Medical Device Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service (Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing), By Application (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care, Others), By Class (Class I, Class II, Class III), By Region and Competition, 2020-2030F

Market Overview

Global Medical Device Outsourcing Market was valued at USD 131.66 Billion in 2024 and is expected to reach USD 270.86 Billion in the forecast period with a CAGR of 12.75% through 2030. The Global Medical Device Outsourcing Market is experiencing significant growth due to the increasing demand for high-quality medical devices and the rising complexity of regulatory requirements. The demand for outsourced services is driven by the growing need for cost-effective and efficient manufacturing processes, allowing original equipment manufacturers (OEMs) to focus on core activities such as innovation, product development, and marketing. This trend is evident across various segments of the market, including design, testing, manufacturing, assembly, packaging, and logistics services. Outsourcing enables companies to reduce costs associated with in-house production and streamline their operations by leveraging the expertise of third-party service providers. As the medical device industry becomes more competitive, outsourcing helps firms remain agile and focus on improving product quality, accelerating time-to-market, and meeting regulatory standards.

Key trends fueling the market include the increasing adoption of advanced technologies such as automation and additive manufacturing, which have significantly improved the speed and efficiency of production. Companies are also integrating digital technologies into their operations, including artificial intelligence (AI) and machine learning (ML), to optimize processes and enhance product development. Additionally, the demand for personalized medical devices is on the rise, leading to greater collaboration with outsourcing partners that can provide specialized services. As the market continues to evolve, innovation in design, rapid prototyping, and custom manufacturing will be pivotal in meeting the needs of both large and small device manufacturers.

Despite its growth, the Global Medical Device Outsourcing Market faces several challenges. A major issue is the regulatory burden, as medical device manufacturers must comply with stringent standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Ensuring adherence to these regulations can be time-consuming and costly for outsourcing partners. Furthermore, intellectual property (IP) protection remains a critical concern, as manufacturers seek to safeguard proprietary technologies and designs when sharing sensitive information with third-party service providers. Another challenge is the dependency on external suppliers, which can lead to supply chain disruptions or quality control issues. To mitigate these risks, OEMs must carefully evaluate and select outsourcing partners that offer proven capabilities and a reliable track record in delivering quality products.

Key Market Drivers

Rising Demand for Cost-Effective Solutions

​The rising demand for cost-effective solutions is a key driver propelling the growth of the global medical device outsourcing market. As healthcare costs continue to escalate globally, medical device manufacturers are under growing pressure to reduce operational expenses while maintaining high-quality standards and regulatory compliance. Outsourcing offers a strategic advantage by enabling companies to shift non-core activities such as design, development, testing, production, and packaging to specialized third-party service providers, often located in low-cost regions. This approach allows manufacturers to significantly cut costs associated with labor, infrastructure, and logistics, without compromising product quality or innovation. Outsourcing also reduces capital expenditure as companies no longer need to invest heavily in manufacturing facilities, advanced machinery, or skilled labor for every process in the value chain.​

With rising competition and shortening product life cycles, manufacturers are increasingly seeking agile and scalable production models to bring products to market faster and at a lower cost. Outsourcing partners help accelerate time-to-market by offering specialized expertise, proven manufacturing processes, and ready access to global regulatory knowledge. This results in reduced turnaround times, optimized supply chain management, and enhanced flexibility in responding to market demands. In emerging economies where healthcare budgets are limited, the emphasis on affordability has made cost-effective devices a top priority. Outsourcing enables manufacturers to meet these cost constraints while still ensuring compliance with international standards and performance expectations. As a result, companies are now strategically aligning with outsourcing partners not just to save money but also to enhance competitiveness, focus on innovation, and scale operations efficiently. The growing awareness among OEMs of these benefits is leading to long-term partnerships with outsourcing providers, especially those offering end-to-end services across the product lifecycle. This ongoing shift in operational strategy continues to strengthen the market for medical device outsourcing worldwide.

Increase in Regulatory Compliance Needs

​The increasing complexity of regulatory frameworks globally has significantly influenced the growth trajectory of the Global Medical Device Outsourcing Market. In 2023, the U.S. Food and Drug Administration (FDA) received approximately 19,100 medical device submissions, marking an increase from 18,800 in 2022. This surge underscores the heightened regulatory demands manufacturers face, prompting many to seek specialized outsourcing partners to navigate the intricate approval processes efficiently. 

Similarly, the European Union's Medical Device Regulation (EU MDR) has introduced more stringent requirements, impacting manufacturers' ability to bring products to market promptly. The transition to the EU MDR has posed challenges, with some companies lacking the necessary resources to meet the new standards, potentially leading to bottlenecks in device availability. To address these challenges, many manufacturers are turning to outsourcing partners who specialize in regulatory compliance, ensuring adherence to both FDA and EU MDR standards.​

In response to these evolving regulatory landscapes, outsourcing providers have emerged as crucial allies, offering expertise in navigating complex regulatory environments, ensuring timely approvals, and maintaining compliance throughout the product lifecycle. This strategic collaboration allows medical device manufacturers to focus on innovation and core competencies while effectively managing the intricacies of regulatory compliance.

Growing Globalization

​The increase in regulatory growing globalization is a key driver for the Global Medical Device Outsourcing Market. As medical device manufacturers expand into international markets, they face complex regulatory frameworks that vary across regions. Navigating these regulations is challenging, especially as many countries impose stringent safety, efficacy, and quality standards for medical devices. To manage these complexities and expedite market entry, companies increasingly turn to outsourcing partners with expertise in regulatory affairs and compliance. Outsourcing regulatory functions such as market approval processes, clinical trials, product testing, and certification enables manufacturers to ensure compliance with both local and international standards without investing heavily in regulatory infrastructure in each region.​

Countries like the U.S., European Union member states, Japan, and emerging markets in Asia have well-defined regulations, requiring manufacturers to adapt their devices to local regulatory norms. By leveraging the knowledge of outsourcing partners who are familiar with the regulatory environment in multiple jurisdictions, companies can reduce the risk of delays or failures in product launches. In addition, as globalization accelerates, manufacturers can expand their reach in regions with emerging healthcare markets, where the demand for medical devices is growing. Outsourcing regulatory affairs to specialized providers enables manufacturers to streamline product development processes, ensuring devices meet both global and regional standards more efficiently.​

The increasing globalization of the medical device industry also leads to the need for more robust supply chains and the efficient distribution of devices across borders. Medical device outsourcing partners who have an established global network are better positioned to manage logistics and compliance processes in multiple markets. As a result, the integration of regulatory expertise into the outsourcing strategy helps global manufacturers reduce costs, avoid compliance risks, and accelerate time to market, ultimately driving growth in the medical device outsourcing sector.

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Key Market Challenges

Intellectual Property (IP) Risks

Intellectual Property (IP) risks present a significant challenge for the Global Medical Device Outsourcing Market. As companies increasingly look to outsource various stages of the medical device manufacturing process, they often share proprietary designs, processes, and technologies with third-party suppliers or manufacturers. This sharing of sensitive information raises the potential for intellectual property theft, misuse, or unauthorized copying, particularly in countries with less stringent enforcement of IP laws. The risk of IP infringement can lead to financial losses, reputational damage, and loss of competitive advantage in the marketplace.

Many regions, especially in emerging markets, lack the robust legal frameworks and IP protection mechanisms seen in developed nations, increasing the vulnerability of outsourced operations to IP-related issues. Inadequate enforcement of IP rights in these regions can result in counterfeiting, reverse engineering, or unauthorized production of medical devices, undermining the investments made by original device manufacturers. Furthermore, disputes regarding IP ownership and licensing can lead to lengthy legal battles, delays in product development, and the potential loss of market share to competitors who gain access to proprietary technologies.

To mitigate these risks, companies must establish strong contracts with clear terms regarding IP protection, confidentiality agreements, and mechanisms to resolve disputes. Additionally, conducting thorough due diligence on outsourcing partners, including evaluating their track record with IP protection and their compliance with international IP standards, is crucial. As the global medical device industry becomes more interconnected, managing intellectual property risks will remain a top priority for companies seeking to safeguard their innovations while benefiting from outsourcing partnerships.

Quality Control Issues

Quality control issues present a significant challenge for the Global Medical Device Outsourcing Market, as maintaining stringent standards across various regions and manufacturing partners is essential. As outsourcing medical device manufacturing involves multiple vendors and suppliers, ensuring uniformity and consistency in the production process becomes more complex. Discrepancies in quality control measures can lead to inconsistencies in product performance, safety, and regulatory compliance. Even minor defects or failures in product testing can result in costly product recalls, regulatory penalties, and loss of customer trust, all of which are detrimental to a company’s reputation and bottom line.

The challenge intensifies in low-cost regions where labor and material costs are lower but may lack the advanced infrastructure, technology, and expertise typically found in high-cost regions. These regions may struggle with adherence to internationally accepted quality standards, such as ISO 13485, leading to discrepancies in product quality. Additionally, discrepancies in how quality control procedures are implemented across different outsourcing partners, particularly those with varying levels of expertise, can cause delays in production and complications in meeting the required quality benchmarks. Such issues also arise when working with contract manufacturers that may not have the necessary resources or systems in place for rigorous testing, inspection, and certification.

Ensuring quality control is further complicated by the evolving nature of regulatory requirements. The medical device industry is heavily regulated, and each market—such as the U.S., Europe, or Asia has different standards for product approval. Outsourcing companies may face difficulties in aligning their production processes with these varying regulatory demands. Companies looking to expand their operations globally must invest significantly in developing strong, consistent quality control measures and closely monitor the production process across all stages to avoid compromising product integrity. Quality assurance becomes especially critical for high-risk devices, where any deviation from set standards can have severe consequences for patient safety.

Key Market Trends

Expansion of Analytical Testing Services

​The expansion of analytical testing services in the Global Medical Device Outsourcing Market is significantly influenced by the increasing complexity of medical devices and the need for rigorous safety and efficacy evaluations. In 2023, the U.S. Food and Drug Administration (FDA) authorized a total of 5,807 marketing submissions, slightly higher than the 5,731 authorized in 2022. This uptick underscores the growing demand for comprehensive testing services to meet stringent regulatory standards.​

Moreover, the FDA's approval of artificial intelligence (AI) and machine learning-enabled medical devices has surged in recent years. In 2015, the FDA authorized six AI medical devices, whereas, in 2023, the agency approved 221 such devices. This rapid advancement in AI-driven medical technologies necessitates specialized analytical testing to ensure these sophisticated devices are safe and effective for clinical use.​

The International Organization for Standardization (ISO) also plays a pivotal role in this landscape. As of December 31, 2023, there were 20,682 valid ISO 13485 certificates worldwide, reflecting a global commitment to quality management systems in the medical device industry. This standard is crucial for manufacturers aiming to demonstrate their dedication to producing safe and reliable medical devices, further driving the need for robust analytical testing services.​

These developments highlight a trend towards more sophisticated and diverse medical devices, which in turn amplifies the demand for specialized analytical testing services. Outsourcing these services allows manufacturers to leverage expert knowledge and state-of-the-art facilities, ensuring compliance with evolving regulatory requirements and maintaining high-quality standards in their products.

Growth in Personalized and Wearable Medical Devices

The growth in personalized and wearable medical devices is a key trend driving the Global Medical Device Outsourcing Market. Technological advancements in sensors, wireless communication, and miniaturization have led to the development of devices that monitor vital health metrics in real-time, such as heart rate, blood glucose, blood pressure, and oxygen levels. The demand for these devices is expanding as healthcare providers focus on improving patient outcomes through more individualized and continuous monitoring. Personalized devices, such as smart insulin pumps and wearable ECG monitors, cater to the increasing preference for healthcare solutions that can be tailored to the needs of individual patients, enabling better management of chronic conditions.

Outsourcing plays a pivotal role in the growth of this segment, as medical device manufacturers increasingly look to external partners for specialized expertise in areas like device design, development, and testing. The complexity of developing personalized devices requires advanced knowledge in hardware and software integration, requiring manufacturers to collaborate with external service providers who have the required capabilities. Additionally, wearable devices that are designed to be worn continuously or intermittently demand high levels of accuracy, reliability, and comfort. Outsourcing allows companies to leverage expert engineering services for the development of these sophisticated devices, including miniaturization, power management, and sensor integration.

The growing trend toward remote patient monitoring and telehealth solutions also drives the demand for wearable devices that can provide constant health data to healthcare professionals, fostering a shift toward more preventative care models. As the market for personalized and wearable devices expands, companies continue to look for cost-effective, high-quality outsourcing solutions that allow them to quickly adapt to this rapidly changing landscape while meeting stringent regulatory requirements.

Segmental Insights

Service Insights

Based on the Service, Contract Manufacturing emerged as the dominant segment in the Global Medical Device Outsourcing Market in 2024. This is due to its critical role in helping original equipment manufacturers (OEMs) reduce operational costs, optimize resource utilization, and accelerate time-to-market. As regulatory requirements for medical devices continue to tighten globally, OEMs increasingly rely on contract manufacturers who possess specialized expertise, state-of-the-art infrastructure, and regulatory certifications to ensure compliance and maintain product quality. The growing complexity of medical devices, including the integration of digital components and advanced materials, further drives the demand for skilled external partners with deep technical capabilities. Contract manufacturers offer end-to-end solutions including component production, device assembly, and packaging, which help streamline the supply chain and reduce manufacturing burdens for OEMs. The flexibility to scale production capacity based on market needs, without incurring high capital investment, is another major reason driving this segment’s dominance.

Class Insights

Based on the Class, Class II emerged as the dominant segment in the Global Medical Device Outsourcing Market in 2024. This dominance is due to their widespread clinical applications, moderate risk profile, and growing demand across diagnostic and therapeutic categories. Class II devices, such as infusion pumps, surgical drapes, diagnostic imaging equipment, and powered wheelchairs, require special controls and rigorous performance standards to ensure safety and efficacy. These devices often involve more complex manufacturing processes compared to Class I devices, prompting medical device companies to outsource production to specialized partners with advanced capabilities and regulatory expertise. The steady growth in chronic disease prevalence, aging populations, and increasing surgical volumes globally has further fueled the need for high-quality Class II devices, making them a significant part of OEM product portfolios. Outsourcing allows companies to meet stringent quality and compliance requirements while managing costs and reducing time-to-market.

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Regional Insights

North America emerged as the dominant region in the Global Medical Device Outsourcing Market in 2024. This is due to the region’s robust healthcare infrastructure, advanced technological ecosystem, and strong presence of both medical device OEMs and specialized contract service providers. The United States, in particular, serves as a global hub for medical device innovation and production, housing several leading multinational corporations that increasingly rely on outsourcing partners to streamline operations and maintain regulatory compliance. The region’s stringent regulatory environment, led by the U.S. Food and Drug Administration (FDA), has created a demand for outsourcing partners with in-depth regulatory expertise and proven quality management systems. This need has fueled the growth of outsourcing relationships, particularly for services such as contract manufacturing, product design and development, regulatory consulting, and packaging and sterilization.

Asia-Pacific emerged as the fastest growing region in the Global Medical Device Outsourcing Market during the forecast period. This is due to the rapid expansion of the medical device manufacturing sector across countries like China, India, Malaysia, and South Korea. These countries have witnessed substantial investments in infrastructure, regulatory streamlining, and research and development, encouraging global medical device companies to shift their outsourcing operations to the region. The presence of a large, technically skilled workforce at significantly lower labor costs compared to Western nations enhances the region's attractiveness for outsourced engineering, product development, and component manufacturing. Government initiatives supporting “Make in India” and China's “Made in China 2025” have provided incentives to multinational companies to set up or expand their manufacturing and R&D facilities. The rise of local contract manufacturers with strong quality certifications, such as ISO 13485 and FDA registrations, also boosts confidence among global players seeking reliable partners for device production. Increasing demand for affordable medical technologies within domestic markets further drives collaboration between local manufacturers and international companies aiming to co-develop cost-effective solutions.

Recent Developments

• In February 2025, Jabil Inc. finalized the acquisition of Pharmaceutics International Inc. (Pii), a contract development and manufacturing organization (CDMO) specializing in aseptic filling, lyophilization, and oral solid dose manufacturing for early-stage, clinical, and commercial volumes. This acquisition strengthens their ability to offer pharmaceutical companies comprehensive, end-to-end support, enhancing the supply chain with a focus on quality and safety as healthcare innovation accelerates. Jabil’s expanded pharmaceutical solutions now include auto-injectors, pen injectors, inhalers, and on-body pumps, further bolstered by Pii’s expertise in scientific insights and manufacturing capabilities.
• In February 2025, Arterex, a leading global medical device developer and contract manufacturer, acquired Adroit USA Inc., a vertically integrated contract manufacturer specializing in complete medical device production. The company based in Pleasanton, California, Adroit USA operates two ISO 13485-certified manufacturing facilities in Bangalore, India, and an engineering applications development lab in Milpitas, California. The company specializes in high-precision injection-molded plastic components, stainless steel and nitinol parts, and fully assembled medical devices. Adroit USA's comprehensive "all under one roof" model provides tailored solutions for businesses of all sizes, from startups to large enterprises.
• In January 2025, Spectra Medical Devices (Spectra) and XL Precision Technologies (XLPT) unveiled their unified brand, Elevaris Medical Devices. This new contract development and manufacturing organization (CDMO) combines a legacy of excellence with advanced capabilities in precision medical device development and manufacturing. The merger followed Spectra’s acquisition of XLPT in September 2024, facilitated by healthcare investor QHP Capital. The integration of Spectra’s engineering and manufacturing expertise with XLPT’s specialization in precision micro-components, complex tubular components, and sub-assemblies strengthens their ability to serve both large OEMs and startups in the medical device industry.
• In November 2024, MDC (Medical Device Components), a leading provider of high-precision medical device components, announced the acquisition of Lighteum, a pioneer in nitinol-based medical component manufacturing. The deal merges MDC's expertise in platinum group metals and micromachining with Lighteum's advanced nitinol processing capabilities, including laser cutting, welding, heat shaping, and electropolishing. This acquisition enhances MDC’s portfolio and strengthens its ability to meet the growing demands of the medical device industry.
• In October 2024, NAMSA, a leading MedTech Contract Research Organization (CRO), and Terumo, a global leader in medical technology, announced a strategic outsourcing partnership. This collaboration aims to expedite the regulatory approval and commercialization of Terumo’s product portfolio. Terumo, based in Tokyo and operating worldwide, offers a broad range of innovative medical solutions, including vascular intervention, cardio-surgical products, blood transfusion technology, diabetes care, and peritoneal dialysis treatments.

Key Market Players

• Laboratory Corporation of America Holdings
• Pace Analytical Services, Inc.
• Intertek Group plc
• Charles River Laboratories
• Medical Device Testing Services
• PAREXEL International Corporation
• Accell Clinical Research, LLC
• Criterium, Inc.
• ICON plc.
• IQVIA Inc.
• Integer Holdings Corporation

Report Scope:

In this report, the Global Medical Device Outsourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Medical Device Outsourcing Market, By Service:

o   Quality Assurance

o   Regulatory Affairs Services

o   Product Design and Development Services

o   Product Testing & Sterilization Services

o   Product Implementation Services

o   Product Upgrade Services

o   Product Maintenance Services

o   Contract Manufacturing

• Medical Device Outsourcing Market, By Application:

o   Cardiology

o   Diagnostic Imaging

o   Orthopedic

o   IVD

o   Ophthalmic

o   General and Plastic Surgery

o   Drug Delivery

o   Dental

o   Endoscopy

o   Diabetes Care

o   Others

• Medical Device Outsourcing Market, By Class:

o   Class I

o   Class II

o   Class III

• Medical Device Outsourcing Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Medical Device Outsourcing Market.

Available Customizations:

Global Medical Device Outsourcing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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