U.S. Medical Device Contract Manufacturing Market Size, Share & Trends Analysis Report By Product (Class I, Class II, Class III), By Services (Accessories Manufacturing, Assembly Manufacturing), By Therapeutic Area, By End Use, And Segment Forecasts, 2025 - 2033

U.S. Medical Device Contract Manufacturing Market Summary

The U.S. medical device contract manufacturing market size was estimated at USD 16.72 billion in 2024 and is projected to reach USD 51.76 billion by 2033, growing at a CAGR of 13.77% from 2025 to 2033. The U.S. medical device contract manufacturing sector is witnessing significant growth, fueled by increasing incidence of chronic illnesses such as diabetes, cardiovascular issues, and cancer, rising outsourcing among small to medium sized original equipment manufacturers (OEMs), the growing complexity of medical technologies, rising demand for advanced, high-quality devices and growing need for cost-efficiency.

Moreover, integration of automation, 3D printing, and smart manufacturing technologies to enhance precision and scalability is anticipated to drive the market growth. In addition, rising investments and strategic mergers and acquisitions in U.S. medical device contract manufacturing is expected to expand the market’s service portfolios, further contributing to market growth.

In addition, in the U.S. Original Equipment Manufacturers (OEMs) are increasingly outsourcing various production processes to improve operational efficiency, reduce capital expenses, and expedite product launches. These companies are increasingly shifting to CMOs to enhance their operations with standard quality, addressing the evolving demands of the medical device industry. Moreover, CMOs support facilitating faster market entry for medical devices, improving production and workflow efficiencies by managing multiple functional areas within production processes. Besides, medical devices companies are increasingly focusing on outsourcing a portion of their production further reducing the pressure on internal resources while maintaining lower costs. In addition, partnering with CMOs reduces the cost of device development by 10-30%, enabling further medical device companies to deliver innovative medical devices to stay ahead in a competitive market.

Moreover, in the U.S., strict regulatory standards imposed by the FDA necessitate contract manufacturers to establish comprehensive quality control systems, enhancing their competitiveness on a global scale. Moreover, with the increasing demand for smart and connected devices, medical device contract manufacturers are investing in Internet of Medical Things to focus on adhering the cybersecurity standards. In addition, trends such as reshoring and diversifying supply chains are expected to accelerate geopolitical developments and recent tariff adjustments, which further supports market growth.

Furthermore, the medical device manufacturers are increasingly witnessing increasing competition with rapid product development, increasing the need for contract manufacturers to address these challenges. Moreover, advancements in medical devices, such as minimally invasive techniques, wearable technologies, and diagnostic tools, combined with an increased focus on regulatory quality assurance are anticipated to drive the market growth over the estimated time period. These innovations are likely to enhance precision, scalability, and customization in the production of devices, particularly within minimally invasive and wearable technologies, as well as combination products. Thus, the U.S. medical device contract manufacturing market is expected to witness new opportunities within a technology-driven and innovation-centric landscape, addressing the evolving requirements of medical device companies by offering a wide array of services, including design, prototyping, assembly, testing, and regulatory compliance.

U.S. Medical Device Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at 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, the analyst has segmented the U.S. medical device contract manufacturing market report based on product, services, therapeutic area, and end use:

Product Outlook (Revenue, USD Million, 2021 - 2033)

• Class I
• Class II
• Class III

Services Outlook (Revenue, USD Million, 2021 - 2033)

• Accessories Manufacturing
• Assembly Manufacturing
• Component Manufacturing
• Device Manufacturing
• Packaging and Labeling
• Others

Therapeutic Area Outlook (Revenue, USD Million, 2021 - 2033)

• Cardiovascular Devices
• Orthopedic Devices
• Ophthalmic Devices
• Diagnostic Devices
• Respiratory Devices
• Surgical Instruments
• Dental
• Others

End Use Outlook (Revenue, USD Million, 2021 - 2033)

• Original Equipment Manufacturers (OEMs)
• Pharmaceutical & Biopharmaceutical Companies
• Others

Why should you buy this report?

• Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
• Competitive Landscape: Explore the market presence of key players worldwide.
• Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
• Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

• Market intelligence to enable effective decision-making
• Market estimates and forecasts from 2018 to 2030
• Growth opportunities and trend analyses
• Segment and regional revenue forecasts for market assessment
• Competition strategy and market share analysis
• Product innovation listing for you to stay ahead of the curve
• COVID-19's impact and how to sustain in these fast-evolving markets

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