Medical Device Contract Manufacturing Market Size by Device Type (IVD, Cardiovascular, Drug Delivery (Autoinjectors, Infusion Device), Diabetes Care, Orthopedic, Ophthalmology, Endoscopy, Surgical), Device Class (I, II, III), Services & Region - Global Forecast to 2029
The global size of medical device contract manufacturing market in terms of revenue was estimated to be worth USD 78.9 billion in 2024 and is poised to reach USD 149.4 billion by 2029, growing at a CAGR of 11.4% from 2024 to 2029. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.
Medical device contract manufacturing is rapidly transforming the industry, offering significant advantages for manufacturers. Industry 4.0 includes integration of automation, robotics, and data analytics in MDCM enhances production efficiency, precision, and consistency. Additive manufacturing (3D printing) technology allows for the creation of complex and customized medical devices, expanding the possibilities for innovative solutions which is expected drive the medical device contract manufacturing.
In this report, the medical device contract manufacturing market is segmented into – device type, class of device, service and region.
Attractive Opportunities in the Medical Device Contract Manufacturing Market
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Medical device contract manufacturing Market Dynamics
Driver: Rising aging population
Life expectancy is increasing globally, while birth rates are declining in many countries. This leads to a larger proportion of older adults in the population pyramid, the United Nations reports that the global population aged 60 years or over is projected to nearly double from 1 billion in 2020 to 2.1 billion by 2050 an aging population creates a higher demand for healthcare services, particularly those related to age-related conditions like dementia, heart disease, and chronic illnesses which is expected to drive the market growth.
Restraint: Stringent regulatory guidelines for medical devices.
Devices are categorized based on their level of potential risk to patients (e.g., Class I - low risk, Class III - high risk). Stringency of regulations increases with higher risk classifications, manufacturers must demonstrate a documented and controlled design process that adheres to safety and performance standards further manufacturers are obligated to monitor their devices after they reach the market and report any adverse events which is expected to restrain the market growth.
Opportunity: Potential for growth in emerging countries
The potential for medical device contract manufacturing in emerging countries is significant, offering exciting opportunities for improved diagnostic devices access and enhanced treatment approaches. Emerging economies are experiencing rapid population growth, leading to an increased demand for healthcare services and medical devices. A burgeoning middle class with rising disposable income creates a larger consumer base willing to spend on advanced medical treatments and technologies. Governments in emerging countries are increasingly allocating resources towards improving healthcare accessibility and affordability. This can involve subsidies for medical devices or promoting local manufacturing which is expected to create opportunities for the growth of the market.
Challenge: Lack of constant innovation to balance technological capabilities against costs
High costs of innovation which includes expensive materials, complex manufacturing processes, and extensive clinical trials also strict regulatory guidelines necessitate rigorous testing and data collection, further adding to the overall cost of bringing new devices to market. The substantial investment required for innovation can translate to higher priced medical devices. This can limit accessibility for patients, especially in regions with limited resources which is expected to challenge the market growth.
Medical Device Contract Manufacturing Industry Ecosystem
The medical device contract manufacturing market is becoming increasingly competitive, with new players entering the market and established players vying for market share. This competition drives down prices as companies try to undercut each other. The cost of materials, equipment, and labor is increasing, putting pressure on dental businesses to maintain profitability while keeping prices competitive. Consolidation within the dental industry, particularly the rise of dental laboratories creates larger entities with greater purchasing power. This can lead to lower prices for supplies and equipment, further pressuring smaller players also government regulations and changes in insurance coverage can impact reimbursement rates for dental procedures, forcing providers to adjust their pricing strategies
By class of devices, class III is expected to show the highest CAGR of medical device contract manufacturing industry from 2024 to 2029.
The class of device segment is segmented into class I, class II and class III devices.
Class III devices are often critical for treating life-threatening conditions or supporting vital bodily functions. Examples include pacemakers, heart valves, and implantable defibrillators. These devices can restore or improve a patient's physical capabilities or organ function, significantly enhancing their quality of life which is expected to drive the segment growth.
By drug delivery devices, syringes is expected to show the highest CAGR of medical device contract manufacturing industry from 2024 to 2029.
The drug delivery devices market segment is sengemented into infusion sets/administration sets, syringes, inhalers and autoinjectors & pedn injectors.
Syringes play a crucial role in various drug delivery devices, serving as a core component due to several advantages. Syringes can be adapted to deliver a wide range of drugs, including medications, vaccines, and fluids also the design of syringes allows for accurate measurement and administration of specific drug volumes, ensuring patients receive the intended dosage. which is expected to drive the market growth.
Asia Pacific accounted for the largest CAGR of the global medical device contract manufacturing industry, by region in the forecast period.
The medical device contract manufacturing market in Asia Pacific is expected to grow at the highest CAGR due to a combination of factors that highlight the region's changing healthcare landscape. Some APAC governments are promoting diagnostic health awareness and offering subsidies for several treatments, further stimulating market growth. The aging population in APAC is increasing the demand for medical devices to address several chronic diseases. Increasing wealth in APAC countries is leading to higher spending on healthcare, including medical device contract manufacturing.
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The key players in the Medical device contract manufacturing market include Flex Ltd. (Singapore), Jabil Inc. (US), TE Connectivity Ltd. (Switzerland), Sanmina Corporation (US), Nipro Corporation (Japan), Celestica Inc. (Canada), Plexus Corp. (US), Integer Holdings Corporation (US), West Pharmaceutical Services, Inc. (US), Benchmark Electronics Inc. (US), Recipharm AB (Sweden), Gerresheimer AG (Germany), Kimball Electronics Inc. (US), Nortech Systems, Inc. (US), Nemera Development S.A. (France), Viant Medical Holdings, Inc. (US), Tecomet, Inc. (US), SMC Ltd. (US), Phillips-Medisize Corporation (US), Tessy Plastics Corp. (US), Carclo Plc (UK), Nolato GW, Inc. (US), MeHow (China), Tekni-Plex (US), and Peter’s Technology (China).
Scope of the Medical Device Contract Manufacturing Industry
|
Report Metric |
Details |
|
Market Revenue in 2024 |
$78.9 billion |
|
Projected Revenue by 2029 |
$149.4 billion |
|
Revenue Rate |
Poised to Grow at a CAGR of 11.4% |
|
Market Driver |
Rising aging population |
|
Market Opportunity |
Potential for growth in emerging countries |
The study categorizes the medical device contract manufacturing market to forecast revenue and analyze trends in each of the following submarkets:.
By Device Type
-
IVD Devices
- IVD Consumables
- IVD Equipment
- Diagnostic Imaging Devices
- Cardiovascular Devices
-
Drug Delivery Devices
- Infusion Devices and Administration Sets
- Syringes
- Inhalers
- Autoinjectors and Pen Injectors
- Orthopedic Devices
- Respiratory Care Devices
- Ophthalmology Devices
- Surgical Devices
- Diabetes Care Devices
- Dental Devices
- Endoscopy and Laparoscopy Devices
- Gynecology and Urology Devices
- Personal Care Devices
- Neurology Devices
- Patient Monitoring Devices
- Patient Assistive Devices
- Other Devices
By Class of Device
- Class I Medical Device
- Class II Medical Device
- Class III Medical Device
By Service
-
Device Development and Manufacturing Services
- Device and Component Manufacturing
- Process Development Services
- Device Engineering Services
-
Quality Management Services
- Packaging Validation Services
- Inspection and Testing Services
- Sterilization Services
-
Packaging and Assembly Services
- Primary and Secondary Packaging
- Labelling
- Others
- Other Services
By Region
-
Asia Pacific
- China
- Japan
- Malaysia and Singapore
- India
- Australia and New Zealand
- South Korea
- Rest of Asia Pacific
-
North America
- US
- Canada
-
Europe
- France
- Germany
- UK
- Italy
- Spain
- Rest of Europe
-
Latin America
- Mexico
- Brazil
- Rest of Latin America
- Middle East and Africa
- GCC Countries
Recent Developments of Medical Device Contract Manufacturing Industry:
- In November 2023, Jabil Inc. announced the successful acquisition of Retronix, an innovative provider in the reclamation and refurbishment of electronic components, completed earlier this year.
- In January 2023, Integer announced the acquisition of Pulse Technologies, Inc., a privately held technology, engineering and contract manufacturing company focused on complex micro machining of medical device components for high growth structural heart, heart pump, electrophysiology, leadless pacing, and neuromodulation markets.
- In January 2022, MixComm, the mmWave Antennas to Algorithms pioneer, announced it has selected Advanced Microsystems Technologies, a division of Sanmina as a lead partner to productize its 5G wireless infrastructure solutions
- In November 2021, Nipro Corporation entered into a partnership with toyobo for cellulose triacetate (CTA) dialyzers (artificial kidneys).
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the global medical device contract manufacturing market?
The global medical device contract manufacturing market boasts a total revenue value of $149.4 billion by 2029.
What is the estimated growth rate (CAGR) of the global medical device contract manufacturing market?
The global medical device contract manufacturing market has an estimated compound annual growth rate (CAGR) of 11.4% and a revenue size in the region of $78.9 billion in 2024. .
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The study involved four major activities in estimating the current size of the medical device contract manufacturing market. Exhaustive secondary research was done to collect information on the market, peer market, and parent market. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation were used to estimate the market size of segments and subsegments.
Secondary Research
The secondary research process involved the widespread use of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B Hoovers), white papers, annual reports, company house documents, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the medical device contract manufacturing market. It was also used to obtain important information about the key players and market classification and segmentation according to industry trends to the bottom-most level, and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.
Primary Research
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include industry experts such as CEOs, vice presidents, marketing and sales directors, technology & innovation directors, and related key executives from various key companies and organizations operating in the medical device contract manufacturing market. The primary sources from the demand side included industry experts, purchase & sales managers, doctors, and personnel from research organizations. Primary research was conducted to validate the market segmentation, identify key players in the market, and gather insights on key industry trends and key market dynamics.
A breakdown of the primary respondents for the medical device contract manufacturing market is provided below:
Note 1: C-level primaries include CEOs, COOs, CTOs, and VPs.
Note 2: Other primaries include Others include sales managers, marketing managers, and product managers.
Note 3: Companies are classified into tiers based on their total revenue. As of 2020: Tier 1=>USD 1 billion, Tier 2 = USD 500 million to USD 1 billion, Tier 3=<USD 500 million
To know about the assumptions considered for the study, download the pdf brochure
The research methodology used to estimate the size of the medical device contract manufacturing market includes the following details.
The market sizing of the market was undertaken from the global side.
Country-level Analysis: The size of the medical device contract manufacturing market was obtained from the annual presentations of leading players and secondary data available in the public domain. The share of products and services in the overall medical device contract manufacturing market was obtained from secondary data and validated by primary participants to arrive at the total medical device contract manufacturing market. Primary participants further validated the numbers.
Geographic market assessment (by region & country): The geographic assessment was done using the following approaches:
Approach 1: Geographic revenue contributions/splits of leading players in the market (wherever available) and respective growth trends
Approach 2: Geographic adoption trends for individual product segments by end users and growth prospects for each of the segments (assumptions and indicative estimates validated from primary interviews)
At each point, the assumptions and approaches were validated through industry experts contacted during primary research. Considering the limitations of data available from secondary research, revenue estimates for individual companies (for the overall medical device contract manufacturing market and geographic market assessment) were ascertained based on a detailed analysis of their respective product offerings, geographic reach/strength (direct or through distributors or suppliers), and the shares of the leading players in a particular region or country.
Global Medical device contract manufacturing Size: Top-Down Approach
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Global Medical device contract manufacturing Size: Bottom-Up Approach
Data Triangulation
After arriving at the overall market size—using the market size estimation processes explained above—the market was split into several segments and sub-segments. To complete the overall market engineering process and arrive at the exact statistics of each market segment and subsegment, data triangulation, and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
Medical Device Contract Manufacturing is a process where a MedTech company that owns the idea (sole proprietorship) outsources manufacturing to another Medical device manufacturing firm. The product is developed according to the specifications sent by the OEM company in compliance with ISO:13485 and FDA guidelines.
Key Stakeholders
- Manufacturers and distributors of medical devices
- Manufacturers and distributors of medical device components
- Medical device contract manufacturing companies
- Healthcare institutes
- Diagnostic laboratories
- Hospitals and clinics
- Academic institutes
- Research institutes
- Government associations
- Market research and consulting firms
- Venture capitalists and investors
Objectives of the Study
- To define, describe, segment, analyze, and forecast the global medical device contract manufacturing market by device type, class of device, service and region
- To provide detailed information about the factors influencing the market growth (drivers, restraints, opportunities, and challenges)
- To analyze micromarkets concerning individual growth trends, prospects, and contributions to the overall market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players.
- To forecast the size of the medical device contract manufacturing market in North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa and GCC countries.
- To profile the key players in the medical device contract manufacturing market and comprehensively analyze their core competencies.
- To track and analyze competitive developments such as agreements, collaborations, and partnerships; expansions; acquisitions; and product launches and approvals in the medical device contract manufacturing market.
- To analyze the impact of the recession on the medical device contract manufacturing market
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the report:
Geographic Analysis
- Further breakdown of the Rest of Asia Pacific medical device contract manufacturing market into Indonesia, Philippines, Vietnam, Hong Kong, and other countries
- Further breakdown of the Rest of Europe medical device contract manufacturing market into Belgium, Russia, the Netherlands, Switzerland, and other countries.
- Further breakdown of the Rest of Latin America medical device contract manufacturing market into Argentina, Peru, and other countries.
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