jgajgajgajgajgajagjgajgajgajgajgajga jgajgajgajgajgajgajgajgajgajgajgajga Generic Challenge In Japan jgajgajgajgajgajgajgajgajgajgajgajga jgajgajgajgajgajgajgajgajgajgajgajga Tamotsu Fujino jgajgajgajgajgajgajgajgajgajgajgajga Japan Generic Medicines Association jgajgajgajgajgajgajgajgajgajgajgajga at New York Pharma Forum jgajgajgajgajgajgajgajgajgajgajgajga Sept 29, 2009 jgajgajgajgajgajgajgajgajgajgajgajga jgajgajgajgajgajgajgajgajgajgajgajga Japan Generic Medicines Association 1
Japan Generic Medicines Association • Established : 1968 • Name : Japan Generic Medicines Association (JGA) Renamed in April 2008 from former Japan Generic Pharmaceutical Manufacturers Association （ JGPMA) • Members: 44 Companies （ Regular members ） • President: Hiroyuki Sawai • Associated with a) Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) b) International Generic Pharmaceutical Alliance (IGPA) Japan Generic Medicines Association 2
1. Global Generic Market (2008) ⓒ 2009 IMS Health. All right reserved. Source: IMS Health, MIDAS, Market segmentation, Rx only, Dec 2008; 27 Market Segmentation Countries, Ex - Mfr basis Japan Generic Medicines Association 3
1-2. Global Generic Shares (2008) Tota tal l Mar Marke ket 50 50 U.S. .S. 69 69 Can Canad ada 66 66 German Ger any 64 64 U.K .K. 61 61 Fran ance 40 40 Spai pain 35 35 Italy taly 33 33 Volume(%) Japa apan 20 20 Japan Ja pan* 17 17 0 20 40 60 80 ⓒ 2009 IMS Health. All right reserved. Source: IMS Health MIDAS Market Segmentation, Rx only, Dec 2008. Ex-Mfr basis. *Japan: JGA’s 2007 Data Japan Generic Medicines Association 4
1-3. Global Generic Shares of Off-Patent Products (2008) Volume （％） ⓒ 2009 IMS Health. All right reserved. Source: IMS Health MIDAS Market Segmentation, Rx only, Dec 2008. Ex-Mfr basis. Japan Generic Medicines Association 5
1-4. Global Major Generic League GENERICS bulletin, 1 June 2009 Japan Generic Medicines Association 6
1-5. Global Generic Minor League GENERICS bulletin, 1 June 2009 Japan Generic Medicines Association 7
2. Japanese Generic Classification in 2007 Reimbursement List Generic Medicines in Japan are not fully legally defined but reimbursable items as generics are clear and convenient for listing as below. Share by Share by ＣＡＴＥＧＯＲＩＥＳ Items Volume Value 1,893 21.6 ％ 49.0 ％ a) w/ Patent （ 1,761 ） （ 21.4 ％） （ 47.6 ％） 1) Original 34.9 ％ 35.1 ％ 1,528 b) Off-Patent （ 1,430 ） （ 34.9 ％） （ 35.4 ％） 18.7 ％ 6.6 ％ 6,700 2) Generics （ 6,016 ） （ 16.8 ％） （ 5.9 ％） 24.8 ％ 9.3 ％ 4,238 3) Others(JP, Herbs ） （ 4,104 ） （ 27.0 ％） （ 11.2 ％） Source ： MHLW Price Investigations ’ 05 & ’ 07 Figures in ( ) are from 2005 Japan Generic Medicines Association 8
2- 2. Japan’s Generics Sales Recent Share Trend of Generics Source: JGA Japan Generic Medicines Association 9
3. Members Current Business Status (2007) • • Annual Sales (Responded 42 companies) Total Sales Turnover (42 companies) 425.8 billion yen * More than 10 billion yen/year 11 companies (out of which more than 30 billion yen 4 companies) 6 to 10 billion yen 12 companies less than 6 billion yen 19 companies (out of which less than 2 billion yen 5 companies) • Capital (Responded 44 companies) More than 2 billion yen 5 companies Less than 50 million yen 3 companies Less than 0.5 billion yen 30 companies *other pharmaceutical products are included Source:JGA Japan Generic Medicines Association 10
3-2. Members Current Business Status (2007) • Main Business (Responded 42 companies) Mainly Ethical Medicines 40 companies Mainly OTC Medicines 1 companies Mainly APIs 1 companies • Distribution (Responded 41 companies) Mainly Wholesalers 11 companies Mainly Wholesale Agents 13 companies Mainly Consignments 9 companies Others 8 companies • Employees (Responded 44 companies) Total 15,090 (out of which part-timers and temp staff 1,879) Number of companies w/no less than 1000 3 companies “ with less than 50 2 companies “ with less than 300 29 companies • Sales Value per Employee No less than 40 million yen 8 companies Less than 20 million yen 12 companies Less than 30 million yen 29 companies Source:JGA Japan Generic Medicines Association 11
3-3. Members Current Business Status (2007) • Number of Detailmen (Responded 43 companies) Total 2,870 No less than 300 2 companies More than 100 and less than 300 6 companies Less than 100 35 companies • Number of Listed Reimbursable Medicines (44 companies) Total 5,809 (corresponding to 36.6% of all listed 15,868 products) No less than 200 products 12 companies Less than 10 products 3 companies Less than 100 products 24 companies • Number of Supplementary Listing Medicines in July 2008 (Responded 44 companies) Total 358 (corresponding to 77.3% of all supplementary -listed 463 products) No less than 30 products 1 company No product 7 companies Less than 10 products 28 companies Source:JGA Japan Generic Medicines Association 12
3-4. Members Current Business Status (2007) • R & D Expenses Total 24.2 billion yen No less than 2 billion yen 2 companies Less than 50 million yen 8 companies Less than 500 million yen 29 companies • R&D Ratio vs. Sales No less than 15.0% 3 companies Less than 5.0% 23 companies Less than 10.0% 38 companies Source:JGA Japan Generic Medicines Association 13
3-5. Members Current Business Status (2007) Sales Evolution 2003-2007 (42 companies responded) (Billion Yen) 40 COs/2003 37 COs/2004 37 COs/2005 39 COs/2006 42 COs/2007 Total Sales 294.8 302.0 338.1 390.8 425.8 Medicines 266.7 272.0 304.7 358.2 392.1 Ethicals 228.5 232.1 260.5 309.8 342.4 OTCs 10.3 8.9 12.7 13.6 11.8 Diagnostics 15.7 16.6 17.3 18.5 20.1 APIs 12.2 14.4 14.2 16.3 17.8 There is no continuity due to differences in membership in respective years and no retrospective traceability of the previous years ’ results. Financial Results of Latest 5 Years (39 companies responded with full retrospective data) (Billion Yen) 2003 2004 2005 2006 2007 296.8 313.6(105.7%) 346.5(110.5%) 391.2(112.9%) 413.2(105.6%) Sales Turnover 110.3 116.5(105.6%) 131.1(112.5%) 142.9(109.0%) 148.1(103.6%) Gross Profit Operating 77.4 85.2(110.1%) 95.5(112.1%) 105.8(110.8%) 114.2(103.6%) Expenses Operating 32.9 31.2(94.8%) 35.6(114.1%) 37.1(104.2%) 33.8(91.1%) Profit 30.2 30.2(100%) 35.7(118.2%) 36.2(101.4%) 32.1(88.7%) Current Profit Differences in two tables are caused by differences in membership and with or without retrospective traceability. Figures in parentheses are ratios against previous years. Source:JGA Japan Generic Medicines Association 14
3-6.Members Current Business Status (2007) Sales by Formulations (39 companies responded) (Billion Yen) Oral Injectable Topical Total 195.2 67.9 39.7 302.8 R & D Expenses vs. Sales Turnover ( 39 companies responded) (Billion Yen) 2003 2004 2005 2006 2007 20.0 21.9 22.6 23.9 23.4 R&D Expenses 6.7% 7.0% 6.5% 6.1% 5.7% Ratio vs. Sales 109.5% 103.2% 105.8% 97.9% Ratio vs. Previous Year R&D expenses ratio is about 6%. Member companies are investing in formulation development to give added values to their products. Source: JGA Japan Generic Medicines Association 15
3-7.Members Ranking by Generic Registrations *Only those JGA Generic Latest No No Company latest Registrations Turnover* available 1 Taiyo 524 524 42.0 2 Towa 447 447 36.0 3 Sawai 361 361 44.3 4 Nichiiko 288 288 40.1 5 Mylan 259 259 - 6 NiproPharma 232 232 - 7 Tatsumi 220 220 4.5 8 Choseido 198 198 5.6 9 Tsuruhara 193 193 - 10 10 Kyowa 190 190 9.5 11 11 Nisshin 187 187 - 12 12 Fuji 169 169 14.9 non-member 13 13 Maruko 169 169 - Acquired by Nichiiko 14 14 160 160 - Medisa Shinyaku 15 15 Yoshindo 160 160 8.7 16 16 159 159 10.0 Taisho Yakuhin 17 17 154 154 - Kobayashi Kako 18 18 Isei 151 151 - 19 19 144 144 17.9 non-member Shiono Chemical 20 20 Takata 130 130 13.6 21 21 Termo 108 108 302.7 non-member 22 22 Kyorin Rimedio 107 107 6.0 23 23 Iwaki 91 91 - 24 24 Fuso 90 90 45.9 non-member 25 25 Ohara 85 85 - 26 26 TeikokuMedix 84 84 10.7 Acquired by Nichiiko 27 27 Sandoz 77 77 - Source: JGA & Gekkan Generic Aug 2009 Japan Generic Medicines Association 16
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