Global Medical Device Outsourcing Market By Service (Contract Manufacturing, Quality Assurance, and Other Services), By Application (Cardiology, Drug delivery, and Other Applications), By Class, By Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends, and Forecast 2023-2032

Report Overview

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.

Medical device outsourcing is a service that is offered by many companies to commission quality management services to third-party companies or medical device consulting companies to ensure the compliance of the medical devices with guidelines provided by regulatory authorities.

This allows companies to offer high-quality and effective medical devices to users. Medical devices are used for various purposes in the healthcare sector. These medical devices are classified on many bases, such as class, service, and application.

The classes of medical devices include many medical devices right, from bandages, masks, and latex gloves to pacemakers, breast implants, and defibrillators. These medical devices are classified into classes according to the threat they pose to the human body. The medical devices are categorized from low and moderate risk to high risk. Medical devices need to comply with the guidelines provided by the FDA and also maintain a reasonable price of it. Therefore, medical device companies are outsourcing the third-party companies to improve the quality and effectiveness of the medical devices.

Key Takeaways

• Medical Device Outsourcing Market size is expected to be worth around USD 352.3  Billion by 2033 from USD 130.7 Billion in 2023.
• Market growing at a CAGR of 12.0% during the forecast period from 2023 to 2032.
• Contract manufacturing accounts for 53.8% of the service segment.
• Class 2 medical devices hold the largest market share of 64.8% in the class segment.
• The Asia Pacific region leads the global market with 40.6% revenue share, followed by North America.
• Contract manufacturing is the leading service segment, accounting for 53.8% of the market’s revenue.
• Cardiology is the dominant application segment, driven by the increasing prevalence of cardiovascular diseases.
• Class 2 medical devices, with moderate to high risk, hold the largest market share of 64.8% in the class segment.
• The Asia Pacific region leads the global market with 40.6% revenue share, followed by North America with significant growth potential.
• Key players in the market include IQVIA Inc., SGS SA, Eurofins Scientific, Intertek Group plc, WuXiAppTec, Charles River Laboratories, PAREXEL International Corporation, Pace Analytical Services Inc., Sterigenics U.S. LLC, Freyr Solutions, and others.

By Service Analysis

Contract Manufacturing Leads the Service Segment by Covering a Major Share of the Global Medical Device Outsourcing Market.

Based on service, the global medical device outsourcing market is classified into contract manufacturing, quality assurance, design and development services, maintenance services, regulatory affairs services, and other services. Among these services, contract manufacturing led the service segment by accounting for a major revenue share of 53.8% in the global medical device outsourcing market.

This growth of contract manufacturing is attributed to the increasing demand for low-cost medical devices in the market. The complex regulations and guidelines from the regulatory authority are forcing the companies to commission the contract manufacturing to other companies to lower the cost and comply with the guidelines. These key factors are boosting the growth of contract manufacturing in the service segment of the global medical device outsourcing market.

After contract manufacturing, the quality assurance service segment is anticipated to cover a significant share of the market over the forecast period. The increasing focus on quality improvement and regulatory compliance is driving the growth of the quality assurance service in the global this market.

By Application Analysis

Cardiology Leads the Application Segment with Major Revenue Share in Account.

The global medical device outsourcing market is classified on the basis of application into cardiology, general and plastic surgery, drug delivery, diagnostic imaging, IVD, and other applications. From these applications, cardiology dominates the application segment by accounting for a major revenue share of 20.4%. The increase in cardiovascular diseases in the last few years is driving the growth of cardiology in the application segment of the global medical device outsourcing market.

The high prevalence of CVDs like rheumatic heart disease, atrial fibrillation, angina pectoris, myocardial infarction, congenital heart disease, and many other heart-related diseases has increased the demand for various medical devices that can be used in the treatment of these diseases. These key factors are propelling the growth of cardiology in the application segment of global medical device outsourcing.

However, general and plastic surgery devices are anticipated to grow at a significant CAGR of 12.8% during the forecast period. The rising demand for cosmetic surgeries is driving the growth of general and plastic surgery in the application segment of the global medical device outsourcing market.

By Class Analysis

High Demand for Class 2 Medical Devices is Driving the Growth of Global Medical Devices Outsourcing Market.

Based on class, the global medical device outsourcing market is classified into class 1, class 2, and class 3. Out of these classes, the class 2 type medical devices held the major revenue share of 64.8% in the class segment of the global medical device outsourcing market. This exponential growth of class 2 medical devices is due to the high demand for class 2 medical devices like syringes, catheters, surgical gloves, contact lenses, pregnancy tests, and many such medical devices.

The Class 2 medical devices include devices that possess moderate to high risk. Class 2 of medical devices contains a major share of the medical devices in the account. These key factors are driving the growth of class 2 medical devices in the class segment of the global medical device outsourcing market.

After class 2 medical devices, class 1 medical devices are expected to experience significant growth over the forecast period. Class 1 medical devices include devices with low to moderate risk. These medical devices are easy to access or purchase than the other class medical devices. It is rarely used in critical or life-threatening situations; therefore, they are easy to purchase in the market. These key factors are boosting the growth of class 2 medical devices in the class segment of the global medical device outsourcing market.

Market Key Segments

By Service

• Contract Manufacturing
• Quality Assurance
• Design and Development Services
• Maintenance Services
• Regulatory Affairs Services
• Other Services

By Application

• Cardiology
• General and plastic surgery
• Diagnostic imaging
• Drug delivery
• IVD
• Other Applications

By Class

• Class I
• Class II
• Class III

Driver Factors

The primary driver of the medical device outsourcing market is the increasing complexity and cost of medical device development and production. Regulatory requirements have become more stringent, demanding comprehensive testing, validation, and compliance with international standards. This has led medical device companies to seek outsourcing partners who can provide specialized expertise and advanced facilities at a lower cost.

Additionally, the rapid pace of technological advancements necessitates constant innovation, which outsourcing partners can often deliver more efficiently than in-house teams. This trend is particularly prevalent among small and medium-sized enterprises that lack the resources to maintain extensive R&D and regulatory compliance departments.

Trending Factors

A significant trend in the medical device outsourcing market is the growing integration of advanced technologies such as artificial intelligence (AI), machine learning, and big data analytics into outsourcing services. These technologies enhance the efficiency and accuracy of product development, regulatory compliance, and market forecasting. For instance, AI can streamline the design and testing phases, reducing time-to-market for new devices.

Additionally, outsourcing companies are increasingly offering end-to-end solutions, from product conceptualization and design to post-market surveillance and compliance management. This trend towards comprehensive service offerings helps medical device companies manage their projects more effectively and stay competitive in a fast-paced industry.

Restraint Factors

One of the main restraints in the medical device outsourcing market is concerns over data security and intellectual property (IP) protection. As companies outsource critical aspects of their development process, they must share sensitive information with third-party vendors.

This raises the risk of data breaches and IP theft, which can have significant financial and reputational repercussions. Furthermore, there can be challenges related to managing and coordinating activities across different time zones and cultural environments, which can lead to communication issues and project delays.

Opportunity

The growing demand for wearable and home-use medical devices presents a substantial opportunity for the medical device outsourcing market. As healthcare shifts towards more personalized and remote patient monitoring solutions, there is a rising need for devices that are both user-friendly and highly reliable. Outsourcing firms that can offer expertise in miniaturization, wireless technology, and user interface design will be well-positioned to capitalize on this trend.

Additionally, expanding into emerging markets where healthcare infrastructure is developing rapidly can provide outsourcing companies with new growth avenues, as these regions often require cost-effective and innovative medical device solutions.

Regional Analysis

Asia Pacific Region Dominates the Global Medical Devices Outsourcing Market by Covering Major Revenue Share

The Asia Pacific region leads the global medical device outsourcing market by covering a major revenue share of 40.6%. This growth of the Asia Pacific region is attributed to the presence of many key players in the market in the countries like China, South Korea, and Japan.

The presence of a large share of the population in the Asia Pacific region has increased the number of patients suffering from various chronic diseases. This has raised the demand for medical devices within the region. The governments of many countries in the Asia Pacific region have increased their healthcare expenditure. This has positively affected the growth of the medical device outsourcing market within the region.

After Asia Pacific, the North American region is expected to cover a significant revenue share during the forecast period. This growth of the North American region is owing to the presence of developed infrastructure within the region. The existence of advanced technologies and the presence of the USFDA are further propelling the medical device outsourcing market in the region.

Key Regions

• North America
  • The US
  • Canada
  • Mexico
• Western Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Portugal
  • Ireland
  • Austria
  • Switzerland
  • Benelux
  • Nordic
  • Rest of Western Europe
• Eastern Europe
  • Russia
  • Poland
  • The Czech Republic
  • Greece
  • Rest of Eastern Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Australia & New Zealand
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Colombia
  • Chile
  • Argentina
  • Costa Rica
  • Rest of Latin America
• Middle East & Africa
  • Algeria
  • Egypt
  • Israel
  • Kuwait
  • Nigeria
  • Saudi Arabia
  • South Africa
  • Turkey
  • United Arab Emirates
  • Rest of MEA

Key Players Analysis

With rising demand for medical devices across the world, medical device manufacturing companies are collaborating with outsourcing companies to meet the market demand and lower the cost of medical devices. The major companies in the market are expanding their product portfolio with advancements in the products.

Key players in the market are adopting various strategies to expand their market share and strengthen their position in the global medical device outsourcing market. Some of the key players in the medical device outsourcing market are IQVIA Inc., SGS SA, Euro fins Scientific, Intertek Group plc, WuXiAppTec, Charles River Laboratories, PAREXEL International Corporation, Pace Analytical Services Inc., Sterigenics U.S. LLC, Freyr Solutions, and other key players.

Key Players

• IQVIA Inc.
• SGS SA
• Euro fins Scientific
• Intertek Group plc
• WuXiAppTec
• Charles River Laboratories
• PAREXEL International Corporation
• Pace Analytical Services Inc.
• Sterigenics U.S. LLC
• Freyr Solutions
• Other Key Players

Recent Developments

• IQVIA Inc. (April 2024): IQVIA Inc. has announced the acquisition of Clinipace, a global clinical research organization. This acquisition is aimed at enhancing IQVIA’s capabilities in providing comprehensive clinical trial services, particularly in the medical device sector. Clinipace’s expertise in clinical development and regulatory consulting will complement IQVIA’s existing offerings, enabling more robust support for medical device companies in bringing innovative products to market. The strategic acquisition is expected to expand IQVIA’s footprint in the clinical research market and drive growth in their medical device outsourcing services.
• SGS SA – New Service Launch (March 2024): SGS SA has launched a new service line dedicated to medical device biocompatibility testing. This new offering includes a range of in vitro and in vivo testing services that comply with international standards, aimed at ensuring the safety and efficacy of medical devices. The launch of these services is in response to the growing demand for comprehensive testing solutions in the medical device industry, driven by stringent regulatory requirements. This development is expected to enhance SGS’s position as a leading provider of testing and certification services in the medical device market.
• Eurofins Scientific (May 2024): Eurofins Scientific has completed its merger with Toxikon Corporation, a contract research organization specializing in preclinical testing services. This merger is designed to expand Eurofins’ capabilities in providing end-to-end testing solutions for medical device companies. Toxikon’s expertise in toxicology and biocompatibility testing will integrate with Eurofins’ extensive laboratory network, offering clients more comprehensive and efficient testing services. The merger is expected to strengthen Eurofins’ market position and enhance its service offerings in the medical device outsourcing market.
• Intertek Group plc (June 2024): Intertek Group plc has acquired ProVeritas Group, a consulting firm specializing in regulatory compliance and quality assurance for medical devices. This acquisition aims to bolster Intertek’s consulting services by adding ProVeritas’ deep regulatory expertise and established client base. By integrating ProVeritas’ capabilities, Intertek plans to offer enhanced support for medical device companies navigating complex regulatory landscapes, ultimately improving their market entry timelines. This strategic move is set to expand Intertek’s service portfolio and increase its market share in the medical device outsourcing sector.

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