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医疗设备契约製造市场:按服务、设备类别、设备类型、应用、最终用户 - 2024-2030 年全球预测Medical Device Contract Manufacturing Market by Services, Class of Device, Device Type, Application, End User - Global Forecast 2024-2030 |
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预计2023年医疗设备契约製造市场规模为1,104.1亿美元,2024年达到1,212.9亿美元,2030年预计将达2,150.6亿美元,复合年增长率为9.99%。
医疗设备契约製造是公司将医疗设备和零件的生产委託给专业第三方的过程。这种模式允许目的地设备製造商(OEM)利用製造外包的专业知识、先进技术和生产能力,使医疗设备扩充性、更具成本效益,并且更快地推向市场变得更加容易。全球慢性病的流行和人口老化正在推动对医疗设备的需求,并刺激契约製造服务的成长。医疗设备日益复杂,全球市场监管标准更加严格,正在推动对受託製造服务的需求。这些服务涵盖製造过程的各个阶段,包括设计和开发、法规遵循支援、製造、组装和包装。然而,对医疗设备契约製造的依赖可能会引发与智慧财产权保护、不同契约製造之间品质保证差异以及潜在供应链漏洞相关的问题。也就是说,采用 3D 列印、自动化和机器人技术等先进製造技术提供了提高效率、降低成本和客製化医疗设备的机会。医疗保健市场的日益全球化以及对个人化医疗解决方案不断增长的需求也为业务扩张提供了肥沃的土壤。
主要市场统计 | |
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基准年[2023] | 1104.1亿美元 |
预测年份 [2024] | 1212.9亿美元 |
预测年份 [2030] | 2150.6亿美元 |
复合年增长率(%) | 9.99% |
服务端到端流程依赖设备开发和製造服务
设备开发和製造服务包括医疗设备从概念到实现的端到端流程。这包括初始设计、原型製作、材料选择和最终产品的製造。对于希望简化开发流程、获取先进製造技术并利用专业合作伙伴的专业知识的医疗设备公司来说,这项服务至关重要。服务还包括专注于医疗设备製造方面的设备工程服务,例如设计最佳化、功能增强以及遵守医疗标准和法规。此外,装备製造服务提供医疗设备的实际製造能力,从单一零件到完整的系统。这包括各种製造工艺,例如成型、机械加工和组装。製程开发服务着重于製造流程本身的设计、评估和最佳化。开发高效、经济高效且扩充性的流程来提供高品质的生产。
最终产品组装服务对复杂的医疗设备进行全面组装,将多个组件整合到可包装的最终产品中。这项服务需要精确、注重细节以及对组装过程的透彻了解,以确保最终产品符合所有规格和功能要求。品管服务确保设计、开发和製造过程的各个方面都遵守既定的品质标准和监管要求。这包括实施品管系统、进行审核、管理文件等。这些服务对于维护医疗设备的完整性和确保病人安全至关重要。检查和测试服务对于证明医疗设备按预期运作且不存在缺陷至关重要。它涵盖了从物理检查到性能测试的广泛测试方法,确保所有设备在投放市场之前符合严格的行业标准。包装验证服务检验医疗设备包装在运输和储存过程中满足安全性、稳定性和耐用性的所有监管要求和标准。
器材类别 由于高风险器材和法律规范, III 类医疗设备製造快速成长
就设计复杂性和发生故障时对病患的潜在风险而言,I 类医疗设备代表了医疗设备最基本的水准。这些医疗设备通常被认为是低风险的。这些医疗设备包括非无菌绷带、检查手套和基本牙科器械。由于风险低,I 类医疗设备受到的监管最少。在大多数司法管辖区,此类医疗设备必须遵循一般法规以确保安全性和有效性,包括适当的标籤、上市前通知以及遵守良好生产规范。 II 类医疗设备被认为如果发生故障会对患者构成中度至高度风险。此类别包括更广泛的设备,例如电动轮椅、输液帮浦和外科用覆盖巾。第二类医疗设备比第一类医疗设备受到更严格的监管,以确保安全性和有效性。除了一般法规外,公司通常还需要遵守特殊法规,例如性能标准、上市后监督、病患登记和 FDA 指导文件。通常需要提供上市前通知(称为 510(k) 许可),并证明该设备与市场上已有的设备基本相同。 III 类医疗设备的风险最高,通常被归类为对于防止对人类健康造成伤害并带来潜在的、不合理的疾病或伤害风险非常重要。这包括植入式心律调节器、心臟瓣膜、乳房植入等。这些设备受到最高级别的法律规范,包括上市前核准(PMA) 和对临床试验资料的彻底审查,以确保安全性和有效性。 III类医疗设备复杂且风险较大,要求製造商全面了解监管要求,维持严格的品管和风险管理流程,并大力投资临床研究。
区域洞察
在技术进步、人口老化以及对研发 (R&D) 的高度重视的推动下,美国市场,尤其是美国,是医疗设备契约製造最重要的市场之一。美国在医疗设备的创新和需求方面处于领先地位,巴西和墨西哥由于医疗保健支出增加和需要医疗照护的中阶不断壮大而成长。欧洲、中东和非洲地区呈现出多元化的市场环境,其中欧洲在市场成熟度和技术创新方面处于领先地位。中东和非洲是一个新兴市场,在医疗投资增加和医疗基础设施扩张的推动下,具有巨大的成长潜力。欧洲医疗设备法规 (MDR) 对市场产生重大影响,要求增加文件记录和合规性。亚太地区正迅速崛起为医疗设备契约製造中心。由于人口增长和疾病负担增加,中国、印度和新加坡等国家正在大力投资医疗保健和医疗技术。
FPNV定位矩阵
FPNV定位矩阵对于评估医疗设备契约製造市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对医疗设备契约製造市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,以获得市场竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争力评估及资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.医疗设备契约製造市场的市场规模和预测是多少?
2.医疗设备契约製造市场预测期间需要考虑投资的产品、细分市场、应用和领域有哪些?
3.医疗设备契约製造市场的技术趋势和法规结构是什么?
4.医疗设备契约製造市场主要厂商的市场占有率是多少?
5.进入医疗设备契约製造市场的合适型态和策略手段是什么?
[197 Pages Report] The Medical Device Contract Manufacturing Market size was estimated at USD 110.41 billion in 2023 and expected to reach USD 121.29 billion in 2024, at a CAGR 9.99% to reach USD 215.06 billion by 2030.
Medical device contract manufacturing is the process where companies outsource the production of medical devices or components to specialized third parties. This model enables original equipment manufacturers (OEMs) to leverage contract manufacturers' expertise, sophisticated technologies, and production capabilities, facilitating scalability, cost efficiency, and quicker time-to-market for medical devices. Global prevalence of chronic diseases and the aging population drive demand for medical devices, fueling the growth of contract manufacturing services. The increasing complexity of medical devices and stringent regulatory standards across global markets have amplified the demand for contract manufacturing services. These services span across various stages of the production process, including design and development, regulatory compliance support, manufacturing, assembly, and packaging. However, the reliance on medical device contract manufacturing may raise issues related to intellectual property protection, variability in quality assurance across different contract manufacturers, and potential supply chain vulnerabilities. Nevertheless, adopting advanced manufacturing technologies such as 3D printing, automation, and robotics presents opportunities for enhancing efficiency, reducing costs, and customizing medical devices. The ongoing globalization of healthcare markets and the rising demand for personalized medical solutions also present fertile ground for expansion.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 110.41 billion |
Estimated Year [2024] | USD 121.29 billion |
Forecast Year [2030] | USD 215.06 billion |
CAGR (%) | 9.99% |
Services: Reliance on device development & manufacturing services for end-to-end process
Device development & manufacturing services encompass the end-to-end process of bringing a medical device from concept to realization. This includes initial design, prototyping, material selection, and the manufacturing of final products. This service is crucial for medical device companies looking to streamline the development process, access advanced manufacturing technologies, and leverage the expertise of specialized partners. It includes device engineering services focused on the technical aspects of medical device creation, including design optimization, functionality enhancement, and compliance with medical standards and regulations. Further, device manufacturing services provide the actual production capabilities for medical devices, ranging from single components to complete systems. This covers various manufacturing processes such as molding, machining, and assembly. Process Development Services focus on designing, evaluating, and optimizing the manufacturing process itself. It involves the development of efficient, cost-effective, and scalable processes to ensure high-quality production.
Final Goods Assembly Services entail the comprehensive assembly of complex medical devices, incorporating multiple components into a finished product ready for packaging. This service demands precision, attention to detail, and a thorough understanding of assembly processes to ensure that the final product meets all specifications and functionality requirements. Quality Management Services are dedicated to ensuring that all aspects of the design, development, and manufacturing process adhere to established quality standards and regulatory requirements. This includes implementing quality control systems, conducting audits, and managing documentation. These services are essential for maintaining the integrity of medical devices and ensuring patient safety. Inspection and Testing Services are critical for certifying that medical devices function as intended and are free from defects. This encompasses a wide range of testing methods, from physical inspections to performance tests, ensuring that every device complies with strict industry standards before reaching the market. Packaging Validation Services verify that medical device packaging meets all regulatory requirements and standards for safety, stability, and durability during transportation and storage.
Class of Device: Proliferation of Class III medical device manufacturing owing to high risk devices and regulatory oversight
Class I medical devices represent the most basic level of medical devices in terms of design complexity and potential risk to patients if they malfunction. These devices are generally regarded as low-risk. They include products such as non-sterile bandages, examination gloves, and basic dental instruments. Due to their low-risk nature, Class I devices are subject to the least regulatory control. In most jurisdictions, such devices must comply with general controls to ensure safety and effectiveness, including proper labeling, premarket notification, and adherence to good manufacturing practices. Class II medical devices are considered to carry a moderate to high risk to the patient if they malfunction. This category includes a wider range of devices, such as powered wheelchairs, infusion pumps, and surgical drapes. Class II devices are more prone to stringent regulatory controls than Class I devices to ensure safety and effectiveness. In addition to general controls, they are often required to comply with special controls, such as performance standards, postmarket surveillance, patient registries, and FDA guidance documents. Premarket notification, known as 510(k) clearance, is commonly required, demonstrating that the device is substantially equivalent to a device already present on the market. Class III medical devices are classified as the highest risk, often of substantial importance in preventing impairment of human health and presenting a potential, unreasonable risk of illness or injury. These include implantable pacemakers, heart valves, and breast implants. These devices are subject to the highest level of regulatory oversight, including premarket approval (PMA), thorough review of clinical trial data to ensure safety and effectiveness. Given the complexity and high stakes of Class III devices, manufacturers must demonstrate a comprehensive understanding of regulatory requirements, maintain rigorous quality control and risk management processes, and invest significantly in clinical research.
Regional Insights
The American market, particularly the United States, is one of the most significant for medical device contract manufacturing, driven by technological advancements, an aging population, and a strong focus on research and development (R&D). The U.S. leads in innovation and demand for medical devices, while Brazil and Mexico are witnessing growth due to increasing healthcare expenditures and a growing middle class requiring medical care. The EMEA region presents a diverse market environment, with Europe leading in terms of market maturity and innovation. The Middle East & Africa are emerging markets with significant growth potential, driven by increasing healthcare investments and an expanding healthcare infrastructure. Medical Device Regulation (MDR) in Europe is significantly impacting the market, requiring enhanced documentation and compliance. Asia Pacific is rapidly emerging as a hub for medical device contract manufacturing. Countries including China, India, and Singapore are investing heavily in healthcare and medical technology, spurred by growing populations and an increasing burden of diseases.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Medical Device Contract Manufacturing Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Medical Device Contract Manufacturing Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Medical Device Contract Manufacturing Market, highlighting leading vendors and their innovative profiles. These include Advantech Plastics, LLC, American Urethane, Inc., Angiplast Private Limited, Benchmark Electronics Inc., Britech Industries, C&J Industries, Cadence, Inc., Carclo PLC, Celestica Inc. by Onex Corporation, Cirtronics Corp., D&K Engineering, Digicom Electronics, Inc., Enercon Technologies, Federal Electronics, Flex, Ltd., Forefront Medical Technologies, Gerresheimer AG, Hankscraft OEM, HDA Technology, Integer Holdings Corporation, Jabil Inc., KDI Manufacturing, Kimball Electronics Inc., MME Group, Inc. by Seaway Plastics Engineering, Nipro Corporation, Nordson Corp., Petro Extrusion Technologies, Inc., Phillips Medisize by Molex LLC, Plexus Corp., Poly Medicure Ltd., Precipart, Qualitel Corporation, Recipharm AB, Remington Medical, Inc., RSP, Inc., Sanbor Medical, Sanmina Corporation, Scapa Healthcare by SWM International, SeaskyMedical, SGS Tekniks, Sino Mould, SMC Ltd., Spectrum Solution, Steripack Group Ltd., TE Connectivity, Tessy Plastics Corp., Tricor Systems, Inc., Viant Technology LLC by Time Inc., West Pharmaceutical Services, Inc., and Wuxi AppTech.
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Medical Device Contract Manufacturing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Medical Device Contract Manufacturing Market?
3. What are the technology trends and regulatory frameworks in the Medical Device Contract Manufacturing Market?
4. What is the market share of the leading vendors in the Medical Device Contract Manufacturing Market?
5. Which modes and strategic moves are suitable for entering the Medical Device Contract Manufacturing Market?
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