Forewords - JPMA · Forewords This data book organizes the statistics on pharmaceutical industries both ... Yakult YAKULT HONSHA CO., LTD. Zeria ZERIA PHARMACEUTICAL CO

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　

前付け_eng.indd 1 16/03/18 20:51

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.

前付け_eng.indd 2 16/03/18 20:51

Abbreviated Names of Member Companies

　　　　Abbreviated Name Official Name

AbbVie AbbVieG.K.AjinomotoPharma. AJINOMOTOPHARMACEUTICALSCO.,LTD.Alcon AlconJapanLTD.AsahiKaseiPharma ASAHIKASEIPHARMACORPORATIONASKA ASKAPHARMACEUTICALCO.,LTD.Astellas ASTELLASPHARMAINC.AstraZeneca AstraZenecaK.K.AYUMI AYUMIPharmaceuticalCorp.Baxalta BaxaltaJapanLtd.Bayer BAYERYAKUHIN,LTD.BoehringerIngelheim NIPPONBOEHRINGERINGELHEIMCO.,LTD.Bristol-Myers BRISTOL-MYERSK.K.Celgene CelgeneK.K.Chugai CHUGAIPHARMACEUTICALCO.,LTD.DaiichiSankyo DAIICHISANKYOCO.,LTD.DainipponSumitomo DAINIPPONSUMITOMOPHARMACO.,LTD.Eisai EISAICO.,LTD.EliLilly ELILILLYJAPANK.K.Fujimoto FUJIMOTOPHARMACEUTICALCORP.Fuso FUSOPHARMACEUTICALINDUSTRIES,LTD.Genzyme GenzymeJapanK.K.GlaxoSmithKline GlaxoSmithKlineK.K.Hisamitsu HISAMITSUPHARMACEUTICALCO.,INC.Janssen JANSSENPHARMACEUTICALK.K.JapanTobacco JAPANTOBACCOINC.Kaken KAKENPHARMACEUTICALCO.,LTD.Kissei KISSEIPHARMACEUTICALCO.,LTD.Kowa KOWACompany,Ltd.KraciePharma KRACIEPHARMA,LTD.KyorinPharma. KYORINPHARMACEUTICALCO.,LTD.Kyoto KYOTOPHARMACEUTICALINDUSTRIES,LTD.KyowaHakkoKirin KYOWAHAKKOKIRINCO.,LTD.Maruho MARUHOCO.,LTD.Maruishi MARUISHIPHARMACEUTICALCO.,LTD.MeijiSeikaPharma MeijiSeikaPharmaCO.,LTD.MerckSerono MerckSeronoCO.,LTD.Minophagen MINOPHAGENPHARMACEUTICALCO.,LTD.

2_会社略名_eng.indd 1 16/03/18 20:51

　　　　Abbreviated Name Official Name

MitsubishiTanabe MITSUBISHITANABEPHARMACORPORATIONMochida MOCHIDAPHARMACEUTICALCO.,LTD.MSD MSDK.K.Mylan MylanEPDG.K.NihonPharma. NIHONPHARMACEUTICALCO.,LTD.NipponChemiphar NIPPONCHEMIPHARCO.,LTD.NipponKayaku NIPPONKAYAKUCO.,LTD.NipponShinyaku NIPPONSHINYAKUCo.,Ltd.NipponZoki NIPPONZOKIPHARMACEUTICALCO.,LTD.Novartis NOVARTISPHARMAK.K.NovoNordisk NOVONORDISKPHARMALTD.Ono ONOPHARMACEUTICALCO.,LTD.Otsuka OTSUKAPHARMACEUTICALCo.,Ltd.Pfizer PFIZERJAPANINC.POLAPHARMA POLAPHARMAINC.Sanofi SanofiK.K.Santen SANTENPHARMACEUTICALCO.,LTD.SanwaKagaku SANWAKAGAKUKENKYUSHOCO.,LTD.Seikagaku SEIKAGAKUCORPORATIONSenju SENJUPHARMACEUTICALCO.,LTD.Shionogi SHIONOGI&CO.,LTD.Taiho TAIHOPHARMACEUTICALCO.,LTD.Taisho TAISHOPHARMACEUTICALCO.,LTD.Takeda TAKEDAPHARMACEUTICALCOMPANYLIMITEDTeijinPharma TEIJINPHARMALIMITEDTeikokuSeiyaku TEIKOKUSEIYAKUCO.,LTD.Terumo TERUMOCORPORATIONToaEiyo TOAEIYOLTD.Toray TorayIndustries,Inc.Torii TORIIPHARMACEUTICALCO.,LTD.ToyamaChemical TOYAMACHEMICALCO.,LTD.Tsumura TSUMURA＆CO.UCB UCBJAPANCO.,LTD.Wakamoto WAKAMOTOPHARMACEUTICALCO.,LTD.Yakult YAKULTHONSHACO.,LTD.Zeria ZERIAPHARMACEUTICALCO.,LTD.

2_会社略名_eng.indd 2 16/03/18 20:51

CONTENTS

Domestic Statistics　 ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥ 1 〜 55

International Statistics　 ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥57 〜 76

Statistics on Health　 ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥77 〜 97

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 ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥10 〜 13

　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

目次_eng.indd 1 16/03/18 20:52

　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 ‥‥‥‥‥‥‥‥‥‥‥22 〜 23

　Expansion into Overseas Markets by JPMA Member Companies ‥‥‥‥‥‥‥‥‥24 〜 26

　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

目次_eng.indd 2 16/03/18 20:52

　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

　

目次_eng.indd 3 16/03/18 20:52

　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 ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥ 100 〜 101

Exchange Rates ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥ 104

目次_eng.indd 4 16/03/18 20:52

— DOMESTIC STATISTICS —

Ⅰ . Pharmaceutical Industry Outlook

DO

ME

STIC

ST

ATIS

TIC

S

Ⅰ. P

harm

aceu

tica

l Ind

ustr

y O

utlo

ok

扉_eng.indd 1 16/03/18 20:52

− 3 −

Number of Pharmaceutical ManufacturersJapan

FiscalYear Total Ethical Drug

ManufacturersOTC Drug

ManufacturersOther

Manufacturers

Manufacturerswith NHI

Price listedDrugs

JPMAMembers

* Refer to the User's Guide.

Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry http://www.e-stat.go.jp/SG1/estat/NewList.do?tid=000001034412 Manufacturers with NHI Price listed Drugs: Jiho, NHI Drug Price Directory by Therapeutic Category August issues of each year

Note : The figures within parentheses show the number of generic makers.

1_01_医薬品産業の現況_eng.indd 3 16/03/18 20:53

− 4 −

Employment in the Pharmaceutical IndustryJapan, by Function Unit : %, no. of persons


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 , http://www.mhlw.go.jp/toukei/list/87-1.html

MedicalRepresentative

Research &Development Marketing

ResearchersFiscalYear Total Administration Production &

Quality Control


− 5 −

Number of Pharmaceutical Manufacturers by Number of EmployeesJapan % in parentheses

Fiscal Year

* Refer to the User s Guide.

Source : Ministry of Health, Labour and Welfare, Statistics on Pharmaceutical and Medical Device Industry , http://www.e-stat.go.jp/SG1/estat/NewList.do?tid=000001034412

101300

3011,000

Over3,001 Total1,001

3,00010 employees

or less1150

51100

1_01_医薬品産業の現況_eng.indd 5

16/03/18 20:53

− 6 −

Pharmaceutical MarketJapan Manufacturers Sales Unit : JPY bil.

Generic drugs


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.


Raw materialsand Others

FiscalYear Total Ethical drugs OTC drugs


− 7 −

Sales of Pharmaceutical Manufacturers by Capital ScaleJapan FY2013* : 345 Companies Unit : JPY mil.

Less than10 mil.

10 50 mil.

50 100 mil.

100 300 mil.

300 mil.1 bil.

1 5 bil.

Over5 bil. Total

Generic

Raw materials and Others

Generic

Raw materials and Others Total

Generic

Raw materials and Others


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.


DiversifiedCompanies

Ethical Drug

OTC

Total

Ethical Drug

OTC

Total

ProductCategory

Capital Scale

SpecializedPharmaceutical

Companies

Ethical Drug

OTC

Total


16/03/18 20:53

−8

−

Concentration on Pharmaceutical Sales to Leading CompaniesJapan Unit : %

FiscalYear

5 LeadingCompanies

10 LeadingCompanies

30 LeadingCompanies

50 LeadingCompanies

100 LeadingCompanies

TotalCompanies




16/03/18 20:53

− 9 −

Comparison of Pharmaceutical Sales between Domestic and Foreign Companies

Total Sales JPY mil.

Ratio %

Counted Companies


Ratio %

Counted Companies


Ratio %

Counted Companies



Fiscal Year

Domestic

Foreign

Total

%

Fiscal Year

Ratio of Foreign Company

* * * *


−10

−

Financial Results of JPMA Member Companies

Company

Fiscal Year

AbbVie

Ajinomoto Pharma.

Asahi Kasei Pharma*

ASKA

Astellas

AstraZeneca*

Bayer*

Boehringer Ingelheim

Chugai

Daiichi Sankyo

Dainippon Sumitomo

Eisai

Eli Lilly*

Fuso*

Genzyme Japan*

Unit : JPY mil.

Total Sales Pharmaceutical Sales Operating Income Ordinary Income Net Income No.of Employees


16/03/18 20:53

− 11 −

Company

Fiscal Year

Hisamitsu

Japan Tobacco

Kaken

Kissei

Kowa

Kracie Pharma

Kyorin Pharma.*

Kyowa Hakko Kirin

Maruho*

Maruishi*

Meiji Seika Pharma

Minophagen

Mitsubishi Tanabe

Mochida

MSD*

Nippon Chemiphar

Unit : JPY mil.



16/03/18 20:53

−12

−

Company

Fiscal Year

Nippon Kayaku

Nippon Shinyaku

Nippon Zoki*

Novartis*

Ono

Otsuka*

Pfizer*

Sanofi*

Santen

Sanwa Kagaku*

Seikagaku

Senju*

Shionogi

Taiho*

Taisho

Unit : JPY mil.



16/03/18 20:53

− 13 −

Company

Fiscal Year

Takeda

Teijin Pharma

Teikoku Seiyaku*

Toa Eiyo*

Toray

Torii*

Toyama Chemical*

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.

Unit : JPY mil.



16/03/18 20:53

−14

−

Ethical Drug Market

Japan Unit : JPY mil.

NHI price basis Change % NHI price

basis Change % NHI price basis Change % NHI price

basis Change %

2016 IMS Health

Source : IMS Japan, Calculated based on Japan Pharmaceutical Market Sales 2005-2015(Reprinted with permission)

Year

Hospitals General Practitioners Others Total


16/03/18 20:53

− 15 −

Ethical Drug Sales

Japan 2014 Jan.-Dec.Promotion Company Level Unit : JPY mil. Distributor Level Unit : JPY mil.

Company SalesNHI price basis Company Sales

NHI price basis Pfizer Takeda Takeda Astellas Daiichi Sankyo Daiichi SankyoChugai 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)


16/03/18 20:53

−16

−

Financial Results of the Leading Pharmaceutical Manufacturers

Japan FY2014 Consolidated Accounts

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 ShinyakuKissei

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

Return onAsset

%

Return onEquity

%

Overseas SalesCompany Sales

JPY mil.Ordinary Income Net Income Total

AssetsJPY mil.

EquityRatio

%


16/03/18 20:53

− 17 −

Value-Added Ratio of Industrial SectorsJapan

No.ofFirmsInves-tigated

Value-AddedRatio

%


Value-AddedRatio

%


Value-AddedRatio

%


Value-AddedRatio

%


Value-AddedRatio

%


Value-AddedRatio

%

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 100

Industry


−18

−

Profitability of Research-based Industries

Japan 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 loss Total assets 100 Return on equity % Net income Equity 100

Optical Instruments 5 companies Manufacturing Industries 972 companies

Pharmaceuticals29 companies

Computers & Electric Eq. 5 companies Electronic Eq. & Comp. 61 companies Household Electric Appl. 19 companies

Automobiles 10 companies


16/03/18 20:53

− 19 −

Profitability of Research-based Companies Specific companies by sector

Japan FY2014

SalesJPY mil.

OrdinaryIncomeJPY mil.

Return onAsset

%

Return onEquity

%

Net IncomeMargin

%

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.)


Precision Machinery

Pharmaceuticals

Electric Machinery & Equipment

Automobiles

Communication & Electronic Machinery & Equipment


16/03/18 20:53

−20

−

International Trade of Pharmaceutical ProductsJapan

Value A Change % Value B Change % Value B/A times

Source : Ministry of Finance, Trade Statistics of Japan , http://www.customs.go.jp/toukei/suii/html/time.htm

Unit : JPY mil., %

YearExports Imports Trade Deficit


16/03/18 20:53

− 21 −

International Trade of Pharmaceutical Products by Partner Countries

JapanExports to : Unit : JPY mil., %

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 : Unit : JPY mil., %

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 , http://www.customs.go.jp/toukei/suii/html/time.htm

CountryValue Share

CountryValue Share


− 22 −

Overseas Business of Japanese Pharmaceutical Companies

Overseas Subsidiaries Equity ownership of more than 50%

ManufactureProduction Plant

MarketingIncluding 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

Fiscal YearNo. of

PharmaceuticalCompanies


− 23 −

Overseas Business of Japanese Pharmaceutical Companies

Number of Japanese Companies by Country

No. ofCompanies

Percentageof total

No. ofCompanies

Percentageof total

No. ofCompanies

Percentageof total

No. ofCompanies

Percentageof total

No. ofCompanies

Percentageof total

No. ofCompanies

Percentageof total

U.S.A.

U.K.

Germany

France

China

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


16/03/18 20:53

− 24 −

Expansion into Overseas Markets by JPMA Member Companies*

1. Overseas Sales

Fiscal Year No. ofCompanies

Note : No. of Companies represents number of valid answers only.

2. Number of Employees - Overseas

No. ofEmployees

No. ofCompanies

No. ofEmployees

No. ofCompanies

No. ofEmployees

No. ofCompanies

No. ofEmployees

No. ofCompanies

Note : 1. No. of 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

Fiscal YearNorth America Europe Asia and Others Total

Overseas Sales JPY mil.


− 25 −

3. Number of Overseas Bases

Note : No. of Companies represents number of valid answers only.

4-1. Number of Laboratories by Geographic Area

Denmark Spain

Brazil

From 2005, all countries are shown in the schedule. No. of companies of the total column shows the number of companies having the laboratories abroad.

Source : JPMA survey

No. ofCompanies

No. ofFacilities

No. ofCompanies

Fiscal YearLaboratory R&D Bases Factory

No. of Facilities

No. ofCompanies

No. of Facilities

No. ofCompanies

No. of Facilities

No. ofCompanies

CountryNo. of

FacilitiesNo. of

CompaniesNo. of

FacilitiesNo. of

CompaniesNo. of

FacilitiesNo. of

CompaniesNo. of

FacilitiesNo. of

CompaniesNo. of

Facilities

U.S.A. Canada U.K. Netherlands Switzerland

Germany France

Ireland Italy

Korea China

India Taiwan

Singapore

Indonesia Others

Note : In 2000, the survey required specification of 10 countries. The other countries are shown as ‘Others’.

Total


− 26 −

4-2. Number of R&D Bases by Geographic Area

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

U.S.A. Canada U.K. Germany Switzerland Netherlands Finland France Ireland Denmark China Singapore Korea Taiwan Brazil

Total

Note : No. of companies of the total column shows the number of companies having the R&D Bases abroad.

4-3. Number of Factories by Geographic Area

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

No. ofFacilities

No. ofCompanies

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. No. of companies of the total column shows the number of companies having the factories abroad.

Source : JPMA Survey

Country

Country



Ⅱ . Pharmaceutical Production

DO

ME

STIC

ST

ATIS

TIC

S

Ⅱ. P

harm

aceu

tica

l Pro

duct

ion

扉_eng.indd 2 16/03/18 20:52

− 29 −

Pharmaceutical Production

Japan

ValueJPY bil.

Import/Ethicals %

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 , http://www.mhlw.go.jp/topics/yakuji/2013/nenpo/1.html Economic and Social Research Institute, Cabinet Office, Statistics of GDP , http://www.esri.cao.go.jp/jp/sna/menu.html JPMA Survey

'14 JPMA Total

Year

Pharmaceutical Production

Percentageof GDPTotal

JPY bil.Change

%

Ethicals

ValueJPY bil.

Change%

% ofTotal

Imports

1_02_医薬品生産の現況_eng.indd 29

16/03/18 20:53

−30

−

Pharmaceutical Production by Therapeutic Category

Japan 2013 Unit : JPY mil., %

% of Total 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 , http://www.mhlw.go.jp/topics/yakuji/2013/nenpo/xls/04.xls

Therapeutic Category TotalEthical Drug

OTC, etc.Sub-total Domestic

Products Imports


16/03/18 20:53

− 31 −

Trends in Ethical Drug Production by Composition Ratio of Main Therapeutic Category

Japan Unit : %

YearCardio-vascularagents

C.N.S.agents

Othermetabolic

agents

Blood/Bloodformingorgans

Gastro-intestinalagents

Bio-logicals

Anti-allergics

Dermato-logicalagents

Anti-biotics

In vitroDiagnostics

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 2004.

Source : Ministry of Health, Labour and Welfare, Statistics of Production by Pharmaceutical Industry , http://www.mhlw.go.jp/topics/yakuji/2013/nenpo/xls/04.xls


16/03/18 20:53

−32

−

Pharmaceutical Production by Dosage Forms Japan Unit : JPY mil., %

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

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 , http://www.mhlw.go.jp/topics/yakuji/2013/nenpo/19.html

Dosage Form


16/03/18 20:53

− 33 −

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

22,000

24,000

26,000

28,000

30,000

32,000

34,000

36,000

38,000

40,000

200099989796 2001 2003 2004 2005 2006 2007 2008 2009 20102002 2012201196959085

Ethical Drug Production and National Health Care Expenditures

Ethical Drug Production（'12）￥6,263.0 bil.

JPY bil.

Note : MHLW renewed the definition of manufactured products and imported products in 1996.

Source : Ministry of Health, Labour and Welfare, Estimates of National Medical Care Expenditure, http://www.mhlw.go.jp/toukei/list/37-21c.html Ministry of Health, Labour and Welfare, Statistics of Production by Pharmaceutical Industry, http://www.mhlw.go.jp/toukei/list/105-1c.html

National Health CareExpenditures（'12）￥39,211.7 bil.

1_02_医薬品生産の現況_eng.indd 33 16/03/18 20:53


Ⅲ . Pharmaceutical Research and Development

DO

ME

STIC

ST

ATIS

TIC

S

Ⅲ. P

harm

aceu

tica

l Res

earc

h an

d D

evel

opm

ent

扉_eng.indd 3 16/03/18 20:52

− 37 −

R&D Expenditures of the Pharmaceutical Industry

Japan

Value %

Source : Ministry of Internal Affairs and Communications, Report on the Survey of Research and Development , http://www.stat.go.jp/data/kagaku/kekka/kekkagai/pdf/27ke_gai.pdf

Unit : JPY bil., %

Fiscal Year

R&DExpenditures

Change from the previous year Percentage of Sales

1_03_研究開発の現況_eng.indd 37 16/03/18 20:54

−38

−

R&D Expenditures of 20* Major Pharmaceutical ManufacturersJapan

Expendi-tures

Change%

R&D/Sales

%

Expendi-tures

Change%

R&D/Sales

%

Expendi-tures

Change%

R&D/Sales

%

Expendi-tures

Change%

R&D/Sales

%

Expendi-tures

Change%

R&D/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 ShinyakuKissei

* 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.


Unit for Expenditures, JPY mil.

Company

1_03_研究開発の現況_eng.indd 38

16/03/18 20:54

− 39 −

17.918.3 18.4 18.9

7.3

32.133.4

34.6 36.938.6

7.3 7.6

8.3 7.5 8.5

11.7 12.0 11.812.6

14.3

43.3

48.853.9

58.8

61.2 62.1

9.1 9.1

10.5

7.88.8

11.7

11.2

13.8 13.3

11.1

12.9 12.7

13.814.2 14.2

74.7

85.8

14.6

14.8

13.3

5.9

15.3

16.9 18.2

20.9

19.1

10.6

18.9

10.0

112.5

133.3

139.0

136.0

127.4126.2

119.0

125.0

Japan（10 companies）JPY bil.

（Fisical Year）

R&D Expenditures per Company（Average of 10 companies）

Net Profit Margin （%）

R&D Expenditures per Sales （%）

20111994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

to 2004 : Takeda, Sankyo, Yamanouchi, Daiichi, Taisho, Eisai, Shionogi, Fujisawa, Chugai, and Tanabe. 2005 : Takeda, Astellas, Eisai, Sankyo, Daiichi, Chugai, Mitsubishi, Dainippon Sumitomo, Shionogi, and Taisho. 2006 : 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 1999. 3. Chugai had an irregular 9 months financial result (Apr.-Dec.) in FY2003.

Note : 1. Companies surveyed :


%40

35

30

25

20

15

10

5

0

140

135

130

125

120

115

110

105

100

95

90

85

80

75

70

65

60

55

50

45

40

35

30

25

0

Trends of R&D Expenditures and Profits as Sales Ratio

2012 2013 2014

1_03_研究開発の現況_eng.indd 39 16/03/18 20:54

−40

−

R&D Expenditures as a Percentage of Sales by Industry

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 , http://www.stat.go.jp/data/kagaku/kekka/kekkagai/pdf/27ke_gai.pdf


16/03/18 20:54

− 41 −

R&D Expenditures by Industry and Type

Japan FY2014

Industry BasicResearch

AppliedResearch 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 , http://www.e-stat.go.jp/SG1/estat/GL08020103.do?_toGL08020103_&tclassID= 000001055409&cycleCode=0&requestSender=search

Unit : %

1_03_研究開発の現況_eng.indd 41 16/03/18 20:54

−42

−

Number of Pharmaceutical Approvals Granted in Japan

Japan

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

FiscalYear

Ethical Drugs OTC DrugsManufacturing

ApprovalImport

ApprovalMarketingApproval Total Manufacturing

ApprovalImport

ApprovalMarketingApproval Total

FiscalYear

Ethical Drugs OTC DrugsManufacturing

ApprovalImport

Approval Total ManufacturingApproval

ImportApproval Total


16/03/18 20:54

− 43 −

Number of Pharmaceuticals Included in the NHI Price List in Japan

Japan

Fiscal Year Internal Injections External DentalDrugs Total

Source : Ministry of Health, Labour and Welfare, Notice by Health Insurance Bureau

1_03_研究開発の現況_eng.indd 43 16/03/18 20:54

− 44 −

Number of New Molecular Entities Approved

Japan as of the end of November 2015

ManufacturingApproval

ImportApproval

SalesApproval

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

Year No. of New Drugs New Molecular Entities

Total

1_03_研究開発の現況_eng.indd 44 16/03/18 20:54

− 45 −

Number of New Molecular Entities ApprovedJapan Accumulation from 2000 to 25 Nov. 2014

ManufacturingApproval

ImportApproval

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 PharmaBristol-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 33. 2. Approval until 25 Nov. 2015 are listed. (A) Approval until 25 Nov. 2014. (B) Approval from Jan. 2015 to 25 Nov. 2015. 3. The figure for AbbVie Inc. includes data for the former Abbott Japan. The figure for Baxalta includes data for the former Baxter.

Source : Yakumu Kohosha, Yakumu Koho

Company Total SalesApproval

1_03_研究開発の現況_eng.indd 45 16/03/18 20:54

− 46 −

Success Rate of Developing New Drugs in Japan

. Low Molecular Weight Compounds

1) Success rate for 5 years 2010 2014

Phase

Synthesized Compounds

Pre-Clinical Studies Started Clinical Studies Started in Japan

Approval Granted

2) Trends by Fiscal Year

Item

Synthesized Compounds


Approval Granted

Number of Companies

. Biologicals

AntibodyDrugs

OtherDrugs*

AntibodyDrugs

OtherDrugs*

AntibodyDrugs

OtherDrugs*


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.)

No. of Chem. Entity Probability to Movefrom Previous Phase Success Rate

Item

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.

1_03_研究開発の現況_eng.indd 46 16/03/18 20:54

− 47 −

Median Development Times for New Molecular Entities

Number ofApprovals

MedianDevelopment

Time Months

Number ofApprovals

MedianDevelopment

Time Months

Number ofApprovals

MedianDevelopment

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”

by NDA approval year

YearNDA approved

All Products Priority Review Products Standard Review Products


16/03/18 20:54

−48

−

Median Approval Times for New Drugs

by NDA filing year

Number ofApplications

Median ApprovalTime Months


Median ApprovalTime Months


Median ApprovalTime 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 2014. (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”

YearNDA filed

All Products Priority Review Products Standard Review Products


16/03/18 20:54

− 49 −

MHLW(Ministry of Health, Labour and Welfare)

Appointment/Appointment/ConsultationConsultation

AdviceAdvice

Pharmaceuticals and Medical Devices Agency (PMDA)

External experts

External expertsand

Team reviewCompliance review

Review report①

Review report②

GMP auditManufacturing site

Withdrawal request

Withdrawal request

Expert Discussion on Review Ⅰ

Discussion on main issues and conclusionDocument -based discussion possible

Summary of main issues

Expert Discussion on Review Ⅱ

GMP compliance audit result( result notification )

Report onreview result

( review result notification )

Approval Consultation

AdviceDisapproval

Pharmaceutical Affairsand Food SanitationCouncil

Applicant

Interviewand

Inquiry and confirmation from PMDAPresentation from the applicant and response

ApplicantReviewers

Reviewers

Investigators

and

Interview Review Meeting

Opportunity for applicant to explain (presentation ) Consider main issues Conducted by Office Director (or Review Director )

Reviewers

External expertsSpecialist on the applicant side

Applicant

Continue after interview review

External expertsandReviewers

Review Process for Approval

1_03_研究開発の現況_eng.indd 49 16/03/18 20:54

−50

−

Trends in Notification of Clinical Trials

Initial

Notificationon NMEs

Initial Notificationon New Administration Routeand New Ethical Combination

Notificationof nth time

Notificationof Change

Notificationof Completion

Notificationof Suspension

Notificationof Development

Suspension

FYFYFYFYFYFYFYFYFYFYFYFYFY

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 1997. 2. "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 1997. 4. "Notification of Development Suspension" is required its submission since April 1997. 5. Data for 2013 have been revised in accordance with changes in quoted sources.

Source : Yakumu Kohosha, Yakumu Koho

Initial Notification


16/03/18 20:54

− 51 −

Number of Drug Patents

Japan

A DomesticApplicants

ForeignApplicants

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

YearNo. of Drug Patents

Total No. ofPatents B

Ratio to TotalNo. of Patents

A/B %

1_03_研究開発の現況_eng.indd 51 16/03/18 20:54

−52

−

Number of Drug Patents in Japan

Japanese Companies

Meiji Seika Taisho

Sankyo Daiichi

Kowa Otsuka

Yamanouchi Fujisawa Sumitomo Dainippon

Takeda Shionogi Ajinomoto Taiho

Kyowa Hakko Kirin Welfide 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

Company \ Year

Daiichi Sankyo

Mitsubishi Tanabe

Dainippon Sumitomo

Kyowa Hakko Kirin

Astellas


16/03/18 20:54

− 53 −

Number of Drug Patents in Japan

Foreign Companies

Roche Novartis Alcon

GlaxoSmithKline Boehringer Ingelheim

Aventis Sanofi-Synthelabo Genzyme Merck Schering-Plough Organon Bayer Schering AG

Johnson & Johnson Avvie (- '13;Abbott)

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

Company \ Year

Merck USA

Novartis

Pfizer

Sanofi

Bayer


16/03/18 20:54

− 54 −

Number of Bio-technology Patents

Area \ Year

Japan

U.S.A.

Europe

Others

Total

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

Number of Published Patent Applications in Japanby Applicant's Nationality

0

500

1,000

1,500

2,000

2,500

Japan

U.S.A.

Europe

Others

1_03_研究開発の現況_eng.indd 54 16/03/18 20:54

− 55 −

Technology Exports and Imports in the Pharmaceutical Industry

Japan

Cases Value Cases Value Cases Value Cases Value Cases Value Cases Value

Source : Ministry of Internal Affairs and Communications, Report on the Survey of Research and Development , http://www.e-stat.go.jp/SG1/estat/GL08020103.do?_toGL08020103_&tclassID=000001051223&cycleCode=0&requestSender=search

Contracts with Parent / Affiliated Company

Unit : JPY mil.

FiscalYear

Total Contracts New ContractsRevenue Payment Balance Revenue Payment Balance


16/03/18 20:54

— INTERNATIONAL STATISTICS —

Ⅰ . Pharmaceutical Industry Outlook

INT

ERN

ATIO

NA

L ST

ATIS

TIC

S

Ⅰ. P

harm

aceu

tica

l Ind

ustr

y O

utlo

ok

扉_eng.indd 4 16/03/18 20:52

− 59 −

Number of Pharmaceutical ManufacturersMajor 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” http://www.census.gov/econ/susb/


16/03/18 20:54

− 60 −

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 , http://www.efpia.eu/


− 61 −

Pharmaceutical MarketSales by Geographic Region Unit : USD bil., %

Sales Share Sales Share Sales Share Sales Share Sales Share

North America

Japan

Germany

France

Italy

U.K.

Other Europe

Central / South America

Asia-Pacific excluding Japan , Africa and Middle East

World Total

Source : Calculated based on IMS World Review 2015 (Reprinted with permission)

2016 IMS Health. All rights reserved.

Country


16/03/18 20:54

− 62 −

Concentration on Pharmaceutical Sales to Leading Companies

Worldwide 2014 from January to December Unit : USD mil., %

Value Share Value Share 1st 10th

11th 20th21st 30th31st 40th41st 50th51st 60th61st 70th71st 80th81st 90th

91st 100thOthers

Total 100+Others

Source : Calculated based on IMS World Review 2015 (Reprinted with permission)

Change in the concentration on Leading Companies Unit : %

Fiscal Year 10 LeadingCompanies

20 LeadingCompanies

30 LeadingCompanies

50 LeadingCompanies

Fiscal Year 10 LeadingCompanies

20 LeadingCompanies

30 LeadingCompanies

50 LeadingCompanies

Source : from 2000 to 2005, SCRIP, Pharmaceutical Company League Tables

Calculated based on IMS World Review 2015 (Reprinted with permission)

Order by SalesTotal Sales Cumulative

2016 IMS Health. All rights reserved.

from 2005 to 2014, 2016 IMS Health. All rights reserved.


− 63 −

Operating Results of Leading Pharmaceutical Manufacturers

Worldwide 2014 including Japanese manufacturers

% %

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.

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 2013. Ordinary income for Otsuka Holdings only.

Source : SPEEDA (UZABASE, Inc.), Annual reports, and Financial statements

Net Income No.ofEmployeesCompany Currency Total

SalesPharmaSales

%PharmaSales

PharmaSales byUSD mil.

Pretax Income* TotalAssets


16/03/18 20:54

−64

−

Financial Results of Leading Pharmaceutical Manufacturers

Worldwide 2014 including Japanese manufacturers

% 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.

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

EquityRatio %

Return onAsset %

Return onEquity %Company Currency Net

IncomeTotal

Assets EquityTotalSales


16/03/18 20:54

− 65 −

Profitability of Research-based Companies

U.S.A. and Europe 2014

Currency TotalSales

NetIncome

Return onAsset %

Return onEquity %

Net IncomeMargin %

Pfizer USD mil. Merck USD mil. Eli Lilly USD mil. General Electric GE USD mil. Ford Motor USD mil. IBM USD mil. Texas Instruments USD mil. Motorola USD mil. ITT USD mil. Novartis USD mil. Roche CHF mil. Bayer EUR mil. Sanofi EUR mil. AstraZeneca USD mil. GlaxoSmithKline GBP mil. Volkswagen EUR mil. Daimler Chrysler EUR mil. BASF EUR mil. Siemens EUR mil.Nokia EUR mil.

Source : Annual reports, SPEEDA(UZABASE Inc.)

U.S.A.

Pharmaceuticals

Other Industries

Europe

Pharmaceuticals

Other Industries


16/03/18 20:54

−66

−

International Trade of Pharmaceutical Products

Major Countries Unit : USD mil. Country

Year

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

Exports Imports Surplus


16/03/18 20:54

− 67 −

Exports of Pharmaceutical Products by Partner Country

Worldwide 2013 Unit : USD thousandExporter

Importer Austria Belgium Denmark France Germany Ireland Italy Netherlands Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan Others World Total

Exporter Importer Austria Belgium Denmark France Germany Ireland Italy Netherlands Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan Others World Total


Italy Netherlands

Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan

Austria Belgium Denmark France Germany Ireland


16/03/18 20:54

−68

−

Imports of Pharmaceutical Products by Partner Country

Worldwide 2013 Unit : USD thousandImporter

Exporter Austria Belgium Denmark France Germany Ireland Italy Netherlands Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan Others World Total

Importer Exporter Austria Belgium Denmark France Germany Ireland Italy Netherlands Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan Others World Total


Italy Netherlands

Spain Sweden Switzerland U.K. U.S.A. Canada Australia Japan

Austria Belgium Denmark France Germany Ireland


16/03/18 20:54

− 69 −

Overseas Sales of Leading Pharmaceutical Manufacturers

Worldwide excluding Japanese manufacturers

Percentageof Sales

Percentageof Sales

Percentageof Sales

Percentageof Sales

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. Abbott USD mil. Amgen USD mil. Teva USD mil. Eli Lilly USD mil. Baxter USD mil. Bayer EUR mil. Bristol-Myers Squibb USD mil. Novo Nordisk DKK mil. Boehringer Ingelheim EUR mil. Merck (Germany) EUR mil. Mylan USD mil.

Note : Abbott Laboratories (Abbott) separated into two publicly traded companies in 2013, as AbbVie and Abbott. The data since 2011 for each company is showed in this table.

Overseas sales includes the sales figures of pharmaceuticals and non-pharmaceuticals. *1 : Outside Europe *2 : Outside Switzerland *3 : Europe and North America Teva is an Israeli company *4 : Outside UK *5 : Outside France *6 : Outside Germany

Source : Annual reports

OverseasSales

OverseasSales

OverseasSales

OverseasSales

Manufacturer Currency


16/03/18 20:54

−70

−

Miscellaneous IndexesTable 1 Table 2 Table 3

CompanyIncome before tax*

No. of Employees1000 $

Industry CompanyLiquidityRatio* Company

Aggregate MarketValue of stock***

bil $ Astellas Otsuka Holdings Takeda Otsuka Holdings Daiichi Sankyo Astellas Daiichi Sankyo Astellas Daiichi Sankyo Eisai Eisai Eisai Takeda Takeda Mitsubishi Tanabe Amgen Amgen Johnson & Johnson Merck (USA) Pfizer Pfizer Johnson & Johnson Sanofi Merck (US)Pfizer Merck (US) AmgenBristol-Myers Squibb Novartis AbbVie AbbVie GlaxoSmithKline BMSEli Lilly Canon Eli Lilly Baxter Nissan Baxter Novo Nordisk Richo Novartis Roche NEC Roche Novartis Panasonic Sanofi Sanofi Fujitsu Bayer Merck (Germany) Hitachi GlaxoSmithKline Bayer Honda Novo Nordisk B. Ingelheim Toshiba AstraZeneca GlaxoSmithKline Toyota Merck (Germany) AstraZeneca Sony

Texas Instruments * Closing price for the end of December 2014 * The figure for Otsuka Holdings is ordinary income. ITT Industries at each stock exchange.

NokiaSource : Annual reports, Financial statements BASF Source: SPEEDA (UZABASE, Inc.) Siemens

IBM

Source : SPEEDA (UZABASE, Inc.)

Japan

U.S.A.

Europe

Japan

U.S.A.

Europe

* Liquidity Ratio=Current Assets/Current Liabilities

Foreign Non-Pharmaceutical Industries

Japanese Pharmaceutical Manufacturers

Foreign Pharmaceutical Manufacturers

Japanese Non-Pharmaceutical Industries


16/03/18 20:54

— INTERNATIONAL STATISTICS —

Ⅱ . Pharmaceutical Research and Development

INT

ER

NAT

ION

AL

ST

ATIS

TIC

S

Ⅱ. P

harm

aceu

tica

l Res

earc

h

a

nd D

evel

opm

ent

扉_eng.indd 5 16/03/18 20:52

− 73 −

R&D Expenditures of Leading Pharmaceutical Manufacturers

Worldwide excluding Japanese manufacturers

Expendi-tures

Change%

R&D/Sales

%

Expendi-tures

Change%

R&D/Sales

%

Expendi-tures

Change%

R&D/Sales

%

Expendi-tures

Change%

R&D/Sales

%

Expendi-tures

Change%

R&D/Sales

% 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. Abbott USD mil. Amgen USD mil. Teva USD mil. Eli Lilly USD mil. Baxter USD mil. Bayer EUR mil. Bristol-Myers Squibb USD mil. Novo Nordisk DKK mil. Boehringer Ingelheim EUR mil. Merck Germany EUR mil. Mylan USD mil.

Note : 1. Pfizer merged Wyeth in 2009. 2. Merck (USA) merged with Schering-Plough in 2009. 3. Abbott Laboratories (Abbott) separated into two publicly traded companies in 2013, as AbbVie and Abbott. The data since 2011 for each company is showed in this table.

Source : Annual reports

Company Currency


16/03/18 20:55

−74

−

R&D Expenditures by Developmental Stage

U.S.A.

ExpendituresUSD mil.




Prehuman / Preclinical

Phase

Phase

Phase

Approval

Phase

Subtotal

Uncategorized

Total

Source : PhRMA, Pharmaceutical Industry Profile , http://www.phrma.org/profiles-reports

Percentage%

Percentage%

Percentage%

Percentage%


16/03/18 20:55

− 75 −

1,411

904

1,100

1,272

1,565

1,900

2,310

2,490

2,619

3,115

3,482

3,692

4,069

4,375

4,486

4,894

6,045

5,898

5,7985,717

5,847

15.816.4

15.9 16.116.6

17.8

16.517.2

18.2

18.2

15.2

16.617.0

16.2

26.2

21.8

19.6

10.211.0

10.6 10.7

10.711.4 11.4

13.313.8

14.2

16.2

15.9 15.415.2

11.3

12.2

14.9

15.1

15.1

16.9

17.7

22.3

20.2

14.7 15.0

Trends of R&D Expenditures and Profits as Sales Ratio

Note : 1. Companies surveyed: Abbvie & Abbott (as former Abbott), Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck and Pfizer.

Number of companies surveyed:2. 1991 to 1998: 10 companies (excluded Amgen, Wyeth and included AHP (currently Wyeth),

Upjohn, Warner Lambert)3. 1999, and 2003 to 2005: 8 companies (excluded Amgen)4. 2000 to 2002: 9 companies (excluded Amgen, included Pharmacia)5. From 2009: 7 companies (Merck incorporated Schering-Plough, Pfizer acquired Wyeth)6. In 2013, Abbott Laboratories (Abbott) separated into two publicly traded companies as Abbott

and AbbVie.The enumeration data as of 2013 is combined both of two companies' data as one firm.

Source : Annual Report

U.S.A（7 companies）R&D Expenditures per Company（Average of 7 companies）

Net Profit Margin （%）

R&D Expenditures per Sales （%）

（year）

020111994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005　2006 2007 2009 20102008

4,600

4,500

4,400

4,300

5,000

4,900

4,800

4,700

4,200

4,100

5,600

5,500

5,400

5,300

6,000

5,900

5,800

5,700

5,200

5,100

4,000

3,900

3,800

3,700

3,600

3,500

3,400

3,300

3,200

3,100

3,000

2,900

2,800

2,700

2,600

2,500

2,400

2,300

2,200

2,100

2,000

1,900

1,800

1,700

1,600

1,500

1,400

1,300

1,200

1,100

1,000

900

800

700

600

USD mil.

%40

35

30

25

20

15

10

5

02012 2013 2014

7. 2014: AbbVie, Amgen, Bristol-MyersSquibb, EliLilly, Johnson&Johnson, Merck, Pfizer.

2_02_研究開発の現況_eng.indd 75 16/03/18 20:55

− 76 −

Published PCT Applications by Pharmaceutical Company

Company Abbott Abbott Laboratories Amgen Amgen AstraZeneca AstraZeneca AB

Bayer Pharmaceutical Corp. Bayer Pharma AG. Bayer CropScience Bayer Schering Pharma AG Bayer HealthCare Schering Aktiengesellshaft

B.Ingelheim Boehringer Ingelheim Intn'l GmbH BMS Bristol-Myers Squibb Co. Eli Lilly Eli Lilly and Co.

Glaxo Group Ltd. SmithKline Beecham Corp. GlaxoSmithKline LLC GlaxoSmithKline Biological S.A. GlaxoSmithKline Intellectual Property Janssen Pharmaceutica N.V. Centocor, Alza Corp. Alza Corp.

Merck Germany Merck Patent GmbH Schering-Plough Merck & Co.,Inc. Organon Merck Sharp and Dohme Corp Novartis AG Alcon, Chiron Corp.,

Novo Nordisk Novo Nordisk A/S Pfizer Inc. Pfizer Ltd. Pfizer Products Inc. Warner-Lambert Co. Pharmacia & Upjohn Co. Pharmacia Corp. Wyeth F.Hoffmann-La Roche AG Genentech,Inc. Sanofi Sanofi-Aventis Sanofi-Aventis Deutschland GmbH Aventis Pharma S.A. Genzyme

Teva Teva Pharmaceutical Industries, Ltd.

Note : Non-pharmaceutical patents are included.

Source : Until 2012, WIPO/PCT Patents Fulltext, and Derwent World Patents Index(DWPI) is used only for Warner-Lambert Co. 2013-, JP-Net Overseas

Daiichi Sankyo Sankyo/Daiichi Pharma Asubio Pharmaceuticals,Inc Daiichi Suntory, Daiichi Asubio Takeda Chemical Industries, Ltd. Takeda Pharma

Sanofi

Bayer

Merck USA

Roche

Novartis

Pfizer

Johson & Johson

GSK

Astellas

Eisai Eisai Eisai/Eisai R&D Management

Daiichi Sankyo

Takeda

Astellas Pharma Inc. Yamanouchi Pharma/Fujisawa Pharma

2_02_研究開発の現況_eng.indd 76 16/03/18 20:55

Statistics on Health Care

Stat

isti

cs o

n H

ealt

h C

are

扉_eng.indd 6 16/03/18 20:52

− 79 −

Life Expectancy

Japan Unit : Years

Year

Age

Source : Ministry of Health, Labour and Welfare, Abridged Life Table , http://www.mhlw.go.jp/toukei/saikin/hw/seimei/list54-57-02.html

Male Female

3_参考資料_eng.indd 79 16/03/18 20:55

− 80 −

Life Expectancy

Worldwide Unit : Years

Area Country Period Male Female Period Male Female

Asia Japan

Israel

India

Indonesia

Korea

China

Europe Iceland

Italy

U.K.

Austria

Netherlands

Switzerland

Sweden

Czech Republic

Denmark

Germany

Norway

Finland

France

Russia

North America U.S.A.

Canada

Mexico

South America Argentina

Brazil

Africa Egypt

South Africa

Oceania Australia

New Zealand

Source : Ministry of Health, Labour and Welfare, Abridged Life Table , http://www.mhlw.go.jp/toukei/saikin/hw/seimei/list54-57-02.html

United Nations, Statistics Division, Demographic Yearbook , http://unstats.un.org/unsd/default.htm

3_参考資料_eng.indd 80 16/03/18 20:55

− 81 −

Trends of Vital Statistics

JapanLive

Births Deaths NaturalChange

InfantDeaths

NeonatalDeaths

Note : No data available for 1945.

Source : Ministry of Health, Labour and Welfare, Vital Statistics , http://www.mhlw.go.jp/toukei/list/81-1a.html

Yearper 1,000 Population per 1,000 Births

3_参考資料_eng.indd 81 16/03/18 20:55

− 82 −

Trends of Vital Statistics Foreign Countries

LiveBirths Deaths Infant

DeathsNeonatalDeaths

LiveBirths Deaths Infant

DeathsNeonatalDeaths*

Source : United Nations, Statistics Division, Demographic Yearbook *UNICEF, Child Mortality Estimates

Canada

U.S.A.

Mexico

Brazil

Australia

Argentina

New Zealand

U.K.

Switzerland

Russia

Sweden

Germany

Norway

Italy

Netherlands

France

Czech Rep.

Finland

Denmark

Austria

Egypt

Israel

Country

per 1,000 Populat. per 1,000 Births per 1,000 Populat. per 1,000 Births

Indonesia

Korea

China

India

3_参考資料_eng.indd 82 16/03/18 20:55

− 83 −

Mortality Rate by Major Causes

Japan

Year

Source : Ministry of Health, Labour and Welfare, Vital Statistics , http://www.mhlw.go.jp/toukei/list/81-1a.html

Malignant Neoplasms

Stomach

Liver

Trachea, Bronchus & Lung

Diabetes

Hypertensive disease

Suicides

Cerebrovascular Disease

Pneumonia

Hepatic disease

Renal disease

Senility without psychosis

Accidents

Heart disease excluding hypertensive heart disease

Causes of Death

Total

Tuberculosis

Deaths Deaths per 100,000 population

3_参考資料_eng.indd 83

16/03/18 20:55

−84

−

Mortality Rate by Major Causes

Cross Countries Comparison, 2013 Unit : Per 100,000 population

(2011) (2011)

France France

Total Deaths Total Mortality Rate Tuberculosis Malignant Neoplasms Esophagus Stomach Colon, Rectosigmoid Junction, Rectum & Anus Liver Trachea, Bronchus & Lung Prostate Breast Female Cervix Uteri Lymphoid, Leukemia & Haematopoietic tissue Diabetes Hypertensive Disease Ischaemic Heart Diseases Cerebrovascular Diseases Pneumonia Gastric & Duodenal Ulcer Diseases of the Liver Disorders of Kidney and Ureter Transport Accidents Intentional Self-Harm

Source : United Nations, Statistics Division, Demographic Yearbook , http://unstats.un.org/unsd/default.htm

GermanyJapan Japan

FemaleCause of Death

Male

U.S.A. U.K. Germany U.S.A. U.K.


16/03/18 20:55

− 85 −

National Health Care Expenditures

Japan

Value Change%

per Capita1,000 Yen

Change%

Percentageof GDP

Percentageof National

Income

Note : Long-term care insurance cost was excluded since 2000.

Source : Ministry of Health, Labour, and Welfare, Estimates of National Medical Care Expenditure , http://www.mhlw.go.jp/toukei/list/37-21c.html Economic and Social Research Institute, Cabinet Office, Annual Report on National Accounts , http://www.esri.cao.go.jp/jp/sna/menu.html

FiscalYear

National Health Care Expenditures Proportion of NationalHealth Care Expenditures

3_参考資料_eng.indd 85 16/03/18 20:55

−86

−

National Health Care Expenditures

Major Countries Unit : USD mil.Country \ Year

Australia Austria Belgium Canada Denmark France Germany Ireland Italy Japan Korea Luxembourg Netherlands Norway Portugal Spain Sweden Switzerland United Kingdom United States

*Figures may differ from those of past DATA BOOKs due to revision in accordance with changes in data in the quoted sources.

Source : OECD, OECD Health Data


16/03/18 20:55

− 87 −

National Health Care Expenditures %GDP

Major CountriesCountry \ Year

Australia Austria Belgium Canada Denmark France Germany Ireland Italy Japan Korea Luxembourg Netherlands Norway Portugal Spain Sweden Switzerland United Kingdom United States

*Figures may differ from those of past DATA BOOKs due to revision in accordance with changes in data in the quoted sources.

Source : OECD, OECD Health Data


16/03/18 20:55

−88

−

National Health Care Expenditures and Share by Source of Revenues

Japan

JPY bil.

GDP %

1,000 Yen

Nation

Prefectures

Employer

Employee

Note : 1. Until 1995, Percentage of GDP was the GNP ratio. 2. Long-term care insurance cost was excluded since 2000.

Source : Ministry of Health, Labour and Welfare, Estimates of National Medical Care Expenditure , http://www.mhlw.go.jp/toukei/list/37-21c.html GDP : Economic and Social Research Institute, Cabinet office, Annual Report on National Accounts , http://www.esri.cao.go.jp/jp/sna/menu.html

Source ofRevenue

%

Public Expenses

Health Insurance

Out of pockets

Others

Fiscal Year

NationalHealthCare

Expend.

Total

Percentage of

per Capita


16/03/18 20:55

− 89 −

National Health Care Expenditures and Share by Source of Revenues

U.S.A.

Federal

State & Local

Note : 1. National Health Care Expenditure are Personal Health Care which is equivalent to Japanese National Health Care Expenditure. 2. The ratio to GDP and medical treatment expenses per capita are calculated based on National Health Expenditure in NHE Web tables of CMS data. 3. Insurance Premium includes only Private Health Insurance. Data for the 2014 Source of Revenue (%) have been revised.

Source : CMS, National Health Expenditures by type of service and source of funds , NHE Web tables , http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html

Year

NationalHealthCare

Expend.

Total

Percentage of GDP

USD

USD bil.

% per Capita

Source ofRevenue

%

Government

Insurance Premium

Out of pockets

Others


16/03/18 20:55

−90

−

Proportion of National Treasury Expenses in National Health Care Expenditures

Japan Unit : JPY bil.

FiscalYear

General AccountsBudget

A

National HealthCare Expenditures

B

National TreasuryExpenses in B

C C / A % C / B %

* Data published in past DATA BOOK have been revised.

Source : National Health Care Expenditures : Ministry of Health, Labour and Welfare, Estimates of National Medical Care Expenditure , http://www.mhlw.go.jp/toukei/list/37-21c.html General Accounts Budget : Ministry of Finance Japan, Budget , http://www.mof.go.jp/budget/budger_workflow/budget/index.html


16/03/18 20:55

− 91 −

Proportion of National Treasury Expenses in National Health Care Expenditures

U.S.A. Unit : USD bil.

YearGeneral Accounts

BudgetA

National Health CareExpenditure

B

National TreasuryExpense in B

CC / A % C / B %

Note: 1. National Health Care Expenditure are Personal Health Care which is equivalent to Japanese National Health Care Expenditure. 2. National Treasury Expense represent the expense of the Federal Government. 3. Datum for 2012 (c) has been revised.

Source : National Health Care Expenditure : CMS, National Health Expenditures by type of service and source of funds ,

http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/ NationalHealthAccountsHistorical.html National Treasury Expense :

Until 1997, Bank of Japan, Comparative Economic and Financial Statistics Japan and Other Major Countries From 1998 to 2002, Toyo Keizai, Economic Statistic Almanac From 2003, United States Department of the Treasury, Joint Statement on Budget Results for Fiscal Year ,

http://search.treasury.gov/search?affiliate=treasury&commit=Search&query=Table%203.--OUTLAYS%202012


16/03/18 20:55

−92

−

Social Benefit

Social Benefit by Category and the Percentage of National Income Japan

Source : National Institute of Population and Social Security Research, The Financial Statisics of Social Security in Japan FY2013 , http://www.ipss.go.jp/ss-cost/j/fsss-h25/fsss_h25.asp

Percentageof

NationalIncome

Medical Care

Pensions

Welfare & Others

Long-term Care

Total

ValueJPY bil.

Category

Medical Care

Pensions

Welfare & Others

Long-term Care

Total


16/03/18 20:55

− 93 −

Number of Medical Care FacilitiesJapan

Number of Facilities

Total Hospitals Psychiatric Hospitals Infectious Dis. Hospitals Tuberculosis Sanatoria General Hospitals Comprehensive Hospitals re-sum General Practitioners With Beds Without Beds Dental Clinics With Beds Without Beds Pharmacies

Number of Facilities per 100,000 Population

Total Hospitals Psychiatric Hospitals Infectious Dis. Hospitals Tuberculosis Sanatoria General Hospitals Comprehensive Hospitals re-sum General Practitioners With Beds Without Beds Dental Clinics Pharmacies

Note : Infectious Disease Hospitals were abolished in April 1999.

Source : Hospitals : Ministry of Health, Labour and Welfare, Medical Care Facility Survey, Hospital Report , http://www.mhlw.go.jp/toukei/list/79-1a.html Pharmacies : Ministry of Health, Labour and Welfare, Hygiene Administration Report in Japan , http://www.mhlw.go.jp/toukei/list/36-19a.html


16/03/18 20:55

−94

−

Number of Beds in Medical Care Facilities Japan

Number of Beds Number of Beds

Hospitals Hospitals Psychiatric Care Psychiatric Care Infection Care Infection Care Tuberculosis Care Tuberculosis Care Convalescent Ward Convalescent Ward General Hospitals General Hospitals former Other Facilities General Practitioners former Convalescent Ward re-sum Convalescent Ward re-sum Comprehensive Hospitals re-sum Dental Clinics General Practitioners Total Convalescent Ward re-sum Dental Clinics Total

Number of Beds per 100,000 Population Number of Beds per 100,000 Population

Hospitals Hospitals Psychiatric Care Psychiatric Care Infection Care Infection Care Tuberculosis Care Tuberculosis Care Convalescent Ward Convalescent Ward General Hospitals General Hospitals

General Practitionersre-sum Convalescent Ward re-sum

Comprehensive Hospitals re-sum Dental Clinics General Practitioners Total Convalescent Ward re-sum Dental Clinics Total

Source : Ministry of Health, Labour and Welfare, Medical Care Facility Survey,Hospital Report , http://www.mhlw.go.jp/toukei/list/79-1a.html


16/03/18 20:55

− 95 −

Number of Medical Care Personnel JapanTotal Number

FiscalYear Physicians*1 Dentists*1 Nurses*2 Pharmacists*1

Number per 100,000 PopulationFiscalYear Physicians*1 Dentists*1 Nurses*2 Pharmacists*1

Note : *1. Number of licensed specialists. *2. Number of actual workers including nurses and assistant nurses.

Source : Ministry of Health, Labour and Welfare, Report on Public Health Administration and Services Medical Personnel , http://www.mhlw.go.jp/toukei/list/36-19a.html Ministry of Health, Labour and Welfare, Report on Survey of Physicians, Dentists and Pharmacists, http://www.e-stat.go.jp/SG1/estat/NewList.do?tid=000001030962

3_参考資料_eng.indd 95 16/03/18 20:55

− 96 −

Ajinomoto

Banyu

Torii（Merck）

Torii（Asahi Breweries）

Hokuriku（BASF）

Hokuriku（Abbott）

SSP（NBI）

Shimizu（Ajinomoto）

Ajinomoto Medica（Manufacturing）

Ajinomoto Pharma（Marketing）

Nikken Chemicals（Kowa）

Kayaku（Manufacturing）

Kyowa Hakko（Kirin）

Kyowa Hakko Kirin（Kirin）

POLAPharma

Torii（JT）

MitsubishiTanabe

AbbottJapan

Mitsubishi

AbbottJapan

Chugai（Roche）

UCB

MSD

AbbVie

Nippon Schering

Hisamitsu

BayerYakuhin

BayerYakuhin

Taisho

Taisho Toyama

Toyama Chemical

Astellas

Daiichi Sankyo

Dainippon Sumitomo

ASKA

Kowa

Kowa Pharmaceutical

SSP（NBI）

Torii

Merck

Green Cross

Yoshitomi

Tanabe

Hokuriku

Dainabbott

BASF

Fujirebio

UCB

Nippon Roche

Chugai

Mitsui

Hisamitsu

Tokyo Tanabe

Mitsubishi Chemical（Pharmaceutical Div.）

Nippon Schering

SSP

Nippon Boehringer Ingelheim（NBI）

Taisho

Toyama Chemical

Shimizu

Ajinomoto Pharma（Ajinomoto）

Yamanouchi

Sankyo

Daiichi

Dainippon

Sumitomo

Teikoku Hormone

Fujisawa

Kowa

Grelan

Nikken Chemicals

Asahi Breweries

JT

Welfide

Taisho Toyama

Zepharma

Kayaku

Mitsubishi

Abbott

Kirin Pharma

’83 Acq

’10 Mrg

’98 Mrg

’99 Mrg

’01 Mrg

’03 Intg

’02 Intg

’07 Intg

’00 Pharmaceutical 　Business Sold

’05 Ethical Drug Sector Sold

’07 Pharmaceutical Business Transferred

’07 Marketing SectorTransferred

’06 Ethical Drug　　　　　　Business Transferred

’05 Business Function Changed

Pharmaceutical Function’05 Business Function Changed

’04 OTC Sector　　　　　　 Separated & Merged

’06 Sold

’05 Mrg

’07 Mrg

’05 Mrg

’05 Mrg

’02 Ethical Drug Mkt. Company founded

’88 Acq

’01 Acq

’07 Mrg

’96 Acq

’00 Acq

’01 Acq

’03 Acq

（POLA Chemical）

（Kirin）

POLA Chemical

Kyowa Hakko

Kayaku AntibioticResearch

’83 Capital Participation

’07 Capital Participation

Acq：Acquisition Mrg：Merger Intg：Integration

’84 Company Name Changed

’08 Pharmaceutical Business Separated

Kirin

’08 Mrg

’02 Acq

’98 Acq

’10 Mrg

M&A in Japan

Schering-Plough

Ajinomoto

Ajinomoto Medica

Ajinomoto Pharma

AjinomotoPharma

’13 Sep

Ayumi

SantenSanten

Baxter

’15 Sep

Baxalta

Baxter’15 Sep

Sep：Separation

3_参考資料_eng.indd 96 16/03/18 20:55

− 97 −

M&A in the World

Glaxo（UK）’95 Mrg

Beecham（UK）

SmithKline（US）

Wellcome（UK）Glaxo Wellcome（UK）

SmithKlineBeecham（UK） ’89 Mrg

’00 Mrg GlaxoSmithKline（UK）

Hoechst（Ger）

Rorer（US）

Rhone-Poulenc（Fr）

Marion Merrell Dow（US）

Hoechst （Ger）

Rhone-PoulencRorer（Fr）

Delagrange（Fr）

Delalande（Fr）

Sanofi（Fr）

Synthelabo（Fr）

Aventis （Fr）

’99 Mrg

’04 Acq

’11 Acq

’91 Acq

’91 Acq

Sanofi（Fr）

’90 Mrg

Synthelabo（Fr）

’99 Mrg

Sanofi Synthelabo （Fr）

Roussell（Fr）

Farmitalia（Italy）

Pharmacia（Sweden）

Kabi Vitrum （Sweden）

Carlo Erba（Italy）

Kabi Pharmacia（Sweden）

FarmitaliaCarlo Erba（Italy）

Pharmacia （Sweden）

Upjohn（US）

Monsanto（US）

Wyeth（US）

Searle（US） Monsanto（US）

’78 Mrg

’91 Mrg

’93 Mrg

Pharmacia &Upjohn（US）

’95 Mrg

Pharmacia（US）’00 Mrg

’85 Acq

’03 Acq

’09 Acq

Pfizer（US）

Warner -Lambert（US）’00 Mrg Pfizer（US）

Pfizer（US）

Squibb （US）

Bristol-Myers（US） Bristol -Myers 　Squibb（US）

’89 Mrg

Schering（Ger）

Bayer（Ger）’06 Acq

Bayer（Ger）

’09 Mrg

’13 Sep

’11 Mrg

Merck（US） Merck（US）

Organon（NL）

Schering Plough（US） Schering Plough（US）’07 Acq

’93 Ethical Drug Sector Separated

I C I（UK）

AstraZeneca（UK）

Zeneca （UK）’99 Mrg

Astra（Sweden）

（ I C I ）

Roche（Switz）

Roche（Switz）’90 Acq

Genentech（US）

Chugai（JPN）

Syntex（US） Roche（Switz）

Roche（Switz）’94 Acq

’02 Acq

Boehringer Mannheim （Ger）’97 Acq

’98 ReorganizationRoche

DiagnosticsRoche

Diagnostics Company Name changed

Company Name changed

Acq：Acquisition Mrg：Merger Sep：Separation

’06 Acq

’96 MrgSandoz（Switz）

Chiron（US）

Alcon（US）

Novartis（Switz）

Novartis（Switz）

Ciba-Geigy（Switz）

Genzyme（US）

AbbVie（US）

Abbott（US）Abbott（US）

’15 SepBaxalta（US）

Baxter（US）Baxter（US）

3_参考資料_eng.indd 97 16/03/18 20:55

Appendix

扉_eng.indd 7 16/03/18 20:52

AbbVie G.K. 3-5-27 Mita,Minato-ku,Tokyo 108-6302

AJINOMOTO PHARMACEUTICALS CO., LTD. 2-1-1 Irifune, Chuo-ku, Tokyo 104-0042

Alcon Japan LTD.1-23-1 Toranomon,Minato-ku, Tokyo 105-6333

ASAHI KASEI PHARMA CORPORATION1-105 Kanda-Jinbocho,Chiyoda-ku, Tokyo 101-8101

ASKA PHARMACEUTICAL CO., LTD.2-5-1 Shibaura,Minato-ku, Tokyo 108-8532

ASTELLAS PHARMA INC, 2-5-1 Nihonbashi-Honcho,Chuo-ku, Tokyo 103-8411

AstraZeneca K.K. 3-1 Ofukacho, Kita-ku, Osaka 530-0011

AYUMI PHARMACEUTICAL CORP. 4-12-15 Ginza, Chuo-ku, Tokyo 104-0061

BAXALTA, LTD.1-23-1 Toranomon, Minato-ku, Tokyo 105-6320

BAYER YAKUHIN, LTD.2-4-9 Umeda, Kita-ku, Osaka 530-0001

BRISTOL-MYERS K.K.6-5-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 163-1328

Celgene K.K.2-7-2 Marunouchi,Chiyoda-ku, Tokyo 100-7010

CHUGAI PHARMACEUTICAL CO., LTD.2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-8324

DAIICHI SANKYO CO., LTD3-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-8426

DAINIPPON SUMITOMO PHARMA CO., LTD.2-6-8 Doshomachi, Chuo-ku, Osaka 541-0045

EISAI CO., LTD.4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088

ELI LILLY JAPAN K.K.7-1-5 Isogamidori, Chuo-ku, Kobe, Hyogo 651-0086

FUJIMOTO PHARMACEUTICAL CORP. 1-3-40 Nishi-Otsuka, Matsubara, Osaka 580-8503

FUSO PHARMACEUTICAL INDUSTRIES, LTD.2-3-11 Morinomiya, Joto-ku, Osaka 536-8523

Genzyme Japan K.K.3-20-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo 163-1488

GlaxoSmithKline K.K.4-6-15 Sendagaya, Shibuya-ku, Tokyo 151-8566

HISAMITSU PHARMACEUTICAL CO., INC.408 Daikanmachi, Tashiro, Tosu, Saga 841-0017

JANSSEN PHARMACEUTICAL K.K.3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065

JAPAN TOBACCO INC.2-2-1 Toranomon,Minato-ku, Tokyo 105-8422

KAKEN PHARMACEUTICAL CO., LTD.2-28-8 Honkomagome, Bunkyo-ku, Tokyo 113-8650

KISSEI PHARMACEUTICAL CO., LTD.19-48 Yoshino, Matsumoto, Nagano 399-8710

KOWA Company, Ltd.3-4-14 Nihonbashi-Honcho,Chuo-ku, Tokyo 103-8433

KRACIE PHARMA, LTD.3-20-20 Kaigan,Minato-ku, Tokyo 108-8080

KYORIN PHARMACEUTICAL CO., LTD.4-6 Kanda-Surugadai,Chiyoda-ku, Tokyo 101-8311

KYOTO PHARMACEUTICAL INDUSTRIES, LTD.38 Nishinokyo-Tsukinowacho,Nakagyo-ku, Kyoto 604-8444

KYOWA HAKKO KIRIN CO., LTD. 1-6-1 Otemachi,Chiyoda-ku, Tokyo 100-8185

MARUHO CO., LTD.1-5-22 Nakatsu,Kita-ku, Osaka 531-0071

MARUISHI PHARMACEUTICAL CO., LTD.2-4-2 Imazunaka, Tsurumi-ku, Osaka 538-0042

Meiji Seika Pharma CO., LTD. 2-4-16 Kyobashi,Chuo-ku, Tokyo 104-8002

Merck Serono CO., LTD. 1-8-1 Simomeguro,Meguro-ku, Tokyo 153-8926

MINOPHAGEN PHARMACEUTICAL CO. LTD.3-2-11 Nishi-Shinjuku,Shinjuku-ku, Tokyo 160-0023

MITSUBISHI TANABE PHARMA CORPORATION3-2-10 Doshoumachi,Chuo-ku, Osaka 541-8505

MOCHIDA PHARMACEUTICAL CO., LTD.1-7 Yotsuya,Shinjuku-ku, Tokyo 160-8515

Member Companies ofThe Japan Pharmaceutical Manufacturers Association

4_付録_eng.indd 100 16/03/18 20:56

MSD K.K. 1-13-12 Kudan-Kita,Chiyoda-ku, Tokyo 102-8667

Mylan EPD G.K. 3-5-27 Mita,Minato-ku, Tokyo 108-6306

NIHON PHARMACEUTICAL CO., LTD1-9-8 Higashi-Kanda, Chiyoda-ku, Tokyo 101-0031

NIPPON BOEHRINGER INGELHEIM CO., LTD.2-1-1 Osaki,Shinagawa-ku, Tokyo 141-6017

NIPPON CHEMIPHAR CO., LTD.2-2-3 Iwamotocho,Chiyoda-ku, Tokyo 101-0032

NIPPON KAYAKU CO., LTD.2-1-1 Marunouchi,Chiyoda-ku, Tokyo 100-0005

NIPPON SHINYAKU Co., Ltd.14 Nishinosho Monguchicho, Kisshoin,Minami-ku Kyoto 601-8550

NIPPON ZOKI PHARMACEUTICAL CO., LTD.2-1-2 Hiranomachi,Chuo-ku, Osaka 541-0046

NOVARTIS PHARMA K.K.1-23-1 Toranomon,Minato-ku, Tokyo 105-6333

NOVO NORDISK PHARMA LTD.2-1-1 Marunouchi,Chiyoda-ku, Tokyo 100-0005

ONO PHARMACEUTICAL CO., LTD.1-8-2 Kyutaromachi,Chuo-ku, Osaka 541-8564

OTSUKA PHARMACEUTICAL Co., Ltd.2-16-4 Kounan, Minatoku, Tokyo 108-8242

PFIZER JAPAN INC.3-22-7 Yoyogi,Shibuya-ku, Tokyo 151-8589

POLA PHARMA INC.8-9-5 Nishi-Gotanda,Shinagawa-ku, Tokyo 141-0031

Sanofi K.K.3-20-2 Nishi-Shinjuku,Shinjuku-ku, Tokyo 163-1488

SANTEN PHARMACEUTICAL CO., LTD.4-20 Ofukacho,Kita-ku, Osaka 530-8552

SANWA KAGAKU KENKYUSHO CO., LTD.35 Higashi-Sotoboricho,Higashi-ku, Nagoya 461-8631

SEIKAGAKU CORPORATION1-6-1 Marunouchi,Chiyoda-ku, Tokyo 100-0005

SENJU PHARMACEUTICAL CO., LTD. 2-5-8 Hiranomachi,Chuo-ku, Osaka 541-0046

SHIONOGI & CO., LTD.3-1-8 Doshomachi,Chuo-ku, Osaka 541-0045

TAIHO PHARMACEUTICAL CO., LTD.1-27 Kanda-Nishikicho,Chiyoda-ku, Tokyo 101-8444

TAISHO PHARMACEUTICAL CO., LTD.3-24-1 Takata,Toshima-ku, Tokyo 170-8633

TAKEDA PHARMACEUTICAL COMPANY LIMITED4-1-1 Doshomachi,Chuo-ku, Osaka 540-8645

TEIJIN PHARMA LIMITED3-2-1 Kasumigaseki,Chiyoda-ku, Tokyo 100-8585

TEIKOKU SEIYAKU CO., LTD.567 Sanbonmatsu,Higashi-kagawa, Kagawa 769-2695

TERUMO CORPORATION3-20-2 Nishi-Shinjuku,Shinjuku-ku, Tokyo 163-1450

TOA EIYO LTD.3-10-6 Hatchobori,Chuo-ku, Tokyo 104-0032

Toray Industries, Inc.2-1-1 Nihonbashi-Muromachi,Chuo-ku, Tokyo 103-8666

TORII PHARMACEUTICAL CO., LTD.3-4-1 Nihonbashi-Honcho,Chuo-ku, Tokyo 103-8439

TOYAMA CHEMICAL CO., LTD. 3-2-5 Nishi-Shinjuku,Shinjuku-ku, Tokyo 160-0023

TSUMURA & CO., LTD.3-2-5 Nishi-Shinjuku,Shinjuku-ku, Tokyo 160-0023

UCB JAPAN CO., LTD8-17-1 Nishi-Shinjuku,Shinjuku-ku, Tokyo 160-0023

WAKAMOTO PHARMACEUTICAL CO., LTD.2-2-2 Nihonbashi-Honcho,Chuo-ku, Tokyo 103-8330

YAKULT HONSHA CO., LTD.1-1-19 Higashi-Shinbashi,Minato-ku, Tokyo 105-8660

ZERIA PHARMACEUTICAL CO., LTD.10-11 Nihonbashi-Kobunacho,Chuo-ku, Tokyo 103-8351

（as of March, 2016）

4_付録_eng.indd 101 16/03/18 20:56

MEMO

DATA BOOK 2016

4_付録_eng.indd 102 16/03/18 20:56

MEMO

DATA BOOK 2016

4_付録_eng.indd 103 16/03/18 20:56

Exchange Rates

Country Currency CurrencyAbbreviation

Australia AustralianDollar AUD

Canada CanadianDollar CAD

China Yuan CNY

Denmark DanishKrone DKK

Japan Yen JPY

Korea KoreanWon KRW

Sweden SwedishKrone SEK

Switzerland SwissFranc CHF

United Kingdom PoundSterling GBP

United States US Dollar USD

EU Euro EUR

Austria Schilling NLG

Belgium BelgianFranc BEF

France Franc FRF

Germany DeutscheMark DEM

Italy ItalianLira ITL

Netherlands Guilder NLG

Portugal PortugueseEscudo PTE

Spain SpanishPeseta ESP

Notes : Currency unit of EU : The euro has been used in Austria, Belgium, France, Germany, Italy, Netherlands, Portugal and Spain since 1999.

Source : International Financial Statistics Yearbook 2015

4_付録_eng.indd 104

16/03/18 20:56

Documents

Forewords - JPMA · Forewords This data book organizes the statistics on pharmaceutical industries both ... Yakult YAKULT HONSHA CO., LTD. Zeria ZERIA PHARMACEUTICAL CO