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1968486

人工智慧驅動的視網膜影像分析市場－全球產業規模、佔有率、趨勢、機會、預測：按類型、應用、地區和競爭格局分類，2021-2031年

AI Powered Retina Image Analysis Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type, By Application, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 181 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球人工智慧驅動的視網膜成像市場預計將從 2025 年的 11.5 億美元成長到 2031 年的 17.3 億美元，複合年成長率為 7.04%。

該市場涵蓋用於數位眼底影像分析的機器學習軟體，旨在實現眼科疾病的自動檢測。主要成長要素包括需要頻繁眼科檢查的慢性疾病盛行率不斷上升，以及由於全球眼科醫師短缺而迫切需要加快診斷速度。根據國際糖尿病聯盟預測，到2024年，全球將有約5.89億成年人患有糖尿病，顯示迫切需要可擴展的篩檢工具來追蹤視網膜健康狀況。

市場概覽
預測期 2027-2031
市場規模：2025年 11.5億美元
市場規模：2031年 17.3億美元
複合年成長率：2026-2031年 7.04%
成長最快的細分市場 糖尿病視網膜病變的檢測
最大的市場 北美洲

阻礙市場擴張的主要障礙是醫療人工智慧檢驗方面嚴格的監管環境。製造商必須遵守複雜的核准程序，需要提供強力的臨床證據來證明其演算法在不同患者群體和硬體系統上的準確性。這種監管負擔構成了重大的准入門檻，並減緩了自動化診斷工具在常規醫療實踐中的應用。

市場促進因素

糖尿病視網膜病變和老齡化黃斑部病變的發生率不斷上升，是全球人工智慧驅動的視網膜成像分析市場的主要驅動力。隨著全球糖尿病患者人數的不斷成長，醫療保健系統面臨著常規視網膜篩檢的巨大需求，而眼科醫師的手動評估已無法充分應對這項挑戰。因此，迫切需要可擴展的、人工智慧驅動的解決方案來有效地篩選患者。根據美國疾病管制與預防中心 (CDC) 於 2024 年 5 月發布的 VEHSS 模型估計值報告，美國約有 960 萬人患有糖尿病視網膜病變，凸顯了製定有效篩檢通訊協定以預防視力喪失的緊迫性。

同時，越來越多的監管機構核准基於人工智慧的醫療軟體，降低了進入門檻，並證實了這些技術的臨床效用。監管機構正在為自主診斷制定明確的路徑，並鼓勵製造商將適用於桌上型和攜帶式成像設備的創新技術商業化。例如，2024年4月，AEYE Health宣布其首個使用攜帶式眼底攝影機影像診斷糖尿病視網膜病變的完全自主人工智慧解決方案獲得了FDA核准，該解決方案可幫助患者轉院治療。這項監管進展得到了強勁資金籌措的支持。 2024年，《眼科時報》報道稱，Mediwhale已籌集1,200萬美元，用於開發人工智慧驅動的視網膜掃描技術，以預測心血管疾病。

市場挑戰

醫療人工智慧有效性檢驗的嚴格監管環境是全球人工智慧驅動的視網膜成像分析市場擴張的主要障礙。企業必須提供大量的臨床證據，證明其演算法在不同的患者群體和成像設備上都能保持高精度。這種全面的檢驗要求造成了巨大的財務和營運壁壘，常常阻礙小規模的創新者將解決方案推向市場，並延緩了先進診斷工具的發布。

這些監管障礙直接導致產品商業化和市場滲透速度放緩。近期行業數據顯示，獲得核准的難度顯而易見。根據美國眼科學會 (ARVO) 2024 年的調查，自 2016 年以來開發的 47 種眼科人工智慧演算法中，僅有 26 種獲得監管部門核准。這一巨大差距凸顯了製造商在遵守監管環境方面面臨的困難，從而限制了可用自動化篩檢技術的供應，並阻礙了整體市場成長。

市場趨勢

眼科領域基礎模型和生成式人工智慧的興起，標誌著模式轉移，從針對特定任務的專用演算法轉向能夠處理各種臨床場景的通用型自監督系統。與基於有限標註資料集訓練的傳統模型不同，這些基礎模型利用龐大的未標註視網膜影像庫來學習通用特徵。這顯著減輕了數據標註的負擔，並提高了對不同人群和硬體環境的適應性。這項技術進步使得即使在影像品質波動較大的真實臨床環境中，也能實現卓越的診斷效能。例如，根據2025年6月《眼科醫生》雜誌的報道，RETFound基礎模型應用於社區醫療保健的眼底疾病篩檢時，其敏感度和特異性比標準商業人工智慧工具提高了15%以上。

同時，市場正迅速向系統性疾病生物標記的檢測領域拓展，將視網膜成像轉變為一種非侵入性的生理健康監測手段，其應用範圍已超越眼科疾病。開發人員正利用深度學習技術，增強識別視網膜中與神經退化性疾病相關的微小微血管和神經變化的能力，從而實現對以往難以診斷的疾病的早期療育。這項技術透過將視網膜分析平台的效用擴展到基層醫療和神經病學領域，創造了新的價值提案。為了凸顯這一進展，PMLiVE於2025年7月報告稱，其新開發的深度學習框架「Eye-AD」成功分析了視網膜血管結構，並以0.9355的AUC值檢測出早期阿茲海默症。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球人工智慧視網膜影像分析市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 按類型（糖尿病視網膜病變檢測、青光眼檢測、其他）
    • 透過申請（眼科診所、醫院或其他）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美人工智慧視網膜影像分析市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲人工智慧視網膜影像分析市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區人工智慧視網膜影像分析市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲人工智慧視網膜影像分析市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美人工智慧視網膜影像分析市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球人工智慧視網膜影像分析市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Altris, Inc
  • EarlySight SA
  • Eyenuk, Inc.
  • LumiThera, Inc.
  • Mediwhale Inc.
  • Optina Diagnostics
  • Optos plc
  • PulseMedica Corp.
  • Ikerian AG
  • RetInSight GmbH

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 27566

The Global AI Powered Retina Image Analysis Market is projected to increase from USD 1.15 Billion in 2025 to USD 1.73 Billion by 2031, reflecting a CAGR of 7.04%. This market encompasses machine learning software developed to analyze digital fundus images for the automated detection of ocular diseases. Primary growth drivers include the rising burden of chronic illnesses that necessitate frequent eye exams and the urgent requirement to improve diagnostic speed due to a worldwide shortage of ophthalmologists. According to the International Diabetes Federation, roughly 589 million adults were living with diabetes in 2024, highlighting the critical need for scalable screening tools to track retinal health.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 1.15 Billion
Market Size 2031USD 1.73 Billion
CAGR 2026-20317.04%
Fastest Growing SegmentDiabetic Retinopathy Detection
Largest MarketNorth America

A major obstacle hindering market expansion is the rigorous regulatory landscape regarding the validation of medical artificial intelligence. Manufacturers must navigate complicated approval procedures that require robust clinical evidence to demonstrate algorithm precision across diverse patient populations and hardware systems. This regulatory weight establishes significant barriers to entry and delays the incorporation of automated diagnostic tools into routine medical practice.

Market Driver

The growing incidence of diabetic retinopathy and age-related macular degeneration acts as a primary catalyst for the Global AI Powered Retina Image Analysis Market. As the global diabetic population increases, healthcare systems struggle with an excessive demand for regular retinal screenings that manual assessment by ophthalmologists cannot support. This burden creates a pressing need for scalable, AI-driven solutions capable of triaging patients efficiently. As noted in the 'VEHSS Modeled Estimates' report by the Centers for Disease Control and Prevention in May 2024, an estimated 9.6 million individuals in the United States were living with diabetic retinopathy, emphasizing the vital need for effective screening protocols to prevent vision loss.

Concurrently, rising regulatory approvals for AI-based medical software are lowering entry barriers and confirming the clinical utility of these technologies. Regulators are defining clearer routes for autonomous diagnostics, encouraging manufacturers to commercialize innovations that function with both tabletop and portable imaging devices. For example, AEYE Health announced in April 2024 that it received the first FDA clearance for a fully autonomous AI solution designed to diagnose referable diabetic retinopathy using handheld fundus camera images. This regulatory momentum is supported by strong investment; Ophthalmology Times reported in 2024 that Mediwhale secured $12 million to advance its AI-powered retina scan technology for cardiovascular disease prediction.

Market Challenge

The strict regulatory environment governing the validation of medical artificial intelligence serves as a major obstruction to the expansion of the Global AI Powered Retina Image Analysis Market. Companies face rigorous requirements to provide extensive clinical evidence proving that their algorithms maintain high accuracy across varied patient demographics and imaging hardware. This necessity for comprehensive validation creates substantial financial and operational entry barriers, often preventing smaller innovators from launching their solutions and delaying the release of advanced diagnostic tools.

These regulatory hurdles directly correlate with a slower rate of product commercialization and market penetration. The challenge of securing authorization is evident in recent sector data. According to the Association for Research in Vision and Ophthalmology, research in 2024 indicated that only 26 ophthalmology AI algorithms had successfully achieved regulatory approval out of 47 developed since 2016. This significant gap underscores the difficulty manufacturers face in navigating compliance landscapes, which ultimately restricts the volume of available automated screening technologies and hampers the overall growth trajectory of the market.

Market Trends

The rise of ophthalmic foundation models and generative AI marks a paradigm shift from task-specific algorithms to versatile, self-supervised systems capable of handling diverse clinical scenarios. Unlike traditional models trained on limited labeled datasets, these foundation models utilize vast repositories of unlabeled retinal images to learn generalizable features, significantly reducing the data annotation burden and improving adaptability across different demographics and hardware. This technological advancement enables superior diagnostic performance in real-world settings where image quality varies. For example, according to The Ophthalmologist in June 2025, the RETFound foundation model demonstrated greater than 15 percent better sensitivity and specificity compared to standard commercial AI tools when applied to community-based fundus disease screenings.

Simultaneously, the market is witnessing a rapid expansion into systemic disease biomarker detection, effectively transforming retinal imaging into a non-invasive window for monitoring physiological health beyond ocular pathologies. Developers are increasingly leveraging deep learning to identify subtle microvascular and neuronal changes in the retina that correlate with neurodegenerative conditions, facilitating earlier intervention for diseases that are traditionally difficult to diagnose. This capability is creating new value propositions for retinal analysis platforms by extending their utility into primary care and neurology sectors. Highlighting this progress, PMLiVE reported in July 2025 that the newly developed Eye-AD deep learning framework successfully analyzed retinal vasculature to detect early-onset Alzheimer's disease with an AUC of 0.9355.

Key Market Players

  • Altris, Inc
  • EarlySight SA
  • Eyenuk, Inc.
  • LumiThera, Inc.
  • Mediwhale Inc.
  • Optina Diagnostics
  • Optos plc
  • PulseMedica Corp.
  • Ikerian AG
  • RetInSight GmbH

Report Scope

In this report, the Global AI Powered Retina Image Analysis Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

AI Powered Retina Image Analysis Market, By Type

  • Diabetic Retinopathy Detection
  • Glaucoma Detection
  • Others

AI Powered Retina Image Analysis Market, By Application

  • Ophthalmic Clinic
  • Hospital
  • Others

AI Powered Retina Image Analysis Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global AI Powered Retina Image Analysis Market.

Available Customizations:

Global AI Powered Retina Image Analysis Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global AI Powered Retina Image Analysis Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (Diabetic Retinopathy Detection, Glaucoma Detection, Others)
    • 5.2.2. By Application (Ophthalmic Clinic, Hospital, Others)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America AI Powered Retina Image Analysis Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By Application
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States AI Powered Retina Image Analysis Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
        • 6.3.1.2.2. By Application
    • 6.3.2. Canada AI Powered Retina Image Analysis Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
        • 6.3.2.2.2. By Application
    • 6.3.3. Mexico AI Powered Retina Image Analysis Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type
        • 6.3.3.2.2. By Application

7. Europe AI Powered Retina Image Analysis Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By Application
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany AI Powered Retina Image Analysis Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
        • 7.3.1.2.2. By Application
    • 7.3.2. France AI Powered Retina Image Analysis Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
        • 7.3.2.2.2. By Application
    • 7.3.3. United Kingdom AI Powered Retina Image Analysis Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
        • 7.3.3.2.2. By Application
    • 7.3.4. Italy AI Powered Retina Image Analysis Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
        • 7.3.4.2.2. By Application
    • 7.3.5. Spain AI Powered Retina Image Analysis Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type
        • 7.3.5.2.2. By Application

8. Asia Pacific AI Powered Retina Image Analysis Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By Application
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China AI Powered Retina Image Analysis Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
        • 8.3.1.2.2. By Application
    • 8.3.2. India AI Powered Retina Image Analysis Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
        • 8.3.2.2.2. By Application
    • 8.3.3. Japan AI Powered Retina Image Analysis Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
        • 8.3.3.2.2. By Application
    • 8.3.4. South Korea AI Powered Retina Image Analysis Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Type
        • 8.3.4.2.2. By Application
    • 8.3.5. Australia AI Powered Retina Image Analysis Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Type
        • 8.3.5.2.2. By Application

9. Middle East & Africa AI Powered Retina Image Analysis Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By Application
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia AI Powered Retina Image Analysis Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
        • 9.3.1.2.2. By Application
    • 9.3.2. UAE AI Powered Retina Image Analysis Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
        • 9.3.2.2.2. By Application
    • 9.3.3. South Africa AI Powered Retina Image Analysis Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type
        • 9.3.3.2.2. By Application

10. South America AI Powered Retina Image Analysis Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By Application
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil AI Powered Retina Image Analysis Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
        • 10.3.1.2.2. By Application
    • 10.3.2. Colombia AI Powered Retina Image Analysis Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
        • 10.3.2.2.2. By Application
    • 10.3.3. Argentina AI Powered Retina Image Analysis Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type
        • 10.3.3.2.2. By Application

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global AI Powered Retina Image Analysis Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Altris, Inc
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. EarlySight SA
  • 15.3. Eyenuk, Inc.
  • 15.4. LumiThera, Inc.
  • 15.5. Mediwhale Inc.
  • 15.6. Optina Diagnostics
  • 15.7. Optos plc
  • 15.8. PulseMedica Corp.
  • 15.9. Ikerian AG
  • 15.10. RetInSight GmbH

16. Strategic Recommendations

17. About Us & Disclaimer