Major companies have continued to dominate medical device manufacturing, making strategic acquisitions and heavily investing in research and development (R&D) to boost market share. Industry giants like Johnson & Johnson and Boston Scientific have actively pursued acquisitions to expand their portfolios and strengthen their market positions. Johnson & Johnson's 2022 acquisition of Abiomed fortified its place in treating cardiovascular diseases, and Boston Scientific's 2023 acquisition of Axionics expanded its urology product offerings. At the same time, high demand for healthcare from the aging population has made room for an influx of start-ups. Revenue has been climbing at a CAGR of 1.2% to an estimated $56.4 billion over the five years through 2025, including an expected lift of 3.1% in 2024 alone. Innovation has remained a pivotal element in securing growth for medical device manufacturers. Advances in technology and research have led to the development of sophisticated products that can treat rare chronic conditions and ailments. New smart implantable devices, like Biotronik's Dynagen A3 cardiac defibrillator, enhance physicians' ability to treat patients. Government support has been a solid boon for manufacturers, with initiatives like revamped R&D tax credits fuelling innovation. Medical device manufacturers are increasingly focusing on personalizing products and integrating AI, as seen with Medtronic's Genius GI endoscopy tool, allowing them to cater to specific patient needs and improve healthcare outcomes. Since healthcare professionals are under pressure to use the best tools available, the release of new innovative products has directly spurred sales and pushed revenue upward. Buyers' reliance on effective medical devices gives manufacturers significant control over prices, allowing them to maintain solid profit despite swelling R&D budgets. Demographic changes and technological advancements will continue enabling medical device manufacturers to drive revenue growth. As the median age of the U.S. population climbs, demand for orthopedic and neurological devices will surge. Companies will continue investing heavily in R&D to outpace competition in domestic and international markets. Upcoming regulatory changes and potential tariffs under the second Trump administration could present opportunities and challenges, easing regulations but deterring international trade. Despite these hurdles, revenue is set to outpace the previous period's growth, surging at a CAGR of 2.6% to an estimated $64.3 billion through the end of 2030.

In 2023, the medical device market was worth approximately *** billion U.S. dollars in the United States. Throughout the time interval, the revenue in the medical device market increased year-on-year, except for the pandemic-affected 2020.

The U.S. Medical Device Manufacturers Market size was valued at USD 256.2 billion in 2023 and is projected to reach USD 380.17 billion by 2032, exhibiting a CAGR of 5.8 % during the forecasts period. Medical Device Manufacturers are entities responsible for the design, production, packaging, and labeling of medical devices before they are placed on the market. These manufacturers can be natural or legal persons who either perform these operations themselves or outsource them to third parties. The definition also extends to those who assemble, package, process, fully refurbish, or label one or more ready-made products and assign them their intended purpose as a device to be marketed under their own name. The manufacturing of medical devices is a highly regulated process, overseen by various regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Union's Medical Device Regulation (MDR), to ensure the safety and efficacy of the devices. These regulations require manufacturers to adhere to strict standards throughout the device's lifecycle, from initial concept to post-market surveillance. Recent developments include: In September 2023, Abbott acquired Bigfoot Medical, a global leader in developing smart insulin management systems for people suffering with diabetes. Bigfoot manufactures Bigfoot Unity, an FDA approved connected insulin pen with integrated continuous glucose monitoring system. , In June 2023, Eli Lily and Company acquired Sigilon Therapeutics, Inc. Sigilon develops functional cures for acute and chronic diseases. Moreover, both companies have worked together from 2018 to develop encapsulated cell therapies to treat type 1 diabetes. , In May 2023, Stryker acquired Cerus Endovascular Ltd., a manufacturer of neurointerventional devices. Some of the key products marketed by the acquired company are Contour Neurovascular System and the Neqstent Coil Assisted Flow Diverter. .

Market Size statistics on the Medical Device Manufacturing industry in the US

Unlocking the Future: US Medical Devices Market 2027. Discover trends, leading MedTech companies, and industry insights with Ken Research.

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Medical Device Contract Manufacturing Market Size 2025-2029

The medical device contract manufacturing market size is forecast to increase by USD 58.46 billion, at a CAGR of 12.5% between 2024 and 2029.

The market is experiencing significant shifts driven by the integration of Industry 4.0 technologies and the growing preference for point-of-care testing. Industry 4.0, characterized by advanced automation and interconnected systems, is revolutionizing manufacturing processes, enabling medical device companies to improve efficiency, reduce costs, and enhance product quality. Simultaneously, the trend toward point-of-care testing is gaining momentum, with an increasing focus on decentralized healthcare services and real-time patient monitoring. However, this market is not without challenges. Stringent regulations governing medical device manufacturing pose significant hurdles for contract manufacturers. Compliance with these regulations requires substantial investments in infrastructure, technology, and human resources. Additionally, maintaining the highest standards of quality and ensuring regulatory compliance can be a complex and time-consuming process. Companies must navigate these challenges effectively to capitalize on the opportunities presented by Industry 4.0 and the shift to point-of-care testing. To succeed, they must invest in advanced technologies, establish robust quality control systems, and maintain a deep understanding of regulatory requirements. By doing so, they can streamline their manufacturing processes, reduce costs, and deliver high-quality medical devices to meet the evolving needs of healthcare providers and patients.

What will be the Size of the Medical Device Contract Manufacturing Market during the forecast period?

Explore in-depth regional segment analysis with market size data - historical 2019-2023 and forecasts 2025-2029 - in the full report.
Request Free SampleThe market continues to evolve, driven by advancements in technology and the expanding application of medical devices across various sectors. Entities such as surface treatments, CNC machining, risk management, design and development, design control, product recall, ERP systems, neurological devices, medical grade materials, cardiology devices, on-time delivery, and precision machining play integral roles in this dynamic industry. Surface treatments, for instance, enhance the performance and longevity of medical devices, while CNC machining ensures precise manufacturing of complex components. Risk management and design control mitigate potential hazards and ensure regulatory compliance, enabling the production of safe and effective medical devices. Neurological devices and cardiology devices, which require high levels of accuracy and reliability, are increasingly being manufactured using advanced technologies like ERP systems and 3D printing. Medical grade materials, such as stainless steel and implantable materials, undergo rigorous testing and verification to ensure biocompatibility and sterility assurance. On-time delivery and precision machining are crucial for maintaining customer satisfaction, while inventory management and component sourcing contribute to efficient supply chain operations. Manufacturing process validation, quality metrics, and data analytics further enhance the overall quality and performance of medical devices. The ongoing unfolding of market activities reveals evolving patterns in medical device manufacturing, with a focus on continuous improvement, innovation, and regulatory compliance. Entities involved in this industry must stay abreast of the latest trends and technologies to remain competitive and meet the evolving needs of the healthcare sector.

How is this Medical Device Contract Manufacturing Industry segmented?

The medical device contract manufacturing industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD million' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments. DeviceIVDDrug deliveryDiagnostic ImagingCardiovascularOthersEnd-userOEMsPharmaceutical and biopharmaceutical companiesOthersTypeClass I DevicesClass II DevicesClass III DevicesService TypeDevice Development & Manufacturing ServicesQuality Management ServicesAssembly & Packaging ServicesApplicationCardiologyOrthopedicsNeurologyOncologyDistribution ChannelDirect SalesThird-Party DistributorsOnline PlatformsGeographyNorth AmericaUSCanadaEuropeFranceGermanyItalyUKAPACChinaIndiaJapanSouth KoreaRest of World (ROW)

By Device Insights

The ivd segment is estimated to witness significant growth during the forecast period.The market encompasses various segments, with the in vitro diagnostics (IVD) sector holding significant importance. IVD devices are integral to diagnosing diseases, conditions, and infections through sample testing, ranging from home-use kits to sophis

The Medical Device Contract Manufacturing Market is Segmented by Device (In-Vitro Diagnostic Devices, Drug-Delivery Devices {Syringes, Pen Injectors, and More} and More), Service (Device Development & Manufacturing Services {Device Engineering, and More}, Quality Management Services, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Sizes and Forecasts are Provided in Terms of Value (USD).

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Medical Devices Market Size 2025-2029

The medical devices market size is valued to increase USD 223 billion, at a CAGR of 6.5% from 2024 to 2029. Increasing prevalence of diseases will drive the medical devices market.

Major Market Trends & Insights

North America dominated the market and accounted for a 37% growth during the forecast period.
By End-user - Hospitals and ASCs segment was valued at USD 380.90 billion in 2023
By Product Type - Diagnostic devices segment accounted for the largest market revenue share in 2023

Market Size & Forecast

Market Opportunities: USD 64.11 billion
Market Future Opportunities: USD 223.00 billion
CAGR : 6.5%
North America: Largest market in 2023

Market Summary

The market encompasses a dynamic and evolving landscape, driven by the increasing prevalence of diseases and the emergence of innovative medical technologies. Core technologies, such as robotics, artificial intelligence, and nanotechnology, are revolutionizing healthcare delivery, while applications span from diagnostics and monitoring to therapy and surgery. Service types and product categories, including medical implants, diagnostic equipment, and therapeutic devices, continue to expand, driven by advancements in materials science and biotechnology. Regulatory bodies play a crucial role in shaping market dynamics, with stringent regulations ensuring safety and efficacy.
For instance, the US Food and Drug Administration (FDA) approved over 4,000 medical devices in 2020 alone. Despite these opportunities, challenges persist, including declining reimbursement and cost containment measures, which impact market growth. Overall, the market demonstrates a robust and continually evolving ecosystem, offering significant potential for innovation and growth.

What will be the Size of the Medical Devices Market during the forecast period?

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How is the Medical Devices Market Segmented and what are the key trends of market segmentation?

The medical devices industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD billion' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

End-user

  Hospitals and ASCs
  Clinics
  Others


Product Type

  Diagnostic devices
  Therapeutic devices
  Monitoring devices
  Assistive and rehabilitation devices
  Others


Application

  Cardiovascular
  Orthopedic
  Diagnostic imaging
  Dental
  Others


Geography

  North America

    US
    Canada


  Europe

    France
    Germany
    Italy
    UK


  APAC

    China
    India
    Japan
    South Korea


  Rest of World (ROW)

By End-user Insights

The hospitals and ascs segment is estimated to witness significant growth during the forecast period.

The market encompasses a diverse range of technologies and applications, with hospitals and Ambulatory Surgical Centers (ASCs) representing a significant and growing sector. Hospitals and ASCs are essential consumers of medical devices, requiring equipment for diagnosis, treatment, and patient monitoring. The market's expansion is fueled by increasing healthcare expenditures from both public and private entities. Approximately 45% of global medical device sales stem from hospitals and ASCs, with this figure projected to reach 48% by 2026. Simultaneously, the market's overall value is anticipated to surge by 12% in the next five years, reaching a total worth of USD675 billion.

Sensor technology, including wearable sensors, plays a pivotal role in this market, enabling remote patient monitoring and minimally invasive procedures. Quality control systems, diagnostic imaging, and medical implants, such as prosthetic limbs, are other key areas of growth. Advanced technologies like artificial intelligence, data analytics, and data encryption are revolutionizing medical devices, enhancing their capabilities and improving patient outcomes. Minimally invasive surgery, risk management, supply chain management, design controls, and patient monitoring are some of the market trends shaping the industry. Signal processing, clinical trials, device sterilization, electrical stimulation, surgical instruments, tissue engineering, regulatory compliance, material science, biocompatible materials, wireless communication, software validation, therapeutic devices, human factors engineering, machine learning, manufacturing processes, drug delivery systems, image processing, and additive manufacturing are all integral components of the market.

In summary, the market is a dynamic and evolving sector, driven by advancements in technology and increasing demand from hospitals and ASCs. With a projected growth of 12% and a total value of USD675 billion by 2026, this market offers significant opportunities for innovation and expansion.

The top medical technology companies globally include big name companies such as General Electric, Philips, and Medtronic. As of 2021, the leading medical technology company based on market share was Medtronic (U.S.). At that time, Medtronic held *** percent of the overall medical technology market. The company’s hold on medical technology is projected to increase slightly to *** percent by 2024. Medical technology industry The global medical technology industry includes different types of technology that are broadly categorized as medical devices, in vitro diagnostics and digital health solutions. The total medical technology revenue has been increasing in recent years and is expected to increase dramatically by the year 2024. Research and development in the industry is also gaining ground and has experienced some of the largest growth in spending from 2015 to 2016, with significant growth expected in the future. Company spotlight: Medtronic Among the various medical technology companies, Medtronic is among the top in many measures. Medtronic produces medical products and devices for cardiac and vascular disease, minimally invasive therapies, restorative therapies and diabetes. In 2017, Medtronic was the top medical technology company among those that produce cardiac devices. The company beat out other competitors such as Abbott and Boston Scientific by a significant percentage of the market share. Medtronic’s total revenue worldwide has been increasing significantly in recent years and in the company’s fiscal year 2022 had reached an all time high.

The U.S. Medical Devices Market is projected to reach USD 311.50 billion by 2033, growing at a CAGR of 5.9% from 2025-2033.

Unlock data-backed intelligence on the USA Medical Device Manufacturers Market, size at USD 243.3 billion in 2023, featuring growth drivers, key challenges, and future opportunities.

The U.S. Medical Device Outsourcing Market size was valued at USD 27.4 billion in 2023 and is projected to reach USD 38.81 billion by 2032, exhibiting a CAGR of 5.10 % during the forecasts period. Medical Device Outsourcing is a business model that is adopted by medical device companies to sell some parts of the managed service chain and outsource the tasks to third-party vendors. The outsourcing services provided by these vendors range across the different stages of a device’s life cycle, such as innovation, modeling, production, and marketing and distribution. It is noted that some of the major features of outsourcing medical devices include the opportunity to gain access to a variety of expertise, such as compliance, engineering, and manufacturing, which relieves the medical device manufacturer of the additional costs of hiring such specialized workers and speeds up the rate of market introduction of new products while conforming to regulatory requirements. Outsourcing also creates an opportunity for firms to concentrate on key success factors, including innovation and market positioning, as well as leverage outsourcing partners’ proven structures and resources.

Medical Device Contract Manufacturing Market Outlook

The global medical device contract manufacturing market size was valued at USD 76.2 billion in 2023 and is expected to reach USD 141.8 billion by 2032, growing at a CAGR of 6.7% during the forecast period. The growth of this market is influenced by various factors such as the increasing demand for advanced medical devices and the rising need for cost-effective manufacturing solutions. Notably, technological advancements and the growing prevalence of chronic diseases have significantly contributed to this market's expansion.

One of the primary growth factors driving the medical device contract manufacturing market is the rising demand for innovative and technologically advanced medical devices. As the global healthcare industry evolves, there is an increasing need for sophisticated medical devices that can effectively address complex health conditions. This has led to a surge in research and development activities, necessitating the outsourcing of manufacturing processes to specialized contract manufacturers. By leveraging the expertise and advanced facilities of contract manufacturers, medical device companies can bring new and improved products to market more efficiently and cost-effectively.

Another key factor contributing to market growth is the increasing focus on cost optimization. Medical device companies are under constant pressure to reduce operational costs while maintaining high-quality standards. Outsourcing manufacturing to contract manufacturers allows these companies to achieve significant cost savings by eliminating the need for substantial capital investments in infrastructure and machinery. Additionally, contract manufacturers often have economies of scale and can procure raw materials at lower costs, further enhancing the cost-effectiveness of the manufacturing process.

Furthermore, the rising prevalence of chronic diseases and the aging global population are driving the demand for medical devices. Chronic conditions such as cardiovascular diseases, diabetes, and orthopedic disorders require continuous monitoring and management, leading to an increased need for medical devices. Contract manufacturers play a crucial role in meeting this growing demand by providing efficient and scalable manufacturing solutions. Their ability to produce medical devices in large volumes while adhering to stringent regulatory standards ensures a steady supply of high-quality products to the market.

The regional outlook for the medical device contract manufacturing market reveals a promising landscape. North America currently dominates the market, accounting for the largest share due to the presence of well-established healthcare infrastructure, advanced technological capabilities, and a high prevalence of chronic diseases. Additionally, the Asia Pacific region is expected to witness significant growth during the forecast period. Factors such as the increasing healthcare expenditure, growing medical tourism industry, and favorable government initiatives to promote local manufacturing are driving market expansion in this region. Europe, Latin America, and the Middle East & Africa are also anticipated to experience steady growth, supported by rising investments in healthcare infrastructure and expanding medical device markets.

Device Type Analysis

The medical device contract manufacturing market can be segmented based on device type into three categories: Class I, Class II, and Class III medical devices. Class I medical devices are those with low risk to the patient and include items like bandages and handheld surgical instruments. These devices require minimal regulatory controls to ensure their safety and effectiveness. The demand for Class I medical devices is driven by their widespread use in routine healthcare procedures and the growing emphasis on preventive care. Contract manufacturers play a crucial role in producing these devices efficiently and cost-effectively, meeting the increasing market demand.

Class II medical devices are those with moderate risk to the patient, necessitating stricter regulatory controls and performance standards. Examples include infusion pumps, surgical drapes, and diagnostic imaging equipment. The rising prevalence of chronic diseases and the growing need for accurate diagnostic tools are major factors driving the demand for Class II medical devices. Contract manufacturers specializing in the production of these devices must adhere to stringent quality standards and regulatory requirements. Their expertise in manufacturing and compliance ensures the delivery of reliable and

In 2021, the AI and machine learning medical device market was valued at around *** billion U.S. dollars globally. By 2032, the market was forecast to increase to a value of **** billion U.S. dollars.

The Report Covers North America Medical Device Reprocessing Companies and the market is segmented by Device (Class I Devices, Class II Devices) and Geography.

• The industry was valued at US$ 27.6 Bn in 2022
• It is estimated to grow at a CAGR of 6.3% from 2023 to 2031 and reach US$ 47.4 Bn by the end of 2031

Pediatric Medical Devices Market Snapshot

Attribute	Detail
Market Size in 2022	US$ 27.6 Bn
Market Forecast (Value) in 2031	US$ 47.4 Bn
Growth Rate (CAGR)	6.3%
Forecast Period	2023-2031
Historical Data Available for	2017-2021
Quantitative Units	US$ Bn for Value
Market Analysis	It includes segment analysis as well as regional level analysis. Furthermore, qualitative analysis includes drivers, restraints, opportunities, key trends, Porter’s Five Forces Analysis, value chain analysis, and key trend analysis.
Competition Landscape	Market share analysis by company (2022) Company profiles section includes overview, product portfolio, sales footprint, key subsidiaries or distributors, strategy and recent developments, and key financials
Format	Electronic (PDF) + Excel
Market Segmentation	Product In Vitro Diagnostic (IVD) Devices Cardiology Devices Diagnostic Imaging Devices Anesthesia & Respiratory Care Devices Neonatal ICU Devices Monitoring Devices Telemedicine Home-use Medical Devices End-user Hospitals Diagnostic Laboratories Ambulatory Surgical Centers Others
Regions Covered	North America Latin America Europe Asia Pacific Middle East & Africa
Countries Covered	U.S. Canada Germany U.K. France Spain Italy Russia and CIS Japan China India ASEAN Brazil Mexico GCC South Africa
Companies Profiled	Abbott Boston Scientific Corporation Baxter International, Inc. Medtronic Cardinal Health, Inc. F. Hoffmann-La Roche Ltd. GE Healthcare Johnson & Johnson Siemens Healthinners Koninklikje Philips N.V. Stryker Corporation
Customization Scope	Available upon request
Pricing	Available upon request

Overview

New York, NY – Aug 21, 2025 – Global Medical Device Outsourcing Market size is expected to be worth around USD 352.3 Billion by 2032 from USD 130.7 Billion in 2023, growing at a CAGR of 12.0% during the forecast period from 2023 to 2032.

The global Medical Device Outsourcing market is experiencing robust expansion, driven by the increasing need for cost optimization, regulatory compliance, and rapid product development. Outsourcing has emerged as a strategic approach adopted by OEMs (Original Equipment Manufacturers) to enhance operational efficiency and focus on core competencies.

The market is being propelled by growing complexities in device design, stringent regulatory frameworks, and the rising demand for technologically advanced and high-quality medical devices. Contract manufacturers, especially those with regulatory expertise and strong quality management systems, are gaining traction as preferred partners.

Segments such as Class II and Class III devices are witnessing heightened outsourcing activity due to their intricate design and regulatory requirements. Key services include device design, prototyping, component manufacturing, assembly, packaging, and regulatory consulting.

North America continues to lead the global market, attributed to the presence of major OEMs and established regulatory standards. However, Asia-Pacific is projected to record the fastest growth, driven by lower production costs, expanding healthcare infrastructure, and skilled labor availability.

Strategic collaborations, mergers, and investments in innovation by outsourcing firms are further shaping the competitive landscape. The growth of this market reflects a shift toward integrated service models and value-based partnerships, making outsourcing a cornerstone strategy for long-term competitiveness in the medical device industry.

https://market.us/wp-content/uploads/2023/06/Medical-Device-Outsourcing-Market-by-service.jpg" alt="Medical Device Outsourcing Market by service" class="wp-image-102334">

United States Medical Devices Market Size, Share, Growth, Trend & US Medical Devices Market Analysis 2027, By Type, By End User, By Company, By Region, Forecast & Opportunities,

Pages	70
Market Size
Forecast Market Size
CAGR
Fastest Growing Segment
Largest Market
Key Players

The Medical Devices and Equipment Logistics Market Report is Segmented by Product Type (Medical Devices and Medical Equipment) and Geography (North America, Europe, Asia-Pacific, Latin America, and Middle East and Africa). The Report Offers Market Size and Forecasts for all the Above Segments in Value (USD).

This statistic represents the leading medical device companies in the United States in FY 2014, based on revenue. With medical revenue of around **** billion U.S. dollars, General Electric Healthcare was ranked second that year.