User s Guide Please note the following when using the Data Book. The survey results featured in the Report of the Pharmaceutical Industry Survey are c

Transcription

1 Forewords This data book organizes the statistics on pharmaceutical industries both in Japan and around the world. Those contain such figures as yearly transition of a variety of data such as demographic changes, national healthcare expenditure, and social security payments. Japan Pharmaceutical Manufacturers Association (JPMA) has also summarized pharmaceutical industries overall pictures including the outcome of our research to the member companies, delivering the data collected from a variety of different angles: environment of pharmaceutical industries or comparison with other industries, current situations of production of medicinal drugs, factors of expansion to non-japanese countries, the latest situation of research and development, or trends in approval for new products. With the exception of some statistical data from government or other public agency sources, the latest data in this issue are for FY2014. We would be grateful if this data book is utilized as a tool for promotion of understanding about pharmaceutical industries, making medical care policies, or planning strategies for pharmaceutical industries. Since the 2015 issue, it has become possible to browse the DATA BOOK on the JPMA website. This DATA BOOK will therefore be the last to be published in printed form. Issuance of the new edition of the Data Book owes so much to cooperation offered by a wide variety of relevant organizations: a variety of ministries including Ministry of Health, Labour and Welfare at the top, non-japanese pharmaceutical manufacturers associations, research agencies, or member companies of JPMA. We here would like to appreciate all their effort and cooperation. March 2016 Japan Pharmaceutical Manufacturers Association

2 User s Guide Please note the following when using the Data Book. The survey results featured in the Report of the Pharmaceutical Industry Survey are cited on pages 3 through 9. The surveys up to FY2005 targeted all the companies whose head offices (1) manufacture and sell pharmaceuticals, (2) manufacture drugs, and (3) import and sell drugs, as of the end of each business year (March 31), based on a license for the Manufacture and Sale of Drugs, the Manufacture of Drugs, and the Import and Sale of Drugs, under the Pharmaceutical Affairs Law. Among the companies, having obtained a pharmaceutical manufacturing and marketing license under the Pharmaceutical Affairs Law as of the end of each business year (March 31), the surveys since FY2006 targeted the member companies under the fourteen industrial bodies affiliated with the Federation of Pharmaceutical Manufacturers Associations of Japan. Moreover, various numerical values for FY2004, including drug sales, decreased by 15 to 20% from other years. This, however, was the result of a considerable number of corporations, including large-scale entities, not being incorporated as the compilation targets, causing the figures to deviate considerably from the actual status. Therefore, these figures were not reproduced or included.

3 Abbreviated Names of Member Companies Abbreviated Name AbbVie Ajinomoto Pharma. Alcon Asahi Kasei Pharma ASKA Astellas AstraZeneca AYUMI Baxalta Bayer Boehringer Ingelheim Bristol-Myers Celgene Chugai Daiichi Sankyo Dainippon Sumitomo Eisai Eli Lilly Fujimoto Fuso Genzyme GlaxoSmithKline Hisamitsu Janssen Japan Tobacco Kaken Kissei Kowa Kracie Pharma Kyorin Pharma. Kyoto Kyowa Hakko Kirin Maruho Maruishi Meiji Seika Pharma Merck Serono Minophagen Official Name AbbVie G.K. AJINOMOTO PHARMACEUTICALS CO., LTD. Alcon Japan LTD. ASAHI KASEI PHARMA CORPORATION ASKA PHARMACEUTICAL CO., LTD. ASTELLAS PHARMA INC. AstraZeneca K.K. AYUMI Pharmaceutical Corp. Baxalta Japan Ltd. BAYER YAKUHIN, LTD. NIPPON BOEHRINGER INGELHEIM CO., LTD. BRISTOL-MYERS K.K. Celgene K.K. CHUGAI PHARMACEUTICAL CO., LTD. DAIICHI SANKYO CO., LTD. DAINIPPON SUMITOMO PHARMA CO., LTD. EISAI CO., LTD. ELI LILLY JAPAN K.K. FUJIMOTO PHARMACEUTICAL CORP. FUSO PHARMACEUTICAL INDUSTRIES, LTD. Genzyme Japan K.K. GlaxoSmithKline K.K. HISAMITSU PHARMACEUTICAL CO., INC. JANSSEN PHARMACEUTICAL K.K. JAPAN TOBACCO INC. KAKEN PHARMACEUTICAL CO., LTD. KISSEI PHARMACEUTICAL CO., LTD. KOWA Company, Ltd. KRACIE PHARMA, LTD. KYORIN PHARMACEUTICAL CO., LTD. KYOTO PHARMACEUTICAL INDUSTRIES, LTD. KYOWA HAKKO KIRIN CO., LTD. MARUHO CO., LTD. MARUISHI PHARMACEUTICAL CO., LTD. Meiji Seika Pharma CO., LTD. Merck Serono CO., LTD. MINOPHAGEN PHARMACEUTICAL CO., LTD.

4 Abbreviated Name Official Name Mitsubishi Tanabe Mochida MSD Mylan Nihon Pharma. Nippon Chemiphar Nippon Kayaku Nippon Shinyaku Nippon Zoki Novartis Novo Nordisk Ono Otsuka Pfizer POLA PHARMA Sanofi Santen Sanwa Kagaku Seikagaku Senju Shionogi Taiho Taisho Takeda Teijin Pharma Teikoku Seiyaku Terumo Toa Eiyo Toray Torii Toyama Chemical Tsumura UCB Wakamoto Yakult Zeria MITSUBISHI TANABE PHARMA CORPORATION MOCHIDA PHARMACEUTICAL CO., LTD. MSD K.K. Mylan EPD G.K. NIHON PHARMACEUTICAL CO., LTD. NIPPON CHEMIPHAR CO., LTD. NIPPON KAYAKU CO., LTD. NIPPON SHINYAKU Co., Ltd. NIPPON ZOKI PHARMACEUTICAL CO., LTD. NOVARTIS PHARMA K.K. NOVO NORDISK PHARMA LTD. ONO PHARMACEUTICAL CO., LTD. OTSUKA PHARMACEUTICAL Co., Ltd. PFIZER JAPAN INC. POLA PHARMA INC. Sanofi K.K. SANTEN PHARMACEUTICAL CO., LTD. SANWA KAGAKU KENKYUSHO CO., LTD. SEIKAGAKU CORPORATION SENJU PHARMACEUTICAL CO., LTD. SHIONOGI & CO., LTD. TAIHO PHARMACEUTICAL CO., LTD. TAISHO PHARMACEUTICAL CO., LTD. TAKEDA PHARMACEUTICAL COMPANY LIMITED TEIJIN PHARMA LIMITED TEIKOKU SEIYAKU CO., LTD. TERUMO CORPORATION TOA EIYO LTD. Toray Industries, Inc. TORII PHARMACEUTICAL CO., LTD. TOYAMA CHEMICAL CO., LTD. TSUMURA & CO. UCB JAPAN CO., LTD. WAKAMOTO PHARMACEUTICAL CO., LTD. YAKULT HONSHA CO., LTD. ZERIA PHARMACEUTICAL CO., LTD.

5 CONTENTS Domestic Statistics 1 55 International Statistics Statistics on Health Ⅰ.PHARMACEUTICAL INDUSTRY OUTLOOK Number of Pharmaceutical Manufacturers Japan 3 Major Countries 59 Employment in the Pharmaceutical Industry Japan, by Function 4 Europe, by Country 60 Number of Pharmaceutical Manufacturers by Number of Employees Japan 5 Pharmaceutical Market Japan 6, 14 Major Countries and Regions 61 Sales of Pharmaceutical Manufacturers by Capital Scale Japan 7 Concentration on Pharmaceutical Sales to Leading Companies Japan 8 Worldwide 62 Comparison of Pharmaceutical Sales between Domestic and Foreign Companies 9 Financial Results of JPMA Member Companies All Member Companies Ethical Drug Sales Japan 15 Financial Results of Leading Pharmaceutical Manufacturers Japan, Financial Results 16 Worldwide, Operating Results 63 Worldwide, Financial Results 64 Value-Added Ratio of Industrial Sectors Japan 17

6 Profitability of Research based Industries Japan, by Industry 18 Japan, Leading Companies 19 U.S.A. and Europe, Leading Companies 65 International Trade of Pharmaceutical Products Japan, by Year 20 Japan, Partner Country 21 Major Countries 66 Exports, Partner Country 67 Imports, Partner Country 68 Overseas Business of Japanese Pharmaceutical Companies Expansion into Overseas Markets by JPMA Member Companies Overseas Sales of Leading Pharmaceutical Manufacturers Japan 16 Worldwide(excluding Japanese Manufacturers) 69 Miscelleneous Indexes 70 Ⅱ.PHARMACEUTICAL PRODUCTION Pharmaceutical Production Japan, by year 29 Japan, by Therapeutic Category 30 Trends in Ethical Drug Production by Composition Ratio of Main Therapeutic Category Japan 31 Pharmaceutical Production by Dosage Forms Japan 32 Ethical Drug Production and National Health Care Expenditures Japan 33 Ⅲ.PHARMACEUTICAL RESEARCH AND DEVELOPMENT R&D Expenditures of the Pharmaceutical Industry Japan, by Year 37 R&D Expenditures of Leading Pharmaceutical Manufacturers Japan 38 Worldwide(excluding Japanese Manufacturers) 73 R&D Expenditures by Developmental Stage U.S.A. 74

7 Trends of R&D Expenditures and Profits as Sales Ratio Japan 39 U.S.A. 75 R&D Expenditures as a Percentage of Sales by Industry Japan 40 R&D Expenditures by Industry and Type Japan 41 Number of Pharmaceutical Approvals Granted in Japan 42 Number of Pharmaceuticals Included in the NHI Price List in Japan 43 Number of New Molecular Entities Approved Japan, by year 44 Japan, Leading Companies, (Accumulation from 2000) 45 Success Rate of Developing New Drugs Japan 46 Median Development Times for New Molecular Entities Japan 47 Median Approval Times for New Drugs Japan 48 Review Process for Approval Japan 49 Trends in Notification of Clinical Trials Japan 50 Number of Drug Patents Japan, by Year 51 Japan, Domestic Applicant 52 Japan, Foreign Applicant 53 Published PCT Applications by Pharmaceutical Company 76 Number of Bio-technology Patents 54 Technology Exports and Imports in the Pharmaceutical Industry Japan 55 STATISTICS ON HEALTH CARE Life Expectancy Japan 79 Worldwide 80 Trends of Vital Statistics Japan 81 Foreign Countries 82

8 Mortality Rate by Major Causes Japan 83 Major Countries 84 National Health Care Expenditures Japan 85 Major Countries 86 National Health Care Expenditures - % GDP Major Countries 87 National Health Care Expenditures and Share by Source of Revenues Japan 88 U.S.A. 89 Proportion of National Treasury Expenses in National Health Care Expenditures Japan 90 U.S.A. 91 Social Benefit 92 Number of Medical Care Facilities Japan 93 Number of Beds in Medical Care Facilities Japan 94 Number of Medical Care Personnel Japan 95 M&A in Japan 96 in the World 97 (Appendix) List of JPMA Member Companies Exchange Rates 104

9 DOMESTIC STATISTICS DOMESTIC STATISTICS Ⅰ. Pharmaceutical Industry Outlook Ⅰ. Pharmaceutical Industry Outlook

10 Number of Pharmaceutical Manufacturers Japan Fiscal Year Total Ethical Drug Manufacturers OTC Drug Manufacturers Other Manufacturers Manufacturers with NHI Price listed Drugs JPMA Members * Refer to the User's Guide. Note : The figures within parentheses show the number of generic makers. Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry Manufacturers with NHI Price listed Drugs: Jiho, NHI Drug Price Directory by Therapeutic Category August issues of each year 3

11 Employment in the Pharmaceutical Industry Japan, by Function Unit : %, no. of persons Fiscal Year Total Administration Production & Quality Control Research & Development Researchers Marketing Medical Representative * Refer to the User's Guide. Note : 1 The number of employees counted in this figure belongs to the pharmaceutical divisions. 2 Instructors are not included in Medical Representative. 3 The figures in the parenthesis show the number of surveyed companies. 4 The sum of the categories does not equal to JPMA total sum shown due to incomplete responses. The figures in the parenthesis in this row show the number of companies responded. Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry, 4

12 Number of Pharmaceutical Manufacturers by Number of Employees Japan Fiscal Year 10 employees or less ,000 1,001 3,000 Over 3,001 % in parentheses Total 5 * Refer to the User s Guide. Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry,

13 Pharmaceutical Market Japan Manufacturers Sales Unit : JPY bil. Fiscal Year Total Ethical drugs OTC drugs Generic drugs Raw materials and Others * Refer to the User's Guide. Note : 1. Ethical drugs includes in vitro diagnostics. 2. Raw materials and Others includes bulk products and medical supplies such as hygiene products. The figures from 2006 include products sold by distributors. 3. The figures in parenthesis are the number of companies surveyed. Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry, 6

14 Sales of Pharmaceutical Manufacturers by Capital Scale Japan FY2013* : 345 Companies Product Category Less than 10 mil mil mil mil. Capital Scale 300 mil. 1 bil. 1 5 bil. Over 5 bil. Unit : JPY mil. Total 7 Specialized Pharmaceutical Companies Diversified Companies Total Ethical Drug Generic OTC Raw materials and Others Total Ethical Drug Generic OTC Raw materials and Others Total Ethical Drug Generic OTC Raw materials and Others Total * Refer to the User's Guide. Note : 1. Ethical drug includes in vitro diagnostics. 2. Raw materials and Others includes bulk products, medical supplies e.g. hygiene products and in-house products sold by distributors. Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry,

15 Concentration on Pharmaceutical Sales to Leading Companies 8 Japan Fiscal Year 5 Leading Companies 10 Leading Companies 30 Leading Companies 50 Leading Companies 100 Leading Companies Unit : % Total Companies * Refer to the User s Guide. Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry,

16 Comparison of Pharmaceutical Sales between Domestic and Foreign Companies Fiscal Year Total Sales JPY mil. Domestic Ratio % Counted Companies Total Sales JPY mil. Foreign Ratio % Counted Companies Total Sales JPY mil. Total Ratio % Counted Companies % Ratio of Foreign Company * * * * Fiscal Year * Refer to the User s Guide. Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry, 9

17 Financial Results of JPMA Member Companies Unit : JPY mil. Company Total Sales Pharmaceutical Sales Operating Income Ordinary Income Net Income No.of Employees Fiscal Year AbbVie Ajinomoto Pharma. Asahi Kasei Pharma* ASKA Astellas AstraZeneca* Bayer* 10 Boehringer Ingelheim Chugai Daiichi Sankyo Dainippon Sumitomo Eisai Eli Lilly* Fuso* Genzyme Japan*

18 Unit : JPY mil. Company Total Sales Pharmaceutical Sales Operating Income Ordinary Income Net Income No.of Employees Fiscal Year Hisamitsu Japan Tobacco Kaken Kissei Kowa Kracie Pharma Kyorin Pharma.* 11 Kyowa Hakko Kirin Maruho* Maruishi* Meiji Seika Pharma Minophagen Mitsubishi Tanabe Mochida MSD* Nippon Chemiphar

19 Unit : JPY mil. Company Total Sales Pharmaceutical Sales Operating Income Ordinary Income Net Income No.of Employees Fiscal Year Nippon Kayaku Nippon Shinyaku Nippon Zoki* Novartis* Ono Otsuka* Pfizer* 12 Sanofi* Santen Sanwa Kagaku* Seikagaku Senju* Shionogi Taiho* Taisho

20 Unit : JPY mil. Company Total Sales Pharmaceutical Sales Operating Income Ordinary Income Net Income No.of Employees Fiscal Year Takeda Teijin Pharma Teikoku Seiyaku* Toa Eiyo* Toray Torii* Toyama Chemical* 13 UCB* Wakamoto* Yakult Zeria *Non-consolidated Financial Statements Note : 1. Only includes JPMA members who responded to the survey. 2. represents invalid answers or not-public. 3. Total Sales of Japan Tobacco shows Sales Revenues in this table. 4. FY2014 data for AbbVie Inc. is that for Abbott Laboratories. Source : JPMA Survey questionnaire survey to member companies, Financial statements.

21 Ethical Drug Market Japan Unit : JPY mil. Hospitals General Practitioners Others Total Year NHI price basis Change % NHI price basis Change % NHI price basis Change % NHI price basis Change % IMS Health Source : IMS Japan, Calculated based on Japan Pharmaceutical Market Sales (Reprinted with permission)

22 Ethical Drug Sales 15 Japan 2014 Jan.-Dec. Promotion Company Level Unit : JPY mil. Distributor Level Unit : JPY mil. Company Sales NHI price basis Company Sales NHI price basis Pfizer Takeda Takeda Astellas Daiichi Sankyo Daiichi Sankyo Chugai Chugai MSD Pfizer Novartis Pharma Mitsubishi Tanabe Mitsubishi Tanabe MSD AstraZeneca Novartis Pharma Sanofi Otsuka GlaxoSmithKline GlaxoSmithKline Otsuka Eisai Astellas Sanofi Eisai Eli Lilly Japan Nippon Boehringer Ingelheim Kyowa Hakko Kirin Bayer Bayer Eli Lilly Japan Shionogi Kyowa Hakko Kirin Dainippon Sumitomo Shionogi AstraZeneca Dainippon Sumitomo Janssen Ono Ono 2016 IMS Health Source : IMS Japan, Calculated based on Japan Pharmaceutical Market Sales 2015 (Reprinted with permission)

23 Financial Results of the Leading Pharmaceutical Manufacturers 16 Japan FY2014 Consolidated Accounts Company Sales JPY mil. Ordinary Income Net Income Total Equity Return on Return on Overseas Sales Assets Ratio Asset Equity JPY mil. % JPY mil. % JPY mil. % % % JPY mil. % Takeda Astellas Otsuka Holdings Daiichi Sankyo Eisai Kowa Mitsubishi Tanabe Dainippon Sumitomo Kyowa Hakko Kirin Taisho Shionogi Santen Hisamitsu Ono Kyorin Tsumura Kaken Mochida Nippon Shinyaku Kissei Note : Takeda, Astellas, Eisai, Daiichi Sankyo, Santen, and Ono have adopted IFRS (International Financial Reporting Standards) in their financial statements. In the case of a consolidated financial statements using IFRS only, the data have been handled in the following way. Ordinary income figures (in yen and %) are not stated, and income in the current term is taken to be net income. Source : SPEEDA (UZABASE, Inc.), Financial statements

24 Value-Added Ratio of Industrial Sectors Japan Industry No.of Firms Investigated Value- Added Ratio % No.of Firms Investigated Value- Added Ratio % No.of Firms Investigated Value- Added Ratio % No.of Firms Investigated Value- Added Ratio % No.of Firms Investigated Value- Added Ratio % No.of Firms Investigated Value- Added Ratio % Manufacturing Industries Foods Textiles Paper & Pulp Printing Chemicals Chemicals-Major Organic Chemicals Inorganic Chemicals Oil, Fats & Cosmetics Paints Pharmaceuticals Petroleum Rubber Products Stone, Clay & Glass Pds. Iron & Steel Nonferrous Metals Fabricated Metal Products Machinery Electric Equipment Computers & Electric Eq. Industrial Electric Eq. Communications Equipment Electric Measuring Instr. Electric Eq. & Comp. Household Electric Appl. Transportation Equipment Automobiles Auto Parts & Accessories Precision Instruments Misc. Manufacturing Source : Development Bank of Japan, Handbook of Industrial Financial Data Formulation Value added ratio % Value added Adjusted sales

25 Profitability of Research-based Industries 18 Japan Pharmaceuticals 29 companies Computers & Electric Eq. 5 companies Electronic Eq. & Comp. 61 companies Household Electric Appl. 19 companies Automobiles 10 companies Optical Instruments 5 companies Manufacturing Industries 972 companies Unit : % Net Income Loss after Taxes Business Income to Total Assets Return on Equity Net Income Loss after Taxes Business Income to Total Assets Return on Equity Net Income Loss after Taxes Business Income to Total Assets Return on Equity Net Income Loss after Taxes Business Income to Total Assets Return on Equity Net Income Loss after Taxes Business Income to Total Assets Return on Equity Net Income Loss after Taxes Business Income to Total Assets Return on Equity Net Income Loss after Taxes Business Income to Total Assets Return on Equity Source : Development Bank of Japan, Handbook of Industrial Financial Data The pharmaceutical companies surveyed include Kyowa Hakko Kirin, Kaken, Hisamitsu, Mitsubishi Tanabe, Eiken Chemical, Eisai, Ono, Santen, Shionogi, Dainippon Sumitomo, Takeda, Chugai, ASKA, Nippon Chemiphar, Nippon Shinyaku, Morishita Jintan, Mochida, Astellas, Rohto, Nichi-Iko, Zeria, Seikagaku, Tsumura, Kissei, Towa, Sawai, SNBL(Shin Nippon Biochemical Laboratories), Daiichi Sankyo, Taisho Pharmaceutical Holdings Formulation Total asset employed : Current assets Non-current assets Deferred Assets Note discounted Operating income loss : Sales income loss Accounts receivable and dividends Business income to total assets % Operating income losstotal assets 100 Return on equity % Net income Equity 100

26 Profitability of Research-based Companies Specific companies by sector Japan FY2014 Sales JPY mil. Ordinary Income JPY mil. Return on Asset % Return on Equity % Net Income Margin % 19 Pharmaceuticals Electric Machinery & Equipment Automobiles Communication & Electronic Machinery & Equipment Precision Machinery Takeda IFRS Astellas IFRS Daiichi Sankyo IFRS Panasonic * SEC Hitachi * IFRS Toshiba * SEC Toyota * SEC Nissan Japan Honda * IFRS NEC Japan Fujitsu IFRS Sony * SEC Canon * SEC Ricoh * IFRS Note: IFRS: International Financial Reporting Standards, SEC: Generally Accepted Accounting Principles (U.S.) Source : SPEEDA (UZABASE, Inc.), Financial statements

27 International Trade of Pharmaceutical Products 20 Japan Unit : JPY mil., % Year Exports Imports Trade Deficit Value A Change % Value B Change % Value B/A times Source : Ministry of Finance, Trade Statistics of Japan,

28 International Trade of Pharmaceutical Products by Partner Countries Japan Exports to : Country Unit : JPY mil., % Value Share U.S.A. China Korea Switzerland Taiwan Germany France Belgium Netherlands Italy Hong Kong Thailand U.K. Indonesia India Singapore Spain Mexico Brazil Australia Philippine Canada Turkey Others Total Imports from : Country Unit : JPY mil., % Value Share U.S.A. Germany Switzerland France Singapore Italy Belgium U.K. China Spain Canada Korea Netherlands Australia Mexico Taiwan Brazil Others Total Source : Ministry of Finance, Trade Statistics of Japan, 21

29 Overseas Business of Japanese Pharmaceutical Companies Overseas Subsidiaries Equity ownership of more than 50% Fiscal Year Pharmaceutical Companies Manufacture Production Plant Marketing Including Import Note : 1. Japanese overseas subsidiaries whose investment ratio is more than 50% independently. 2. Business relating to pharmaceutical bulk products, medical devices and equipments, nutrition-tonics and R&D activities are included. Source : Yano Research Institute 22

30 Overseas Business of Japanese Pharmaceutical Companies Number of Japanese Companies by Country Companies Percentage of total Companies Percentage of total Companies Percentage of total Companies Percentage of total Companies Percentage of total Companies Percentage of total U.S.A. U.K. Germany France China 23 Taiwan Indonesia Korea Hong Kong Singapore Others Total Note : 1. Japanese overseas subsidiaries whose investment ratio is more than 50% independently. 2. Business relating to pharmaceutical bulk products, medical devices and equipments, nutrition-tonics and R&D activities are included. Source : Yano Research Institute

31 Expansion into Overseas Markets by JPMA Member Companies* 1. Overseas Sales Fiscal Year Companies Overseas Sales JPY mil. Note : Companies represents number of valid answers only. 2. Number of Employees - Overseas Fiscal Year North America Europe Asia and Others Employees Companies Employees Companies Employees Companies Employees Companies Note : 1. Companies represents the companies who have their own employees in that region. 2. The total number of employees being greater that the total of the numbers of employees in the three regions reflects the fact that some companies responded by giving only the total number of employees. *Survey of companies with more than 50% domestic capital. Source : JPMA Survey Total 24

32 3. Number of Overseas Bases Fiscal Year Facilities Laboratory R&D Bases Factory Companies Facilities Companies Note : Companies represents number of valid answers only. Facilities Companies 4-1. Number of Laboratories by Geographic Area Country U.S.A. Canada U.K. Netherlands Switzerland France Germany Italy Ireland Denmark Spain China Korea Taiwan India Singapore Brazil Indonesia Others Total Note : In 2000, the survey required specification of 10 countries. The other countries are shown as Others. From 2005, all countries are shown in the schedule. companies of the total column shows the number of companies having the laboratories abroad. Source : JPMA survey Facilities Companies Facilities Companies Facilities Companies Facilities Companies Facilities Companies Facilities Companies 25

33 4-2. Number of R&D Bases by Geographic Area Country Facilities Companies Facilities Companies Facilities 26 Companies Facilities Companies Facilities Companies U.S.A. Canada U.K. Germany Switzerland Netherlands Finland France Ireland Denmark China Singapore Korea Taiwan Brazil Total Note : companies of the total column shows the number of companies having the R&D Bases abroad Number of Factories by Geographic Area Country Facilities Companies Facilities Companies Facilities Companies Facilities Companies Facilities Companies Facilities Companies U.S.A. Canada Ireland Denmark Norway Finland Germany Spain Italy U.K. France Netherlands Belgium Austria Switzerland Poland Russia Estonia China Indonesia Taiwan Vietnam Korea Thailand India Philippines Malaysia Pakistan Mexico Brazil Colombia Argentina Venezuela Egypt Others Total Note : In 2000, the survey required specification of 10 countries. The other countries are shown as Others. From 2005, all countries are shown in the schedule. companies of the total column shows the number of companies having the factories abroad. Source : JPMA Survey

34 DOMESTIC STATISTICS Ⅱ. Pharmaceutical Production DOMESTIC STATISTICS Ⅱ. Pharmaceutical Production

35 Pharmaceutical Production 29 Japan Year Total JPY bil. Change % Pharmaceutical Production Value JPY bil. Change % Ethicals Value JPY bil. Import/ Ethicals % '14 JPMA Total % of Total Imports Percentage of GDP Note : 1. Imports means pharmaceutical products manufactured from imported active ingredients. 2. JPMA Total is based on fiscal year data. Source : Ministry of Health, Labour and Welfare, Statistics of Production by Pharmaceutical Industry, Economic and Social Research Institute, Cabinet Office, Statistics of GDP, JPMA Survey

36 Pharmaceutical Production by Therapeutic Category 30 Japan 2013 Unit : JPY mil., % Ethical Drug Therapeutic Category Total Domestic OTC, etc. Sub-total Imports % of Total Products Total CNS Peripheral nervous system Sensory organ Cardiovascular system Respiratory system Gastrointestinals Hormones Genito-urinary system Dermatologicals Dental use Other agents affecting individual organs Vitamins Nutrients/Tonics Blood/Blood forming organs Artificial dialysis agents Other metabolic agents Agents activating cellular function Antitumor agents Radio pharmaceuticals Antiallergics Crude drugs Chinese herbal drugs Other natural drugs & Chinese medicine Antibiotics Chemotherapeutics Biological products Antiparasitics Dispensing drugs Diagnostics, In Vivo Hygiene products Diagnostics, In Vitro Other agents Alkaloidal narcotics Non-alkaloidal narcotics Note : Imports consists of pharmaceutical products manufactured from imported active ingredients. Source : Ministry of Health, Labour and Welfare, Statistics of Production by Pharmaceutical Industry,

37 Trends in Ethical Drug Production by Composition Ratio of Main Therapeutic Category 31 Japan Year C.N.S. agents Other metabolic agents Blood/Blood forming organs Note : 1. The numbers in parenthesis represent the production ranking of the main therapeutic category. 2. Chemotherapeutic agents ranks 10th in 1995 and during 2001 through Cardiovascular agents Gastrointestinal agents Biologicals Antiallergics Dermatological agents Antibiotics Unit : % In vitro Diagnostics Source : Ministry of Health, Labour and Welfare, Statistics of Production by Pharmaceutical Industry,

38 Pharmaceutical Production by Dosage Forms Japan Unit : JPY mil., % Dosage Form Value Share Value Share Value Share Value Share Value Share Value Share Powders and granules etc. Tablets Pills *1 Capsules Oral liquid preparations Injections *2 32 Powders for injection *3 Solution for external application Aerosols Ointments and creams Suppositories Cataplasms etc *4 Others Total *1 Usually prepared by mixing drugs uniformly with diluents, binders and others and rolling into spherical form *2 Solutions, Suspensions or Emulsions *3 To be dissolved before use *4 Pasty Preparation or those spread on cloth or plastic film for external application Source : Ministry of Health, Labour and Welfare, Statistics of Production by Pharmaceutical Industry,

39 Ethical Drug Production and National Health Care Expenditures JPY bil. 40,000 38,000 National Health Care Expenditures('12) 39,211.7 bil. 36,000 34,000 32,000 30,000 28,000 26,000 24,000 22,000 20,000 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 Ethical Drug Production('12) 6,263.0 bil. 2, Note : MHLW renewed the definition of manufactured products and imported products in Source : Ministry of Health, Labour and Welfare, Estimates of National Medical Care Expenditure, Ministry of Health, Labour and Welfare, Statistics of Production by Pharmaceutical Industry, 33

40 DOMESTIC STATISTICS Ⅲ. Pharmaceutical Research and Development DOMESTIC STATISTICS Ⅲ. Pharmaceutical Research and Development

41 R&D Expenditures of the Pharmaceutical Industry Japan Unit : JPY bil., % Fiscal Year R&D Expenditures Change from the previous year Value % Percentage of Sales Source : Ministry of Internal Affairs and Communications, Report on the Survey of Research and Development, 37

42 R&D Expenditures of 20 * Major Pharmaceutical Manufacturers 38 Japan Company Unit for Expenditures, JPY mil. Expenditures R&D/ R&D/ R&D/ R&D/ Change Expenditures % tures % tures % tures % Change Expendi- Change Expendi- Change Expendi- Change Sales Sales Sales Sales % % % % % Takeda Astellas Otsuka Holdings Daiichi Sankyo Eisai Kowa Mitsubishi Tanabe Dainippon Sumitomo Kyowa Hakko Kirin Taisho Shionogi Santen Hisamitsu Ono Kyorin Tsumura Kaken Mochida Nippon Shinyaku Kissei R&D/ Sales % * Top 20 companies in consolidated sales in FY2014 (excluding those companies with a pharmaceutical sales share of less than 30%) Note : 1. R&D/Sales % is the ratio of research cost to total sales. 2. Merged companies pre-merger numbers are the combined numbers of company before merger. 3. The figure for Kyorin Holdings, Inc. in 2005 is R&D expenditures for Kyorin Pharmaceutical Co., Ltd. 4. Otsuka Holdings expenditures up to 2005 are Otsuka s figures. 5. Takeda, Astellas, Eisai, Daiichi Sankyo, Santen, and Ono adopted IFRS in their financial statements for FY2014. Source : SPEEDA (UZABASE, Inc.), Financial statements

43 Trends of R&D Expenditures and Profits as Sales Ratio % Japan(10 companies) JPY bil R&D Expenditures per Company (Average of 10 companies) Net Profit Margin (%) R&D Expenditures per Sales (%) (Fisical Year) Note : 1. Companies surveyed : to 2004 : Takeda, Sankyo, Yamanouchi, Daiichi, Taisho, Eisai, Shionogi, Fujisawa, Chugai, and Tanabe : Takeda, Astellas, Eisai, Sankyo, Daiichi, Chugai, Mitsubishi, Dainippon Sumitomo, Shionogi, and Taisho : Takeda, Astellas, Daiichi Sankyo, Eisai, Dainippon Sumitomo, Mitsubishi, Shionogi, Tanabe, Taisho, and Ono. from 2007 : Takeda, Astellas, Daiichi Sankyo, Eisai, Mitsubishi Tanabe, Dainippon Sumitomo, Shionogi, Taisho(from 2013 Taisho Holdings), Ono and Otsuka Holdings(took Otsuka s consolidated result for 2007). 2. Consolidated basis since Chugai had an irregular 9 months financial result (Apr.-Dec.) in FY2003. Source : SPEEDA (UZABASE, Inc.), Financial statements 39

44 R&D Expenditures as a Percentage of Sales by Industry 40 Japan Unit : % Industry All Industries* Agriculture, Forestry & Fisheries Mining, Quarrying & Gravel Extraction Construction Manufacturing Food Textiles Pulp, Paper& Paper Products Publishing, Printing & Allied Industries Pharmaceuticals Chemicals Industrial Chemicals Oils & Paints Other Chemicals Petroleum & Coal Products Plastic Products Rubber Products Ceramics, Stone & Clay Products Iron & Steel Non-ferrous Metals & Products Metal Products General Machinery Machinery & Tools for Production Machinery & Tools for Institutional Use Electric Component, Devices, Electric Circuit Electric Machinery Electronic Equipment & Electric Measurements Other Electric Machinery Information & Telecommunications Equipment Transportation Equipment Motor Vehicles & its Accessories Other Transport Equipment Precision Instruments Other Manufacturing Information & Communication Information Services *Excluding special public corporations, independent administrative institutions IAIs, and finance and insurance industries. Note : Japan Standard Industrial Classification was revised in FY2007. Source : Ministry of Internal Affairs and Communications, Report on the Survey of Research and Development,

45 R&D Expenditures by Industry and Type Japan FY2014 Industry Basic Research Applied Research Unit : % Development All Industries Agriculture, Forestry & Fisheries Mining, Quarrying & Gravel Extraction Construction Manufacturing Food Textiles Pulp, Paper & Paper Products Publishing, Printing & Allied Industries Pharmaceuticals JPMA Member Firms* Chemicals Petroleum & Coal Products Plastic Products Rubber Products Ceramics, Stone & Clay Products Iron & Steel Non-ferrous Metals & Products Metal Products Machinery & Tools for Production Machinery & Tools for Institutional Use Electric Component, Devices, Electric Circuit Electric Machinery Electronic Equipment & Electric Measurements Other Electric Machinery Information & Telecommunications Equipment Transportation Equipment Motor Vehicles & its Accessories Other Transport Equipment Other Manufacturing Information & Communication *JPMA Survey (31 companies of JPMA members responded to the survey.) Source : Ministry of Internal Affairs and Communications, Report on the Survey of Research and Development, &cycleCode=0&requestSender=search 41

46 Number of Pharmaceutical Approvals Granted in Japan 42 Japan Fiscal Year Fiscal Year Ethical Drugs OTC Drugs Manufacturing Import Manufacturing Import Total Approval Approval Approval Approval Total Ethical Drugs OTC Drugs Manufacturing Import Marketing Manufacturing Import Marketing Total Approval Approval Approval Approval Approval Approval Total Note : In the revised Japan s Pharmaceutical Affairs Law of April 1, 2005, Manufacturing Approval and Import Approval were replaced by Marketing Approval. Source : Until 2004, The Yakuji Nippo, Recent New Drugs From 2005, Jiho, Yakuji Handbook

47 Number of Pharmaceuticals Included in the NHI Price List in Japan Japan Fiscal Year Internal Injections External Dental Drugs Total Source : Ministry of Health, Labour and Welfare, Notice by Health Insurance Bureau 43

48 Number of New Molecular Entities Approved Japan Year New Drugs New Molecular Entities Manufacturing Approval Import Approval as of the end of November 2015 Sales Approval Total Note : 1. In vitro diagnostics, insecticides, and OTC products are excluded. 2. The numbers with an asterisk in the total column are less than the sum of Approval numbers as some drugs contain the same ingredients. Source : Until 1986, The Society of Japanese Pharmacopoeia, Drug Approval and Licensing Procedures in Japan From 1987, Yakumu Kohosha, Yakumu Koho 44

49 Number of New Molecular Entities Approved Japan Accumulation from 2000 to 25 Nov Company Total Manufacturing Approval Import Approval A A A B Pfizer GlaxoSmithKline MSD Novartis Bayer Chugai Sanofi Janssen Astellas Mitsubishi Tanabe Kyowa Hakko Kirin Takeda Daiichi Sankyo AstraZeneca Eli Lilly Dainippon Sumitomo Ono Shionogi Eisai Novo Nordisk Genzyme Boehringer Ingelheim Kyorin Pharma Bristol-Myers AbbVie Otsuka Meiji Seika Pharma Japan Tobacco Nippon Shinyaku Nippon Kayaku Baxalta Toyama Chemical Kissei Note : 1. Accumulative number of JPMA Member Companies top Approval until 25 Nov are listed. (A) Approval until 25 Nov (B) Approval from Jan to 25 Nov The figure for AbbVie Inc. includes data for the former Abbott Japan. The figure for Baxalta includes data for the former Baxter. Sales Approval Source : Yakumu Kohosha, Yakumu Koho 45

50 Success Rate of Developing New Drugs in Japan. Low Molecular Weight Compounds 1) Success rate for 5 years Phase Synthesized Compounds Pre-Clinical Studies Started Clinical Studies Started in Japan Approval Granted Chem. Entity Probability to Move from Previous Phase Success Rate Note : 1. Chemical libraries (such as combinatorial chemistry) are not included in Synthesized Compounds. 2. Only the compounds of in-house (excl. in-licensing). Additional dosage forms and indications are excluded. 2) Trends by Fiscal Year Item Synthesized Compounds Pre-Clinical Studies Started Clinical Studies Started in Japan Approval Granted Number of Companies. Biologicals Item Pre-Clinical Studies Started Clinical Studies Started in Japan Antibody Drugs Other Drugs* Antibody Drugs Other Drugs* Antibody Drugs Other Drugs* Approval Granted Number of Companies *Including nucleic acid medicine and peptide. Note : Survey was started in FY2012. Source : JPMA Survey (Data obtained from domestic companies of the R&D Committee members.) 46

51 Median Development Times for New Molecular Entities 47 by NDA approval year Year NDA approved Number of Approvals All Products Priority Review Products Standard Review Products Median Development Time Months Number of Approvals Median Development Time Months Number of Approvals Median Development Time Months Note : 1. Development time is the period from initial protocol application to the approval date. 2. Standard review products include accelerated approval products. Source : From 2000, Office of Pharmaceutical Industry Research of JPMA, Research Paper Series No.68 Research on trend of time period for Clinical Development and Review Procedures for New Drugs approved in Japan

52 Median Approval Times for New Drugs 48 by NDA filing year Year NDA filed Number of Applications All Products Priority Review Products Standard Review Products Median Approval Time Months Number of Applications Median Approval Time Months Number of Applications Median Approval Time Month Note: 1. About products filed for NDA since 2012, they have some pending items hence it does not include counting in this table. Further information should be required to evaluate this table totally. 2. Researched items are the products in which approved from 2000 to (From 2000 to 2004: Product items for Subcommittee of Pharmaceutical Affairs and Food Sanitation Council, and After 2005: Product items for Subcommittee of Pharmaceutical Affairs and Food Sanitation Council, plus its reported items) 3. Standard review products include accelerated approval products. Source : Office of Pharmaceutical Industry Research of JPMA, Research Paper Series No.68 Research on trend of time period for Clinical Development and Review Procedures for New Drugs approved in Japan

53 Review Process for Approval Applicant Pharmaceuticals and Medical Devices Agency (PMDA) External experts Interview Applicant and Withdrawal request Manufacturing site Reviewers Investigators Inquiry and confirmation from PMDA Presentation from the applicant and response GMP audit Team review Compliance review Review report Appointment/ Consultation Ad vice Expert Discussion on Review Reviewers and External experts Discussion on main issues and conclusion Document - based discussion possible Summary of main issues Interview Review Meeting Applicant Specialist on the applicant side and Reviewers External experts Opportunity for applicant to explain ( presentation ) Consider main issues Conducted by Office Director(or Review Director) Expert Discussion on Review Reviewers and External experts Continue after interview review Withdrawal request Review report GMP compliance audit result ( result notification ) Report on review result (review result notification ) Approval Disapproval MHLW (Ministry of Health, Labour and Welfare) Consultation Advice Pharmaceutical Affairs and Food Sanitation Council 49

54 Trends in Notification of Clinical Trials 50 Initial Notification on NMEs Initial Notification on New Administration Route and New Ethical Combination Notification of n th time Notification of Change Notification of Completion Notification of Suspension Notification of Development Suspension Initial Notification FY FY FY FY FY FY FY FY FY FY FY FY FY Note: 1. Regarding 1997 data, this is combined of the data from existing "Clinical Trial Plan Notification" (CTPN) until March, 1997, and the data of those after Revision of Pharmaceutical Affairs Act" effectively since April "Notification of "n"th time" represents on and after 2nd time of CTPN. 3. About "Notification of Completion", it was formerly allowed submitting each Clinical Trial Plan and/or all Clinical Trial Plans. It is currently only allowed submitting each Clinical Trial Plan respectively, since April "Notification of Developm ent Suspension" is required its submission since April Data for 2013 have been revised in accordance with changes in quoted sources. Source : Yakumu Kohosha, Yakumu Koho

55 Number of Drug Patents Japan Year A Drug Patents Domestic Applicants Foreign Applicants Total Patents B Ratio to Total Patents A/B % Note : The total number of patents : Until 1995, the total number of disclosed patents From 1997, the number of registered patent publications Counted by the International Patent Classification A61P Therapeutic Activity of Chemical Compounds or Medicinal Preparations. Source : Until 1999, Japan Patent Information Organization From 2000 to 2012, Patent On-Line Information System PATOLIS 2013-, JP-Net 51

56 Number of Drug Patents in Japan 52 Japanese Companies Company \ Year Meiji Seika Taisho Daiichi Sankyo Sankyo Daiichi Kowa Otsuka Astellas Dainippon Sumitomo Sumitomo Dainippon Yamanouchi Fujisawa Takeda Shionogi Ajinomoto Taiho Kyowa Hakko Kirin Kyowa Hakko Kirin Welfide Mitsubishi Tanabe Mitsubishi Chemical etc. Tanabe Santen Chugai Toray Eisai Ono Nippon Chemiphar Asahi Kasei Note : Counted by the International Patent Classification A61P Therapeutic Activity of Chemical Compounds or Medicinal Preparations. Source : 2000 to 2012, Patent On-Line Information System PATOLIS 2013, JP-Net

57 Number of Drug Patents in Japan 53 Foreign Companies Company \ Year Roche Novartis Novartis Alcon GlaxoSmithKline Boehringer Ingelheim Aventis Sanofi Sanofi-Synthelabo Genzyme Merck Merck USA Schering-Plough Organon Bayer Bayer Schering AG Johnson & Johnson Avvie (- '13;Abbott) Pfizer Pfizer Wyeth Bristol-Myers Squibb Allergan Baxalta (Baxter) Merck (Germany) Amgen Gilead Sciences Novo Nordisk Celgene AstraZeneca Eli Lilly Note : Counted by the International Patent Classification A61P Therapeutic Activity of Chemical Compounds or Medicinal Preparations. Source : 2000 to 2012, Patent On-Line Information System PATOLIS 2013-, JP-Net

58 Number of Bio-technology Patents Number of Published Patent Applications in Japan by Applicant's Nationality Area \ Year Japan U.S.A. Europe Others Total 2,500 2,000 1,500 1,000 Japan U.S.A. Europe Others Note : Europe includes 5 countries, namely, the UK, Germany, France, Switzerland and the Netherlands. International Patent Classification C12N15/00 Adjusted and counted by Convention Priority Right countries. Source : JP-Net 54

59 Technology Exports and Imports in the Pharmaceutical Industry 55 Japan Fiscal Year Total Contracts Cases Value Cases Value Cases Value Cases Value Cases Value Cases Value New Contracts Contracts with Parent / Affiliated Company Unit : JPY mil. Revenue Payment Balance Revenue Payment Balance Source : Ministry of Internal Affairs and Communications, Report on the Survey of Research and Development,

60 INTERNATIONAL STATISTICS Ⅰ. Pharmaceutical Industry Outlook INTERNATIONAL STATISTICS Ⅰ. Pharmaceutical Industry Outlook

61 Number of Pharmaceutical Manufacturers 59 Major Countries Year \ Country U.S.A. Germany U.K. Switzerland France Italy Spain Source : Associazione delle imprese del farmaco, Evoluzione del settore farmaceutico U.S. Census Bureau, Statistics of U.S. Businesses - Pharmaceutical preparation mfg

62 Employment in the Pharmaceutical Industry Europe Country Austria Belgium Denmark Finland France Germany Greece Ireland Italy Netherlands Norway Portugal Spain Sweden Switzerland U.K. Total Source : EFPIA, The Pharmaceutical Industry in Figures, 60

63 Pharmaceutical Market Sales by Geographic Region Country Unit : USD bil., % Sales Share Sales Share Sales Share Sales Share Sales Share North America Japan Germany France 61 Italy U.K. Other Europe Central / South America Asia-Pacific excluding Japan, Africa and Middle East World Total 2016 IMS Health. All rights reserved. Source : Calculated based on IMS World Review 2015 (Reprinted with permission)

64 Concentration on Pharmaceutical Sales to Leading Companies Worldwide 2014 from January to December Unit : USD mil., % Order by Sales Total Sales Cumulative Value Share Value Share 1st 10th 11th 20th 21st 30th 31st 40th 41st 50th 51st 60th 61st 70th 71st 80th 81st 90th 91st 100th Others Total 100+Others 2016 IMS Health. All rights reserved. Source : Calculated based on IMS World Review 2015 (Reprinted with permission) Change in the concentration on Leading Companies Fiscal Year 10 Leading Companies 20 Leading Companies 30 Leading Companies Unit : % 50 Leading Companies Fiscal Year 10 Leading Companies 20 Leading Companies 30 Leading Companies 50 Leading Companies Source : from 2000 to 2005, SCRIP, Pharmaceutical Company League Tables from 2005 to 2014, 2016 IMS Health. All rights reserved. Calculated based on IMS World Review 2015 (Reprinted with permission) 62

65 Operating Results of Leading Pharmaceutical Manufacturers 63 Worldwide 2014 including Japanese manufacturers Company Currency Total Sales Pharma Sales %Pharma Sales Pharma Sales by USD mil. Pretax Income* Novartis USD mil. Pfizer USD mil. Sanofi EUR mil. Roche CHF mil. Merck USA USD mil. Johnson & Johnson USD mil. GlaxoSmithKline GBP mil. AstraZeneca USD mil. Gilead Sciences USD mil. AbbVie USD mil. Amgen USD mil. Teva USD mil. Eli Lilly USD mil. Baxter USD mil. Bayer EUR mil. Takeda JPY bil. Bristol-Myers Squibb USD mil. Novo Nordisk DKK mil. Boehringer Ingelheim EUR mil. Astellas JPY bil. Merck Germany EUR mil. Daiichi Sankyo JPY bil. Otsuka Holdings JPY bil. Abbott USD mil. Mylan USD mil. Eisai JPY bil. % Net Income % Total Assets No.of Employees Note : Abbott Laboratories (Abbott) separated into two publicly traded companies in 2013, as AbbVie and Abbott. Enumeration data for each company is showed in this table. The number of employees of Amgen, Baxter, and Boehringer Ingelheim are data for Ordinary income for Otsuka Holdings only. Source : SPEEDA (UZABASE, Inc.), Annual reports, and Financial statements

66 Financial Results of Leading Pharmaceutical Manufacturers Worldwide 2014 including Japanese manufacturers 64 Company Currency Total Sales Net Income % Total Assets Equity Ratio % Return on Asset % Return on Equity % Novartis USD mil. Pfizer USD mil. Roche CHF mil. Merck USA USD mil. Johnson & Johnson USD mil. Sanofi EUR mil. GlaxoSmithKline GBP mil. AstraZeneca USD mil. Gilead Sciences USD mil. AbbVie USD mil. Amgen USD mil. Teva USD mil. Eli Lilly USD mil. Baxter USD mil. Bayer EUR mil. Takeda JPY bil. Bristol-Myers Squibb USD mil. Novo Nordisk DKK mil. Boehringer Ingelheim EUR mil. Astellas JPY bil. Merck Germany EUR mil. Daiichi Sankyo JPY bil. Otsuka Holdings JPY bil. Abbott USD mil. Mylan USD mil. Eisai JPY bil. Equity Note : Abbott Laboratories (Abbott) separated into two publicly traded companies in 2013, as AbbVie and Abbott. Enumeration data for each company is showed in this table. Source : SPEEDA(UZABASE Inc.), Annual reports, Financial statements

67 Profitability of Research-based Companies U.S.A. and Europe 2014 Currency Total Sales Net Income Return on Asset % Return on Equity % Net Income Margin % Pfizer USD mil. Pharmaceuticals Merck USD mil. Eli Lilly USD mil. General Electric GE USD mil. U.S.A. Ford Motor USD mil. Other Industries IBM USD mil. Texas Instruments USD mil. Motorola USD mil. 65 ITT USD mil. Novartis USD mil. Roche CHF mil. Pharmaceuticals Bayer EUR mil. Sanofi EUR mil. AstraZeneca USD mil. Europe GlaxoSmithKline GBP mil. Volkswagen EUR mil. Daimler Chrysler EUR mil. Other Industries BASF EUR mil. Siemens EUR mil. Nokia EUR mil. Source : Annual reports, SPEEDA(UZABASE Inc.)

68 International Trade of Pharmaceutical Products 66 Major Countries Unit : USD mil. Country Year Exports Imports Surplus Austria Belgium Denmark Finland France Germany Greece Ireland Italy Netherlands Norway Portugal Spain Sweden Switzerland U.K. Canada U.S.A. Japan Others Total OECD Source : OECD, International Trade by Commodities Statistics Classification No.54

69 Exports of Pharmaceutical Products by Partner Country 67 Worldwide 2013 Unit : USD thousand Exporter Importer Austria Austria Belgium Denmark France Germany Ireland Italy Netherlands Belgium Denmark France Germany Ireland Italy Netherlands Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan Others World Total Exporter Importer Austria Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan Belgium Denmark France Germany Ireland Italy Netherlands Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan Others World Total Source : OECD, International Trade by Commodities Statistics Classification No.54