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U.S. Medical Device Outsourcing Market Size, Share & Trends Analysis Report by Service (Product Upgrade Services, Product Design & Development Services, Quality Assurance, Contract Manufacturing), and Segment Forecasts, 2022-2030

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    Report

  • 79 Pages
  • February 2022
  • Region: United States
  • Grand View Research
  • ID: 5450226
The U.S. medical device outsourcing market size is expected to reach USD 59.0 billion by 2030, registering a CAGR of 11.2% over the forecast period. The COVID-19 pandemic has significantly impacted the market. During the crisis, medical devices and supplies played an important role in assisting COVID-19 patients and medical professionals. The diagnostic tests and kits were manufactured and played an important role in fighting the coronavirus. But the manufacturing was disrupted as few supplies were imported from other countries. This dependency hampered the timely availability of raw materials/consumables required for the manufacturing of medical devices.



The government authorities have escalated funds for the research & development of essential devices, thus driving the market. Major companies have solely relied on contract manufacturers to ramp up the production of COVID-19-related medical components, such as test kits, ventilators, and respirators. The major reasons for outsourcing amid the COVID-19 crisis include a streamlined supply chain and cost efficiencies. The market has started to recover as the manufacturing of medical devices used for other diseases has commenced. Furthermore, the barriers are reduced leading to smooth import of supplies. The growing complexity in product engineering and an increasing number of small-sized manufacturers are also anticipated to contribute to the market growth.

The medical device industry has always been highly competitive and categories, such as coronary stents, orthopedic devices, and wound care, are moving towards 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, many medical device manufacturers have opted for outsourcing business models to reduce cost, manage business risks, and improve service delivery. This factor is also expected to propel market growth over the forecast period.

U.S. Medical Device Outsourcing Market Report Highlights

  • The contract manufacturing segment dominated the market in 2021 owing to the increased focus on decreasing the cost of production.
  • The quality assurance services are projected to exhibit the fastest growth rate 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.
  • Mergers & acquisitions and capacity expansions are some of the common strategies adopted by companies to gain a competitive edge in the market.
  • For instance, in February 2020, Teleflex acquired HPC Medical Products (HPC), a company involved in medical tubing and wire components. The acquisition will help Teleflex to strengthen its catheter contract manufacturing capabilities.


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Frequently Asked Questions about the U.S. Medical Device Outsourcing Market

What is the estimated value of the U.S. Medical Device Outsourcing Market?

The U.S. Medical Device Outsourcing Market was estimated to be valued at $25.16 Billion in 2022.

What is the growth rate of the U.S. Medical Device Outsourcing Market?

The growth rate of the U.S. Medical Device Outsourcing Market is 11.2%, with an estimated value of $59 Billion by 2030.

What is the forecasted size of the U.S. Medical Device Outsourcing Market?

The U.S. Medical Device Outsourcing Market is estimated to be worth $59 Billion by 2030.

Who are the key companies in the U.S. Medical Device Outsourcing Market?

Key companies in the U.S. Medical Device Outsourcing Market include Integer Holdings Corporation, Avail Medical Products, Inc, Active Implants, Omnica Corporation, Teleflex Incorporated, Kinetic Climax Inc., Cantel Medical Corp., Accellent Inc. and Mdmi Technologies Inc..

Table of Contents

Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 Services
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
1.3.5.1 Data For Primary Interviews In U.S.
1.4 Information Or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.5.1 Model Details
1.5.2 Commodity Flow Analysis (Model 1)
1.5.2.1 Approach 1: Commodity Flow Approach
1.5.3 Volume Price Analysis (Model 2)
1.5.3.1 Approach 2: Volume Price Analysis
1.6 List Of Secondary Sources
1.7 Objectives
1.7.1 Objective 1
1.7.2 Objective 2
1.7.3 Objective-3
1.7.4 Objective-4
Chapter 2 Executive Summary
2.1 Market Outlook
Chapter 3 Market Variables, Trends & Scope
3.1 Market Dynamic
3.1.1 Market Driver Analysis
3.1.1.1 Changing Regulatory Landscape
3.1.1.2 Rising Demand For The Advanced Products
3.1.1.3 Implementation Of The International Standards By The Contract Manufacturers
3.1.1.4 Rising Price Competition And The Requirement To Reduce Cost
3.1.1.5 Increasing Complexity With Respect To Product Design And Engineering
3.1.2 Market Restraint Analysis
3.1.2.1 Compliance Issues While Outsourcing
3.1.2.2 Contractual Obligation
3.1.3 Industry Challenges
3.1.3.1 Managing Relationships
3.1.4 Impact Of Covid-19 Pandemic
3.1.4.1 Impact On The U.S. Medical Device Outsourcing Market
3.1.4.2 Impact On Supply Chain
3.1.4.3 After Effect Of The Pandemic
3.1.4.4 Impact Analysis
3.2 U.S. Medical Devices Outsourcing Market Analysis Tools
3.2.1 Industry Analysis-Porter’s
3.2.2 Pestel Analysis
Chapter 4 Services Business Analysis
4.1 Definitions And Scope
4.2 Services Market Share Analysis
4.3 Segment Dashboard
4.4 Quality Assurance Services
4.4.1 Quality Assurance Services Market Estimates And Forecast, 2018-2030
4.5 Regulatory Consulting Services
4.5.1 Regulatory Consulting Services Market, 2018-2030 (USD Million)
4.5.2 Clinical Trial Application And Product Registration
4.5.2.1 Clinical Trial Application And Product Registration Market, 2018-2030 (USD Million)
4.5.3 Regulatory Writing And Publishing
4.5.3.1 Regulatory Writing And Publishing Market, 2018-2030 (USD Million)
4.5.4 Legal Representation
4.5.4.1 Legal Representation Market, 2018-2030 (USD Million)
4.5.5 Other Regulatory Affairs Services
4.5.5.1 Other Regulatory Affairs Service Market, 2018-2030 (USD Million)
4.6 Product Design And Development
4.6.1 Product Design And Development Services Market, 2018-2030 (USD Million)
4.6.2 Designing And Engineering
4.6.2.1 Designing And Engineering Market, 2018-2030 (USD Million)
4.6.3 Machining
4.6.3.1 Machining Market, 2018-2030 (USD Million)
4.6.4 Molding
4.6.4.1 Molding Market, 2018-2030 (USD Million)
4.6.5 Packaging
4.6.5.1 Packaging Market, 2018-2030 (USD Million)
4.7 Product Testing And Sterilization
4.7.1 Product Testing And Sterilization Market, 2018-2030 (USD Million)
4.8 Product Implementation
4.8.1 Product Implementation Market, 2018-2030 (USD Million)
4.9 Product Upgrade
4.9.1 Product Upgrade Market, 2018-2030 (USD Million)
4.10 Product Maintenance
4.10.1 Product Maintenance Market, 2018-2030 (USD Million)
4.11 Contract Manufacturing
4.11.1 Contract Manufacturing Market, 2018-2030 (USD Million)
4.11.2 Accessories Manufacturing
4.11.2.1 Accessories Manufacturing Market, 2018-2030 (USD Million)
4.11.3 Assembly Manufacturing
4.11.3.1 Assembly Manufacturing Market, 2018-2030 (USD Million)
4.11.4 Component Manufacturing
4.11.4.1 Component Manufacturing Market, 2018-2030 (USD Million)
4.11.5 Device Manufacturing
4.11.5.1 Device Manufacturing Market, 2018-2030 (USD Million)
Chapter 5 Competitive Landscape
5.1 Key Company Profiles
5.1.1 INTEGER HOLDINGS CORPORATION
5.1.1.1 Company overview
5.1.1.2 Financial performance
5.1.1.3 Product benchmarking
5.1.1.4 Strategic initiatives
5.1.2 AVAIL MEDICAL PRODUCTS, INC
5.1.2.1 Company overview
5.1.2.2 Product benchmarking
5.1.2.3 strategic Initiatives
5.1.3 ACTIVE IMPLANTS
5.1.3.1 Product benchmarking
5.1.3.2 strategic Initiatives
5.1.4 OMNICA CORPORATION
5.1.4.1 Product Benchmarking
5.1.5 TELEFLEX INCORPORATED
5.1.5.1 Company overview
5.1.5.2 financial performance
5.1.5.3 Product benchmarking
5.1.5.4 Strategic initiatives
5.1.6 KINETIC CLIMAX INC.
5.1.6.1 Company overview
5.1.6.2 Product benchmarking
5.1.6.3 Strategic initiatives
5.1.7 CANTEL MEDICAL CORP.
5.1.7.1 Company Overview
5.1.7.2 Financial Performance
5.1.7.3 Product Benchmarking
5.1.7.4 Strategic Initiatives
5.1.8 ACCELLENT INC.
5.1.8.1 Company Overview
5.1.8.2 Financial Performance
5.1.8.3 Product Benchmarking
5.1.8.4 Strategic Initiatives
5.1.9 ACTIVE IMPLANTS CORPORATION LLC
5.1.9.1 Company Overview
5.1.9.2 Financial Performance
5.1.9.3 Product Benchmarking
5.1.9.4 Strategic Initiatives
5.1.11 MDMI TECHNOLOGIES INC.
5.1.10.1 Company Overview
5.1.10.2 Financial Performance
5.1.10.3 Product Benchmarking
5.1.10.4 Strategic Initiatives
List of Tables
Table 1 List of secondary sources
Table 2 List of Abbreviation
Table 3 U.S. Medical Device Outsourcing Market, by Services, 2018-2030 (USD Million)
Table 4 U.S. Regulatory Consulting Market, by Services, 2018-2030 (USD Million)
Table 5 U.S. Design and Development Market, by Services, 2018-2030 (USD Million)
Table 6 U.S. Medical Devices Contract Manufacturing Outsourcing Market, by Services, 2018-2030 (USD Million)
List of Figures
Fig. 1 Market research process
Fig. 2 Data triangulation technique
Fig. 3 Primary research pattern
Fig. 4 Primary interviews in U.S.
Fig. 5 Market research approaches
Fig. 6 QFD modeling for market share assessment
Fig. 7 U.S. medical devices outsourcing market: Market outlook (2021)
Fig. 8 U.S. medical devices outsourcing market Driver impact
Fig. 9 Current shared services and outsourcing usage levels
Fig. 10 U.S. Medical devices outsourcing market Restraint Impact
Fig. 11 Porter’s five forces analysis
Fig. 12 SWOT analysis, by factor (political & legal, economic and technological)
Fig. 13 U.S. medical devices outsourcing market: Services movement analysis
Fig. 14 U.S. medical devices outsourcing market: Services outlook and key takeaways
Fig. 15 Quality assurance services market estimates and forecast, 2018 - 2030
Fig. 16 Regulatory affairs services market, 2018 - 2030 (USD Million)
Fig. 17 Stages of review of PMA devices
Fig. 18 Clinical trial application and product registration market, 2018 - 2030 (USD Million)
Fig. 19 Regulatory writing and publishing market, 2018 - 2030 (USD Million)
Fig. 20 Legal representation market, 2018 - 2030 (USD Million)
Fig. 21 Others market, 2018 - 2030 (USD Million)
Fig. 22 Product design and development services market, 2018 - 2030 (USD Million)
Fig. 23 Designing and engineering market, 2018 - 2030 (USD Million)
Fig. 24 Machining market, 2018 - 2030 (USD Million)
Fig. 25 Molding market, 2018 - 2030 (USD Million)
Fig. 26 Packaging market, 2018 - 2030 (USD Million)
Fig. 27 Product testing and sterilization market, 2018 - 2030 (USD Million)
Fig. 28 Product implementation market, 2018 - 2030 (USD Million)
Fig. 29 Product upgrade market, 2018 - 2030 (USD Million)
Fig. 30 Product maintenance market, 2018 - 2030 (USD Million)
Fig. 31 Contract manufacturing market, 2018 - 2030 (USD Million)
Fig. 32 Accessories manufacturing market, 2018 - 2030 (USD Million)
Fig. 33 Accessories manufacturing market, 2018 - 2030 (USD Million)
Fig. 34 Component manufacturing market, 2018 - 2030 (USD Million)
Fig. 35 Device manufacturing market, 2018 - 2030 (USD Million)

Companies Mentioned

  • Integer Holdings Corporation
  • Avail Medical Products, Inc
  • Active Implants
  • Omnica Corporation
  • Teleflex Incorporated
  • Kinetic Climax Inc.
  • Cantel Medical Corp.
  • Accellent Inc.
  • Active Implants Corporation LLC
  • Mdmi Technologies Inc.

Methodology

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