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 info-tf@firm.or.jp

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

info-tf@firm.or.jp

http://www.firm.or.jp/en/en_rmit