診斷軟體即醫療器材（SaMD）和放射基因組學市場規模、佔有率和成長分析：按軟體類型、應用領域、模式整合、最終用戶和地區分類－2026-2033年產業預測

2024 年全球診斷 SaMD 和放射基因組學市場價值為 350 億美元，預計到 2033 年將從 2025 年的 367.5 億美元成長至 543 億美元，預測期（2026-2033 年）的複合年成長率為 5.0%。

全球診斷用軟體即醫療器材 (SaMD) 和放射基因組學市場的主要驅動力是將先進的人工智慧與高解析度影像和基因組數據相結合，從而提高診斷準確性和臨床決策能力。此市場涵蓋軟體即醫療設備(SaMD) 工具和影像/基因組分析，可實現非侵入性表現型分析和分層治療，有助於加快治療速度並降低醫療成本。從啟發式處理到利用多模態資料集的深度學習模型的演進，凸顯了可擴展地存取帶註釋資料的重要性。這增強了演算法的穩健性，並有助於獲得監管部門的核准。影像存檔和基因組生物樣本庫之間的協同作用，能夠實現標靶治療的預測建模，從而促進與醫院和製藥公司的夥伴關係。這種合作加速了藥物研發，擴大了人工智慧驅動工具的應用，最終改善了患者預後並簡化了常規臨床工作流程。

全球診斷軟體即醫療器材（SaMD）與放射基因體學市場促進因素

人工智慧演算法和模型訓練的進步正在改變醫療設備器材軟體（SaMD）和放射基因組學，透過提供更精準可靠的診斷工具，增強臨床實踐的信心。演算法效能的提升縮短了開發週期，並使其能夠更廣泛地應用於各種成像模式，從而使開發人員能夠建立彌合現有診斷差距的解決方案。隨著醫療服務提供者認知到這些工具帶來的持續價值，投資和採用率正在激增，從而在科技公司和醫療專業人員之間形成持續創新與合作的良性循環。這種協同效應不僅推動了市場成長，也加速了該領域產品的演進。

全球診斷SAMD和放射基因組學市場的限制因素

由於不同司法管轄區的法規結構各異，全球診斷軟體和放射基因組學市場面臨許多阻礙。醫療設備軟體相關指南的不斷變化給開發商和醫療服務提供者都帶來了不確定性，使產品設計、檢驗和核准等關鍵流程變得複雜。企業往往被迫投入大量資源來應對這種複雜的監管環境，分散了對產品改進的能量。這種複雜的環境會延長新產品的上市時間，阻礙小規模創新企業進入市場，並增加合規成本，最終阻礙新參與企業和老牌企業在不同市場有效拓展產品線的能力。

全球診斷SAMD和放射基因組學市場趨勢

全球診斷SAMD和放射基因組學市場正呈現出整合多體學診斷的顯著趨勢。相關人員越來越傾向於將影像衍生放射基因組學特徵與軟體主導的診斷工作流程結合的平台。這種整合能夠提供更深入、更具臨床應用價值的見解，增強疾病的早期表徵，並有助於選擇個人化治療方法。放射學、病理學和資料科學之間的協作日益受到重視，這正在加速檢驗，並促進其在臨床實踐中的廣泛應用。此外，醫療系統優先考慮那些強調互通性、模型可解釋性透明度以及與電子健康記錄無縫整合的供應商，因為這些功能能夠顯著提高診斷可靠性並最佳化患者管理流程。

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

全球診斷軟體即醫療器材（SaMD）和放射基因組學市場規模：按軟體類型分類

• 基於人工智慧的診斷 SAMD
• 連結到放射基因組學平台
• 臨床決策支援系統（CDSS）

全球診斷軟體即醫療器材（SaMD）和放射基因組學市場規模：按應用領域分類

• 腫瘤學
• 神經病學
• 心血管影像

全球診斷軟體即醫療器材（SaMD）和放射基因組學市場規模：按模式整合分類

• 基於磁振造影的放射基因組學
• 基於CT的分析
• PET/SPECT影像

全球診斷軟體即醫療器材（SaMD）和放射基因組學市場規模：按最終用戶分類

• 診斷影像中心
• 生物技術和製藥公司的研究與開發
• 三級醫療醫院

全球診斷軟體即醫療器材（SaMD）和放射基因組學市場規模：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
• 主要企業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
• 主要企業完整公司簡介
  • 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）

主要企業簡介

• GE HealthCare
• Siemens Healthineers
• Philips Healthcare
• Fujifilm Holdings
• Canon Medical
• IBM Watson Health
• NVIDIA
• AiCure
• Viz.ai
• HeartFlow Inc.
• Butterfly Network
• Zebra Medical Vision
• Aidoc
• ScreenPoint Medical
• Lunit
• Riverain Technologies
• Quantib
• ContextVision
• Median Technologies
• TeraRecon

結論與建議

Global Diagnostic Samd And Radiogenomics Market size was valued at USD 35.0 Billion in 2024 and is poised to grow from USD 36.75 Billion in 2025 to USD 54.3 Billion by 2033, growing at a CAGR of 5.0% during the forecast period (2026-2033).

The global Diagnostic SaMD and Radiogenomics market is primarily driven by the integration of advanced artificial intelligence with high-resolution imaging and genomic data, which enhances diagnostic accuracy and clinical decision-making. This market encompasses software-as-medical-device tools and imaging-genomics analytics, facilitating noninvasive phenotyping and stratified therapies that expedite treatment and reduce healthcare costs. The evolution from heuristic processing to deep learning models utilizing multimodal datasets underscores the importance of scalable access to annotated data, which strengthens algorithmic robustness and attracts regulatory approval. The synergy between imaging archives and genomic biobanks enables predictive modeling for targeted therapies, fostering partnerships with hospitals and pharmaceuticals. This collaboration accelerates drug development and broadens the adoption of AI-driven tools, ultimately improving patient outcomes and streamlining workflows in routine care.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Diagnostic Samd And Radiogenomics 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 Diagnostic Samd And Radiogenomics Market Segments Analysis

Global diagnostic samd and radiogenomics market is segmented by software type, application area, modality integration, end-user and region. Based on software type, the market is segmented into AI-based Diagnostic SaMD, (Radiogenomics Platforms Link) and Clinical Decision Support Systems (CDSS). Based on application area, the market is segmented into Oncology, Neurology and Cardiovascular Imaging. Based on modality integration, the market is segmented into MRI-based Radiogenomics, CT-based Analysis and PET/SPECT Imaging. Based on end-user, the market is segmented into Diagnostic Imaging Centers, Biotech & Pharma R&D and Tertiary Care Hospitals. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Diagnostic Samd And Radiogenomics Market

The advancement of artificial intelligence algorithms and model training has significantly transformed diagnostic Software as a Medical Device (SaMD) and radiogenomics, leading to more accurate and dependable diagnostic tools that instill greater clinical confidence. This enhancement in algorithmic performance facilitates shorter development cycles and a broader application across various imaging modalities, thereby empowering developers to craft solutions that meet existing diagnostic gaps. As healthcare providers recognize the consistent value these tools bring, both investment and adoption rates surge, fostering a cycle of continuous innovation and collaboration between technology companies and healthcare professionals. This synergy not only drives market growth but also accelerates the evolution of products within the sector.

Restraints in the Global Diagnostic Samd And Radiogenomics Market

The global market for diagnostic software and radiogenomics faces significant restraints due to the varied regulatory frameworks that exist across different jurisdictions. The fluid nature of guidelines regarding software as a medical device introduces uncertainty for both developers and healthcare providers, complicating essential processes such as product design, validation, and approval. Companies are often compelled to dedicate substantial resources to navigate these complex regulatory landscapes, diverting attention from product improvement. This intricate environment can prolong the time required to introduce new products, deter smaller innovative firms, and elevate compliance costs, ultimately hindering the ability of both new entrants and established companies to effectively expand their offerings in diverse markets.

Market Trends of the Global Diagnostic Samd And Radiogenomics Market

The Global Diagnostic Samd and Radiogenomics market is witnessing a significant trend towards integrated multiomic diagnostics, where stakeholders increasingly favor platforms that merge imaging-derived radiogenomic signatures with software-driven diagnostic workflows. This integration provides deeper, clinically actionable insights that enhance early disease characterization and facilitate personalized therapeutic selections. The emphasis on collaboration among radiology, pathology, and data science is fostering accelerated validation and widespread clinical adoption. Additionally, healthcare systems are prioritizing vendors that emphasize interoperability, transparent model explainability, and seamless integration with electronic health records, as these features significantly enhance diagnostic confidence and optimize patient management pathways.

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 Diagnostic SaMD and Radiogenomics Market Size by Software Type & CAGR (2026-2033)

• Market Overview
• AI-based Diagnostic SaMD
• Radiogenomics Platforms Link
• Clinical Decision Support Systems (CDSS)

Global Diagnostic SaMD and Radiogenomics Market Size by Application Area & CAGR (2026-2033)

• Market Overview
• Oncology
• Neurology
• Cardiovascular Imaging

Global Diagnostic SaMD and Radiogenomics Market Size by Modality Integration & CAGR (2026-2033)

• Market Overview
• MRI-based Radiogenomics
• CT-based Analysis
• PET/SPECT Imaging

Global Diagnostic SaMD and Radiogenomics Market Size by End-User & CAGR (2026-2033)

• Market Overview
• Diagnostic Imaging Centers
• Biotech & Pharma R&D
• Tertiary Care Hospitals

Global Diagnostic SaMD and Radiogenomics Market Size & CAGR (2026-2033)

• North America (Software Type, Application Area, Modality Integration, End-User)
  • US
  • Canada
• Europe (Software Type, Application Area, Modality Integration, End-User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Software Type, Application Area, Modality Integration, End-User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Software Type, Application Area, Modality Integration, End-User)
  • Mexico
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Software Type, Application Area, Modality Integration, 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
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Siemens Healthineers
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Philips Healthcare
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fujifilm Holdings
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Canon Medical
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IBM Watson Health
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NVIDIA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AiCure
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Viz.ai
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• HeartFlow Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Butterfly Network
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Zebra Medical Vision
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Aidoc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ScreenPoint Medical
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lunit
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Riverain Technologies
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Quantib
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ContextVision
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Median Technologies
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TeraRecon
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations