North America and Asia Pacific Medical Device Contract Manufacturing Market to Reach USD 190.88 Billion by 2033, Driven by Outsourcing Trends and Advanced Manufacturing Technologies | DataM Intelligence

The global medical device contract manufacturing market size reached US$76.43 billion in 2024, up from US$69.54 billion in 2023, and is expected to reach US$190.88 billion by 2033, growing at a CAGR of 10.9% during the forecast period 2025-2033.

This growth is mainly driven by increasing outsourcing trends to cut costs and speed up time-to-market. Key factors include a rising demand for complex, high-precision medical devices, technological improvements such as automation and IoT, pressures for regulatory compliance, an aging population with greater healthcare needs, and a move toward minimally invasive procedures. Together, these factors support market expansion around the globe.

United States: Key Industry Developments

✅ October 2025: The global medical device contract manufacturing market is projected to reach USD 140.84 billion by 2030, driven mainly by the demand for advanced therapeutic devices and OEM outsourcing.

✅ September 2025: Major market players, including Jabil and Thermo Fisher Scientific, integrate AI, robotics, and automation to boost manufacturing precision and scalability.

✅ August 2025: Rising demand for cardiovascular and orthopedic implants escalates outsourcing to specialized contract manufacturers emphasizing sterile, high-precision production.

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Japan: Key Industry Developments

✅ Mid-2025: Japanese CMOs adopt Industry 4.0 technologies such as automation and IoT-enabled quality control to improve manufacturing reliability and regulatory compliance.

✅ Early 2025: Government initiatives ease regulatory pathways and provide funding to boost domestic manufacturing self-sufficiency.

Mergers and Acquisitions (2025):

✅ Growth is driven by rising demand for complex and miniaturized medical devices in diagnostics imaging, wearable health tech, minimally invasive surgeries, and remote patient monitoring.

✅ Key players are expanding operations in Asia Pacific, particularly China, driven by growing chronic diseases and increased public and institutional awareness of medical devices.

✅ The industry faces challenges such as regulatory compliance, supply chain complexities, and intellectual property concerns; however, advances in robotics, 3D printing, and regulatory support are facilitating growth.

✅ Device types such as Class III devices and cardiovascular devices dominate market segments in terms of revenue, while accessories manufacturing is a major service segment.

Growth Drivers:

-Market growth is driven by increasing development of medical devices, rising outsourcing by OEMs to reduce costs, and stringent regulatory policies requiring advanced manufacturing capabilities.

-Government funding and policies support innovation, while AI, automation, and IoT integration enhance workflow efficiency and product quality.

-North America leads with 39% market share in 2025, backed by a strong healthcare infrastructure and presence of leading market players.

-Asia Pacific is the fastest-growing region due to expanding healthcare access, low labor costs, and growing investments in healthcare infrastructure.

-Key segments include cardiovascular devices, orthopedic implants, and diagnostic equipment, with OEMs leveraging contract manufacturing to scale production, reduce capital expenditures, and accelerate time-to-market.

Market Segmentation Analysis:

-By Device Class

Class I Devices constitute a significant portion, generally comprising low-risk devices that require simpler manufacturing processes.

Class II Devices form a larger segment, involving moderate risk devices such as surgical instruments, requiring compliance with stringent regulatory standards.

Class III Devices represent the highest risk category including implantable and life-supporting devices, leading the fastest growth with advanced manufacturing needs and complex quality assurance.

-By Service Type

Device & Component Manufacturing Services dominate the market, covering processes from prototyping to full-scale production of medical devices and components.

Quality Management Services are critical for regulatory compliance, testing, validation, and certification, representing a substantial market segment.

Packaging & Assembly Services include sterile packaging and logistical coordination, essential for device safety and distribution.

Other services encompass design, regulatory consulting, sterilization, and post-market support.

-By Therapeutic Area

Cardiovascular Devices lead the market with the largest revenue share (around 27% in 2024) due to high demand for pacemakers, stents, and diagnostic equipment.

Orthopedic Devices hold a significant share, driven by rising orthopedic surgeries and aging populations.

Ophthalmic Devices cater to growing eye care needs with advanced implantable lenses and diagnostic devices.

Respiratory Devices segment grows with increased chronic respiratory conditions globally.

Others include dental devices, neurology, urology, and wound care products.

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Report Highlights:

56 Tables
53 Figures
159 Pages of Analysis

Regional Insights:

United States

-The U.S. medical device contract manufacturing market was valued at approximately USD 25.95 billion in 2024.

-It is projected to grow at a CAGR of around 11% from 2025 to 2034, reaching nearly USD 73.48 billion by 2034.

-Growth drivers include increasing in-house manufacturing costs prompting OEMs to outsource, presence of leading medical device companies, and demand for advanced and precision medical devices.

-The trend toward outsourcing manufacturing process steps such as design, feasibility, regulatory compliance, and sterilization enables OEMs to focus on core R&D.

Europe

-Europe accounts for a significant share of the global market, driven by countries like Germany, the UK, France, and Spain.

-The market is expanding due to stringent regulatory frameworks, demand for high-quality medical devices, and advancements in manufacturing technologies including automation and robotics.

-Investments in healthcare infrastructure and focus on minimally invasive devices augment contract manufacturing demand.

Asia-Pacific

-The Asia-Pacific region is the fastest-growing market with a CAGR of roughly 10.7% from 2025-2034.

-Growth is fueled by improving healthcare infrastructure, rising demand for affordable medical devices, government initiatives supporting manufacturing, and increasing aging populations in countries like Japan, China, and India.

-The region is expected to overtake North America in market size by late 2024-2025.

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Competitive Landscape:

According to DataM Intelligence, the Medical Device Contract Manufacturing Market is moderately consolidated, led by industry giants investing in advanced manufacturing technologies like AI, robotics, and 3D printing to enhance efficiency and meet rising demand for complex medical devices globally.

Key Players:
Jabil Inc. | Thermo Fisher Scientific Inc. (PPD) | Integer Holdings Corporation | Sanmina Corporation | Celestica Inc. | Phillips Medisize | Plexus Corp., Inc. | Gerresheimer AG

Key Highlights (Top 5 Key Players):

-Jabil Inc. leads with around 18-20% market share, supported by strategic collaborations with innovative medical device startups and investments in AI-driven manufacturing efficiency improvements.

-Thermo Fisher Scientific Inc. holds about 15-17% share, focusing on integrated contract development and manufacturing services (CDMO) facilitating precision and compliance in regulated markets.

-Integer Holdings Corporation possesses nearly 12-14% market share, expanding capabilities in high-complexity device assembly and regulatory expertise.

-Sanmina Corporation accounts for 10-12% share, with strong emphasis on technologies for minimally invasive devices and IoT-enabled medical products.

Celestica Inc. commands approximately 8-10% share, leveraging global scale and advanced supply chain management to support fast ramp-up of device production.

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