The U.S. medical device contract manufacturing market size is expected to be worth around USD 62.42 billion by 2034, increasing from USD 19.51 billion in 2025, representing a healthy CAGR of 13.79% from 2025 to 2034.
The U.S. medical device contract manufacturing market is expanding rapidly due to it has a broad range of applications, from easy disposables to multifaceted electromechanical systems. It is a process where a major MedTech company that owns the idea outsources industrial manufacturing to another medical device manufacturing firm. Contract manufacturing has presently emerged as a strategic solution for companies looking to modernize their operations, improve efficiency, and bring advanced-quality medical devices.
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U.S. Medical Device Contract Manufacturing Market Highlights:
⬥︎ By product, the class II segment dominated the market with the largest share in 2024.
⬥︎ By product, the class I segment is expected to show the fastest growth over the forecast period.
⬥︎ By services, the accessory manufacturing segment held the largest market share in 2024.
⬥︎ By services, the device manufacturing segment is expected to register the fastest growth during the forecast period.
⬥︎ By therapeutic area, the cardiovascular devices segment captured the largest market share in 2024.
⬥︎ By therapeutic area, the surgical instrument segment is expected to show the fastest growth during the forecast period.
⬥︎ By end use, the original equipment manufacturers segment generated the highest market revenue in 2024.
⬥︎ By end use, the pharmaceutical and biopharmaceutical companies’ segment is expected to register the fastest CAGR over the forecast period.
Market Overview and Industry Potential
The U.S. medical device contract manufacturing market is growing due to the contract manufacturing provides many benefits to healthcare device companies, including affordability, scalability, access to technology and expertise, improved quality assurance, and increased ability to focus on essential competencies. It scales up production up or down based on demand, allowing medical device companies to respond rapidly to market fluctuations.
A medical device contract manufacturer provides a broad range of solutions that include the whole production process. They are investing in novel technologies and equipment to remain competitive in the healthcare sector. Through increasing partnership with these manufacturers, major companies have an opportunity to use modern technologies, lacking much investment in their facilities. Such availability of modern technologies enables the production of innovative, high-quality medical devices that comply with stringent regulatory standards.
⬥︎ For Instance, In April 2025, Novartis announced the expansion of its manufacturing and R&D presence in the United States with the investment of $23 billion during the next five years. The company will build seven new facilities, bringing production of 100% of its key products to the US.
U.S. Medical Device Contract Manufacturing Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 19.51 Billion |
|
Revenue forecast in 2034 |
USD 62.42 Billion |
|
Growth rate |
CAGR of 13.79% from 2025 to 2034 |
|
Historical Year |
2021 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2025 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Product, services, therapeutic area, end use |
|
Country scope |
U.S. |
|
Key companies profiled |
Jabil Inc.; Terumo Corporation; WuXi AppTec, Inc.; Integer Holdings Corporation; Flex Ltd.'s U.S; Sanmina Corporation; TE Connectivity; Sonic Healthcare; Forefront Medical Technology; Nortech Systems; Phillips-Medisize (a Molex company); Celestica HealthTech; Viant Medical |
|
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
What are Latest Trends in U.S. Medical
Device Contract Manufacturing Market? ⬥︎ In April 2024, the FDA launched the healthcare at home initiative.
The main aim of this initiative is to better position the agency to address
health care requirements by shifting care into the home setting, to support
reimagine the home environment as an integral part of the health care system,
and to advance health and wellness for all people in the U.S. ⬥︎ In February 2024, University Medical Devices (UMD) announced the
closure of its first round of seed funding. UMD, which brings to market
advanced healthcare technology from the University of Nebraska Medical Center
and its commercialization wings UNeMed/UNeTech, raised $1.6 million to drive
the company’s mission of revolutionizing healthcare diagnostics. ⬥︎ In January 2025, BD, a leading global medical technology company,
announced additional investments in its U.S. manufacturing network to add
capacity for critical medical devices, including syringes, needles, and IV
catheters, to meet the ongoing needs of the nation's health care system. Increasing Partnership of Healthcare
Companies and Contract Manufacturing: Market’s Largest Potential The increasing use of contract
manufacturing solutions in the medical care and medical device industries shows
a significant paradigm shift. By growing partnerships with dedicated
manufacturers, medical tools companies redirect their focus to modern
innovation and increasing progress in the field. This collaborative strategy
not only drives the industry forward but also translates into tangible benefits
for patients, granting them access to novel, profitable, and transformative
medical devices, which contributes to the growth of the market. ⬥︎ For Instance, In January 2025, Spine Guard announced the
strengthening of their strategic partnership with the signing of a novel
agreement establishing the foundation for an expansion of their collaboration
to other products and countries and a reallocation of SpineGuard resources to
support Omnia’s product launches, including PsiFGuard, in the United States. Country-Level Analysis of U.S. Medical
Device Contract Manufacturing Market: The United States is increasing the
adoption of advanced medical devices manufacturing technology due to the
growing demand for these devices from various factors such as diagnosis, treatment,
home healthcare, and the increasing prevalence of chronic diseases. ⬥︎ For Instance, the U.S. has imported $14.9 billion in medical
equipment in 2024, compared with $14 billion in 2023. Nearly 5,800 companies
are employing over 350,000 people in the industry. In 2024, the United States
alone accounted for nearly half 45% of sales, of the $413 billion global market
for medical devices, driving the growth of the market. Buy Now Full Report: https://www.novaoneadvisor.com/report/checkout/9163
Top Medical Device Contract
Manufacturing Companies Company Name Founded Year Description Jabil 1996 They handle the entire production process, from receiving
designs and components to assembling, testing, and shipping finished
products. Celestica 1994 It is involved in designing the supply chain for electronics
manufacturing. Flex 1969 Flex manufactures a wide range of electronic components and
devices for other companies according to their specifications. Sanmina 1980 Sanmina Corporation is a leading global provider of electronic
manufacturing services (EMS), specializing in designing and manufacturing. Integer Holdings 1970 Integer is a leader in advanced medical device outsourcing Synecco 2004 global supplier of world-leading contract manufacturing and
design solutions for medical devices. West Pharmaceutical Services 1923 West Pharmaceutical Services, Inc. is a designer and
manufacturer of injectable pharmaceutical packaging and delivery systems.
U.S. Medical Device Contract
Manufacturing Market Segmentation Analysis: By Product Analysis: The class II segment dominates in the U.S.
medical device contract manufacturing market, as these medical devices are
those that pose a moderate challenge to patients and therefore require stricter
regulation than class I products. Medical devices of class II include blood
pressure cuffs, syringes,
pregnancy test kits, infusion pumps, and oximeters. Manufacturers ensure that
their tools are steadily produced and controlled based on the quality standards
to ensure they are effective and safe. This contains detailed records, regular
audits, and adherence to FDA guidelines for device updates or modifications. On the other hand, the class I segment is
expected to grow significantly during the forecast period as these medical
devices is that they are usually easier and quicker to bring to market than
other class devices. This permits manufacturers to bring novel products to the
market more rapidly, which is eventually advantageous for patients by offering
them access to novel and potentially effective treatments. It is generally
considered to be less risky. The fewer challenges design and materials used in
class I devices often require to less manufacturing expenses. By Services Analysis: The accessory manufacturing segment
dominates the U.S. medical device contract manufacturing market, as it provides
major advantages to U.S. patients, such as enhanced patient safety, improved
treatment results, and growing convenience for both patients and healthcare
providers. They offer more precise diagnoses and can lead to cost savings in
the long run by encouraging efficiency and preventing challenges. The device manufacturing segment is
expected to grow significantly during the forecast period as the healthcare
device manufacturer in the U.S. stands at the forefront of novelty, catalysing
ground-breaking advancements that redefine how and where people access medical
care. Growing demand for these devices from hospitals, doctor offices, nursing
and residential care facilities, and diagnostic labs. The increasing geriatric
population and growing prevalence of chronic diseases are driving the medical
devices market. By Therapeutic Area Analysis: The cardiovascular
devices segment accounted for the largest market share in 2024, as the
growing use of modern technologies is causing growth in health care costs for
CAD and CHF patients. It provides significant advantages for improved patient
results through more targeted and effective treatments. The rising prevalence
of cardiovascular diseases and the demand for personalized
care drive the evolving landscape, with technologies such as wearables
in the U.S. On the other hand, the surgical instrument
segment is expected to grow significantly during the forecast period as modern
surgical equipment incorporates advanced navigation and imaging technologies
like real-time fluoroscopy, 3D imaging,
and augmented
reality (AR). These tools offer detailed anatomical visuals, allowing
surgeons to perform complex procedures such as spine fusion surgery with
greater precision. The United States has ranged from 12.0 to 21.4 operations
per 100,000 persons, which drives the growth of the market. By End User Analysis The original equipment manufacturers
segment accounted for the largest market share 55% in 2024, as it manufactures
and sells products or parts of a product to its buyer, another company, which
sells to its customers while putting the products under its branding. To
reproduce the quality and precision of specialized OEM parts, a VAR would have
to allocate valuable time and resources for their team to prototype, design,
finalize, and produce the parts they require. It offers many benefits like better
performance, quality, compatibility, and dependability. Pharmaceutical
and biopharmaceutical companies are expected to grow significantly
during the forecast period as medical devices are a fundamental component of
health care systems; they provide benefits, continue to increase as they're
essential to diagnose, prevent, treat, and rehabilitate weakness and diseases
safely and effectively. These devices contain everything from simple devices
such as tongue depressors and bandages to multifaceted imaging machines and
hi-tech surgical robots, which all help pharmaceutical
and biopharmaceutical
services. Some of the Prominent Players in the
U.S. Medical Device Contract Manufacturing Market • Forefront Medical Technology • Integer Holdings Corporation • Jabil
Inc. • Nortech Systems • Phillips-Medisize (a Molex company) • Sanmina Corporation • TE Connectivity • WuXi AppTec, Inc. What is Going Around the Globe? ⬥︎ In April 2025, Boston Scientific
announced via social media that it had closed the acquisition of Bolt Medical,
which recently gained FDA clearance of its intravascular lithotripsy (IVL)
platform for the above-the-knee (ATK) indication. ⬥︎ In March 2025, Canon Medical proudly announces that major AI
enhancements have been cleared for the Aquilion ONE / INSIGHT Edition,
including the new PIQE 1024 matrix and SilverBeam across a broader range of
clinical applications. You can place an order or ask any
questions, please feel free to contact at sales@novaoneadvisor.com |
+1 804 441 9344 Related Report – ⬥︎ Medical Device Contract Manufacturing Market- The global medical
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to 2034. Segments Covered in the Report This report forecasts revenue growth at
country levels and provides an analysis of the latest industry trends in each
of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc.
has segmented the U.S. Medical Device Contract Manufacturing Market. By Product • Class I • Class II • Class III By Services • Accessories Manufacturing • Assembly Manufacturing • Component Manufacturing • Device Manufacturing • Packaging and Labeling • Others By Therapeutic Area • Cardiovascular Devices • Orthopedic Devices • Ophthalmic Devices • Diagnostic Devices • Respiratory Devices • Surgical Instruments • Dental • Others By End Use • Original Equipment Manufacturers (OEMs) • Pharmaceutical & Biopharmaceutical
Companies • Others Immediate Delivery Available | Buy This
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