Top Medical Device Contract Manufacturing Companies

The market size was USD 78.90 billion in 2024 and expected to reach USD 187.15 billion by 2032, growing at a CAGR of 11.40% during the forecast period 2025-2032.

There are lots of big players, including Thermo Fisher Scientific, Jabil Inc, Flex Ltd, Plexus Corp, Sanmina Corporation, Integer Holdings, TE Connectivity, Nipro Corporation, Gerresheimer AG, and many more in not just the U.S., but also in Europe and Asia.

North America (specifically, the U.S.) has the largest share based on the number of significant R&D investments, number of key OEMs and contract manufacturers, advanced healthcare infrastructure, and a strict regulatory body governing medical devices leading to increased outsourcing.

Asia Pacific will have the fastest growth because of cost benefits, improving infrastructure and government incentives in China and India, while North America is still the largest market.

Technological advancements like 3D printing and automation, along with a rising focus on sustainability, are key trends shaping the future of medical device contract manufacturing.

Class II (moderate complexity) devices, such as surgical gloves, diagnostic imaging, and infusion pumps are most commonly contracted out to contract manufacturers because they cover moderate levels of regulatory complexity and are applied in a wide variety of high-demand therapeutic areas.

The main drivers include the increased demand for medical devices, more OEMs outsourcing to reduce costs, searching for innovation, and the introduction of technology such as 3D Printing and automation.

Regulatory compliance creates challenges due to differences in worldwide standards. Manufacturers must adhere to both the FDA, EMA, and a multitude of other regulatory bodies, therefore it is essential to find partners who have experience in and understand compliance.

Although the economy has slowed, the medical device contract manufacturing market has managed to withstand the economic fluctuations. Increased outsourcing from OEMs and consistent demand for medical devices (including ventilators and high-demand IVD products) led to a significant share of the medical device market being added even during a recession in years like 2020.

The challenges facing the industry are of major concern given the complex regulatory requirements, which are coupled with supply chain disruptions globally, making production difficult, costly, and challenging for new devices to enter the market.