スマートフォン対応医療機器の世界市場：2025年～2033年

世界のスマートフォン対応医療機器の市場規模は、2024年に227億6,000万米ドルに達し、2033年には891億5,000万米ドルに達すると予測され、予測期間の2025年～2033年のCAGRは14.6%となる見込みです。

ウェアラブルECGモニター、グルコースメーター、パルスオキシメーター、デジタル聴診器などのスマートフォン対応医療機器は、携帯電話と統合して病状をモニター、診断、管理するリアルタイムヘルスケアツールです。これらのデバイスは、スマートフォンアプリケーション、ワイヤレス接続、センサーを使用して患者データを収集・送信し、アクセシビリティの向上、疾患の早期発見、個別化ヘルスケアを実現するもので、現代のデジタルヘルスソリューションの重要な一部となっています。

世界のスマートフォン対応医療機器市場は、特に慢性疾患における遠隔医療と遠隔患者モニタリングの増加により勢いを増しています。これらの機器はリアルタイムのデータ追跡を提供し、患者の転帰を改善します。モバイルヘルスソリューションの利便性、ワイヤレス接続の進歩、AI主導の診断が市場成長の原動力となっている一方、スマートフォンの普及率の上昇や非侵襲的モニタリングに対する患者の嗜好も需要を押し上げています。

例えば、デジタル医療とバイオマーカーの主要企業であるElectronRxは2024年12月、CES 2025で医療機器基準を満たすように設計された心肺評価アプリpurpleDxを発表しました。このアプリは、慢性呼吸器疾患患者が自宅で肺機能をモニターすることを可能にし、臨床医が治療計画をカスタマイズし、患者の転帰を改善するためのリアルタイムのデータを提供します。

世界のスマートフォン対応医療機器市場は、データプライバシーとセキュリティの懸念による課題に直面しています。これらの医療機器は機密性の高い患者の健康データを収集・送信するため、サイバー脅威や不正アクセスに対して脆弱です。標準化されたデータ保護規制がないためコンプライアンスが複雑化し、第三者によるアクセス、ハッキングリスク、医療情報の悪用の可能性に対する懸念が普及を妨げています。

当レポートでは、世界のスマートフォン対応医療機器市場について調査し、市場の概要とともに、製品タイプ別、用途別、エンドユーザー別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 市場のイントロダクションと範囲

• 報告書の目的
• 調査範囲と定義
• 調査範囲

第2章 エグゼクティブの洞察と重要なポイント

第3章 市場のハイライトと戦略的ポイント

• 主な動向と将来の予測

第4章 製品タイプ別概要

• 用途別
• エンドユーザー別
• 地域別

第5章 市場力学

• 影響要因
  • 促進要因
  • 抑制要因
  • 機会
  • 影響分析

第6章 戦略的洞察と業界展望

• 市場のリーダーと先駆者
• CXOの視点
• 最新の開発とブレークスルー
• ケーススタディ/進行中の調査
• 規制と償還の情勢
• ポーターのファイブフォース分析
• サプライチェーン分析
• 特許分析
• SWOT分析
• アンメットニーズとギャップ
• 市場参入と拡大のための推奨戦略
• シナリオ分析ベストケース、ベースケース、ワーストケースの予測
• 価格分析と価格動向
• キーオピニオンリーダー

第7章 製品タイプ別

• 診断機器
• モニタリング機器
• 治療機器
• フィットネスおよびウェルネス機器
• その他

第8章 用途別

• 患者モニタリング
• 慢性疾患管理
• フィットネストラッキング
• リモート診断

第9章 エンドユーザー別

• 病院・クリニック
• 在宅医療
• フィットネスセンター

第10章 地域市場分析と成長機会

第11章 イントロダクション

• 北米
  • 地域特有の主な動向
    • 米国
    • カナダ
• 欧州
  • 地域特有の主要な動向
    • ドイツ
    • 英国
    • フランス
    • スペイン
    • イタリア
    • その他
• ラテンアメリカ
  • 地域特有の主な動向
    • メキシコ
    • ブラジル
    • アルゼンチン
    • その他
• アジア太平洋
  • 地域特有の主な動向
    • 中国
    • インド
    • 日本
    • 韓国
    • その他
• 中東・アフリカ
  • 地域特有の主要な動向

第12章 競合情勢と市場ポジショニング

第13章 競合状況の概要と主要参入企業

• 市場シェア分析とポジショニングマトリックス
• 戦略的パートナーシップ、合併、買収
• 製品ポートフォリオとイノベーションにおける主な発展
• 企業ベンチマーク

第14章 企業プロファイル

• Apple Inc

第15章 財務概要

• 会社の収益
• Samsung Electronics
• DexCom, Inc
• Masimo Corporation
• Sonova Holding AG
• Oura Health Ltd
• Beurer GmbH
• Medtronic
• Abbott Laboratories
• AliveCor, Inc

第16章 仮定と調査手法

第17章 付録

The global smartphone enabled medical devices market reached US$ 22.76 billion in 2024 and is expected to reach US$ 89.15 billion by 2033, growing at a CAGR of 14.6% during the forecast period 2025-2033.

Smartphone-enabled medical devices, such as wearable ECG monitors, glucose meters, pulse oximeters, and digital stethoscopes, are real-time healthcare tools that integrate with mobile phones to monitor, diagnose, and manage medical conditions. These devices use smartphone applications, wireless connectivity, and sensors to collect and transmit patient data, improving accessibility, early disease detection, and personalized healthcare, making them a crucial part of modern digital health solutions.

Market Dynamics: Drivers & Restraints

Growing Adoption of Telemedicine and Remote Patient Monitoring

The global smartphone-enabled medical devices market is gaining momentum due to the rise in telemedicine and remote patient monitoring, particularly in chronic diseases. These devices offer real-time data tracking, improving patient outcomes. The convenience of mobile health solutions, advancements in wireless connectivity, and AI-driven diagnostics are driving market growth while increasing smartphone penetration and patient preference for non-invasive monitoring are also driving demand.

For instance, in December 2024, ElectronRx, a leading digital medicine and biomarker company, launched purpleDx, a cardiopulmonary assessment app designed to meet medical device standards at CES 2025. The app allows chronic respiratory disease patients to monitor lung function at home, providing real-time data for clinicians to customize treatment plans and improve patient outcomes.

Data Privacy and Security Concerns

The global smartphone-enabled medical devices market faces challenges due to data privacy and security concerns. These devices collect and transmit sensitive patient health data, making them vulnerable to cyber threats and unauthorized access. The lack of standardized data protection regulations complicates compliance, and concerns about third-party access, hacking risks, and potential misuse of medical information hinder widespread adoption.

Segment Analysis

The global smartphone enabled medical devices market is segmented based on product type, application, end-user and region.

Product Type:

The diagnostic devices from product type segment is expected to dominate the smartphone enabled medical devices market with the highest market share

Diagnostic devices are medical instruments used to detect, monitor, and analyze diseases in patients. They range from imaging systems like MRI and CT scans to portable tools like glucose monitors and ECG devices. Modern diagnostic devices offer enhanced accuracy, portability, and real-time data integration, making them essential in clinical and home healthcare settings.

The diagnostic devices market is driven by the rise in chronic and infectious diseases, fueled by technological advancements like AI-driven diagnostics, point-of-care testing, and smartphone-enabled devices. The focus on personalized medicine and government initiatives to improve healthcare infrastructure also contribute to market growth. Telemedicine and home-based diagnostic solutions, driven by smartphone penetration and wearable health technologies, further fuel global adoption.

For instance, in August 2023, GE HealthCare received FDA clearance for its Portrait Mobile wireless and wearable monitoring solution, which offers real-time continuous monitoring and personalized patient vitals tracking. The platform keeps patients mobile during critical recovery periods, particularly after surgery or intensive care unit discharge.

Geographical Analysis

North America is expected to hold a significant position in the smartphone enabled medical devices market with the highest market share

North America dominates the diagnostic devices market due to its advanced healthcare infrastructure, innovative medical technologies, and key industry players. The rising prevalence of chronic diseases like diabetes, cardiovascular disorders, and cancer drives demand for accurate diagnostics. Government investments, favorable reimbursement policies, telemedicine expansion, home-based diagnostic solutions, and AI-powered devices are accelerating adoption across the region.

For instance, in March 2025, Smart Meter, a leader in remote patient monitoring (RPM) solutions, partnered with FibriCheck to launch their Atrial Fibrillation (Afib) detection app in the U.S. The app uses smartphones as diagnostic tools, enabling users to control their heart health. FibriCheck uses advanced algorithms and the built-in camera on smartphones to detect irregular heart rhythms, potentially signaling Afib, a leading cause of stroke and cardiovascular complications. Smart Meter's seamless integration allows healthcare professionals to access near real-time heart rhythm data, enabling faster intervention and improved patient outcomes.

Competitive Landscape

The major global players in the smartphone enabled medical devices market include Apple Inc, Samsung Electronics, DexCom, Inc, Masimo Corporation, Sonova Holding AG, Oura Health Ltd, Beurer GmbH, Medtronic, Abbott Laboratories, and AliveCor, Inc, among others.

Why Purchase the Report?

• Technological Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global smartphone enabled medical devices market report delivers a detailed analysis with 62 key tables, more than 55 visually impactful figures and 165 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Application & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Market Introduction and Scope

• 1.1. Objectives of the Report
• 1.2. Report Coverage & Definitions
• 1.3. Report Scope

2. Executive Insights and Key Takeaways

3. Market Highlights and Strategic Takeaways

• 3.1. Key Trends and Future Projections

4. Snippet by Product Type

• 4.1. Snippet by Application
• 4.2. Snippet by End-User
• 4.3. Snippet by Region

5. Dynamics

• 5.1. Impacting Factors
  • 5.1.1. Drivers
    • 5.1.1.1. Growing Adoption of Telemedicine and Remote Patient Monitoring
    • 5.1.1.2. Increasing Penetration of Smartphones and Mobile Health Apps
  • 5.1.2. Restraints
    • 5.1.2.1. Data Privacy and Security Concerns
    • 5.1.2.2. Regulatory Challenges and Approval Complexities
  • 5.1.3. Opportunity
    • 5.1.3.1. Development of Advanced Biosensors for Real-time Health Tracking
  • 5.1.4. Impact Analysis

6. Strategic Insights and Industry Outlook

• 6.1. Market Leaders and Pioneers
  • 6.1.1. Emerging Pioneers and Prominent Players
  • 6.1.2. Established leaders with largest selling Brand
  • 6.1.3. Market leaders with established Product
• 6.2. CXO Perspectives
• 6.3. Latest Developments and Breakthroughs
• 6.4. Case Studies/Ongoing Research
• 6.5. Regulatory and Reimbursement Landscape
  • 6.5.1. North America
  • 6.5.2. Europe
  • 6.5.3. Asia Pacific
  • 6.5.4. Latin America
  • 6.5.5. Middle East & Africa
• 6.6. Porter's Five Force Analysis
• 6.7. Supply Chain Analysis
• 6.8. Patent Analysis
• 6.9. SWOT Analysis
• 6.10. Unmet Needs and Gaps
• 6.11. Recommended Strategies for Market Entry and Expansion
• 6.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
• 6.13. Pricing Analysis and Price Dynamics
• 6.14. Key Opinion Leaders

7. By Product Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 7.1.2. Market Attractiveness Index, By Product Type
• 7.2. Diagnostic Devices*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Monitoring Devices
• 7.4. Therapeutic Devices
• 7.5. Fitness and Wellness Devices
• 7.6. Others

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Patient Monitoring*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Chronic Disease Management
• 8.4. Fitness Tracking
• 8.5. Remote Diagnostics

9. By End-User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.1.2. Market Attractiveness Index, By End-User
• 9.2. Hospitals & Clinics*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Home Care Settings
• 9.4. Fitness Centers

10. Regional Market Analysis and Growth Opportunities

11. Introduction

• 11.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 11.1.1. Market Attractiveness Index, By Region
• 11.2. North America
  • 11.2.1. Introduction
  • 11.2.2. Key Region-Specific Dynamics
  • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.2.6.1. U.S.
    • 11.2.6.2. Canada
• 11.3. Europe
  • 11.3.1. Introduction
  • 11.3.2. Key Region-Specific Dynamics
  • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.3.6.1. Germany
    • 11.3.6.2. U.K.
    • 11.3.6.3. France
    • 11.3.6.4. Spain
    • 11.3.6.5. Italy
    • 11.3.6.6. Rest of Europe
• 11.4. Latin America
  • 11.4.1. Introduction
  • 11.4.2. Key Region-Specific Dynamics
  • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.4.6.1. Mexico
    • 11.4.6.2. Brazil
    • 11.4.6.3. Argentina
    • 11.4.6.4. Rest of Latin America
• 11.5. Asia-Pacific
  • 11.5.1. Introduction
  • 11.5.2. Key Region-Specific Dynamics
  • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.5.6.1. China
    • 11.5.6.2. India
    • 11.5.6.3. Japan
    • 11.5.6.4. South Korea
    • 11.5.6.5. Rest of Asia-Pacific
• 11.6. Middle East and Africa
  • 11.6.1. Introduction
  • 11.6.2. Key Region-Specific Dynamics
  • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

12. Competitive Landscape and Market Positioning

13. Competitive Overview and Key Market Players

• 13.1. Market Share Analysis and Positioning Matrix
• 13.2. Strategic Partnerships, Mergers & Acquisitions
• 13.3. Key Developments in Product Portfolios and Innovations
• 13.4. Company Benchmarking

14. Company Profiles

• 14.1. Apple Inc*
  • 14.1.1. Company Overview
  • 14.1.2. Product Portfolio
    • 14.1.2.1. Product Description
    • 14.1.2.2. Product Key Performance Indicators (KPIs)
    • 14.1.2.3. Historic and Forecasted Product Sales
    • 14.1.2.4. Product Sales Volume

15. Financial Overview

• 15.1. Company Revenue's
  • 15.1.1. Geographical Revenue Shares
    • 15.1.1.1. Revenue Forecasts
  • 15.1.2. Key Developments
    • 15.1.2.1. Mergers & Acquisitions
    • 15.1.2.2. Key Product Development Activities
    • 15.1.2.3. Regulatory Approvals, etc.
  • 15.1.3. SWOT Analysis
• 15.2. Samsung Electronics
• 15.3. DexCom, Inc
• 15.4. Masimo Corporation
• 15.5. Sonova Holding AG
• 15.6. Oura Health Ltd
• 15.7. Beurer GmbH
• 15.8. Medtronic
• 15.9. Abbott Laboratories
• 15.10. AliveCor, Inc LIST NOT EXHAUSTIVE

16. Assumption and Research Methodology

• 16.1. Data Collection Methods
• 16.2. Data Triangulation
• 16.3. Forecasting Techniques
• 16.4. Data Verification and Validation

17. Appendix

• 17.1. About Us and Services
• 17.2. Contact Us