| 【英語タイトル】Japan Medical Devices Market Size, Share, Trends and Forecast by Type, End User, and Region, 2026-2034
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 | ・商品コード：IMA3994NR6665
・発行会社（調査会社）：IMARC
・発行日：2026年1月
・ページ数：約120
・レポート言語：英語
・レポート形式：PDF+Excel
・納品方法：Eメール（受注後3営業日）
・調査対象地域：グローバル
・産業分野：医療
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❖ レポートの概要 ❖
日本の医療機器市場規模は2025年に341億7024万米ドルに達した。今後、IMARCグループは2034年までに市場規模が567億9559万米ドルに達し、2026年から2034年にかけて年平均成長率（CAGR）5.81％で成長すると予測している。本市場の成長要因は、急速な高齢化による高度な診断・治療機器への需要拡大、医療機器の機能を変革するAI搭載・デジタルヘルスソリューションの普及、持続的な市場拡大を支える国内製造・イノベーション基盤の強化である。さらに、慢性疾患管理と予防医療の重要性増大が日本医療機器市場のシェア拡大を促進している。
高齢化が医療機器需要を牽引
日本の医療機器市場は、世界最高水準の高齢者比率を示す急速な人口高齢化に牽引され、著しい成長を遂げている。2024年時点で65歳以上人口は3,625万人（総人口の29.3％）に達し、2040年までに34.8％に達すると予測されている。
この人口構造の変化は医療ニーズを根本的に変容させ、複数カテゴリーにわたる医療機器への前例のない需要を喚起している。高齢者は心血管疾患、糖尿病、整形外科疾患、認知障害などの慢性疾患の発症率が著しく高く、高度な診断・治療ソリューションを必要とする。医療機器メーカーは、移動制限、感覚障害、複数の併存疾患管理の複雑性に対応する年齢に適した技術開発でこれに応えている。在宅医療機器は特に重要性を増しており、高齢患者が施設介護よりも自宅での生活継続を望む傾向が強まっている。この政策環境と、医療機器の広範な利用を保証する国民皆保険制度が相まって、日本の医療機器市場持続的成長に有利な条件を形成している。高齢化は機器設計の革新も促進しており、メーカーは高齢者ユーザーとその介護者向けに特化した、ユーザーフレンドリーなインターフェース、簡素化された操作手順、強化された安全機能を組み込んでいる。
医療機器におけるデジタルヘルスとAIの統合
日本の医療機器分野は、診断・治療機器への人工知能（AI）とデジタルヘルス機能の急速な統合を特徴とする技術的変革を遂げている。大塚メディカルデバイス株式会社は2025年8月、難治性高血圧症に特に適応する医療機器として、Paradise™超音波腎除神経術（uRDN）システムが日本で初の承認を取得した。これにより同社は日本で本機器の製造・販売を開始できる。この進展は、診断精度向上・処置時間短縮・臨床判断支援を目的としたAI技術の医療機器への組み込み事例を示す。AI搭載医療機器は特に画像解析分野で優位性を発揮し、機械学習アルゴリズムが放射線画像・内視鏡画像・病理標本における微細な異常を、専門家並みあるいはそれ以上の精度で検出可能である。規制環境もこうした革新に対応するため進化しており、医薬品医療機器総合機構（PMDA）はAIベースのソフトウェア医療機器（SaaS）の評価枠組みを確立し、臨床使用を通じて継続的に学習・改善する機器向けの適応型承認プロセスを実施している。デジタルヘルス統合はAIを超え、遠隔医療プラットフォーム、遠隔患者モニタリングシステム、モバイルヘルスアプリケーションまで広がり、物理的な診療所訪問を必要とせずに継続的な健康データ収集と医師相談を可能にしている。COVID-19パンデミックは、医療提供者と患者の双方におけるこれらのデジタルソリューションの受容を加速させ、パンデミック後の環境でも持続する行動パターンを確立しました。医療機関がデジタルインフラに投資し、相互運用性基準が成熟するにつれ、AI対応かつデジタル接続された医療機器の導入軌跡は大幅に加速すると予想されます。
日本医療機器市場のセグメンテーション：
IMARC Groupは、各市場セグメントの主要トレンド分析に加え、2026年から2034年までの国別・地域別予測を提供します。本レポートでは、市場をタイプ別およびエンドユーザー別に分類しています。
タイプ別インサイト：
整形外科用機器
診断用画像機器
循環器用機器
創傷管理機器
低侵襲手術（MIS）機器
糖尿病ケア機器
歯科用機器
眼科用機器
体外診断用医薬品（IVD）
一般外科
その他
本レポートでは、タイプ別市場の詳細な内訳と分析を提供しています。これには整形外科機器、診断用画像機器、心血管機器、創傷管理機器、低侵襲手術（MIS）機器、糖尿病ケア機器、歯科用機器、眼科用機器、体外診断用医薬品（IVD）、一般外科機器、その他が含まれます。
エンドユーザー別分析：
病院および外来手術センター（ASC）
診療所
その他
本レポートではエンドユーザー別の詳細な市場分析も提供しています。これには病院および外来手術センター（ASC）、診療所、その他が含まれます。
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The Japan medical devices market size reached USD 34,170.24 Million in 2025. Looking forward, IMARC Group expects the market to reach USD 56,795.59 Million by 2034, exhibiting a growth rate (CAGR) of 5.81% during 2026-2034. The market is driven by Japan’s rapidly aging population, creating substantial demand for advanced diagnostic and therapeutic devices, widespread adoption of AI-powered and digital health solutions transforming medical device capabilities, and strengthening domestic manufacturing and innovation infrastructure supporting sustained market expansion. Additionally, the growing significance of chronic disease management and preventive healthcare is expanding the Japan medical devices market share.
Aging Population Driving Medical Device Demand
Japan’s medical device market is experiencing substantial growth driven by the country’s rapidly aging demographic profile, which represents the highest proportion of elderly citizens globally. As of 2024, the nation had 36.25 million people aged 65 and over, accounting for 29.3 percent of the total population, with projections indicating this will reach 34.8 percent by 2040. This demographic transformation is fundamentally reshaping healthcare needs and driving unprecedented demand for medical devices across multiple categories. The elderly population experiences significantly higher incidence of chronic conditions including cardiovascular diseases, diabetes, orthopedic ailments, and cognitive disorders, necessitating advanced diagnostic and therapeutic solutions. Medical device manufacturers are responding by developing age-appropriate technologies that address mobility limitations, sensory impairments, and the complexity of managing multiple concurrent health conditions. Home healthcare devices are gaining particular prominence as elderly patients increasingly prefer aging in place rather than institutional care settings. This policy environment, combined with universal health insurance coverage ensuring widespread device accessibility, creates favorable conditions for sustained Japan medical devices market growth. The aging demographic also drives innovation in device design, with manufacturers incorporating user-friendly interfaces, simplified operation procedures, and enhanced safety features specifically tailored for elderly users and their caregivers.
Digital Health and AI Integration in Medical Devices
The Japanese medical device sector is undergoing a technological transformation characterized by the rapid integration of artificial intelligence and digital health capabilities into diagnostic and therapeutic equipment. Otsuka Medical Devices Co., Ltd. secured Japan’s inaugural approval for a medical device specifically indicated for resistant hypertension with its Paradise™ Ultrasound Renal Denervation (uRDN) system in August 2025. This allows the company to begin manufacturing and marketing the device in Japan. This development exemplifies how AI technologies are being embedded into medical devices to enhance diagnostic accuracy, reduce procedural times, and support clinical decision-making processes. AI-powered medical devices offer particular advantages in imaging analysis, where machine learning algorithms can detect subtle anomalies in radiological scans, endoscopic images, and pathology slides with accuracy levels comparable to or exceeding human experts. The regulatory environment is evolving to accommodate these innovations, with the Pharmaceuticals and Medical Devices Agency establishing evaluation frameworks for AI-based Software as a Medical Device and implementing adaptive approval processes for devices that continuously learn and improve through clinical use. Digital health integration extends beyond AI to encompass telemedicine platforms, remote patient monitoring systems, and mobile health applications that enable continuous health data collection and physician consultation without requiring physical clinic visits. The COVID-19 pandemic accelerated acceptance of these digital solutions among both healthcare providers and patients, establishing behavioral patterns that persist in the post-pandemic environment. As healthcare institutions invest in digital infrastructure and interoperability standards mature, the adoption trajectory for AI-enabled and digitally connected medical devices is expected to accelerate substantially.
Japan Medical Devices Market Segmentation:
IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the country and regional levels for 2026-2034. Our report has categorized the market based on type and end user.
Type Insights:
Orthopedic Devices
Diagnostic Imaging
Cardiovascular Devices
Wound Management
Minimally Invasive Surgical (MIS)
Diabetes Care
Dental Devices
Ophthalmic Devices
In Vitro Diagnostics (IVD)
General Surgery
Others
The report has provided a detailed breakup and analysis of the market based on the type. This includes orthopedic devices, diagnostic imaging, cardiovascular devices, wound management, minimally invasive surgical (MIS), diabetes care, dental devices, ophthalmic devices, in vitro diagnostics (IVD), general surgery, and others.
End User Insights:
Hospitals and Ambulatory Surgery Centers (ASCs)
Clinics
Others
A detailed breakup and analysis of the market based on the end user have also been provided in the report. This includes hospitals and ambulatory surgery centers (ASCs), clinics, and others.
1 Preface
2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology
3 Executive Summary
4 Japan Medical Devices Market – Introduction
4.1 Overview
4.2 Market Dynamics
4.3 Industry Trends
4.4 Competitive Intelligence
5 Japan Medical Devices Market Landscape
5.1 Historical and Current Market Trends (2020-2025)
5.2 Market Forecast (2026-2034)
6 Japan Medical Devices Market – Breakup by Type
6.1 Orthopedic Devices
6.1.1 Overview
6.1.2 Historical and Current Market Trends (2020-2025)
6.1.3 Market Forecast (2026-2034)
6.2 Diagnostic Imaging
6.2.1 Overview
6.2.2 Historical and Current Market Trends (2020-2025)
6.2.3 Market Forecast (2026-2034)
6.3 Cardiovascular Devices
6.3.1 Overview
6.3.2 Historical and Current Market Trends (2020-2025)
6.3.3 Market Forecast (2026-2034)
6.4 Wound Management
6.4.1 Overview
6.4.2 Historical and Current Market Trends (2020-2025)
6.4.3 Market Forecast (2026-2034)
6.5 Minimally Invasive Surgical (MIS)
6.5.1 Overview
6.5.2 Historical and Current Market Trends (2020-2025)
6.5.3 Market Forecast (2026-2034)
6.6 Diabetes Care
6.6.1 Overview
6.6.2 Historical and Current Market Trends (2020-2025)
6.6.3 Market Forecast (2026-2034)
6.7 Dental Devices
6.7.1 Overview
6.7.2 Historical and Current Market Trends (2020-2025)
6.7.3 Market Forecast (2026-2034)
6.8 Ophthalmic Devices
6.8.1 Overview
6.8.2 Historical and Current Market Trends (2020-2025)
6.8.3 Market Forecast (2026-2034)
6.9 In Vitro Diagnostics (IVD)
6.9.1 Overview
6.9.2 Historical and Current Market Trends (2020-2025)
6.9.3 Market Forecast (2026-2034)
6.10 General Surgery
6.10.1 Overview
6.10.2 Historical and Current Market Trends (2020-2025)
6.10.3 Market Forecast (2026-2034)
6.11 Others
6.11.1 Historical and Current Market Trends (2020-2025)
6.11.2 Market Forecast (2026-2034)
7 Japan Medical Devices Market – Breakup by End User
7.1 Hospitals and Ambulatory Surgery Centers (ASCs)
7.1.1 Overview
7.1.2 Historical and Current Market Trends (2020-2025)
7.1.3 Market Forecast (2026-2034)
7.2 Clinics
7.2.1 Overview
7.2.2 Historical and Current Market Trends (2020-2025)
7.2.3 Market Forecast (2026-2034)
7.3 Others
7.3.1 Historical and Current Market Trends (2020-2025)
7.3.2 Market Forecast (2026-2034)
8 Japan Medical Devices Market – Breakup by Region
8.1 Kanto Region
8.1.1 Overview
8.1.2 Historical and Current Market Trends (2020-2025)
8.1.3 Market Breakup by Type
8.1.4 Market Breakup by End User
8.1.5 Key Players
8.1.6 Market Forecast (2026-2034)
8.2 Kansai/Kinki Region
8.2.1 Overview
8.2.2 Historical and Current Market Trends (2020-2025)
8.2.3 Market Breakup by Type
8.2.4 Market Breakup by End User
8.2.5 Key Players
8.2.6 Market Forecast (2026-2034)
8.3 Central/Chubu Region
8.3.1 Overview
8.3.2 Historical and Current Market Trends (2020-2025)
8.3.3 Market Breakup by Type
8.3.4 Market Breakup by End User
8.3.5 Key Players
8.3.6 Market Forecast (2026-2034)
8.4 Kyushu-Okinawa Region
8.4.1 Overview
8.4.2 Historical and Current Market Trends (2020-2025)
8.4.3 Market Breakup by Type
8.4.4 Market Breakup by End User
8.4.5 Key Players
8.4.6 Market Forecast (2026-2034)
8.5 Tohoku Region
8.5.1 Overview
8.5.2 Historical and Current Market Trends (2020-2025)
8.5.3 Market Breakup by Type
8.5.4 Market Breakup by End User
8.5.5 Key Players
8.5.6 Market Forecast (2026-2034)
8.6 Chugoku Region
8.6.1 Overview
8.6.2 Historical and Current Market Trends (2020-2025)
8.6.3 Market Breakup by Type
8.6.4 Market Breakup by End User
8.6.5 Key Players
8.6.6 Market Forecast (2026-2034)
8.7 Hokkaido Region
8.7.1 Overview
8.7.2 Historical and Current Market Trends (2020-2025)
8.7.3 Market Breakup by Type
8.7.4 Market Breakup by End User
8.7.5 Key Players
8.7.6 Market Forecast (2026-2034)
8.8 Shikoku Region
8.8.1 Overview
8.8.2 Historical and Current Market Trends (2020-2025)
8.8.3 Market Breakup by Type
8.8.4 Market Breakup by End User
8.8.5 Key Players
8.8.6 Market Forecast (2026-2034)
9 Japan Medical Devices Market – Competitive Landscape
9.1 Overview
9.2 Market Structure
9.3 Market Player Positioning
9.4 Top Winning Strategies
9.5 Competitive Dashboard
9.6 Company Evaluation Quadrant
10 Profiles of Key Players
10.1 Company A
10.1.1 Business Overview
10.1.2 Products Offered
10.1.3 Business Strategies
10.1.4 SWOT Analysis
10.1.5 Major News and Events
10.2 Company B
10.2.1 Business Overview
10.2.2 Products Offered
10.2.3 Business Strategies
10.2.4 SWOT Analysis
10.2.5 Major News and Events
10.3 Company C
10.3.1 Business Overview
10.3.2 Products Offered
10.3.3 Business Strategies
10.3.4 SWOT Analysis
10.3.5 Major News and Events
10.4 Company D
10.4.1 Business Overview
10.4.2 Products Offered
10.4.3 Business Strategies
10.4.4 SWOT Analysis
10.4.5 Major News and Events
10.5 Company E
10.5.1 Business Overview
10.5.2 Products Offered
10.5.3 Business Strategies
10.5.4 SWOT Analysis
10.5.5 Major News and Events
Company names have not been provided here as this is a sample TOC. Complete list to be provided in the final report.
11 Japan Medical Devices Market – Industry Analysis
11.1 Drivers, Restraints, and Opportunities
11.1.1 Overview
11.1.2 Drivers
11.1.3 Restraints
11.1.4 Opportunities
11.2 Porters Five Forces Analysis
11.2.1 Overview
11.2.2 Bargaining Power of Buyers
11.2.3 Bargaining Power of Suppliers
11.2.4 Degree of Competition
11.2.5 Threat of New Entrants
11.2.6 Threat of Substitutes
11.3 Value Chain Analysis
12 Appendix
