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医疗设备契约製造市场规模、份额和成长分析（按产品类别、服务类型、治疗领域、最终用户和地区划分）－2026-2033年产业预测

市场调查报告书

商品编码

1902504

医疗设备契约製造市场规模、份额和成长分析（按产品类别、服务类型、治疗领域、最终用户和地区划分）－2026-2033年产业预测

Medical Device Contract Manufacturing Market Size, Share, and Growth Analysis, By Product Class (Class I, Class II), By Service Type, By Therapeutic Area, By End User, By Region - Industry Forecast 2026-2033

出版日期: 2025年12月22日 | 出版商:

SkyQuest | 英文 187 Pages | 商品交期: 3-5个工作天内

价格

简介目录

预计到 2024 年，全球医疗设备契约製造市场规模将达到 708.3 亿美元，到 2025 年将成长至 789 亿美元，到 2033 年将成长至 1871.5 亿美元，预测期（2026-2033 年）的复合年增长率为 11.4%。

全球医疗设备契约製造市场正经历显着成长，这主要得益于各类医疗设备需求的不断增长和技术的快速进步。企业越来越依赖契约製造製造商的专业技术和能力，尤其是在人工呼吸器和体外诊断医疗设备（IVD）等关键产品方面，这导致外包製造业务的成长。没有自有生产设施的企业也越来越依赖这些合作伙伴，推动了市场扩张。此外，不断完善的法规结构和策略性措施也在推动市场成长，促进了医疗设备的普及和应用。特别是体外诊断（IVD）领域，预计将占据相当大的市场份额，这主要得益于主要市场参与者（尤其是在北美地区）对照护现场解决方案的需求不断增长，并有望对整体市场产生重大影响。

全球医疗设备契约製造市场按产品类别、服务类型、治疗领域、最终用户和地区进行细分。依产品类别划分，分为I类、II类及III类医疗器材。按服务类型划分，分为器械开发和製造、品管、包装和组装服务以及其他服务。依治疗领域划分，分为心血管器械、整形外科器械、眼科器械、诊断器械、呼吸器械、外科器械、牙科器械以及其他治疗领域。按最终用户划分，分为原始设备製造商 (OEM)、製药和生物製药公司以及其他最终用户。按地区划分，医疗设备契约製造市场涵盖北美、欧洲、亚太地区、中东和非洲以及拉丁美洲。

全球医疗设备契约製造市场驱动因素

受医疗设备需求不断增长的推动，全球医疗设备契约製造市场正经历显着成长。这种快速增长主要归因于慢性病盛行率的上升、人口老化以及医疗技术的不断进步。因此，原始设备製造商 (OEM) 正与承包商建立策略联盟和伙伴关係关係，以提高生产效率并优化成本。这种合作模式不仅满足了对创新医疗设备的需求，还有助于维持高效的供应和製造流程，从而跟上不断变化的医疗保健格局，最终改善患者的治疗效果。

全球医疗设备契约製造市场面临的限制因素

影响全球医疗设备契约製造市场的主要挑战之一是监管合规的复杂性。医疗设备生产和认证的标准因地区和国家而异。例如，製造商和OEM生产企业必须遵守不同机构制定的法规，例如欧洲的欧洲药品管理局（EMA）和美国的食品药物管理局（FDA）。这些监管要求的差异可能会造成障碍，阻碍产业内的顺利运作。

全球医疗设备契约製造市场趋势

全球医疗设备契约製造市场正经历着一场重大变革，先进製造技术（例如自动化、3D列印和机器人技术）的整合正在推动这项变革。这些创新提高了生产效率、精度和成本效益，同时实现了针对特定医疗需求的医疗设备个人化客製化。 3D列印技术能够快速製作复杂医疗零件的原型并进行生产，从而缩短新产品开发的前置作业时间。同时，自动化确保了产品品质的扩充性，推动了整个产业的创新和营运效率的提升。这一发展趋势反映了医疗设备产业正持续向更灵活、反应迅速的製造解决方案转型。

北美洲
- 美国
- 加拿大
欧洲
- 德国
- 西班牙
- 法国
- 英国
- 义大利
- 其他欧洲地区
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 亚太其他地区
拉丁美洲
- 巴西
- 其他拉丁美洲地区
中东和非洲
- 海湾合作委员会国家
- 南非
- 其他中东和非洲地区

竞争资讯

前五大公司对比
主要企业的市场定位（2025 年）
主要市场参与者所采取的策略
近期市场趋势
公司市占率分析（2025 年）
主要企业公司简介
- 公司详情
- 产品系列分析
- 依业务板块进行公司股票分析
- 2023-2025年营收年比比较

主要企业简介

Thermo Fisher Scientific Inc.（United States）
Jabil Inc.（United States）
Flex Ltd.（United States）
Plexus Corp.（United States）
Sanmina Corporation（United States）
Integer Holdings Corporation（United States）
TE Connectivity Ltd.（Switzerland）
Nipro Corporation（Japan）
Onex Corporation（Celestica Inc.）（Canada）
West Pharmaceutical Services, Inc.（United States）
Benchmark Electronics Inc.（United States）
EQT Group（Recipharm AB）（Sweden）
Gerresheimer AG（Germany）
Kimball Electronics, Inc.（United States）
Nortech Systems Incorporated（United States）
Carclo plc（United Kingdom）
Nolato GW, Inc.（Sweden）
Viant Medical Holdings, Inc.（United States）
Tecomet, Inc.（United States）
SMC Corporation（United States）

结论与建议

简介目录

Product Code: SQMIG35A2534

Global Medical Device Contract Manufacturing Market size was valued at USD 70.83 Billion in 2024 and is poised to grow from USD 78.9 Billion in 2025 to USD 187.15 Billion by 2033, growing at a CAGR of 11.4% during the forecast period (2026-2033).

The global medical device contract manufacturing market is witnessing significant growth, largely propelled by rising demand for various medical devices and rapid technological advancements. The trend of outsourcing manufacturing is on the rise, particularly for critical products like ventilators and in vitro diagnostic (IVD) devices, as companies seek expertise and specialized capabilities from contract manufacturers. Organizations lacking in-house production facilities increasingly rely on these partners, spurring market expansion. Furthermore, enhanced acceptance and utilization of medical devices, influenced by evolving regulatory frameworks and strategic initiatives, further fuel growth. Notably, the IVD segment is expected to capture a considerable market share as demand for point-of-care solutions rises, driven by major market players, particularly in North America, significantly impacting the overall landscape.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Medical Device Contract Manufacturing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Medical Device Contract Manufacturing Market Segments Analysis

The global medical device contract manufacturing market is segmented into product class, service type, therapeutic area, end user, and region. By product class, the market is classified into Class I, Class II, and Class III. Depending on service type, it is divided into device development and manufacturing, quality management, packaging and assembly services, and others. According to therapeutic area, the market is categorized into cardiovascular devices, orthopedic devices, ophthalmic devices, diagnostic devices, respiratory devices, surgical instruments, dental, and others. By end user, the market is classified into Original Equipment Manufacturers (OEMs), pharmaceutical &biopharmaceutical companies, and others. Regionally, the medical device contract manufacturing market is analyzed across North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America.

Driver of the Global Medical Device Contract Manufacturing Market

The Global Medical Device Contract Manufacturing market is experiencing notable growth driven by the rising demand for medical devices. This surge is largely attributed to the growing prevalence of chronic diseases, an aging population, and ongoing advancements in healthcare technology. As a result, original equipment manufacturers (OEMs) are forming strategic alliances and partnerships with contractors to enhance productivity and optimize costs. This collaborative approach not only addresses the need for innovative medical equipment but also supports the efficient delivery and manufacturing processes necessary to cater to the evolving healthcare landscape, ultimately facilitating improved patient outcomes.

Restraints in the Global Medical Device Contract Manufacturing Market

One of the significant challenges impacting the Global Medical Device Contract Manufacturing market is the complexity associated with regulatory compliance. The diverse standards governing the production and certification of medical devices differ widely across regions and countries. For instance, organizations involved in manufacturing and original equipment production must navigate the regulations set forth by various authorities, such as the European Medicines Agency (EMA) in Europe and the Food and Drug Administration (FDA) in the United States. This variability in regulatory requirements can create obstacles and hinder seamless operations within the industry.

Market Trends of the Global Medical Device Contract Manufacturing Market

The Global Medical Device Contract Manufacturing market is experiencing a significant transformation driven by the integration of advanced manufacturing technologies, including automation, 3D printing, and robotics. These innovations enhance production efficiency, accuracy, and cost-effectiveness, while enabling personalized customization of medical devices to meet specific healthcare needs. The capabilities of 3D printing facilitate rapid prototyping and the creation of intricate medical components, improving turnaround times for new product development. Meanwhile, automation ensures consistent quality and scalability, fostering innovation and operational efficiency across the industry. This evolution reflects the ongoing shift towards more agile and responsive manufacturing solutions in the medical device sector.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Drivers & Opportunities
- Restraints & Challenges
Porters Analysis
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2025
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Regulatory Landscape
Case Study Analysis

Global Medical Device Contract Manufacturing Market Size by Product Class & CAGR (2026-2033)

Market Overview
Class I
Class II
Class III

Global Medical Device Contract Manufacturing Market Size by Service & CAGR (2026-2033)

Market Overview
Device Development and Manufacturing
- Device and Component Manufacturing
- Process Development
- Device Engineering
Quality Management
- Packaging Validation
- Inspection and Testing
- Sterilization Services
Packaging and Assembly Services
- Primary and Secondary Packaging
- Labelling
- Others
Others

Global Medical Device Contract Manufacturing Market Size by Therapeutic Area & CAGR (2026-2033)

Market Overview
Cardiovascular Devices
Orthopedic Devices
Ophthalmic Devices
Diagnostic Device
Respiratory Devices
Surgical Instruments
Dental
Others

Global Medical Device Contract Manufacturing Market Size by End-user & CAGR (2026-2033)

Market Overview
Original Equipment Manufacturers (OEMs)
Pharmaceutical & Biopharmaceutical Companies
Others

Global Medical Device Contract Manufacturing Market Size & CAGR (2026-2033)

North America (Product Class, Service, Therapeutic Area, End-user)
- US
- Canada
Europe (Product Class, Service, Therapeutic Area, End-user)
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific (Product Class, Service, Therapeutic Area, End-user)
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America (Product Class, Service, Therapeutic Area, End-user)
- Brazil
- Rest of Latin America
Middle East & Africa (Product Class, Service, Therapeutic Area, End-user)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2025
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2025
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

Thermo Fisher Scientific Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Jabil Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Flex Ltd. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Plexus Corp. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sanmina Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Integer Holdings Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
TE Connectivity Ltd. (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Nipro Corporation (Japan)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Onex Corporation (Celestica Inc.) (Canada)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
West Pharmaceutical Services, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Benchmark Electronics Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
EQT Group (Recipharm AB) (Sweden)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Gerresheimer AG (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Kimball Electronics, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Nortech Systems Incorporated (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Carclo plc (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Nolato GW, Inc. (Sweden)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Viant Medical Holdings, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Tecomet, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
SMC Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments