Health Industry Development Institute (KHIDI)

Korea Drug Research Association
Korea Health Industry Development Institute
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Overview of
Korea Drug Research Association(KDRA)
General Overview
Organization
In 1986 Korea Drug Research Association(KDRA) was established as
non-profit organization to cope with the introduction of a new product
patent system based on the law for fostering industrial technology
association and represents R&D based pharmaceutical & biotech industry
in Korea.
From its establishment KDRA has been working for the development of
Korean Pharmaceutical & Biotech industries promoting the industrial
technologies in pharmaceutical & biotech fields. For this KDRA has been
participating in and leading biotech R&D policy-making, strategyformulating and improvement of advanced R&D systems. KDRA has since
1986 engaged in mid-and long-term nat'l R&D programs, drived and
managed various kinds of R&D programs including those sponcered by
the government in several innovation areas; NCE, NME, API, herbal
medicine, New Indication, New Route of Administration, New
Formulation, New Ester, Salt or Other Non-covalent Derivative, New
Dosage Form or Strength, Combination Product etc.
KDRA has also been working in business partnering and technology
transfer & licensing between the pharmaceutical & biotech industries,
academic and public research organizations domestically and
internationally. For these activities, KDRA has since 2002 been organizing
annual business partnering event, InterBiz Bio-Partnering & Investment
Forum, a key conference for technology transfer & collaboration with
average 100 domestic & international companies & orgs.
To provide the industry with additional opportunities for domestic &
global business development, KDRA has established and is managing a
distinctive subsidiary organization, PTBC(PharmaTech Business Center)
for providing services in technology transfer, licensing and R&D
collaboration activities between KDRA members and domestic &
international partners.
To cope with the global mega trends and environmental changes
surrounding the pharmaceutical industry in several areas; market,
technology, regulation and business, KDRA has since 1994 established
several subsidiary associations; Association of API Development
Professionals(1994), Association of Regulatory Affairs Professionals(2006),
Association of Pharmaceutical Research Analysis(2008) and Korea Herbal
Medicine Association(2011). Additionally to provide theoretical & statistical
approaches to the industry of its importance and contribution to the
promotion of national healthcare, reduction of
pr
healthcare budget and control & management of life
threatening, chronic and intractable diseases of the
population, KDRA has in 2010 established
Innovation Policy Research Center(InnoPol).
Inno
Major Activities
◐ Representing R&D based pharmaceutical & biotech Industries in
Korea
◐ Providing unified voice fostering an environment which responds to
the needs of Korean R&D based pharmaceutical & biotech Industry
◐ Promotion of pharmaceutical & biotech R&D Activities
◐ Leading & participating in R&D policy-making in pharmaceutical &
biotech fields
◐ Planning mid-and long-term national R&D programs supported by
the government
◐ Operation of national new drug R&D consortiums and various kinds
of committees
◐ Support & management of R&D funds secured from the government
etc.
◐ Supporting services of R&D collaboration & technology diffusion
※ Establishment & Management of PTBC(PharmaTech Business Center)
※ Technology Evaluation & Valuation (through PTBC Technology Business
Committee)
※ Annual organizing & hosting of “InterBiz Bio-Partnering & Investment Forum”
◐ Establishment & Management of subsidiary associations
※ Association of API Development Professionals
※ Association of Regulatory Affairs Professionals
※ Association of Pharmaceutical Research Analysis
※ Korea Herbal Medicine Association
◐ State-of-the-art information services & publication of various kinds of
industrial reports
◐ Education and trainning in several fields; R&D, CMC, IP, BD, Mgmt,
RA, Strategy, API, Analysis etc.
◐ Establishment & Management of Korea New Drug Award(KNDA) etc.
Member companies
KDRA member companies, regular and associate, are all leading and
representing the R&D based pharmaceutical & biotech industries of Korea
and have been conducting almost all of research and development
activities in the field of Korean pharmaceutical & biotech industry. These
companies are investing more considerable R&D expenditure than any
other companies existing in the industry and occupying over 60% of the
domestic market.
KDRA member companies have been involving in pioneering unmet
medical needs areas investing over 65% to their annual net profit with the
strong support from the Korean government, continuous pursuit of R&D
productivity & efficiency to overcome the disadvantageous R&D resources
in comparision with the advanced nations, highly educated & experienced
R&D manpower, strong passion for new drug development, strategic &
dynamic nationwide collaboration network between the industry,
academia and public research orgs. and strong will & vision for global
market.
Regular Members
Ahn-gook Pharm Co., Ltd.
ILYANG Pharm. Co., Ltd.
Whanin Pharm Co., Ltd.
DreamPharma Corp.
Institut Pasteur Korea
BCWORLD PHARM
JW Pharmaceutical
YUHAN Corporation
Hanall Biopharma Inc.
Bukwang Pharm. Co., Ltd.
CJ HealthCare Corp.
KUKJE Pharma. Ind.
Co., Ltd.
Korea United Pharm. Inc.
Hanlim Pharm. Co., Ltd.
Sam Chun Dang Pharm.
Co., Ltd.
Daewoong Pharmaceutical
Co., Ltd.
KYONGBO Pharmaceutical
Co., Ltd.
Amore PACIFIC Co., Ltd.
HUONS Co., Ltd.
Samyang Biopharmaceuticals
Co., Ltd.
Dong-A Pharmaceutical
Co., Ltd.
Korea Otsuka Pharmaceutical
Co., Ltd.
BORYUNG Pharmaceutical
CO., Ltd
ILDONG Pharmaceutical Co.,
Ltd.
SK biopharmaceuticals
Co., Ltd.
Dong-A ST Co., Ltd.
Samjin Pharm
Chong Kun Dang
Pharmaceutical Corp.
JEIL Pharmaceutical
Co., Ltd.
YD life science company
Dong Wha Pharm. Ind.
Co., Ltd.
Shin Poong Pharmaceutical
Co., Ltd.
Deawon Pharm. Co., Ltd
Kolmar Korea Co., Ltd.
Yung Jin Pharm. Co., Ltd.
Green Cross Corp.
Hanmi Pham Co Ltd.
Dong Kook Pharmaceutical
Co., Ltd.
Korean Drug Co., Ltd.
Korea Institute of Toxicology
Handok Co., Ltd.
SK Chemicals
LG Life Sciences Ltd.Yung Jin
Pharm. Co., Ltd.
Kwang-dong Pharmaceutical
Co., Ltd.
Hyundai Pharm. Ind. Co., Ltd.
Sanofi Aventis Korea
KT&G Life Sciences Corp.
Associate Members classified by subsidiary associations
Association of
Regulatory
Affairs Professionals
(160 Member companies)
Association of API
Development
Professionals
Associate Members
classified
by subsidiary
associations
(174 Member companies)
Association of
Pharmaceutical Research Analysis
(140 Member companies)
Korea Herbal
Medicine Association
(70 Member companies)
Contact
Hun Che Cho, MBA, TTA,
Director, Research & Development Promotion Dept.,
Korea Drug Research Association(KDRA)
121-150, Dangsan-Dong, Yeongdeungpo-Gu,
Seoul, 150-040, Korea
T. 82-2-525-3108
E-mail. [email protected]
F. 82-2-525-3109
URL. http://www.kdra.or.kr
Overview of
Korea Health Industry Development Institute(KHIDI)
Korea Health Industry Development Institute (KHIDI) is a public
organization that consists of a group of experts dealing with various
programs on promoting and developing health industry in Korea, while
helping improve the national healthcare services.
Growing interest in health issues and an aging society have highlighted
the importance of health industry. The government of Korea has also
made a special effort to stimulate health industry by designating it as one
of new growth engines of the country. Today, health industry is more than
mere medical treatments; it has now become a pivotal business in
developing the national economy.
Since its establishment in 1999, KHIDI has been playing a major role in
the industry development as the nation’s only one organization
responsible for fostering health industry. While we have striven to produce
more successful research outcomes by means of greater investments in
Health Technology (HT) R&D, KHIDI also took the initiative in increasing
competitiveness in different areas of health industry, including
pharmaceuticals, medical devices, foods, and beauty & cosmetics
businesses.
What is more, we’ve been continuously endeavoring to have local
health industries make inroads into a global market. In doing so, global
healthcare business in Korea has grown rapidly, and now we’re
witnessing an enormous growth in the number of foreign patients visiting
Korea. Not only that, a significant number of Korean medical institutions is
now considering overseas hospital planting as the demand continues to
grow.
KHIDI, as a health industry hub, will spare no effort to advance the
industry as well as to sharpen the industry’s competitive edge in the
international community. Your continued help and support for the Korean
health industry will serve as a cornerstone for the industry becoming the
nation’s hope business in the future.
Vision
The Korea Health Industry Development Institute(KHIDI) will contribute
to the improvement of the standard of living for the people and to the
development of national economy, by fostering health industry as a
national core strategic industry in the 21st century.
Bio-health Advanced country
To raise the competitiveness of our health and medical industry to
global standards through implementation of projects for development of
Bio-health industry and improvement of health services.
Advanced countries: G7 in health and medical industry with
pharmaceuticals ranked 7th, medical equipment 5th, food 8th, cosmetics
7th, 95% of level of medical service technology and etc.
Professional Institution
We are in pursuit of establishing a professional institution with superior
domestic health services through customized supports (customer
satisfaction), maximized organizational effectiveness (managerial
innovation) and human resources armed with professional knowledge.
Organization
President
Audit
Planning &
Management
Health
Industry
Policy
R&D
Promotion
Department of
Strategy & Coordination
Department of National Health
Economy Policy Research
Department of
HT R&D Strategy Planning
Department of
Pharmaceutical Industry
Department of
Overseas Global Healthcare
Operation Support Office
Department of Converging
Technology & Industry Strategy
Department of
Translational Research
Department of
Medical Device Industry
Department of
Global Healthcare Business
External Cooperation
Office
Department of
Senior-Friendly Industry
Department of New
Technology Development
Department of
Consulting Operation
Global Healthcare Center
– Middle East
Center for Health Industry
Information & Statistics
Center for Health
Infrastructure Development
Technology
Cooperation Center
Department of Innovative
Performance Management
Health
Industry
Support
Global
Healthcare
Service
Development Strategy Office
1. Planning new strategic projects, setting up development strategy,
setting up mid to long term management goal
2. Human resources (human resources policy, human management,
employee evaluation, employee education, employee adjustment
in each development)
3. Minister performance contract (administer performance contract)
4. Labor affairs
Management Support office
1. Set up business plan by year and budget planning
2. Business adjustment
3. Management rationalization
4. Support for Board of Directors
5. Manage Articles of Incorporation and other regulations
6. Manage management disclosures and books/publications
7. Supervise parliamentary affairs and national assembly inspection
8. Management evaluation and innovation (including innovation level
diagnosis)
9. Customer satisfaction
10. BSC planning and operation
11. Education for industrial professionals
12. Public health industry forum
13. Internal and external promotion, events and external cooperation
7. Medical resources
8. Medical institution evaluation
9. Provincial medical center evaluation
10. Evaluation of industrial insurance hospitals and oriental medical
hospitals
Food and drug industry group
1. BT policy research, fostering methods of BT, system research of
pharmaceuticals, cosmetics, and oriental industry
2. Research on policies and systems at home and abroad
3. Research and analysis of BT policy trends, support to build
Osong Bio Health Technopolis
4. Research on medical device industry policy, fostering methods of
the medical device industry and system research
5. Research and analysis of policy, system and trends at home
and abroad
6. Policy and system research of food hygiene and safety trends
7. Research and analysis of policy, system and trends at home and
abroad
8. Technical support to improve hygiene control and safety of
companies
9. Provincial food industry development support
10. Evaluation of functionality, effectiveness and standards
11. GH evaluation support
12. Activation of Korean medical devices
Industrial Statistics Office
1. Industrial supervision (comprehensive plan for development
strategy of public health industry, FTA impact assessment,
fostering laws, etc.) *Supervise industry-specific policy and
system development: FTA, industry fostering TF operation,
industry analysis, white paper, report, etc.
2. Statistical DB deployment, development of statistics indicators,
implementation and operation of statistical system *Drugs,
medical devices, foods (production basis), cosmetics
Medical Service Industry Group
1. Research medical service industry policy (including oriental
medical service), fostering methods, and system research
2. Trend analysis of medical service industry
3. Accounting principle operation support
4. Medical hospital consulting, Medical institution management
rationalization including management support for small hospitals
5. Management support for leveraged hospitals
6. Survey on management of medical institutions (hospital
management analysis, etc.)
Global Healthcare Business Center
1. Technical evaluation, brokerage of technical support at home and
abroad (technical loan support, technology business network,
bio-Korea included)
2. Technical export and import
3. Support for venture companies
4. Support for licenses, permits and patent
5. GHHT certification
6. Support for overseas marketing (expos, provision of import and
export information)
7. Support for overseas license, permission and authentication
8. Attraction of foreign patients and advance of medical institutions
to overseas markets
9.Affairs on overseas residents including the operation of export
support center
10. International trade (assistance for bilateral and multilateral
international trade negotiation)
11. International cooperation (Global alliance, cooperation with
international organization, international cooperation for public
health and medical technology)
Senior Products industrial center
1. Provide information on policy development to foster the senior
product industry
2. Senior products industrial center (designate good products)
3. Lay a foundation to foster the nursing service industry
Nutritional policy center
1. Support for the development of nutritional policy
2. Support and operation of nutrition management for pregnant
women, infants and babies
3. Nutritional research, nutritional DB deployment, provision of
nutritional information
Public health and medical business group
1. Support for modernization of facilities and equipment in public hospitals
2. Set up, execution, evaluation and assistance for public health and
medical planning
3. Policy development of public hospitals and reinforcement of
functions of state-run university hospitals
4. Modernization of facilities and equipment in public health centers
located in rural areas
5. Set-up of provincial health and medical plan and execution result
evaluation
6. Education for professionals in the public health area
8. Technical service contract, royalty control
9. Convention, settlement, call center management
10. Project expense and operating cost control
11. R&D information system, comprehensive management system
(electronic convention, statistics, DB management)
12. Project announcement and explanatory meeting
13. Business support for national assembly inspection and audits
related to R&D, management evaluation, customer satisfaction
control, budgeting
Disease research group
1. Supervise evaluatiom, evaluation report and schedule
2. Responsible for R&D business plan (set u annual action plans)
3. Technical trend research and analysis (demand research, technical
level investigation, technical forecast, overseas R&D trends)
4. Responsible for mid to long term health and medical technology
strategy planning (brokering clinical research, rare diseases,
innovative research hospitals, etc.)
5. Set up implementation plan of disease research, research
demand analysis, research planning including mid to long term
technical strategy planning
6. Improve evaluation system templates in the disease research area
7. Issue evaluation of disease research (selection, annual, interim
and final), issue control during research period, performance
report evaluation
8. Professional committee related to disease research
R&D support office
1. Overall support and adjustment of research and development projects
2. Issues on establishment and revision of rules and guidelines of
R&D projects
3. Health and medical technical policy review committee, R&D
council in service
4. R&D project performance management analysis and evaluation,
performance-tracking management
5. Research, analysis and evaluation
6. Performance presentation and promotion (Technical fair and PR
for the general public)
7. IP control
New technology development group
(New drugs, bio, medical devices, foods, cosmetics, oriental
medicine, etc.)
1. Set up action plan in new drug development area, book-building,
research plan like mid to long term strategy establishment
2. Improve evaluation system, and form in the new technical
development
3. Define issues in the new technical development area (Selection,
annual, interim, final), issue management during the research
period, performance result evaluation
4. Form a professional committee for new technical development
Contact
Lee, Gaeun, Ph.D., Team Head, Department of Pharmaceutical Industry,
Pharmaceutical Support Team, Korea Health Industry Development Institute(KHIDI)
187 Osongsaengmyeong2(i)-ro, Heungdeok-gu, Cheongju-si, Chungcheongbukdo, 363-951 Korea
T. 82-43-710-0056
F. 82-43-710-0001
E-mail. [email protected]
URL. http://www.khidi.or.kr
Overview of
Korean Pharmaceutical Industry
Global Pharmaceutical Industry in its operation and innovation activities is
now facing serious challenges resulted by mega trends in healthcare
paradigm. Global pharmaceutical industry including Korean pharmaceutical
industry is trying to approach the smart strategies to avoid the slow-down in
productivity, cut-down of innovation value, reinforcement of regulation, lack of
real innovation, patent expiration etc through making value-based innovation
and level-up of innovation meeting the market needs from the population and
government.
To accelerate the innovation activities and meet the various kinds of call for
innovative therapeutic agents having better therapeutic benefits from patients,
the government, health insurance agency and market, Korean R&D-based
pharmaceutical companies have been involving in pioneering unmet medical
needs areas investing over 65% to their annual net profit with the strong
support from the Korean government.
Korean R&D-based pharmaceutical companies have continuously been
pursuing R&D productivity & effectiveness to overcome the disadvantageous
R&D resources in comparision with the advanced nations. The main driving
power of the industry is highly educated & experienced R&D manpower,
strong passion for new drug development, strategic & dynamic nationwide
collaboration network between the industry, academia and public research
orgs. and strong will & vision for global market.
Korea emerging as a hub country in north east Asian area has also been
emerging as a key contributor in global healthcare innovation. During the past
10 years global pharmaceutical & biotech industries have witnessed Korea
coming up to the global pharmaceutical market as one of the countries
possessing new drug R&D abilities.
Modern pharmaceutical industry in Korea has 110 years of history initiating
at the end of the 1800s, when a first modern pharmaceutical company began
its operation. With the introduction of product patent system in 1987, Korean
pharmaceutical companies initiated full-scale R&D activities as the last
breakthrough to cope with the rapidly changing pharmaceutical environment,
and spared no efforts to expedite their R&D activities towards the
development of new drugs for around 30 years with a firm conviction for being
major contributor to the global pharmaceutical innovation for the healthy life of
the population.
Although with a comparatively small market size, US$ 16billion in
production occupying 1.5% of global market at present, Korean market is
expected to grow up unceassingly with rapid annual growth rate of 10% in
domestic market surpassing the world average 3-5%. To overcome the small
market size in comparision with bigger market in US, EU etc, the Korean
pharmaceutical industry has been accelerating their innovation activities in new
drug R&D for early entering the overseas market.
According to the recent analysis data by Korea Health Industry
Development Institute(KHIDI), major 46 R&D-Based Korean pharmaceutical
companies recently designated to be innovative pharmaceutical companies by
the Ministry of Health & Welfare of Korea will increase R&D investment from
1,272,300 KRW million to 3,879,800 KRW million by 2020.
As for the Korean pharmaceutical industry, during the past 30 years there
has been marvelous advancement in new drug research and development;
market-launched 33 new drugs approved by the Korean regulatory
agency(MFDS), US-FDA approved 2 drugs, world's first monoclonal antibody
biosimilar, around 15 IND-approved(by US FDA, EMA) new drug candidates,
150 or so out-licenced(to 30 countries) new drug candidates & technologies,
150 or so finished drugs & APIs already launched in overseas market including
US and EU, 700 or so leads or druggable candidates existing in Korean
pharmas' labs, 124 to be commercialized in the global market by 2014~2016
etc. Considering the success possibility, 31 of new drugs are expected by
2020.
Korean pharmaceutical industry owes these successful innovation activities
and future vision to not only their own strong passion & resolute R&D
investment for growth strategy through innovation in new drug research and
development but also systemic R&D ecosystem surrounding the industry;
optimized R&D environment closely linked to the industry and strong
governmental support.
Accompanied by 150 or so universities and colleges having strong needs
for R&D co-works and technology commercialization with the industry with
their excellent IP assets in early stage research areas, 6 major public research
institutes(Korea Institute of Science & Technology, Korea Research Institute of
Bioscience & Biotechnology, Korea Research Institute of Chemical Technology,
Korea Basic Science Institute, Institute Pasteur Korea, Korea Institute of
Toxicology) having excellent research abilities in basic & applied science and
superior research infrastructure and 19 preclinical trial organizations & 163
clinical trial facilities, most of the R&D based Korean pharmaceutical
companies have been pioneering the future with new drug R&D.
In this new drug R&D ecosystem well designed & functionally organized in
the direction of concentrating to the acceleration of the innovation activities of
Korean pharmaceutical industry there also exist strong support from the
Korean government in several areas; establishment of the Act for supporting &
raising pharmaceutical industry, a special law enacted in 2011 to prepare
important basis to support & accelerate the industrial growth through
reinforcement of innovation, vast amount of R&D funding and preparation of
important R&D infrastructures etc.
Before the legislation of the Act for supporting & raising pharmaceutical
industry, the Korean Government, keeping pace with the efforts of the industry,
has chosen the pharmaceutical & biotech industry as one of the 10 fastest
growing industry sectors in parallel with IT sector and has planned mid-and
long-term fostering programs.
Recently the Korean government(the Ministry of Health & Welfare) in
accordance with the provisions of the Act for supporting & raising
pharmaceutical industry has designated 46 Korean pharmaceutical companies
including 2 foreign-based company as Korea innovative pharmaceutical
company to provide special benefits in tax reduction & exemption, preferential
governmental research funding, postponement of drug price cutting-down etc.
in order to promote R&D investment and support sustainable growth. More
than anything else this means that the government guide and urge the
industry to be innovative to become the leading industry in global market
through the designation of innovative pharmaceutical companies to be
appealled to the whole pharmaceutical industry as role-model.
Korean government has also been supporting tremendous governmental fund
to new drug R&D and biotechnology areas since 1987 and recently it amount to
around 2.0 US B$ in a year as of 2010 coincidently establishing Korea Drug
Development Fund, National OncoVenture and Hitech Medical Clusters in Osong
& Daegu-Gyeongbuk as important national new drug R&D infrastructures.
Total R&D Expenditure of Korea
R&D Personnel
Korea's total R&D expenditure in 2013 has increased by 3,850.8 billion
won(6.9%) from the previous year to 59,300.9 billion won. R&D expenditure
accounts for 4.15% of GDP, a 0.13 percentage points increase compared to
2012. With R&D expenditure of 54,164 million USD, Korea is ranked 6th in the
world while the nation's R&D expenditure accounts for 4.15% of GDP, which
indicates the highest worldwide.
With 321,842 persons, Korea is ranked 6th in the world in terms of the
number of FTE(Full Time Equivalent) researchers. The total number of
personnel (FTE) in Korea is estimated to be 401,444 persons. Despite this, as
for the researchers per thousand population or labor force, among the major
economies, Korea's number of researchers(Full Time Equivalent) per thousand
labor force is 12.4 persons, which indicates the highest worldwide.
※ Source : Bank of Korea
※ Source : OECD, Main Science and Technology Indicators 2014-1
※ Source : OECD, Main Science and Technology Indicators 2014-1
※ Source : OECD, Main Science and Technology Indicators 2014-1
BT accounts for 7.6% of the total R&D expenditure, and has grown by
258.4 billion won to reach 4,504.3 billion won.
※ Source : Survey of Research and Development in Korea, 2013, Ministry of Science, ICT
and Future Planning
Korean Pharmaceutical Market
Trade Balance and Korean Pharmaceutical Market Status
(Unit, KRW 100Million)
Classification
2011
2012
2013
Production Amount
155,968
157,140
163,761
Export
19,585
23,409
23,185
Import
55,263
58,535
52,789
Balance of Trade
-35,678
-35,126
-29,488
Market Size
191,646
192,266
193,365
Market Opportunity Ranking of Asian Territories
※ Source : Food & Drug Statistical Yearbook. Ministry of Food and Drug Safety. 2014
Pharmaceutical Companies & Annual Pharmaceutical
Production in Korea(Unit, KRW Billion)
Year
Companies
Items
Production(Value)
2008
587
25,118
13,894
2009
580
25,362
14,789
2010
656
25,534
15,710
2011
638
26,425
15,597
2012
662
27,567
15,714
2013
666
26,652
16,376
※ Source : The Changing dynamics of pharma outsourcing in Asia, PWC, Sep.2008
Ranking of Asian Territories across all factors
※ Source : Food & Drug Statistical Yearbook. Ministry of Food and Drug Safety. 2014
Current Status of Employment in Korean Pharmaceutical Industry
Classification
2011
2012
2013
No. of Employees % No. of Employees % No. of Employees %
R&D
8,765
11.8
9,872
12.6
10,613
12.0
Production
23,539
31.6
24,942
31.9
28,226
31.9
Sales & Mkt
24,535
32.9
24,714
31.6
25,889
29.2
Administrative
14,426
19.4
15,403
19.7
16,598
18.7
Others
3,212
4.3
3,328
4.3
7,219
8.2
Total
74,477
100
78,259
100
88,545
100
※ Source : Ministry of Food and Drug Safety. 2014
Number of Pharmaceutical Manufacturers in Compliance
with GMP(2013)
Total
KGMP
BGMP
398
261
137
※ Source : The Changing dynamics of pharma outsourcing in Asia, PWC, Sep.2008
Wider Risk Ranking of Asian Countries
※ Source : Food & Drug Statistical Yearbook. Ministry of Food and Drug Safety. 2014
Number of Approved Clinical Trial &
Non-Clinical Trial Facilities(2013)
Total
Clinical
Non-Clinical
182
163
19
※ Source : Food & Drug Statistical Yearbook. Ministry of Food and Drug Safety. 2014
Number of Approved Clinical Trials for Drug Products
Classification
Approved
Local
Multinational
2011
503
309
194
2012
670
367
303
2013
607
356
251
※ Source : Food & Drug Statistical Yearbook. Ministry of Food and Drug Safety. 2014
※ Source : The Changing dynamics of pharma outsourcing in Asia, PWC, Sep.2008
R&D
New Drug Approval Status of Major Korean Pharmaceutical
Companies by Therapeutic Category
Rank
Category
R&D Projects
%
1
Antiarthritics
6
18.2
2
Anti-cancer
5
15.2
3
Antibiotics
5
15.2
4
Antiulcer
4
12.1
5
Erectile Dysfunction
3
9.1
6
Antidiabetic
3
9.1
7
Respiratory system
2
6.1
8
Liver Disease
1
3.0
9
Immunomodulator
1
3.0
10
Antihypertensive
1
3.0
2
6.1
33
※ Source : KDRA Survey over 41 Leading Pharmaceutical companies in 2014
※ Source : KDRA Survey over 41 Leading Pharmaceutical companies in 2014
※ Source : KDRA Survey over 41 Leading Pharmaceutical companies in 2014
New drug R&D ecosystem of Korean Pharmaceutical Industry
Others
100
Anfungal
255
Erecle Dysfuncon
Total
0
Osteoporosis
21.6
Anhypertensive
55
Analgesics
Natural Products
Hormone drug
3
10
An-hyperlipidemia
32.5
6.3% 5.9%
5.5% 5.1% 5.1%
16
15
14
13
13 3.9%
10 2.7% 2.7%
2.0% 2.0%
7
7
0.8% 0.8% 0.4% 0.4% 0.4%
5
5
2
2
1
1
1
Liver Disease
83
8.2%
21
20
Respiratory system
New Biological Entities
12.9%
33
30
Immunomodulator
2
40
CNS
45.9
16.1%
41
Anulcer
117
18.8%
48
50
Anbiocs
New Chemical Entities
%
60
Cardiovascular
1
No. of Projects
(Active ingredients)
Anviral
Rank
Classification of
Active ingredient
New Drug R&D Pipelines of Major Korean Pharmaceutical
Companies by Therapeutic Category
Anarthrics
New Drug R&D Pipelines of Major Korean Pharmaceutical
Companies by Active Ingredient
An-cancer
※ Source : KDRA Survey over 41 Leading Pharmaceutical companies in 2014
Andiabec
other
Total
New Drug Pipelines Under Development Catagorized by
Disease Sector
11
New Drug R&D Pipelines of Major Korean Pharmaceutical
Companies by R&D Stage
R&D Investment
R&D Investment to Sales Revenue of
Major Korean Pharmaceutical Companies
※ Source : KDRA Survey over 41 Leading Pharmaceutical companies in 2014
R&D Investment Plan(2012-2020) of 44 Innovative Korean
Pharmaceutical Companies
※ Source : KHIDI Survey over 44 Innovative Korean Pharmaceutical companies in 2012
Korean Regulatory & Healthcare System
Ministry of Food and Drug Safety
R&D Investment to Net Profit of Major
Korean Pharmaceutical Companies
※ Source : KDRA Survey over 41 Leading Pharmaceutical companies in 2014
Results from Innovation Activities Highlighted
Market-launched 33 new drugs approved by Korean regulatory agency(MFDS)
15 IND-approved(by US FDA, EMA) new drug candidates
150 or so out-licenced(to 30 countries) new drug candidates & technologies
150 or so finished drugs & APIs already launched in overseas market including US and EU
8 Overseas Regulators Approved & Market Launched New Drugs already launched in
U.S. E.U etc.
700 or so leads or druggable candidates existing in Korean pharmas' labs etc
124 to be Commercialized in the Global Market by 2014~2016
Considering the Success Possibility, 31 of New Drugs Expected by 2020
Key Factors in Korean Pharmaceutical Innovation
Resolute R&D investment by pharmaceutical industry sector with major R&D intensive
companies investing up to 90% to net profit
Continuous pursuit of R&D productivity & efficiency to overcome the insufficient R&D
resources & infrastructures in comparision with the advanced nations
Highly Educated & Experienced R&D Manpower
Strong Passion for New Drug Development in spite of insufficient R&D
Strategic & Dynamic Nationwide Collaboration Network between the industry, academia
and public research orgs.
Strong Government Support & R&D Programs since 1982
Strong will & vision for pioneering the real innovation & entering in Global Market