Japan - Country Commercial Guide
Medical Devices

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2022-11-05

Overview

Table: Market Size for Medical Devices   

 

2018

2019

2020

2021

(estimated)*

Local Production

17,602

23,558

22,719

23,913

Exports

6,047

9,258

9,278

8,119

Imports

14,679

24,982

24,693

24,907

Imports from the U.S.

7,141

9,643

9,233

11,208

Market Size

26,233

39,282

38,134

40,701

Exchange Rates

110.40

109.0

106.8

109.8

Market Size = local production + imports – exports

Data Source: Annual Pharmaceutical Production Statistics, Ministry of Health, Labour and Welfare (“MHLW”)

*U.S. Commercial Service Japan (“CS Japan”) estimated 2021 local production and import data using MHLW monthly reports.  CS Japan estimated export and import data based on past trends.

Japan’s market for medical devices continues to be among the world’s largest.  Since 2013, the Government of Japan (“GOJ”) has promoted the healthcare industry as an important growth engine under the country’s economic revitalization and growth strategy.  Japan’s healthcare field, including the medical devices sector, has recently experienced renewed attention.  The COVID-19 pandemic, which demonstrated the importance of innovative healthcare products, is one reason for this heightened attention on Japan’s healthcare sector.  Another important factor for growing interest in Japan’s healthcare sector is the emergence of Japan’s digital health industry.

Japan’s Ministry of Health, Labour and Welfare (“MHLW”) data show that the Japanese market for medical devices in 2020 totaled $38 billion.  Based on CS Japan’s research, U.S. imports’ share of Japan’s medical device market is significantly higher than the percentage reflected in official statistics.  CS Japan estimates that U.S. imports may account for as much as 60 percent of Japan’s medical device market, including production in Japan by U.S. companies.

Many U.S. medical device companies – including larger companies such as GE Healthcare, Johnson & Johnson, Abbott, Edwards Lifesciences, Medtronic, Stryker, Zimmer, and 3M – have subsidiaries in Japan.  The American Medical Devices and Diagnostics Manufacturers’ Association (“AMDD”), an industry association for Japanese subsidiaries of U.S.-based corporations engaged in the manufacture and sale medical devices and in-vitro diagnostics, currently has over 60 member companies in Japan.  In addition, many U.S. medical devices are sold through Japanese importers and distributors.

Medical Devices Addressing Specific Diseases in Japan

Fitch Solutions estimates that Japan’s medical device market will exhibit a compound annual growth rate (“CAGR”) of 5.9% from 2021 to 2026.  In March 2021, Japan’s Office of Healthcare Policy of the Cabinet Secretariat concluded a survey identifying key diseases in Japan that may require high levels of medical devices and pharmaceuticals for remediation purposes.  The survey identified the following diseases associated with high medical needs in Japan based on factors such as leading causes of death and those diseases that require support and long-term care: (1) malignant neoplasm; (2) diabetes; (3) cardiovascular disease; (4) Alzheimer’s and other dementia; (5) pneumonia; (6) kidney disease; and (7) frailty and sarcopenia, including weakness, fractures, and falls due to old age. 

U.S. companies produce a wide variety of medical devices and diagnostics in many of these disease segments.  U.S. companies that offer innovative solutions, including smartphone applications, that promote behavioral changes and monitor the progress of prognosis may find new opportunities in the Japanese market.  In addition, U.S. companies that produce devices and diagnostics that are minimally invasive or that use artificial intelligence (“AI”) and robot-assisted technology may find new commercial opportunities in Japan, especially in the disease areas identified in the previously referenced survey.

Foreign Average Price Rule Considerations

While the market for U.S. medical devices in Japan remains strong, U.S. firms face challenges with reimbursement pricing due to GOJ efforts to contain overall healthcare costs that continue to increase given Japan’s aging population and low birthrate.  Under these circumstances, the GOJ has taken various measures to cut healthcare spending.  Concerning medical devices, one such measures is the Foreign Average Price (“FAP”) Rule.  The FAP is the average list price of specific medical devices in the United States, the United Kingdom, France, Germany, and Australia. 

Japan uses this FAP as a reference price when setting reimbursement prices for medical devices sold in Japan.  Since Japan implemented the FAP Rule in 2002, the GOJ has continued to revise application of the rule in order to most effectively reduce medical device reimbursement prices, including prices of innovative U.S. medical devices.  The U.S. medical device industry remains concerned that continued frequent changes in Japan’s FAP Rule will further undermine the predictability of Japan’s medical device pricing system and adversely impact the U.S. industry’s ability to introduce innovative medical devices in Japan. 

Medical Device Digitalization

Japan generally lags behind other countries in the digital health sector.  To address this issue, the GOJ has taken several steps to promote early commercialization of stand-alone medical software, or Software as a Medical Device (“SaMD”).  The United States approves five times more SaMD products than Japan – including those medical devices that use artificial intelligence (“AI”) and machine learning.  In November 2020, the MHLW launched a strategy called Digital Transformation Action Strategies in Healthcare for SaMD or “DASH for SaMD.”  In April 2021, the MHLW established an office dedicated to SaMD development, as did the Pharmaceutical and Medical Device Agency (“PMDA”), a GOJ agencies with regulatory oversight similar to the U.S. Food & Drug Administration. 

The MHLW established a SaMD study group under one of its advisory councils.  In addition, and in collaboration with PMDA, the MHLW set up an integrated contact desk to take inquiries from companies interested in introducing SaMD products in Japan.  The contact desk responds to inquiries about the SaMD application criteria, regulatory affairs, and reimbursement issues. 

Moreover, the GOJ’s 2022 Annual Economic and Fiscal Policy Blueprint, Honebuto in Japanese, overviewed the need for Japan to strengthen drug discovery capabilities, advance scientific technologies, and promote innovation by various measures, including regulatory reforms in healthcare data utilization for drug discovery, clinical trials, and SaMD.  The U.S. medical device industry regards this as a positive step toward the GOJ’s embracing and promoting sophisticated medical device technology that will result in greater opportunities for medical device manufacturers in Japan.

In Japan, individuals with cardiovascular disease and mental health concerns are the patients that most use digital health technologies.  In addition, 48% of individuals in Japan receiving nursing care were serviced through digital health technologies, and a large proportion of those receiving digital nursing care were between the ages of 18 to 41 years old.  This data demonstrates that Japan has opportunities to further develop its use of digital healthcare and SaMD for individuals only receiving nursing care – particularly younger individuals who are more comfortable using their smartphones for purposes of communicating about healthcare issues.

Leading Sub-Sectors

Digital Health

The 2020 spread of COVID-19 highlighted various concerns in Japan’s medical and healthcare fields and reaffirmed the importance of promptly collecting, analyzing, and using health data.  In addition, following the COVID-19 pandemic, Japan has undertaken efforts to evaluate how patients receive needed examinations and treatments.  These GOJ analyses have resulted in increased demand for new medical and healthcare services utilizing digital technology.

According to the Fuji Chimera Research Institute’s February 2021 report Internet of Medical Things (“IoMT”) New Market Outlook, Japan’s domestic telemedicine market is expected to grow from USD $243 million in 2020 to USD $404.5 million in 2025.  Concerning Japan’s future domestic healthcare IT opportunities, wearable healthcare equipment and the associated service systems segment are projected to reach USD $16,208 million in 2025. Within the universe of wearable healthcare equipment, Japan sees a special demand for pulse oximeters and thermometers that resulted from the COVID-19 pandemic. Wearable devices, especially smart watches, have grown steadily in demand given consumers’ increased health consciousness and the greater availability of wearable technology.

Services

In the service systems area, in addition to online medical care, “watch-over” services for elderly individuals living remotely from their families have been growing.

Japan’s health tech segment is also expected to grow to USD $1.9 billion in 2025.  Areas such as “sleep-tech,” consisting of sleep improvement support services comprised of bed sheet-type sensors and smart watches, are expected to grow.  Technologies for infants including baby monitors, baby scales, and nursing room search systems are also expected to see sales growth.

Telemedicine

The telemedicine-related segment is expected to grow from USD $243 million in 2020 to USD $404 million in 2025.  Within this segment, the online medical consultation market has expanded rapidly due to the entry of major IT vendors and an increase in the number of companies engaged in health management.  Following the COVID-19 pandemic, Japan’s online medical consultations and medication guidance services have grown rapidly.  In addition, the implementation of image analysis solutions – that is, remote diagnostic imaging services and remote pathological diagnosis systems communicated between doctors – is expanding due to the shortage of specialists and the continuous need for operational efficiency.

Wearable Medical Devices

The segment for “smart-ware” solutions that can help medical institutions evaluate a patient’s condition via smart-ware biometric information is expected to rise rapidly in the future.  However, in Japan, the ratio of using digital technology for health management is 37%, which is significantly lower than the global average of 60%.  According to the 2021 Accenture Health and Life Sciences Experience Survey, the percentages of Japanese institutions using online medical care, electronic health records, and wearable technology is 7%, 9% and 9% respectively.

Table: Major Japanese Domestic Healthcare IT Market Size and Future Projections
Unit: USD $ Millions

Table: Major Japanese Domestic Healthcare IT Market Size and Future Projections

 

2020

Projection in 2025

Wearable/Healthcare Service Systems

6,051

16,208

Health Promotion

776

931

Medical-Related

769

934

Nursing-Related

2,260

3,520

Healthcare Peripherals

2,245

4,665

Health Tech (Sleep Tech/Sports Tech/Baby Tech/Brain Tech/Skin Care Tech)

1,139

1,912

Telemedicine-Related (Telemedicine System/Online Medicine/Image Analysis Solutions)

243

404

Smartwear Solutions (Wearable Device that Acquires Biological Information by Wearing Clothes)

1.3

281

Surgery/Treatment Support Robot

76

171

Source: Fuji Chimera Research Institute Wearable / Healthcare Business Survey 2021 and Future Outlook for IoMT New Market 2021

2020 Exchange Rate of 106.8 Yen /USD

Opportunities

Japan’s medical device market remains heavily dependent on imports, especially sophisticated medical devices.  The demand for advanced medical technologies is expected to increase as Japan has a fast-aging demographic profile.  Japan’s relatively prosperous seniors have increasingly high expectations for improved quality of life in their later years.  Opportunities in Japan exist for innovative new medical technologies and therapies that alleviate pain, complement lost functions, and improve quality of life.  Specific medical devices that are likely to see increased sales potential are minimally invasive medical devices as well as medical technologies and diagnostics utilizing Internet of things (“IoT”) and Artificial Intelligence (“AI”) technologies.  Other medical devices that will likely enjoy increased market opportunities are those associated with telemedicine, in-home care, self-care, and preventive care.

U.S. medical device technology has been traditionally well-received in Japan because of its perceived high quality.  However, Japan’s medical device market is sophisticated and mature with both well-established local and foreign medical device companies. 

Japan’s medical device market is also highly regulated by the Pharmaceutical and Medical Device Act.  A Japanese importer that intends to market a U.S. medical device needs to receive a license for manufacturing/marketing business.  The importer holding this license is a Marketing Authorization Holder (MAH) and is responsible for safety and quality of devices entering the Japanese market by properly managing the manufacturing and quality control of the devices, post-marketing surveillance activities, and other measures.  As such, Japanese importers are conservative when selecting new medical devices and typically seek to import those devices that provide a significant improvement in clinical outcomes, reduce healthcare costs, have clearly differentiated capabilities, and are generally cost-effective.

Resources

Government of Japan Agencies

Ministry of Health, Labor and Welfare (“MHLW”)
 

Medical Device Organizations

The Federation of Japan Pharmaceutical Wholesalers Association (“JPWA”)

Japan Bioindustry Association “(JBA”)

Prime Minister’s Office of Japan

Japan Generic Medicines Association (“JGA”)

The Japan Pharmaceutical Manufacturers Association (“JPMA”)

Medical Japan

Pharmaceutical and Medical Device Agency (“PMDA”)

Pharmaceutical and Medical Device Regulatory Science Society of Japan (“PMRJ”; http://www.pmrj.jp/ )

Pharmaceutical Research and Manufacturers of America (“PhRMA”)

The Pharmaceutical Society of Japan (“PSJ”)
 

Annual Trade Events

CPhI Japan
February (Chiba) / October (Osaka)

MEDTEC Japan;  http://www.medtecjapan.com/en)
April (Tokyo)

International Technical Exhibition of Medical Imaging (ITEM)
April (Tokyo)

INTERPHEX Week JAPAN
April (Yokohama)

International Modern Hospital Show (IMHS)
July (Chiba)

Bio Japan
July (Tokyo)

HOSPEX Japan
October (Tokyo)

Commercial Service Japan

For additional information about Japan’s medical device business sector, please contact Commercial Service Japan (“CS Japan”) at Office.Tokyo@trade.gov, Mr. Hiroyuki Hanawa at Hiroyuki.Hanawa@trade.gov, or Ms. Akiko Sugiura at Akiko.Sugiura@trade.gov.