The U.S. medical device outsourcing market size is expected to reach USD 58.5 billion by 2030, expanding at a CAGR of 11.5% during the forecast period. This market is growing as a result of increased offshore trends, a rise in demand for high-tech medical devices, and stringent regulation for medical devices in the U.S.
The medical device industry has always been highly competitive, and categories such as coronary stents, orthopedic devices, and wound care are moving toward maturity. As high-impact scientific innovation in the above categories is difficult to achieve and is a time-consuming process, smaller companies are gaining market share by offering low prices and introducing innovative business models. Due to the convergence of mounting challenges and changing market dynamics, medical device manufacturers are likely to opt for outsourcing business models to reduce costs, manage business risks, and improve service delivery. This factor is expected to propel market growth over the forecast period.
The government authorities have escalated funds for the research and development of essential devices, thus driving the market. The majority of clinical research globally devices are conducted in the U.S. alone according to Clinical Trials. gov. In case of the medical device also significant studies are conducted in the U.S.
For instance, as of February 2023, over 25033, research for medical devices was registered in the Clinical Trials. gov. Medical device companies are conducting research in the country owing to the availability of skilled labor and advanced infrastructure, as well as the presence of a significant number of CROs offering quality services. All these factors are expected to support the market in the post-Pandemic period.
The medical device industry has always been highly competitive, and categories such as coronary stents, orthopedic devices, and wound care are moving toward maturity. As high-impact scientific innovation in the above categories is difficult to achieve and is a time-consuming process, smaller companies are gaining market share by offering low prices and introducing innovative business models. Due to the convergence of mounting challenges and changing market dynamics, medical device manufacturers are likely to opt for outsourcing business models to reduce costs, manage business risks, and improve service delivery. This factor is expected to propel market growth over the forecast period.
The government authorities have escalated funds for the research and development of essential devices, thus driving the market. The majority of clinical research globally devices are conducted in the U.S. alone according to Clinical Trials. gov. In case of the medical device also significant studies are conducted in the U.S.
For instance, as of February 2023, over 25033, research for medical devices was registered in the Clinical Trials. gov. Medical device companies are conducting research in the country owing to the availability of skilled labor and advanced infrastructure, as well as the presence of a significant number of CROs offering quality services. All these factors are expected to support the market in the post-Pandemic period.
U.S. Medical Device Outsourcing Market Report Highlights
- The quality assurance services are projected to exhibit the fastest CAGR of 13.7% over the forecast period. This is due to the necessity of maintaining an effective quality management system, which has become an integral part of the production of every medical device
- Cardiology segment has held the largest share of 21.8% in 2022, based on application owing to the growing demand for cardiac devices due to the rising disease burden in the country
- Based on class, the Class II segment is expected to grow at the fastest CAGR of 11.8% over the forecast period, owing to the high complexity in developing these devices that are promoting the demand for an expert team to conduct development and manufacturing of these devices
Table of Contents
Chapter 1 Methodology and Scope1.1 Market Segmentation & Scope
1.1.2 Service
1.1.3 Application
1.1.4 Class
1.1.5 Estimates And Forecast Timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased Database
1.3.2 Internal Database
1.3.3 Secondary Sources
1.3.4 Primary Research
1.3.5 Details of Primary Research
1.4 Information or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.6 Model Details
1.6.1 Commodity Flow Analysis (Model 1)
1.7 List of Secondary Sources
1.8 List of Primary Sources
1.9 List of Abbreviations
1.10 Objectives
1.10.1 Objective - 1: Understanding the market dynamics
1.10.2 Objective - 2: Understanding the market estimates and forecasts
1.10.3 Objective - 3: Understanding the attributes such as strategy framework
1.10.4 Objective - 4: Understanding the key service and application scopes to conclude on the market size
Chapter 2 Executive Summary
2.1 Market Outlook
Chapter 3 U.S. 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 User Perspective Analysis
3.2.1 Consumer Behavior Analysis
3.2.2 Market Influencer Analysis
3.3 Regulatory Framework
3.4 Market Variable Analysis
3.4.1 Market Driver Analysis
3.4.1.1 Changing Regulatory Landscape
3.4.1.2 Increase in Off-Shoring Medical Device Manufacturing to the Emerging Economies
3.4.1.3 Rising Demand for the Advanced Products
3.4.1.4 Implementation of the International Standards by the Contract Manufacturers
3.4.1.5 Rising Price Competition and the Requirement to Reduce Cost
3.4.1.6 Increasing Complexity Concerning Product Design and Engineering
3.4.2 Market Restraint Analysis
3.4.2.1 Compliance Issues While Outsourcing
3.4.2.2 Changing Scenarios Within Developing Countries
3.4.2.3 Regulatory and Legal Compliance
3.4.2.4 Contractual Obligation
3.4.3 Industry Challenges
3.4.3.1 Managing Relationships
3.5 U.S. Medical device outsourcing market: Analysis Tools
3.5.1 Porter’s Five Forces Analysis
3.5.2 Pestel Analysis
3.6. COVID-19 Impact and Reformation Strategies
Chapter 4 U.S. Medical Device Outsourcing Market: Services Segment Analysis
4.1 Definition & Scope
4.2 U.S. medical device outsourcing market: Market Share Analysis, 2022 & 2030
4.3 Quality Assurance
4.3.1 Quality Assurance Services Market, 2018 - 2030 (USD Million)
4.4 Regulatory Consulting Services
4.4.1 Regulatory Consulting Services Market, 2018 - 2030 (USD Million)
4.4.2 Clinical Trial Application and Product Registration
4.4.2.1 Clinical Trial Application and Product Registration Market, 2018 - 2030 (USD Million)
4.4.3 Regulatory Writing and Publishing
4.4.3.1 Regulatory Writing and Publishing Market, 2018 - 2030 (USD Million)
4.4.4 Legal Representation
4.4.4.1 Legal Representation Market, 2018 - 2030 (USD Million)
4.4.5 Others
4.4.5.1 Others Market, 2018 - 2030 (USD Million)
4.5 Product Design and Development
4.5.1 Product Design and Development Services Market, 2018 - 2030 (USD Million)
4.5.2 Designing and Engineering
4.5.2.1 Designing and Engineering Market, 2018 - 2030 (USD Million)
4.5.3 Machining
4.5.3.1 Machining Market, 2018 - 2030 (Usd Million)
4.5.4 Molding
4.5.4.1 Molding Market, 2018 - 2030 (Usd Million)
4.5.5 Packaging
4.5.5.1 Packaging Market, 2018 - 2030 (USD Million)
4.6 Product Testing and Sterilization
4.6.1 Product Testing and Sterilization Market, 2018 - 2030 (USD Million)
4.7 Product Implementation
4.7.1 Product Implementation Market, 2018 - 2030 (USD Million)
4.8 Product Upgrade
4.8.1 Product Upgrade Market, 2018 - 2030 (USD Million)
4.9 Product Maintenance
4.9.1 Product Maintenance Market, 2018 - 2030 (USD Million)
4.10 Contract Manufacturing
4.10.1 Contract Manufacturing Market, 2018 - 2030 (USD Million)
4.10.2 Accessories Manufacturing
4.10.2.1 Accessories Manufacturing Market, 2018 - 2030 (USD Million)
4.10.3 Assembly Manufacturing
4.10.3.1 Assembly Manufacturing Market, 2018 - 2030 (USD Million)
4.10.4 Component Manufacturing
4.10.4.1 Component Manufacturing Market, 2018 - 2030 (USD Million)
4.10.5 Device Manufacturing
4.10.5.1 Device Manufacturing Market, 2018 - 2030 (USD Million)
Chapter 5 U.S. Medical device outsourcing market: Application Segment Analysis
5.1 Definition & Scope
5.2 U.S. medical device outsourcing market: Market Share Analysis, 2022 & 2030
5.3 Cardiology
5.3.1 Cardiology market, 2018 - 2030 (USD Million)
5.3.2 Class I
5.3.2.1 Class I market, 2018 - 2030 (USD Million)
5.3.3 Class II
5.3.3.1 Class II market, 2018 - 2030 (USD Million)
5.3.4 Class III
5.3.4.1 Class III market, 2018 - 2030 (USD Million)
5.4 Diagnostic Imaging
5.4.1 Diagnostic imaging market, 2018 - 2030 (USD Million)
5.4.2 Class I
5.4.2.1 Class I market, 2018 - 2030 (USD Million)
5.4.3 Class II
5.4.3.1 Class II market, 2018 - 2030 (USD Million)
5.4.4 Class III
5.4.4.1 Class III market, 2018 - 2030 (USD Million)
5.5 Orthopedic
5.5.1 Orthopedic market, 2018 - 2030 (USD Million)
5.5.2 Class I
5.5.2.1 Class I market, 2018 - 2030 (USD Million)
5.5.3 Class II
5.5.3.1 Class II market, 2018 - 2030 (USD Million)
5.5.4 Class III
5.5.4.1 Class III market, 2018 - 2030 (USD Million)
5.6 IVD
5.6.1 IVD market, 2018 - 2030 (USD Million)
5.6.2 Class I
5.6.2.1 Class I market, 2018 - 2030 (USD Million)
5.6.3 Class II
5.6.3.1 Class II market, 2018 - 2030 (USD Million)
5.6.4 Class III
5.6.4.1 Class III market, 2018 - 2030 (USD Million)
5.7 Ophthalmic
5.7.1 Ophthalmic market, 2018 - 2030 (USD Million)
5.7.2 Class I
5.7.2.1 Class I market, 2018 - 2030 (USD Million)
5.7.3 Class II
5.7.3.1 Class II market, 2018 - 2030 (USD Million)
5.7.4 Class III
5.7.4.1 Class III market, 2018 - 2030 (USD Million)
5.8 General & plastic surgery
5.8.1 General & plastic surgery market, 2018 - 2030 (USD Million)
5.8.2 Class I
5.8.2.1 Class I market, 2018 - 2030 (USD Million)
5.8.3 Class II
5.8.3.1 Class II market, 2018 - 2030 (USD Million)
5.8.4 Class III
5.8.4.1 Class III market, 2018 - 2030 (USD Million)
5.9 Drug delivery
5.9.1 Drug delivery market, 2018 - 2030 (USD Million)
5.9.2 Class I
5.9.2.1 Class I market, 2018 - 2030 (USD Million)
5.9.3 Class II
5.9.3.1 Class II market, 2018 - 2030 (USD Million)
5.9.4 Class III
5.9.4.1 Class III market, 2018 - 2030 (USD Million)
5.10 Dental
5.10.1 Dental market, 2018 - 2030 (USD Million)
5.10.2 Class I
5.10.2.1 Class I market, 2018 - 2030 (USD Million)
5.10.3 Class II
5.10.3.1 Class II market, 2018 - 2030 (USD Million)
5.10.4 Class III
5.10.4.1 Class III market, 2018 - 2030 (USD Million)
5.11 Endoscopy
5.11.1 Endoscopy market, 2018 - 2030 (USD Million)
5.11.2 Class I
5.11.2.1 Class I market, 2018 - 2030 (USD Million)
5.11.3 Class II
5.11.3.1 Class II market, 2018 - 2030 (USD Million)
5.11.4 Class III
5.11.4.1 Class III market, 2018 - 2030 (USD Million)
5.12 Diabetes care
5.12.1 Diabetes care market, 2018 - 2030 (USD Million)
5.12.2 Class I
5.12.2.1 Class I market, 2018 - 2030 (USD Million)
5.12.3 Class II
5.12.3.1 Class II market, 2018 - 2030 (USD Million)
5.12.4 Class III
5.12.4.1 Class III market, 2018 - 2030 (USD Million)
5.13 Others
5.13.1 Others market, 2018 - 2030 (USD Million)
5.13.2 Class I
5.13.2.1 Class I market, 2018 - 2030 (USD Million)
5.13.3 Class II
5.13.3.1 Class II market, 2018 - 2030 (USD Million)
5.13.4 Class III
5.13.4.1 Class III market, 2018 - 2030 (USD Million)
Chapter 6 U.S. Medical device outsourcing market: Class Analysis
6.1 Definition & Scope
6.2 U.S. medical device outsourcing market: Market Share Analysis, 2022 & 2030
6.3 Class I
6.3.1 Class I market, 2018 - 2030 (USD Million)
6.4 Class II
6.4.1 Class II market, 2018 - 2030 (USD Million)
6.5 Class III
6.5.1 Class III market, 2018 - 2030 (USD Million)
Chapter 7 Company Profiles
7.1.1 SGS SA
7.1.1.1 Company Overview
7.1.1.2 Financial Performance
7.1.1.3 Service Benchmarking
7.1.1.4 Strategic Initiatives
7.1.2 Laboratory Corporation of America Holdings
7.1.2.1 Company Overview
7.1.2.2 Service Benchmarking
7.1.2.3 Strategic Initiatives
7.1.3 Eurofins Scientific
7.1.3.1 Company Overview
7.1.3.2 Financial Performance
7.1.3.3 Service Benchmarking
7.1.3.4 Strategic Initiatives
7.1.4 Pace Analytical Services, Inc.
7.1.4.1 Company Overview
7.1.4.2 Financial Performance
7.1.4.3 Service Benchmarking
7.1.4.4 Strategic Initiatives
7.1.5 Intertek Group plc
7.1.5.1 Company Overview
7.1.5.2 Financial Performance
7.1.5.3 Service Benchmarking
7.1.5.4 Strategic Initiatives
7.1.6 Wuxi Apptec
7.1.6.1 Company Overview
7.1.6.2 Financial Performance
7.1.6.3 Service Benchmarking
7.1.6.4 Strategic Initiatives
7.1.7 North American Science Associates, LLC
7.1.7.1 Company Overview
7.1.7.2 Financial Performance
7.1.7.3 Service Benchmarking
7.1.7.4 Strategic Initiatives
7.1.8 Integer Holdings Corporation
7.1.8.1 Company Overview
7.1.8.2 Financial Performance
7.1.8.3 Service Benchmarking
7.1.9 ICON plc
7.1.9.1 Company Overview
7.1.9.2 Financial Performance
7.1.9.3 Service Benchmarking
7.1.9.4 Strategic Initiatives
7.1.10 Sterigenics U.S., LLC (GTCR, LLC)
7.1.10.1 Company Overview
7.1.10.2 Service Benchmarking
7.1.10.3 Strategic Initiatives
7.1.11 Charles River Laboratories
7.1.11.1 Company Overview
7.1.11.2 Financial Performance
7.1.11.3 Service Benchmarking
7.1.11.4 Strategic Initiatives
7.1.12 Avail Medsystems, Inc. ;
7.1.12.1 Company Overview
7.1.12.2 Financial Performance
7.1.12.3 Service Benchmarking
7.1.13 Active Implants.
7.1.13.1 Company Overview
7.1.13.2 Service Benchmarking
7.1.14 Omnica Corp.
7.1.14.1 Company Overview
7.1.14.2 Financial Performance
7.1.14.3 Service Benchmarking
7.1.15 Teleflex Incorporated;
7.1.15.1 Company Overview
7.1.15.2 Service Benchmarking
7.1.15.3 Strategic Initiatives
7.1.16 Cantel Medical Corp. (STERIS plc)
7.1.16.1 Company Overview
7.1.16.2 Financial Performance
7.1.16.3 Service Benchmarking
7.1.17 Parexel International Corporation
7.1.17.1 Company Overview
7.1.17.2 Financial Performance
7.1.17.3 Service Benchmarking
7.1.17.4 Strategic Initiatives
7.1.18 Medpace
7.1.18.1 Company Overview
7.1.18.2 Financial Performance
7.1.18.3 Service Benchmarking
7.1.19 Premier Research
7.1.19.1 Company Overview
7.1.19.2 Financial Performance
7.1.19.3 Product Benchmarking
7.1.20 IQVIA Inc.
7.1.20.1 Company Overview
7.1.20.2 Financial Performance
7.1.20.3 Service Benchmarking
List of Tables
Table 1 List of secondary sources
Table 2 List of Abbreviations
List of Figures
Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Primary research pattern
Fig. 4 Primary interviews in the U.S.
Fig. 5 Market research approaches
Fig. 6 Value - chain - based sizing & forecasting
Fig. 7 QFD modeling for market share assessment
Fig. 8 Market formulation & validation
Fig. 9 Commodity Flow Analysis
Fig. 10 Volume Price Analysis
Fig. 11 U.S. medical device outsourcing market snapshot (2022)
Fig. 12 U.S. medical device outsourcing market segmentation
Fig. 13 U.S. medical device outsourcing market: Strategy framework
Fig. 14 Parent market outlook
Fig. 15 Related/ancillary market outlook
Fig. 16 Market driver relevance analysis (Current & future impact)
Fig. 17 Current shared services and outsourcing usage levels
Fig. 18 Market restraint relevance analysis (Current & future impact)
Fig. 19 Porter’s five forces analysis
Fig. 20 PEST Analysis
Fig. 21 U.S. medical device outsourcing market service outlook: Segment Dashboard
Fig. 22 U.S. medical device outsourcing market: Service movement analysis
Fig. 23 Quality assurance services market, 2018 - 2030 (USD Million)
Fig. 24 Regulatory Consulting Services market, 2018 - 2030 (USD Million)
Fig. 25 Clinical trial application and product registration market, 2018 - 2030 (USD Million)
Fig. 26 Regulatory writing and publishing market, 2018 - 2030 (USD Million)
Fig. 27 Legal representation market, 2018 - 2030 (USD Million)
Fig. 28 Others market, 2018 - 2030 (USD Million)
Fig. 29 Product design and development services market, 2018 - 2030 (USD Million)
Fig. 30 Designing and engineering market, 2018 - 2030 (USD Million)
Fig. 31 Machining market, 2018 - 2030 (USD Million)
Fig. 32 Molding market, 2018 - 2030 (USD Million)
Fig. 33 Packaging market, 2018 - 2030 (USD Million)
Fig. 34 Product testing and sterilization market, 2018 - 2030 (USD Million)
Fig. 35 Product implementation market, 2018 - 2030 (USD Million)
Fig. 36 Product upgrade market, 2018 - 2030 (USD Million)
Fig. 37 Product maintenance market, 2018 - 2030 (USD Million)
Fig. 38 Contract manufacturing market, 2018 - 2030 (USD Million)
Fig. 39 Accessories manufacturing market, 2018 - 2030 (USD Million)
Fig. 40 Component manufacturing market, 2018 - 2030 (USD Million)
Fig. 41 Device manufacturing market, 2018 - 2030 (USD Million)
Fig. 42 U.S. medical device outsourcing market application outlook: Segment Dashboard
Fig. 43 U.S. medical device outsourcing market: Application movement analysis
Fig. 44 Cardiology market, 2018 - 2030 (USD Million)
Fig. 45 Class I market, 2018 - 2030 (USD Million)
Fig. 46 Class II market, 2018 - 2030 (USD Million)
Fig. 47 Class III market, 2018 - 2030 (USD Million)
Fig. 48 Diagnostic imaging market, 2018 - 2030 (USD Million)
Fig. 49 Class I market, 2018 - 2030 (USD Million)
Fig. 50 Class II market, 2018 - 2030 (USD Million)
Fig. 51 Class III market, 2018 - 2030 (USD Million)
Fig. 52 Orthopedic market, 2018 - 2030 (USD Million)
Fig. 53 Class I market, 2018 - 2030 (USD Million)
Fig. 54 Class II market, 2018 - 2030 (USD Million)
Fig. 55 Class III market, 2018 - 2030 (USD Million)
Fig. 56 IVD market, 2018 - 2030 (USD Million)
Fig. 57 Class I market, 2018 - 2030 (USD Million)
Fig. 58 Class II market, 2018 - 2030 (USD Million)
Fig. 59 Class III market, 2018 - 2030 (USD Million)
Fig. 60 Ophthalmic market, 2018 - 2030 (USD Million)
Fig. 61 Class I market, 2018 - 2030 (USD Million)
Fig. 62 Class II market, 2018 - 2030 (USD Million)
Fig. 63 Class III market, 2018 - 2030 (USD Million)
Fig. 64General & plastic surgery market, 2018 - 2030 (USD Million)
Fig. 65 Class I market, 2018 - 2030 (USD Million)
Fig. 66 Class II market, 2018 - 2030 (USD Million)
Fig. 67 Class III market, 2018 - 2030 (USD Million)
Fig. 68 Drug delivery market, 2018 - 2030 (USD Million)
Fig. 69 Class I market, 2018 - 2030 (USD Million)
Fig. 70 Class II market, 2018 - 2030 (USD Million)
Fig. 71 Class III market, 2018 - 2030 (USD Million)
Fig. 72Dental market, 2018 - 2030 (USD Million)
Fig. 73 Class I market, 2018 - 2030 (USD Million)
Fig. 74 Class II market, 2018 - 2030 (USD Million)
Fig. 75 Class III market, 2018 - 2030 (USD Million)
Fig. 76 Endoscopy market, 2018 - 2030 (USD Million)
Fig. 77 Class I market, 2018 - 2030 (USD Million)
Fig. 78 Class II market, 2018 - 2030 (USD Million)
Fig. 79 Class III market, 2018 - 2030 (USD Million)
Fig. 80 Diabetes care market, 2018 - 2030 (USD Million)
Fig. 81 Class I market, 2018 - 2030 (USD Million)
Fig. 82 Class II market, 2018 - 2030 (USD Million)
Fig. 83 Class III market, 2018 - 2030 (USD Million)
Fig. 84 Others market, 2018 - 2030 (USD Million)
Fig. 85 Class I market, 2018 - 2030 (USD Million)
Fig. 86 Class II market, 2018 - 2030 (USD Million)
Fig. 87 Class III market, 2018 - 2030 (USD Million)
Fig. 88 U.S. medical device outsourcing market class outlook: Segment Dashboard
Fig. 89 U.S. medical device outsourcing market: Class movement analysis
Fig. 90 Class I market 2018 - 2030 (USD Million)
Fig. 91 Class II market 2018 - 2030 (USD Million
Fig. 92 Class III market, 2018 - 2030 (USD Million)
Companies Mentioned
- SGS SA
- Laboratory Corporation of America Holdings
- Eurofins Scientific
- Pace Analytical Services, Inc.
- Intertek Group plc
- Wuxi Apptec
- North American Science Associates, LLC
- Integer Holdings Corporation
- ICON plc
- Sterigenics U.S., LLC (GTCR, LLC)
- Charles River Laboratories
- Avail Medsystems, Inc. ;
- Active Implants.
- Omnica Corp.
- Teleflex Incorporated;
- Cantel Medical Corp. (STERIS plc)
- Parexel International Corporation
- Medpace
- Premier Research
- IQVIA Inc.
Methodology
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 240 |
| Published | February 2023 |
| Forecast Period | 2022 - 2030 |
| Estimated Market Value ( USD | $ 25.2 Billion |
| Forecasted Market Value ( USD | $ 58.5 Billion |
| Compound Annual Growth Rate | 11.5% |
| Regions Covered | United States |
| No. of Companies Mentioned | 20 |
