Sept High-Tech Industry Investment Promotion Team

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1 Sept. 9. High-Tech Industry Investment Promotion Team

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3 Government Policy Semiconductor s No. market share in DRAM, SRAM, LDII and NANO.% share of the global market Exports exceeded US$9billion Automobile s World s th biggest producer for yrs with.6% share Exports amounted to US$ billion Foreign-invested tier- suppliers, 6.8% of all parts sales Shipbuilding Exports reached US$ billion in 8 Ranked st globally in terms of new orders, order backlogs and volume of vessels built - % of all orders worldwide Displays No. market share in LCD, PDP and OLED displays ex. World TV market share : Samsung TV (.6%- st ), LG Electronics (.- nd ) Major players: LG Display, Samsung Electronics, LG Electronics, Samsung SDI Fiber Veneer Board Wigs Light Industry Steel Machinery Chemicals Heavy Industry Appliances Shipbuilding Automobiles Assembly & Process Industry Semiconductors Computers Telecom Devices IT Industry Biotech & the Green Industry : New Drug Development : Medical- Healthcare 96 s 97 s 98 s 99 s s

4 Government Policy The amount of the government s BT sector investment has been growing at a CAGR of.%, and the Ministry of Education, Science, and Technology is investing much more into the BT sector than other main ministries Government s Annual Investment in BT Sector (Unit: KRW Million),,, 6, 8, 8.7%,6 8.9%.9%,,78 9.6%.7% 8,9 6,8 (Unit: %).8%, ' ' '6 '7 '8 '9(E).% Gov. Total.% R&D Growth Rate 9.% 6.%.%.% CAGR ( ~ 9).7% BT Sector Investment.% The Korean government s BT sector investment amount has been growing at a CAGR of.%,, faster than the CAGR of the government s total R&D investment amount, (.7%) Ministry Roles & Investment Section Roles 7 MW MIR (MKE) MIC (MKE) MST (MEST) MEH (MEST) MIFAFF Promotion of R&D, business and research on Biotechnology Development and improvement of Biotechnology process Strategic planning, Development of HR, Support for fundamental bio-science & tech. Support for applied research, and fundamental research (Unit: KRW Million) R&D 8 Equip ment/ Infra Educa tion 67,68 - -,67 8, , Total 6,7 6, Source: Analysis Data of the National Research and Development Industry( ~ 7), Compilation of the Budget Result( 8~ 9), 7 Healthcare Industry White Book (KHIDI, 8. 6), Postech Biotech Center, Annual Life Science Fostering Operation Plan Data

5 Government Policy Government investment in biotech is expected to increase further, ranking the BT sector as # among government R&D investments in 9 Biotech IT Energy Machines Aerospace, marine Materials, Nano Basic sciences Transport, Construction Environment Government Investments in 9 Tech Sectors ( ~ 9) (Unit: Million KRW),6,6,7 6,67,6,667,,6,67,,,6 6,6,6,9,7,,96,78 7,67 6, 9,7 6,6,67,79,7,99 6,8,7 7,9 8, 7,86,9,86,76,7 8,9 8,989,78,8 8,797,8,7,69, 9, ,,767,76 9,6,98,79,68, CAGR ( ~ 9).%.6%.% 6.7%.% 7.%.% 8.%.6% (Unit: % total government R&D budgets) Ranks IT (.%) IT (9.8%) IT (7.%) BT (7.%) BT (.6%) BT (7.%) BT (6.6%) IT (6.%) Machines (9.%) Machines (.%) Machines (.8%) Energy (.%) Energy (7.%) Aerospace, marine (7.%) Energy (.6%) Machines (.%) Aerospace, marine (.7%) Energy (7.%) Aerospace, marine (7.9%) Aerospace, marine (7.8%) Source: Investigation and Analysis of Governmental R&D projects ( ~ 7), Result of the compilation of the budget ( 8~ 9)(Research on humanities and sociology, research on policy and HR investment are excluded from the total R&D investment)

6 Government Policy 6 Total investment in 6T* increased to.7%, or KRW 6,7 billion in 8. Investment into BT increased to KRW,76 billion (+.6%), while that into IT decreased (-9.%). It is now necessary to focus more on the investment in BT and ET which create greater value..9% of total R&D project investment is carried out via international collaboration. It is necessary to increase international collaboration to build competitive international joint R&D activities. Investment in 6T ( 7, 8) International joint-r&d type 7 IT 9.% 8 Etc.,98 IT,98.8% BT,6 7.% BT.6% Etc.,66 IT,76 7.% BT,76 7.% R&D,6 6% joint- R&D, % International joint-r&d,.9% Country / Region Share US.8% Europe.% CT 6 ET,8 ST 96 NT 9 CT 67 ET,6 ST 8 NT 7 Japan.% China.8% Etc..6% The sum of investment in BT increased to,76 billion won, +.6%. In 8, BT has grown in importance in terms of investment in 6T compared to 7. %(,) of the total R&D projects(8,6) are being carried out via joint-r&d, while.9% of joint-r&d is carried out by international collaboration. * 6T: IT (Information Technology), BT (Biology Technology), NT (Nano Technology), ST (Space Technology), ET (Environment Technology), CT (Culture Technology)

7 Market Status 7 Compared to other OECD members, Korea is rapidly becoming an aging society where both quantity and rate of drug consumption are expected to grow as a result Population Change Percentage of Population Over 6 Years (Unit: %) Korea.8% ' ' ' ' ' '6 '7 '8 '9 ' ' ' ' ' ' OECD Avg. CAGR.% Percentage of Population Over 6 Years and Drug Manufacturing Cost in 6 % 8% 6% % 9.% Implications Below 6 yrs. 7.% Korea is becoming an aging society rapidly The percentage of Koreans over 6 is expected to reach about % by Time it takes for the % of those over 6 years old to double Korea Japan UK Sweden 8 yrs. yrs. 6 yrs. 8 yrs. % % 9.% About 6 yrs. Old 8.% Population % Drug Manufacturing Cost % % of population over 6 years which consumes drugs is times over the population percentage ( 6) The amount of drugs and the percentage of consumption are expected to grow because of the increasingly aging population

8 Korae Czech Republic Switzerland Mexico Japan New Zealand France OECD average United States Germany Australia Netherlands Ireland Hungary Canada Market Status 8 CAGR of healthcare expenditure to GDP in Korea is about twice higher (.98%) than the OECD average(.6%), and also, the percentage of drug expenditure in total healthcare expenditure (.8%) is higher than the OECD average (7.6%) CAGR of Healthcare Expenditure to GDP ) ( 9~ 6) % of Drug Expenditure in Total Healthcare Expenditure ( 6) (Unit:. %) KOREA.8% OECD 7.6%.7. The CAGR of Health Spending from 99 to 6 is the highest of all OECD member countries with.98% Higher than the OECD average of.6%.8% out of Korea s total health spending is being used as pharmaceutical spending One of the highest out of the OECD countries, following Slovak Republic, Hungary, and Poland Higher percentage than the OECD average of 7.6% ) The growth rate of Hungary is calculated from 99, Netherlands with current cost, not with the total health spending, and New Zealand with current cost, not with the total health spending, from Source: OECD Factbook 9, ceutical pricing in a global market (OECD, 8), OECD Health Data 8, Nemo Analysis

9 Market Status 9 Among various types of disease in the Korean market, the growth rate of cardiovascular ailments, CNS, diabetes, and oncology/cancer are the highest, taking 9% of chronic diseases caused by aging Area Anti-Infective (Antibiotics/Antiphrastic/ Chemotherapeutic/Vaccine) Cardiovascular (Hypertensions/Arteriosclerosis) Neurological Gastrointestinal Other Metabolic agents (Diabetes) Nutrients/Tonics Dermatological Respiratory Vitamins Oncology/Cancer 999 Chronic Diseases with High Growth Rate Market Size for Main Diseases Production Trends (Unit : KRW Billion) ,7,6,78,96 Source: Korea ceutical Manufacturers Association Statistical Yearbook (6) and Statistics Archives (999-) ,,,9 Generally, hypertension, high cholesterol, arteriosclerosis, diabetes, cancer, etc., are the most prevalently cured chronic diseases. These chronic disease are categorized by their medical treatment area rather than the condition of the disease, and out of those diseases mentioned above, cardiovascular, CNS, other metabolism disease, anti-cancer medicine sectors are more are 9% of main chronic disease of aging population CAGR 99~.%.% 8.%.9%.% -.%.7%.9%.% 9.% Market Share 99.%.6%.6%.%.6% 9.6%.%.%.%.%.% 8.% 6.8%.% 7.%.%.%.7%.6%.% M/S 99~ -.8% 6.6%.% -.%.6% -.% -.% -.6% -.7%.%

10 Market Status In spite of the Government s ongoing Drug Price ) Control Policy, the bio/pharma market is continuously growing based on the demand of aging population, increasing number of patients with chronic diseases, etc. Production Changes by Medical Supplies Manufacturing Classification Number of Companies Amount of Production (Unit: # of Companies) 6 Drug manufacturer Quasi-drug (Unit: KRW Million) Drug manufacturer Quasi-drug ,, 8, 79,768 8, 8,,,,98,7 8 7,, 9,67,6,98,,7,8 ' ' '6 '7 ' ' '6 '7 Drug manufacturing sector is showing externally satisfactory growth, in spite of the Government s ongoing Drug Price Cost Control Policy in 7, started in 6, because of increased medical supplies concerning the insurance deficit finance Quasi-drug manufacturers sector production size is relatively small compared to that of the drug manufacturer, and thus, annual production levels are being maintained without any fluctuation ) Cost of pure insurance drugs that does not include medical charge(charge provided to provider of the medical service, like doctors and pharmacists) or manufacturing cost, etc., Source: KPMA

11 Market Status Production levels rank that is classified according to each therapeutic category is antibiotics, fever pain killers, depressants, circulation system related drugs, respectively, and out of theses, depressants increased about 9% and arteriosclerosis drugs 6% compared to the last year Actual Annual Output of Main Medicinal Category Rank Medicinal Category (Unit: KRW Million, %) Increased Rate ( 7-8) Antibiotic Medicine (operating mainly in gram-positive ad gram-negative),8,,67,7,,79. Fever, Pain, Antichloristic Medicine 78,9 78,9 87,.7 Depressants 66,79 67,9 78,6 8.6 Other Circulating System Medicine 78,9 7, 76,77. Peptic Ulcer Related Medicine 6, 8,89 6,6. 6 Other Chemotherapy Medicine,8 7,769, Sclerosis of the Arteries Related Medicine 8,76 78,6, Others Digestive Organ Related Medicine,9 6,777 9, Blood Medicine 9, 8,87 8,87. Others Metabolism Related Medical Supplies 7,8 6,9 6,9 9. The increased rate of depressant, sclerosis of the arteries related medicine, etc., seems to be caused by entering into the aging society and an increase in the types of diseases found in adults in developed countries Source: KFDA, 8

12 Market Status Out of top companies measured by the total production in 8, Dong-A Pharm., Hanmi Pharm., Daewoong Pharm., Handok Pharm. ranked at the top four, in that order. These top four companies total production amounted to 8.8% of the market s total production in 8 Top Actual Outputs of Domestic s (Unit: KRW Thousand, %) Rank Company Name Complete Drugs Raw Materials Total Mkt. Share Acc. Mkt Share Rank Company Names Complete Drugs Raw Materials Total Mkt. Share Acc. Mkt. Share Dong-A 698,9,87,7,97 79,97,8.. Dong-Wha,97,6 -,97, Hanmi 79,6, - 79,6,. 9. Jeil 98,, 7,7,76 6,7, Daewoong Source: KFDA 8 67,6,97-67,6,97..6 Handok 9,, - 9,,.7 7. Yuhan Corp.,86,6 -,86, Choongwae 9,98,77 6,97,88,6, CJ,,99,,6 6,6, Chong Kun Dang 9,,7-9,, Il Dong 8,,96 7,6,,7,8.. Green Cross,,6,8,766,9,.. SK Chemicals Life Science 8,,696,,8 9,, Bukwang LG Life Science Janssen Korea SAMJIN Boryung Berna Biotech Korea Red Cross Blood Service HQ,6,98 -,6,98.. 9,77,6 7,7,999,, ,,6-9,8,6.. 9,7,969 9,7 9,99,..9 9,8,8 8,87 9,8, ,6,,7,9 8,76, ,,6 8,8,97 66,9, Total 6,9,7,9 9,89,67 6,79,8,8 8.8

13 Market Status ETC drug market, taking 8% of the total Korean market, has been leading the growth of domestic pharma industry and is forecasted to grow more in the future because of its high CAGR, % Domestic Sales ( 8) Top Companies for Drug Sales (Unit: KRW Million), Total Sales : KRW.86 Trillion 8, 9, Company Name OTC Drugs 8 Sales Market Share Company Name (Unit: KRW Million) ETC Drugs 8 Sales Market Share 6, 7, Dong-A, 6.% Sanofi-Aventis,8.% Yuhan 8.8% Pfizer Korea,7.8%, 7,9 7,97 7, 6,9 The domestic market size in 8 is KRW.86 trillion ETC drug market size is KRW 9. trillion (8%), OTC drug market is KRW.69 trillion (6%) Unlike the sales of ETC which are rising, those of OTC are declining every year In - years, the ratio of special drugs and general drugs is expected to grow to 9: Source: KPMA, Nemo Analysis OTC ( ~ 8) = -.89% ' '6 '7 '8 Dong-Wha Il Dong 8.76% GSK,6.9% 777.6% Dong-A,6.86% Hami 7.% Novartis,89.9% 6 Daewoong 7 Bayer Korea 9.9% 8 9 Kwang Dong Bukwang Boryung 67.99% Hanmi,8.% Daewoong 8.86% Choongwae,8.7%,9.%.7% MSD Korea,6.9%.% Yuhan,9.8% Total 6,6 9.7% Total,6.6%

14 R&D Infrastructure As the Gateway to Asia, Korea provides opportunities to diversify business portfolios and develop new therapies including stem cells and gene therapies 6 cities with population over million within hours India Northeast Asia is home to / of the world s population. Northeast Asia s GDP = % of global GDP (% by ) Region s purchasing power is equal to that of the United States / / World GDP 8.7% Russia Vladivostok hrs Beijing. hrs China Malaysia Singapore World Population Republic of Korea Shanghai.hrs Hong Kong hrs Pacific Ocean Average Growth Rate (Asian Countries but Japan) World:.%, OECD:.7% Korea Gateway to Asia Test Bed of Asia Gateway to China / Japan New Therapy Specialty Prevalent Diseases High attack rate of liver, stomach cancer in Korea Disease pattern similar with developed countries (USA, EU) Ethnic Sensitivity Drug s efficacy for cancer in Asian Representative for Asian country as important spot Agreement with Adjacent Countries Activation for partnership among Korea, China, Japan Authority in Korea Similarities in genetic polymorphism between Korean and Chinese (China s pivotal regional trial country) Japanese authorities accept data from Korea High edge technology in the field of stem cells Cha-bio tech company - One stop system with Seoul CRO for stem cell R&D - Bio bank and cell medication - R&D pipeline for embryo, adult stem cell Gene Therapy Area Global standard gene recombination / transfer technology

15 R&D Infrastructure Most major hospitals are in the metropolitan areas, reachable in one hour, and cost effective to conduct clinical trials Regional Clinical Trial Centers ( sites) Pre-Clinical Seoul Nat l Univ. Hospital Inje Univ. Hospital Yonsei Univ. Hospital Ajou Univ. Hospital 7 8 Korea Institute of Toxicology (Daejeon / Jeongeup) Biotoxtech (Cheongwon) Chem-on (Yangji / Suwon) Kyungpook Nat l Univ. Hospital Battelle ISS research institute (Chun cheon) Chonnam Nat l Univ. Hospital Asan Medical Center Catholic Medical Center 6 9 CRO Dream CIS (Seoul) 9 Chonbuk Nat l Univ. Hospital C&R Research (Seoul / Busan) Samsung Medical Center Seoul CRO (Seoul) Chungnam Nat l Univ. Hospital Inha Univ. Hospital CRAs ) go to any part of Korea, complete monitoring, and return home in one day. CRAs are all centrally located, and can be supervised more readily. Patients come to hospitals in Seoul from remote areas, and return home in one day. ) Clinical Research Associate

16 R&D Infrastructure 6 Korea s Bio Clusters are established in major cities and are all connected, forming one national cluster within one hour s distance by air 6 7 One Hour (Airway) Two Hours (Railway / KTX) Regional Clinical Trial Center Pre-Clinical Medical Cluster Cluster Osong Bio- Health Science Technopolis Daedeok Innopolis Wonju Medical Instrument Cluster Daegu Medical Cluster(Pohang) Gwanggyo Techno Valley (Gyeonggi Bio Center) 6 Incheon Bio- Medical Hub Value Chain. > R&D R&D Production > R&D R&D > Production R&D Medical Service > R&D Area (m unit: thousand).6 km Public Inst. (. km ) Production Inst.(.6 km ) Research Inst. (. km ) 7.km District I : Daedeok Research Inst. (.78 km ) District II :Daedeok Techno Valley (. km ) District III: Daejeon Industry Complex (. km ) 9, m Donghwa Medical Instruments (,8 m ) Medical Instruments Complex (,7 m ) High-tech Medical Instruments Venture Center (,7 m ) High-tech Medical Instruments Techno Tower (,7 m ),8 m Life Science Research Center (aprox, m ) Life Science Hall (aprox 7,6 m ) Chemistry Hall (aprox 9, m ),967 m stories above ground and under.8 km Medical Service (. km ) Medical Supplies (. km ) Medical Instrument (. km ), Dielectric Center(7, m ) Regenerative Medical Science Center(, m ) Enterprise Ent. 7 Pharm. Medical Instruments Others 7 Ventures 6 Small and Medium Ent. 7 Establishment Nurturing Ent. Approximately Venture Businesses 7 Venture Businesses Bio company like Celltrion, etc. Intl. Business Center IT Business Institute 6 Inst. KFDA Toxic Academy of Science Others Development Period Period: 97~ Investment : 8.9 billion won 7 Inst. Period : ~ Donations Investment 9 Private :6. billion won Investments High-tech Period : 98~ Medical Investment Instrument :. billion Techno Tower/ won Venture Center 6 Inst. Period : 9~ 8 Inst. Ajou Univ. Cell Medical Treatment Center BIO Venture Business Inst. Period : ~ 7 Investment :79.6 billion won Planning

17 R&D Infrastructure 7 Korea outnumbers Japan and China in the number of clinical trials, recording 6 international cases and 8 domestic cases in 8 No. of Korean Clinical Trials by Year and Sponsor # of Clinical Trials (IND) Japan vs. Korea (Unit : No. of Clinical Trials) Japan Korea Korea (international) Local '98 '99 ' ' ' ' ' ' '6 '7 '8 Source: Biotechnology White Paper (7), KFDA (9) 6Interna- tional Japan (First IND) Korea 9 (local) '9 '9 '9 '96 '97 '98 '99 ' ' ' ' ' ' Since 99, the number of clinical trials has steadily increased in Korea, while in Japan they have decreased # of Multinational Trials in China from to ' ' ' ' '6 '7 '8 6 7 No. of application No. of approval Although China is expected to catch up in the future, at present Korea is more active in multinational trials than China 9 8

18 R&D Infrastructure 8 Korean human resources in biotechnologies have grown to world-class level and are reliable, due to government support, westernized curriculum and studies in the US Highly Motivated Westernized Curriculum Bio vision 6 Rank 7 th worldwide in life science Investment of,88 billion won is planned Most investigators are trained in the US for - years Motivated to participate in global trials and well versed with GCP Translational Research Korean doctors and investigators actively engaged in medical research until retirement Integration of BT-IT-NT research activities aiming at Intermediary research system Cooperation with IP-K (Institute Pasteur Korea) Post-Doc in the U.S. Global research program KOSEF ) Increase number of professors hired by US colleges Matured attitude of research makes excellent results Work Ethic & Compliance Business mind based on trust and higher reliability of data than other Asian countries High compliance with advanced GCP standards ) Korea Science and Engineering Foundation ) Institut national de la santé et de la recherche médicale - Inserm (France National Institute for Health and Medical Research) Source: Global Networking Trend and Implications for Bio Industry Development (KIET, 7.)

19 R&D Infrastructure 9 Over one-half of biotech human resources are dedicated to drug development and basic research is expected to grow relatively fast in the future Expected Growth of R&D Human Resources (`7 ~ `7) By R&D Functions Focus on the Drug Development Area (Unit: Person) 7, 6,,, 8,7 (%) 6,,7 (%),66 (%) CAGR(E) Basic.% Research Medical.% Research 7(E) Discovery Pre-Clinical / Clinical,,6,96 (%) (%) (6%) (Unit: Person) Manufacturing / / Preparation,7.%.%.% CAGR(E) 8,,,6 (%),66 (7%),7 (%) Drug.9% Development 7 8,896 6,77 9,96 (%) (7%) (8%),66 7 7(E) 8, 6,,,, Share of drug development area exceeds others Basic research area is expected to grow more rapidly at a CAGR of.% R&D HR in preclinical and clinical step of drug development are expected to increase more rapidly than others (CAGR of.%) Source: Health Care Industry Report ( st edition of 8, KHIDI), Nemo Analysis

20 R&D Infrastructure Patents in biotech have increased rapidly and Korea is ranked nd in Asia Patents and Technical Strength of Korea (Unit: # of patents) Trends in Korea ( 9~ 8) Patent `9~`97 `98~` `~`6 `7~`8 `9~`8 (Unit: point) TS ) `9~`97 `98~` `~`6 `7~`8 `9~`8 World Ranking ( 8) Rank ) Country TS # of Patents US 98.8, Japan.9 99 Germany.9 98 Canada Swiss UK France. 8 Denmark. 7 9 Belgium. Netherlands. Korea 6. ) Technological Strength (TS) = (no. of patents) X (no. of quotations), ) Ranked by TS Source: Biotech Policy Research Center, Patent (Korea Institute of Patent Information, 9)

21 R&D Infrastructure Korean scientists in biotech have rapidly increased the contributions of research papers, particularly to Nature, Cell and Science The Number of N S C publications ) ( 9~ 7) Average Citation Intensity of Paper ( 7) (Unit :the number of papers) 9,79,,8,7 7,9,6 6,99 SCIE papers,9 of Korean BT,89 ( 9~ 7) ),89 9 8,97 Cell, Nature Science '9 9~ 97 '9 '96 '97 98~ '98 '99 ' ' ' ~ ' ' ' 6~ 7 '6 '7 (Unit :the number of citation) ~ 98~ 99~ ~ ~ ~ 6 Global Average Korea Average Citation Intensity of Korean BT paper is growing faster than the average of all countries ) Sorted papers relevant to biotechnology and written by South Koreans from all of papers published on NSC (Nature, Science, Cell) Source : KRIBB (Korea Research Institute of Bioscience and Biotechnologies, KRIBB, KAIS

22 R&D Infrastructure new drugs of Korean bio & pharmaceutical companies have been approved ( ~8) New Drugs Approved by Korean Bio & ceutical Companies ( 9) NO Company Product Name Specific Indication CategoryLicense Date NO Company Product Name Specific Indication License Category Date Dong Wha Pharm. Co., LTD. Millican Inj. Liver Cancer Radiation 7. 8 Bukwang. Levovir Cap. Chronic Hepatitis B Chemical 6. Chong Kun Dang Pharm. Camtobell Inj. SK Chemicals Sunpla Inj. Ovarian Cancer, Lung Chemical. Cancer Stomach Cancer Chemical Yuhan Pharm REVANEX Tab. Anti-Ulcer Chemical.9 Il-Yang Pharm. Co., Ltd. Noltech (Ilaprazole) Anti-Gastric Ulcer (Protein Pump Inhibitor) - 8. Guju Pharm. Co., Ltd. Daewoong Pharm. Co. Apitoxin EGF Topical Solution Rheumatism, Osteoarthritis Glycemic Ulcer and wound by diabetes Natural.6 Bio. Choonwae. Corp. CJ Q-roxin Tab. Pseudovaccine Inj. Antibiotics (Urinary Infection) Prendomonas Infection Prevention Chemical.7 Bio Daewon Pharm. Co. Dong-A ceutcal Pelubi Osteoarthritis - 7. Zydena Tab. Erectile Dysfuction Chemical. LG Life Science FACTIVE Tab. SK Chemicals MVIX Antibiotics (Chronic Respiratory Disease) Erectile Dysfunction Chemical Source: Industry Academy Co-study Cooperation Plan for Improvement of Organizational Reform in ceutical Industry (STEPI, 6), Domestic Drug Approvals(KFDA, 8), National BT s Progress Plan and Prospect (Eunhee Bae, member of National Assembly, 9), 8 Directory of (KHIDI, 8), 8 Overview of Bio-Venture (MKE / Korea Bio Venture Association), Korea Drug Research Association 9, Nemo Analysis