市場調查報告書
商品編碼
1519453
2024-2032 年按服務、治療、應用和地區分類的醫療器材外包市場報告Medical Device Outsourcing Market Report by Service, Therapeutics, Application, and Region 2024-2032 |
IMARC Group年,全球醫療器材外包市場規模達到1,262億美元。降低整體醫療成本的需求不斷成長、嚴格的監管要求和品質標準的實施、穿戴式醫療設備的廣泛採用以及個人化醫療需求的激增是推動市場成長的關鍵因素。
醫療器材外包是指與外部公司或服務提供者簽訂合約或合作以處理醫療器材產品生命週期各個方面的做法。這些外部合作夥伴通常是專業合約製造商、設計和開發公司、監管顧問、物流提供者或其他在醫療器材行業擁有專業知識的服務提供者。這些服務為公司帶來了多種好處,包括節省成本、獲得專業知識、提高營運效率以及更有效地適應市場需求的能力。它還允許醫療設備製造商專注於核心競爭力,例如研發、行銷和策略規劃,同時利用外部合作夥伴的能力來處理產品生命週期的其他重要方面。
由於醫療疾病的日益普及以及對優質醫療服務的需求不斷增加,該市場正在經歷顯著成長。此外,外包也為醫療器材公司提供了根據市場需求擴大生產規模的靈活性。這種適應性對於管理產品需求的波動至關重要,特別是對於具有季節性變化或響應意外市場變化的設備。此外,個人化醫療需求的激增、穿戴式醫療設備的廣泛採用、微創外科手術的日益普及以及家庭醫療保健、遠距醫療和醫療旅遊的興起是推動市場的其他因素。此外,擁有國際業務的合約製造商可以提供進入多元化市場的機會並遵守進出口法規,促進更順利地擴展到新地區並影響市場成長。
降低整體醫療費用的需求不斷成長
醫療設備外包為醫療保健提供者和醫療設備公司節省了成本。與專業製造商或服務提供者簽訂合約比維持內部營運更具成本效益。外部合作夥伴已經建立了生產設施、規模經濟和簡化的流程,使他們能夠以更低的成本生產醫療器材。此外,外包非核心活動,例如製造和物流,可以使醫療器材公司最佳化資源配置。透過將日常任務委託給外部合作夥伴,公司可以將內部資源集中在研究、開發和創新等核心能力上,從而生產出更具成本效益和競爭力的產品。
執行嚴格的監管要求和品質標準
嚴格法規的實施給醫療器材公司及其外包合作夥伴帶來了更高的合規負擔。合約製造商必須遵守與原始設備製造商相同的監管標準,以確保他們生產的醫療器材符合所需的安全和品質基準。這需要嚴格的文件記錄、品質管理系統並遵守良好生產規範 (GMP)。此外,隨著監管審查越來越嚴格,品質保證在醫療器材外包過程中變得至關重要。合約製造商現在面臨著實施強力的品質控制措施和風險管理策略的壓力,以識別和減輕生產過程中的潛在問題。
穿戴式醫療設備的廣泛採用
穿戴式醫療設備通常包含先進的感測器、無線連接和複雜的資料分析功能。此類技術密集型設備的開發和製造需要專門的專業知識和資源,從而導致對具有先進電子和軟體開發專業知識的外包合作夥伴的需求增加。此外,醫療設備需要輕巧、舒適且符合人體工學設計,以確保使用者的合規性和長期配戴性。擁有小型化技術和材料選擇專業知識的合約製造商在實現這些設計要求方面發揮著至關重要的作用。
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.