Presentation about the Japanese Medical Device Industry by Miyahara Mitsuho, Director, METI- Ministry of Economy, Trade and Industry, Commerce and Information Policy Bureau, Medical and Assistive Device Industries Office

1. Medical Devices Industry in Japan
February 2018
Ministry of Economy, Trade and Industry
Commerce and Information Policy Bureau
Medical and Assistive Device Industries Office

2. 2
○ The scale of Japan’s medical device market has been growing. In 2015, it was over 2.7 trillion yen.
○ Trearapeutic devices have a large market scale and a high growth rate.
(Source：From the Ministry of Health. Labour and Welfare “Statistics of Production by
Pharmaceutical Industry”
（Units：hundred million yen）
Trends in Japan’s Medical Device Market
9,7219,83910,24710,02410,97811,304
12,50612,563
13,85014,10314,85314,987
5,7396,166
6,5246,194
6,2095,536
5,7036,124
6,7826,963
7,0366,1135,1355,100
5,816
5,095
5,0524,920
4,946
5,173
5,304
5,692
5,968
6,378
0
5,000
10,000
15,000
20,000
25,000
30,000
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Other medical devices
Diagnostic-type medical
devices
Therapeutic-type
medical devices

3. 3
Trends in the Global Medical Device Market
○ The scale of the global medical device market is $336 billion. (2016）
○ By country, Japan has the second largest market size level after the U.S.
○ In areas such as China, Asia, rapid growth is expected.
○ In the expanding global market, the position of Japan is relatively declining.
Source：From BMI Research “Worldwide Medical Devices Market Forecasts to 2021”
(MIZUHO Bank)
Trends in the Global Medical Device Market Regional avg growth rate of medical equipment
Market Size of Medical Device by country（2016）
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
2012 2013 2014 2015 2016 2017e 2018e 2019e 2020e 2021e
（$100
million ）
North America Latin America Japan
China Other Asia Central & East Europe
Middle East & Africa Western Europe
1,459
281 245 188 132 97 86 67 58 48
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
（$100million）
Average expected rate of growth
(2016-2021)
North America 5.2%
Latin America 8.0%
Japan 3.0%
China 9.6%
Other Asia 7.4%
Central & East Europe 4.9%
Middle East & Africa 7.0%
Western Europe 3.6%
Global 5.2%

4. CAMPANY
sales
（B$）
1 Johnson & Johnson 8.4
2 Abbott 5.3
3 Baxter 5.3
4 GE 4.9
5 Tyco 4.7
6 Siemens 4.4
7 Fresenius 3.8
8 Medtronic 3.0
9 3M 3.0
10 Becton Dickinson 2.8
11 Philips 2.0
12 Gambro 2.0
13 Toshiba 1.9
14 B Braun 1.8
15 Boston Scientific 1.8
16 Bristol-Myers Squibb 1.8
17 Eastman Kodak 1.5
18 Olympus 1.4
19 Smith & Nephew 1.3
20 Guidant 1.3
21 C R Bard 1.2
22 Agilent 1.2
23 Marconi Medical Systems 1.1
24 St Jude Medical 1.0
25 Stryker 1.0
1997 2007 2017
Source：MDDI&Qmed”Top 100 Medical Device Companies of 2017” etc.,(Made by JAAME)
CAMPANY
sales
（B$）
1 Johnson & Johnson 21.7
2 GE 17.0
3 Siemens 14.0
4 Medtronic 12.3
5 Baxter 12.0
6 Philips 11.3
7 Covidien 9.5
8 Abbott 8.4
9 Cardinal Health 8.1
10 Stryker 6.4
11 Danaher 6.3
12 Becton Dickinson 6.0
13 Boston Scientific 5.3
14 B Braun 4.0
15 Essilor 3.9
16 St. Jude Medical 3.8
17 Novartis 3.4
18 3M 3.4
19 Zimmer 3.0
20 Terumo 2.8
21 Olympus 2.8
22 Smith & Nephew 2.6
23 Hospira 2.5
24 Toshiba 2.5
25 Getinge 2.3
CAMPANY
sales
（B$）
1 Medtronic 29.6
2 Johnson & Johnson 26.2
3 Fresenius 21.7
4 GE 18.8
5 Philips 17.1
6 Siemens 16.6
7 Cardinal Health 14.0
8 Abbott 12.3
9 Stryker 12.1
10 Becton, Dickinson 12.1
11 Baxter 10.4
12 Boston Scientific 8.8
13 Essilor 8.5
14 Zimmer Biomet 7.8
15 Novartis 5.9
16 3M 5.7
17 Olympus 5.2
18 Terumo 4.9
19 Smith & Nephew 4.7
20 Canon 3.9
21 DENTSPLY SIRON 3.9
22 Getinge 3.7
23 Edwards Lifesciences 3.3
24 Hologic 3.1
25 Intuitive Surgical 3.0
Tyco、Fresenius、東芝、B Braun、Smith & Nephewは1998年データ
Abbott、Siemensは1999年データ
Top25 Medical Device Companies
○ Japanese companies are within top 20 in terms of sales.
3

5. International Competitiveness by field
○ In the field of diagnostics, Japanese industries maintain their international competitiveness
to a certain extent.
5(Source) Collection of Information on Positions of Japanese Companies in the International Competition in FY 2016 (NEDO) (March, 2017)
【Market Share of Medical Market (World Medical Market 2016）】
453
Billion

6. International Competitiveness by field
○ Generally, international competitiveness of Japanese industries in therapeutics is weak.
6
(Source) Collection of Information on Positions of Japanese Companies in the International Competition in FY 2016 (NEDO) (March, 2017)
【Market Share of Medical Market (World Medical Market 2016）】

7. ○ Findings for advancing research and development in medical fields based on medical field research
promotion plans.
(1) Centralize the budgets for research and development in medical fields for each Ministry.
(2) Provide comprehensive support from basic research to practical implementation.
*Established on April 1, 2015. Chairperson: Makoto Suematsu (former Dean of Keio University School of Medicine).
Budget for fiscal 2017: 126.5 billion yen. Number of personnel: roughly 300 (of these, 102 are full-time personnel).
Japan Agency for Medical Research and Development (AMED)
Prime Minister
Responsible for
“general
coordination”
<Competent Ministers>
60.3
billion yen
Fiscal year 2017
budget amounts for
medical devices 47.5
billion yen
18.3
billion yen
Minister of Education,
Culture, Sports,
Science and
Technology
Responsible for
“basic research”
Minister of Health,
Labour and Welfare
Responsible for
“clinical research”
Minister of Economy,
Trade and Industry
Responsible for
“practical
implementation”
Overview of the Japan Agency for Medical Research and Development
(AMED)
6

8. Summary Examples of devices
1.
Surgery assistance
robots / system
●Development of devices and systems in
medical fields with the application of robot
technology
Endoscope robot, Surgery
navigation/simulation, Smart treatment room
●Flexible endoscope robots applying industrial
robot technology
●Smart treatment rooms applying information
processing (IP) technology proven by industrial
robots
2.
Artificial tissue
and organs
●Device development with the cutting
edge technology and manufacturing
Implantable medical devices e.g. artificial
heart / joints and cochlear implant etc,
sophisticated materials e.g. dental implant
●System to create organs such as blood
vessels and bones, piling up cells with 3-D
printing technology.
●System to create 3-dimensional tissue such
as cardiac wall with cell sheet lamination
technology.
3.
Minimally-invasive
treatment
●Filling a need for early recovery reducing
patient’s physical burden
Technology of real-time tumor tracking
radiotherapy, guide wire for intravascular
catheter, radiotherapy, endovascular
treatment etc
●High-precision radiation therapy equipment
applying technology to deliver radiation to organs
influenced by respiratory movement, e.g. lungs.
●Recovery support system for impaired
motor function with technology to control
devices reading brain activity signals.
4.
Diagnostic imaging
●Improvement of medical efficiency by
early diagnosis, extension of healthy life
expectancy
MRI, CT,PET, highly functional endoscope,
molecular imaging etc
●Diagnostic devices for cancer metastases to
detect spreading cancer cells using
microparticulated contrast media.
●Diagnostic devices for cancer without biopsy,
using image processing technology of light
microscope.
5.
Home health care
●Filling a need for medical setting in an
aging society
●Taking advantage of Japan’s strong
fields such as “downsizing and weight
saving”
Oxygen enricher, portable dental treatment
devices
●Dedicated equipment package for home
dental care to combine downsized and weight
saved devices depending on a need.
●Diagnosis support system with combination
of blood pressure data from wearable appliance
and ICT technology
Technology development in 5 high-priority fields
of medical device industry
7

9. Overall Situation of Industrial Policies for Medical Devices Promoted by
the Ministry of Economy, Trade and Industry
● Development of the most advanced medical devices in the world
・Collaboration between industry, academia, and the government, and
promotion of cutting-edge diagnostic and treatment system development
(Development of Medical Devices and Systems for Advanced Medical Services:
budget amount for fiscal year 2017 - 4.38billion yen)
・Formulation of evaluation indices and development guidelines that allow
smooth development and reviews
● Development of medical devices through collaboration between
medicine and industry
・Facilitate collaboration between corporations, universities, and other
parties possessing manufacturing technology, with medical institutions,
to develop and implement devices that can answer the needs of medical
sites
(Development of Medical Devices through Collaboration between Medicine and Industry: budget amount
for fiscal year 2017 - 3.45 billion yen)
● Support by the Network for Supporting Development of Medical Devices
・Provide continuous support according to development stages in the form of “accompanying consultation”
・Comprehensively mobilize development institutions and provide one-stop support
such as for discovering medical site needs and for industrialization
(approval and authorization, intellectual properties, market cultivation, finances).
Market cultivation,
planning of designs and
concepts
Development, clinical
trials,
manufacturing, provision
of services
Sales,
marketing
8

10. Formulation of Medical Device Development Guidelines (Manuals)
Medical Device Development Guidelines
(Manuals)
Prepare industrial evaluation standards, etc. to
be considered at the time of development.
Evaluation indices for next-generation
medical devices
Prepare evaluation indices to be used in reviews,
based on regulatory science.
Medical Device Development Guidelines (Manuals)
[Ministry of Economy, Trade and Industry] 34 cases
Evaluation indices for next-generation medical devices
[Ministry of Health, Labor and Welfare] 28 cases
(Major guidelines)
○ Development Guidelines for High-performance
artificial heart systems
○ Development Guidelines for DNA chips
○ Basic concepts (manuals) for health software
development
○ Development Guidelines (manuals) for the
recovery devices of movement functions by
application of robot technology
○ Development Guidelines (manuals) for
Osteosynthesis (Custom-made) bone spine implants
(Major evaluation indices)
○ Evaluation indices for clinical evaluation of next-
generation high-performance artificial hearts
○ Evaluation indices for DNA Chips for Genotyping Test
○ Evaluation indices for self-derived iPS cells Retinal
Pigment Epithelium
○ Evaluation indices related to custom-made artificial
knee joints for plastic surgery
○ Evaluation indices related to custom-made artificial hip
joints
Collaboration
9

11. The 1st Well Aging Society Summit Asia-Japan
In Japan, there is strong demand and opportunity for
transformation in our healthcare ecosystem.
Our rapid aging population is driving strong social demand for
change. Japan has some of the most advanced basic
sciences, applied sciences such as regenerative medicine,
and has quality healthcare data from 120 million people. This
provides opportunity for new technology, new business
models, new culture to be implemented through partnerships
within and globally.
FOCUS TOPIC
The technology; Biotech startups
The business model; Quality digital health
The culture; Well aging society
(elderly care and support, preventive healthcare)
 Format: Partnering event (symposium, pitch) inviting
diverse global players such as healthcare ventures, 10

12. 11
Our interest
1 Make innovation in medical devices in Japan more active
 Learn from innovation ecosystem in the global cutting-edge areas
 Attract medtech startups and companies from the world to do
business in/with Japan
2 Make Japanese corporations more competitive in the
global medical devices market
 Encourage Japanese corporations to invest in or ally with potential
startups in the world