- Regenative Medicine Industry in Japan -

(updated:2015/5/18)

Rapid Growth of the Japanese Regenerative Medicine Industry

METI estimates the market size for regenerative medicine at about US$10 billion in 2030 (Japan), which promises enormous economic benefits.

Japan is the second-largest pharmaceutical market (2012) in the world after the United States .

Market Forecasts for Regenerative Medicine (Japan)2020

US$ 950 mil.2030

US$ 10 bil.2012

US$ 90 mil.

（Million US Dollars）

Source: Ministry of Economy Trade and Industry (METI)

0

2000

4000

6000

8000

10000

12000

2012 2020 2030

2030US$ 10 billion

2020US$ 950 million

stry of Ef Ef conomy Trade and Indust

Others

Immune Cell

Blood

Pancreas

Liver

Kidney

Vessel

Alveolar Bone

Nerve

Heart

Eye

Cartilage

Skin

Introduced world-class expedited approval system for regenerative medicinal products

Japan introduced an expedited approval system for regenerative medicinal products in 2014 and created an environment conducive to the development and provision of regenerative medicinal products.

Source: Ministry of Health, Labour and Welfare (MHLW)

PMD Act (formerly PAL) (Implemented November 2014)

In addition, the Regenerative Medicine Safety Act, also implemented in November 2014, allows outsourcing from medical institutions to private companies.

*Source: National Institute of Health Sciences, "International Comparison of Regenerative Medicine and Cell Therapy Regulations“, 2013

• US/EU• Japan(until Nov. 2014)

Clinicalresearch

Clinical trials(confirmation of efficiency and safety)

Approv-al

Onmarket

Regenerative medicinal product approval system

Can be as short as 3 years

Normally 6 years

Japan(after Nov. 2014)

Approv-al

Clinicalresearch

OnmarketWith applied

conditionsand time limit

(likely to predict efficacy, confirming safety)

On market

Time Required Until Approval HalvedShorter product launch period compared to the US/EUShorter product launch period compared to the US/EU

Clinical trials

y tocy

Approval

• Confirm efficiency • Additional safety

confirmationApply for re-approval within the time limit

New System

Traditional System

Business opportunities created by the expansion of the regenerative medicine market in Japan

Regenerative medicine is supported by a range of related industries, and the regenerative medicine market is expected to expand through advances in Japanese manufacturing technology and new technology entering the market from overseas.

Source: Ministry of Economy Trade and Industry (METI)

1) Mediums2) Reagents3) Culture vessels

Cell Processing Center (CPC)

Autologous transplantation

Japan Tissue Engineering Co.（skin, cartilage）

Terumo Co.,

Cultured skin

Cardiac cell sheet

Consumable Supplies and Materials

1) Transportation of cultured cells

Transportation Services

1) Design, construction

2) Maintenance

Cardiac cells

iPS cells Drug evaluation system w/ cardiac cells

1) Incubators2) Auto-culturing devices

Cell Culture Devices

1) Flow cytometers2) Image analysis devices

Healios K.K.（retina cell sheet processed by iPS cell）

Leading companies on regenerative medicine

products / services

mm

Innovative Drug

Discovery

Drug Evaluation System / Appliances

3) Culture vessels

Cell Processing Center (CPC)

Supporting Industries

Procurement

C lt

Genetic Manipulation

Culture

Tissue Formation

Cell Assessment Devices

Trans-portation

AAAAAuuuttttttooollogous

Regenerative Medicine

Retina cell sheet

Allogenic transplantation

Trans-portation (Marketed

2 products) (Under review in Japan)CellSeed Inc.（cardiac cell sheet）

(Under review in Europe)

(Under development)

State of the Clinical Trial Support Environment

Japan has more than 70 CRO/SMO companies that provide assistance with clinical trials and approval procedures required to enter the Japanese market. It is expected that the regenerative medicine industry will also be supported by those companies. In addition, the government has already approved 10 Clinical Trial Core Hospitals.

Source ：Ministry of Health, Labour and Welfare (MHLW)

CRO(Contract Research

Organization)Agency contracted to

implement clinical trials

SMO(Site Management

Organization)Agency contracted for clinical

trial site management

Assisting with clinical trials• Preparing clinical trial protocols• Enrolling subjects• Monitoring, etc.

Preparing pharmaceutical materials• Preparing applications for Marketing Business

License/Manufacturing/Foreign Manufacturer Accreditation for drugs, etc.

• Preparing applications and other related documentation, etc.

Assisting with clinical trials• Assisting with conducting clinical trials in medical

institutions• Assisting with establishing and operating an IRB• Training and staffing CRCs

Tasks

National Cancer Center

National Center for Global Health andMedicineNational Center for Child Health andDevelopmentNational Hospital OrganizationNational Center Hospital

※They are able to plan Keio University School of Medicineand implementcomplicated clinical

Chiba Chiba University Hospital

Kanagawa Kitasato University School of Medicine

Osaka The National Cardiovascular Center(NCVC)

Oita Oita University Hospital

Tokyo

Clinical Trial CoreHospitals

Regenerative Medical Clusters

Regenerative Medical Clusters are located in the three major regions of Kanto, Chubu and Kansai.

Source: Ministry of Health, Labour and Welfare (MHLW)

Kanagawa (Yokohama/ Kawasaki): Kanagawa has a cluster of medical and pharmaceutical research institutions that pursue research based on collaboration by industry, government and academia. It ranks 6th in the nation in terms of the monetary value of medicines and pharmaceuticals (2013).

TokyoNagoya

Sapporo

Kyoto:

Kyoto is the location of Kyoto University, famous for its iPS cell research

Osaka (Saito): ・Osaka has the largest number of top pharmaceutical companies. ・It is developing a cluster centered on Osaka University.・It ranks 3rd in the nation in terms of the monetary value of medicines and pharmaceuticals.

Hyogo (Kobe):The Kobe Biomedical Innovation Cluster (KBIC) has nearly 292 companies (as of April 1st, 2015). The world’s first clinical research for retina regeneration using iPS cells is being done here

Shizuoka:・Shizuoka ranks 2nd in the nation in terms of the monetary value of medical device shipments (2009-2013). ・It is currently promoting the Pharma Valley Project centered on the Shizuoka Cancer Center.(Aichi is the location of Japan Tissue Engineering Co., Ltd. (J-TEC), a leader in regenerative medicine.)

Fukuoka

Sendai

Kansai region Chubu region

Kanto region

of Health, Labour and Welfa

World-class environment for research and development

Kyoto University`s CiRA Research Institute, the world leader in iPScell research, is targeting the initiation of regenerative medicine research in humans, the search for drugs for intractable diseases, and the “iPS cell stock project”. Active research is also being conducted at other universities. In addition, numerous regenerative medicine associations have been newly established, and the research environment is in place.

Osaka UniversityRegeneration of heart muscle using cell sheets

Kyoto University

・Regenerative medicine research in humans ・The search for drugs for intractable diseases・The “iPS cell stock project”

Prof. Yamanaka

Prof. Sawa

（Source）Kyoto University：http://www.cira.kyoto-u.ac.jp/j/research/stock.htmlOsaka University：http://www.med.osaka-u.ac.jp/pub/surg1/www/result/01.htmlTerumo Life Science Foundationhttps://www.terumozaidan.or.jp/labo/class/11/interview01.htmlKeio University：http://www.keio.ac.jp/ja/about_keio/publications/kr7a430000000ifi-att/P3_4_2013.pdfNational Research and Development Agencyhttp://www.jst.go.jp/ips-trend/column/interview/11/no01.htmlRiken：http://www.cdb.riken.jp/research/laboratory/takahashi.html

Keio University

Regenerative therapy for spinal cord injuries

Prof. Okano

RIKEN

Implementation of clinical trials for retina implants

Dr. Takahashi

・The Japanese Society for Regenerative Medicine (JSRM)・The Japanese Society of Inflammation and Regeneration (JSIR)・World Academy of Anti-Aging & Regenerative Medicine (WAARM)・Japanese Society for Repro-Regeneral Medicine (JSRR)・Japanese Association of Regenerative Dentistry (JARD)

Key Points for Entering the Japanese MarketRegulatory review required prior to marketing regenerative medical products in Japan is performed in three main areas, as shown below.

Review of Corporate Responsibility

Review of Efficacy and Safety of the Products

(Domestic Manufacturing ) （Foreign Manufacturing)

Review of the Production and Management of the Products

Company Code Registration

① Application forMarketing

Business License

Obtaining of License

R&D, etc.

②Application forMarketing Approval

Review for Approval, etc.(PMDA)

Contract Manufacturing Agreement(Outsourcing Manufacturers make the following applications )

Company Code Registration

Company Code Registration

③Application for Manufacturing

④Foreign Manufacturer Accreditation

Document Exam or On-site Audit by Relevant Authority

Document Review or On-site Audit by Relevant Authority

Obtaining of License

Obtaining of License

⑤GCTP （Good Gene, Cellular, and Tissue-based Products Manufacturing Practice）

Inspection

＜In case of Contract Manufacturing＞

＜In case of in-house manufacturing＞

Document Exam or On-site Audit by Relevant Authority

Approval

Commencement of Marketing

＜Regenerative Medicine Market specific＞

＜Overall Judgment＞

Source：PMDA

The Attractive Regenerative Market in Japan

JETRO offers a wide range of support services for setting up R&D centers and manufacturing and

sales centers in Japan.

Please contact us for more information, or to discuss your business development needs.

Market Attractiveness of Japan☆World-class expedited approval system☆Eight hundred thousand patients for

biopharmaceuticals☆An estimated market size for regenerative medicine

of US$10 billion in 2030

World-leading regenerative medicine related research and

development centers

☆Vast accumulation of clinical research

JETRO IBSC Services

JETRO is a governmental organization with more than 70 overseas offices in over 50 countries across the world. For foreign companies planning to start a business in Japan, we provide information, consultation and other services free of charge, as well as a few fee-based services. When you come to Japan, JETRO IBSC will support you depending on your businessneeds by providing consultation and facilities for establishing a business base and starting your business in Japan.

We provide a wide range of services for your needs. Please contact your nearest JETRO office.

☆Overseas Offices：http://www.jetro.go.jp/jetro/overseas

☆Domestic Offices：http://www.jetro.go.jp/jetro.japan/E-mail: invest-japan@jetro.go.jp

Kanagawa（Yokohama）

東京中部地域

札幌

Kyoto：

福岡

仙台

関西地域

関東地域

Shizuoka

Hyogo（Kobe）：

IBSC Kobe

Osaka：

IBSC Osaka

IBSC Yokoha

ma

IBSC Kyoto

JETRO IBSC

Consulting Facilities InformationFree individual consultation

for your companyTemporary office spaceoffered free of charge

Gather a wide range ofinformation needed for your

business・Legal system ・50 working days free ・Market reports・Cost estimation ・Located in 6 major cities ・Business advisor・Taxation ・Fully equipped ・Online database・Market regulation ・Shared reception ・Platform of professional・Business practice ・PC room with printer/scanner etc. service provider・Human resource ・Conference rooms available ・Connection to ministries and・Location Event hall available regulatory authority・Subsidy application ・Deregulation Request

JETRO IBSC is a one-stop center for establishing a businessbase and starting your business in Japan.

FIRM ServicesFIRM (The Forum for Innovative Regenerative Medicine) is an industrial organization of approximately 150 regenerative medicine related companies. FIRM has organized a Regenerative Medicine Industrialization Task Force (RMIT) and has newly established a consultation service to answer questions from overseas.

Overview

Major Services

Established on April 1, 2015・Consultation service for partnering with Japanese firms・Inquiry service for specialized topics related to Japan`s regenerative medicine system・The service is basically provided free of charge.・Please see the website below for more details. http://firm.or.jp/en/en_rmit

① Consultations and inquiries on regulatory affairs② Consultations on procurement of ingredients and materials ③ Consultations on procurement, provision, and trial use of machines,

equipment and facilities④ Consultations and requests on manufacturing and quality assurance⑤ Consultations on clinical studies⑥ Consultations on clinical trials⑦ Consultations on clinical applications and marketing plans including

alliances with medical institutions⑧ Consultations, requests and inquiries on industrialization of regenerative

medical products and others

Contact

For consultations, requests, and inquiries, please contact us at the e-mail address below.For phone consultations, please contact us at one of the phone numbers during the times indicated below (Japan time).E-mail： info-tf@firm.or.jpPhone： +81 3-3510-9620（Japanese)

+81 3-3510-9621（English）Business hours：9:00～12:00, 13:00～16:00 (Monday ～Friday)

Source: RMIT

FIRM (RMIT) Consultation Service for Overseas Companies

Regenerative Medicine Related Events and Industry Organizations

Regenerative medicine-related businesses are brought together at events held throughout the year; presenting opportunities to seek potential business partners and identify trends in the Japanese market.

Regenerative medicine related events

Related industry organizations

BIOJAPAN

BioPhJapan

RegenerativeMedicine Expo& Conference

• Event aimed primarily at business partnering with a focus on bio-clusters and ventures

• Over 600 exhibiting companies

• Biotechnology industry showcase for medical-related products and services, including bio-pharmaceuticals and regenerative medicine products, contract services, licensing, etc.

• Over 420 exhibiting companies

• Showcase for products and services related to the commercialization of regenerative medicine, including media, reagents, culture/cell products, contract services, licensing, etc.

• First meeting was held in February 2015

Event overview

• Yokohama/annual （Next meeting 2015/10/14-16）

• Tokyo /annual（Next meeting 2016/4/20-22）

• Osaka/annual（Next meeting 2016/2/24-26

Location/Timing

FIRM (Regenerative Medicine Innovation Forum)• An industry body with a membership of approximately 150 main players, focused on supporting

regenerative medicine businesses all the way from discovery of seeds up to development of advanced technology in the industrial manufacturing base

• Activities include recommendations on regenerative medicine commercialization strategies and issues, exchanges and partnerships among stakeholders in regenerative medicine in Japan and abroad, and implementation and publication of research and statistics on regenerative medicine

【Participating companies】 A wide variety of regeneration medicine related companies covering products, reagents, mediums, culture vessels, devices, chemicals, insurance, etc.

JBA（Japan Bioindustry Association )• Pharmaceuticals, food, cosmetics, chemical, information, Natural Resources and

Energy, such as biotechnology companies about 190 companies of business and universities, public research institutions, including about 90 organizations to affiliation

• Through the advancement of science and technology relating to biotechnology industry, comprehensively promote to have the organization to the development of biotechnology industry in the industry, academia and government cooperation