Medical Device Outsourcing Market Surpass $193.6 Billion By 2026 | CAGR 10.7%

Author: Acumen Research and Consulting

The global medical device outsourcing market size in terms of revenue reached USD 84.7 billion in 2017. The global market for medical device outsourcing is expected to experience a CAGR of 10.7% during the forecast period. Growing competition among medical device manufacturers is the primary reason to making of products at lower and reasonable cost. This factor is positively impacting the growth of global medical device outsourcing market. Continuous change in regulatory landscape and growing awareness and inclination towards outsourcing services such as quality assurance, product implementation, and regulatory consulting are also expected to augment the global medical device outsourcing market during the forecast period.

Moreover, increasing complexities in the product manufacturing coupled with growing number of new entrants globally are expected to outline the future of the global medical device outsourcing market. Increasing occurrence of chronic disorders among the global population is raising the demand for medical devices. This factor, in turn, is working in favour of the market.

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Rising geriatric population is also influencing the demand for medical devices. This demographic shapes a large customer base with limited health resource, thereby approaching manufacturers towards subcontracting of activities such as packaging, assembling, and many others. For instance, new entrants in the medical device industry are likely to outsource device designing in order to be technologically updated and meet demands of patients.

Additionally, growing importance by regulatory bodies to maintain quality of healthcare devices offered to public is increasingly becoming cumbersome to handle. In order to carter the regulatory situation, regulatory consulting services are being availed by industry players. For instance, the European Medical Device Regulation (EMDR) undertakes special unannounced scrutiny of outsourced products in order to check for quality and conformity with standards.

However, some major regulatory changes are expected to occur across the globe, which is expected to have an impact on the medical device outsourcing market over the forecast period.


Few major changes in regulations are:

  • Alteration in ISO certification related to medical device
  • Adoption of medical device single audit program

Many other regulatory reforms including the above are expected to add to the demand for outsourcing services, thereby offering a tremendous drive to the market during the forecast period. In order to gain substantial share in the specific market segment large CROs are collaborating with specialized service providers.

The global medical outsourcing market is segmented into service, therapeutic area, and regions. On the basis of service the global medical outsourcing market is segmented into Product Implementation Services, Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Upgrade Services, Product Maintenance Services, and Contract Manufacturing. Regulatory Affairs Services is further sub-segmented into Clinical trials applications and product registrations, Regulatory writing and publishing, Legal representation, and others. Product Design and Development Services segment is further sub-segmented among Designing & engineering, Machining, Molding, and packaging. Contract Manufacturing segment is further sub-segmented into Accessories manufacturing, Assembly manufacturing, Component manufacturing and Device manufacturing. On the basis of Therapeutic Area, the global medical device outsourcing market is segmented into cardiology, Diagnostic imaging, Orthopedic, IVD, Ophthalmic, General and plastic surgery, Drug delivery, Dental, Endoscopy, Diabetes care and others. Each of the Therapeutic Area segment is further sub-segmented into class I, class II and class III. On the basis of region the global medical device outsourcing market is segmented into Latin America, Europe, Asia Pacific, North America, and Middle East & Africa.

The global contract manufacturing market is expected to reach 103.9 billion by 2025, expanding at a CAGR of 10.3% from 2018 to 2025. In terms of service, quality assurance is expected to grow the fastest during the forecast period. Asia Pacific medical device outsourcing market is expected to dominate during the forecast period. North America and Europe constituted considerable cumulative share in 2016 attributable to well established manufacturing infrastructure for expensive and complex medical devices.

The key players catering to the global medical device outsourcing market are Integer; Tecomet; Jabil; Flextronics; Celestica; Sanmina; Plexus; SGS SA; Toxikon Inc.; Eurofins Scientific; Pace Analytical Services; Intertek Group; MAPI; PPD; Freyr Solutions; and Wuxi Apptec. The global players are continuously investing in R&D activities and innovating to have updated technology based product portfolio to attract more and more business opportunity from the emerging nation such as that in Asia Pacific countries.


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