Press release
Japan Software as a Medical Device Market is expected to reach US$ 96.20 million by 2033 | Leading key players - Japan Medical Device Corporation, Nipro Corporation, Micron, Inc
Japan Software as a Medical Device Market
The Japan Software as a Medical Device Market size reached US$ 19.55 million in 2024 and is expected to reach US$ 96.20 million by 2033, growing at a CAGR of 17.3% during the forecast period 2025-2033.
DataM Intelligence has published a new research report on "Japan Software as a Medical Device Market Size 2026". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.
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The Japan Software as a Medical Device (SaMD) Market refers to the sector involving software applications designed to perform medical functions without being part of a physical medical device. These include diagnostic, monitoring, and therapeutic software that support clinical decision-making, patient management, and disease prevention. The market encompasses regulatory-compliant software solutions used in hospitals, clinics, and remote care settings. Growth is driven by rising healthcare digitization, AI integration, increasing chronic diseases, and supportive government initiatives promoting advanced medical technologies in Japan.
Recent Key Developments of Japan:
✅ February 2026: PMDA launched fast-track approvals for AI-based diagnostic and monitoring SaMD systems.
✅ January 2026: Japan accelerated SaMD integration in hospitals via national digital healthcare programs with AI diagnostics.
✅ December 2025: Government initiatives promoted SaMD hospital adoption, emphasizing digital health for chronic condition monitoring.
✅ November 2025: PMDA enhanced guidelines for AI-powered SaMD, prioritizing transparency and validation to support aging population needs.
Recent Key Developments of United States:
✅ February 2026: Regulatory updates streamlined reimbursement pathways for SaMD therapeutics, boosting adoption in telemedicine platforms.
✅ January 2026: Major collaborations emerged between U.S. medtech firms and AI developers for wearable-integrated SaMD focused on real-time health data processing.
✅ December 2025: HHS funded new initiatives integrating SaMD with predictive analytics for chronic disease management in hospitals nationwide.
✅ November 2025: FDA accelerated approvals for AI-driven SaMD diagnostics under the Digital Health Center of Excellence, enabling faster market entry for remote monitoring tools.
List of the Key Players in the Japan Software as a Medical Device Market:
Japan Medical Device Corporation
Nipro Corporation
Micron, Inc
Olympus Medical Systems
Anaut Inc
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This Report Covers:
✔ Go-to-market Strategy.
✔ Neutral perspective on the market performance.
✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.
✔Customized regional/country reports as per request and country level analysis.
✔ Potential & niche segments and regions exhibiting promising growth covered.
✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).
Segments Covered in the Japan Software as a Medical Device 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 Outline:
Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by region, product type, application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter 2: key insights, key emerging trends, etc.
Chapter 3: Manufacturers competitive analysis, detailed analysis of Japan Software as a Medical Device manufacturers competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.
Chapter 5 & 6: Revenue of Japan Software as a Medical Device in regional level and country level. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and market size of each country in the world.
Chapter 7: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 8: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 9: Analysis of industrial chain, including the upstream and downstream of the industry.
Chapter 10: The main points and conclusions of the report.
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People Also Ask:
◆ How big is the Japan Software as a Medical Device Market in 2026?
◆ What is the projected growth rate of the Japan Software as a Medical Device Market through 2034?
◆ Who are the key players in the Japan Software as a Medical Device Market?
◆ Which region is expected to dominate the industry during the forecast period?
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DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.
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