U.S. Medical Device Outsourcing - Industry Report

The U.S. medical device outsourcing market size was evaluated at USD 31,630 million in 2024 and is expected to grow around USD 94,800 million by 2034, registering a CAGR of 11.6% from 2025 to 2034.

U.S. Medical Device Outsourcing Market  Report Highlights

• By application, the cardiology segment accounted for the largest share of the market in 2024.
• By application, the general and plastic surgery segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034.
• By service, the quality assurance segment held a dominant presence in the U.S. medical device outsourcing market in 2024.
• By service, the regulatory affairs services segment is predicted to witness significant growth in the market over the forecast period.

The U.S. medical device outsourcing market is an emerging market that deals with the section of the medical industry where one company contacts another company or manufacturer to help them design and manufacture their products. In this kind of exchange, they prefer contacting a third party to do the same instead of manufacturing the products in-house. This is done not only to reduce the cost of manufacturing but also to improve supply chain management. It also allows the company to focus and emphasize the core elements to maintain a competitive edge. There are different types of medical outsourcing. One includes contract manufacturing, where the product is outsourced to a third-party company.

Several factors effectively contribute to driving the growth of the U.S. medical device outsourcing market. However, the three major driving factors in the market include the prevalence of an always aging population, the rise in chronic disorders, and an increase in investments in research and development. One of the major factors that primarily affect the market’s growth is the aging population. With an increase in the aged population, there is also an increase in the demand for medical devices. Medical devices are crucial for the aged, who suffer from dementia, heart disease, etc. Hence, outsourcing is done to increase the pace of production while also maintaining the quality of production. 

Another major factor that affects the market’s growth is the rise in chronic disorders around the globe. The increase in the number of people diagnosed with chronic illnesses such as diabetes, heart disease, arthritis, and respiratory diseases has led to an increase in the need for specialized medical devices. Such chronic illnesses require monitoring devices, wearables, and implantable devices on a comparatively larger scale. Hence, outsourcing the manufacturing of such devices gives medical companies a lot of time to grow and expand, boosting growth in the U.S. medical device outsourcing market.

The significant increase in investments for research and development purposes has led to the production of more innovative products with new designs that are highly relevant to today’s times. Apart from the ones mentioned, other factors help in driving the growth of the U.S. medical devices outsourcing market. These comprise the rise in clinical trials, the rise in demand for medically advanced and competent devices, and technological advancements. Artificial intelligence is leading to several advancements in the U.S. medical device outsourcing market space. It is also greatly contributing to driving the growth of the U.S. medical devices outsourcing market.  With the integration of artificial intelligence and manufacturing processes, there is a significant increase in production rates.

Artificial intelligence not only helps with the optimization of manufacturing processes but also replaces time-consuming tasks like analyzing complex data and predictive analysis. AI has proved to be very useful in analyzing large amounts of data, which has led to quicker development of treatment processes. Predictive maintenance driven by artificial intelligence is gaining traction in the industry. The technology is deployed to predict equipment failure preemptively, mitigating downtime and ensuring smoother production. Almost every step in this process is optimized using artificial intelligence. These algorithms also help enhance quality control by detecting defects or anomalies in manufacturing processes early, ensuring higher-quality products and compliance with regulatory standards. With the integration of artificial intelligence and the manufacturing process, the market ensures a smooth and quick production of efficient devices. 

The U.S. medical device outsourcing market is expected to expand and grow in a few years with the introduction of advanced technology and mechanization. Some new and upcoming drivers in the market will help the market grow as well as expand all over the globe. These include factors such as increasing demand for medical devices with an increase in the population rates, the need to reduce costs compelling manufacturers to outsource, and technical advancements in the medical field.