Medical Device Contract Manufacturing Market By Type (Class I, Class II, and Class III Devices), By Application (Orthopedic & Spine Devices, Cardiovascular Devices, Radiology Devices, General Medical Devices, and Others), Industry Trends, Estimation & Forecast, 2023-2030

Market Overview

Contract manufacturing is the outsourcing of whole products or, a single element of a larger product. Medical device contract manufacturers are specialized in a certain process. Medical device contract manufacturers are specialized in the service area, such as moulding, machining, or assembly, or provide full-contract manufacturing services that can encompass R&D, design, and engineering assistance, prototyping, and full-scale production. The regulatory policy for these devices is strict and follows three-tiered classification system, Class I, II, and III.

Medical Device Contract Manufacturing market is estimated to reach $176.1 billion by 2030; growing at a CAGR of 11.7% till 2030

Market Dynamics

Improvements and advancement in medical devices manufacturing technologies are boosting the global medical device contract manufacturing market. The objective to reduce the time-to-market in the manufacturing of medical devices so as to achieve higher sales volume have rapidly transformed the production technologies of contract manufacturers to improved facilities. The manufacturers have shifted focus from traditional methods to an intensive technology setup furnished with high-tech equipment and huge investment. These technological enhancements improve the production process with higher efficiency and help the drug supply to meet the increased demand while maintaining quality standards. In order to have a shortened development cycle, pharmaceutical companies are continually finding new ways to reduce the product’s time-to-market. By engaging with contract manufacturers at the intermediate stage of development, pharma companies are able to contain the launch timelines. In addition, as the sourcing companies can introduce the generics at a faster pace, it assists them in gaining a significant share of the market and also helps them stay competitive. The introduction of automated systems in contract manufacturing facilities have thereby improved the production and inspection procedures of medical devices that have significantly reduced the time-to-market for products. Moreover, Increasing growth in manufacturing volume of medical devices are key driving factors of the market. However, Lack of standardization in manufacturing capabilities of contract manufacturers might hamper the market growth. Contract manufacturers are required to be kept updated on the same data sets and are required to abide by similar regulatory strictness. The contract manufacturers also face inadequacies in supply-demand dynamics and quality assurance risks related to production services. The lack of transparent communication channels between contract manufacturers, suppliers, and distributors leads to a disruption in service, because of which the contract manufacturers have to start stockpiling raw materials to ensure that they do not miss out on timely deliveries of medical devices and associated products. In addition, inadequate infrastructure and malpractices from the manufacturers also present significant hindrance to market growth. For instance, on September 13, 2019, the U.S. Food and Drug Administration, has filed and settled a civil fraud lawsuit under False Claims Act against Avalign Technologies, Inc., and it’s subsidiary Instrumed International, Inc., for manufacturing and selling medical devices that were not cleared by the FDA. Increasing investment for medical device would provide lucrative opportunities for the market in the coming years.

Market Segmentation

Global Medical Device Contract Manufacturing market is mainly classified based on Type, Application. Type is further segmented into, Class I, Class II, and Class III devices. Class II medical devices are dominating the global medical device contract manufacturing market.

Class II medical devices have a moderate to high risk to the patient. 43% of medical devices fall under class II devices. Class II devices include infusion pumps, acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and surgical drapes. The regulatory approvals of Class II medical devices and the development of new devices are boosting the global medical device contract manufacturing market. For instance, Douglas Medical Products, Inc., a contract manufacturing of IV Administration/Extension Sets and Enteral (ENFit)Sets have received 510(k) clearance for TUBETECH IV Administration Sets from the U.S. Food and Drug Administration (FDA). TUBETECH IV Administration Sets are used in peristaltic IV infusion pumps. The FDA clearance will provide Douglas Medical Products to begin commercialization of TUBETECHIV Administration Sets for use in peristaltic IV infusion pumps. Global Class II Medical Device Contract Manufacturing market is estimated to reach $ 46,308.4Million. By Application, the market is further divided into Orthopedic & Spine Devices, Cardiovascular Devices, Radiology Devices, General Medical Devices, Others.

Regional Analysis

Based on geography, the global Medical Device Contract Manufacturing market is divided into North America, Europe, Asia-Pacific, South America, and Middle East & Africa. North America is further divided in the U.S., Canada, and Mexico, whereas Europe consists of the UK, Germany, France, Italy, and Rest of Europe. Asia-Pacific is segmented into India, China, Japan, South Korea, and Rest of Asia-Pacific. The South America region includes Brazil, Argentina, and the Rest of South America, while the Middle East & Africa is categorized into GCC Countries, Egypt, South Africa, and Rest of Middle East & Africa.

North America has shown significant growth in 2019, due to the expansion of the manufacturing facility by the contract manufacturer. For instance, Integer Holdings Corporation (Integer), a medical device outsource manufacturer, has introduced implantable pulse generator (IPG) cleanroom assembly and testing capabilities at Tijuana-North facility to support its OEM customers. Integer’s Tijuana-North facility in Mexicois the first-Class III active implantable medical device manufacturing siteto receive FDA approval. Moreover, GW Plastics, Inc. advanced contract manufacturing and injection molding companyhas expanded of its Royalton, Vermont Manufacturing and Technology Center. GW Plastics has added a 30,000 ft² expansion to grow its thermoplastic injection molding and medical device contract assembly business.

North America Medical Device Contract Manufacturing market is estimated to reach $23,6739.5Million.

Competitive landscape

Key players operating in the Medical Device Contract Manufacturing industry include Benchmark Electronics, Flextronics, Forefront Medical Technology, Integer, Jabil Circuit, Nortech Systems, TE Connectivity (Creganna Medical), Tecomet (Symmetry Medical), The Tech Group (West Pharmaceutical Services), Viant.

Increasing commercialization of new products, regulatory approvals for medical devices, with the expansion of manufacturing facilities by the contract manufacturer for further development of products and competitive advancement between companies is key factor boosting the market growth. For instance, on February 4, 2020, Heraeus Medical Components, a medical device outsourcing provider, has acquired Contract Medical International (CMI) to focus on complex delivery systems for minimally invasive medical devices. CMI provides contract design, development, manufacturing, and global regulatory services for medical device OEMs.

Medical Device Contract Manufacturing Market Key Segments

By Type
• Class I devices
• Class II devices
• Class III devices

By Application
• Orthopedic & Spine Devices
• Cardiovascular Devices
• Radiology Devices
• General Medical Devices
• Others

By Geography

• North America
o The U.S.
o Canada
o Mexico

• Europe
o U.K
o Germany
o France
o Italy
o Rest of Europe

• Asia Pacific
o India
o China
o Japan
o South Korea
o Rest of Asia Pacific

• South America
o Brazil
o Argentina
o Rest of South America

• Middle East & Africa
o GCC Countries
o Egypt
o South Africa
o Rest of Middle East & Africa

Key Global Medical Device Contract Manufacturing Industry Players

• Benchmark Electronics
• Flextronics
• Forefront Medical Technology
• Integer
• Jabil Circuit
• Nortech Systems
• TE Connectivity (Creganna Medical)
• Tecomet (Symmetry Medical)
• The Tech Group (West Pharmaceutical Services)
• Viant

Table of Content

1. Market Introduction
1.1. Executive Summary
1.2. Market Definition
1.3. Market Scope

2. Research Methodology
2.1. Primary Research
2.2. Research Methodology
2.3. Assumptions & Exclusions
2.4. Secondary data sources

3. Medical Device Contract Manufacturing Market Overview
3.1. Report Segmentation & Scope
3.2. Key Market Trend
3.3. Drivers
3.3.1. Improvements and advancement in medical devices manufacturing technologies
3.3.2. Increasing growth in manufacturing volume of medical devices
3.4. Restraints
3.4.1. Lack of standardization in manufacturing capabilities of contract manufacturers
3.5. Opportunity
3.5.1. Increasing investment for medical device
3.6. Porter’s Five Forces Analysis
3.6.1. Porter’s Five Forces Analysis
3.7. Market Share Analysis

4. Type Overview
4.1. Introduction
4.1.1. Market Size & Forecast
4.2. Class I devices
4.2.1. Market Size & Forecast
4.3. Class II devices
4.3.1. Market Size & Forecast
4.4. Class III devices
4.4.1. Market Size & Forecast

5. Application Overview
5.1. Introduction
5.1.1. Market Size & Forecast
5.2. Orthopedic & Spine Devices
5.2.1. Market Size & Forecast
5.3. Cardiovascular Devices
5.3.1. Market Size & Forecast
5.4. Radiology Devices
5.4.1. Market Size & Forecast
5.5. General Medical Devices
5.5.1. Market Size & Forecast
5.6. Others
5.6.1. Market Size & Forecast

6. Medical Device Contract Manufacturing Market Regional Overview
6.1. Introduction
6.1.1. Market Size & Forecast
6.2. North America Medical Device Contract Manufacturing Market
6.2.1. North America Market Size & Forecast, By Country
6.2.2. North America Market Size & Forecast, By Type
6.2.3. North America Market Size & Forecast, By Application
6.2.4. The U.S.
6.2.4.1. Market Size and Forecast
6.2.5. Canada
6.2.5.1. Market Size and Forecast
6.2.6. Mexico
6.2.6.1. Market Size and Forecast
6.3. Europe Medical Device Contract Manufacturing Market
6.3.1. Europe Market Size & Forecast, By Country
6.3.2. Europe Market Size & Forecast, By Type
6.3.3. Europe Market Size & Forecast, By Application
6.3.4. Germany
6.3.4.1. Market Size and Forecast
6.3.5. France
6.3.5.1. Market Size and Forecast
6.3.6. UK
6.3.6.1. Market Size and Forecast
6.3.7. Italy
6.3.7.1. Market Size and Forecast
6.3.8. Spain
6.3.8.1. Market Size and Forecast
6.3.9. Rest of Europe
6.3.9.1. Market Size and Forecast
6.4. Asia-Pacific Medical Device Contract Manufacturing Market
6.4.1. Asia-Pacific Market Size & Forecast, By Country
6.4.2. Asia-Pacific Market Size & Forecast, By Type
6.4.3. Asia-Pacific Market Size & Forecast, By Application
6.4.4. Japan
6.4.4.1. Market Size and Forecast
6.4.5. China
6.4.5.1. Market Size and Forecast
6.4.6. Australia
6.4.6.1. Market Size and Forecast
6.4.7. India
6.4.7.1. Market Size and Forecast
6.4.8. South Korea
6.4.8.1. Market Size and Forecast
6.4.9. Rest of Asia-Pacific
6.4.9.1. Market Size and Forecast
6.5. South America Medical Device Contract Manufacturing Market
6.5.1. South America Market Size & Forecast, By Country
6.5.2. South America Market Size & Forecast, By Type
6.5.3. South America Market Size & Forecast, By Application
6.5.4. Brazil
6.5.4.1. Market Size and Forecast
6.5.5. Argentina
6.5.5.1. Market Size and Forecast
6.5.6. Rest of South America
6.5.6.1. Market Size and Forecast
6.6. Middle East & Africa Medical Device Contract Manufacturing Market
6.6.1. Middle East & Africa Market Size & Forecast, By Country
6.6.2. Middle East & Africa Market Size & Forecast, By Type
6.6.3. Middle East & Africa Market Size & Forecast, By Application
6.6.4. GCC Countries
6.6.4.1. Market Size and Forecast
6.6.5. Egypt
6.6.5.1. Market Size and Forecast
6.6.6. South Africa
6.6.6.1. Market Size and Forecast
6.6.7. Rest of Middle East & Africa
6.6.7.1. Market Size and Forecast

7. Company Profile
7.1. Benchmark Electronics
7.1.1. Company Basic Information, Manufacturing Base, Sales Area and Its Competitors
7.1.2. Benchmark Electronics Product Category, Application, and Specification
7.1.3. Benchmark Electronics Financial Performance (2016-2018)
7.1.4. Main Business/Business Overview
7.2. Flextronics
7.3. Forefront Medical Technology
7.4. Integer
7.5. Jabil Circuit
7.6. Nortech Systems
7.7. TE Connectivity (Creganna Medical)
7.8. Tecomet (Symmetry Medical)
7.9. The Tech Group (West Pharmaceutical Services)
7.10. Viant