医療機器アウトソーシング市場- 世界の産業規模、シェア、動向、機会、予測、サービス別、用途別、クラス別、地域別、競合別セグメント、2020-2030F

医療機器アウトソーシングの世界市場規模は、2024年に1,316億6,000万米ドルとなり、2030年には2,708億6,000万米ドルに達すると予測され、予測期間中のCAGRは12.75%で拡大します。

この成長の背景には、高品質な医療機器に対する需要の高まり、規制の複雑化、コスト効率の高い運用の必要性があります。相手先ブランド製造業者（OEM）は、設計、製造、包装、物流などのプロセスを合理化するためにアウトソーシングを利用するようになっており、イノベーションとコアコンピタンスに集中できるようになっています。この業界の進化は、自動化、デジタル統合の進展、個別化された医療機器への嗜好の高まりによっても形作られています。競争が激化する中、アウトソーシングは市場投入までの時間を短縮し、製品品質を高め、規制コンプライアンスを維持する上で戦略的優位性を提供します。

市場促進要因

費用対効果の高いソリューションに対する需要の高まり

主な市場課題

知的財産（IP）リスク

主な市場動向

分析試験サービスの拡大

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の医療機器アウトソーシング市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • サービス別（品質保証、規制関連サービス、製品設計・開発サービス、製品試験・滅菌サービス、製品実装サービス、製品アップグレードサービス、製品保守サービス、契約製造）
  • 用途別（心臓病学、診断画像、整形外科、体外診断、眼科、一般外科および形成外科、ドラッグデリバリー、歯科、内視鏡検査、糖尿病ケア、その他）
  • クラス別（クラスI、クラスII、クラスIII）
  • 企業別（2024）
  • 地域別
• 市場マップ

第6章 北米の医療機器アウトソーシング市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第7章 欧州の医療機器アウトソーシング市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第8章 アジア太平洋地域の医療機器アウトソーシング市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • 韓国
  • 日本
  • オーストラリア

第9章 南米の医療機器アウトソーシング市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの医療機器アウトソーシング市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 合併と買収
• 製品上市
• 最近の動向

第13章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第14章 競合情勢

• Laboratory Corporation of America Holdings
• Pace Analytical Services, Inc.
• Intertek Group plc
• Charles River Laboratories
• Medical Device Testing Services
• PAREXEL International Corporation
• Accell Clinical Research, LLC
• Criterium, Inc.
• ICON plc.
• IQVIA Inc.
• Integer Holdings Corporation

第15章 戦略的提言

第16章 調査会社について・免責事項

The Global Medical Device Outsourcing Market was valued at USD 131.66 Billion in 2024 and is projected to reach USD 270.86 Billion by 2030, expanding at a CAGR of 12.75% during the forecast period. This growth is driven by rising demand for high-quality medical devices, increasing regulatory complexities, and the need for cost-efficient operations. Original Equipment Manufacturers (OEMs) are increasingly turning to outsourcing to streamline processes like design, manufacturing, packaging, and logistics, allowing them to focus on innovation and core competencies. The industry's evolution is also being shaped by advancements in automation, digital integration, and a growing preference for personalized medical devices. As competition intensifies, outsourcing offers a strategic edge in reducing time-to-market, enhancing product quality, and maintaining regulatory compliance.

Key Market Drivers

Rising Demand for Cost-Effective Solutions

The rising need for cost-effective production strategies is a primary force fueling the global medical device outsourcing market. As healthcare expenditures escalate worldwide, manufacturers are under pressure to maintain high product quality while cutting operational costs. Outsourcing offers a viable solution, allowing OEMs to delegate non-core tasks such as product design, manufacturing, testing, and packaging to third-party experts, often in cost-effective regions. This shift reduces capital investment in facilities, labor, and technology, enabling companies to focus on R&D and innovation. In addition to reducing costs, outsourcing accelerates product development cycles and time-to-market, especially important in highly competitive markets. Furthermore, in cost-sensitive emerging economies, outsourcing helps deliver affordable medical devices without compromising on safety or standards, thereby increasing market accessibility and driving strategic collaborations across the industry.

Key Market Challenges

Intellectual Property (IP) Risks

Intellectual property protection remains a critical challenge in the global medical device outsourcing landscape. As OEMs outsource core functions, they often share proprietary technologies and designs with external partners, raising concerns over IP theft and unauthorized replication. This is particularly concerning in regions with limited regulatory enforcement or weaker IP laws. Infringements can result in financial losses, reputational harm, and reduced market competitiveness. Furthermore, disagreements over ownership rights and licensing can delay product development and lead to legal disputes. To mitigate these risks, companies must adopt stringent contractual frameworks, enforce non-disclosure agreements, and carefully vet outsourcing partners for compliance with international IP standards. Vigilance in IP management is vital for sustaining innovation and securing competitive advantage in the outsourcing ecosystem.

Key Market Trends

Expansion of Analytical Testing Services

The growing complexity of medical devices has increased the demand for advanced analytical testing services, a key trend shaping the global medical device outsourcing market. Regulatory authorities like the FDA are intensifying scrutiny, especially for emerging technologies such as AI-enabled devices. In 2023 alone, the FDA approved 221 AI-powered devices, up from just six in 2015. This surge requires rigorous testing to ensure safety and effectiveness, propelling the need for outsourced analytical expertise. Additionally, adherence to global standards such as ISO 13485-which had over 20,000 valid certifications globally by the end of 2023-further underscores the critical role of robust quality management systems. Outsourcing analytical testing allows manufacturers to access specialized labs, reduce compliance risks, and maintain consistent quality throughout the product lifecycle. This trend is expected to gain momentum as medical devices become increasingly sophisticated and regulated.

Key Market Players

• Laboratory Corporation of America Holdings
• Pace Analytical Services, Inc.
• Intertek Group plc
• Charles River Laboratories
• Medical Device Testing Services
• PAREXEL International Corporation
• Accell Clinical Research, LLC
• Criterium, Inc.
• ICON plc.
• IQVIA Inc.
• Integer Holdings Corporation

Report Scope:

In this report, the Global Medical Device Outsourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Medical Device Outsourcing Market, By Service:

• Quality Assurance
• Regulatory Affairs Services
• Product Design and Development Services
• Product Testing & Sterilization Services
• Product Implementation Services
• Product Upgrade Services
• Product Maintenance Services
• Contract Manufacturing

Medical Device Outsourcing Market, By Application:

• Cardiology
• Diagnostic Imaging
• Orthopedic
• IVD
• Ophthalmic
• General and Plastic Surgery
• Drug Delivery
• Dental
• Endoscopy
• Diabetes Care
• Others

Medical Device Outsourcing Market, By Class:

• Class I
• Class II
• Class III

Medical Device Outsourcing 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 Medical Device Outsourcing Market.

Available Customizations:

Global Medical Device Outsourcing 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, and Trends

4. Voice of Customer

5. Global Medical Device Outsourcing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Service (Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing)
  • 5.2.2. By Application (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care, Others)
  • 5.2.3. By Class (Class I, Class II, Class III)
  • 5.2.4. By Company (2024)
  • 5.2.5. By Region
• 5.3. Market Map

6. North America Medical Device Outsourcing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Service
  • 6.2.2. By Application
  • 6.2.3. By Class
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Medical Device Outsourcing 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 Service
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By Class
  • 6.3.2. Mexico Medical Device Outsourcing 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 Service
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By Class
  • 6.3.3. Canada Medical Device Outsourcing 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 Service
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By Class

7. Europe Medical Device Outsourcing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Service
  • 7.2.2. By Application
  • 7.2.3. By Class
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Medical Device Outsourcing 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 Service
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By Class
  • 7.3.2. Germany Medical Device Outsourcing 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 Service
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By Class
  • 7.3.3. United Kingdom Medical Device Outsourcing 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 Service
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By Class
  • 7.3.4. Italy Medical Device Outsourcing 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 Service
      • 7.3.4.2.2. By Application
      • 7.3.4.2.3. By Class
  • 7.3.5. Spain Medical Device Outsourcing 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 Service
      • 7.3.5.2.2. By Application
      • 7.3.5.2.3. By Class

8. Asia-Pacific Medical Device Outsourcing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Service
  • 8.2.2. By Application
  • 8.2.3. By Class
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Medical Device Outsourcing 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 Service
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By Class
  • 8.3.2. India Medical Device Outsourcing 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 Service
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By Class
  • 8.3.3. South Korea Medical Device Outsourcing 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 Service
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By Class
  • 8.3.4. Japan Medical Device Outsourcing 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 Service
      • 8.3.4.2.2. By Application
      • 8.3.4.2.3. By Class
  • 8.3.5. Australia Medical Device Outsourcing 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 Service
      • 8.3.5.2.2. By Application
      • 8.3.5.2.3. By Class

9. South America Medical Device Outsourcing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Service
  • 9.2.2. By Application
  • 9.2.3. By Class
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Medical Device Outsourcing 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 Service
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By Class
  • 9.3.2. Argentina Medical Device Outsourcing 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 Service
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By Class
  • 9.3.3. Colombia Medical Device Outsourcing 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 Service
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By Class

10. Middle East and Africa Medical Device Outsourcing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Service
  • 10.2.2. By Application
  • 10.2.3. By Class
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Medical Device Outsourcing 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 Service
      • 10.3.1.2.2. By Application
      • 10.3.1.2.3. By Class
  • 10.3.2. Saudi Arabia Medical Device Outsourcing 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 Service
      • 10.3.2.2.2. By Application
      • 10.3.2.2.3. By Class
  • 10.3.3. UAE Medical Device Outsourcing 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 Service
      • 10.3.3.2.2. By Application
      • 10.3.3.2.3. By Class

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. Porters Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Laboratory Corporation of America Holdings
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Pace Analytical Services, Inc.
• 14.3. Intertek Group plc
• 14.4. Charles River Laboratories
• 14.5. Medical Device Testing Services
• 14.6. PAREXEL International Corporation
• 14.7. Accell Clinical Research, LLC
• 14.8. Criterium, Inc.
• 14.9. ICON plc.
• 14.10. IQVIA Inc.
• 14.11. Integer Holdings Corporation

15. Strategic Recommendations

16. About Us & Disclaimer