MEDICAL DEVICE CONTRACT MANUFACTURING MARKET: OVERVIEW
As per Roots Analysis, the global medical device contract manufacturing market valued at USD 78.8 billion in the current year is anticipated to grow at a CAGR of 8.2% during the forecast period.
The market sizing and opportunity analysis has been segmented across the following parameters:
Application Areas
- Therapeutic Medical Devices
- Diagnostic Medical Devices
- Drug Delivery Medical Devices
- Other Devices
Device Class
- Class I
- Class II
- Class III
Target Therapeutic Area
- Cardiovascular Disorders
- CNS Disorders
- Metabolic Disorders
- Oncological Disorders
- Ophthalmic Disorders
- Orthopedic Disorders
- Pain Disorders
- Respiratory Disorders
- Others
Key Geographical Regions
- North America (US)
- Europe (Italy, Germany, France, Spain, UK, Rest of the Europe)
- Asia-Pacific (China, Japan, India)
- Rest of the World
MEDICAL DEVICE CONTRACT MANUFACTURING MARKET: GROWTH AND TRENDS
Over the past 50 years, the medical device industry has seen several notable developments, such as the introduction of minimally invasive surgical instruments and the rise of implantable devices like pacemakers. Additionally, the use of biomedical devices like prostheses has increased substantially over time owing to the fact that each year, millions of individuals undergo surgeries and implantations. Further, cardioverter defibrillators, prosthetic hips and knees, contact lenses, and cardiac pacemakers are some of the most commonly implanted medical devices, while fixation devices and artificial joints account for about 44% of all medical devices. This is indicative of the growing demand for medical devices in the healthcare domain. However, most developers lack adequate resources and the necessary expertise to manufacture medical devices and related components.

Given the rise of medical device CROs, the opportunity for CMOs with expertise in medical devices is also steadily rising. It is worth highlighting that, since 2000, more than 65 CMOs have been established. Further, the World Health Organization reports approximately 2 million unique medical devices worldwide, classified into more than 7,000 generic device categories. Notably, CMOs are known to offer significant cost-benefits, access to sophisticated / up-to-date infrastructure, large production capacities and reduction in time-to-market. As a result, the opportunity for medical device contract manufacturing service providers is steadily increasing.
MEDICAL DEVICE CONTRACT MANUFACTURING MARKET: KEY INSIGHTS
The report delves into the current state of the medical device contract manufacturing market and identifies potential growth opportunities within industry. Some key findings from the report include:
- Novel technologies and platforms have emerged as one of the primary factors responsible for the establishment and success of a number of small and mid-sized medical device companies.
- Owing to complexities associated with regulatory compliance and approvals, increasing manufacturing costs and varying technologies, sponsors seek a manufacturing partner that can support the entire lifecycle of the device.
- Over 275 companies worldwide have the necessary expertise and authorization to offer contract manufacturing services for various types of medical devices, including therapeutic and diagnostic products
- The market landscape is fragmented, featuring the presence of both established players and new entrants; presently, most medical device manufacturing facilities are located in the developed geographies.

- Medical device CMOs are actively engaged in aligning their operations to comply with the standards established by various global and regional regulatory bodies.
- Implants have emerged as one of the most prominent segments for which the acquisition activity is relatively higher; key value drivers behind such acquisitions include capability addition and geographical consolidation.
- In the last six years, over 9,600 trials evaluating various medical devices have been registered by different types of sponsors covering a wide range of therapeutic areas.
- Companies involved in this domain are steadily expanding their capabilities in order to enhance their respective service portfolios and comply with evolving industry benchmarks.
- Driven by a rapidly growing demand, medical device contract services market is anticipated to grow at annualized rate of over 8.2% for a variety of therapeutic areas and geographies for finished products.

- Established CMOs currently occupy a major share; in the long term, the opportunity is anticipated to be better distributed across different types of companies, device classes and application areas.
MEDICAL DEVICE CONTRACT MANUFACTURING MARKET: KEY SEGMENTS
Therapeutic Medical Devices Segment holds the Largest Share of the Medical Device Contract Manufacturing Market
Based on the application areas, the market is segmented into therapeutic medical devices, diagnostic medical devices, drug delivery medical devices and other devices. At present, the therapeutic medical devices segment holds the maximum share of the global medical device contract manufacturing market owing to the increasing demand for therapeutic devices such as insulin pumps and infusion pumps. Further, the medical device contract manufacturing market for drug delivery devices segment is expected to show the highest market growth potential during the forecast period.
By Device Class, Class II is the Fastest Growing Segment of the Global Medical Device Contract Manufacturing Market
Based on the device class, the market is segmented into Class I, Class II and Class III. At present, the class II segment holds the maximum share of the global medical device contract manufacturing market. Further, owing to the various benefits offered by class II devices, such as ease of customization and diverse product range, the market for class II segment is expected to grow at a higher CAGR during the forecast period.
By Target Therapeutic Area, Orthopedic Disorders Segment Accounts for the Largest Share of the Global Medical Device Contract Manufacturing Market
Based on the target therapeutic area, the market is segmented into cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others. Currently, the orthopedic disorders segment captures the highest proportion of the global medical device contract manufacturing market. However, the metabolic disorders segment is expected to grow at a higher CAGR during the forecast period owing to the growing prevalence of metabolic disorders such as obesity, insulin resistance, Type 1 diabetes and hypertension.
North America Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. Currently, North America dominates the global medical device contract manufacturing market and accounts for the largest revenue share. Further, the market in Asia-Pacific is likely to grow at a higher CAGR in the coming future.
Example Players in the Medical Device Contract Manufacturing Market
- Cirtec Medical
- Creganna Medical
- DynaFlex Technologies
- Europlaz Technologies
- I-Tek Medical Technologies
- Interplex
- Keystone Solutions Group
- Modern Medical
- Oscor
- Riverside Medical Packaging
- SMC
- Synecco
- Suzhou Jenitek
- Stellartech Research
- Trelleborg Sealing Solutions
MEDICAL DEVICE CONTRACT MANUFACTURING MARKET: RESEARCH COVERAGE
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global medical device contract manufacturing market, focusing on key market segments, including [A] application areas, [B] device class, [C] target therapeutic area and [D] key geographical regions.
- Market Landscape: A comprehensive evaluation of the medical device contract manufacturers, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] manufacturing facilities, [D] geographical location, [E] type of device manufactured, [F] the scale of operation and [G] types of services offered.
- Regulatory Landscape for Medical Devices: A comprehensive discussion of the various guidelines established by major regulatory bodies for medical device approval across different countries. Additionally, the section includes a multi-dimensional bubble analysis, focusing on a comparison of the contemporary regulatory scenario in key geographies across the globe.
- Benchmark Analysis: A comprehensive benchmark analysis emphasizing the primary focus areas of small, mid-sized, and large companies, comparing their current capabilities within and across peer groups, and offering stakeholders insights to achieve a competitive advantage in the industry.
- Supply Chain Analysis: A detailed analysis of medical device supply chain, highlighting the role of CMOs engaged in the medical device contract manufacturing market and analysis based on services offered, such as [A] supply chain management services, [B] logistics services, [C] shipping services, and [D] warehousing services.
- Company Profiles: In-depth profiles of key players that specialize in providing services for both pre-commercial and commercial scale manufacturing of medical devices, focusing on [A] overview of the company, [B] service portfolio, [C] manufacturing facilities and [D] recent developments and an informed future outlook.
- Clinical Trial Analysis: An insightful analysis of clinical trials related to medical devices, based on several parameters, such as [A] number of registered trials, [B] current status of trials, [C] phase of development, [D] type of sponsor, [E] therapeutic area(s), [F] target disease indication(s), and [G] number of patients enrolled.
- Mergers and Acquisitions: An in-depth analysis of mergers and acquisitions undertaken in the medical device contract manufacturing market highlighting the number of companies acquired in recent years. Further, in depth-analysis of the key value drivers for these mergers and acquisitions was performed. In addition, the analysis features an ownership change matrix, providing a summary of the involvement of private and public sector entities in the market.
- SWOT Analysis: An analysis of industry affiliated trends, opportunities and challenges, which are likely to impact the evolution of antibody contract manufacturing market; it includes a Harvey ball analysis, assessing the relative impact of each SWOT parameter on industry dynamics.
KEY QUESTIONS ANSWERED IN THIS REPORT
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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