Japan’s Medical Software Device Market Projected to Achieve US$

Last updated on December 29, 2025December 29, 2025 by RS Web Solutions on Categories Software

Table of Contents

Japan Software as a Medical Device Market

Market Size and Growth

The Japanese Software as a Medical Device Market reached a valuation of US$19.55 million in 2024. Projections indicate growth to US$96.20 million by 2033, reflecting a remarkable compound annual growth rate (CAGR) of 17.3% during the forecast period from 2025 to 2033.

The report from DataM Intelligence delves into the intricacies of this burgeoning market, spotlighting critical trends, burgeoning opportunities, and imminent challenges.

By harnessing a blend of qualitative and quantitative research techniques, DataM Intelligence seeks to arm businesses with actionable insights, thus enabling informed strategic decisions and ensuring they maintain a competitive edge in a landscape that is perpetually transforming.

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The Japan Software as a Medical Device (SaMD) Market comprises software solutions designed for medical purposes—diagnosis, monitoring, and treatment—without being tethered to any physical apparatus.

This domain includes AI-infused applications, mHealth solutions, and clinical decision-support tools that not only enhance patient care but also streamline healthcare processes and augment diagnostic precision within Japan’s healthcare framework.

Recent Key Developments in Japan

November 2025: Fujitsu Limited unveiled an AI-driven SaMD aimed at the early detection of diabetic retinopathy, subsequently receiving approval from the PMDA and being incorporated into national screening initiatives.
October 2025: NEC Corporation broadened its remote monitoring software platform, augmenting predictive analytics catered to heart failure patients through collaborations with leading hospitals.
September 2025: Canon Medical Systems launched a cloud-enabled radiology SaMD utilizing deep learning reconstruction techniques to enhance image resolution and diagnostic accuracy.

Recent Key Developments in Europe

November 2025: The European Commission ratified Decision (EU) 2025/2371, affirming the operational status of crucial EUDAMED modules, thereby mandating registrations for SaMD and other devices commencing May 2026.
November 2025: WHO Europe advocated for AI safety within SaMD, urging postponements on AI Act enforcement that overlaps with MDR to alleviate dual compliance demands for manufacturers.
October 2025: MedTech Europe published a position paper promoting risk-based Post-Market Clinical Follow-up (PMCF) strategies for low-risk SaMD under MDR, addressing fears concerning overly burdensome clinical investigations.

Key Players in the Japanese Software as a Medical Device Market

The competitive arena includes:

Japan Medical Device Corporation
Nipro Corporation
Micron, Inc
Olympus Medical Systems
Anaut Inc

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Report Highlights

Comprehensive go-to-market strategy.
A neutral perspective on market performance dynamics.
Emerging trends, competitive landscape analysis, supply and demand analytics, year-on-year growth metrics, and essential strategic evaluations.
Customized regional or country-specific reports as requested, with granular insights at the country level.
Insight into potential and niche segments and regions demonstrating significant growth potential.
Thorough analysis of market size—historical and projected, as well as assessments of TAM, SAM, SOM, and market dynamics.

Market Segmentation

a sign on the side of a building that says market

By Application: Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, Others.

By Indication: Diabetes, Mental Health, Oncology, Cardiovascular, Respiratory Conditions, Others.

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Chapter Overview

Market Overview: Insight into research scope, key manufacturers, market segments, objectives, and the years under review.
Market Landscape: Evaluation of competitive dynamics, encompassing revenue, market share, and recent advancements.
Company Profiles: In-depth studies of leading market players based on sales, product offerings, and profitability metrics.
Regional Market Outlook: Analysis of gross margins, sales trends, income, and growth forecasts segmented by region.
Market Segments: Detailed exploration of contributions from various end-user segments.
Market Forecast: Production forecasts, key producer insights, and projected value growth by category.
Research Findings: Presentation of principal findings and analytical insights of the report.
Conclusion: Summative section encapsulating the study’s primary insights.

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Source link: Openpr.com.

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