市場調査レポート

商品コード

1670254

医療機器受託製造市場規模、シェア、成長分析：デバイスタイプ別、製品別、サービス別、治療領域別、最終用途別、地域別 - 産業予測 2025～2032年

Medical Device Contract Manufacturing Market Size, Share, and Growth Analysis, By Device Type (IVD Devices, Diagnostic Imaging Devices), By Product (Class I, Class Ii), By Service, By Therapeutic Area, By End-use, By Region - Industry Forecast 2025-2032

出版日: 2025年02月28日
発行: SkyQuest
ページ情報: 英文 219 Pages
納期: 3～5営業日

価格

PDF & Excel (Single User License)

USD 5,300 760,921円

レポートPDF・Excelを1 名様のみがご利用頂けるライセンスです。PDF・Excell内のテキスト等のコピーは可能です。PDF・Excelの印刷は可能ですが、印刷したもののご利用はPDF・Excelのご利用範囲に準拠します

PDF & Excel (Multiple User License)

USD 6,200 890,134円

レポートPDF・Excel2-5名様までがご利用頂けるライセンスです。PDF・Excel内のテキスト等のコピーは可能です。PDF・Excelの印刷は可能ですが、印刷したもののご利用はPDF・Excelのご利用範囲に準拠します。

PDF & Excel (Enterprise License)

USD 7,100 1,019,347円

レポートPDF・Excelを同一企業に所属の全世界の方にご使用頂けるライセンスです。PDF・Excel内のテキスト等のコピーは可能です。PDF・Excelの印刷は可能ですが、印刷したもののご利用はPDF・Excelのご利用範囲に準拠します。

価格表記: USDを日本円(税抜)に換算

本日の銀行送金レート: 1USD=143.57円

全表示
概要
目次

概要

サンプル依頼リストに入れる

医療機器受託製造の世界市場規模は、2023年に708億3,000万米ドルと評価され、2024年の789億米ドルから2032年には1,871億5,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは11.4％で成長する見通しです。

医療機器受託製造市場は、医療機器に対する需要の高まりと技術の進歩に後押しされ、力強い成長を遂げています。特に、人工呼吸器やCOVID-19関連製品のようなデバイスの専門知識を請負業者に求める企業がアウトソーシングを急増させており、この分野の回復力と回復が顕著です。このような多様な市場情勢により、自社で製造を行っていない主要企業は、製造委託先への依存度を高めており、成長をさらに促進しています。新たな規制の枠組みを含め、医療機器の受け入れと利用を強化することを目的とした世界の取り組みも、市場拡大に大きな役割を果たしています。特に、体外診断（IVD）機器分野は、ポイント・オブ・ケア機器に対する需要の高まりにより、北米、特に米国が重要な市場促進要因となって、大きな市場シェアを獲得すると予想されます。

市場概要
IVDデバイス
- IVD消耗品
- 体外診断用機器
画像診断装置
心臓血管デバイス
ドラッグデリバリーデバイス
- 輸液装置および投与セット
- 注射器
- 吸入器
- 自動注射器とペン型注射器
整形外科用機器
呼吸ケア機器
眼科用機器
外科用機器
糖尿病ケア機器
歯科用機器
内視鏡および腹腔鏡装置
婦人科/泌尿器科用機器
パーソナルケア機器
神経学デバイス
患者モニタリング装置
患者補助装置
その他のデバイス

医療機器受託製造市場規模：製品別& CAGR（2025-2032）

市場概要
クラス I
クラス II
クラス III

医療機器受託製造市場規模：サービス別& CAGR（2025-2032）

市場概要
デバイス開発と製造
- デバイスおよびコンポーネントの製造
- プロセス開発
- デバイスエンジニアリング
品質管理
- パッケージ検証
- 検査とテスト
- 滅菌サービス
梱包および組立サービス
- 一次包装と二次包装
- ラベリング
- その他の梱包および組立サービス
その他のサービス

医療機器受託製造市場規模：治療領域別& CAGR（2025-2032）

市場概要
心臓血管デバイス
整形外科用機器
眼科用機器
診断装置
呼吸器
手術器具
歯科
その他

医療機器受託製造市場規模：最終用途別& CAGR（2025-2032）

市場概要
オリジナル機器製造会社（OEM）
製薬・バイオ医薬品企業
その他

医療機器受託製造市場規模：地域別& CAGR（2025-2032）

北米
- 米国
- カナダ
欧州
- ドイツ
- スペイン
- フランス
- 英国
- イタリア
- その他欧州地域
アジア太平洋地域
- 中国
- インド
- 日本
- 韓国
- その他アジア太平洋地域
ラテンアメリカ
- ブラジル
- その他ラテンアメリカ地域
中東・アフリカ
- GCC諸国
- 南アフリカ
- その他中東・アフリカ

競合情報

上位5社の比較
主要企業の市場ポジショニング（2024年）
主な市場企業が採用した戦略
最近の市場動向
企業の市場シェア分析（2024年）
主要企業の企業プロファイル
- 企業の詳細
- 製品ポートフォリオ分析
- 企業のセグメント別シェア分析
- 収益の前年比比較（2022-2024）

主要企業プロファイル

Medtronic（Ireland）
Terumo Corporation（Japan）
Hologic, Inc.（United States）
WuXi AppTec（China）
Integer Holdings Corporation（United States）
Jabil Inc.（United States）
Flex Ltd.（Singapore）
Sanmina Corporation（United States）
TE Connectivity（Switzerland）
Celestica Inc.（Canada）
Kimball Electronics（United States）
Plexus Corp.（United States）
Benchmark Electronics, Inc.（United States）
TT Electronics plc（United Kingdom）
Nipro Corporation（Japan）
Mitsubishi Chemical Holdings Corporation（Japan）
Phillips-Medisize Corporation（United States）
Nordson Corporation（United States）
LISI Group（France）

結論と提言

Product Code: SQMIG35A2534

Global Medical Device Contract Manufacturing Market size was valued at USD 70.83 billion in 2023 and is poised to grow from USD 78.9 billion in 2024 to USD 187.15 billion by 2032, growing at a CAGR of 11.4% during the forecast period (2025-2032).

The medical device contract manufacturing market is witnessing strong growth, propelled by heightened demand for medical devices and technological advancements. The sector's resilience and recovery are evident, particularly with a surge in outsourcing as companies seek contractor expertise for devices like ventilators and COVID-19-related products. This diverse market landscape is leading companies without in-house manufacturing to increasingly rely on contract manufacturers, further fueling growth. Global initiatives aimed at enhancing the acceptance and usage of medical devices, including new regulatory frameworks, also play a significant role in market expansion. Notably, the in vitro diagnostic (IVD) device segment is expected to capture a substantial market share due to rising demand for point-of-care devices, with North America-especially the US-serving as a critical market driver.

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

Global Medical Device Contract Manufacturing Market is segmented by Device Type, Product, Service, Therapeutic Area, End-use and region. Based on 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. Based on Product, the market is segmented into Class I, Class Ii and Class Iii. Based on Service, the market is segmented into Device Development and Manufacturing, Quality Management, Packaging And Assembly Services and Other Services. Based on Therapeutic Area, the market is segmented into Cardiovascular Devices, Orthopedic Devices, Ophthalmic Devices, Diagnostic Devices, Respiratory Devices, Surgical Instruments, Dental and Others. Based on End-use, the market is segmented into Original Equipment Manufacturers (OEMs), Pharmaceutical & Biopharmaceutical Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Medical Device Contract Manufacturing Market

The Global Medical Device Contract Manufacturing market is primarily driven by the escalating demand for medical devices, which stems from the rising prevalence of chronic illnesses, an aging population, and advancements in healthcare technologies. As the need for cutting-edge equipment grows, original equipment manufacturers (OEMs) are increasingly partnering with contract manufacturers to improve efficiency and reduce operational costs. This collaborative approach leverages shared core competencies, facilitating quicker production schedules while promoting the development of world-class medical technologies. The combination of these factors is significantly propelling the growth of the medical device contract manufacturing sector worldwide.

Restraints in the Global Medical Device Contract Manufacturing Market

A significant obstacle for the global medical device contract manufacturing market is the intricate landscape of regulatory compliance. Each country and region imposes its own unique standards regarding the manufacturing and certification of medical devices, exemplified by the rigorous requirements set forth by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in Europe. These varying regulations present challenges for manufacturers and original equipment manufacturers (OEMs), as they must navigate a complex web of compliance requirements that can impact production timelines, increase operational costs, and hinder market entry strategies in different geographic areas.

Market Trends of the Global Medical Device Contract Manufacturing Market

The Global Medical Device Contract Manufacturing market is witnessing a significant trend driven by the adoption of advanced manufacturing technologies such as automation, 3D printing, and robotics. These innovations are transforming the landscape of medical device production by enhancing efficiency, reducing costs, and allowing for precise customization. The integration of 3D printing enables rapid prototyping and the delivery of intricate components, while automation ensures consistent quality and scalability in manufacturing processes. As companies seek to leverage these technologies, the industry is poised for substantial growth, enhancing productivity and fostering innovation across the medical device sector, ultimately improving patient care outcomes.

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, 2024
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis

Global Medical Device Contract Manufacturing Market Size by Device Type & CAGR (2025-2032)

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

Global Medical Device Contract Manufacturing Market Size by Product & CAGR (2025-2032)

Market Overview
Class I
Class Ii
Class Iii

Global Medical Device Contract Manufacturing Market Size by Service & CAGR (2025-2032)

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

Global Medical Device Contract Manufacturing Market Size by Therapeutic Area & CAGR (2025-2032)

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

Global Medical Device Contract Manufacturing Market Size by End-use & CAGR (2025-2032)

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

Global Medical Device Contract Manufacturing Market Size & CAGR (2025-2032)

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

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2024
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2024
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

Medtronic (Ireland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Terumo Corporation (Japan)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Hologic, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Integer Holdings Corporation (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. (Singapore)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sanmina Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
TE Connectivity (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Celestica Inc. (Canada)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Kimball Electronics (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Plexus Corp. (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
TT Electronics plc (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Nipro Corporation (Japan)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Mitsubishi Chemical Holdings Corporation (Japan)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Phillips-Medisize Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Nordson Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
LISI Group (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments