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mHealth Israel_Japanese Medical Device Industry 2018_Miyahara Mitsuho, Director, METI


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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

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mHealth Israel_Japanese Medical Device Industry 2018_Miyahara Mitsuho, Director, METI

  1. 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. 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. 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 ($100million) Average expected rate of growth (2016-2021) North America 5.2% Latin America 8.0% Japan 3.0% China 9.6% Other Asia 7.4% Central & East Europe 4.9% Middle East & Africa 7.0% Western Europe 3.6% Global 5.2%
  4. 4. CAMPANY sales (B$) 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. 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. 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. 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. 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. 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. 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. 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. 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