의료기기 제조 아웃소싱(MDMO) 시장 규모 조사 : 제품별, 의료기기 규제 분류별, 지역별 예측(2022-2032년)

Global Medical Device Manufacturing Outsourcing (MDMO) Market is valued at approximately USD 88.37 billion in 2023 and is anticipated to grow with a healthy growth rate of more than 10.87% over the forecast period 2024-2032. Medical Device Manufacturing Outsourcing (MDMO) involves contracting the production of medical devices to external companies. This allows device manufacturers to focus on research, development, and marketing while relying on specialized contract manufacturers for efficient and cost-effective production, ensuring product quality and regulatory compliance. The expansion of the market is driven by several key factors. Original Equipment Manufacturers (OEMs) are increasingly prioritizing the reduction of manufacturing costs for medical devices, seeking efficient and cost-effective solutions through outsourcing. Additionally, the escalating complexities in product design and development necessitate specialized expertise and advanced manufacturing capabilities, which outsourcing partners can provide. Emerging nations are becoming favored hubs for medical device production due to their lower labor costs and growing industrial capabilities, further boosting the market.

A stringent regulatory landscape imposes rigorous standards and compliance requirements, posing hurdles for outsourcing firms. Fierce competition within the market intensifies the need for differentiation and innovation among service providers. Moreover, delays in fulfilling contractual obligations and implementing new technologies can impact the timeliness and quality of production. Despite these challenges, the market continues to grow as the demand for high-quality, cost-efficient medical devices rises globally, driving OEMs to increasingly rely on outsourcing partners to meet their manufacturing needs.

The market is witnessing significant growth driven by several key factors. Firstly, the increasing prevalence of chronic diseases such as oncology, central nervous system diseases, and cardiovascular diseases has led to a rising demand for specialized medical devices tailored to these conditions. This demand, coupled with advancements in scientific innovation, has created opportunities for outsourcing firms to provide quality assurance, regulatory affairs, product design & development, and testing services to meet the evolving needs of the healthcare sector.

Moreover, the complexity and specialization of medical devices, such as coronary stents, orthopedic devices, and wound care products, require expertise in assembly, packaging, and the integration of electronic components and sensors. Outsourcing companies play a crucial role in providing these services efficiently, allowing medical device manufacturers to focus on core competencies like product innovation and market expansion. Additionally, the aging population and the growing prevalence of age-related conditions have further fueled the demand for medical devices, driving the outsourcing market to cater to the production, maintenance, and upgrading of these devices to ensure they meet the highest quality standards and regulatory requirements. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

The market is experiencing significant growth due to various factors, with one key driver being the growing focus of Original Equipment Manufacturers (OEMs) on reducing manufacturing costs. With healthcare budget constraints prevailing globally, OEMs are under pressure to maintain quality healthcare services while minimizing expenses. To achieve this, many OEMs are turning to outsourcing as a cost-effective solution. Outsourcing enables them to streamline operations, reduce production costs, and optimize resource utilization, thereby enhancing overall efficiency and competitiveness in the market.

Moreover, outsourcing manufacturing allows OEMs to leverage the expertise and capabilities of specialized contract manufacturers, particularly in areas such as product design, testing, sterilization, and maintenance. By partnering with experienced contract manufacturers, OEMs can access advanced manufacturing technologies, skilled labor, and efficient production processes, leading to improved product quality and accelerated time-to-market. As OEMs seek to enhance their cost-effectiveness and operational efficiency, the outsourcing of manufacturing is expected to continue to grow, driving the expansion of the market in the coming years.

The key regions considered for the global Medical Device Manufacturing Outsourcing (MDMO) Market study include Asia Pacific, North America, Europe, Latin America, and Rest of the World. North America is a dominating region in the Medical Device Manufacturing Outsourcing (MDMO) Market in terms of revenue. The market growth in the region is being attributed to factors including increasing complexity and cost of medical device development, stringent regulatory requirements, and the rapid pace of technological advancements. To meet these challenges, medical device companies are outsourcing manufacturing and development processes to specialized partners, allowing them to focus on core competencies and reduce costs while ensuring product quality and compliance. Whereas, the market in Asia Pacific is anticipated to grow at the fastest rate over the forecast period fueled by large pool of skilled labor at competitive costs, favorable government policies promoting manufacturing, and a rising geriatric population increasing demand for medical devices. Additionally, the region's focus on cost-reduction strategies and the growing preference for outsourcing non-core activities are propelling market growth.

Major market players included in this report are:

• Benchmark Electronics Inc.
• Celestica Inc.
• Cirtec Medical
• Eurofins Scientific SE
• Flex Ltd.
• Gerresheimer AG
• Heraeus Holding GmbH
• Integer Holdings Corp.
• Jabil Inc.
• Kimball Electronics Inc.
• NN Inc.
• Nortech Systems Inc.
• Plexus Corp.
• Tata Sons Pvt. Ltd.
• TE Connectivity Ltd.

The detailed segments and sub-segment of the market are explained below:

By Product:

• EMS
• Raw Materials
• Finished Goods

By Medical Device Regulatory Classification:

• Class I
• Class II
• Class III

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Spain
  • Italy
  • ROE
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • RoAPAC
• Latin America
  • Brazil
  • Mexico
  • RoLA
• Middle East & Africa
  • Saudi Arabia
  • South Africa
  • RoMEA

Years considered for the study are as follows:

• Historical year - 2022
• Base year - 2023
• Forecast period - 2024 to 2032

Key Takeaways:

• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with Country level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand side and supply side analysis of the market.

Table of Contents

Chapter 1. Global Medical Device Manufacturing Outsourcing (MDMO) Market Executive Summary

• 1.1. Global Medical Device Manufacturing Outsourcing (MDMO) Market Size & Forecast (2022-2032)
• 1.2. Regional Summary
• 1.3. Segmental Summary
  • 1.3.1. By Product
  • 1.3.2. By Medical Device Regulatory Classification
• 1.4. Key Trends
• 1.5. Recession Impact
• 1.6. Analyst Recommendation & Conclusion

Chapter 2. Global Medical Device Manufacturing Outsourcing (MDMO) Market Definition and Research Assumptions

• 2.1. Research Objective
• 2.2. Market Definition
• 2.3. Research Assumptions
  • 2.3.1. Inclusion & Exclusion
  • 2.3.2. Limitations
  • 2.3.3. Supply Side Analysis
    • 2.3.3.1. Availability
    • 2.3.3.2. Infrastructure
    • 2.3.3.3. Regulatory Environment
    • 2.3.3.4. Market Competition
    • 2.3.3.5. Economic Viability (Consumer's Perspective)
  • 2.3.4. Demand Side Analysis
    • 2.3.4.1. Regulatory frameworks
    • 2.3.4.2. Technological Advancements
    • 2.3.4.3. Environmental Considerations
    • 2.3.4.4. Consumer Awareness & Acceptance
• 2.4. Estimation Methodology
• 2.5. Years Considered for the Study
• 2.6. Currency Conversion Rates

Chapter 3. Global Medical Device Manufacturing Outsourcing (MDMO) Market Dynamics

• 3.1. Market Drivers
  • 3.1.1. OEMs prioritizing cost reduction
  • 3.1.2. Complexity and specialization in medical devices
  • 3.1.3. Growing demand for high-quality, cost-efficient devices
• 3.2. Market Challenges
  • 3.2.1. Stringent regulatory environment
  • 3.2.2. Fierce market competition
  • 3.2.3. Delays in fulfilling contractual obligations
• 3.3. Market Opportunities
  • 3.3.1. Advancements in drug delivery systems and formulations
  • 3.3.2. Increasing prevalence of chronic diseases

Chapter 4. Global Medical Device Manufacturing Outsourcing (MDMO) Market Industry Analysis

• 4.1. Porter's 5 Force Model
  • 4.1.1. Bargaining Power of Suppliers
  • 4.1.2. Bargaining Power of Buyers
  • 4.1.3. Threat of New Entrants
  • 4.1.4. Threat of Substitutes
  • 4.1.5. Competitive Rivalry
  • 4.1.6. Futuristic Approach to Porter's 5 Force Model
  • 4.1.7. Porter's 5 Force Impact Analysis
• 4.2. PESTEL Analysis
  • 4.2.1. Political
  • 4.2.2. Economical
  • 4.2.3. Social
  • 4.2.4. Technological
  • 4.2.5. Environmental
  • 4.2.6. Legal
• 4.3. Top investment opportunity
• 4.4. Top winning strategies
• 4.5. Disruptive Trends
• 4.6. Industry Expert Perspective
• 4.7. Analyst Recommendation & Conclusion

Chapter 5. Global Medical Device Manufacturing Outsourcing (MDMO) Market Size & Forecasts by Product 2022-2032

• 5.1. Segment Dashboard
• 5.2. Global Medical Device Manufacturing Outsourcing (MDMO) Market: Product Revenue Trend Analysis, 2022 & 2032 (USD Billion)
  • 5.2.1. EMS
  • 5.2.2. Raw Materials
  • 5.2.3. Finished Goods

Chapter 6. Global Medical Device Manufacturing Outsourcing (MDMO) Market Size & Forecasts by Medical Device Regulatory Classification 2022-2032

• 6.1. Segment Dashboard
• 6.2. Global Medical Device Manufacturing Outsourcing (MDMO) Market: Medical Device Regulatory Classification Revenue Trend Analysis, 2022 & 2032 (USD Billion)
  • 6.2.1. Class I
  • 6.2.2. Class II
  • 6.2.3. Class III

Chapter 7. Global Medical Device Manufacturing Outsourcing (MDMO) Market Size & Forecasts by Region 2022-2032

• 7.1. North America Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.1.1. U.S. Medical Device Manufacturing Outsourcing (MDMO) Market
    • 7.1.1.1. Product breakdown size & forecasts, 2022-2032
    • 7.1.1.2. Medical Device Regulatory Classification breakdown size & forecasts, 2022-2032
  • 7.1.2. Canada Medical Device Manufacturing Outsourcing (MDMO) Market
• 7.2. Europe Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.2.1. U.K. Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.2.2. Germany Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.2.3. France Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.2.4. Spain Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.2.5. Italy Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.2.6. Rest of Europe Medical Device Manufacturing Outsourcing (MDMO) Market
• 7.3. Asia-Pacific Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.3.1. China Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.3.2. India Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.3.3. Japan Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.3.4. Australia Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.3.5. South Korea Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.3.6. Rest of Asia Pacific Medical Device Manufacturing Outsourcing (MDMO) Market
• 7.4. Latin America Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.4.1. Brazil Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.4.2. Mexico Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.4.3. Rest of Latin America Medical Device Manufacturing Outsourcing (MDMO) Market
• 7.5. Middle East & Africa Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.5.1. Saudi Arabia Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.5.2. South Africa Medical Device Manufacturing Outsourcing (MDMO) Market
  • 7.5.3. Rest of Middle East & Africa Medical Device Manufacturing Outsourcing (MDMO) Market

Chapter 8. Competitive Intelligence

• 8.1. Key Company SWOT Analysis
  • 8.1.1. Benchmark Electronics Inc.
  • 8.1.2. Celestica Inc.
  • 8.1.3. Cirtec Medical
• 8.2. Top Market Strategies
• 8.3. Company Profiles
  • 8.3.1. Benchmark Electronics Inc.
    • 8.3.1.1. Key Information
    • 8.3.1.2. Overview
    • 8.3.1.3. Financial (Subject to Data Availability)
    • 8.3.1.4. Product Summary
    • 8.3.1.5. Market Strategies
  • 8.3.2. Celestica Inc.
  • 8.3.3. Cirtec Medical
  • 8.3.4. Eurofins Scientific SE
  • 8.3.5. Flex Ltd.
  • 8.3.6. Gerresheimer AG
  • 8.3.7. Heraeus Holding GmbH
  • 8.3.8. Integer Holdings Corp.
  • 8.3.9. Jabil Inc.
  • 8.3.10. Kimball Electronics Inc.
  • 8.3.11. NN Inc.
  • 8.3.12. Nortech Systems Inc.
  • 8.3.13. Plexus Corp.
  • 8.3.14. Tata Sons Pvt. Ltd.
  • 8.3.15. TE Connectivity Ltd.

Chapter 9. Research Process

• 9.1. Research Process
  • 9.1.1. Data Mining
  • 9.1.2. Analysis
  • 9.1.3. Market Estimation
  • 9.1.4. Validation
  • 9.1.5. Publishing
• 9.2. Research Attributes