軟體即醫療設備(SAMD) 市場規模、佔有率和成長分析：按應用、部署模式、平台、技術、適應症、最終用戶和地區分類－2026-2033 年產業預測

2024 年全球醫療設備軟體 (SaMD) 市場價值為 107.5 億美元，預計到 2025 年將成長至 131.3 億美元，到 2033 年將成長至 649.4 億美元，在預測期（2026-2033 年）內複合年成長率為 2.12%。

軟體即醫療設備(SaMD) 的市場格局正在快速演變，這主要得益於數據整合技術的進步，該技術將病患治療結果與軟體增強功能和收入來源緊密聯繫起來。電子健康記錄和遠端監測的整合使得利用機器學習模型進行風險分層成為可能，從而實現及時調整治療方案。這項技術帶來了顯著的臨床效益，例如大幅降低心臟衰竭再入院率，吸引了保險公司對 SaMD 的投資。創業投資的湧入進一步推動了市場成長，加速了擴充性創新產品的開發。這一趨勢的特點是新興企業的興起以及醫療設備製造商與雲端原生公司之間策略合作的建立，凸顯了 SaMD 行業的巨大潛力，並拓展了其在診斷和封閉回路型治療解決方案等領域的應用範圍。

全球醫療器材軟體（SaMD）市場促進因素

全球醫療器材軟體（SaMD）市場的發展得益於監管機構透明度的提高，這簡化了開發商的核准流程。這種透明度的提高使製造商能夠從一開始就使其設計和檢驗工作與既定標準保持一致，從而縮短產品上市時間。隨著開發商對其投資的信心增強，專注於SaMD創新的公司數量顯著增加。這個充滿活力的生態系統促進了相關人員之間的合作，形成良性循環，從而提高產品品質並加快產品上市速度，最終使開發商和終端用戶都受益。

全球醫療器材軟體（SaMD）市場面臨的限制因素

全球醫療器材軟體（SaMD）市場面臨來自不同司法管轄區嚴格資料隱私法規的挑戰。供應商必須實施強大的加密方法、建立有效的知情同意管理系統並維護全面的稽核流程。這些合規要求可能導致開發週期延長和營運成本增加，尤其對於缺乏專門合規團隊的中小型企業而言。此外，對保護患者資料的日益重視可能會阻礙資料分析工作，並限制利用真實世界證據改進產品的機會。因此，企業可能會延遲進入市場或扼殺創新，從而阻礙SaMD市場的整體成長。

全球醫療器材軟體（SaMD）市場趨勢

全球醫療器材軟體（SaMD）市場正呈現出將人工智慧驅動的診斷功能整合到臨床工作流程中的顯著趨勢。這項進步實現了即時影像分析和模式識別，增強了臨床醫生的決策流程，同時最大限度地減少了對外部IT系統的依賴。隨著SaMD成為臨床實踐中的關鍵資源，演算法透明度和持續學習的重要性日益凸顯，促使醫療設備開發商和醫療服務提供者之間開展合作檢驗工作。這項轉變旨在確保符合監管要求，增強人們對人工智慧應用的信心，促進其在不同醫療領域的更廣泛應用，並最終改善患者照護。

目錄

介紹

• 調查目的
• 市場定義和範圍

調查方法

• 研究過程
• 二級資料和一級資料的方法
• 市場規模估算方法

執行摘要

• 全球市場展望
• 市場主要亮點
• 細分市場概覽
• 競爭環境概述

市場動態及展望

• 總體經濟指標
• 促進者和機會
• 抑制因素和挑戰
• 供給面趨勢
• 需求面趨勢
• 波特的分析和影響

關鍵市場分析

• 關鍵成功因素
• 影響市場的因素
• 主要投資機會
• 生態系測繪
• 2025年市場魅力指數
• PESTLE分析
• 監理情勢

全球醫療設備軟體（SAMD）市場規模：按應用領域分類

• 診斷
• 疾病監測
• 臨床決策支援（CDS）
• 治療計劃和管理
• 藥物管理
• 預防醫學與健康

全球醫療設備軟體（SAMD）市場規模：依部署模式分類

• 基於雲端的
• 現場
• 混合

全球醫療設備軟體（SAMD）市場規模：依平台分類

• 基於網路的
• 移動基地
• 桌面型

全球醫療設備軟體（SAMD）市場規模：依技術分類

• 基於人工智慧（AI）/機器學習（ML）
• 基於規則的軟體
• 傳統分析軟體

全球醫療設備軟體（SAMD）市場規模：依適應症分類

• 心血管疾病
• 糖尿病
• 腫瘤學
• 神經病學
• 呼吸系統疾病
• 心理健康
• 肌肉骨骼疾病
• 其他

全球醫療設備軟體（SAMD）市場規模：依最終用戶分類。

• 醫院和醫療保健系統
• 診所及門診醫療中心
• 診斷中心
• 家庭醫療保健環境
• 病人/消費者

全球醫療設備軟體（SAMD）市場規模：按地區分類

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太國家
• 拉丁美洲
  • 墨西哥
  • 巴西
  • 其他拉丁美洲國家
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲國家

競爭資訊

• 前五大公司對比
• 主要公司2025年的市場定位
• 主要市場公司採取的策略
• 近期市場趨勢
• 企業市場占有率分析，2025 年
• 主要公司的完整公司簡介
  • 公司詳情
  • 產品系列分析
  • 按細分市場進行企業市佔率分析
  • 銷售收入年比比較（2023-2025 年）

主要公司簡介

• GE HealthCare Technologies Inc
• Siemens Healthineers AG
• Koninklijke Philips NV
• Fujifilm Holdings Corporation
• Canon Medical Systems Corporation
• Volpara Health Technologies Limited
• Brainlab AG
• iCAD Inc
• MaxQ AI Ltd
• Viz ai Inc
• HeartFlow Inc
• IDx Technologies Inc
• Pear Therapeutics Inc
• Akili Inc
• Click Therapeutics Inc
• GlobalLogic
• ICON plc
• Medtronic plc
• ResMed Inc
• Propeller Health

結論與建議

Global Software As A Medical Device Samd Market size was valued at USD 10.75 Billion in 2024 and is poised to grow from USD 13.13 Billion in 2025 to USD 64.94 Billion by 2033, growing at a CAGR of 22.12% during the forecast period (2026-2033).

The landscape of Software as a Medical Device (SaMD) is rapidly evolving, driven by advancements in data integration that connect patient outcomes with software enhancements and revenue streams. The fusion of electronic health records and remote monitoring allows machine-learning models to deliver risk stratification, enabling timely therapeutic modifications. This technology demonstrates significant clinical benefits, such as reducing heart failure rehospitalizations by a notable percentage, attracting payer investment in SaMD. The influx of venture capital fosters scalable, innovative products, further stimulating market growth. This trend is marked by emerging players and strategic collaborations between device manufacturers and cloud-native firms, broadening applications across diagnostics and closed-loop treatment solutions, underscoring the dynamic potential within the SaMD sector.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Software As A Medical Device Samd market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Software As A Medical Device Samd Market Segments Analysis

Global software as a medical device SAMD market is segmented by application, deployment mode, platform, technology, indication, end user and region. Based on application, the market is segmented into diagnostics, disease monitoring, clinical decision support (CDS), treatment planning & management, medication management and preventive care & wellness. Based on deployment mode, the market is segmented into cloud-based, on-premises and hybrid. Based on platform, the market is segmented into web-based, mobile-based and desktop-based. Based on technology, the market is segmented into artificial intelligence (AI)/machine learning (ML)-based, rule-based software and conventional analytics software. Based on indication, the market is segmented into cardiovascular disorders, diabetes, oncology, neurology, respiratory disorders, mental health, musculoskeletal disorders and others. Based on end user, the market is segmented into hospitals & health systems, clinics & ambulatory care centers, diagnostic centers, home healthcare settings and patients/consumers. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Software As A Medical Device Samd Market

The Global Software as a Medical Device (SaMD) market is driven by the enhanced clarity provided by regulatory agencies, which enables smoother approval processes for developers. This increased transparency allows manufacturers to align their design and validation efforts with established standards from the outset, consequently abbreviating the time to market. As developers gain confidence in their investments, there is a notable rise in companies focusing on SaMD innovation. This thriving ecosystem fosters collaboration among stakeholders, creating a positive feedback loop that enhances product quality and accelerates market entry, ultimately benefiting both developers and end users.

Restraints in the Global Software As A Medical Device Samd Market

The Global Software as a Medical Device (SaMD) market faces challenges from stringent data privacy regulations across various jurisdictions. Vendors are required to implement robust encryption methods, establish effective consent management systems, and maintain comprehensive auditing practices. These compliance demands can extend development timelines and elevate operational expenses, particularly for small and medium-sized enterprises lacking dedicated compliance teams. Furthermore, a heightened emphasis on safeguarding patient data can hinder data analytics initiatives, limiting opportunities to utilize real-world evidence for enhancing products. Consequently, companies may delay market entry or scale back on innovation, which can impede the overall growth of the SaMD market.

Market Trends of the Global Software As A Medical Device Samd Market

The Global Software As A Medical Device (SaMD) market is experiencing a significant trend towards the integration of AI-driven diagnostic capabilities into clinical workflows. This advancement enables real-time image analysis and pattern recognition, enhancing decision-making processes for clinicians while minimizing dependence on external IT systems. As SaMD becomes a critical point-of-care resource, the focus on algorithm transparency and continuous learning is intensifying, leading to collaborative validation efforts among device developers and healthcare institutions. This shift aims to ensure regulatory compliance, foster trust in AI applications, and promote broader adoption across diverse medical specialties, ultimately transforming patient care.

Table of Contents

Introduction

• Objectives of the Study
• Market Definition & Scope

Research Methodology

• Research Process
• Secondary & Primary Data Methods
• Market Size Estimation Methods

Executive Summary

• Global Market Outlook
• Key Market Highlights
• Segmental Overview
• Competition Overview

Market Dynamics & Outlook

• Macro-Economic Indicators
• Drivers & Opportunities
• Restraints & Challenges
• Supply Side Trends
• Demand Side Trends
• Porters Analysis & Impact
  • Competitive Rivalry
  • Threat of Substitute
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Key Success Factors
• Market Impacting Factors
• Top Investment Pockets
• Ecosystem Mapping
• Market Attractiveness Index 2025
• PESTEL Analysis
• Regulatory Landscape

Global Software as a Medical Device Samd Market Size by Application & CAGR (2026-2033)

• Market Overview
• Diagnostics
• Disease Monitoring
• Clinical Decision Support (CDS)
• Treatment Planning & Management
• Medication Management
• Preventive Care & Wellness

Global Software as a Medical Device Samd Market Size by Deployment Mode & CAGR (2026-2033)

• Market Overview
• Cloud-Based
• On-Premises
• Hybrid

Global Software as a Medical Device Samd Market Size by Platform & CAGR (2026-2033)

• Market Overview
• Web-Based
• Mobile-Based
• Desktop-Based

Global Software as a Medical Device Samd Market Size by Technology & CAGR (2026-2033)

• Market Overview
• Artificial Intelligence (AI)/Machine Learning (ML)-Based
• Rule-Based Software
• Conventional Analytics Software

Global Software as a Medical Device Samd Market Size by Indication & CAGR (2026-2033)

• Market Overview
• Cardiovascular Disorders
• Diabetes
• Oncology
• Neurology
• Respiratory Disorders
• Mental Health
• Musculoskeletal Disorders
• Others

Global Software as a Medical Device Samd Market Size by End User & CAGR (2026-2033)

• Market Overview
• Hospitals & Health Systems
• Clinics & Ambulatory Care Centers
• Diagnostic Centers
• Home Healthcare Settings
• Patients/Consumers

Global Software as a Medical Device Samd Market Size & CAGR (2026-2033)

• North America (Application, Deployment Mode, Platform, Technology, Indication, End User)
  • US
  • Canada
• Europe (Application, Deployment Mode, Platform, Technology, Indication, End User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Application, Deployment Mode, Platform, Technology, Indication, End User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Application, Deployment Mode, Platform, Technology, Indication, End User)
  • Mexico
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Application, Deployment Mode, Platform, Technology, Indication, End User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

• GE HealthCare Technologies Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Siemens Healthineers AG
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Koninklijke Philips NV
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fujifilm Holdings Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Canon Medical Systems Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Volpara Health Technologies Limited
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Brainlab AG
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• iCAD Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• MaxQ AI Ltd
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Viz ai Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• HeartFlow Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IDx Technologies Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pear Therapeutics Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Akili Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Click Therapeutics Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GlobalLogic
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ICON plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medtronic plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ResMed Inc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Propeller Health
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations