Major services outsourced by medical device manufacturers include design, development, testing, and consulting services. The services market covers designing, prototyping, validation and verification and regulatory consulting; while the applications market covers Class I, II, and III medical devices as per FDA norms.
The global medical devices outsourcing market is estimated to account for US$ 50,775 Mn in terms of value in 2020 and is expected to reach US$ 109,818.8 Mn by the end of 2027.
Global Medical Devices Outsourcing Market: Drivers
Increasing product recalls are expected to propel growth of the global medical devices outsourcing market over the forecast period. For instance, in February 2019, Medtronic Plc received FDA product recall for implanted cardiac pacemakers, which affected 13,440 devices manufactured and distributed between March 2017 and January 2019.
Global Medical Devices Outsourcing Market: Opportunities
Initiatives to improve intellectual property rights and patent protection systems in by mandating trade-related IP rights agreements between outsourcing partners is expected to offer lucrative growth opportunities for players in the global medical devices outsourcing market.
Global Medical Devices Outsourcing Market: Restraints
Lack of certified outsourcing partners is expected to hinder growth of the market. Outsourcing services providers need to have ISO 13485:2003, ISO 9001:2000, ISO 14971 and 21 CFR part 820 certifications in order to operate effectively. However, many of the smaller outsourcing service providers lack the proper certifications required for consulting Class II and Class III medical device manufacturers.
The global medical devices outsourcing market was valued at US$ 45,491.2 Mn in 2019 and is forecast to reach a value of US$ 109,817.8 Mn by 2027 at a CAGR of 11.7% between 2020 and 2027. Major factor driving the growth of global medical devices outsourcing market during the forecast period include increasing prevalence of chronic diseases requiring medical intervention, and increasing research and development.
Product Design And Development held dominant position in the global medical devices outsourcing market in 2019, accounting for 27.6% share in terms of value, followed by Regulatory Consulting and other services, and Product maintenance, respectively. Development of new medical devices is a complex process and may require additional technical help from outsourcing which is expected to support growth of the segment.
Major players in the market are focused on adopting M&A strategies to expand their product portfolio. For instance, in February 2020, Integer Holdings Corporation, an outsource manufacturer for cardiac, neuromodulation, vascular, portable medical, advanced surgical and orthopedics markets, acquired Inomec Ltd., a provider of design, development and production services for medical device companies.
Major players in the market are also focused on launch of new products to expand their product portfolio. For instance, in March 2019, BrightInsight a Flex Company, launched a web-based CE-marked Dosing Calculator for emicizumab, a drug which is prescribed by physicians to treat patients with Hemophilia A. The development and distribution of the Dosing Calculator for emicizumab was sponsored by F. Hoffmann-La Roche.
Global Medical Devices Outsourcing Market: Competitive Landscape
Major players operating in the global medical devices outsourcing market include, Onex Corporation, Cardinal Health, Inc., Integer Holdings Corporation, TE Connectivity Ltd., Flex Ltd., Heraeus Holding GmbH, Plexus Corporation, Sanmina Corporation, West Pharmaceutical Services, Inc., Accellent Inc., Active Implants Corporation, CIRTEC Medical Systems LLC, Mdmi Technologies Inc., Micro Systems Engineering GmbH, Creganna-Tactx Medical, and Avail Medical Product.
Global Medical Devices Outsourcing Market: Key Developments
June 2020: Heraeus Holding GmbH started operations in its new centralized Collaboration Hub in Minneapolis, U.S., to accelerate speed to market for medical devices
January 2020: Heraeus Medical Components, a part of Integer Holdings Corporation, established implantable pulse generator clean room assembly and testing capabilities at its Tijuana-North facility to support its OEM customers