Medical Device Contract Manufacturing Market Analysis and Forecast to 2031: By Device (IVD Device, Diagnostic Imaging Devices, Cardiovascular Devices, Drug Delivery Devices, Endoscopy Devices, Drug Delivery Devices, Endoscopy Devices, Ophthalmology Devices, Orthopedic Devices, Dental Devices, Others), Services (Device Development & Manufacturing Service, Quality Management Service, Assembly Service), and Region
The global medical device contract manufacturing market was valued at USD 66.9 billion in 2021 and it is anticipated to grow further till USD 195.3 billion by 2031, at a CAGR of 11.3% during the forecast period.
Medical device contract manufacturing is a business model where a medical device company or Original Equipment Manufacturer (OEM) outsources some or all of the production activities of their entire medical device or some specific components of the device to another company with specialized knowledge, technical expertise, and effective business operations. Medical device contract manufacturing (MDCM) companies provide a range of services, including product development, manufacture, and assembly, quality assurance and control, packaging, sterilization, and regulatory advising. In response to the rapidly expanding and changing medical device industry, today's contract manufacturers have expanded their manufacturing capabilities, technological know-how, and business definitions to become total solutions providers, full-service providers, or end to end solution providers.
Market Trends and Drivers
Due to the increased development and production of sophisticated items like pacemakers and implanted medical devices, innovation in Class III medical devices is increasing. Given the intricacy of the assembly and testing processes, medical device manufacturers confront difficulties producing Class III devices in high amounts. Additionally, regulatory compliance for component traceability and verification, storage, and access must be met by both the devices and the processes. Automated production and manufacturing are essential due to the intricacy involved in generating a Class III device in these quantities. In order to achieve automation, high-quality manufacturing processes, and regulatory compliance, OEMs are using the knowledge of electronic manufacturing services. Advanced automation is made possible by Industry 4.0 technologies, such as cloud computing, machine-to-machine connectivity, and cyber-physical systems, which aid in overcoming these production issues. These technologies' improved connectivity and data collection capabilities enable the development of high-volume, legally compliant manufacturing processes with effective inventory and production management.
Governments in numerous APAC nations are enticing manufacturers to include Industry 4.0 into their production methods in order to further the development of cutting-edge medical products. For instance, Thailand's 4.0 growth model led to the establishment of an inventive centre to boost medtech device development and production. To help small and medium-sized businesses (SMEs) create newer technologies, the Intellectual Property Innovation-driven Entrepreneurship Center (IP-IDE) maintains its own data pool and patent information. The Thai government hopes to inspire Thai medical device companies to develop and expand into both domestic and international markets with the IP-IDE centre. The market for medical device outsourced manufacturing is anticipated to expand rapidly over the course of the forecast period due to the growing adoption of Industry 4.0 technologies in the production of sophisticated and crucial medical devices.
Market Restraints and Challenges
To improve their internal capabilities, large medical device makers are currently actively investing in the acquisition of small and medium-sized specialist businesses. Given that acquirers will be able to conduct manufacturing in-house, this could restrict outsourcing to CMOs. One illustration of this is Linden's December 2018 acquisition of Avalign Technologies Medical, which significantly increased Linden's capabilities and opened up new growth prospects for the company. To lower their costs for contract manufacturing, other medical device businesses are also acquiring CMOs. A change in the manufacturing of medical devices is the result of this. The advanced technology business unit of Vention Medical (US) was bought by Nordson (US) in 2017. Catheters, sophisticated components, and minimally invasive interventional delivery devices are all areas in which this market excels. Due to this advancement, OEMs will now manufacture a small portion of medical devices instead of CMOs.
Global Medical Device Contract Manufacturing Market Segmental Overview
The report analyses the global medical device contract manufacturing market based on the device, service, and region.
Global Medical Device Contract Manufacturing Market by Device
Based on the device, it is segmented into IVD devices, diagnostic imaging devices, cardiovascular devices, drug delivery devices, endoscopy devices, ophthalmology devices, orthopedic devices, dental devices, and other devices. The IVD devices segment is anticipated to dominate the market during the forecast period. The rising number of IVD tests conducted globally, the COVID-19 pandemic, the expanding availability of IVD kits and reagents, the rise in hospitals and clinical laboratories in developing nations, automation and technological advancements in instruments with high-throughput capabilities, and developments in life sciences research are all factors that contribute to the large share of this market.
Global Medical Device Contract Manufacturing Market by Service
Based on the service, it is segmented into device deployment manufacturing service, quality management service, assembly service. The device deployment manufacturing service segment is anticipated to dominate the market during the forecast period. The main causes of the large share of this market are the expanding use of contract manufacturing services in the medical device industry, expansion of the market for medical devices (particularly the market for single-use disposable medical devices), and improved device development and manufacturing capabilities.
Geographical Analysis of the Global Medical Device Contract Manufacturing Market
Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. The APAC region is anticipated to dominate the market during the forecast period. The majority of the APAC region's market share can be attributed to several factors, including lower labour and raw material costs than in developed nations, rising demand for medical devices as a result of better healthcare infrastructure, adoption of technologically advanced products, and laxer regulations than in most developed nations.
Major Players in the Global Medical Device Contract Manufacturing MarketCOVID-19 Impact
Major corporations around the world have experienced both positive and negative effects from the COVID-19 epidemic, which has disrupted production cycles and supply lines across industries. Since the number of infections shows no indications of decreasing, the medical device industry has encountered enormous obstacles in its efforts to end the pandemic. A second wave of the epidemic is currently affecting half of the planet.
The pandemic is anticipated to have an effect on the market since less people are using medical devices for elective treatments. The need for medical devices such as ventilators and respirators, on the other hand, has multiplied, enhancing the growth prospects for medical device contract makers.
Since the beginning of the epidemic, medical device contract manufacturing businesses have been closely observing the situation. Market participants have made sure that their clients' supply chains are disrupted as little as possible. Companies have also established stricter cleaning and disinfection protocols, enforced visitor supervision and screening, limited business travel, set up remote working arrangements, and adopted strict quarantine procedures to assure safety.
Recent Developments
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