Medical Device Contract Manufacturing Market to Reach USD 268.6 Billion by 2035
The medical device contract manufacturing market is projected to expand from USD 87.32 billion in 2025 to USD 268.6 billion by 2035, at a compound annual growth rate of 11.89%.
The global market for contract manufacturing of medical devices is forecast to reach USD 268.6 billion by 2035, growing at a compound annual growth rate of 11.89% from 2026 to 2035. The market was valued at USD 87.32 billion in 2025, with growth driven by a significant increase in outsourcing by original equipment manufacturers (OEMs) to specialized contract manufacturing organizations (CMOs).
Rising manufacturing costs and increasingly stringent regulatory requirements are compelling OEMs to leverage the expertise and infrastructure of CMOs. These specialized partners offer advanced cleanroom facilities, automated processes, and robust quality management systems, allowing OEMs to focus on innovation and R&D. CMOs are incorporating technologies such as robotics, AI-assisted quality checks, and additive manufacturing to enhance efficiency and speed up the development and commercialization of new medical devices.
In terms of service types, device development and manufacturing constituted the largest market segment in 2025. However, the quality management and testing segment is expected to exhibit the fastest growth, driven by stricter regulations like the EU Medical Device Regulation (MDR) and enhanced inspection programs by bodies such as the FDA.
By device type, diagnostic and in-vitro diagnostic (IVD) devices dominated the market in 2025. The drug delivery devices segment is anticipated to experience significant growth, fueled by increasing demand for advanced drug delivery solutions.