The global medical device outsourcing market size is expected to reach USD 292.9 billion by 2030, at a CAGR of 12.8% from 2024 to 2030, according to a new report by Grand View Research, Inc. Rising demand for advanced medical products and a growing trend of offshoring is fueling the medical device outsourcing market growth.
Regulatory bodies are emphasizing the quality of the healthcare devices provided to the public which is becoming burdensome to handle. To meet the regulatory scenario, various services like regulatory consulting are being utilized by the industry players. For example, the European Medical Device Regulation undertakes special spontaneous inspection of outsourced products to test the quality as well as conformity with standards.
Contract manufacturers, especially in developed countries like the U.S., EU nations, and Japan, comply with the international standard for the quality management system, which makes them a preferred option as compared with contract manufacturers in India and China. However, regulatory changes anticipated in developing countries ensure compliance by contract manufacturers. Demand for regulatory compliance is expected to boost the growth of consulting services such as remediation, compliance, and QMS, thereby contributing to the growth of the global medical device outsourcing market.
Owing to COVID-19, there was a decline in the number of diagnoses for other diseases like cancer and tuberculosis among others. The recovery from COVID-19 is expected to increase demand for the medical devices used for diagnosing these diseases. Public organizations across the globe are taking initiatives to increase the production of medical equipment to prevent a future shortage. For instance, in January 2021, U.S. president Joseph Biden in response to the pandemic preparedness emphasized improving gaps in the supply chain by augmenting domestic manufacturing of test kits, PPE, and durable medical equipment.
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The contract manufacturing market dominated the market with a share of 54.4% in 2023 owing to the growing trend of outsourcing by OEM to third-party manufacturers, especially in emerging countries
The cardiology segment dominated the application segment with a market share of 21% in 2023. Rising demand for cardiovascular devices as a result of the increasing prevalence of associated conditions is attributed to the growth of outsourcing of these devices
The Class II segment dominated the class type market and accounted for 81.34% in 2023. The key factors contributing to the growth of the segment are the majority of the devices almost 43.0% fall under this category and the cost of medical devices is also high
Asia Pacific region dominated the global market in 2022 with a share of 41.3% owing to lower cost and availability of skilled human resources.
Grand View Research has segmented the global medical device outsourcing market based on the service, application, class, and region.
Medical Device Outsourcing Service Outlook (Revenue, USD Million, 2018 - 2030)
Quality Assurance
Regulatory Affairs Services
Clinical Trials Applications & Product Registrations
Regulatory Writing & Publishing
Legal Representation
Others
Product Design & Development Services
Designing & Engineering
Machining
Molding
Packaging
Product Testing & Sterilization Services
Product Implementation Services
Product Upgrade Services
Product Maintenance Services
Contract Manufacturing
Accessories Manufacturing
Assembly Manufacturing
Component Manufacturing
Device Manufacturing
Medical Device Outsourcing Application Outlook (Revenue, USD Million, 2018 - 2030)
Cardiology
Class I
Class II
Class III
Diagnostic Imaging
Class I
Class II
Class III
Orthopedic
Class I
Class II
Class III
IVD
Class I
Class II
Class III
Ophthalmic
Class I
Class II
Class III
General & Plastic Surgery
Class I
Class II
Class III
Drug Delivery
Class I
Class II
Class III
Dental
Class I
Class II
Class III
Endoscopy
Class I
Class II
Class III
Diabetes Care
Class I
Class II
Class III
Others
Class I
Class II
Class III
Medical Device Outsourcing Class Outlook (Revenue, USD Million, 2018 - 2030)
Class I
Class II
Class III
Medical Device Outsourcing Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Europe
Germany
U.K.
France
Italy
Spain
Netherlands
Switzerland
Sweden
Belgium
Russia
Asia Pacific
Japan
China
India
Indonesia
Malaysia
Singapore
South Korea
Thailand
Taiwan
Australia
Philippines
Latin America
Brazil
Mexico
Argentina
Colombia
Chile
Middle East and Africa (MEA)
South Africa
Saudi Arabia
UAE
Israel
Egypt
List of Key Players in Medical Device Outsourcing Market
SGS SA
Laboratory Corporation of America Holdings
Euro fins Scientific
Pace Analytical Services, Inc.
Intertek Group plc
WuXiAppTec
North American Science Associates, LLC
TÜV SÜD
Sterigenics U.S., LLC (GTCR, LLC)
Charles River Laboratories
Medical Device Testing Services (Element Minnetonka)
RJR Consulting, Inc.
Mandala International
Freyr
Global Regulatory Partners
PAREXEL International Corporation (EQT Private Equity and Goldman Sachs Asset Management)
Emergo (UL LLC)
Bioteknica
Accell Clinical Research, LLC
Genpact
Criterium, Inc.
Promedica International
Med pace
ICON plc.
IQVIA Inc.
Integer Holdings Corporation
Tecomet Inc. (Charles bank Capital Partners, LLC)
Jabil Inc.
FLEX LTD.
Celestica Inc.
Sanmina Corporation
Plexus Corp.
Phillips Medisize (Molex, LLC)
Cantel Medical Corp. (STERIS plc)
West Pharmaceutical Services, Inc.
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