Medical Device Contract Manufacturing Market
Number of pages: 120 | Report Format: PDF | Published date: January 28, 2022
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
|
Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 73.72 billion |
|
Revenue Forecast in 2031 |
US$ 178.14 billion |
|
CAGR |
10.3% |
|
Base Year for Estimation |
2022 |
|
Forecast Period |
2023 to 2031 |
|
Historical Year |
2021 |
|
Segments Covered |
Product Type, Services, Application, and Region |
|
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global medical device contract manufacturing market was valued at US$ 73.72 billion in 2022 and is expected to register a revenue CAGR of 10.3% to reach US$ 178.14 billion by 2031.
Medical Device Contract Manufacturing Market Fundamentals
Medical device contract manufacturing refers to the outsourcing of the production and assembly of medical devices to a third-party manufacturer. In this arrangement, a medical device company partners with a specialized contract manufacturing organization (CMO) with the expertise, capabilities, and facilities to manufacture medical devices according to the company's specifications. Contract manufacturing in the medical device industry is a common practice for various reasons. Some medical device companies may lack the necessary resources, infrastructure, or expertise to manufacture their products in-house. By partnering with a contract manufacturer, they can benefit from its established facilities, skilled workforce, and regulatory compliance. The contract manufacturer takes on the responsibility of producing the medical devices, following the specifications provided by the medical device company. This includes sourcing the necessary raw materials, components, and specialized equipment required for manufacturing. The contract manufacturer may also handle quality control, testing, packaging, and labeling of the medical devices.
Medical Device Contract Manufacturing Market Dynamics
Medical device contract manufacturing offers cost advantages to medical device companies. Outsourcing manufacturing to specialized contract manufacturers can reduce capital investment in facilities, equipment, and labor. Contract manufacturers often operate at a larger scale, allowing for economies of scale and cost efficiencies in the production process. Medical device companies can focus on their core competencies, such as research, development, and marketing, by outsourcing manufacturing to contract manufacturers. This allows them to allocate resources and expertise to areas where they have a competitive advantage while leaving the manufacturing process to specialized partners, increasing the medical device contract manufacturingmarket demand. Contract manufacturers often have extensive experience and expertise in manufacturing medical devices. They possess specialized knowledge of industry standards, regulatory requirements, and manufacturing processes. By partnering with contract manufacturers, medical device companies gain access to advanced technologies, production capabilities, and best practices. Contract manufacturing provides flexibility and scalability to medical device companies. They can adapt production volumes based on market demand without the need for significant investments in infrastructure or workforce. Contract manufacturers can quickly scale up or down production to accommodate fluctuations in demand, ensuring efficient supply chain management. Medical device contract manufacturing allows companies to expand their global reach and enter new markets. Contract manufacturers often have a global footprint and established distribution networks, enabling medical device companies to access new customer bases and geographies.
However, medical device companies may have concerns about protecting their intellectual property when outsourcing manufacturing to contract manufacturers. Sharing proprietary designs, processes, and technologies with a third party introduces a potential risk of IP infringement or unauthorized use, which restricts the medical device contract manufacturing market growth. Medical devices are subject to stringent regulatory requirements to ensure safety and efficacy. Medical device contract manufacturing needs to adhere to these regulations and maintain the highest quality standards, which is also expected to hinder the medical device contract manufacturing market growth.
Medical Device Contract Manufacturing Market Ecosystem
The global medical device contract manufacturing market is analyzed from four perspectives: product type, services, application, and region.
Medical Device Contract Manufacturing Market by Product Type
Based on the product type, the global medical device contract manufacturing market is segmented into diagnostic & monitoring devices, therapeutic devices, and others.
The diagnostic & monitoring devices segment accounted for the largest revenue share of the medical device contract manufacturing market in 2022. The demand for diagnostic and monitoring devices has increased due to factors such as an aging population, the prevalence of chronic diseases, and the growing focus on preventive healthcare. These devices play a crucial role in early detection, disease management, and patient health monitoring. As a result, the need for contract manufacturing services for diagnostic and monitoring devices has also increased. According to WHO, by 2030, 1 in every 6 persons on the planet will be 60 or older. At this point, the proportion of the population aged 60 and up will rise from 1 billion in 2020 to 1.4 billion. The world's population of persons aged 60 and up will double (2.1 billion) by 2050. The number of people aged 80 and more is predicted to treble between 2020 and 2050, reaching 426 million. Diagnostic and monitoring devices have seen significant technological advancements in recent years. These devices often incorporate complex sensors, wireless connectivity, data analytics, and software integration. The manufacturing of these sophisticated devices requires specialized expertise, advanced manufacturing processes, and stringent quality control. Diagnostic and monitoring devices are subject to strict regulatory requirements, such as FDA regulations in the United States and European CE marking. Compliance with these regulations is critical to ensure patient safety and device effectiveness. Contract manufacturers specializing in diagnostic and monitoring devices have established quality management systems and expertise in navigating regulatory frameworks, making them attractive partners for medical device companies seeking compliance assurance.
Medical Device Contract Manufacturing Market by Services
Based on the services, the global medical device contract manufacturing market is segmented into device development & manufacturing services, quality management services, and final goods assembly services.
The device development & manufacturing services segment accounted for the highest medical device contract manufacturing market share in 2022. The device development & manufacturing services segment is further sub-segment into device engineering services, process development services, and device manufacturing services. The device development & manufacturing services segment offers end-to-end support throughout the entire product development and manufacturing process. This includes services such as product design, prototyping, testing, regulatory compliance, and full-scale manufacturing. By providing a comprehensive range of services, contract manufacturers can cater to the diverse needs of medical device companies and assist them in bringing their products to market efficiently. The device development & manufacturing services segment emphasizes collaboration between contract manufacturers and medical device companies. This collaborative approach ensures that the medical device company's specific requirements and design preferences are considered throughout the development and manufacturing process. Engaging device development & manufacturing services mitigates risks for medical device companies. Contract manufacturers possess the necessary infrastructure, resources, and expertise to handle complex manufacturing processes and regulatory compliance. By outsourcing device development and manufacturing, medical device companies can leverage the contract manufacturer's capabilities, reduce their own operational risks, and scale production as needed to meet market demand.
Medical Device Contract Manufacturing Market by Application
Based on the applications, the global medical device contract manufacturing market is segmented intocardiovascular, orthopedic, diabetes, pulmonary, oncology, diagnostic imaging, and others.
The orthopedic segment accounted for the prominent medical device contract manufacturing market share in 2022. The orthopedic market has experienced steady growth due to an aging population, increasing prevalence of musculoskeletal disorders, and advancements in surgical techniques. This has increased demand for orthopedic devices such as joint implants, spinal implants, trauma fixation devices, and orthobiologics.According to WHO, around 1.71 billion people globally are affected by musculoskeletal conditions.Musculoskeletal conditions are the leading contributor to disability worldwide. The orthopedic field has witnessed significant technological advancements, including using advanced materials, minimally invasive surgical techniques, and personalized implants. These advancements require specialized manufacturing capabilities and expertise, making orthopedic contract manufacturing an important service for medical device companies operating in this field. Orthopedic devices often involve complex manufacturing processes, such as precision machining, surface coatings, biomaterial selection, and sterilization. Contract manufacturers specializing in orthopedics have the necessary infrastructure, equipment, and technical expertise to handle these complex manufacturing processes effectively.
Medical Device Contract Manufacturing Market by Region
Geographically, the global medical device contract manufacturing market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The North America region has the largest medical device contract manufacturing market size in terms of revenue generation accounting for around 40.5% share of the market. North America, particularly the United States, possesses a robust and advanced healthcare infrastructure. The region is home to numerous medical device companies, research institutions, and healthcare facilities. This infrastructure creates a favorable environment for medical device contract manufacturing, as it provides access to skilled professionals, cutting-edge technology, and a strong regulatory framework. Healthcare providers and medical device companies in North America increasingly seek ways to reduce costs while maintaining high-quality products. Outsourcing manufacturing to contract manufacturers can help achieve cost efficiencies by leveraging the contract manufacturer's expertise, economies of scale, and streamlined manufacturing processes. North America is known for its innovation and technological advancements in the medical device industry. The region continues to witness developments in areas such as robotics, artificial intelligence, nanotechnology, and digital health. Contract manufacturers in North America are well-positioned to support the manufacturing of technologically advanced devices and integrate these innovations into their manufacturing processes. The medical device industry in North America is governed by strict regulatory requirements, particularly in the U.S., where the FDA oversees the approval and safety of medical devices. Contract manufacturers in North America are familiar with these regulations and possess the expertise to navigate the regulatory landscape effectively, which is also boosting regional growth.
Medical Device Contract Manufacturing Market Competitive Landscape
The prominent players operating in the global medical device contract manufacturingmarket are:
Medical Device Contract Manufacturing Market Strategic Developments
Medical device contract manufacturing refers to the outsourcing of the production and assembly of medical devices to a third-party manufacturer. In this arrangement, a medical device company partners with a specialized contract manufacturing organization (CMO) with the expertise, capabilities, and facilities to manufacture medical devices according to the company's specifications.
Asia Pacific can be considered the key growth region due to the surge in medical device contract manufacturing industry trends in China, Japan, and the Indian subcontinent.
The prominent players operating in the global medical device contract manufacturing market are Gerresheimer AG, Integer Holdings Corporation, West Pharmaceutical Services, Inc, Jabil Inc., and Plexus Corp.
The global medical device contract manufacturing market growth is estimated to grow at a revenue CAGR of 10.3% during the forecast period from 2023 to 2031.
The estimated size of the global medical device contract manufacturing market in 2031 is US$ 178.14 billion.
*Insights on financial performance are subject to the availability of information in the public domain