Unlocking Potential: How Industry 4.0 Transforms Medical Device Outsourced Manufacturing

Innovation in Class III medical devices is on the rise, consequent to the growing development and production of complex products such as pacemakers and implantable medical devices. Medical device companies face challenges in manufacturing Class III devices in high volumes, given the complexity of the assembly and test processes. Furthermore, both the devices and processes must meet regulatory compliance for component traceability and verification, storage, and access. 

Industry 4.0 technologies—including cloud computing, machine-to-machine communication, and cyber-physical systems—enable advanced automation that helps overcome these production challenges. The increased connectivity and data-gathering capabilities of these technologies make it possible to build high-volume, regulation-compliant manufacturing processes with efficient inventory and production management.

The Medical Device Outsourced Manufacturing Market is projected to reach USD 56.2 billion by 2026 from USD 29.3 billion in 2021 and is expected to grow at a CAGR of 13.9% during the forecast period.

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Market Segmentation: –

Based on device type, the Asia Pacific market is broadly segmented into IVD devices, diagnostic imaging devices, cardiovascular devices, drug delivery devices, orthopedic devices, respiratory care devices, ophthalmology devices, surgical devices, diabetes care devices, dental devices, endoscopy devices, gynecology/urology devices, personal care devices, neurology devices, and other devices. In 2020, the IVD devices segment accounted for the largest share of the Asia Pacific market.

Based on the class of device, the medical device outsourced manufacturing market is segmented into Class I, Class II, and Class III medical devices. In 2020, the Class II medical devices segment accounted for the largest share of the Asia Pacific market.

Based on service, the Asia Pacific medical device outsourced manufacturing market is segmented into device development and manufacturing services, quality management services, packaging and assembly services and other services.

Based on process, the Asia Pacific market is broadly segmented into production, prototyping, pilot production, design for manufacturing, process evaluation, validation, project management, packaging, and assembly.

Regional Analysis:

The Asia Pacific medical device outsourced manufacturing market, by country, has been segmented into China, Japan, Malaysia & Singapore, India, Australia & New Zealand, South Korea, and the Rest of APAC. China is expected to witness fastest growth during the forecast period of 2021–2026. China’s fastest growth is mainly due to the lower cost of raw materials and labor in the country than in developed countries.

Recent Developments:

  • In November 2020, Nipro Corporation (Japan) acquired Venari Medical’s (Ireland)  exclusive sales rights for a vascular treatment device developed by Venari Medical in Japan and overseas
  • In October 2020, Nemera (France) acquired Copernicus (Poland) to become a leading patient-centric drug device combination solutions company. This acquisition will bolster the company’s production capabilities and expand its product portfolio
  • In September 2020, Nipro Corporation established its sales offices in Xi’an, Wuhan, Hefei, and Xiamen. The new offices will further strengthen the company’s sales and service network in China to provide more community-based, meticulous services and respond to the needs of the medical scene, thereby enhancing the presence of the “Nipro brand”
  • In January 2020, Nipro Asia Pte Ltd. (Singapore) acquired JMI Marketing (Bangladesh) to secure a large market share in Bangladesh’s rapidly growing economy for disposable medical devices, including infusion sets, syringes, and IV catheters

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Top Key Players: –

The prominent players in this medical device outsourced manufacturing market are Flex, Ltd. (Singapore), Jabil, Inc. (US), TE Connectivity, Ltd. (Switzerland), Sanmina Corporation (US), Nipro Corporation (Japan), Celestica International (Canada), Plexus Corporation (US), Benchmark Electronics, Inc. (US), Integer Holdings Corporation (US), Gerresheimer Ag (Germany), West Pharmaceutical Services, Inc. (US), Nortech Systems, Inc. (US), Consort Medical PLC (UK), Kimball Electronics Inc. (US), and Teleflex Incorporated (US), Nordson Corporation (US), Tecomet, Inc. (US), SMC Ltd. (US), Nemera (France), and Tessy Plastics Corporation (US), among others.

These driving growth factors are expected to continue shaping the Medical Device Outsourced Manufacturing Market as the medical device industry evolves, demands cost-effective solutions, and seeks to maintain compliance with regulatory standards while fostering innovation and agility.