슬라이드 1

Transcription

슬라이드 1

Chairman of the board
Yong Joon, Cho
-Jan. 24, 2016-
I.
Global Pharmaceutical Market
II.
Korean Pharmaceutical Market
III.
Features of Korean Pharmaceutical
Market
Regulation standards,
Development process, New
medicine, IMD
IV.
Pharma Korea 2020 Road Map
2
GLOBAL PHARMACEUTICAL MARKET
(USD 1 billion)
Nations
Global market (total)
Advanced countries
USA
EU 5
Germany
France
Italy
UK
Spain
Japan
Canada
Republic of Korea
Pharmerging Market
China
Tier2
Brazil
Russia
India
Tier3
Others
2013
989.3
623.6
340.0
156.3
45.9
37.1
27.9
24.6
20.7
94.1
21.4
11.7
242.9
97.7
62.4
30.6
17.7
14.1
82.8
122.9
Share
100.0%
63.0%
34.4%
15.8%
4.6%
3.8%
2.8%
2.5%
2.1%
9.5%
2.2%
1.2%
24.6%
9.9%
6.3%
3.1%
1.8%
1.4%
8.4%
12.4%
CAGR('09~'13)
5.2
3.1
3.6
2.2
3.9
-0.7
2.5
5.5
0.3
3.2
1.4
4.2
13.6
19
14.4
15.2
12.8
14.9
8.1
3.3
2018(E)
1,280~1,310
766~796
450~480
157~185
48~58
30~40
28~36
27~37
20~26
94~120
23~33
12~19
358~388
155~185
88~98
36~46
20~30
21~31
95~125
124~154
CAGR('14~'18)
4~7%
3~6%
5~8%
1~4%
2~5%
(-)2~1%
2~5%
4~7%
(-)1~2%
1~4%
3~6%
2~5%
8~11%
10~13%
9~12%
9~12%
7~10%
9~12%
5~8%
2~5%
[IMS Health, IMS Market Prognosis, Sep. 2014]
3
GLOBAL PHARMACEUTICAL MARKET
 Global pharmaceutical market size was USD 989 billion by the end
of 2013.
 A five-year average growth rate of the market is 5.2%, and 4~7%
average growth rate is expected over the next 5 years.
 Pharmerging markets have led the market growth. Remarkable
growth of pharmaceutical markets has been shown in China, Brazil,
Russia and India.
 The growth was driven by development of generic market, as 21
blockbuster patents were expired between 2010 and 2012.
 Republic of Korea has 1.2% market share among others.
4
KOREAN PHARMACEUTICAL MARKET – MARKET SIZE
(KRW 1million, %)
Category
2009
2010
2011
2012
2013
Growth rate
/ previous
year
CAGR
(`08-`12)
Production
14,788,387
15,569,588
15,440,251
15,560,663
16,191,845
4.1
2.3
Exportation
1,772,242
1,770,059
1,946,493
2,309,534
2,318,522
0.4
6.9
Importation
4,953,881
5,108,911
5,447,053
5,728,874
5,155,829 -
10.0
1.0
3,181,639 -
3,338,852 -
3,500,560 -
3,419,340 -
2,837,307 -
17.0 -
2.8
0.3
1.4
Trade balance
Market size
-
17,970,026
18,908,440
18,940,811
18,980,003
19,029,152
[Korea Pharmaceutical Manufacturers Association(2014), Korea Pharmaceutical Traders Association(2014) Facts & Survey Report]
25,000,000
20,000,000
15,000,000
10,000,000
수IMPORT
입
82.3%
82.3%
81.5%
82.0%
85.1%
2009년
2010년
2011년
2012년
2013년
수EXPORT
출
생PRODUCTION
산
5,000,000
-
5
KOREAN PHARMACEUTICAL MARKET – ETC/OTC
(KRW 1 billion, ea, %)
Category
2009
Amount(A)
OTC
Items
2010
2011
2012
2013
2,522.3
2,530.9
2,551.8
2,309.7
2,435.4
6,866
6,401
6,338
6,226
6,057
Volume GR
-0.9
0.3
0.8
-9.5
5.4
Amount(B)
10,653.7
11,509.8
11,329.0
11,225.8
11,453.4
9,359
9,362
9,704
10,028
11,040
ETC
Items
Volume GR
ETC portion(B/(A+B)*100)
7.1
8.0
-1.6
-0.9
2.0
80.9
82.0
81.6
82.9
82.5
[Korea Pharmaceutical Manufacturers Association(2014)]
16,000.0
14,000.0
12,000.0
10,000.0
80.9%
82.0%
81.6%
82.9%
82.5%
8,000.0
PRESCRIPTION
전문의약품
6,000.0
OTC
일반의약품
4,000.0
2,000.0
-
2009년
2010년
2011년
2012년
2013년
6
KOREAN PHARMACEUTICAL MARKET –
LABOR STATUS
(person)
Year Manpower
2005
2006
2007
2008
2009
2010
2011
2012
2013
65,003
70,681
72,179
75,406
81,204
77,314
74,477
78,259
88,545
Office work
Sales
manpower rate manpower
rate
12,183 18.7% 22,915 35.3%
12,833 18.2% 24,490 34.6%
13,119 18.2% 25,252 35.0%
14,009 18.6% 26,721 35.4%
15,924 19.6% 27,520 33.9%
14,792 19.1% 26,626 34.4%
14,426 19.4% 24,535 32.9%
15,403 19.7% 24,714 31.6%
16,598 18.7% 25,889 29.2%
R&D
manpower
5,555
6,372
6,845
7,801
8,640
8,699
8,765
9,872
10,613
rate
8.5%
9.0%
9.5%
10.3%
10.6%
11.3%
11.8%
12.6%
12.0%
Production
manpower
rate
20,728
31.9%
21,633
30.6%
22,123
30.7%
23,212
30.8%
24,354
30.0%
24,050
31.1%
23,539
31.6%
24,942
31.9%
28,226
31.9%
Others
manpower
rate
3,622
5.6%
5,353
7.6%
4,840
6.7%
3,663
4.9%
4,766
5.9%
3,147
4.1%
3,212
4.3%
3,328
4.3%
7,219
8.2%
30,000
25,000
Office
사무직
20,000
Sales
영업직
15,000
R&D
연구직
10,000
생산직
Production
기타
Others
5,000
-
2005년
2006년
2007년
2008년
2009년
2010년
2011년
2012년
2013년
7
KOREAN PHARMACEUTICAL MARKET
 Market size of Korean pharmaceutical market is about USD
19billion in consideration of the trade balance.
 Sales volume of finished products and APIs were USD 16.2billion
and USD 2.1billion respectively in 2013.
 Portion of ETC exceeded 82% among finished products.
 No. of products in 2013 : ETC - 11,040, OTC - 6,057
 No. of manufacturers : total 666 (in 2013, pharmaceuticals - 285,
API manufacturer - 381)
 Production rate of finished products : 30.6% / top 10 companies ,
47% / top 20 companies
 Structure of workforce : constant increase in R&A (exceed 10,000 in
2013, 12%)
8
PAST
 Maintaining stable growth focused on domestic market
 Contributed to the national health and treatments of diseases
 Played an important role in overall growth of the
pharmaceutical market supplying affordable medicines
with excellent quality
 Accompany with long-term investments and various risks –
high risk and higher value-added business
FUTURE
FEATURES OF KOREAN PHARMACEUTICAL MARKET
 Emerge as a representative industry leading Post-IT
generation
 Future industry which concentrates technology and specialists
based on basic sciences and multidisciplinary convergence
industry
 Strengthening new drug development capacity through
continuously increased investment in R&D
9
REGULATION STANDARDS AND PRODUCTION BASES
AT THE LEVEL OF ADVANCED COUNTRIES

Construction of advanced production bases of pharmaceutical products
- Regulation standard and production ability at the level of advanced countries
- Quality management system with cGMP standard
- Investment in cGMP facilities : exceed USD 3 billion
* Bioequivalence tests (Single-dose drug  expanded to multidose drug, Sep., 2010)
* joined PIC/S (Jul., 2014)
Searching for
Non-
candidate
clinical
substance
tests
GLP
Clinical
tests
GCP
Licensing
Production
Sales
cGMP
GSP
10
DEVELOPMENT PROCESS OF KOREAN PHARMACEUTICAL INDUSTRY
[1960/70s]
[1990s]
[2010s]
Localization of finished
Beginning of new
Producing globalized
products/APIs
drug development
new drugs
Present
[1980s]
2000s]
Development of new
Regularized new drug
production process
development
 1~2 new drug development ability annually
 1993~2015 : Licensing 25 new drugs
11
KOREAN NEW MEDICINE (1)
Product
Company
Ingredient
Classification
Date
Sivextro Inj.
Dong-A ST
Tedizolid phosphate
Antimicrobial
agent(antibiotics)
`15.04.07
Sivextro tab
Dong-A ST
Tedizolid phosphate
Antimicrobial
agent(antibiotics)
`15.04.07
Zabolante tab
DongWha Pharm.
Zabofloxacin
Antimicrobial
agent(antibiotics)
`15.03.20
Acelex cap.
Crystalgenomics
Polmacoxib
Bone & Joint disease
`15.02.05
Riavax Inj.
Kaelgemvax
Tertomotide HCl
Anticancer
drug(pancreatic
cancer)
`14.09.15
Duvie tab
Chong Kun Dang Pharm
Lobeglitazone sulfate
Antidiabetics
`13.07.04
Zemiglo tab
LG Life Sciences
Gemigliptin tartrate 1.5 hydrate
Antidiabetics
`12.06.27
Supect cap.
IL-YANG Pharm.
Radotinib HCl
Anticancer
drug(leukemia)
`12.01.05
Zepeed tab
JW pharmaceutical
Avanafil
Erectile dysfunction
`11.08.17
Pyramax tab
Shin Poong Pharm.
Pyronaridine phosphate,
Altesunate
Anti-malaria drug
`11.08.17
Kanarb tab
BoRyung Pharm.
Fimasartan potassium trihydrate
Hypertension
`10.09.09
Noltec tab
IL-YANG Pharm.
Ilaprazole
Antiulcer drug
`08.10.28
Mvix tab
SK Chemicals
Mirodenafil HCl
Impotency drug
`07.07.18
12
KOREAN NEW MEDICINE (2)
Product
Company
Ingredient
Classification
Date
Pelubi tab
Daewon Pharm.
Pelubiprofen
Bone & Joint disease
`07.04.20
Levovir cap
Bukwang Pharm.
Clevudine
Hepatitis B vaccine
`06.11.13
Zydena tab
Dong-A Pharm.
Udenafil
Erectile dysfunction
`05.11.29
Revanex tab
Yuhan Corporation
Revaprazan
Antiulcer drug
`05.09.15
Camtobel tab
Chong Kun Dang Pharm
Belotecan
Anticancer drug
`03.10.22
Pseudovaccine Inj.
CJ Cheiljedang
Dried pseudomonas vaccine
Antimicrococcus agent
`03.05.28
Apitoxin Inj.
Guju pharma.
Dried honey bee venom
Arthritic drug
`03.05.03
Factive tab*
LG Life Sciences
Gemifloxacin
Antimicrobial agent(antibiotics)
`02.12.27
Quroxin tab
JW pharmaceutical
Balofloxacin
Antimicrobial agent(antibiotics)
`01.12.17
Milican Inj.
DongWha Pharm.
Holmium nitrate-166
Anticancer drug(liver cancer)
`01.07.06
Easyef
Daewoong
Pharmaceutical
Human epithelial cell growth factor
Diabetic foot ulcer drug
`01.05.30
Sunpla Inj.
SK Chemicals
Heptaplatin
Anticancer drug(gastric cancer)
`99.07.15
Factive tab* : USFDA approval (4 Apr., 2013)
13
KOREAN INCREMENTALLY MODIFIED DRUG
[KRW 100 million]
Product
Company
Date of approval
Indication
2012
2013
GR
Hanmi
Pharmaceuticals
Hanmi
Pharmaceuticals
2009. 3. 31 Depressant
370
438
18.4%
2009. 3. 31 Depressant
317
316
-0.3%
Cozaar XQ tab 5/50mg
MSD Korea
2009.11.20 Depressant
75
76
1.3%
Cozaar XQ tab 5/100mg
MSD Korea
61
47
-23.0%
Postatin OD tab
Hanmi
Pharmaceuticals
2010.2.11 Antihistamine
38
49
28.9%
Clanza CR tab
Korea United Pharm.
2010.4.14
62
45
-27.4%
Daewoong
Pharmaceutical
Hanmi
Pharmaceuticals
2010.6.23 Osteoporosis
-
46
Ultraset ER tab
Janssen Korea
2010.11.22
Loxfen CR tab
Shin Poong Pharm.
2011.3.18
Hanlim
Pharmaceuticals
Korea Otsuka
Pharmaceuticals
Amosartan tab 5/50mg
Risen plus tab
Risenex plus tab
Pletaal SR capsule
Fever reducer. analgesic.
Anti-inflammatory
Anti-inflammatory
Anti-inflammatory
5
55 1000.0%
156
123
-21.2%
14
123
778.6%
84
88
4.8%
2011.4.19 Thrombolytic agent
42
92
119.0%
-
46
10
32
Motesone plus nazal spray
Hanmi
Pharmaceuticals
Letopra tab 20mg
Ahn-Gook Pharm.
2012.6.18 Antipeptic ulcer drug
Cilostal CR tab
Korea United Pharm.
2013.2.28 Thrombolytic agent
-
24
Bonviva plus tab
Dream Pharm.
-
21
2012.11.16 Otolaryngology
220.0%
14
EXPORT OF TECHNOLOGY
Month
Product name
Indication
Business partner
– HANMI PHARMACEUTICALS, 2015
Amount
Note
HM71224
Immunological
disorders
Eli Lilly
$690million
Global
copyright
7
HM61713
Anticancer drug
targeted drug
resistance agent
Boehringer
Ingelheim
$730million
License out
11
Quantum
project
Diabetes
Sanofi S.A
EUR
3.9billion
License out
11
HM12525A
Obesity
Janssen
$810million
License out
3
Source technology : LAPSCOVERY , Long Acting Protein / Peptide
Discovery
15
EXCELLENCE OF KOREAN
PHARMACEUTICAL INDUSTRY
 Although the portion of Korean pharmaceutical industry takes more or less 1.2% among the
global market, Korea has developed a world-class R&D capability through New drug production,
incrementally modified drug and accumulation of technology.
 Especially, international standards(GLP, GCP, cGMP, GSP) have been strictly applied to the entire
process of new drug development, clinical trial and production. Consequently, credibility in
quality of pharmaceutical products has reached nearly at the level of advanced countries such as
the U.S., the EU.
 Pharmaceutical industry was evaluated as a Post IT industry by Korean government. Since 2012,
Korean pharmaceutical industry has gone through the government’s support and growth
strategies including Pharm Korea 2020 Road Map. Eventually, overseas expansion of the
pharmaceutical market is highly expected.
 Together with the pharmerging markets, Korean pharmaceutical industry is considered as a
meaningful market which can build an active partnership with Saudi Arabia and other Middle
Eastern countries. Mutual benefit and progress are expected by various technical exchanges in
pharmaceutical products and manufacturing plants.
16
Pharma Korea 2020 ROAD MAP
2012
2016
2020
10ea
20ea
50~60ea
Innovative new drug
0ea
3ea
Incrementally
modified drug
124 IMDs -> Quantum Jump
Global Top 50
1ea
3ea
10th
7th
New
drug(accumlate)
Ranking
Gxs
BS
Strategy
Vaccine
IMDs
Bb
DDS
National
policy
support
IND,
Orphan
drug
Open
Innova
M/A fund
Development
of human
resource
Ecosystem
Top 20
INDs Jump-up
Niche generics
1st Gx USA/EU licensing
Specialized company
Invested capital, cost reduction
Global standard production
facilities,WHO
Development of various IMDs
aimed at advanced countries
Buyout -> Overseas expansion
Direct marketing in pharmerging
market
Vertical systematization
Mutual life cycle with originals
Concentration on R&D
Foundation technology and IP
Best-in-Class
IND USA/EU licensing
Search & Develop.(VIPCO*)
Superior candidate substance
Prompt commercialization
Secure client IP
Advance in premier market
Global specialty
Global pharmaceutical company
specialized in particular disease
Prior occupation of the market and
technological leading company
Open Innovation support program
Operate local service centers and policies for exportation
Management of global M/A fund
Invite 300 foreign experts
Training 8,000 domestic experts
Activation of hightech medical complex
Operate accompanied growth network program
*VIPCO Virtually Integrated
Pharmaceutical Company
17
Company Profile –
DONGKOO Bio&Pharma.Co.Ltd
Factory and Research Institute
Brief History
• 1970 “DongKoo Pharm" founded on May 1st ,
by the late Chairman Mr. DongSub Cho
Overview of DKBP
Business Area
• 1990
KGMP* approved & Founded Central
Research Institute
• 2004
Won “Exportation Tower” for USD
1Million
• 2011
Strategic Alliance with “Novacell”
- Bio-technology based Skin/Hair solution
• 2012
Completed remodeling of Plant
- cGMP** approved
• 2014
Acquired the title of “Distinguished &
Longstanding Enterprise” selected by
Government organization
• 2015
First developed & approved stem cell
extraction kit in the world (SmartX® )
Development, manufacture and sales of
pharmaceuticals
Total Sales (‘15)
KRW 83.6 Billion (USD 80 Million)
Capital (‘15)
KRW 3.5 Billion (USD 3.2Million)
No. of Employees (‘15)
Core Therapeutic
Categories
No.1 in Dermatology, Urology, etc.
18
Company Profile –
DONGKOO Bio&Pharma.Co.Ltd
 SmartX® : First developed & approved disposable stem cell extraction kit in the world
- Stem cell extractor from bone marrow and adipose tissue
 Product Portfolio
• Stem cell
Extract Kit
 Go-to-market Strategy
Position
ing
• Enzyme
and Buffer
• Enzyme
Comm.
• Operational
Channel
Establishing Entry Barriers
• Secure product
competitiveness by
producing clinical
evidence continuously
• Strategic partnering for
getting key customers
• Worldwide patent
protection
(USA, Japan, EU, China etc.)
• Speedy Market
penetration for preparing
bio-similar emergence
 Maximize word of mouth
effect by holding and/or
participate academic
conference
Total Healthcare
Leader
(Set up platform for
penetrating Biomarket)
 Technical journal advertisement · Brochure · 3D Video
Separator
Supplies
3rd Target
Internal Med.
 Emphasize comparative
advantage and
Differentiation
1st Target
Plastic Surgery
 Experiential marketing for
medical institutions
KRW 2.6Bio.+α(2015)
1.57Bio.
 Focusing on Key customers by
using medical representatives
0.72Bio.
 Channel Mix
Domestic
0.31Bio.
Overseas
Kit
Direct
+α
 Direct Dealing
Enzyme
X
Japan
Others
1
Dealer
2
 CSO Option
Indirect
 Agency Option Dealer
Separator
Optimize
channel Mix
Supplies
Annual Sales(E)
Company Profile – Green Cross Healthcare
Green Cross Healthcare Corp. is one of the affiliated companies of Green Cross Corp.
where provides Korea’s best healthcare services.
- Green Cross Healthcare
Healthcare solutions & Total Healthcare Service
- GC Lab Cell
Development of stem cell treatment, Cell banking, Commercial Lab Business
- Green Cross Health Promotion Center
Comprehensive health promotion center for efficient healthcare
Healthcare
- Mogam Biotechnology Institute
Foundation
Green Cross Healthcare Corp.
Drug development and biotechnology research
-GC Labs Pioneering Diagnosis
Korea's best and first clinical inspection institute
- Green Cross Medical Science
• Establishment: August, 2003
• CEO: Do-Gyu, Jeon
GreenCross
Pharmaceutical
• Address: 10F Pan-Pacific
Building, 12, Digital-ro 31-gil,
Guro-gu, Seoul, Korea 08380
- Green Cross Health Science
Personalized drug development using enzyme engineering
methods
- GC-JBP
Production of placenta and vitamin preparations, etc.
• No. of Employees: 75
• Business Area:
- Medical Tourism (MT)
- Customer Health (CH)
- Biz Health (BH)
Production of In vitro diagnostics business, home medical
equipment, medical equipment, medical supplies and blood
bags
- Green Cross Cell
Overseas
Research & development of antitumor immune cell therapy
- GC China (China)
Production of plasma fractionation preparations
Other
- GCAM (USA)
Operating blood bank
- GC Engineering Maintenance
GMP Plant & Construction company specializing in bio-research facilities
- Invacfarm
Egg supply for vaccine production
20
Company Profile – Kukje Pharma
Company Overview
Under the company motto of “ Love is the best medicine ” ,we,
KUKJE Pharma Ind. Co., Ltd. have devoted our constant attention to
manufacturing various medicines of the highest quality
by using a state-of-the art synthesis technology and sophisticated
facilities complying with PIC/S GMP guideline recommended by WHO.
Sales by Therapeutic Area
:28%
Founded in 1959
Capital 15.1 M.USD
:33%
Sales (2014) 112
M.USD
Total Employees 450
Headquarter in BunDang, SeongNam City
Sales & Marketing
Production
R&D
221
132
30
Business Area
Overseas Business(Alliance & Trading)
15 countries, Export sales: USD 3M
ETC
OTC
APIs
Cosmetics
21
Company Profile –
Daewon Pharmaceutical Company
Company Overview
Name
Daewon Pharmaceutical Company (Logo :
)
Establishment
January 1958
Business Area
Pharmaceuticals and Hearing Aids (700 Employees)
Sales Turnover (‘15)
8 Year CAGR
Headquarter
200 Mil USD (20 Mil USD Export in 35 countries)
14.5%
Manufacturing Facilities
R&D Center
22
Company Profile –
Arlico Pharma
• Arlico Pharma is a dynamic pharmaceutical company involved in
development, manufacturing and distribution of pharmaceutical
products over 10 countries around the world.
• Established in 1992 and manufacturing around 150 products
including oral solid dosage form and ointment.
• Our core business areas are cardiovascular drugs, gastrointestinal
drugs and multivitamin.
• Currently we are importing 40 products to Asian countries, CIS
and South American countries.
• Our capital is 1.1 bn Kwon (1 mill USD)
• Sales revenue in 2015 is 30 bn Kwon (29 mill USD)
• No. of employees are 107
23
End of Documents
24

슬라이드 1

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