醫療設備契約製造市場規模、佔有率、成長分析，按設備類型、類別設備、服務、地區 - 產業預測，2024-2031 年

預計2022年全球醫療設備契約製造市場規模為635.8億美元，從2023年的708.3億美元成長到2031年的1679.9億美元，預計將從2023年的708.3億美元成長到2031年的1679.9億美元預計複合年增率為11.4%。

由於對先進醫療設備的需求不斷成長以及對具有成本效益的生產解決方案的需求，醫療設備契約製造市場正在經歷顯著成長。醫療設備製造商正在將製造流程外包給專業公司，以專注於創新和降低營運成本。委託製造提供設計、原型製作和全面生產等領域的專業知識，使您能夠縮短上市時間並生產更高品質的產品。慢性病的增加、人口老化以及對微創醫療設備的需求不斷增加進一步推動了該市場，特別是在北美和歐洲等已開發地區。此外，由於生產成本低且熟練勞動力，亞太地區的新興市場已成為受歡迎的外包地點。遵守嚴格監管標準的需要和醫療設備日益增加的技術複雜性是塑造該產業發展軌跡的主要因素。這種擴張得到了醫療設備領域先進製造技術和精密工程日益一體化的支持。

目錄

介紹

• 研究目的
• 定義
• 市場範圍

調查方法

• 資訊採購
• 二手資料來源和主要資料來源
• 市場規模預測
• 市場假設與限制

執行摘要

• 市場概況展望
• 供需趨勢分析
• 按細分市場的機會分析

市場動態及展望

• 市場動態
  • 促進因素
  • 機會
  • 抑制因素
  • 任務
• 波特的分析

主要市場考察

• 市場生態系統
• 主要投資分析
• 關鍵成功因素
• 競爭程度
• 價格分析
• 價值鏈分析
• 技術分析
• 專利分析
• 貿易分析
• 監管環境
• 供應鏈分析
• 案例研究分析
• 投資金籌措場景

醫療設備契約製造市場：依設備類型

• 市場概況
• 體外診斷設備
  • 體外診斷耗材
  • 體外診斷設備
• 診斷影像設備
• 心血管設備
• 藥物輸送裝置
  • 輸液裝置及給藥裝置
  • 注射器
  • 吸入器
  • 自動注射器和筆式注射器
• 整形外科裝置
• 呼吸照護裝置
• 眼科設備
• 手術器械
• 糖尿病照護裝置
• 牙科設備
• 內視鏡和腹腔鏡設備
• 婦科/泌尿系統設備
• 個人護理設備
• 神經病學設備
• 病患監測裝置
• 病人輔助裝置
• 其他設備

醫療設備契約製造市場：按器材類別

• 市場概況
• 第一類：綜合管理
• 類別 II：一般控制加特殊控制
• III 類：一般控制、特殊控制、上市前核准

醫療設備契約製造市場：依服務分類

• 市場概況
• 設備開發與製造
  • 設備和組件製造
  • 製程開發
  • 設備工程
• 品管
  • 包裹檢驗
  • 檢查和測試
  • 滅菌服務
• 包裝和組裝服務
  • 初級包裝和次級包裝
  • 標籤
  • 其他包裝和組裝服務
• 其他服務

醫療設備契約製造市場規模：按地區分類

• 市場概況
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 中東和非洲 (MEA)
  • 海灣合作理事會國家
  • 南非
  • 其他中東/非洲地區

競爭格局

• 前5名企業對比
• 主要企業市場定位（2023年）
• 主要市場參與者所採取的策略
• 近期市集活動
• 主要企業市場佔有率（2023年）

主要企業簡介

• Jabil Inc.（US）
• Flex Ltd.（US）
• Plexus Corp.（US）
• Integer Holdings Corporation（US）
• Celestica Inc.（Canada）
• West Pharmaceutical Services, Inc.（US）
• Benchmark Electronics Inc.（US）
• Kimball Electronics, Inc.（US）
• Nortech Systems Incorporated（US）
• Phillips-Medisize Corporation（US）
• Tessy Plastics Corp.（US）
• Tekni-Plex（US）
• Recipharm AB（Sweden）
• Gerresheimer AG（Germany）
• Carclo PLC（UK）
• Nemera（France）
• SMC Ltd.（UK）
• Sanmina Corporation（Japan）
• Nipro Corporation（Japan）
• NOLATO GW, Inc.（NOLATO AB）（Sweden）

Global Medical Device Contract Manufacturing Market size was valued at USD 63.58 billion in 2022 and is poised to grow from USD 70.83 billion in 2023 to USD 167.99 billion by 2031, growing at a CAGR of 11.4% in the forecast period (2024-2031).

The Medical Device Contract Manufacturing Market is witnessing significant growth due to the increasing demand for advanced medical devices and the need for cost-effective production solutions. Medical device companies are outsourcing manufacturing processes to specialized firms to focus on innovation and reduce operational expenses. Contract manufacturers provide expertise in areas such as design, prototyping, and full-scale production, enabling faster time-to-market and higher-quality outputs. The market is further driven by the rising prevalence of chronic diseases, aging populations, and the growing demand for minimally invasive devices, especially in developed regions like North America and Europe. Additionally, emerging markets in the Asia-Pacific region are becoming popular outsourcing hubs due to their lower production costs and skilled labor. The need for adherence to strict regulatory standards and the increasing technological complexity of medical devices are key factors shaping the industry's trajectory. This expansion is supported by the growing integration of advanced manufacturing technologies and precision engineering in the medical device sector.

Top-down and bottom-up approaches were used to estimate and validate the size of the 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.

Medical Device Contract Manufacturing Market Segmental Analysis

Global Medical Device Contract Manufacturing Market is segmented on the basis of device type, class device, service, and region. By Device Type, the market is segmented into IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Drug Delivery Devices, Orthopedic Devices, Respiratory Care Devices, Ophthalmology Devices, Surgical Devices, Diabetes Care Devices, Dental Devices, Endoscopy & Laparoscopy Devices, Gynecology/Urology Devices, Personal Care Devices, Neurology Devices, Patient Monitoring Devices, Patient Assistive Devices, and Other Devices. By Class Device, the market is segmented into Class I: General controls, Class II: General controls with special controls, and Class III: General controls, special controls, and premarket approval. By service, market is segmented into Device Development and Manufacturing, Quality Management, Packaging and Assembly Services, and Other Services. By region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.

Drivers of the Medical Device Contract Manufacturing Market

The rising complexity of medical devices, such as implants, diagnostic tools, and wearable healthcare monitors, is driving growth in the contract manufacturing market. Medical device companies are outsourcing production to contract manufacturers with specialized capabilities to handle advanced manufacturing processes, such as microelectronics assembly, precision molding, and 3D printing. As medical technology evolves, the demand for devices with integrated sensors, connectivity features, and high-performance materials is growing. This shift requires manufacturers to develop precise and scalable solutions that meet stringent quality standards. Contract manufacturers offer expertise in managing the intricate production needs of these devices, including design optimization, cost-effective manufacturing methods, and compliance with global regulatory frameworks. Their ability to meet these evolving demands allows medical device companies to focus on research and development, reducing time-to-market and ensuring competitive advantage.

Restraints in the Medical Device Contract Manufacturing Market

One of the primary restraints in the medical device contract manufacturing market is the strict regulatory landscape. Compliance with international standards such as the U.S. FDA's Quality System Regulations (QSR) and the European Medical Device Regulation (MDR) is mandatory for market entry. These regulations require rigorous quality control, documentation, and process validation, which increase the complexity and cost of manufacturing. Contract manufacturers must invest in comprehensive quality management systems and stay updated with evolving regulations to avoid delays and market entry barriers. Additionally, frequent changes in regulatory standards, such as updates to the MDR, can slow down product approvals and hinder the introduction of new devices. These challenges, while essential for patient safety and product efficacy, often limit the agility of manufacturers, particularly smaller firms, in meeting market demands efficiently.

Market Trends of the Medical Device Contract Manufacturing Market

A growing trend in the medical device contract manufacturing market is the adoption of smart manufacturing technologies such as automation, artificial intelligence (AI), and data-driven production systems. These technologies are enhancing the precision, efficiency, and scalability of manufacturing processes. Automation is being integrated into assembly lines to reduce human error and improve consistency in the production of complex medical devices. AI-driven systems are used to optimize workflows, enhance quality control, and predict equipment maintenance needs. The integration of real-time monitoring through Internet of Things (IoT) devices provides manufacturers with critical insights into machine performance and production quality, improving overall output. As the demand for advanced, high-quality medical devices continues to grow, manufacturers are increasingly leveraging smart manufacturing technologies to meet regulatory standards while reducing costs and accelerating production times. This trend is set to redefine production processes, making the industry more agile and responsive to market needs.

Table of Contents

Introduction

• Objectives of the Study
• Definitions
• Market Scope

Research Methodology

• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Market Overview Outlook
• Supply Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Ecosystem of the Market
• Top Investment Analysis
• Key Success Factor
• Degree of Competition
• Pricing Analysis
• Value Chain Analysis
• Technology Analysis
• Patent Analysis
• Trade Analysis
• Regulatory Landscape
• Supply Chain Analysis
• Case Study Analysis
• Investment And Funding Scenario

Medical Device Contract Manufacturing Market by Device Type

• Market Overview
• IVD Devices
  • IVD Consumables
  • IVD Equipment
• Diagnostic Imaging Devices
• Cardiovascular Devices
• Drug Delivery Devices
  • Infusion Devices & Administration Sets
  • Syringes
  • Inhalers
  • Autoinjectors & Pen Injectors
• Orthopedic Devices
• Respiratory Care Devices
• Ophthalmology Devices
• Surgical Devices
• Diabetes Care Devices
• Dental Devices
• Endoscopy & Laparoscopy Devices
• Gynecology/Urology Devices
• Personal Care Devices
• Neurology Devices
• Patient Monitoring Devices
• Patient Assistive Devices
• Other Devices

Medical Device Contract Manufacturing Market by Class of Device

• Market Overview
• Class I: General controls
• Class II: General controls with special controls
• Class III: General controls, special controls, and premarket approval

Medical Device Contract Manufacturing Market by Service

• 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
  • Labeling
  • Other Packaging and Assembly Services
• Other Services

Medical Device Contract Manufacturing Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• Jabil Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Flex Ltd. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Plexus Corp. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Integer Holdings Corporation (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celestica Inc. (Canada)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• West Pharmaceutical Services, Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Benchmark Electronics Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Kimball Electronics, Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nortech Systems Incorporated (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Phillips-Medisize Corporation (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tessy Plastics Corp. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tekni-Plex (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Recipharm AB (Sweden)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Gerresheimer AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Carclo PLC (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nemera (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SMC Ltd. (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sanmina Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nipro Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NOLATO GW, Inc. (NOLATO AB) (Sweden)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments