US and Costa Rica Medical Contract Manufacturing Market Size and Forecast (2021 - 2031), Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Service Type (Full-device Manufacturing, Sub-assembly and Components, and Materials-specifi

According to our new research study on “US and Costa Rica Medical Contract Manufacturing Market Forecast to 2031 -Global Analysis - by Service Type and Device Type,” the market is anticipated to grow from US$ 29.49 billion in 2024 to US$ 62.83 billion by 2031; the market is expected to register a CAGR of 11.5% from 2025 to 2031. The US and Costa Rica medical contract manufacturing market growth is attributed to the national security tariff investigations, investment in domestic pharmaceutical manufacturing, and hosting of MPO medtech forum.

Medical contract manufacturing involves outsourcing the production of medical devices, components, or equipment to specialized third-party companies. These manufacturers offer services such as design, prototyping, assembly, and packaging, allowing healthcare companies to reduce costs and focus on core activities like research and marketing. It is widely used in producing surgical instruments, diagnostic devices, and implants, ensuring compliance with regulatory standards while accelerating product development and market entry.

The US and Costa Rica Medical Contract Manufacturing market in North America is segmented into the US, Canada, and Mexico.

OEMs are increasingly outsourcing production to focus on core competencies such as research, development, innovation, and marketing. This shift reduces capital expenditures on in-house facilities, minimizes operational risks, and leverages specialized expertise from contract manufacturers (CMOs). The trend is amplified by the complexity of modern devices, making it challenging for OEMs to maintain full-scale production internally.

The escalating cost pressures and need for cost-effective production, as in-house manufacturing demands substantial capital for facilities and research and development prompting OEMs to outsource to specialized CMOs for economies of scale and reduced overheads; for instance, in November 2024, Taiwan-based Medeologix acquired three US medical device companies to form a comprehensive outsourcing service group, enabling cost savings through integrated supply chains and streamlined operations.

The rising prevalence of chronic diseases and an aging population, which heightens demand for advanced Class II devices such as cardiovascular and diagnostic tools, overwhelming internal capacities and necessitating scalable outsourcing; the FDA's approval of over 30 high-risk devices such as the TriClip G4 System in early 2024 alone, many relying on CMOs for rapid production to meet surging needs. Thus, high prevalence of chronic diseases, rising in-house manufacturing costs, and high demand for medical devices drive the US market growth.

Surging Demand for Personalized and Home Healthcare Devices to Provide Market Opportunities in Future

By leveraging advanced technologies, companies can develop customized solutions that prioritize patient needs. This shift toward developing personalized and home healthcare devices enables better remote monitoring, improved health outcomes, and lower healthcare costs.

In the US, this growth trend is largely driven by contract manufacturers teaming up with OEMs to develop customized implants, wearables, and diagnostic tools. There are supportive regulatory frameworks in place that help speed up innovation. For instance, the NIH's Blueprint MedTech program was updated in July 2025 with a goal of improving patient access to safe and effective medical devices while encouraging investment from both the industry and the government. Although it focuses on neurotechnology, it can also expand into personalized applications, such as biosensors designed for managing chronic diseases. The program provides funding and resources to small businesses and contract manufacturers, helping them develop prototypes, conduct clinical studies, and navigate the complex process of obtaining FDA approvals. This is paving the way for a market that’s set to grow, especially as demand for home-use devices rises.

As of June 2025, BARDA's Detection, Diagnostics, and Devices Infrastructure Division funds medical device countermeasures, including personalized diagnostics for infectious diseases, with an emphasis on contract manufacturing for scalable production. Grants.gov opportunities, such as the Small Business Translator for MedTech, provide access to contract services for biocompatibility and manufacturing, supporting the development of personalized medical devices.

In Costa Rica, this opportunity manifests through the country's evolving MedTech ecosystem, where contract manufacturers specialize in Class II and III devices for personalized care, such as orthopedic implants and medication delivery systems. CINDE reports highlight 10 MedTech companies conducting research and development in 2022, focusing on patient data analytics and pharmacovigilance, which enable personalized treatments, such as those utilizing nanotechnology for cancer. Government support via PROCOMER and free trade agreements (accessing 72% of global GDP as of 2023) facilitates exports of personalized devices, with MedTech exports reaching US$ 5.9 billion in 2023, up 13% from 2021.

Support from the government through initiatives such as PROCOMER, along with free trade agreements that give access to 72% of the global GDP as of 2023, is helping Costa Rica export these personalized devices. The local biotech sector is also leaning into genetic enhancements and clinical trials, positioning the country for growth in home healthcare. Companies such as Align Technology are integrating software for personalized dental solutions, showcasing innovation in this space.

World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), National Center for Biotechnology Information (NCBI), US Census Bureau, National Institute of Statistics and Censuses, are among the primary and secondary sources referred to while preparing the US and Costa Rica medical contract manufacturing market report.

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