內研發新藥pipelines共55項；有29項在國
內外執行臨床試驗，其中生技藥品1項、中藥新藥20
項。
資料來源：生技中心ITIS計畫調查整理
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台灣的醫療市場與品質仍不容忽視
•我國雖內需市場小，但市場成長率高，且醫療消費能力
強，藥品之購買能力高於中國、印度等其他亞洲國家
項目
新加坡
台灣
南韓
印度
中國大陸
日本
1,080.3 1,306.3
127.4
基本資料
人口（百萬）
GDP/人（美元）
4.4
22.9
48.6
26,546
15,118
16,027
705
1,458
35,316
競爭指標
製藥市場（百萬美元）
515
3,900
8,063
8,800
19,158
66,200
醫療支出/人 (美元)
117.0
170.3
165.9
8.1
14.7
519.6
製藥市場成長率（%）
4%
7.0%
7.5%
7.2%
8.5%
0.5%
資料來源：Frost & Sullivan;生技中心ITIS計畫整理
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