• Rising Demand for Outsourced Manufacturing is driving growth as medical device companies seek cost-effective solutions, flexibility, and expertise in complex production processes.

• Technological Advancements in Manufacturing such as precision molding, additive manufacturing, and automated assembly are enhancing product quality and reducing time-to-market.

• Increasing Regulatory Compliance Requirements are encouraging manufacturers to partner with specialized contract service providers who ensure adherence to FDA, ISO, and other international standards.

• Expansion of Healthcare Infrastructure globally is boosting the demand for medical devices, consequently increasing reliance on contract manufacturers for scalable production.

• Focus on Cost Optimization is prompting OEMs to outsource manufacturing to reduce capital expenditure, minimize operational risks, and leverage global supply chains.

• R&D Collaborations between device innovators and contract manufacturers are accelerating development of advanced technologies such as wearable devices, minimally invasive instruments, and diagnostic equipment.

• Regional Growth in Asia-Pacific is driven by favorable labor costs, established industrial hubs, and increasing adoption of medical devices in emerging markets.

• In 2024, Flex Ltd. entered a strategic partnership with a leading biotech company to co-develop cutting-edge contract manufacturing solutions for advanced medical devices. This collaboration focuses on enhancing production efficiency, innovation and scalability to meet the rising demand for next-generation healthcare technologies.

• In 2022, Jabil Inc. completed the acquisition of a specialized medical device manufacturing firm, strengthening its capabilities in high-precision medical component production. This move expands Jabil’s expertise in advanced healthcare manufacturing, supporting innovation and precision in next-generation medical technologies.

In this report, the Medical Device Contract Manufacturing Market has been segmented by Device, Service, Class Device,End-use, and Geography.

Medical Device Contract Manufacturing Market, Segmentation by Device

The Medical Device Contract Manufacturing Market has been segmented by Device into IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Ophthalmology Devices, Orthopedic Devices, Dental Devices, and Others.

IVD Devices
IVD devices represent around 30% of the medical device contract manufacturing market. The segment includes test kits, reagents, and lab equipment, driven by the growing emphasis on early diagnosis, personalized medicine, and demand for COVID-19 testing.

Diagnostic Imaging Devices
Diagnostic imaging devices contribute nearly 20% of the market. Contract manufacturers support the production of X-ray machines, MRI scanners, and ultrasound systems, vital for modern diagnostic workflows.

Cardiovascular Devices
Cardiovascular devices account for approximately 15% of the market. Contract manufacturers provide solutions for catheters, stents, and pacemakers, supporting innovations in cardiac care.

Ophthalmology Devices
Ophthalmology devices hold about 10% of the market. This segment covers intraocular lenses, diagnostic equipment, and surgical tools, addressing rising cases of vision disorders.

Orthopedic Devices
Orthopedic devices represent nearly 10% of the market. Contract manufacturers produce implants, surgical instruments, and prosthetics to meet the growing demand for joint replacement and spinal procedures.

Dental Devices
Dental devices contribute roughly 8% of the market. This includes implants, brackets, and aligners, supported by increasing demand for aesthetic and restorative dental treatments.

Others
Other devices, including ENT instruments, neurological devices, and general surgical tools, make up around 7% of the market. Contract manufacturers offer specialized production capabilities to meet evolving clinical needs.

Medical Device Contract Manufacturing Market, Segmentation by Service

The Medical Device Contract Manufacturing Market has been segmented by Service into Device Development and Manufacturing Service, Quality Management Service, and Assembly Service.

Device Development and Manufacturing Service
Device development and manufacturing service holds about 60% of the medical device contract manufacturing market. It covers design, prototyping, and full-scale production, ensuring seamless supply chain and efficient product delivery.

Quality Management Service
Quality management service accounts for approximately 25% of the market. It includes quality assurance, testing, and regulatory compliance to ensure medical devices meet international standards and safety regulations.

Assembly Service
Assembly service makes up around 15% of the market. This involves the precise integration of medical device components, with labeling, packaging, and final quality checks to ensure reliable and compliant finished products.

Medical Device Contract Manufacturing Market, Segmentation by Class Device

The Medical Device Contract Manufacturing Market has been segmented by Device into Class I: General controls, Class II: General controls with special controls, and Class III: General controls, special controls.

Class I: General Controls
Class I devices make up about 25% of the medical device contract manufacturing market. These low-risk devices, like bandages and surgical gloves, require basic regulatory oversight focused on general safety.

Class II: General Controls with Special Controls
Class II devices account for nearly 50% of the market. They include surgical drapes, infusion pumps, and diagnostic equipment, subject to special controls and performance standards for enhanced safety and effectiveness.

Class III: General Controls and Special Controls
Class III devices hold approximately 25% of the market. This high-risk category includes implantable devices, requiring stringent premarket approvals, extensive clinical testing, and comprehensive quality management systems.

Medical Device Contract Manufacturing Market, Segmentation by End Use

The Medical Device Contract Manufacturing Market has been segmented by End Use into Original Equipment Manufacturers (OEMs), Pharmaceutical & Biopharmaceutical Companies, and Others.

Original Equipment Manufacturers (OEMs)
OEMs hold about 65% of the medical device contract manufacturing market. They partner with contract manufacturers for custom solutions, cost efficiency, and scalability, enabling focus on innovation and market expansion.

Pharmaceutical & Biopharmaceutical Companies
Pharmaceutical & biopharmaceutical companies contribute approximately 25% of the market. They outsource drug delivery devices, diagnostic systems, and combination products to contract manufacturers, concentrating on R&D and product commercialization.

Others
Others account for nearly 10% of the market, comprising research organizations, startups, and small companies. Contract manufacturing provides them with specialized resources, regulatory support, and accelerated product development.

Medical Device Contract Manufacturing Market, Segmentation by Geography

In this report, the Medical Device Contract Manufacturing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

Medical Device Contract Manufacturing Market Share (%), by Geographical Region

North America
North America captures nearly 40% of the medical device contract manufacturing market. The region boasts strong regulatory compliance, advanced manufacturing capabilities, and a concentration of major OEMs, particularly in the U.S..

Europe
Europe holds about 30% of the market, supported by countries such as Germany, France, and the UK. The region’s emphasis on quality standards, R&D investment, and regulatory stringency promotes market growth.

Asia Pacific
Asia Pacific represents around 20% of the market, with rapid growth in China, India, and Japan. Expanding manufacturing bases, rising healthcare investment, and increasing partnerships with global OEMs drive the region’s growth.

Middle East & Africa
Middle East & Africa contribute approximately 5% of the market. Growth is propelled by improving healthcare systems, rising demand for medical devices, and increasing emphasis on modern technologies.

Latin America
Latin America accounts for nearly 5% of the market, led by Brazil and Mexico. The region’s growth is driven by increasing healthcare spending, growing contract manufacturing collaborations, and adoption of advanced medical solutions.