세계 의료기기 아웃소싱 시장 규모는 2023년 1,262억 달러에 달했습니다. 향후 IMARC Group은 시장이 2032년까지 2,582억 달러에 이르며 2024년과 2032년 사이에 8.1%의 성장률(CAGR)을 나타낼 것으로 예측했습니다. 전체 의료비 절감 요구 증가, 엄격한 규제 요건 및 품질 기준의 도입, 웨어러블 의료기기의 채용 확대, 맞춤형 의료에 대한 수요의 급증 등이 시장 성장을 가속하는 주요 요인이 되고 있습니다.
의료기기 아웃소싱이란 의료기기 제품의 수명주기의 다양한 측면을 처리하기 위해 외부 기업 및 서비스 제공업체와 계약 또는 제휴하는 것을 말합니다. 이러한 외부 파트너는 일반적으로 전문 수탁 제조업체, 설계 개발 회사, 규제 컨설턴트, 물류 공급자 또는 의료기기 업계에 익숙한 기타 서비스 제공 업체입니다. 이러한 서비스는 비용 절감, 전문 지식 접근, 업무 효율성 향상, 시장 수요에 보다 효과적으로 적응할 수 있는 능력 등 여러 가지 이점을 기업에 제공합니다. 또한 의료기기 제조업체는 R&D, 마케팅, 전략 입안과 같은 핵심 역량에 집중하는 반면, 제품 수명주기의 다른 중요한 측면을 처리하기 위해 외부 파트너의 능력을 활용할 수 있습니다.
이 시장은 의료 질환 증가와 양질의 건강 관리 서비스에 대한 요구가 증가함에 따라 큰 성장을 이루고 있습니다. 또한 아웃소싱은 의료기기 제조업체에게 시장 수요에 따라 생산량을 확대할 수 있는 유연성을 제공합니다. 이러한 적응성은 제품 수요 변동, 특히 계절 변동이 있는 장비 및 예기치 않은 시장 변화에 대응하는 데 필수적입니다. 또한, 맞춤형 의료에 대한 수요의 급증, 웨어러블 의료기기의 채용 확대, 저침습 외과 수술의 인기가 높아짐, 재택치료, 원격 의료, 의료 관광의 추세가 높아짐은 시장을 추진하고 있는 기타 요인 일부입니다. 또한 국제 사업을 전개하는 수탁 제조업체는 다양한 시장에 대한 액세스를 제공하고 수출입 규제를 피할 수 있으므로 새로운 지역으로의 원활한 진출이 용이 해지고 시장 성장에 영향을 미치고 있습니다.
의료비 절감 요구 증가
의료기기 아웃소싱은 의료 제공업체 및 의료기기 기업에 비용 절감을 제공합니다. 전문 제조업체나 서비스 제공업체와 계약하는 것으로, 사내에서 오퍼레이션을 유지하는 것보다 비용 효율이 높아집니다. 외부 파트너는 확립된 생산 설비, 규모 이점 및 간소화된 공정을 갖고 있어 저비용으로 의료기기를 생산할 수 있습니다. 또한, 제조 및 물류와 같은 비중요 업무를 아웃소싱함으로써 의료기기 제조업체는 자원 배분을 최적화할 수 있습니다. 정형적인 업무를 외부 파트너에게 맡기면 기업은 사내 자원을 연구개발이나 혁신과 같은 핵심 역량에 집중할 수 있어 보다 비용 효율적이고 경쟁력 있는 제품을 만들어 낼 수 있습니다.
엄격한 규제 요건 및 품질 기준 도입
엄격한 규제의 도입은 의료기기 기업과 그 아웃소싱 파트너 모두에게 더 높은 컴플라이언스 부담을 강하게 할 것입니다. 위탁제조업체는 OEM과 동일한 규제기준을 준수하고 제조하는 의료기기가 필요한 안전성과 품질 기준을 충족하도록 해야 합니다. 이를 위해서는 엄격한 문서화, 품질 관리 시스템, 적절한 제조 규범(GMP) 준수가 필요합니다. 또한 규제 당국의 감시가 엄격 해짐에 따라 의료기기의 아웃소싱 프로세스에서 품질 보증이 가장 중요한 과제가되고 있습니다. 수탁 제조업체는 현재 제조 공정에서 잠재적인 문제를 파악하고 완화하기 위한 견고한 품질 관리 대책과 리스크 관리 전략을 시행하고 있습니다.
웨어러블 의료기기 채용 확대
웨어러블 의료기기에는 종종 고급 센서, 무선 연결 및 고급 데이터 분석 기능이 내장되어 있습니다. 이러한 기술 집약형 기기의 개발·제조에는 전문적인 지식과 자원이 필요하기 때문에 고급 전자 및 소프트웨어 개발에 익숙한 아웃소싱 파트너 수요가 높아지고 있습니다. 또한 의료기기는 사용자의 컴플라이언스와 장기간의 착용성을 보장하기 위해 가볍고 편안하고 인체공학적으로 설계되어야 합니다. 소형화 기술과 재료 선택에 관한 전문 지식을 가진 제조 위탁처는 이러한 설계 요건을 실현하는데 중요한 역할을 하고 있습니다.
The global medical device outsourcing market size reached US$ 126.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 258.2 Billion by 2032, exhibiting a growth rate (CAGR) of 8.1% during 2024-2032. The rising need to reduce overall medical costs, the implementation of stringent regulatory requirements and quality standards, the expanding adoption of wearable medical devices, and the surging demand for personalized medicine are among the key factors driving the market growth.
Medical device outsourcing refers to the practice of contracting or partnering with external companies or service providers to handle various aspects of the medical device product lifecycle. These external partners are typically specialized contract manufacturers, design and development firms, regulatory consultants, logistics providers, or other service providers with expertise in the medical device industry. These services offer several benefits to companies, including cost savings, access to specialized expertise, increased operational efficiency, and the ability to adapt to market demands more effectively. It also allows medical device manufacturers to concentrate on core competencies, such as research and development, marketing, and strategic planning, while leveraging the capabilities of external partners to handle other essential aspects of the product lifecycle.
The market is experiencing significant growth due to the increasing prevalence of medical ailments and the surging need for quality healthcare services. In addition, outsourcing offers medical device companies the flexibility to scale production volumes based on market demand. This adaptability is essential for managing fluctuations in product demand, especially for devices with seasonal variations or in response to unexpected market shifts. Moreover, the surging demand for personalized medicine, the expanding adoption of wearable medical devices, the growing popularity of minimally invasive surgical procedures, and the rising trend of home healthcare, telemedicine, and medical tourism are some of the other factors propelling the market. Besides, contract manufacturers with international operations can provide access to diverse markets and navigate import/export regulations, facilitating a smoother expansion into new regions and influencing the market growth.
The rising need to reduce overall medical costs
Medical device outsourcing offers cost savings to healthcare providers and medical device companies. Contracting with specialized manufacturers or service providers is more cost-efficient than maintaining in-house operations. External partners have established production facilities, economies of scale, and streamlined processes, enabling them to produce medical devices at lower costs. Moreover, outsourcing non-core activities, such as manufacturing and logistics, allows medical device companies to optimize resource allocation. By delegating routine tasks to external partners, companies can focus their internal resources on core competencies like research, development, and innovation, which can lead to more cost-effective and competitive products.
The implementation of stringent regulatory requirements and quality standards
The implementation of stringent regulations places a higher compliance burden on both medical device companies and their outsourcing partners. Contract manufacturers must adhere to the same regulatory standards as the OEMs to ensure that the medical devices they produce meet the required safety and quality benchmarks. This requires rigorous documentation, quality management systems, and adherence to good manufacturing practices (GMP). Moreover, with higher regulatory scrutiny, quality assurance becomes paramount in the medical device outsourcing process. Contract manufacturers are now under pressure to implement robust quality control measures and risk management strategies to identify and mitigate potential issues in the production process.
The expanding adoption of wearable medical devices
Wearable medical devices often incorporate advanced sensors, wireless connectivity, and sophisticated data analytics capabilities. The development and manufacturing of such technology-intensive devices require specialized expertise and resources, leading to an increased demand for outsourcing partners with expertise in advanced electronics and software development. Moreover, medical devices need to be lightweight, comfortable, and ergonomically designed to ensure user compliance and long-term wearability. Contract manufacturers with expertise in miniaturization techniques and materials selection play a crucial role in achieving these design requirements.
IMARC Group provides an analysis of the key trends in each segment of the global medical device outsourcing market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on service, therapeutics and application.
Regulatory Consulting
Product Design and Development
Product Testing and Sterilization
Product Implementation
Product Upgrade
Product Maintenance
Product design and development represent the leading segment
The report has provided a detailed breakup and analysis of the market based on the service. This includes regulatory consulting, product design and development, product testing and sterilization, product implementation, product upgrade, and product maintenance. According to the report, product design and development represented the largest segment.
Medical device design and development requires a high level of technical expertise, including knowledge of regulatory requirements, engineering principles, and medical standards. Many medical device companies lack in-house capabilities or resources to handle the complex design process efficiently. Outsourcing product design and development allows them to tap into the specialized expertise of experienced design firms and engineering companies with a proven track record in the medical device industry. Moreover, outsourcing product design and development enables medical device companies to access fresh ideas, creative solutions, and cutting-edge technologies from external design partners.
Cardiology
Diagnostic Imaging
Orthopedic
IVD
Ophthalmic
General and Plastic Surgery
Drug Delivery
Dental
Endoscopy
Diabetes Care
Cardiology exhibits a clear dominance in the market
A detailed breakup and analysis of the market based on therapeutics have also been provided in the report. This includes cardiology, diagnostic imaging, orthopedic, IVD, ophthalmic, general and plastic surgery, drug delivery, dental, endoscopy, and diabetes care. According to the report, cardiology accounted for the largest market share.
Cardiovascular diseases (CVDs) remain one of the leading causes of death worldwide. The increasing prevalence of conditions such as coronary artery disease, heart failure, and arrhythmias has led to a rising demand for innovative medical devices and technologies to diagnose, treat, and manage these conditions. This high demand has driven medical device companies to focus extensively on cardiology-related products and services, leading to a dominant presence in the outsourcing market. Besides, the field of cardiology has witnessed rapid technological advancements and continuous innovation. These innovations include implantable devices such as pacemakers, defibrillators, stents, and heart valves, as well as diagnostic devices like electrocardiograms (ECGs) and cardiac imaging equipment. To keep up with the pace of innovation and meet market demands, medical device companies often seek specialized outsourcing partners with expertise in cardiology product development.
Class I
Class II
Class III
Class II accounts for the majority of the market share
The report has provided a detailed breakup and analysis of the market based on the application. This includes class I, II, and III. According to the report, class II represented the largest segment.
Class II medical devices encompass a wide range of products, including moderate to high-risk devices that do not fall into the highest-risk Class III category. This broad product range includes items such as infusion pumps, diagnostic imaging equipment, electrocardiographs, surgical instruments, and certain implantable devices. The diversity of Class II devices contributes to a larger market share in the outsourcing industry. Moreover, these medical devices are subject to intermediate levels of regulatory scrutiny compared to Class III devices. While Class II devices must still meet strict regulatory requirements for safety and efficacy, the regulatory process is generally less burdensome and time-consuming than that for Class III devices, which is escalating their demand.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
Asia Pacific exhibits a clear dominance, accounting for the largest medical device outsourcing market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Latin America (Mexico, Brazil, Others); Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others); and Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others). According to the report, Asia Pacific was the largest market for medical device outsourcing.
Asia Pacific countries, such as China, India, and Southeast Asian nations, offer a significant cost advantage in terms of labor and manufacturing. The lower labor costs, combined with well-developed manufacturing infrastructure and supply chain networks, make the region an attractive option for medical device companies seeking cost-effective outsourcing solutions. Moreover, the region boasts a large pool of skilled and trained professionals in engineering, science, and technology fields. This skilled workforce includes engineers, scientists, and technicians with expertise in medical device design, development, and manufacturing. The availability of such talent accelerates the outsourcing process and ensures high-quality products.
The competitive landscape of the medical device outsourcing market is highly dynamic with numerous companies offering a wide range of outsourcing services to medical device manufacturers. Nowadays, key players are expanding their service portfolios to provide a comprehensive range of outsourcing solutions. They are diversifying their offerings to include contract manufacturing, product design and development, regulatory support, post-market services, packaging, and logistics. Companies are also engaging in mergers, acquisitions, and strategic partnerships to expand their geographical presence and technical capabilities. They are also investing heavily in advanced manufacturing technologies such as automation, robotics, 3D printing, and data analytics to improve production efficiency, reduce costs, and offer faster turnaround times to medical device manufacturers.
Celestica Inc. (Onex Corporation)
Charles River Laboratories International Inc.
Flex Ltd.
Freyr Inc.
Heraeus Holding GmbH
ICON plc
Integer Holdings Corporation
IQVIA Inc.
Plexus Corp.
Sanmina Corporation
TE Connectivity
West Pharmaceutical Services Inc.
Flex Ltd. launched "Healthcare Solutions," a comprehensive suite of medical device design, engineering, and manufacturing services. The offering includes rapid prototyping, miniaturization expertise, and end-to-end solutions to support medical device companies throughout the product lifecycle.
Celestica acquired PCI Limited, a provider of design and manufacturing services for medical and other industries. This acquisition strengthened Celestica's presence in the medical device outsourcing market and expanded its offerings in the Asia Pacific region.
Celestica Inc. acquired Atrenne Integrated Solutions, a provider of electronic manufacturing and design services for the aerospace, defense, and other industries. This acquisition enhanced Celestica's capabilities in serving the medical device market.