New Regenerative Medicine
Development
in Japanese Industry
Takuya Yokokawa (FUJIFILM)
Head of Steering Committee, FIRM
Forum for Innovative Regenerative Medicine (FIRM)
&
Fuyuhiko Mori
Secretary General, RMIT
Regenerative Medicine Industrialization Task Force (RMIT)
A Task Force of FIRM
Market Forecasts for Regenerative Medicine
○ METI estimates the market size for regenerative medicine at about $ 25 billion in 2050
(Japan), and $ 380 billion (global), which promises enormous economic benefits.
2
年 年 年 年 年
0
5,000
10,000
15,000
20,000
25,000
2012
年
2020
年
2030
年
2040
年
2050
年
2020
$ 950 million
2050
$ 25 billion
Immune
Cell
pancreas
liver
vessel
nerve
eye
(Million Dollar) Others
(hairs etc.)
kidney
skin cartilage
heart
blood
5,000
10,000
15,000
20,000
25,000
0 2012 2020 2030 2040 2050
2030
$ 10 billion
alveolar
bone
Japan
2012
$ 90mill.
2020
$ 950mill.
2030
$ 10bn.
2050
$ 25bn.
Global
2012
$ 1bn.
2020
$ 10bn.
2030
$ 120bn.
2050
$ 380bn.
0
10
20
30
40
2012 2020 2030 2040 2050
(Billion Dollar)
2020
$ 10 billion
2030
$ 120 billion
2050
$ 380 billion
Others (developing
countries)
Japan
Europe
U.S.
400
300
200
100
0 2012 2020 2030 2040 2050
Growth Projections of Supporting Industries for Regenerative Medicine
3
○ METI estimates the size of industries related to regenerative medicine at
about $ 13 billion (Japan), $ 150 billion (global), by 2050.
2012
$ 170 million
2020
$ 950 million
2030
$ 5.5 billion
2050
$ 13 billion
Japan
2012
$ 170mill.
2020
$ 950mill.
2030
$ 5.5bn.
2050
$ 13bn.
0
5000
10000
15000
services
consumabl
e supplies
devices
(Million Dollar)
15,000
10,000
5,000
2012 2020 2030 2040 2050
Global
2012
$ 2.4bn.
2020
$ 11bn.
2030
$ 52bn.
2050
$ 150bn.
U.S.
Europe
Japan
Others
(developing
countries)
2012年 2020年 2030年 2040年 2050年
2012
$ 2.4 billion
2020
$ 11 billion
2030
$ 52 billion
2050
$ 150 billion
(Billion Dollar)
2012 2020 2030 2040 2050
160
140
120
100
80
60
40
20
0
About FIRM The Forum for Innovative Regenerative Medicine (FIRM) was established on June 17, 2011.
Machinery/Device 29
Chemical/Material 40
Regenerative Medicine/Cell Therapy Bio-technology 39 Pharmaceutical
Logistics/Insurance/Consulting etc.
42
FIRM members – 150 companies (1 May, 2015)
Chemical & materials industry
Bio industry
Regenerative medicine & cellular therapy
Machinery & device
Related industry of Regenerative medicine (FIRM members)
Pharmaceutical industry transportation
insurance
Consulting firm
5
Members of FIRM – 150 as of 1 May 2015
AIRTECH JAPN.LTD. B.E. Marubishi Co., Ltd. COREFRONT Corporation Cytori Therapeutics K.K. Fujimori Kogyo Co.,Ltd. GE Healthcare Japan Corporation Hitachi, Ltd.
Machinery・Device(29) IHI Corporation IS Technology Japan Inc. JTEC CORPORATION KATAOKA CORPORATION Kawasaki Heavy Industries, Ltd. KONICA MINOLTA,INC. micronix Co., Ltd. Nichiryo Co.,Ltd.
NIKON CORPORATION Olympus Corporation Osaka Sanitary Co.,Ltd. Pall Corporation Panasonic Healthcare Co., Ltd. Pico-Devicve SHIBUYA KOGYO CO., LTD. Shimadzu Corporation
SMC Corporation SYSMEX CORPORATION Toyo Seikan Group Holdings, Ltd. RICOH COMPANY, LTD. WAKENBTECH CO, LTD. Yokogawa Electric Corporation
360ip JAPAN Pte Ltd. Advantec.co., ltd. CHIYODA CORPORATION Chiyoda TechnoAce Co.,Ltd. CMIC Co., Ltd. COSMO BIO CO., LTD. DAI-DAN CO,.LTD. Drug Safety Testing Center Co., Ltd. Earth Environmental Service Co., Ltd. Ernst & Young ShinNihon LLC. Ikeda Scientific, Co., Ltd.
Logistics etc.(42) iPS Academia Japan, Inc. Ipsos Healthcare Japan Limited iPS PORTAL, Inc. Japan Food Research Laboratories KAITO CO., LTD. Leave a Nest Co,. Ltd. Life Technologies Japan K.K. LOGI SOLUTION CO.,LTD. NTT DATA INSTITUTE OF MANAGEMENT CONSULTING, Inc. Mitsui Fudosan Co., Ltd. Mitsubishi Research Institute, Inc.
Meditranse MEDIPAL HOLDINGS CORPORATION Mitsui Sumitomo Insurance Company, Limited NIPPON EXPRESS Pharma Solutions Co., Ltd. POC Clinical Research Inc. SANKI Engineering Co., Ltd. SAROUTE Co., Ltd. SATO HOLDINGS CORPORATION Seed Planning, Inc. SHIBAMATA TRANSPORT Co.,Ltd.
SHIMIZU CORPORATION Sompo Japan Nipponkoa Insurance Inc. SRD Co., Ltd. Sumitomo Mitsui Banking Corporation TAISEI COEPORARION T Medical Service Inc. Tokio Marine & Nichido Fire Insurance Co., Ltd. YAMATO SYSTEM DEVELOPMENT CO.,LTD. Yokohama BioResearch & Supply, Inc.
Chemical・Material(40) AJINOMOTO CO., INC. Amano Enzyme Inc. API Co.,Ltd. Asahi Kasei Corporation Asahi Glass Co., Ltd. BIOMIMETICS SYMPATHIES Inc. Cell Science & Technology Institute, Inc. DAIKIN INDUSTRIES, LTD. Dai Nippon Printing Co., Ltd. FUJIFILM Corporation
Hitachi Chemical Co.,Ltd. ID Pharma Co., Ltd. JX Nippon Oil & Energy Corporation KANEKA CORPORATION Kohjin Bio Co., Ltd. KURARAY CO., LTD. KYOCERA Corporation Kyokuto Pharmaceutical Industrial Co., Ltd. Lonza Japan Ltd. Mitsubishi Chemical Corporation
MUTOH CO., LTD. NACALAI TESQUE, INC. NICHIREI BIOSCIENCES Inc. Nippi,Incorporated NISSAN CHEMICAL INDUSTRIES, LTD. NISSUI PGARMACEUTICAL CO., LTD. Novozymes Japan Ltd. SEKISUI SEIKEI , LTD. Shiseido Company, Limited Sumitomo Bakelite Co., Ltd. SUMITOMO CHEMICAL Co., Ltd.
TAKARA BIO INC. Teijin Limited TOKYO OHKA KOGYO CO., LTD. TOPPAN PRINTING CO.,LTD. TOSOH CORPORATION Toyobo Co., Ltd. UNIGEN Inc. Veritas Corporation Wako Pure Chemical Industries, Ltd.
Advanced Center for Tissue Engineering Ltd. Astellas Pharma Inc. Asubio Pharma Co., Ltd. Cyfuse Biomedical Inc. CellSeed Inc. CellGenTech, Inc. CellBank Corp. Dainippon Sumitomo Pharma Co., Ltd. Eisai Co. Ltd. FUJISOFT INCORPORATED
RM・Cell Therapy(39) ROHTO Pharmaceutical Co., Ltd. Takeda Pharmaceutical Company Limited TEIJIN PHARMA LIMITED tella, Inc. Terumo Corporation UMN Pharma Inc. ZENOAQ RESOURCE
Grandsoul Research Institute for Immunology, Inc. Healios K.K. iHeart Japan Corporation Japan Tissue Engineering Co., Ltd. Janssen Pharmaceutical K.K. JCR Pharmaceuticals Co., Ltd. Kaken Pharmaceutical Co., Ltd. KAN Research Institute, Inc. KOSHIKAI, Non-Profit Medical Corporation Kyowa Hakko Kirin Co., Ltd.
Life Science Institute, Inc. LYMPHOTEC, Inc. MEDINET Co., Ltd. Mitsubishi Tanabe Pharma Corporation Naito Medical Clinic NIHON PHARMACEUTICAL CO., LTD. NIPRO Novartis Pharma K.K. Otsuka Pharmaceutical Factory, Inc. Pharma Solutions Co., Ltd. Regience K.K. ReproCELL Inc.
Innovative Regulatory Framework
Pharmaceuticals Medical Device
Pharmaceuticals Medical Device
Previous
Framework
New
Framework
Regenerative
Medicine
? ?
Regenerative
Medicine
Regenerative
Medicine
The Act on Pharmaceuticals and Medical Devices (PMD Act)*
The Act on the Safety of
Regenerative Medicine
* Two laws enforced in Nov.25, 2014
[New scheme for regenerative medicine products]
Post-marketing safety measures must be taken,
including prior informed consent of risk to patients
The Act on Pharmaceuticals and Medical Devices (PMD Act)
[Traditional approval process]
8
1) New chapter dedicated to regenerative medicine
2) Expedited approval system
Marketing
(Further confirmation
of efficacy and safety)
Conditional
/term-limited
authorization
Clinical
study Marketing
continues
Clinical trials
(likely to predict
efficacy,
confirming
safety)
Marketing
authorization
or
Revocation
Phased clinical trials
(confirmation of efficacy and safety)
Clinical
study Marketing
Marketing
authorization
Research
Science Market seeds
needs
New healthcare
Industrialization
GAP
Appropriate regulatory framework
研究(R) 市場(M)
Development
【Key to industrialization of regenerative medicine】 FIRM Initiative
Research Market
Search Business strategy
Manufacturing marketing
Seeds Selection
Judge
Regulatory approval
Clinical trial
Stable
production
Branding Patent strategy
Commercial cell culture
Regulatory application
MHI Price
Regulatory framework
Logistics
Product specification
Business model
Needs collection
Market cultivation
Fund
Distribution
Industry cooperation
one for all, all for one
interactive interactive
Standardization
Quality assurance
General Meeting of Members
Executive Committee
Audit
Secretariat
Business
Strategy
Committee
PR Committee
Regulatory
Committee
Medical
Economics
Committee
Standardization
Committee
Supporting
Industry
Committee
Steering sub-Committee
Organization of FIRM
CPC WG
Automation WG
Reagent/Media WG
Transportation WG
Disposable/Material WG
Insurance WG
Reimbursement WG
Steering Committee
WG①:Non-clinical
WG②:Mfg./QA
WG③:Clinical Trials
WG④:Act for Safety of RM
RM Industrialization
Task Force
RMIT
2015 March
FIRM
ARM
Machinery/Device 29
Chemical/Material 40
Regenerative Medicine/Cell Therapy Bio-technology 39 Pharmaceutical
Logistics/Insurance/Consulting etc.
42
FIRM members – 150 company (1 May, 2015)
【Newly established Task Force】
FIRM Initiative
Industrialization Support Team @Downtown Tokyo Open since Apr. 1, 2015
Provide responses to various requests, help partnering with FIRM members
RMIT [email protected]
http://firm.or.jp/en/en_rmit
Entities interested in Regenerative
Medicine industrialization FIRM member companies
Requests,
inquiries, etc. Response &
discussion
Discussion with
applicable
companies Partnering
Collaboration
FIRM
Machinery/Device 29
Chemical/Material 40
Regenerative Medicine/Cell Therapy Bio-technology 39 Pharmaceutical
Logistics/Insurance/Consulting etc.
42
FIRM members – 150 company (1 May, 2015)
Regenerative Medicine Business
Thank you for your attention
http://www.firm.or.jp/en/en_rmit