首頁 > 市場調查報告書 > 醫療設備

醫療設備契約製造市場規模、佔有率和成長分析（按產品類別、服務類型、治療領域、最終用戶和地區分類）－2026-2033年產業預測

市場調查報告書

商品編碼

1902504

醫療設備契約製造市場規模、佔有率和成長分析（按產品類別、服務類型、治療領域、最終用戶和地區分類）－2026-2033年產業預測

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個工作天內

價格

簡介目錄

預計到 2024 年，全球醫療設備契約製造市場規模將達到 708.3 億美元，到 2025 年將成長至 789 億美元，到 2033 年將成長至 1871.5 億美元，預測期（2026-2033 年）的複合年成長率為 11.4%。

全球醫療設備契約製造市場正經歷顯著成長，這主要得益於各類醫療設備需求的不斷成長和技術的快速進步。企業越來越依賴契約製造製造商的專業技術和能力，尤其是在人工呼吸器和體外診斷醫療設備（IVD）等關鍵產品方面，這導致外包製造業務的成長。沒有自有生產設施的企業也越來越依賴這些合作夥伴，推動了市場擴張。此外，不斷完善的法規結構和策略性措施也在推動市場成長，促進了醫療設備的普及和應用。特別是體外診斷（IVD）領域，預計將佔據相當大的市場佔有率，這主要得益於主要市場參與者（尤其是在北美地區）對照護現場解決方案的需求不斷成長，並有望對整體市場產生重大影響。

全球醫療設備契約製造市場按產品類別、服務類型、治療領域、最終用戶和地區進行細分。依產品類別分類，分為I類、II類及III類醫療器材。按服務類型分類，分為器械開發和製造、品管、包裝和組裝服務以及其他服務。依治療領域分類，分為心血管器械、整形外科器械、眼科器械、診斷器械、呼吸器械、外科器械、牙科器械以及其他治療領域。按最終用戶分類，分為原始設備製造商 (OEM)、製藥和生物製藥公司以及其他最終用戶。按地區分類，醫療設備契約製造市場涵蓋北美、歐洲、亞太地區、中東和非洲以及拉丁美洲。

全球醫療設備契約製造市場促進因素

受醫療設備需求不斷成長的推動，全球醫療設備契約製造市場正經歷顯著成長。這種快速成長主要歸因於慢性病盛行率的上升、人口老化以及醫療技術的不斷進步。因此，原始設備製造商 (OEM) 正與承包商建立策略聯盟和夥伴關係關係，以提高生產效率並最佳化成本。這種合作模式不僅滿足了對創新醫療設備的需求，還有助於維持高效的供應和製造流程，從而跟上不斷變化的醫療保健格局，最終改善患者的治療效果。

全球醫療設備契約製造市場面臨的限制因素

影響全球醫療設備契約製造市場的主要挑戰之一是監管合規的複雜性。醫療設備生產和認證的標準因地區和國家而異。例如，製造商和OEM生產企業必須遵守不同機構制定的法規，例如歐洲的歐洲藥品管理局（EMA）和美國的食品藥物管理局（FDA）。這些監管要求的差異可能會造成障礙，阻礙產業內的順利運作。

全球醫療設備契約製造市場趨勢

全球醫療設備契約製造市場正經歷著一場重大變革，先進製造技術（例如自動化、3D列印和機器人技術）的整合正在推動這項變革。這些創新提高了生產效率、精度和成本效益，同時實現了針對特定醫療需求的醫療設備個人化客製化。 3D列印技術能夠快速製作複雜醫療零件的原型並進行生產，從而縮短新產品開發的前置作業時間。同時，自動化確保了產品品質的擴充性，推動了整個產業的創新和營運效率的提升。這一發展趨勢反映了醫療設備產業正持續向更靈活、反應迅速的製造解決方案轉型。

北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 英國
- 義大利
- 其他歐洲地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
拉丁美洲
- 巴西
- 其他拉丁美洲地區
中東和非洲
- 海灣合作理事會國家
- 南非
- 其他中東和非洲地區

競爭資訊

前五大公司對比
主要企業的市場定位（2025 年）
主要市場參與者所採取的策略
近期市場趨勢
公司市佔率分析（2025 年）
主要企業公司簡介
- 公司詳情
- 產品系列分析
- 依業務板塊進行公司股票分析
- 2023-2025年營收年比比較

主要企業簡介

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）

結論與建議

簡介目錄

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