The global medical devices outsourcing market size was valued at US$ 102.6 Bn in 2020 and is expected to reach valuation US$ 232.8 Bn by 2030 with a CAGR of 11.2% from 2021 to 2030.
The global medical devices outsourcing market size was valued at US$ 102.6 Bn in 2020 and is expected to reach valuation US$ 232.8 Bn by 2030 with a CAGR of 11.2% from 2021 to 2030.
Regulatory constraints in different countries during the ongoing COVID-19 pandemic have led many small manufacturers and certain established players to outsource a significant amount of their manufacturing operations to efficient contract manufacturing organizations (CMOs). However, CMOs are expected to face challenges in maintaining smooth functioning of medical device assemblies post the pandemic period. Hence, CMOs in the medical devices outsourcing market should continue to seek alternative sources of critical materials to ensure continuity of supply. Constant and open communication with suppliers & ecosystem partners help to shorten the turnaround time. Furthermore, validating alternative materials and increasing the list of approved suppliers are key strategies to reduce challenges of CMOs for ensuring smooth functioning of medical device assemblies.
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M&As Help Develop Patient-centric Devices and Software Outsourcing Platforms
Companies in the medical devices outsourcing market are entering into mergers & acquisitions (M&As) to unlock incremental opportunities, owing to the constant demand for vascular treatment devices. In addition, efforts are being made to develop patient-centric drug devices.
The growing influx of intelligent devices and smart systems in healthcare has driven the use of embedded software. For instance, infusion pumps capable of automatically controlling the flow of liquids depend on the accuracy of the embedded software. This has increased the trend of outsourcing software design and testing services to firms with extensive domain-specific knowledge.
Tech giants in the medical devices outsourcing market are taking keen interest in developing such systems. Their services have helped in improving the end user experience significantly, thereby optimizing the quality of healthcare services delivered.
| Report Scope | Details |
| Market Size By 2030 | USD 232.8 Billion |
| Growth Rate from 2022 to 2030 | CAGR of 11.2% |
| Largest Market | North America |
| Fastest Growing Region | Asia Pacific |
| Base Year | 2021 |
| Forecast Data | 2022 to 2030 |
Medical Devices Outsourcing Cuts Cost of Manufacture During COVID-19 Pandemic
Medical device contract manufacturing is growing prominent in the medical devices outsourcing market to cut down costs of production of medical devices. Despite interruptions caused by the COVID-19 pandemic, the market for contract manufacturing has attained resilience with strong demand from customers. This is reflected by the high uptick of merger and acquisition activities among outsourcing providers.
Since the global medical device industry has been under scrutiny to control costs without affecting product quality, outsourcing is emerging as a viable alternative to reduce operating costs, avoid regulatory breaches, and shorten time to the market for product launch and delivery to end users.
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Lack of Certifications for Medical Devices Affects Market Growth
Medical devices is a highly regulated market. Outsourcing service providers need to have ISO 1497, 1ISO 13485:2003, ISO 9001:2000, and 21 CFR part 820 certification in order to operate effectively. However, a number of smaller outsourcing service providers lack proper certifications required for consulting class II and III medical device manufacturers.
Around 60% of suppliers have an ISO 9001:2000 certification, but only 20% of these have an ISO 13485:2003 certification. The latter has been made mandatory by governments across the globe for both medical device manufacturers and outsourcing service providers catering to these manufacturers. The dearth of partners with proper certifications hampers the expansion of the global medical devices outsourcing market. Hence, service providers should work closely with med-tech companies to acquire certifications in order to boost their credibility credentials on the global level.
High Quality Medical Devices Necessary for Diagnosis of Chronic Diseases
The high prevalence of chronic diseases has led to the demand for better diagnosis, early prevention, and other healthcare services. The quality of healthcare delivered to patients depends on the quality of diagnostic devices. Cutthroat competition in the healthcare industry had made the quality of a medical device a major factor of differentiation, driving device manufacturers to outsource technology services from third parties. The rise in demand for various medical devices is likely to fuel the expansion of the global medical devices outsourcing market.
Demand for Quality Healthcare Services in Developing Economies Translating into Value-grab Opportunities
Opting for the right medical devices outsourcing provider is a complex decision. The foremost criterion, perhaps, is establishing the trust factor between OEMs and service providers. A few pervasive trends of the healthcare industry are also triggering the demand for medical devices outsourcing.
For instance, the growing demand for medical devices in minimally invasive treatments for chronic diseases in various parts of the world is translating into lucrative opportunities for outsourcing companies. Furthermore, in developing regions, there exists substantial demand for quality healthcare services, which has positively impacted the expansion of the medical devices outsourcing market.
The proliferation of robotics among medical technology manufacturers has unlocked a new potential for players in the medical devices outsourcing market. The growing application of specialized robotic arms in medical device manufacturing is another driver for market expansion.
Medical Devices Outsourcing Market: Overview
The global medical devices outsourcing market for the historical period 2017–2019 and forecast period 2021–2030, increase in geriatric population and rise in demand for upgrade of various medical devices are key factors projected to drive the global medical devices outsourcing market during the forecast period
Outsourcing Aids in Leveraging External Expertise: Key Driver
Growing trend of using intelligent devices and smart systems in healthcare has increased the use of embedded software. For instance, infusion pumps capable of automatically controlling the flow of liquids depend on the accuracy of the embedded software. This has increased the trend of outsourcing software design and testing services to firms with extensive domain specific knowledge. Companies such as HCL, Wipro, and ALT Software have been developing such systems. Their services have helped in improving the end-user experience significantly, thereby optimizing the quality of healthcare services delivered.
Increase in Demand to Lower Healthcare Costs to Boost Market Growth
Governments across the globe are under significant pressure to reduce the soaring healthcare expenditure, fueled by population growth and rise in demand for quality healthcare services in order to make quality services available and affordable for all citizens
The U.S., for instance, spends around 16% of its GDP on healthcare, and this figure is expected to increase to 20% by 2020. Devices such as CT scanners, MRI machines, implantable pacemakers, and dialysis machines add to the cost of overall healthcare expenditure.
This has, in turn induced manufacturers to look for alternate resources to meet the rising demand within the resource-restraints exerted by economic forces. This increases the demand for low cost medical devices.
Lack of Awareness to Hamper Market Growth
Medical devices is a highly regulated market. Outsourcing service providers need to have ISO 13485:2003, ISO 9001:2000, ISO 14971, and 21 CFR part 820 certification in order to operate effectively. However, a number of smaller outsourcing service providers lack the proper certifications required for consulting class II and III medical device manufacturers. Around 60% of suppliers have an ISO 9001:2000 certification, but only 20% of these have an ISO 13485:2003 certification. The latter has been made mandatory by governments across the globe for both medical device manufacturers and the service-providers catering to these manufacturers. Lack of partners with proper certifications hampers the growth of the global medical devices outsourcing market.
Medical Devices Outsourcing Market: Competition Landscape
This report profiles major players in the global medical devices outsourcing market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments
The global medical devices outsourcing market is highly fragmented, with the presence of a number of international as well as regional players
Leading players operating in the global medical devices outsourcing market are
- Accellent, Inc.
- Active Implants Corporation
- Cirtec Medical Systems ll
- MDMI Technologies, Inc.
- Micro Systems Engineering GmbH
- Creganna-Tactx Medical
- Avail Medical Products, among others
Key Questions Answered in Medical Devices Outsourcing Market Report
- What is the scope of growth of product companies in the global medical devices outsourcing market?
- What will be the Y-o-Y growth of the global medical devices outsourcing market between 2017 and 2028?
- What is the influence of changing trends in technologies on the global medical devices outsourcing market?
- Will North America be the most profitable market for medical devices outsourcing devices providers?
- Which factors are anticipated to hamper the growth of the global medical devices outsourcing market during the forecast period?
- Which are the leading companies in the global medical devices outsourcing market?
Medical Devices Outsourcing Market – Segmentation
Service Outsourced for Medical Devices
- Product Design & Development
- Regulatory Consulting & Other Services
- Product Testing & Certification
- Product Implementation
- Product Maintenance
- Product Upgrade
Class of Medical Devices
- Class III
- Class II
- Class I
Application
- Cardiology
- Neurology
- Radiology
- Anesthesia
- Orthopedic
- Others
Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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