USD 73.25 billion
Medical Device Contract Manufacturing Market Size, Share, Growth Analysis, By Device Type (IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Drug Delivery Devices), By Class Device (Class I: General controls, Class II: General controls with special controls, and Class III: General controls, special controls), By Service (Device Development and Manufacturing, Quality Management, Packaging and Assembly Services, and Other Services), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35A2534 |
Region:
Global |
Published Date: September, 2024
Pages:
219
|Tables:
94
|Figures:
75
Medical Device Contract Manufacturing Market Insights
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 for medical devices is experiencing robust growth, driven by increased demand for the medical devices and technological advancements in the market has shown resilience and recovery, with a significant increase in the outsourcing of medical devices. The increase is driven by higher demand for devices such as ventilators and COVID-19-related products, putting companies in touch with contractors for their expertise and capabilities. The medical device contract manufacturing market with its diverse range of devices and product lines drives the demand for contract manufacturing services.
Companies that do not have in-house manufacturing facilities are turning into more contract manufacturers, fueling market growth. The initiatives taken to widen the acceptance and usage of medical devices across the globe, such as new regulatory framework and strategic approach also contribute to the market expansion. The in vitro diagnostic (IVD) device segment is poised to hold a significant share of the market demand for providing point-of-care devices is increasing. The market is driven by accessibility and expansion by key market players in North America, especially the US, as a key contributor to the market.
US Medical Device Contract Manufacturing Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2024-2031
Global Market Size
Largest Segment
IVD devices
Fastest Growth
Patient monitoring devices
Growth Rate
11.30% CAGR
Global medical device contract manufacturing Market ($ Bn)
Country Share for North America Region (%)
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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 medical device contract manufacturing 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 medical device contract manufacturing market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Medical Device Contract Manufacturing Market Analysis by End User
The pharmaceutical and biopharmaceutical companies segment dominated the market in 2023 with a revenue share of 55.6%. Many biotechnology and pharmaceutical companies such as Bristol-Myers Squibb (BMS), GlaxoSmithKline, Novartis, Eli Lilly & Co., AstraZeneca invest in synthetic devices. The market has grown exponentially to introduce new product categories, such as vaccines, nanobodies, rDNA, immunoconjugates, soluble receptors, and immunotherapy. As biologics have revolutionized the treatment of diseases, the industry presents numerous opportunities to explore hybrid systems that blend biologics with well-defined drugs. Pharmaceutical and biopharmaceutical companies are therefore increasingly offering biotechnology contracts to CMOs, increasing the growth of the segment.
The medical device companies segment posted a substantial CAGR of 9.4% from 2024 to 2031. Electronics, material science, & software solutions, rising medical-device therapies have driven shift in paradigms in medical device contract manufacturing market competition. The above factors increased the cost of internal production, thereby outsourcing to industry specialists enabled the market players to concentrate their expertise majors and offered quality products at affordable costs. Stricter regulations and increased the cost pressures have a significant impact on medical device industry. The development of high-quality and safe devices for patient care is a major concern for medical device manufacturers. Additionally, the medical device regulatory landscape is vast and complex due to the regulatory and technical issues. As a result, firms are shifting their focus to innovation rather than non-core activities, and outsourcing has enabled market actors to reduce the risks.
Medical Device Contract Manufacturing Market Analysis by Class Device
Class II medical devices held the largest market share of 81.34% in 2023 and the segment is expected to register the fastest CAGR of 14.0% during the forecast period due to high cost of medical devices. The category includes catheters, syringes, surgical gloves, blood pressure monitors, pregnancy test kits, spectacles, and blood samples. These devices carry a higher risk than Class I devices because they must be in constant contact with patients. OEMs that manufacture Class II equipment often require contractors who can provide valuable services, such as technical support, legal support, and supply chain management. This segment provides a difference between contract manufacturers, as they must coordinate closely with OEMs to ensure compliance and quality control.
Class I medical devices are also expected to witness significant growth during the forecast period. These devices are non-invasive. Currently 47.0% of devices fall into this category and 95.0% of devices in this category are exempt due to low risk. Class I devices are easier and faster to buy from the market due to low risk for patient therefore and rarely life-threatening ongoing care. Class I devices are considered low-risk medical devices that cause minimal harm to users. These items include simple equipment and devices, such as bandages, hearing aids, tongue dressings and hospital beds. Class I machine tools are subject to less stringent regulatory requirements, such as good manufacturing processes (GMPs) and other controls. This simplifies the manufacture of Class I devices, allowing contractors to manufacture them efficiently with minimal financial regulatory burden.
Global medical device contract manufacturing Market By device type
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Medical Device Contract Manufacturing Market Regional Insights
North America dominated the medical device contract manufacturing market share in 2023 with 36.1% revenue. Notably, there are many established biotechnology, pharmaceutical and medical device companies. In addition, increasing R&D investments by life sciences and pharmaceutical companies are expected to increase the sector’s demand for contract manufacturing independently. Strict regulation manufacturing and quality issues are also expected to provide opportunities for growth in medical device contract manufacturing.
Asia-Pacific is expected to witness a profitable growth rate of 10.6% during the forecast period due to improving healthcare infrastructure and economic growth in developing countries. This can be attributed to supportive regulatory changes, especially in countries like India, and cost-saving opportunities in Asian countries. Moreover, cGMP-compliant areas are expected to be established market players in the region will boost the market. Moreover, China is a major producer of low-cost electronics and goods. Therefore, it is expected to attract a significant number of investors. Furthermore, labor flexibility is greater in Asia Pacific due to lower production costs, tax advantages and availability of relatively cheap skilled labor but differences in time zones, cultures, speech and intellectual property rights in may restrain the growth of the market.
Global medical device contract manufacturing Market By Region
- Largest
- Fastest
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Medical Device Contract Manufacturing Market Dynamics
Medical Device Contract Manufacturing Market Drivers
Growing Demand for Medical Devices
- Increasing demand for medical devices arising from increasing incidence of chronic diseases, aging population and advancement in healthcare is a major driver of the medical device contract manufacturing market. Growing demand for new high-end equipment and original equipment manufacturers (OEMs) collaborate with contractors to increase productivity and reduce costs. This collaborative effort that also draws attention building on similar core competencies enables faster production timelines and enhances world-class medical technology.
Increasing Outsourcing in the Healthcare Sector
- In the healthcare industry, outsourcing has become an option for OEMs aiming to streamline operations and reduce costs. Medical device companies are increasingly choosing to outsource manufacturing to specialist organizations that have the expertise and resources necessary to meet stringent regulatory standards. Contractors bring valuable services such as technical support, supply chain management, and compliance expertise, allowing medical device companies to focus on innovation while maintaining quality good and cost in production.
Medical Device Contract Manufacturing Market Restraints
Regulatory Compliance and Quality Control Challenges
- One of the key challenges facing the medical device contract manufacturing market is the complexity of regulatory compliance. Different countries and regions have different standards for medical device manufacturing and certification, such as the FDA in the United States and the European Medicines Agency (EMA) in Europe affecting manufacturers and OEMs.
Supply Chain Disruptions
- Additional global supply chain disruptions due to events such as COVID-19 pandemic, geopolitical conflicts etc. have hindered the growth of medical device contract manufacturing market. Dependence on raw material imports and delays in component deliveries can severely impact production timelines, leading to increased costs and delays in product launches. This volatility in the supply chain forces both contract manufacturers and OEMs to reassess their procurement strategies and invest in more resilient supply chain models.
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Medical Device Contract Manufacturing Market Competitive Landscape
The competitive landscape of the medical device contract manufacturing market is composed of a wide variety of players including established companies, specialty contractors and emerging companies. These companies compete based on their technological expertise, manufacturing capabilities, regulatory compliance, and ability to provide end-to-end services, from product design to production and post-market support. Strategic partnerships, mergers and acquisitions, and investment in cutting-edge technologies are common strategies used by key players to maintain a competitive edge in this rapidly evolving market.
Medical Device Contract Manufacturing Market Top Player's Company Profiles
- 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, Inc. (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)
- Mehow (Japan)
Medical Device Contract Manufacturing Market Recent Developments
- In March 2024, Medibrane Ltd, a prominent contract manufacturer in the Medical Device industry, is excited to announce a significant milestone with the signing of a manufacturing representation agreement with HnG Medical Incorporated, a leading player in the Chinese healthcare market. This collaboration reflects Medibrane's commitment to broadening its global footprint and introducing its cutting-edge solutions to the dynamic healthcare sector in China.
- In January 2024, KBI Biopharma and Argonaut Manufacturing Services have formed a strategic alliance.
- In March 2024, The Canadian Life Science and Technology Park, Allyant, and IPS have announced a strategic, multi-year partnership aimed at advancing the design and engineering of a state-of-the-art Life Science, Healthcare, and Technology Park. This collaboration leverages expertise in design and construction oversight tailored for specialized turnkey startups, commercial manufacturing, and comprehensive support facilities.
Medical Device Contract Manufacturing Key Market Trends
Technological Advances in Manufacturing:
- The adoption of advanced manufacturing technologies such as automation, 3D printing, and robotics is revolutionizing medical device contract manufacturing. These innovations increase, lower production, accuracy time, permitting cost-powerful customization of the medical devices. For instance, 3D printing permits rapid prototyping and production of complex scientific tool parts, at the same time as automation guarantees steady and scalable product quality and increases innovation and efficiency in the medical device contract manufacturing industry.
Increased Focus on Sustainability and Environmentally Friendly Practices:
- Sustainability is a key focus for medical device contract manufacturers, and companies are increasingly adopting environmentally friendly practices. Regulatory pressure and market demand for green solutions are driving this shift. Manufacturers can reduce their environmental impact by investing in energy efficient manufacturing processes, recyclable materials and reducing waste. These sustainable practices not only help companies comply with regulations, but also raise their profile among OEMs and customers who prioritize environmentally friendly products.
Medical Device Contract Manufacturing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to SkyQuest analysis, contract manufacturing of medical devices is experiencing strong growth, driven by increasing demand for medical devices, increasing exports OEMs are relying on contract manufacturers to consume production and meet the requirements and focus on other areas. However, regulatory challenges and supply chain disruptions are severely hampering the growth of the market. Technological advances and sustainability efforts represent key trends shaping the future of the industry. As contract manufacturers continue to innovate and adopt more flexible business models, they are well positioned to play a key role in global healthcare.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 63.58 billion |
| Market size value in 2031 | USD 167.99 billion |
| Growth Rate | 11.4% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Medical Device Contract Manufacturing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Medical Device Contract Manufacturing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Medical Device Contract Manufacturing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Medical Device Contract Manufacturing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Medical Device Contract Manufacturing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Medical Device Contract Manufacturing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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