Japan Software as a Medical Device Market Size, Share, and COVID-19 Impact Analysis, By Indication (Diabetes, Mental Health, Oncology, Cardiovascular, Respiratory Conditions, and Others), By Application (Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, and Others) and Japan Software as a Medical Device Market Insights, Industry Trend, Forecasts to 2035

Japan Software as a Medical Device Market Insights Forecasts to 2035

• The Japan Software as a Medical Device Market Size Was Estimated at USD 19.15 Million in 2024
• The Market Size is Expected to Grow at a CAGR of around 18.08% from 2025 to 2035
• The Japan Software as a Medical Device Market Size is Expected to Reach USD 119.20 Million by 2035

According to a Research Report Published by Spherical Insights & Consulting, The Japan Software as a Medical Device Market Size is anticipated to Reach USD 119.20 Million by 2035, Growing at a CAGR of 18.08% from 2025 to 2035. Japans aging population, growing need for remote healthcare, and the increasing use of AI-powered diagnostic technologies are all contributing factors to this market's rapid expansion.

Market Overview

The Japan Software as a Medical Device (SaMD) Market Size refers to software solutions that are intended for medical purposes—such as diagnosis, treatment, monitoring, or prevention of diseases—without being part of a physical medical device.  Software as a medical device (SaMD) is intended for use in medicine, facilitating clinical decision-making, patient monitoring, illness diagnosis, and therapy suggestions. It enhances patient outcomes and healthcare delivery by utilizing cutting-edge technology including artificial intelligence (AI), machine learning, and cloud computing. SaMD is very accessible and scalable because it runs independently on platforms such as smartphones, tablets, and cloud-based systems.

Report Coverage

This research report categorizes the market for the Japan software as a medical device market based on various segments and regions and forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the Japan software as a medical device market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the Japan software as a medical device market.

Driving Factors

The combination of cloud computing and IoT is transforming the Software as a Medical Device (SaMD) sector in Japan. Cloud-based technologies improve productivity and decision-making by providing medical data with powerful analytics, real-time access, and safe storage. Continuous patient monitoring, remote diagnostics, and early disease identification are made possible by IoT devices, which lower hospital stays and enhance patient outcomes. Cloud computing and IoT are working together to improve healthcare accessibility, increase market prospects, and speed up innovation.

Restraining Factors

The low level of digital literacy among senior citizens and medical professionals in Japan makes it difficult to implement Software as a Medical Device (SaMD) solutions. The advantages of AI-driven diagnostics and remote monitoring are limited by the older population's difficulties with digital health applications.

Market Segmentation

The Japan software as a medical device market share is classified into indication and application.

• The diabetes segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The Japan software as a medical device market is segmented by indication into diabetes, mental health, oncology, cardiovascular, respiratory conditions, and others. Among these, the diabetes segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period. This is largely due to the high and growing prevalence of diabetes in Japan, particularly among the aging population. SaMD solutions for diabetes such as continuous glucose monitoring apps, insulin dose calculators, and AI-driven lifestyle management tools are widely adopted for their ability to support real-time monitoring and personalized care.

• The diagnostics segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The Japan software as a medical device market is segmented by application into disease management, diagnostics, treatment monitoring, predictive health analytics, and others. Among these, the diagnostics segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period. Diagnostics is the process of using a variety of tests, evaluations, and analyses to diagnose illnesses, disorders, or medical anomalies. Imaging, lab work, and clinical assessments are all included.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the Japan software as a medical device market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Japan Medical Device Corporation
• Nipro CorporatioN
• Micron, Inc.
• Olympus Medical Systems
• Anaut Inc.
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Market Segment

This study forecasts revenue at Japan, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the Japan Software as a Medical Device Market based on the following segments:

Japan Software as A Medical Device Market, By Indication

• Diabetes
• Mental Health
• Oncology
• Cardiovascular
• Respiratory Conditions
• Others

Japan Software as A Medical Device Market, By Application

• Disease Management
• Diagnostics
• Treatment Monitoring
• Predictive Health Analytics
• Others