Partnering Data As of November 2018

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Partnering Data As of November 2018 a BioJapan / Regenerative Medicine Japan 2018 Partnering Data As of November 2018 2019年10月9日(水)〜11日(⾦) Oct. 9WED ー11パシフィコ横浜FRI ――――――――――――――――――October 9–11, 2019 Pacifico Yokohama,Pacifico Japan Yokohama 2019 Japan: the World’s Second Largest Pharmaceutical Market Representing 8% of the world pharmaceutical market in 2016, Japan’s pharma sector remains one of the largest in the world. While Japan is often said to be overly insular, a recent sharp rise in the number of international forays from larger Japanese pharmaceutical companies—including many significant M&A deals and the establishment of new R&D sites around the world—indicates a bright and increasingly international future for the industry. Furthermore, the nation’s ageing population is creating an ever-larger domestic market for medicinal products and services, and in particular the easing of regulatory restrictions is set to turn Japan into a hotbed for regenerative medicine-related R&D. 1200 Japan 1000 Asia-Pacific (Excl. Japan), 800 Africa, Middle East 600 Europe 400 Central / S. America 200 0 N. America 2012 2013 2014 2015 2016 Source:JPMA Databook Domestic Japanese Sales Rankings (Distributor Level, FY2017) Company Sales: USD Company Sales: USD (November 2018 rates) (November 2018 rates) 1 Takeda 6,317,258,929 11 Eli Lilly Japan 2,496,991,071 2 Daiichi Sankyo 5,971,785,714 12 Ono 2,266,526,786 3 Astellas 4,919,303,571 13 Bayer 2,146,785,714 4 Pfizer 4,291,142,857 14 Kyowa Hakko Kirin 2,076,625,000 5 Chugai 4,286,526,786 15 Eizai 1,865,482,143 6 Mitsubishi Tanabe 3,230,785,714 16 Sumitomo Dainippon 1,575,205,357 7 MSD 3,203,116,071 17 AstraZeneca 1,556,473,214 8 Otsuka Holdings 3,036,017,857 18 Nichi-iko 1,490,696,429 9 Novartis 2,702,383,929 19 Santen 1,470,553,571 10 GSK 2,638,955,357 20 Sawai 1,451,696,429 Copyright 2018 JTB Communication Design, Inc. 2 Financial Results of the Leading Japanese Pharmaceutical Manufacturers (Japan FY2016 Consolidated Accounts) Sales: USD Company (November 2018 rates) Takeda 15,464,741,071 Astellas 11,711,205,357 Otsuka Holdings 10,674,526,786 Daiichi Sankyo 8,527,892,857 Eisai 4,813,366,071 Mitsubishi Tanabe 3,785,508,929 Dainippon Sumitomo 3,675,339,286 Kyowa Hakko Kirin 3,062,669,643 Shionogi 3,025,803,571 Taisho 2,497,973,214 Ono 2,185,687,500 Santen 1,777,642,857 Hisamitsu 1,302,901,786 Kyorin Holdings 1,030,116,071 Tsumura 1,026,375,000 Kaken 906,062,500 Nippon Shinyaku 881,973,214 Mochida 869,187,500 Kissei 640,232,143 Zaria 579,017,857 Copyright 2018 JTB Communication Design, Inc. 3 Japanese Outbound M&A Deals Japanese pharmaceutical companies are Besides this, many larger companies have becoming more global and strengthening recently been establishing and expanding their pipelines through M&A. To name just R&D sites in countries around the world. one of many, Takeda Pharmaceuticals, Notable examples include Chugai, who are the market leader in Japan, is reported to set to invest almost 500m USD into their have earmarked as much as $20 billion to Singapore research institute over the spend on overseas acquisitions of coming years, and Eisai, who established companies developing cancer, GI, and their first European research site in the CNS drugs in particular. UK in 2009. Company Takeover Candidate Deal Value (USD) Date Takeda Shire (UK) 6trillion 800billion TBD Mitsubishi Tanabe NeuroDerm (Israel) 111.7 billion Jul. 2017 Sawai Upsher-Smith Laboratories (US) 105 billion Apr. 2017 Pharmaceutical Hitachi Chemical PCT, LLC, a Caladrius (US) 75 million Mar. 2017 Takara Bio WaferGen (US) 50 million 2017 ROHTO Ophthalmos (Brazil) Undisclosed Oct. 2016 Duoc Hau Giang Pharmaceutical Taisho Undisclosed Jul. 2016 (Vietnam) Nichi-Iko Sagent Pharmaceuticals (US) 640 million Jul. 2016 Eisai Liaoning TianYi (China) 78 million Nov. 2015 ReproCELL Biopta (UK) 8 million Nov. 2015 Astellas Ocata Therapeutics (US) 379 million Nov. 2015 Sosei Group Heptares Therapeutics (UK) 400 million Feb. 2015 Denki Kagaku Kogyo Icon Genetics (Germany) 75 million Aug. 2015 Panasonic Healthcare Bayer Diabetes Care (Germany) 1.1 billion Jun. 2015 Cellular Dynamics International Fujifilm 307 million Mar. 2015 (US) JSR Corporation KBI Biopharma (US) Undisclosed Feb. 2015 Takeda Neutec (Turkey) *portfolio 121 million Feb. 2015 Sources: NIKKEI Online, Financial Times Copyright 2018 JTB Communication Design, Inc. 4 Japanese Drug Discovery Alliances Drug discovery alliances between Japanese and non-Japanese organizations are also on the rise. With over half of new medicines now stemming from biotech companies and startups, Japanese pharmaceutical companies understand the potential in developing these new drugs and bringing them to market. Company Alliance Partner Date Healios Athersys (US) Jan. 2016 Takeda Teva Pharmaceutical Industries (ISR) Nov. 2015 Astellas Chromocell (US) Sep. 2015 Mitsubishi Tanabe Pharma MedImmune (UK) Sep. 2015 Daiichi Sankyo Translational Sciences (US) Sep. 2015 Sysmex Merck (US) Jun. 2014 Eizai Biogen Idec (UK) Mar. 2014 Ono Pharmaceutical Bristol-Myers Squibb (US) Mar. 2014 Sources: NIKKEI Online Copyright 2018 JTB Communication Design, Inc. 5 Regulatory Changes Make for Faster Access to Market for Regenerative Medicine Regulatory Changes Two acts were enacted in Japan in November 2014 that made revolutionary changes to the regulatory system for regenerative medicines: the Pharmaceuticals and Medical Devices Act and the Act on the Safety of Regenerative Medicine. Pharmaceuticals and Medical Devices Act Under the Pharmaceuticals and Medical Devices Act, a new category for medicinal products called “Regenerative Medical Products” was defined, in addition to the categories of “pharmaceuticals” and “medical devices.” This allows regenerative medical products to be evaluated based on their own unique characteristics. Additionally, a new approval system for regenerative medicine products, diagrammed above, was also introduced as part of this Act. This new system has cut the time required to commercialize regenerative treatment products down to as little as two to three years, making Japan’s approval system the fastest in the world. Copyright 2018 JTB Communication Design, Inc. 6 Japan creates fastest approval system for regenerative medicines in the world Act on the Safety of Regenerative Medicine It is now possible to contract the manufacturing and processing of cells to external enterprises. The culture and processing of cells and tissues for regenerative medicine using human cells could only be conducted by medical institutions under the supervision of the physicians sponsoring the clinical research. Regenerative Medicine Japan It is with the developments that are set to take place thanks to these new regulatory changes in mind that Regenerative Medicine Japan was first held in October 2016. Organized in collaboration between the Forum for Innovative Regenerative Medicine (FIRM), the Japan Bioindustry Association (JBA), and JTB Communication Design, the new exhibition is co-located with BioJapan, sharing both an exhibition space and partnering system to maximize cross-field collaboration and encourage open innovation. Copyright 2018 JTB Communication Design, Inc. 7 BioJapan / Regenerative Medicine Japan 2018 Highlights 1200 1108 983 1000 886 879 782 800 714 678 665 607 551 600 510 538 479 403 327 400 295 200 0 2011 2012 2013 2014 2015 2016 2017 2018 Exhibitor Partnering Member Partnering Companies Participants Countries Meetings Held 1,108 1,848 10,075 2018 34 (113%↗) (110%↗) (117%↗) 2017 983 1,666 33 8,591 Exhibitors Companies Booths Countries Visitors 879 683 16,309 2018 28 (112%↗) (103%↗) (103%↗) of which 114 RMJ of which 107 RMJ 2017 782 658 26 15,711 Copyright 2018 JTB Communication Design, Inc. 8 Top Visitor Count Ranked by Industry Pharma CRO/CMO Chemical/Fiber 1 Daiichi Sankyo 1 Fujifilm Wako Pure Chemical 1 Fujifilm 2 Mitsubishi Tanabe Pharma 2 Sekisui Medical 2 Kanto Kagaku 3 Chugai Pharmaceutical Nikon Cell Innovation 3 Hitachi Kasei 4 Astellas Pharma 3 AGC 4 5 Takeda Pharmaceutical Kaneka 5 Kishi Kasei 6 ROHTO Pharmaceutical 5 Nissan Chemical 6 Meiji Seika Phrma 6 Axcelead Drug Discovery Partners 6 TORAY 8 Teijin Pharma Kyokuto Pharmaceutical Indsutrial 7 Mitsubishi Chemical 8 Otsuka Pharmaceutical 7 Oriental Yeast 8 Asahi Kasei Sumitomo Dainippon EPS 10 9 TOSOH Pharma 10 Medinet 1 Mitsui Chemical Eisai Sumika Chemical 0 JSR 11 Kowa 11 CMIC Novartis 1 NOF IQVIA Services Japan 14 Kyowa Hakko Kirin 2 Teijin Kyowa Hakko Bio Nissui Pharmaceutical 1 Sumitomo Chemical 14 Yokohama Bio Research and Supply 15 Taisho Pharmaceutical 4 Nacalai Tesque Shionogi Kishida Chemical Asahi Kasei Pharma Santen Pharmaceutical 18 Daiichi Sankyo RD Novare Machinery/ Manufacturing Taiho Pharmaceutical University/Research Institute 1 Hitachi ASKA Pharmaceutical 22 2 PHC Japan Agency for Medical Research Kyorin Pharmaceutical 1 3 Yokogawa Electric and Development (AMED) Otsuka Pharmaceutical Factory 4 Panasonic 2 The University of Tokyo JCR Pharma 5 Nikon National Institute of Advanced 3 24 Seikagaku 6 Ricoh Industrial Science and Technology Torii Pharmaceutical 7 Toppan Printing 4 Keio University Nobel Pharma 8 Shimadzu 5 Yokohama National University Kaken Pharmaceutical 9 Olympus 6 Waseda University Kissei Pharmaceutical 10 Ushio 7 Toyo University 25 Sanwa Kagaku Kenkyusho 11 Hitach High-Technologies 8 RIKEN Zeria Pharmaceutical 9 Tokyo Institute of Technology 12 SCREEN Holdings Pfizer Teikyo University 13 Canon Osaka University 10 National Center for Global Health 14 Dai Nippon Printing and Medicine 15 Hitachi Appliances Tohoku University Biotech/Drug Discovery Tokyo Medical and Dental University Central Institute of Experimental 1 Cellseed 13 Animals 2 Reprocell Kyoto University Life Science Institute Okayama University 3 Healios Yokohama City University Scohia Pharma 19 Nagoya University Chitose Laboratory Kyushu University 6 20 Kohjin Bio Academia Sinica (Taiwan) Meiji University Regenerative Medicine iPS Gateway 22 Tokyo Univesity of Science 8 Center Tsukuba University Gene Techno Science Tohkai University Reborna Biosciences 25 Hiroshima University 10 Bonac Tech Manage Integriculture Copyright 2018 JTB Communication Design, Inc.
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