연구보고서 해외 M&A 를통한제약산업경쟁력강화방안 - 조사연구실산업분석 1 팀 - 2012. 8. * 담당 : 엄기현책임연구원 * 내선 : 7573, 이메일 : kh.earm@kofc.or.kr
차례 1. 변화가필요한국내제약산업 1 국내제약산업현황 1 글로벌바이오 제약산업트렌드 4 2. 국내제약산업의경쟁력강화방안 12 글로벌화를위한선행과제 : 연구역량제고및해외진출확대 12 일본제약사의 M&A 전략 15 다케다社의글로벌화성공사례 16 M&A가신약개발에미치는영향 18 3. 결론및정책제언 23 새로운도약을앞둔국내제약산업 23 국내제약사의 M&A 전망 27 - iii -
내용요약 - iv -
1. 변화가필요한국내제약산업 국내제약산업현황 1) Business Monitor International, South Korea Pharmaceuticals & Healthcare Report Q3 2012 2) IMS Institute for Healthcare Informatics, http://www.imshealth.com 3) 308 개파이프라인중합성신약은 129 개 (41.9%) 로가장많았고천연물신약 75 개 (24.4%), 바이오신약 47 개 (15.3%), 개량신약 45 개 (14.6%), 바이오베터 12 개 (3.9%) 가그뒤를이음 4) 생물학적동등성시험 (bioequivalence test) 이란생동성입증을위하여실시하는생체내시험의하나로주성분이전신순환혈에흡수되어약효를나타내는의약품에대하여동일주성분을함유한동일투여경로의두제제가생체이용률에있어서통계학적으로동등하다는것을입증하기위해실시하는시험 - 1 -
5) Business Monitor International (2008) Competitive challenges facing Asian generics producers. 6) Morgan S., McMahon M., and Greyson D. (2008) Balancing health and industrial policy objectives in the pharmaceutical sector: Lessons from Australia. Health Policy, 87(2), 133-145 7) Vandergrift M., and Kanavos P. (1997) Health policy versus industrial policy in the pharmaceutical sector: the case of Canada. Health Policy, 41(3), 241-260 - 2 -
< 보건정책과산업정책의목적 > 자료 : Permanand G (2004) The politics of pharmaceuticals in the European Union, 정윤택 ; 국내제약산업의환경변화와 바이오의약품육성을위한발전방안 바이오의약품시장의도래와성공적비즈니스방안 2011 재구성 8) DiMasi, Hansen, Grabowski (2003) The price of innovation: new estimates of drug development costs, Journal of Heatlh Economics, 22(2): 151-185 9) Adams, Brantner (2006) Estimating the cost of new drug development: is it really $802 million? Health Affairs (Millwood) 25: 420-428 10) DiMasi, Grabowski (2007) The cost of biopharmaceutical R&D: is biotech different? Manergerial and Decision Economics, 28(4-5) 469-479 11) Bloomberg - 3 -
< 국내제약사간 M&A 현황및전략 > 자료 : 경향신문, 정윤택 (2010) 제약산업의구조선진화를통한산업발전방안연구, 한국보건산업진흥원 글로벌바이오 제약트렌드 12) IMAP (2012) Global Pharma & Biotech M&A Report 2012-4 -
< 시장별 2010-2015 년성장률비교 > 주 : Developed Markets 는미국, 일본, 독일, 프랑스, 이탈리아, 스페인, 캐나다, 영국, 한국에해당자료 : IMS Institute on Healthcare Informatics (2011), 'The Global Use of Medicines: Outlook through 2015'; IMAP (2012) Global Pharma & Biotech M&A Report 2012 재인용 13) 현재연매출액 400 억달러이상또는 2015 년까지초과예정인기업 - 5 -
< 다국적제약사의주요 M&A> 자료 : IMS Health <2011 년바이오 제약사간 M&A 15 건 > 자료 : IMAP (2012) Global Pharma & Biotech M&A Report 2012 재구성 - 6 -
14) 일본제약사인다이이찌산쿄 (Daiichi Sankyo) 는지난 2008 년, 란박시를 46 억달러에인수합병함 15) Hess & Evangelista, (2003) Pharma-biotech alliances: jockeying for position in the race to become "partner of choice," Contract Pharma 16) The Lancet (2011) Lessons from lipitor and the broken blockbuster drug model. the Lancet, 378, December 10, p1976-7 -
< 다국적제약사의주요바이오기업인수현황 > 자료 : N. Malik, Biotech acquisitions by big pharma; Drug Discovery Today Vol. 14 Numbers 17/18 September 2009 각사홈페이지, 한국보건산업진흥원 17) Kim Y. (2009) Choosing between international technology licensing parters: An empirical analysis of U.S. biotechnology firms. Journal of Engineering and Technology Management, 26, 57-72 18) Reepmeyer G. (2006) Risk-sharing in the pharmaceutical industry, the case of out-licensing. Physica-Verlag A Springer Company - 8 -
19) 블록버스터 (blockbuster) 는세계매출기준연 10 억달러를넘고복용환자가 1,000 만 ~1 억명인의약품이며 2010 년기준가장높은연매출을기록한의약품은화이자의리피토 ( 약 120 억달러 ) 임. 20) 니치버스터 (nichebuster) 는세계매출기준연 1 억 ~5 억원이고복용환자는 1 만 ~100 만명인의약품으로블록버스터모델과는달리맞춤형의학을지향 21) Meekings K., Williams C., and Arrowsmith J. (2012) Orphan drug development: an economically viable strategy for biopharma R&D. Drug Discovery Today, 17(13/14), 660-664 22) 희귀질환치료제 (orphan drug) 의경우여전히다국적제약사로부터소외되는경향이있음 23) Festel G. (2004) Identifying and realising the hidden value of intellectual property. From Pacl H., Festel G., and Wess G.,; The future of Pharma R&D, challenges and trends. Hunenberg: Festel Capital 24) Thiel K. (2004) Good-bye Clumbus! New NRDOs forego discovery. Nature Biotechnology, 22(9), 1087-1092 25) Frost & Sullivan (2012) Generic pharmaceuticals market- A global analysis, 약사신문 글로벌제너릭시장여전히매력적 (http://www.pharmnews.co.kr/news/news_content.asp?sno=55320&part=%c7%d8%bf%dc%b4%ba%bd%ba) 재인용 - 9 -
26) 데일리팜 (2012. 4.) 신약고갈된다국적사, 제네릭으로국내시장공략 (http://www.dailypharm.com/news/155478) 27) 일본제약사인다이이찌산쿄 (Daiichi Sankyo) 는지난 2008 년, 란박시를 46 억달러에인수합병함 28) Ernst & Young; Beyond Borders: Global biotechnology report 2011-10 -
< 나이코메드인수후매출추정치 > < 나이코메드인수후지역포트폴리오 > 자료 : Nycomed, Company brochure after acquisition by Takeda (2011) 29) 日本經濟新聞 (2011.12.29). 海外 M&A 過去最高, 今年 5 兆円突破, 한일재단일본지식정보센터 (www.kjc.or.kr) 재인용 30) Company brochure after acquisition by Takeda 31) Nycomed Annual Report 2010-11 -
2. 국내제약산업의경쟁력강화방안 글로벌화를위한선행과제 : 국내연구역량제고및해외진출확대 32) Lazonick, Tulum (2011) US biopharmaceutical finance and the sustainability of the biotech business model. Research Policy 40, 1170-1187 33) 엄기현, (2012) 바이오 제약산업육성을위한금융지원방안, 한국정책금융공사 34) Gruber A. (2009) Biotech Funding Trends: Insights from Entrepreneurs and Investors. Wiley-Blackwell 35) Nelson R. and Winter S. (1982) An evolutionary theory of economic change. Harvard University Press - 12 -
< 다국적제약사의 CVC> 자료 : 각사홈페이지, 한국보건산업진흥원 36) Keil T. (2002) External corporate venturing: strategic renewal in rapidly chaning industries. Greenwood Publishing Group 37) Basu S., Phelps C., and Kotha S. (2011) Towards understanding who makes corporate venture capital investments and why. Journal of Business Venturing 26, 153-171 - 13 -
38) Bogdan B., and Villiger R. (2010) Valuation in Life Sciences. 3 rd Edition, Springer - 14 -
일본제약사의 M&A 전략 39) 메디코파마뉴스 ; 제약산업지형변화 -4 일본시장비교 (http://www.emedico.co.kr/news/articleview.html?idxno=14755) 40) Tralau-Stewart C., Wyatt C., Kleyn D., and Ayad A. (2009) Drug discovery: new models for industry-academic partnerships. Drug Discovery Today, 14(1/2), 95-101 - 15 -
다케다社의글로벌화성공전략 41) 스티렌은항궤양제로국산애엽에서분리 정제된유파필린 (Eupatilin) 을주성분으로하는천연물신약임 42) 리피논은화이자의고지혈증치료제리피토 (Lipitor) 의제네릭으로국내고지혈증시장에서리피토, 크레스토 (Crestor) 에이어 3 번째로많이처방되고있음 - 16 -
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< 연구자의 M&A 전후이직율비교 > 자료 : Shibayama et al. (2008) Effect of mergers and acquisitions on drug discovery: perspective from a case study of a Japanese pharmaceutical company. Drug Discovery Today, 13(1), 86-93 55) Prabhu J., Chandy R., and Ellis M. (2005) The impact of acquisitions on innovation poison pill, placebo, or tonic. Journal of Marketing, 69, 114-130 56) Cloodt M., Hagedoorn J., and Van Kranenburg H. (2006) Mergers and acquisitions: Their effect on the innovative performance of companies in high-tech industries. Research Policy, 35, 642-654 - 20 -
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국내제약사의 M&A 전망 75) Fernhaber S., and Li D. (2012) International exposure through network relationships: Implications for new venture internalization. Journal of Business Venturing, Article in Press 76) Croce A., Marti J., and Murtinu S. (2012) The impact of venture capital on the productivity growth of European entrepreneurial firms: 'Screening' or 'value added' effect? Journal of Business Venturing, Article in Press 77) Gans J., and Stern S. (2003) The product market and the market for 'ideas': commercialization strategies for technology entrepreneurs. Research Policy, 32(2), 333-350 78) 정부는 2020 한국제약산업의비전과로드맵 과제 132 차비상경제대책회의 제약산업의 Vision 과발전전략 을통해세계 7 대강국진입을비전으로설정 - 27 -
79) Campione T. (2003) Making research collaborations succees. Research Technology Management, Jul-Aug, 12-15 80) Niosi J. (2003) Alliances are not enough explaining rapid growth in biotechnology firms. Research Policy, 32, 737-750 81) Rosenbusch N., Brinckmann J., and Muller V. (2012) Does acquiring venture capital pay off for the funded firms? A meta-analysis on the relationship between venture capital investment and funded firm financial performance. Journal of Business Venturing, Article in Press 82) Katila R., and Mang P. (2003) Exploiting technological opportunities: The timing of collaborations. Research Policy, 32, 317-332 - 28 -
83) DiMasi, Hansen, Grabowski (2003) The price of innovation: new estimates of drug development costs, Journal of Heatlh Economics, 22(2): 151-185 84) 한국금융연구원 (2012) 우리나라의해외 M&A 활성화를위한정책지원방안 85) Neoclassical Model 에서언급된 industrial, economic, political, regulatory shock 중 regulatory 에해당 (Gregoriou G., and Renneboog L. Understanding mergers and acquisitions: activity since 1990) 86) Harford J. (2005) What drives merger waves? Journal of Financial Economics, 77, 529-560 - 29 -
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