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封面
市场调查报告书
商品编码
1561035

医疗设备契约製造市场规模、份额、成长分析，按设备类型、类别设备、服务、地区 - 产业预测，2024-2031 年

Medical Device Contract Manufacturing Market Size, Share, Growth Analysis, By Device Type, By Class Device, By Service, By Region - Industry Forecast 2024-2031
出版日期: | 出版商: SkyQuest | 英文 219 Pages | 商品交期: 3-5个工作天内

价格
简介目录

预计2022年全球医疗设备契约製造市场规模为635.8亿美元，从2023年的708.3亿美元增长到2031年的1679.9亿美元，预计将从2023年的708.3亿美元增长到2031年的1679.9亿美元预计复合年增率为11.4%。

由于对先进医疗设备的需求不断增长以及对具有成本效益的生产解决方案的需求，医疗设备契约製造市场正在经历显着增长。医疗设备製造商正在将製造流程外包给专业公司，以专注于创新和降低营运成本。委託製造提供设计、原型製作和全面生产等领域的专业知识，使您能够缩短上市时间并生产更高品质的产品。慢性病的增加、人口老化以及对微创医疗设备的需求不断增加进一步推动了该市场，特别是在北美和欧洲等已开发地区。此外，由于生产成本低且熟练劳动力，亚太地区的新兴市场已成为受欢迎的外包地点。遵守严格监管标准的需要和医疗设备日益增加的技术复杂性是塑造该产业发展轨迹的主要因素。这种扩张得到了医疗设备领域先进製造技术和精密工程日益一体化的支持。

目录

介绍

  • 研究目的
  • 定义
  • 市场范围

调查方法

  • 资讯采购
  • 二手资料来源和主要资料来源
  • 市场规模预测
  • 市场假设与限制

执行摘要

  • 市场概况展望
  • 供需趋势分析
  • 按细分市场的机会分析

市场动态及展望

  • 市场动态
    • 促进因素
    • 机会
    • 抑制因素
    • 任务
  • 波特的分析

主要市场考察

  • 市场生态系统
  • 主要投资分析
  • 关键成功因素
  • 竞争程度
  • 价格分析
  • 价值链分析
  • 技术分析
  • 专利分析
  • 贸易分析
  • 监管环境
  • 供应链分析
  • 案例研究分析
  • 投资金筹措场景

医疗设备契约製造市场：依设备类型

  • 市场概况
  • 体外诊断设备
    • 体外诊断耗材
    • 体外诊断设备
  • 诊断影像设备
  • 心血管设备
  • 药物输送装置
    • 输液装置及给药装置
    • 注射器
    • 吸入器
    • 自动注射器和笔式註射器
  • 整形外科装置
  • 呼吸照护装置
  • 眼科设备
  • 手术器械
  • 糖尿病照护装置
  • 牙科设备
  • 内视镜和腹腔镜设备
  • 妇科/泌尿系统设备
  • 个人护理设备
  • 神经病学设备
  • 病患监测装置
  • 病人辅助装置
  • 其他设备

医疗设备契约製造市场：按器材类别

  • 市场概况
  • 第一类：综合管理
  • 类别 II：一般控制加特殊控制
  • III 类：一般控制、特殊控制、上市前核准

医疗设备契约製造市场：依服务分类

  • 市场概况
  • 设备开发与製造
    • 设备和组件製造
    • 製程开发
    • 设备工程
  • 品管
    • 包裹检验
    • 检查和测试
    • 灭菌服务
  • 包装和组装服务
    • 初级包装和次级包装
    • 标籤
    • 其他包装和组装服务
  • 其他服务

医疗设备契约製造市场规模：按地区划分

  • 市场概况
  • 北美洲
    • 美国
    • 加拿大
  • 欧洲
    • 德国
    • 西班牙
    • 法国
    • 英国
    • 义大利
    • 其他欧洲国家地区
  • 亚太地区
    • 中国
    • 印度
    • 日本
    • 韩国
    • 其他亚太地区
  • 拉丁美洲
    • 巴西
    • 其他拉丁美洲地区
  • 中东和非洲 (MEA)
    • 海湾合作委员会国家
    • 南非
    • 其他中东/非洲地区

竞争格局

  • 前5名企业对比
  • 主要企业市场定位（2023年）
  • 主要市场参与者所采取的策略
  • 近期市集活动
  • 主要企业市场占有率（2023年）

主要企业简介

  • 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）
简介目录
Product Code: SQMIG35A2534

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