The U.S. medical device outsourcing market size is expected to reach USD 46.2 billion by 2028 and is expected to expand at a CAGR of 10.3% from 2021 to 2028
The growing geriatric population, rising surgical procedures, and increasing demand for cost curbing tools are some key growth drivers for the U.S. market.
The medical device industry has become 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 identify, 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. All the aforementioned facts are hence expected to propel the market growth over the forecast period.
The development of medical devices and supplies required in assisting COVID patients and medical professionals is increasing. The government authorities have escalated funds for the research & development of essential devices, thus increasing the demand in the U.S. 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 crisis include a streamlined supply chain, costing efficiencies, and logistical alignment.
U.S. Medical Device Outsourcing Market Report Highlights
Based on service, the contract manufacturing segment dominated the market with a share of 55.5% in 2020 owing to the growing trend of outsourcing by OEM to third-party manufacturers, especially in emerging countries
Regulatory consulting services are projected to exhibit a significant growth rate over the forecast period. Complex regulatory requirements related to writing and submission of clinical study reports promote outsourcing of noncore regulatory functions, such as regulatory writing and publishing
By application, class II medical devices held the largest share of 67.2% in 2020 and are expected to dominate the U.S. market throughout the forecast period
Mergers and acquisitions and capacity expansion are a few of the common strategies adopted by market players to gain a competitive edge in the market
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
Key Topics Covered:
Chapter 1 Methodology and Scope
Chapter 2 Executive Summary
Chapter 3 Market Variables, Trends & Scope 3.1 Market Dynamic 3.1.1 Market Driver Analysis 22.214.171.124 Changing Regulatory Landscape 126.96.36.199 Rising Demand for the Advanced Products 188.8.131.52 Implementation of the International Standards by the Contract Manufacturers 184.108.40.206 Rising Price Competition and the Requirement to Reduce Cost 220.127.116.11 Increasing Complexity with Respect to Product Design and Engineering 3.1.2 Market Restraint Analysis 18.104.22.168 Compliance Issues While Outsourcing 22.214.171.124 Contractual Obligation 3.1.3 Industry Challenges 126.96.36.199 Managing Relationships 3.1.4 Impact of Covid-19 Pandemic 188.8.131.52 Impact on the U.S. medical device outsourcing market 184.108.40.206 Impact on Supply Chain 220.127.116.11 After effect of the pandemic 18.104.22.168 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 U.S. Medical Device Outsourcing Market: Segment Analysis, By Service, 2016 - 2028 (USD Million) 4.1 Definitions and Scope 4.2 Service Market Share Analysis 4.3 Segment Dashboard 4.4 Quality Assurance Services 4.4.1 Quality Assurance Services Market Estimates and Forecast, 2016 - 2028 4.5 Regulatory Consulting Services 4.5.1 Regulatory Consulting Services Market, 2016 - 2028 (USD Million) 4.5.2 Clinical Trial Application and Product Registration 4.5.3 Regulatory Writing and Publishing 4.5.4 Legal Representation 4.6 Product Design and Development 4.6.1 Product Design and Development Services Market, 2016 - 2028 (USD Million) 4.6.2 Designing and Engineering 4.6.3 Machining 4.6.4 Molding 4.6.5 Packaging 4.7 Product Testing And Sterilization 4.8 Product Implementation 4.9 Product Upgrade 4.10 Product Maintenance 4.11 Contract Manufacturing 4.11.1 Contract Manufacturing Market, 2016 - 2028 (USD Million) 4.11.2 Accessories Manufacturing 4.11.3 Assembly Manufacturing 4.11.4 Component Manufacturing 4.11.5 Device Manufacturing
Chapter 5 U.S. Medical Device Outsourcing Market: Segment Analysis, By Application, 2016 - 2028 (USD Million) 5.1 Definitions and Scope 5.2 Application Market Share Analysis 5.3 Segment Dashboard 5.4 Class I 5.5 Class II 5.6 Class III
Chapter 6 Competitive Landscape 6.1 Key Company Profiles 6.1.1 Company overview 6.1.2 Financial performance 6.1.3 Product benchmarking 6.1.4 Strategic initiatives