Global Medical Devices Outsourcing Market to Reach USD 592.1 Bn by 2036, Growing at 13.1% CAGR | TMR

R&D efforts, strict regulations, and the need for cost-efficient manufacturing are driving growth in medical device outsourcing.

WILMINGTON, DE, UNITED STATES, February 10, 2026 /EINPresswire.com/ -- The global medical devices outsourcing market was valued at USD 152.7 billion in 2025 and is projected to reach USD 592.1 billion by 2036, expanding at a robust CAGR of 13.1% from 2026 to 2036. Market growth is driven by the increasing complexity of medical device designs, rising regulatory and compliance requirements, and the growing need for cost-efficient, scalable manufacturing solutions, prompting OEMs to rely more heavily on specialized outsourcing partners.

The medical devices outsourcing industry is expanding as Original Equipment Manufacturers (OEMs) utilize specialized third-party providers for designing, manufacturing, testing, regulatory, and quality management processes in order to improve their efficiency and focus on their core areas of innovation. Outsourcing is now looked upon as an important strategy that companies need to pursue due to the increasing complexity of products and the need for shorter life cycles for them. As such, it is difficult for many OEMs to keep up with the capabilities required to manufacture these items and remain competitive in the marketplace.

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Advancements in Precision and Compliance

With the advancement of AI-driven design and material science, devices with improved biocompatibility and miniaturized components have been developed. Design innovations in robotics and wearable sensors have prompted OEMs to lean on contract development and manufacturing organizations (CDMOs) to meet specific technical challenges. To improve patient outcomes, there is a high demand for high-precision components used in cardiovascular and orthopedic implants.

Next-generation devices, such as robotic-assisted surgical systems and smart drug-delivery platforms, are pushing the boundaries of what is possible. In addition to improving procedural accuracy, these devices are becoming safer and more integrated with digital health ecosystems. As these technologies approach mass commercialization, outsourcing partners are scaling their capabilities to overcome technical hurdles in high-volume production.

Key Findings of the Market Report

Based on service, contract manufacturing remains the dominant segment, driven by the need for scalable production facilities.

A greater emphasis on regulatory affairs is likely to create significant opportunities as compliance landscapes become more complex globally.

High demand for outsourcing is particularly notable in the cardiovascular and orthopedic therapeutic areas.
Asia-Pacific held a significant market share in 2025, supported by cost-effective manufacturing hubs in China and India.

Global Medical Devices Outsourcing Market: Growth Drivers

Rising Prevalence of Chronic Diseases: The growing global burden of conditions like diabetes and heart disease increases the demand for sophisticated diagnostic and monitoring equipment.

Cost Suppression Pressures: Manufacturers are increasingly outsourcing non-core functions to reduce operational expenses and manage shrinking profit margins.

Technological Advancements: The integration of AI, 3D printing (additive manufacturing), and the Internet of Medical Things (IoMT) requires specialized technical expertise often found in CDMOs.

Shortened Time-to-Market: By leveraging the existing infrastructure of outsourcing partners, OEMs can accelerate the product development lifecycle and launch devices more quickly.

Complex Regulatory Standards: Navigating the rigorous approval processes of the FDA and European EMA drives the demand for third-party regulatory and clinical support services.

Global Medical Devices Outsourcing Market: Regional Landscape

North America continues to be a leading hub for medical device innovation. In the United States, high R&D investment and a mature healthcare infrastructure drive the outsourcing of high-end Class III devices. Government support for advanced manufacturing and a focus on localized supply chains are further stabilizing regional growth.

Asia-Pacific is expected to witness the fastest growth rate. Lower labor costs, improved healthcare infrastructure, and favorable government policies in countries like China and India make the region an attractive destination for contract manufacturing. The expanding middle class in these nations is also driving domestic demand for affordable medical devices.

Global Medical Devices Outsourcing Market: Key Players

Major players are utilizing strategic acquisitions and facility expansions to strengthen their market presence:

Europlaz
Pro-Tech Design and Manufacturing Inc
SGS Société Générale de Surveillance SA
Preqin
Charles River Laboratories
Intertek Group plc
IQVIA
Labcorp.
Pace Analytical
Sterigenics U.S., LLC
WuXi AppTec
Pro-Tech Design and Manufacturing Inc
Nissha Co. Ltd.
Biomerics.
Other Prominent Players

Key Developments in Medical Device Outsourcing Market

In October 2025, Molded Rubber and Plastic Corporation announced its partnership with Vance Street Capital (“Vance Street”), a Los Angeles-based private equity firm focused on investing in highly engineered solutions. This partnership supports the company’s continued growth as a full-service medical device contract manufacturer, offering end-to-end capabilities across the medical device community with specialized expertise in silicone and thermoplastic molding solutions.

In February 2025, Arterex expanded medical manufacturing, metal fabrication, and machining capabilities with acquisition of Adroit USA Inc. Integration expands Arterex’s platform with additional manufacturing plants in India, thereby strengthening its global footprint in medical device contract manufacturing.

Global Medical Devices Outsourcing Market: Segmentation

By Service

Contract Manufacturing
Regulatory Affairs Services
Product Design & Development
Quality Assurance
Packaging & Sterilization

By Application

Cardiovascular
Orthopedic
Diagnostic Imaging
Diabetes Care
Dental
Others

By Device Class

Class I
Class II
Class III

By Region

North America
Europe
Asia Pacific
Latin America
Middle East & Africa

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