의료기기 아웃소싱 시장 규모, 점유율, 동향 분석 보고서 : 클래스별, 서비스별, 용도별, 지역별, 부문별 예측(2026-2033년)
Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Class Type, By Service, By Application, By Region, And Segment Forecasts, 2026 - 2033
상품코드:1941539
리서치사:Grand View Research
발행일:2026년 01월
페이지 정보:영문 150 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
의료기기 아웃소싱 시장 요약
세계의 의료기기 아웃소싱 시장 규모는 2025년에 1,577억 9,000만 달러로 추정되며, 2033년까지 4,219억 달러에 달할 것으로 예측됩니다.
2026년부터 2033년까지 CAGR 13.36%로 성장할 것으로 예상됩니다. 시장 성장은 의료기기에 대한 수요 증가와 더불어 가격 경쟁 심화 및 비용 절감의 필요성에 의해 주도되고 있습니다.
규제 당국의 승인 절차가 더욱 엄격하고 시간이 오래 걸리기 때문에 시장 기업들은 첫 번째 신청에서 제품 승인을 획득하여 더 높은 시장 점유율을 확보하기 위해 노력하고 있습니다. 의료기기 제조업체는 전 세계의 다양한 사업 활동과 여러 지역에 걸쳐 지속적으로 변화하는 규제 요건에 대응해야 합니다. 변화하는 규제 요건을 준수하지 않으면 벌칙이나 지연으로 이어져 수익 손실로 이어질 수 있습니다. 세계 시장에서의 신속한 승인 획득을 목표로 하는 의료기기 제조업체의 지리적 확장은 규제 관련 업무의 아웃소싱 모델 도입 증가에 더욱 기여할 것으로 예상됩니다.
의료기기 산업은 연구개발 과정, 시장 출시 시간, 관련 안전과 품질을 훼손하지 않으면서도 비용을 지속적으로 관리해야 하는 상황에 직면해 있습니다. 새로운 기술, 공정 개발, 급속한 고령화가 부문 성장을 견인하는 요인입니다. 그 결과, 시장 경쟁의 격화에 따라 규제는 점점 더 엄격하고 복잡해지고 있습니다. 의료기기 OEM 제조업체는 업무의 일부를 아웃소싱함으로써 민첩성 향상, 운영 비용 절감, 시장 출시 시간 단축, 투자 수익률 향상 등의 이점을 얻을 수 있습니다. 또한, OEM 제조업체는 자사를 비용 중심에서 전략적 투자 대상으로 전환할 수 있습니다. 이에 따라 의료 관련 업무의 아웃소싱 서비스에 대한 수요가 창출될 것으로 예상됩니다.
목차
제1장 조사 방법과 범위
제2장 주요 요약
제3장 의료기기 아웃소싱 시장 : 변수, 동향 및 범위
제4장 의료기기 아웃소싱 시장 : 서비스별 추정·동향 분석
제5장 의료기기 아웃소싱 시장 : 용도별 추정·동향 분석
제6장 의료기기 아웃소싱 시장 : 클래스별 추정·동향 분석
제7장 의료기기 아웃소싱 시장 : 클래스별 용도별 추정·동향 분석
제8장 의료기기 아웃소싱 시장 : 지역별 추정·동향 분석(클래스별, 서비스별, 용도별)
제9장 경쟁 구도
KSM
영문 목차
영문목차
Medical Device Outsourcing Market Summary
The global medical device outsourcing market size was estimated at USD 157.79 billion in 2025 and is projected to reach USD 421.90 billion by 2033, growing at a CAGR of 13.36% from 2026 to 2033. The market growth is driven by the increasing demand for medical devices, combined with the rising price competition and the requirement to reduce costs.
Regulatory approval procedures are becoming more stringent & time-consuming, and market players aim to receive product approvals at the first attempt to gain higher market share. Medical device companies must manage continuous changes in regulatory requirements, which span various business activities and multiple geographies worldwide. Noncompliance with changing regulatory requirements may result in penalties and delays, potentially leading to a loss of revenue. Geographic expansion by medical device companies, aimed at securing speedy approvals in global markets, is expected to further contribute to an increase in the adoption of outsourcing models for regulatory affairs services.
The medical device business is under continual pressure to regulate costs without compromising on the R&D process, time to market, or the associated safety & quality. Novel technologies, process developments, and a rapidly aging population are factors driving segment growth. As a result, regulations become increasingly stringent and complex due to heightened market competition. Original Equipment Manufacturers (OEMs) of medical devices can benefit from increased agility, lower operational costs, and a reduced time to market, as well as a higher return on investment, by outsourcing some of their operations. OEMs can also transform their companies into strategic investments from cost centers. Hence, this is expected to create demand for medical affairs outsourcing services.
Global Medical Device Outsourcing Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global medical device outsourcing market report based on service, application, class type, and region:
Service Outlook (Revenue, USD Million, 2021 - 2033)
Quality Assurance
Regulatory Affairs Services
Clinical trials applications and product registrations
Regulatory writing and publishing
Legal representation
Other
Product Design and Development Services
Designing & Engineering
Machining
Molding
Packaging
Product Testing & Sterilization Services
Product Implementation Services
Product Upgrade Services
Product Maintenance Services
Contract Manufacturing
Accessories Manufacturing
Assembly Manufacturing
Component Manufacturing
Device Manufacturing
Application Outlook (Revenue, USD Million, 2021 - 2033)
Cardiology
Diagnostic Imaging
Orthopedic
IVD
Ophthalmic
General and Plastic Surgery
Drug Delivery
Prefilled Syringe
Autoinjector
Infusion Pump
Others
Dental
Endoscopy
Diabetes care
Others
Class Type Outlook (Revenue, USD Million, 2021 - 2033)
Class I
Class II
Class III
Application by Class Type Outlook (Revenue, USD Million, 2021 - 2033)
Cardiology
Class I
Class II
Class III
Diagnostic imaging
Class I
Class II
Class III
Orthopedic
Class I
Class II
Class III
IVD
Class I
Class II
Class III
Ophthalmic
Class I
Class II
Class III
General and plastic surgery
Class I
Class II
Class III
Drug delivery
Class I
Class II
Class III
Dental
Class I
Class II
Class III
Endoscopy
Class I
Class II
Class III
Diabetes care
Class I
Class II
Class III
Others
Class I
Class II
Class III
Regional Outlook (Revenue, USD Million, 2021 - 2033)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Denmark
Norway
Sweden
Asia Pacific
Japan
China
India
Australia
South Korea
Thailand
Latin America
Brazil
Argentina
Colombia
Chile
Middle East and Africa (MEA)
South Africa
Saudi Arabia
UAE
Kuwait
Oman
Qatar
Table of Contents
Chapter 1. Methodology and Scope
1.1. Market Segmentation and Scope
1.2. Market Definitions
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. GVR's internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Value chain-based analysis (Model 2)
1.7.3. Multivariate Analysis (Model 3)
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Landscape Insights
Chapter 3. Medical Device Outsourcing Market: Variables, Trends, & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Ancillary Market Outlook
3.2. Medical Device Outsourcing Market Dynamics
3.2.1. Market Driver Impact Analysis
3.2.2. Market Restraint Analysis
3.2.3. Market Opportunities
3.3. Technological Landscape
3.4. Pricing Model Analysis
3.5. Tariff Impact Analysis
3.6. Supply Chain Analysis
3.7. Market Analysis Tools
3.7.1. Porter's Five Forces Analysis
3.7.2. PESTEL by SWOT Analysis
Chapter 4. Medical Device Outsourcing Market: Service Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Global Medical Device Outsourcing Market Service Movement Analysis
4.3. Global Medical Device Outsourcing Market Size & Trend Analysis, by Service, 2021 to 2033 (USD Million)