KPBMA Brief 2017 6 Vol 12 R&D R&D CSV KPBMA Brief 2017 6 Vol 12 2017 6 1 161 02 6301 2178 FAX 02 597 2742

3 Ⅰ. 들어가며 82 65 65 66 82 17 2009 Ⅱ. 우리나라제약산업의현황 1 2016 1 1 4~7% 2021 1 5 2016 11 26 3 13 2 30% 1 FDA 21 the 21 st Century Cures Act R&D 2 2015 2035 R&D www kpbma or kr

4 KPBMA Brief 2017 6 Vol 12 AMED R&D R&D 40% 11% 5% 3 2011 2013 1 5 1 2020 7 R&D 13 41 R&D 45 R&D 42 5% 100 3 2012 2 3 2015 3 3 42 5% 100 3 2012 EU 8 2 13 1 4% 28 R&D 4 1 60% Ш. 대한민국제약산업발전을위한제언 2018 2 5 80 2 R&D R&D 4 AI R&D 10 15 ~20

5 Ⅰ. 최근건강보험청구의약품의시장변화경향 5 2010 75 3% 24 7% 5 2014 70 3% 29 7% 5% 5% 10 10 2014 1 www kpbma or kr

6 KPBMA Brief 2017 6 Vol 12 50 60% 50 Ⅱ. 국내사품목당평균청구액은다국적사의 6 분의 1 수준 2012 53 55% 53 55% R&D 2016 269 1 7 552 9 3 94 3% 1 5 8000 35 5000 6 1 1 342 1174 3 1 1 83 8000 62 18 9000 5 57% 7 2010 62% 2012 Ш. 제네릭시장활성화와국내제약업계의구조변화모색필요 1 605 9274 12 R D Ⅳ. 국내신약의시장점유증가필요 Best in class R&D

7 KPBMA KRPIA 2000 195 28 / / R&D 1 6 LG MSD DPP4 First in class first in class 1. 신약개발을위한노력 LG 2015 200 26 B C HIV 38 5 1 www kpbma or kr

8 KPBMA Brief 2017 6 Vol 12 19 2015 16 57 KPBMA 2. 임상시험의국제표준준수노력 1 4 19 1% 2 3. 산업이미지제고를위한제언

9 15 28 ' ' R&D 2016 ' ' 8 4 7 4 45 60 TNF a 15 www kpbma or kr

10 KPBMA Brief 2017 6 Vol 12 1 2006~2015 25,000 20,000 15,000 10,000 5,000 0 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2015 1 7 / 54%

11 2 www kpbma or kr

12 KPBMA Brief 2017 6 Vol 12 R&D / Ⅰ. 우리나라의기초연구 R&D 투자현황개관 OECD `14 4 29% 1 1 `14 17 6% 24 2% 2012 15 6% 2012 12 6% 2013 15 5% 2012 2 R&D `15 R&D 1 3 R&D % NTIS 2013 2014 2015 617 17 15 804 21 27 1 044 24 34 1 065 29 61 965 25 54 891 20 77 1 074 29 87 1 149 30 41 1 165 27 16 841 23 38 861 22 78 1 191 27 74 3 596 100 3 779 100 4 292 100 2 098 52 45 2 393 52 46 2 944 51 19 872 21 79 957 20 97 887 15 43 553 13 81 582 12 76 964 16 77 478 11 94 630 13 81 955 16 61 4 001 100 4 562 100 5 751 100 133 7 03 152 7 36 173 7 199 10 52 207 10 02 233 9 43 1 259 66 45 1 262 61 02 1 401 56 77 303 16 01 447 21 6 662 26 8 1 894 100 2 068 100 2 468 100 NTIS 2015 1 OECD Science Technology and Industry Scoreboard 2 KISTEP 2015 16 3 `15 R&D 4 292 3 717 R&D

13 37 68% 28 12% 3 16 17% 3 80% Ⅱ. 기초 R&D 연구와관련한문제점및개선방안 15 20 1 4 R&D 2 2016 4 500 R&D 19 1 8 7% 5 7 R&D 4~6 67 74% 7~10 13 38% 1 ~6 85% 30 4 R&D 2017 3 3 R&D 4 2017 5 18 R&D 5 494 R&D www kpbma or kr

14 KPBMA Brief 2017 6 Vol 12 2 R&D % HTdream kr 2013 2014 2015 1 3 177 28 27 365 21 47 412 15 11 955 18 88 4 6 339 54 05 1 101 64 75 1 986 72 75 3 426 67 74 7 10 111 17 68 234 13 78 331 12 14 677 13 38 628 100 1 701 100 2 730 100 5 058 100 4 10% 1 346 2 358 6 Ⅲ. 제 2 차보건의료 R&D 종합계획및문재인정부공약이행에바라는점 1 2 R&D 4 2 R&D 18 22 R&D R&D 4 2 2011 3 10 2013 3 23 5 7 1 1 000 1 0~20% 1 2 000 70% Valley of Death 10 15 2017 4 23 R&D 10~50 20~50% 6 346 2016 10 3 7 23P

15 High risk High return 1984 2014 Humira Top 10 5 430 45 Humira 8 R&D 8 43 2% 39 1% www kpbma or kr

16 KPBMA Brief 2017 6 Vol 12 1. 들어가며 2009 2015 2016 4 2 2 10 2 R&D 2018~2022 R&D 8% 40% 37% 19% 4 R&D 2. 신약개발 R&D 투자지원현황및개선방안 1 20% 1 2 000 R&D R&D 17 891 15 918 1 2 MSD J&J R&D R&D 37% 1 R&D 2017 2017 1

17 1 R&D 15~ 17 15 16 17 197 189 280 261 300 330 85 60 84 300 250 125 75 61 72 918 860 891 19% 40% 25 3 600 15 1 8 000 20 45% 16 10 3 R&D 15 4 3. 약가제도현황및개선방안 1 OECD 60 30 1 68% 59 5% 2 80% 2 R&D 30% 50% 3 1 3 2 2 2017 1 www kpbma or kr

18 KPBMA Brief 2017 6 Vol 12 2 4 1 200 FTA 4. 나가며 2007 ~2011 R&D 7 9% 2012 ~2016 11 1% 2015 9 3 5

19 Ⅰ. 서론 2015 8 1 GMP cgmp R&D Ⅱ. 바이오제약산업경쟁력강화방안 1 R&D www kpbma or kr

20 KPBMA Brief 2017 6 Vol 12 2 R&D R&D R&D 1995 152 R&D 2015 588 3 8 FDA 1996 56 2012 39 2014 41 2015 45 Open innovation R&D R&D Open Innovation R&D 1 3 R&D 2012 3 2020 7 5 2013 7

21 R&D R&D R&D R&D Ⅲ. 결론 1 15 2 www kpbma or kr

22 KPBMA Brief 2017 6 Vol 12 R&D 400 50 69 2020 1 500 2003 2015 16 8 000 2014 16 6 000 20 EU 1 5% R&D 2015 R&D 2015 R&D R&D

23 R&D 1973 6 R&D 1 1989 600 1997 6400 R&D R&D R&D R&D CEO 1987 FDA LG LG 1 1 11 0 R&D R&D M&A R&D 5 25m 5 100 98 5% R&D 1 11 R&D 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 3 765 4 222 5 010 5 583 6 161 5 950 6 062 6 740 7 301 7 613 13 175 R&D 325 406 548 567 824 852 840 910 1 156 1 525 1 817 8 6 9 6 10 9 10 1 13 4 14 3 13 9 13 5 15 8 20 23 www kpbma or kr

24 KPBMA Brief 2017 6 Vol 12 R&D R&D R&D EU

25 2000 2000 6 4 566 2015 16 9 696 2 6 2000 4 179 1 3 208 R&D 2011 40 6 1 492 6 4 234 4 5% 1~20 21~40 1~20 2011 4 6 506 4 6 601 0 2% 21~40 1 4 986 1 7 643 17 7% 15 0% 32 6% 14 9% 68 5% 32 0% LG 107 3% 43 2% 72 3% 10 2011 3 2 653 3 1 261 4 3% 1. 제약사제네릭실적평준화현상 뚜렷 www kpbma or kr

26 KPBMA Brief 2017 6 Vol 12 2. 리베이트규제강화 약가제도개편으로제네릭시장평준화 2010 2014 1 3 2000 2000 JW 2000 2015 1 587 5 1 457 379 JW 370 352 281 264 240 233 188 216 1 457 379 JW 370 352 288 281 264 257 247 240 235 234 233 230 229 225 225 216 224 2012 80% 53 55%

27 64% 53 55% 2012 4 14% 1 3 814 6 506 100 53 55 53 55 80% 10mg 2011 721 866 5 20 1% 917 662 7 863 1 3 082 66 3% 10mg 110 10mg 110 86 662 660~663 106 600 3. 허가규제완화로제네릭진입봇물.. 영세제약사급증 2009 437 1 112 2 5 7 2 5 2009 386 123 7 3 1 1 www kpbma or kr

28 KPBMA Brief 2017 6 Vol 12 2011 11 2 6 2 3 A B A 2011 2014 3 GMP 3 3 100 9~12 2009 386 2010 437 88% 2015 201 5 5 1 112 5 4 4. 경쟁심화로신규제네릭시장서특정제품두각현상소멸 527 301 2 2016 1 527 2005 07 26 2 301 2005 07 26 3 10mg 287 2008 02 29 4 283 2008 02 29 5 10mg 238 2007 05 25 6 100mg 197 2009 08 21 7 192 1985 11 21 8 10mg 180 2008 01 31 9 153 1999 12 16 10 20mg 133 2007 08 09 11 124 2012 07 20 12 126 2014 04 29

29 3 10 2009 2010 2011 2012 2013 2014 2015 290 270 267 285 285 299 356 10 76 57 58 54 45 51 124 10mg 287 283 10mg 238 10 100 CSO Contract Sales Organization CSO CSO 2015 356 2014 299 19 1% 2009 290 2014 299 2015 57 2015 10 124 2014 51 2 356 3 1 10 1 2010 527 417 5 20 9% R&D R&D 124 183 1 4 758 3 1 124 14 8 560 0 1% www kpbma or kr

30 KPBMA Brief 2017 6 Vol 12 ST CP ST CP 1. 개요 2017 3 10 2016 9 2016 12 Sunshine Act FCPA Sunshine Act 2. 미국 FCPA(Foreign Corrupt Practices Act) 와한국청탁금지법 (Improper Solicitation and Graft Act) 1997 OECD 2003 UN WTO ICC Anti corruption FCPA Foreign Corrupt Practices Act 1977 Bribery 1 FCPA

31 1 Bribery ISO 37001 / anything of value Anti bribery provision Books and Records Provision 1977 FCPA FCPA 3 FCPA FCPA FCPA facilitating payment 3 FCPA 5 FCPA 3 5 25 200 FCPA 2 1 2 2016 9 2 OECD UN Anti bribery management system ABMS www kpbma or kr

32 KPBMA Brief 2017 6 Vol 12 1 The United States Department of Justice Homepage FCPA 2 The United States Department of Justice Homepage FCPA

33 2 FCPA FCPA Improper Solicitation and Graft Act DOJ ACRC 3 1 100 300 1 100 200 $ 10 $ 5 10 $ 5 1 $ 1~3 2 2 2 5 1 3 3 1 1 3 3 www kpbma or kr

34 KPBMA Brief 2017 6 Vol 12 3. 제약산업관련투명화정책 미국 Sunshine Act 와한국 K-Sunshine Act 2010 Sunshine Act Sunshine Act 6002 Section 6002 of the Patient Protection and Affordable Care Act 10 Sunshine Act 4 Sunshine Act Sunshine Act Over The Counter drug Sunshine Act Sunshine Act 10 Teaching Hopitals Sunshine Act 4 CMS Open Payments Data Main Homepage

35 Sunshine Act 10 Sunshine Act 3 100 90 90 10 United States Department of Health Human Services HHS 1 1 15 1 10 1 FDA The Federal Anti Kickback Statue The False Claims Act United States Department of Health & Human Services HHS CMS Centers for Medicare & Medicare Service 5 Open Payments Summary Data 2015 www kpbma or kr

36 KPBMA Brief 2017 6 Vol 12 3 FCPA Sunshine Act K Sunshinhe Act $10 2 CMS 2010 3 2013 2014 9 2013 8 12 1 1 1 15 10 1 2016 12 2 2017 6 3 200 CMS Open Data 10 5 Sunshine Act EU 2~3 3 4 4. 결론 ( 시사점 ) FCPA OECD OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions UN United Nations Convention against Corruption Anti corruption Requirements ISO 37001 Anti Bribery Management Systems World Bank 3 ABMS

37 4 EU EU Sunshine Act EFPIA Code Sunshine Act / Rules / $10 10 25 / / 2010 3 2013 2014 9 2013 8 ~12 2008 3 2013 6 2016 2011 3 2013 EU International Standardization Organization ISO ISO37001 2016 K Sunshine Act 2017 6 K Sunshine Act 4 CP ABMS Anti Bribery Management System www kpbma or kr

38 KPBMA Brief 2017 6 Vol 12 CP Ethics & Compliance Ⅰ. 서론 2016 12 6 sunshine act 2011 1 KPBMA KRPIA 2013 2013 2012 2014 2011

39 Ⅱ. 일본의의약품시장투명성제고를위한노력 M&A 1984 1997 11 2013 1 JPMA Code of Practice 2017 3 9 3 code of practice 72 207 2025 2 www jpma or jp/tomeisei/ www kpbma or kr

40 KPBMA Brief 2017 6 Vol 12 Integrity 2017 IFPMA 3 2011 sunshine act Ⅲ. 기업활동과의료기관등의관계의투명성가이드라인소개 1 2015 2 A B C / D / / / E

41 3 2017 1 1 72 2015 / 100% 3 2015 www kpbma or kr

42 KPBMA Brief 2017 6 Vol 12 4 2015

43 4 JPMA 47 2 2011 1 2012 1 1 2017 6 3 JPMA 200 Ⅳ. 결론 2013 www kpbma or kr

44 KPBMA Brief 2017 6 Vol 12 IMS Health IMS Health Affordable Care Act 2016 65 13% 39% 25 2 000 2005 24% 10 1 6 I. 세계의약품시장동향 1 2021 4 7% 1 700 1 Developed VS Pharmerging 2021 20 87% 2012 2 12 EU5 4 7% 5 5 5 12% 2021 5 6% 2021 6 9% 99 273 1 2021

45 1 / 10 2 10 69% 80% 22% 1 1 $117 $1 955 $577 EU5 $513 $295 17 specialty 10 20% 2016 30% 2021 35% www kpbma or kr

46 KPBMA Brief 2017 6 Vol 12 biologic 2 Therapy Area 2021 5 2 5 9 12% immune oncology 2016 753 2021 1 200 1 350 1 5 8 11% 950 1 100 2016 11 14% 2021 II. 신약연구개발현황및사업개발파트너십 1 R&D 2016 2 2 2401 27% CNS 12% 2 240 27% CNS 12% 2 Global Pharma Deal 2012 30% Product Deal M&A Product Deal 1 2016 Late Stage

47 Licensing Collaborative R&D Licensing 2012 2 000 2016 2 551 6 3% 2016 Allergan Heptares Therapeutics Licensing 33 4 Leo Pharma AstraZeneca 15 2 Collaborative R&D 5 Product Deal 31% 2016 1 500 Jounce Therapeutics Celgene Biogene University of Pennsylvania 30% M&A 2016 25% 2016 Shire Baxalta 320 Abbott St Jude Medical 250 Pfizer Medication 140 Ш. 국내제약 바이오산업의글로벌진출전략 C3 Clinical Commercial Convergence Clinical Commercial Convergence M&A 1 850 4 750 2016 25% 2014 Actavis Allergan 660 Geographic EU5 2016 2021 2 7 2 2011~2016 www kpbma or kr

48 KPBMA Brief 2017 6 Vol 12 EU5 2021 70% 40% 2016 50% 2 C3 Clinical Commercial convergence research clinical development market access pricing & reimbursement global marketing stakeholder partnership cross licensing M&A 78% Portfolio Top 3 8 14% 2021 $290 335 billion 27% CNS 12% CNS IMS Health Top 20 Gilead Novo Nordisk Gilead C HIV J5 2004 51 2016 4 Novo Nordisk 2004 24 2016 14

49 Ⅰ. 동아시아국가의제약산업현황 30 4 4 100 3 1 2015 1 080 2020 1 670 9 1% 2015 / 6 400 2020 1 2 Ⅱ. 정부의제약산업지원정책방향 1 2011 2020 2016 12 13 5 1 2020 8 10 1 360 ~1 700 13 5 2017 01 1 日本製薬工業協会, 医薬産業政策研究所 2 2016 ITA Pharmaceuticals Top Markets Report China www kpbma or kr

50 KPBMA Brief 2017 6 Vol 12 5 2020 10 12 R&D 13 10% 2020 R&D 2% Smart manufacturing 2020 10% 2011 12 5 2016 10 13 5 2025 3 2 2013 2013 医薬品産業ビジョン 2013 2015 医薬品産業強化総合戦略 2015 2 12 5 CO2 20% 16% 20 80% R&D 5% 30 30 200 GMP 100% 200 FDA EU COS 80 WHO GMP 500 5 100 100 100 50% 50 R&D 11 21% Vol 105 3 http //www miit gov cn/n1146285/n1146352/n3054355/n3057601/n3057609/c5346440/content html

51 4 5 13 89% TCM 1 1 2000~2011 2016 4 Ⅲ. 연구개발분야 1 R&D 2011 32 4 R&D 1 41% 19 57 99% TCM 6 18 32% PE VC 2012 34 03% 18 87% VC Guiding Fund VCGF 2012 289 4 4 5% R&D 80% 3 * * * * * 革新的医薬品の創出に向けて 2016 04 4 日本製薬団体連合会, 日本製薬工業協会, 米国研究製薬工業協会在日執行委員会, 欧州製薬団体連合会 5 Jingyun Ni Obstacles and opportunities in Chinese pharmaceutical innovation Globalization and Health 2017 13 21 www kpbma or kr

52 KPBMA Brief 2017 6 Vol 12 5 Incentives for Technologically Advanced Service Companies TASC 2009 2018 21 6 TASC 15% CIT 8% Business Tax BT / Highand New Technology Enterprises HNTE 15% 2008 1 1 5 7 New area HNTE 2 3 half deduction R&D 150% R&D 8 2015 2 2014 9 1 薬機法 2 6 7 Shenzhen Zhuhai Shantou Xiamen 8 KOTRA 2016 07 9 臨床研究法案について 2016

53 ex 2014 6 746 5 653 1 090 2017 8~10% 10 4 O O O X 2 10 2017 KOTRA www kpbma or kr

54 KPBMA Brief 2017 6 Vol 12 5 1 2 1 8~10% 20%~30% 30% 2 2 10% 30% 10% X Ⅲ. 의약품가격정책 1 National Development and Reform Commission NDRC 1980 15% 2009 43% 2002 34% 2009 11 2015 6 NDRC 1 2000 12 2 2018 11 Lifting Drug Price Controls in China Madhurima Nundy Economic&political Vol 50 Issue No 22 30 May 2015 12 http //www theaustralian com au/business/business spectator/china to lift drug price controls/news story/e9d1fd824dd07d66c7a80a5d3f61486d

55 6 13 2017 5 14 1 1 6 1 2 3 4 5 6 7 8 NDB 1 / 2017 2017 2017 薬価制度の抜本改革の検討 案 2017 01 13 2017 04 14 薬価制度の抜本 { 改革に対する意見 2017 05 www kpbma or kr

56 KPBMA Brief 2017 6 Vol 12 Ⅲ. 유통 1 20% 80% 2011 2015 1 3 20 15 2 2017 7 4 16 17 2017 Ⅳ. 시사점 Top 10 5 15 13 2011 8 16 後発医薬品の使用促進及び医療用医薬品の流通改善 2017 17

57 7 IP TOP 10 1 Roche Switzerland 351 patents 2 Jiangnan University China 320 patents 3 Zhejiang University China 274 patents 4 LG Household and Healthcare South Korea 270 patents 5 Foshan Sawiweisi Pharma Technology China 266 patents 6 University of California US 235 patents 7 Sanofi France 232 patents 8 Shanghai Jiaotong University China 225 patents 9 CNRS France 223 patents 10 Guangxi University China 209 patents ChinaBio China Leads the World in Pharmaceutical Innovation 2016 05 18 2011 JPMA 4 10 2009 12 7 6 21 1% 33 8% 軽課税国 20 10~20% 4~29 247 19 / 6 18 2016 07 19 http //www jpma or jp/event_media/forum/repo_29 html 20 20% ex 17% www kpbma or kr

58 KPBMA Brief 2017 6 Vol 12 Ⅰ. 들어가며 5 4 4 2016 1 WEF IoT 2013 221 67 1% ICT 1 1 1 EvaluatePharma World Preview 2016 Outlook to 2022 1 2016

59 2 3 Ⅱ. 설문방법 100 55 55% 2 3 5 28 5 51 5 4 Ⅲ. 설문결과 1 1 2 16~ 18 2016 3 7 2016 www kpbma or kr

60 KPBMA Brief 2017 6 Vol 12 2 5 3 3 1 R&D KGMP R&D PIC/S GMP ICH 4 R&D 2 2 3 R&D R&D Unmet needs 5 2 5 R&D 2 3 R&D R&D 4 R&D 1 2 R&D R&D 4 GCP R&D 4 ICH 2016 11 14

61 5 KGMP FDA EMA 3 R&D 5 3 5 6 R&D 7 4 2 R&D 2017 IP www kpbma or kr

62 KPBMA Brief 2017 6 Vol 12 8 11 R&D G2G 9 R&D 12 R&D VC BT R&D R&D R&D 10 13 CRO R&D VC R&D R&D DB R&D SPC* R&D R&D R&D 5 2016 3 7 6 2016 BioIndustry 2016

63 3 2 R&D 3 R&D 5 4 R&D R&D Ⅳ. 마치며 R&D 1 1 900 6 www kpbma or kr

64 KPBMA Brief 2017 6 Vol 12 CSV 1. 기업의철학과문화를담아내는사회공헌활동 CSR 2000 NGO 2. 기업집단별사회공헌활동비교 2014 231 500 2015 501 ~1000 210 2000 39 18 6% 2~4 89 42 4% 4 81 38 5% 1

65 60 2% 39 8% 51 5% 48 5% 23 2% 2 22 4% 30 6% 88 7% 29 5% 8 7% 25 3% 1 533 1 659 33 9 9 1 8 2 2 3 4 9 CSV 1 1 36% 44 20% 23 20% 15 50% 16% 51 50% 60 20% 23 20% 48 50% 39 80% 66 80% www kpbma or kr

66 KPBMA Brief 2017 6 Vol 12 2 CSV 3 3. CSV 로진화하고있는국내제약산업의사회공헌활동 CSR Corporate Social Responsibility CSV Creating Shared Value CSV CSR CSV

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