Medical Device CDMOs Market Size, Share, By Service Type (Device Development, Testing & Validation, Quality Management, Packaging & Labeling, Regulatory Services, and Others), Device Type (Therapeutic Medical Devices, Diagnostic Medical Devices, Drug Delivery Medical Devices, and Others), Device Class (Class I, Class II, Class III, and Others), Indication (Oncology, Orthopedic, Neurology, Cardiology, and Others), End User (Startups Companies, Mid-size Companies, and Large Medical Device Companies), and Region - Trends, Analysis, and Forecast till 2035

• By 2035, the medical device CDMOs market size is contemplated to enlarge at a valuation of USD 233.0 Billion.
• In 2024, the medical device CDMOs market valuation was USD 79.0 Billion.
• Medical Device CDMOs Market is developing at a CAGR of 11.5%.

The Contract Development and Manufacturing Organization, or CDMO, collaborates with businesses to design, develop, and manufacture medical devices, providing comprehensive solutions from inception to market launch. By integrating specialist knowledge, cutting-edge technology, and regulatory experience, it accelerates time-to-market, allowing innovators to concentrate on core R&D while lowering costs and compliance concerns. This is its main advantage.  

A number of convergent factors are contributing to the strong expansion of the medical device CDMOs market. The need for cutting-edge medical equipment has grown as a result of the world's aging population and the rise in chronic illnesses. The intricacy of these gadgets and the demand for quick innovation have also prompted manufacturers to use specialist CDMOs' knowledge and cutting-edge technology to outsource development and production. With regard to their growing healthcare infrastructure and supportive government policies, emerging markets especially those in Asia-Pacific and Latin America offer substantial development prospects. Together, these factors place CDMOs in a crucial position within the changing medical device manufacturing industry.

The medical device Future Due to strategic industry changes, changing healthcare demands, and technology breakthroughs, the CDMO market is about to undergo a major upheaval. The incorporation of sophisticated manufacturing technologies, such as automation, 3D printing, and artificial intelligence, is one of the major trends. These technologies improve productivity and make it possible to produce intricate, personalized medical equipment. Flexible manufacturing solutions are required due to the increased focus on personalized medicine, which puts CDMOs in a position to meet the demands of each patient. As CDMOs embrace eco-friendly methods to satisfy regulatory obligations and customer expectations, sustainability is also becoming a key focus. Together, these factors put CDMOs in a position to be key actors in the changing landscape of customer expectations and manufacturing requirements for medical devices.

Recession Risk & Tariff Analysis:

• Rising tariffs and the possibility of a recession are putting pressure on the medical device CDMOs market by raising production costs and upsetting international supply networks.
• Economic downturns result in less money being spent on innovation, and CDMOs are forced to reconsider their sourcing and production plans due to tariffs, particularly those imposed by the United States on imports from China and the European Union.
• As a result, companies are diversifying their supply chains and moving toward regional production in an effort to preserve stability, cut down on delays, and remain competitive in a difficult economic environment.

Impact of Generative AI on Medical Device CDMOs Market:

• Through improved quality control, supply chain optimization, and streamlined product development, generative AI is revolutionizing the medical device CDMO business. By producing design alternatives and simulating performance, it speeds up research and development while cutting expenses and time to market.
• AI-driven analytics in manufacturing improve product quality and compliance by identifying flaws early. Furthermore, by forecasting demand and optimizing inventory, generative AI improves supply chain management and results in more effective operations. CDMOs that use generative AI are better positioned to fulfill changing standards and have a competitive edge as regulatory agencies including the FDA use AI for evaluations.

Key Drivers:

The Growing Aging Population has caused the Market to Develop Considerably

Since chronic ailments including diabetes, cardiovascular disease, and mobility limitations are more common in older persons, calling for a wider selection of cutting-edge medical devices, the aging population is a primary driver of the medical device CDMO industry. In addition to their specialized knowledge, speed, and regulatory compliance, CDMOs are frequently used by medtech businesses to expand manufacturing and accelerate product development in response to this spike in demand. With healthcare systems around the world moving toward more senior-focused care, CDMOs are essential partners in providing creative, superior, and reasonably priced solutions for aging populations.

• For Instance, according to the data published by WHO, by 2030, 1 in 6 people in the world will be aged 60 years or over. At this time the share of the population aged 60 years and over will increase from 1 billion in 2020 to 1.4 billion. By 2050, the world’s population of people aged 60 years and older will double (2.1 billion). The number of persons aged 80 years or older is expected to triple between 2020 and 2050 to reach 426 million.

The Market Has Grown Significantly Due to the Increase in Chronic Illness Cases

Demand for cutting-edge, high-performing medical equipment for diagnosis, monitoring, and treatment is being driven by the growing incidence of chronic diseases including diabetes, cancer, and cardiovascular ailments. Medical device manufacturers are compelled by this increase in demand to speed up R&D and production, frequently depending on CDMOs to effectively meet these needs. CDMOs facilitate a quicker time-to-market for life-saving devices by providing scalability, regulatory knowledge, and advanced manufacturing capabilities. As chronic illnesses become a persistent worldwide health concern, CDMOs are essential in facilitating the prompt and economical provision of specialized medical care.

• For Instance, according to the data published by WHO, non-communicable diseases (NCDs), also known as chronic diseases, led to at least 43 million deaths in 2021, or 75% of all non-pandemic deaths worldwide. In 2021, 18 million people died from an NCD before reaching 70 years of age, 82% of these deaths occurring in low- and middle-income countries. 73% of all NCD deaths occurred in low- and middle-income countries. Cardiovascular diseases caused the greatest number of NCD deaths, with at least 19 million deaths in 2021. Other causes of NCD deaths were cancer (10 million), chronic respiratory diseases (4 million), and diabetes (over 2 million deaths, including deaths from kidney disease due to diabetes).

Restraints:

Inadequate Internal Innovation Capability Could Affect Market Development

Some medical device CDMOs have limited in-house innovation capability, which describes their limited capacity to independently create innovative technologies, new device designs, or exclusive procedures without consulting clients. This restriction can lower competitiveness and slow down innovation cycles, particularly in projects that call for sophisticated R&D or quick adjustments to emerging market trends.

• Counterbalance Statements: In order to get around this, CDMOs can make investments in specialized R&D facilities, establish strategic alliances with IT companies and academic institutions, and use open innovation models that promote cooperative problem-solving. Internal creativity and technical capability can also be improved by forming cross-functional innovation teams and using digital tools including artificial intelligence and simulation software.

Opportunities & Trends:

Integration of Advanced Manufacturing Technologies could be used to Investigate Future Market Prospects

A major emerging trend in the medical device CDMOs market is the use of sophisticated manufacturing technologies, including as automation, 3D printing, and AI-driven analytics, which allow for quicker, more accurate, and more economical production. Greater customization, real-time quality monitoring, and quick prototyping are made possible by these technologies, all of which are critical for satisfying the rising demand for intricate and customized medical devices. By adopting these advances, CDMOs may position themselves as essential partners in the changing medtech landscape by improving scalability, lowering mistakes, and accelerating time-to-market.

Service type, device type, device class, indication, end user, and region are the divisions of the medical device CDMOs market.

By Service Type:

Device development, testing & validation, quality management, packaging & labeling, regulatory services, and others are service type on which medical device CDMOs market is segmented. The highest medical device CDMOs market share is held by Quality Management Services, mainly owing to the strict regulations and the necessity of adhering to international standards such as ISO 13485 and ISO 9001.

Due to the growing complexity of medical devices and the need for specialist packaging solutions that guarantee product integrity and regulatory compliance, Packaging and Labeling Services is the second-largest market.

By Device Type:

Based on the device type, the medical device CDMOs market is divided into therapeutic medical devices, diagnostic medical devices, drug delivery medical devices, and others. Delivery of Drugs Due to the growing need for sophisticated, patient-friendly delivery methods such wearable technology, inhalers, and injectables, medical devices now hold the biggest medical device CDMOs market share.

Second is the diagnostic medical devices approach, which offers flexibility and promotes innovation, particularly in voluntary markets, by allowing projects that cut emissions over a predetermined baseline to earn credits.

By Device Class:

Class I, class II, class III, and others are device class of the medical device CDMOs market. In 2024, class II devices will have the biggest medical device CDMOs market share, making up about 53.25%. This dominance is explained by the widespread use of Class II devices, which are crucial for managing chronic illnesses and demand more manufacturing precision and quality control. Examples of these devices include infusion pumps, diagnostic imaging equipment, and surgical instruments.

Class III devices, which include life-sustaining, high-risk items such as pacemakers and neurostimulators, make up the second-largest sector. Despite having a smaller market share, Class III devices are expanding quickly as a result of the growing need for advanced medical technology and the rise in chronic illness.

By Indication:

On the account of indication, medical device CDMOs market is categorized into oncology, orthopedic, neurology, cardiology, and others. With 25% of the market in 2023, cardiology has the most medical device CDMOs market share. The rising incidence of cardiovascular conditions and the need for devices including pacemakers, stents, and diagnostic catheters are the main causes of this dominance.

With a 20% market share, orthopedic devices are the second-largest category. The increasing prevalence of musculoskeletal conditions, the growing need for joint replacement surgery, and developments in orthopedic implant technologies are all factors contributing to this segment's growth.

By End User:

Startups companies, mid-size companies, and large medical device companies are end user of the Medical Device CDMOs Market. The highest medical device CDMOs market share is held by large medical device businesses. To increase operational effectiveness, cut expenses, and concentrate on key skills including research and development, these well-established companies frequently outsource to CDMOs.

The second-largest sector is made up of mid-size businesses. These businesses mostly depend on CDMOs to give them access to cutting-edge manufacturing knowledge and technology that they might not otherwise have, allowing them to launch novel treatments faster.

Regional Insights:

Geographically, the medical device CDMOs market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America: The Medical Device CDMO market is dominated by North America, which accounts for around 40% of the global market. The region's sophisticated healthcare system, thriving biotechnology and pharmaceutical sectors, and powerful regulatory environments that encourage outsourcing are all factors in its dominance. North America's dominant position in the CDMO industry is further supported by the existence of sizable medical device businesses and substantial R&D expenditures.

• U.S. Medical Device CDMOs Market Insights:

Through its high concentration of leading medical device businesses, sophisticated R&D infrastructure, and FDA-led supportive regulatory framework, the United States maintains its dominant position. Additionally, the nation boasts a well-established CDMO ecosystem, significant investments in healthcare research, and a high demand for cutting-edge medical technology.

Europe: With over 35% of the global medical device CDMOs market, Europe has the biggest share of this sector. The European Union Emissions Trading System (EU ETS), the first and biggest carbon market in the world, is largely to blame for this supremacy. It accounts for about 45% of the greenhouse gas emissions in the EU. Europe is now a pioneer in this field thanks to the EU's strict emission reduction goals, strong regulatory frameworks, and dedication to sustainability, which have encouraged the broad adoption of carbon credit trading systems across industries.

• Germany Medical Device CDMOs Market Insights:

Germany's robust manufacturing base, superior engineering, and well-established presence in the pharmaceutical and medical device industries have allowed it to dominate Europe. As a reliable outsourcing partner, the nation is renowned for its meticulous manufacturing and rigorous adherence to legal requirements.

Asia Pacific: The medical device CDMOs market in Asia-Pacific is expanding rapidly due to a number of important factors. These include favorable government policies, a talented yet reasonably priced workforce, and cost-effective manufacturing. The need for medical devices is also growing as a result of the region's aging population and increased rates of chronic illnesses.

• China Medical Device CDMOs Market Insights:

China is the market leader in the Asia-Pacific area and runs the biggest carbon trading program globally in terms of volume. When China's national Emissions Trading Scheme (ETS) was first introduced in 2021, it applied to the power production industry, which was responsible for around 40% of the country's emissions. By expanding the program to cover more high-emission industries, China will be positioned as a major participant in the global medical device CDMOs market.

Medical Device CDMOs Market Report Scope:

Attribute	Details
Market Size 2025	USD 86.5 Billion
Projected Market Size 2035	USD 233.0 Billion
CAGR Growth Rate	11.5% (2025-2035)
Base year for estimation	2024
Forecast period	2025 – 2035
Market representation	Revenue in USD Billion & CAGR from 2025 to 2035
Regional scope	North America - U.S. and Canada Europe – Germany, U.K., France, Russia, Italy, Spain, Netherlands, and Rest of Europe Asia Pacific – China, India, Japan, Australia, Indonesia, Malaysia, South Korea, and Rest of Asia-Pacific Latin America - Brazil, Mexico, Argentina, and Rest of Latin America Middle East & Africa – GCC, Israel, South Africa, and Rest of Middle East & Africa
Report coverage	Revenue forecast, company share, competitive landscape, growth factors, and trends

Segmentation:

By Service Type:

• Device Development
• Testing & Validation
• Quality Management
• Packaging & Labeling
• Regulatory Services
• Others

By Device Type:

• Therapeutic Medical Devices
• Diagnostic Medical Devices
• Drug Delivery Medical Devices
• Others

By Device Class:

• Class I
• Class II
• Class III
• Others

By Indication:

• Oncology
• Orthopedic
• Neurology
• Cardiology
• Others

By End User:

• Startups Companies
• Mid-size Companies
• Large Medical Device Companies

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Russia
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • Indonesia
  • Malaysia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating in the medical device CDMOs market include, TE Connectivity, Gerresheimer AG, Viant, FLEX LTD, Integer Holdings Corporation, and others. Investing in advanced manufacturing technologies (such as automation and 3D printing), growing service offerings to offer end-to-end solutions, establishing strategic alliances with OEMs and startups, maintaining strict regulatory compliance, and concentrating on innovation to support complex, high-value devices are some of the key tactics for medical device CDMOs. To be competitive in a market that is changing quickly, supply chain resilience and global expansion are also essential.

Medical Device CDMOs Market Companies:

• TE Connectivity
• Gerresheimer AG
• SANNER
• Phillips Medisize – a Molex Company
• FLEX LTD
• Integer Holdings Corporation
• sfm medical devices GmbH
• Nipro Corporation
• Viant
• SteriPack Group
• Tegra Medical
• Cadence, Inc.
• Resonetics
• Salt Medical
• Nordson MEDICAL

View an Additional List of Companies in the Medical Device CDMOs Market

• In April 2025, an entire ownership investment in Ajinomoto Althea, Inc., a US-based sterile fill-finish CDMO and 100% subsidiary of Japan-based Ajinomoto Co., Inc., was purchased by PCI Pharma Services, a preeminent international contract development and manufacturing organization (CDMO) specializing in cutting-edge biopharma medicines. The acquisition, which is expected to be completed in May 2025, gives PCI its first-ever North American manufacturing facility for prefilled syringes and cartridges, complete with isolator technology for these formats, as well as manufacturing facilities with high potency appropriate for antibody-drug conjugates (ADCs).
• In March 2025, Raichur-centered A new full-service "hybrid" contract development and manufacturing organization (or CDMO) has been established by Shilpa Medicare. Shilpa will assist clients with peptides, small and big compounds, and oncology as a specific therapeutic specialty at the newly established CDMO. Apart from providing all-inclusive clinical, commercial, and discovery outsourcing services, Shilpa's "hybrid CDMO model" also incorporates commercially viable "off-the-shelf" innovative formulations for exclusive business-to-business license.

Analyst View:

An aging population, an increase in chronic diseases, and the complexity of medical devices are all contributing to the medical device CDMO market's notable expansion. For medical innovators, CDMOs provide end-to-end solutions, from design to production, facilitating quicker time-to-market, cost effectiveness, and regulatory compliance. With the incorporation of cutting-edge technology including automation, 3D printing, and artificial intelligence, and a move toward personalized health and sustainability, the industry is changing quickly. Due to their supportive policies and growing healthcare infrastructure, emerging markets especially those in Asia-Pacific and Latin America offer significant development potential, establishing CDMOs as key participants in the production of medical devices in the future.

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Company Name	TE Connectivity
Headquarter	Galway, Ireland
CEO	Terrence Curtin
Employee Count	85,000 Employees