세계의 의료기기 위탁생산 시장 규모, 점유율, 예측 및 동향 분석 : 의료기기 서비스별 - 예측(-2031년)

Medical Device Contract Manufacturing Market Size, Share, Forecast, & Trends Analysis by Device (Biochemistry, Immunoassay, CT, MRI, X-ray, Ultrasound, Pacemaker, Defibrillator, Oximeter), Service (Development, Manufacturing, QA) - Global Forecast to 2031

The medical device contract manufacturing market is expected to reach $171.19 billion by 2031, at a CAGR of 9.9% from 2024 to 2031. After secondary and primary research and an in-depth analysis of the market scenario, the report discusses key industry drivers, restraints, opportunities, challenges, and trends.

The growth of the medical device contract manufacturing market is driven by the rising trend of outsourcing design, development, and manufacturing in the MedTech sector. Contract manufacturing offers various benefits, such as reduced development costs and time, flexibility to scale production according to demand fluctuations, and access to specialized manufacturing processes. Additionally, changing regulatory landscapes in the medical device industry compel companies to seek regulatory services and engineering expertise from contract manufacturers.

Furthermore, the adoption of Industry 4.0 technologies, coupled with rising healthcare expenditures and the demand for quality healthcare in developing countries, is generating growth opportunities for market players. Moreover, the cost advantages offered by contract manufacturers in emerging economies further contribute to market expansion.

Based on device, the medical device contract manufacturing market is segmented into IVD devices, IVD consumables, imaging devices, cardiovascular devices, drug delivery devices, orthopedic devices, endoscopy devices, ophthalmology devices, dental devices, patient monitoring devices, anesthesia devices, mobility aids, surgical systems, consumables, and other devices. The drug delivery devices segment is projected to witness the highest growth rate of 11.2% during the forecast period 2024-2031. The growth of this segment is driven by the rising incidence of chronic diseases, the growing adoption of biologic drugs and specialty pharmaceuticals, the growing emphasis on patient-centric care, and the trend of self-administering medications.

Based on risk type, the medical device contract manufacturing market is segmented into low-risk medical devices, moderate-risk medical devices, and high-risk medical devices. In 2024, the moderate-risk medical devices segment is expected to account for the largest share of the medical device contract manufacturing market. The segment's large share is attributed to medical device companies' high preference for outsourcing the development & manufacture of moderate-risk medical devices, the high use of syringes, the growing geriatric population leading to high demand for catheters, and the high adoption of self-pregnancy test kits.

Based on service, the medical device contract manufacturing market is segmented into design & development, manufacturing, testing & validation, quality assurance, implementation & maintenance services, packaging services, regulatory affairs services, and other services. In 2024, the design & development segment is expected to account for the largest share of the medical device contract manufacturing market. The large market share of this segment is attributed to the growing demand for advanced medical devices and the high costs associated with the design and development of medical devices.

Based on application, the medical device contract manufacturing market is segmented into IVD, drug delivery, dental applications, diabetes, diagnostic imaging, cardiology, orthopedic applications, endoscopy, surgical applications, and other applications. The drug delivery segment is expected to grow at the highest CAGR during the forecast period 2024-2031. The growth of this segment is driven by the growing trend of self-administering medications, the increasing preference for home healthcare, innovations such as smart inhalers, and growing initiatives by contract manufacturers to strengthen their drug delivery device manufacturing capabilities.

Based on end user, the medical device contract manufacturing market is segmented into large-scale medical device companies, mid-scale medical device companies, and small-scale medical device companies. In 2024, the large-scale medical device companies segment is expected to account for the largest share of the medical device contract manufacturing market. MedTech is a constantly innovating industry that requires high standards of quality. The demand for advanced medical technologies is growing globally owing to the growing disease burden. Established large-scale medical device companies that struggle with cost containment benefit from the cost efficiencies of contract manufacturers while also enhancing scalability, quality, and affordability.

An in-depth analysis of the geographical scenario in the contract medical device manufacturing market provides detailed qualitative and quantitative insights about five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. In 2024, North America is expected to account for the largest share of 44% of the global contract medical device manufacturing market, followed by Europe and Asia-Pacific. Additionally, the U.S. is expected to account for the major share of the medical device contract manufacturing market in North America. The large market share of the U.S. is attributed to the technologically advanced manufacturing capabilities of contract manufacturers, the presence of leading market players, the presence of leading IVD and MedTech companies, and the high demand for medical devices in the country.

The key companies operating in the medical device contract manufacturing market include Jabil Inc. (U.S.), Gerresheimer AG (Germany), Nordson Corporation (U.S.), Teleflex Incorporated (U.S.), Celestica Inc. (Canada), Plexus Corp (U.S.), SteriPack Group Ltd (U.S.), Nortech Systems, Inc. (U.S.), Invetech Pty. Ltd. (Australia), Flextronics International, LTD. (Singapore), Benchmark Electronics Inc. (U.S.), Integer Holdings Corporation (U.S.), and STRATEC SE (Germany).

Scope of the Report:

Medical Device Contract Manufacturing Market-by Device

• IVD Devices
  • IVD Consumables
  • IVD Instruments
• Immunoassay Analyzers
• Biochemistry/Clinical Chemistry Analyzers
• Molecular Diagnostic Instruments
• Other IVD Instruments
• Imaging Devices
  • MRI Scanners
  • CT Scanners
  • Ultrasounds
  • X-rays
  • Other Imaging Devices
• Drug Delivery Devices
  • Nasal & Pulmonary Drug Delivery Devices
  • Parenteral Drug Delivery Devices
  • Other Drug Delivery Devices
• Cardiovascular Devices
  • Defibrillators
  • Pacemakers
  • Cardiac Monitors
• Orthopedic Devices
• Endoscopy Devices
• Ophthalmology Devices
• Dental Devices
• Patient Monitoring Devices
  • Patient Monitors
  • Glucometers
  • Apnea Monitors
  • Fetal Monitors
  • Weight Monitors
  • Oximeters
• Anesthesia Devices
• Mobility Aids
• Surgical Systems
• Consumables
• Other Devices

Note: Other devices include urology devices (dialysis) and sterilization devices.

Medical Device Contract Manufacturing Market- by Service

• Design & Development
  • Molding
  • Designing & Engineering
• Manufacturing
  • Device Manufacturing
  • Component Manufacturing
  • Accessories Manufacturing
  • Assembly Manufacturing
• Testing & Validation
• Quality Assurance
• Implementation & Maintenance Services
• Packaging Services
• Regulatory Affairs Services
  • Legal Representation Services
  • Clinical Trial Services
  • Regulatory Writing & Publishing
  • Other Services

Note: Other services include product upgrade services, product sterilization, labeling, material selection, and supply chain services.

Medical Device Contract Manufacturing Market-by Risk Type

• Low-risk Medical Devices
• Moderate-risk Medical Devices
• High-risk Medical Devices

Medical Device Contract Manufacturing Market-by Application

• IVD
• Drug Delivery
• Dental Applications
• Diabetes
• Diagnostic Imaging
• Cardiology
• Orthopedic Applications
• Endoscopy
• Surgical Applications
• Other Applications

Note: Other applications include neurology, ophthalmology, gastroenterology, and gynecology.

Medical Device Contract Manufacturing Market-by End User

• Large-scale Medical Device Companies
• Mid-scale Medical Device Companies
• Small-scale Medical Device Companies

Medical Device Contract Manufacturing Market-by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Switzerland
  • Sweden
  • Belgium
  • Rest of Europe (RoE)
• Asia-Pacific (APAC)
  • Japan
  • China
  • India
  • Singapore
  • Rest of Asia-Pacific (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America (RoLATAM)
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East & Africa (RoMEA)

TABLE OF CONTENTS

1. Overview

• 1.1. Market Definition and Scope
• 1.2. Market Ecosystem
• 1.3. Currency and Limitations
• 1.4. Key Stakeholders

2. Research Methodology

• 2.1. Research Approach
• 2.2. Process of Data Collection and Validation
  • 2.2.1. Secondary Research
  • 2.2.2. Primary Research/Interviews with Key Opinion Leaders of The Industry
• 2.3. Market Sizing and Forecast
  • 2.3.1. Market Size Estimation Approach
  • 2.3.2. Growth Forecast Approach
  • 2.3.3. Market Share Analysis
• 2.4. Assumptions For the Study

3. Executive Summary

4. Market Insights

• 4.1. Overview
• 4.2. Factors Affecting Market Growth
  • 4.2.1. Market Dynamics
    • 4.2.1.1. Drivers
      • 4.2.1.1.1. Technical Expertise Offered by Medical Device Contract Manufacturers
      • 4.2.1.1.2. Technological Advancements in Manufacturing Processes
      • 4.2.1.1.3. Growth in Medical Device & IVD Industry
      • 4.2.1.1.4. Changing Regulatory Landscape for Medical Devices
    • 4.2.1.2. Restraints
      • 4.2.1.2.1. Stringent Technical & Regulatory Requirements for Medical Devices
    • 4.2.1.3. Opportunities
      • 4.2.1.3.1. Industry 4.0
      • 4.2.1.3.2. Growing Healthcare Expenditure and Demand for Quality Healthcare in Developing Countries
    • 4.2.1.4. Challenges
      • 4.2.1.4.1. Maintaining Product Quality and Protection of Proprietary Information
      • 4.2.1.4.2. Rising Raw Material Costs
• 4.3. Trends
  • 4.3.1. Pricing pressures in MedTech Influencing Outsourcing
  • 4.3.2. Outsourcing of Wearable Medical Devices
• 4.4. Porter's Five Forces Analysis
• 4.5. Value Chain Analysis
• 4.6. Case Studies

5. Medical Device Contract Manufacturing Market Assessment-by Device

• 5.1. Overview
• 5.2. IVD Devices
  • 5.2.1. IVD Consumables
  • 5.2.2. IVD Instruments
    • 5.2.2.1. Immunoassay Analyzers
    • 5.2.2.2. Biochemistry/Clinical Chemistry Analyzers
    • 5.2.2.3. Molecular Diagnostics Instruments
    • 5.2.2.4. Other IVD Instruments
• 5.3. Imaging Devices
  • 5.3.1. MRI Scanners
  • 5.3.2. CT Scanners
  • 5.3.3. X-rays
  • 5.3.4. Ultrasounds
  • 5.3.5. Other Imaging Devices
• 5.4. Drug Delivery Devices
  • 5.4.1. Nasal & Pulmonary Drug Delivery Devices
  • 5.4.2. Parenteral Drug Delivery Devices
  • 5.4.3. Other Drug Delivery Devices
• 5.5. Cardiovascular Devices
  • 5.5.1. Defibrillators
  • 5.5.2. Pacemakers
  • 5.5.3. Cardiac Monitors
• 5.6. Orthopedic Devices
• 5.7. Endoscopy Devices
• 5.8. Ophthalmology Devices
• 5.9. Dental Devices
• 5.10. Patient Monitoring Devices
  • 5.10.1. Patient Monitors
  • 5.10.2. Glucometers
  • 5.10.3. Apnea Monitors
  • 5.10.4. Fetal Monitors
  • 5.10.5. Weight Monitors
  • 5.10.6. Oximeters
• 5.11. Anesthesia Devices
• 5.12. Mobility Aids
• 5.13. Surgical Systems
• 5.14. Consumables
• 5.15. Other Devices

6. Medical Device Contract Manufacturing Market Assessment-by Risk Type

• 6.1. Overview
• 6.2. Low-risk Medical Devices
• 6.3. Moderate Risk Medical Devices
• 6.4. High-risk Medical Devices

7. Medical Device Contract Manufacturing Market Assessment-by Service

• 7.1. Overview
• 7.2. Design & Development
  • 7.2.1. Molding
  • 7.2.2. Designing & Engineering
• 7.3. Manufacturing
  • 7.3.1. Device Manufacturing
  • 7.3.2. Component Manufacturing
  • 7.3.3. Accessories Manufacturing
  • 7.3.4. Assembly Manufacturing
• 7.4. Testing and Validation
• 7.5. Quality Assurance
• 7.6. Implementation and Maintenance Services
• 7.7. Packaging Services
• 7.8. Regulatory Affairs Services
  • 7.8.1. Legal Representation Services
  • 7.8.2. Clinical Trial Services
  • 7.8.3. Regulatory Writing & Publishing
• 7.9. Other Services

8. Medical Device Contract Manufacturing Market Assessment-by Application

• 8.1. Overview
• 8.2. IVD
• 8.3. Drug Delivery
• 8.4. Dental Applications
• 8.5. Diabetes
• 8.6. Diagnostic Imaging Applications
• 8.7. Cardiology Applications
• 8.8. Orthopedic Applications
• 8.9. Endoscopy Applications
• 8.10. Surgical Applications
• 8.11. Other Applications

9. Medical Device Contract Manufacturing Market Assessment-by End User

• 9.1. Overview
• 9.2. Large-scale Medical Device Companies
• 9.3. Mid-scale Medical Device Companies
• 9.4. Small-scale Medical Device Companies

10. Medical Device Contract Manufacturing Market Assessment-by Geography

• 10.1. Overview
• 10.2. North America
  • 10.2.1. U.S.
  • 10.2.2. Canada
• 10.3. Europe
  • 10.3.1. Germany
  • 10.3.2. France
  • 10.3.3. U.K.
  • 10.3.4. Italy
  • 10.3.5. Spain
  • 10.3.6. Switzerland
  • 10.3.7. Sweden
  • 10.3.8. Belgium
  • 10.3.9. Rest of Europe
• 10.4. Asia-Pacific
  • 10.4.1. China
  • 10.4.2. India
  • 10.4.3. Japan
  • 10.4.4. Singapore
  • 10.4.5. Rest of Asia-Pacific
• 10.5. Latin America
  • 10.5.1. Brazil
  • 10.5.2. Mexico
  • 10.5.3. Rest of Latin America
• 10.6. Middle East & Africa
  • 10.6.1. South Africa
  • 10.6.2. Saudi Arabia
  • 10.6.3. Rest of Middle East & Africa

11. Competition Analysis

• 11.1. Overview
• 11.2. Key Growth Strategies
• 11.3. Competitive Benchmarking
• 11.4. Competitive Dashboard
  • 11.4.1. Industry Leaders
  • 11.4.2. Market Differentiators
  • 11.4.3. Vanguards
  • 11.4.4. Emerging Companies
• 11.5. Market Share Analysis/ Market Ranking, by Key Players (2023)

12. Company Profiles (Business Overview, Financial Overview, Product Portfolio, Strategic Developments, and SWOT Analysis*)

• 12.1. Jabil Inc.
• 12.2. Gerresheimer AG
• 12.3. Nordson Corporation
• 12.4. Teleflex Incorporated
• 12.5. Celestica Inc.
• 12.6. Plexus Corp
• 12.7. SteriPack Group Ltd
• 12.8. Nortech Systems, Inc.
• 12.9. Invetech Pty.Ltd.
• 12.10. Flextronics International, LTD.
• 12.11. Benchmark Electronics Inc.
• 12.12. Integer Holdings Corporation
• 12.13. STRATEC SE

(Note: SWOT Analysis of the Top 5 Companies Will Be Provided)

13. Appendix

• 13.1. Available Customization
• 13.2. Related Reports