Medical Device Contract Manufacturing Market

Market Outlook:

The Global Medical Device Contract Manufacturing market was estimated at USD 72,500.0 Million in 2022 and is anticipated to reach USD 163,543.8 Million by 2031, expanding at a CAGR of 9.7% during the forecast period.

The Medical Device Contract Manufacturing (MDCM) market refers to the outsourcing of medical device design, engineering, and manufacturing services to third-party service providers. This market includes various services, such as concept development, prototyping, regulatory consulting, clinical trials, and quality control.

Companies that engage in medical device contract manufacturing to reduce costs, increase efficiency, and accelerate time-to-market for their products. Moreover, they rely on MDCM companies to manage the supply chain, quality control, and regulatory compliance associated with medical device manufacturing.

Medical device contract manufacturers also offer additional services, such as sterilization, testing, and logistics, to provide a complete manufacturing solution for their clients.

Macro-economic Factors

Rising GDPs of Emerging Economies

Gross domestic product (GDP) is a standard measure of an economic performance of a country, and the medical device contract manufacturing market is influenced by the GDP of the country where it operates. A strong GDP usually leads to an expanding market for medical devices, due to the increased demand from a growing population and a rise in income levels. Consequently, medical device contract manufacturing companies experience an increase in the demand for their services. Economic growth reflected in the GDP has a positive impact on the medical device contract manufacturing market. Increased consumer spending and the demand for healthcare services lead to increasing number of orders and contracts for medical devices.

Government Policies

Regulatory Environment: The medical device industry is heavily regulated, and the compliance with regulations & guidelines is crucial. The regulatory environment varies significantly by country, creating challenges for companies operating in multiple jurisdictions. Trade and Tariffs: Government policies related to trade and tariffs also impact the medical device contract manufacturing market. For instance, in 2021, the Government of India announced a new policy that promotes the use of locally-made medical devices in the healthcare system of the country. The policy aims to reduce its dependence on imported medical devices and promote the growth of the local medical device industry.

Market Dynamics

Market Driver- Increasing Demand for Medical Devices Due to Rising Prevalence of Chronic Diseases and Aging Population

The global medical device contract manufacturing market is impacted by the increasing demand for medical devices, due to the rising prevalence of chronic diseases and aging population. The need for advanced and innovative medical devices has escalated in recent years, owing to the growing prevalence of chronic diseases such as cancer, diabetes, cardiovascular diseases, and respiratory disorders. This has subsequently led to an increase in the demand for medical device contract manufacturing services to meet the growing demand for these devices. The geriatric population has been steadily increasing globally, leading to a surge in the demand for medical devices to cater to their medical needs. According to the World Health Organization (WHO), the global geriatric population is expected to reach 2.1 billion by 2050, up from 900 million in 2015, creating a significant demand for medical devices.

Market Driver- Advancements in Technologies and Manufacturing Processes

Advancements in technologies and manufacturing processes have a significant impact on the medical device contract manufacturing market. These advancements have improved the accuracy, precision, and speed of medical device manufacturing, resulting in improved-quality products being produced at low costs. One of the areas where technologies have had the significant impact is in the design and prototyping of medical devices. Computer-aided design (CAD) and computer-aided manufacturing (CAM) technologies have enabled manufacturers to design and test devices quickly and efficiently, reducing the time and cost of product development.

Market Restraint- Stringent Government Regulations and Standards

Stringent government regulations and standards have a significant impact on the medical device contract manufacturing market. Governments across the globe have implemented strict regulations and standards to ensure the safety and efficacy of medical devices produced by contract manufacturers. These regulations and standards cover various aspects of medical device manufacturing, including design, development, production, packaging, labeling, and sterilization. One of the significant challenges faced by contract manufacturers in the medical device industry is meeting the regulatory requirements imposed by local and international regulatory bodies.

Market Opportunity- Increasing Investments in Healthcare Infrastructure in Developing Countries

Increasing investments in healthcare infrastructure in developing countries have had a significant impact on the medical device contract manufacturing market. These countries are increasingly relying on medical device manufacturers to provide the necessary technologies and devices, as they continue to grow and modernize their healthcare systems. This has led to an increase in demand for medical device contract manufacturing services.
Medical device manufacturers have been investing in expanding their facilities and capabilities, as well as forming strategic partnerships and collaborations to meet the increased demand. This has resulted in the access to a greater variety of medical devices and technologies, including advanced surgical equipment, diagnostic devices, and implantable devices, for healthcare providers and patients in the developing countries.

Scope of the Report  

The report on the Global Medical Device Contract Manufacturing Market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
 

Attributes	Details
Report Title	Medical Device Contract Manufacturing Market– Global Industry Analysis, Size, Share, Growth, Trends, and Forecast
Base Year	2022
Historic Data	2016 and 2020
Forecast Period	2022–2031
Segmentation	By Type (Device, Services), By Class (Class I, Class II, Class III), By Device Type (IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Drug Delivery Devices, Endoscopy Devices, Diabetes Care Devices, Personal Care Devices, Ophthalmology Devices, Orthopaedic Devices, Dental Devices, Other Devices), By Service Type (Device Development and Manufacturing Service, Quality Management Service, Assembly Service, Other Services), By Application (Oncology, Neurovascular, Urology & Gynaecology, Radiology, Cardiovascular, Orthopaedic, Others), By Region (North America, Asia Pacific, Europe, Latin America, and the Middle East & Africa)
Regional Scope	Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
Report Coverage	Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast
Key Players Covered	Biofortuna Limited, Celestica Inc., FLEX LTD., Gerresheimer AG, Integer Holdings Corporation, Invetech, Jabil Inc., MICRO, NIPRO PHARMA CORPORATION, Nordson Corporation, Nortech Systems, Inc., Plexus Corp., Sanmina Corporation., SteriPack Group Ltd, Synecco Ltd, TE Connectivity and Tecomet, Inc.

 

Segmental Outlook

Based on type, the global medical device contract manufacturing market is segmented into devices and services. The devices segment is projected to expand at a substantial CAGR during the forecast period, as medical devices help in diagnosis, prevention, monitoring, and treatment of disease. The services segment is expected to hold a significant share of the market during the forecast period, as services are essential to ensure safety, efficacy, and quality of medical devices.

Based on class, the global medical device contract manufacturing market is segmented into Class I, Class II, and Class III. The Class I segment is projected to expand at a substantial CAGR during the forecast period, as devices belonging to this class are low-risk devices with minimal safety considerations. The Class II segment is expected to hold a significant share of the market during the forecast period, as majority of medical devices fall under Class II such as catheters, blood pressure cuffs, and others.

In terms of device type, the global medical device contract manufacturing market is segmented into IVD devices, diagnostic imaging devices, cardiovascular devices, drug delivery devices, endoscopy devices, diabetes care devices, personal care devices, ophthalmology devices, orthopedic devices, dental devices, and other devices. The IVD devices segment is projected to expand at a significant CAGR during the forecast period, as these devices help in determining the state of health, in order to cure, mitigate, treat, or prevent a disease.

Based on service type, the global medical device contract manufacturing market is segmented into device development and manufacturing service, quality management service, assembly service, and other services. The device development and manufacturing service segment is projected to expand at a significant CAGR during the forecast period, as this service aids in a wide range of activities from conceptualization to commercialization.

On the basis of application, the global medical device contract manufacturing market is segmented into oncology, neurovascular, urology & gynecology, radiology, cardiovascular, orthopedic, and others. The oncology segment is expected to hold a considerable share of the market, as medical devices help to diagnose, treat, or monitor cancer.

Regional Outlook

On the basis of region, the global medical device contract manufacturing market is divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

The market in Asia Pacific is projected to expand at a CAGR of 10.3% during the forecast period, owing to the rising burden of chronic disease, growing geriatric population, increasing demand for medical devices, and rapid expansion of the pharmaceutical industry in the region.

Europe holds a significant share of the market in 2022, due to the growing trend of medical device contract manufacturing.

North America accounted for 34.8% share of the market in 2022 and the market in the region is expected to expand at a rapid pace in the coming years. Increasing prevalence of chronic disease, growing demand for medical devices, growing deployment of Industry 4.0, and increasing adoption of technologically advanced medical devices in the region are expected to boost the market during the forecast period. For instance, according to the US Centers for Disease Control and Prevention (CDC), chronic diseases such as heart disease, cancer, and diabetes are the key causes of death and disability in the US. Thus, the demand for medical devices that are used to diagnose and treat such conditions is increasing rapidly with the rising burden of chronic diseases.

Market Key Developments

• In July 2023, TE Connectivity opened an In Vitro Diagnostic (IVD) facility in Denver. This facility is expected to design and produce products that enable rapid and accurate diagnosis, personalized treatments, and novel therapies for the diagnostics and life science industries. The new site is anticipated to eventually replace the present facility in Englewood, Colorado, and complements existing facilities that support the design and manufacture of microfluidic devices in Carlsbad, California, and Mondragon, Spain.

• In December 2021, Integer Holdings Corporation acquired Oscor Inc., Oscor Caribe, LLC, and Oscor Europe GmbH (collectively ‘Oscor’), privately-held companies with operations in Florida, the Dominican Republic, and Germany that design, develop, manufacture, and market a comprehensive portfolio of highly specialized medical devices, venous access systems, diagnostic catheters, and implantable devices. The acquisition has increased the reach of the company in various geographic locations.

• In June 2020, Nordson Corporation acquired Fluortek, Inc. (Fluortek), a precision plastic extrusion manufacturer that provides custom dimensioned tubing to the medical device industry. The acquisition resulted in the rise of its Medical & Fluid solution business segment.

Key Benefits for Industry Participants & Stakeholders

• In-depth Analysis of the Global Medical Device Contract Manufacturing Market

• Historical, Current, and Projected Market Size in terms of Value

• Potential & Niche Segments and Regions Exhibiting Promising Growth Covered

• Industry Drivers, Restraints, and Opportunities Covered in the Study

• Recent Industry Trends and Developments

• Competitive Landscape & Strategies of Key Players

• Neutral Perspective on Global Medical Device Contract Manufacturing Market performance

Segments

By Type

• Device
• Services

By Class

• Class I
• Class II
• Class III

By Device Type

• IVD Devices
  • IVD Consumables
  • IVD Equipment
• Diagnostic Imaging Devices
• Cardiovascular Devices
• Drug Delivery Devices
  • Auto Injectors
  • Infusion Pumps
• Endoscopy Devices
• Diabetes Care Devices
• Personal Care Devices
• Ophthalmology Devices
• Orthopedic Devices
• Dental Devices
• Other Devices

By Service Type

• Device Development and Manufacturing Service
  • Device and Component Manufacturing
  • Process Development Services
  • Device Engineering Services
• Quality Management Service
  • Packaging Validation Services
  • Inspection and Testing Services
• Assembly Service
• Other Services

By Application

• Oncology
• Neurovascular
• Urology & Gynecology
• Radiology
• Cardiovascular
• Orthopedic
• Others

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Key Market Players Profiled in the Report

• Biofortuna Limited
• Celestica Inc.
• FLEX LTD.
• Gerresheimer AG
• Integer Holdings Corporation
• Invetech
• Jabil Inc.
• MICRO
• NIPRO PHARMA CORPORATION
• Nordson Corporation
• Nortech Systems, Inc.
• Plexus Corp.
• Sanmina Corporation.
• SteriPack Group Ltd
• Synecco Ltd
• TE Connectivity
• Tecomet, Inc.

Competitive Landscape

• Manufacturers operating in the Global Medical Device Contract Manufacturing Market include Biofortuna Limited, Celestica Inc., FLEX LTD., Gerresheimer AG, Integer Holdings Corporation, Invetech, Jabil Inc., MICRO, NIPRO PHARMA CORPORATION, Nordson Corporation, Nortech Systems, Inc., Plexus Corp., Sanmina Corporation., SteriPack Group Ltd, Synecco Ltd, TE Connectivity and Tecomet, Inc.

• Market Players are pursuing key strategies such as acquisitions, collaborations, and geographic expansion where a potential opportunity arises for the Medical Device Contract Manufacturing Market.