Medical Device Outsourcing Market Size, Share Detailed Report 2026 to 2035

Report Id: 1698 Pages: 180 Last Updated: 12 January 2026 Format: PDF / PPT / Excel / Power BI
Share With : linkedin twitter facebook

Segmentation of Medical Device Outsourcing Market-

Medical Device Outsourcing Market By Service-

  • 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

Medical Device Outsourcing Market

Medical Device Outsourcing Market By Class Type-

  • Class I
  • Class II
  • Class III

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 Region-

North America-

  • The US
  • Canada

Europe-

  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe

Asia-Pacific-

  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South Africa
  • Rest of the Middle East and Africa

Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Medical Device Outsourcing Market Snapshot

Chapter 4. Global Medical Device Outsourcing Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Industry Analysis – Porter’s Five Forces Analysis
4.7. Competitive Landscape & Market Share Analysis
4.8. Impact of Covid-19 Analysis

Chapter 5. Market Segmentation 1: by Service Estimates & Trend Analysis
5.1. by Service & Market Share, 2025 & 2035
5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2022 to 2035 for the following by Service:

5.2.1. Quality Assurance

5.2.2. Regulatory Affairs Services

5.2.2.1. Clinical trials applications and product registrations
5.2.2.2. Regulatory writing and publishing
5.2.2.3. Legal representation
5.2.2.4. Other

5.2.3. Product Design and Development Services

5.2.3.1. Designing & Engineering
5.2.3.2. Machining
5.2.3.3. Molding
5.2.3.4. Packaging

5.2.4. Product Testing & Sterilization Services
5.2.5. Product Implementation Services
5.2.6. Product Upgrade Services
5.2.7. Product Maintenance Services

5.2.8. Contract Manufacturing

5.2.8.1. Accessories Manufacturing
5.2.8.2. Assembly Manufacturing
5.2.8.3. Component Manufacturing
5.2.8.4. Device Manufacturing

Chapter 6. Market Segmentation 2: by Class Type Estimates & Trend Analysis
6.1. by Class Type & Market Share, 2025 & 2035
6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2022 to 2035 for the following by Class Type:

6.2.1. Class I
6.2.2. Class II
6.2.3. Class III

Chapter 7. Market Segmentation 3: by Application Estimates & Trend Analysis
7.1. by Application & Market Share, 2025 & 2035
7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2022 to 2035 for the following by Application:

7.2.1. Cardiology
7.2.2. Diagnostic imaging
7.2.3. Orthopedic
7.2.4. IVD
7.2.5. Ophthalmic
7.2.6. General and plastic surgery
7.2.7. Drug delivery
7.2.8. Dental
7.2.9. Endoscopy
7.2.10. Diabetes care
7.2.11. Others

Chapter 8. Medical Device Outsourcing Market Segmentation 4: Regional Estimates & Trend Analysis

8.1. North America

8.1.1. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2022 - 2035
8.1.2. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2022 - 2035
8.1.3. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2022 - 2035
8.1.4. North America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2022 - 2035

8.2. Europe

8.2.1. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2022 - 2035
8.2.2. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2022 - 2035
8.2.3. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2022 - 2035
8.2.4. Europe Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2022 - 2035

8.3. Asia Pacific

8.3.1. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2022 - 2035
8.3.2. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2022 - 2035
8.3.3. Asia-Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2022 - 2035
8.3.4. Asia Pacific Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2022 - 2035

8.4. Latin America

8.4.1. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2022 - 2035
8.4.2. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2022 - 2035
8.4.3. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2022 - 2035
8.4.4. Latin America Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2022 - 2035

8.5. Middle East & Africa

8.5.1. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Service, 2022 - 2035
8.5.2. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Class Type, 2022 - 2035
8.5.3. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2022 - 2035
8.5.4. Middle East & Africa Medical Device Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2022 - 2035

Chapter 9. Competitive Landscape

9.1. Major Mergers and Acquisitions/Strategic Alliances

9.2. Company Profiles

9.2.1. SGS SA
9.2.2. Laboratory Corporation of America Holdings
9.2.3. Euro fins Scientific
9.2.4. Pace Analytical Services, Inc.
9.2.5. Intertek Group plc
9.2.6. WuXiAppTec
9.2.7. North American Science Associates, LLC
9.2.8. TÜV SÜD
9.2.9. Sterigenics U.S.
9.2.10. LLC (GTCR, LLC)
9.2.11. Charles River Laboratories
9.2.12. Medical Device Testing Services
9.2.13. RJR Consulting, Inc.
9.2.14. Mandala International.
9.2.15. Freyr
9.2.16. Global Regulatory Partners
9.2.17. PAREXEL International Corporation (EQT Private Equity and Goldman Sachs Asset Management)
9.2.18. Emergo (UL LLC)
9.2.19. Bioteknica
9.2.20. Accell Clinical Research, LLC
9.2.21. Genpact.; Criterium, Inc.
9.2.22. Promedica International
9.2.23. Med pace
9.2.24. ICON plc.
9.2.25. IQVIA Inc.
9.2.26. Integer Holdings Corporation
9.2.27. Tecomet Inc. (Charlesbank Capital Partners, LLC)
9.2.28. Jabil Inc.
9.2.29. FLEX LTD.
9.2.30. Celestica Inc.
9.2.31. Sanmina Corporation.
9.2.32. Plexus Corp.
9.2.33. Phillips Medisize (Molex, LLC)
9.2.34. Cantel Medical Corp. (STERIS plc)
9.2.35. West Pharmaceutical Services, Inc.
9.2.36. Other Prominent Players

Research Design and Approach

This study employed a multi-step, mixed-method research approach that integrates:

  • Secondary research
  • Primary research
  • Data triangulation
  • Hybrid top-down and bottom-up modelling
  • Forecasting and scenario analysis

This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.

Secondary Research

Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.

Sources Consulted

Secondary data for the market study was gathered from multiple credible sources, including:

  • Government databases, regulatory bodies, and public institutions
  • International organizations (WHO, OECD, IMF, World Bank, etc.)
  • Commercial and paid databases
  • Industry associations, trade publications, and technical journals
  • Company annual reports, investor presentations, press releases, and SEC filings
  • Academic research papers, patents, and scientific literature
  • Previous market research publications and syndicated reports

These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.

Secondary Research

Primary Research

Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.

Stakeholders Interviewed

Primary interviews for this study involved:

  • Manufacturers and suppliers in the market value chain
  • Distributors, channel partners, and integrators
  • End-users / customers (e.g., hospitals, labs, enterprises, consumers, etc., depending on the market)
  • Industry experts, technology specialists, consultants, and regulatory professionals
  • Senior executives (CEOs, CTOs, VPs, Directors) and product managers

Interview Process

Interviews were conducted via:

  • Structured and semi-structured questionnaires
  • Telephonic and video interactions
  • Email correspondences
  • Expert consultation sessions

Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.

Data Processing, Normalization, and Validation

All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.

The data validation process included:

  • Standardization of units (currency conversions, volume units, inflation adjustments)
  • Cross-verification of data points across multiple secondary sources
  • Normalization of inconsistent datasets
  • Identification and resolution of data gaps
  • Outlier detection and removal through algorithmic and manual checks
  • Plausibility and coherence checks across segments and geographies

This ensured that the dataset used for modelling was clean, robust, and reliable.

Market Size Estimation and Data Triangulation

Bottom-Up Approach

The bottom-up approach involved aggregating segment-level data, such as:

  • Company revenues
  • Product-level sales
  • Installed base/usage volumes
  • Adoption and penetration rates
  • Pricing analysis

This method was primarily used when detailed micro-level market data were available.

Bottom Up Approach

Top-Down Approach

The top-down approach used macro-level indicators:

  • Parent market benchmarks
  • Global/regional industry trends
  • Economic indicators (GDP, demographics, spending patterns)
  • Penetration and usage ratios

This approach was used for segments where granular data were limited or inconsistent.

Hybrid Triangulation Approach

To ensure accuracy, a triangulated hybrid model was used. This included:

  • Reconciling top-down and bottom-up estimates
  • Cross-checking revenues, volumes, and pricing assumptions
  • Incorporating expert insights to validate segment splits and adoption rates

This multi-angle validation yielded the final market size.

Forecasting Framework and Scenario Modelling

Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.

Forecasting Methods

  • Time-series modelling
  • S-curve and diffusion models (for emerging technologies)
  • Driver-based forecasting (GDP, disposable income, adoption rates, regulatory changes)
  • Price elasticity models
  • Market maturity and lifecycle-based projections

Scenario Analysis

Given inherent uncertainties, three scenarios were constructed:

  • Base-Case Scenario: Expected trajectory under current conditions
  • Optimistic Scenario: High adoption, favourable regulation, strong economic tailwinds
  • Conservative Scenario: Slow adoption, regulatory delays, economic constraints

Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.

Name field cannot be blank!
Email field cannot be blank!(Use email format)
Designation field cannot be blank!
Company field cannot be blank!
Contact No field cannot be blank!
Message field cannot be blank!
3288
Security Code field cannot be blank!

Frequently Asked Questions

Medical Device Outsourcing Market Size is valued at USD 160.96 billion in 2025 and is predicted to reach USD 494.35 billion by the year 2035.

Medical Device Outsourcing Market expected to grow at a 12.0% CAGR during the forecast period for 2026-2035.

SGS SA; Laboratory Corporation of America Holdings; Euro fins Scientific; Pace Analytical Services, Inc.; Intertek Group plc; WuXiAppTec; North Americ

medical device outsourcing market is segmented on the basis of service outlook, type, and application, cardiology, diagnostic imaging, Orthopedic, IVD, ophthalmic, general and plastic surgery, drug delivery, dental, endoscopy, diabetes care, and others.

Asia Pacific region is leading the Medical device outsourcing market.

Report License Selection

Determine the Appropriate License for your Report

Get Sample Report Enquiry Before Buying