MarketsandMarkets：医疗设备合同制造市场2031年将达1354.7亿美元

, /PRNewswire/ -- According to MarketsandMarkets™, the Medical Device Contract Manufacturing Market is projected to reach USD 135.47 billion by 2031 from USD 85.59 billion in 2026, at a CAGR of 9.6% during the forecast period.

Browse 455 market data Tables and 72 Figures spread through 450 Pages and in-depth TOC on "Medical Device Contract Manufacturing Market- Global Forecast to 2031"

Medical Device Contract Manufacturing Market Size & Forecast:

Market Size Available for Years: 2026–2031
2026 Market Size: USD 85.59 billion
2031 Projected Market Size: USD 135.47 billion
CAGR (2026–2031): 9.6%

Medical Device Contract Manufacturing Market Trends & Insights:

By region, Asia Pacific is projected to grow at the highest CAGR of 11.0% from 2026 to 2031.
By device type, the IVD devices segment accounted for the largest share of 19.2% in 2025.
By device class, Class I devices accounted for the largest share of 60.7% in 2025, while Class III devices are projected to grow at the highest CAGR of 10.9% from 2026 to 2031.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=170622851

The market is growing due to increasing demand for medical devices, driven by rising healthcare needs globally. An aging population and a growing prevalence of chronic diseases are creating a greater need for diagnostic, monitoring, therapeutic, and surgical devices. As a result, many medical device companies are outsourcing more design, development, manufacturing, and assembly tasks to specialized contract manufacturers.

Regulatory requirements are also opening doors for established contract manufacturers that have strong quality and compliance capabilities. Medical device companies are increasingly seeking manufacturing partners that can meet regulatory standards across multiple markets and provide consistent quality management systems. Consequently, contract manufacturers with integrated design, manufacturing, testing, validation, and regulatory skills are well positioned to gain a larger share of outsourced activities.

Overall, the trend toward outsourcing, increasing device complexity, demand for faster commercialization, and the need for reliable, compliant manufacturing are creating new revenue opportunities for medical device contract manufacturers.

The IVD devices segment is expected to account for the largest share of the medical device contract manufacturing market during the forecast period.

In 2025, IVD devices held a 19.2% share of the market and are projected to grow at a CAGR of 10.1% from 2026 to 2031. IVD consumables, the disposable components used in in vitro diagnostics (tests conducted outside the living body), offer several advantages that support efficient, accurate medical diagnoses. These diagnostic tests are used in hospitals, laboratories, and homes, resulting in high, repeatable order volumes. IVD manufacturers often outsource the assembly of cartridges, consumables, and instruments to partners equipped with cleanroom capabilities and validated processes. This segment is expected to maintain its leadership through 2031.

The device development & manufacturing services segment is projected to hold the dominant share of the medical device contract manufacturing market throughout the forecast period.

This segment accounted for a 69.1% share in 2025. OEMs typically assign the largest portion of their workload to contract partners for component and finished device production. This is because such production requires specialized tooling, validated processes, and regulated facilities, which OEMs often prefer not to develop themselves. As a result, OEMs are likely to continue engaging partners for comprehensive programs that integrate both development and production.

Inquiry Before Buying: https://www.marketsandmarkets.com/Enquiry_Before_BuyingNew.asp?id=170622851

Asia Pacific is expected to register the highest CAGR in the medical device contract manufacturing market during the forecast period.

The Asia Pacific region is the fastest-growing market, projected to experience a CAGR of 11.0% from 2026 to 2031. This growth is driven by expanding medical device manufacturing capabilities, increased OEM outsourcing, lower manufacturing costs, and rising investments in healthcare infrastructure. China and India are strengthening domestic production capabilities, while Japan remains a key source of demand for advanced, high-quality medical devices. These factors are expected to boost the demand for contract manufacturing services, including design, precision manufacturing, assembly, and other value-added activities.

Key Players

Leading players in the Medical Device Contract Manufacturing companies include Jabil (US), Flex (US), Plexus (US), Sanmina (US), Integer Holdings (US), TE Connectivity (Switzerland), Celestica (Canada), West Pharmaceutical Services (US), Benchmark Electronics (US), and AptarGroup (US).

Get 10% Free Customization on this Report: https://www.marketsandmarkets.com/requestCustomizationNew.asp?id=170622851

Investment & Funding Context

The medical device contract manufacturing market witnessed steady investment and deal activity from 2023 to 2026. This growth was fueled by demand for specialized capabilities, increased involvement in drug delivery, and strong private equity interest in large medical device manufacturers.

In January 2024, Integer Holdings acquired Pulse Technologies, a company that produces micro-machined components for devices related to structural heart treatments, electrophysiology, leadless pacing, and neuromodulation. In February 2025, Jabil acquired Pharmaceutics International, Inc. (PII), which added over 300 team members and 360,000 square feet of GMP-certified manufacturing space in Hunt Valley, Maryland. This acquisition enhances Jabil's ability to provide end-to-end support for pharmaceutical customers. In the same month, Jabil collaborated with Midwest Interventional Systems to expand the range of services contract development and manufacturing organizations can offer medical device developers.

In March 2025, Flex opened a new product introduction center near Boston to better support North American healthcare customers throughout the process, from prototype development to production transfer. In 2026, KKR agreed to acquire Integer Holdings in a transaction valued at approximately USD 5.7 billion, offering USD 127 per share in cash. Overall, investment trends are shifting toward minimally invasive procedures, cardiovascular component capabilities, drug delivery adjacencies, and the capacity for prototype-to-production transitions for device developers.

Revenue Shift Context

The medical device contract manufacturing market is shifting from high-volume, lower-risk device work to a broader range of higher-acuity programs and value-added services. Global market revenue is expected to grow from USD 85.59 billion in 2026 to USD 135.47 billion by 2031, representing a CAGR of 9.6%.

In terms of services, device development & manufacturing services accounted for 69.1% of the revenue in 2025, making them the largest segment. Meanwhile, packaging & assembly services are the fastest-growing segment, at a CAGR of 10.5%. By device type, IVD devices hold the largest share at 19.2%, growing at 10.1%. Diabetes care devices, at 11.2%, and cardiovascular devices, at 11.1%, are experiencing even faster growth from smaller bases. By device class, Class I devices represent 60.7% of revenue but are growing at only 9.2%. In contrast, Class III devices account for 21.8% of revenue and are growing at 10.9%.

Regionally, Asia Pacific is not only the largest market, with a 36.05% share, but also the fastest-growing region, with a growth rate of 11.0%. As a result, revenue is increasingly shifting toward higher-risk device classes, wearable and diagnostic formats, and validated packaging & assembly programs.

Mergers & Acquisitions

Mergers, acquisitions, and portfolio changes in the medical device contract manufacturing market in 2025 were characterized by more deals than in 2024.

MEDICAL DEVICE CONTRACT MANUFACTURING MARKET: MERGERS & ACQUISITIONS, JANUARY 2023–SEPTEMBER 2026

Month & Year	Deal Type	Company 1	Company 2	Description
August 2026	Acquisition	Integer Holdings Corporation (US)	KKR (US)	KKR signed an agreement to acquire Integer Holdings. This acquisition is expected to provide Integer with additional capital for expanding its manufacturing capacity, technology, innovation, and talent.
February 2025	Acquisition	Integer Holdings Corporation (US)	Precision Coating (US)	In 2025, Integer acquired nearly all the assets of Precision Coating, a privately held manufacturer that specializes in high-value surface coating technology. This includes fluoropolymer coatings, anodic coatings, ion treatment solutions, and laser processing. The acquisition price was USD 152 million, which is subject to adjustments for additional contingent considerations.
February 2025	Acquisition	Jabil Inc. (US)	Pharmaceutics International, Inc. (US)	Jabil Inc. announced the successful acquisition of Pharmaceutics International, Inc., a CDMO that specializes in early-stage clinical and commercial aseptic filling, lyophilization, and oral solid dose manufacturing, completed on February 3, 2025.

Company Revenue Share Details

The global medical device contract manufacturing market is highly fragmented. The top five players—Jabil, Flex Ltd., Integer Holdings, Plexus, and Sanmina—accounted for approximately 15% of the market in 2025, generating around USD 11,958.5 million in medical device contract manufacturing revenue.

Jabil leads with a 6.1% market share, bolstered by its regulated industries business and its 2025 acquisition of PII, which expands its capabilities into pharmaceutical delivery. Flex follows with a 3.0% share through its Health Solutions business, serving 85% of the top medical device manufacturers. Integer captures a 2.3% market share, focusing on cardio and vascular products, neuromodulation, and cardiac rhythm management. Plexus holds a 2.0% share through its life sciences, diagnostics, and medical device work, which operates under FDA Class II and Class III regulations. Sanmina has a 1.6% share, supported by ISO 13485-certified manufacturing across its 10 FDA-registered facilities.

The remainder of the market includes AptarGroup (Aptar Pharma), TE Connectivity, West Pharmaceutical Services, Benchmark Electronics, Kimball Electronics, and Celestica, each holding between 0.4% and 1.1% of the market. Other players include Gerresheimer, Nortech Systems, Nolato, Nemera, Viant Medical, Tecomet, Phillips-Medisize, Cirtec Medical, and various regional competitors. These companies primarily specialize in drug delivery components, precision plastics, surgical instruments, electronics assembly, and packaging. The market structure reflects competition between large electronics and manufacturing service groups and focused medtech manufacturers, emphasizing engineering depth, cleanroom capacity, and regulatory compliance.

Browse Adjacent Market: Medical Devices Market Research Reports &Consulting

See More Latest Medical Devices Reports:

Cardiovascular Devices Market by Product (Cardiac Imaging, Rhythm Management, Cardiac Assist Devices, Interventional Cardiology, Electrophysiology, Monitoring), Indication (CAD, MI, CHF), End User (Hospitals & Clinics) - Global Forecast to 2029

Orthopedic Devices Market by Product (Fixation, Replacement, Prosthetics, Spinal Implant, Brace, Orthobiologics (DBM), Bone Graft), Procedures Volume (Knee, Hip, Ankle, Shoulder) Site, Application, End User (Hospital, ASC, Trauma) - Global Forecast to 2030

About MarketsandMarkets™

MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report.

MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe.

Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem.

The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.

Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts.

MarketsandMarkets™ SalesPlay is an AI-driven Revenue Intelligence Co-Pilot designed to help revenue teams prioritize the right accounts, identify critical changes early, and surface opportunities ahead of demand, so pipeline builds naturally and deals close with greater consistency.

To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter, LinkedIn and Facebook.

Contact:
Mr. Rohan Salgarkar
MarketsandMarkets™ INC.
1615 South Congress Ave.
Suite 103, Delray Beach, FL 33445
USA: +1-888-600-6441
Email: [email protected]
Visit Our Website: https://www.marketsandmarkets.com/
Research Insight: https://www.marketsandmarkets.com/ResearchInsight/medical-device-contract-manufacturing-market.asp
Content Source: https://www.marketsandmarkets.com/PressReleases/medical-device-contract-manufacturing.asp

SOURCE MarketsandMarkets