Global Medical Device Contract Manufacturing Market Size By Device Type (IVD Devices, Diagnostic Imaging), Class Of Device (Class 1, Class 2), By Geographic Scope And Forecast

Medical Device Contract Manufacturing Market Size And Forecast

Medical Device Contract Manufacturing Market size was valued at USD 80,768.12 Million in 2023 and is projected to reach USD 200,355.88 Million by 2031, growing at a CAGR of 11.99% from 2024 to 2031.

Increasing prevalence of chronic diseases and increasing demand for early disease diagnosis are the factors driving market growth. The Global Medical Device Contract Manufacturing Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market.

Global Medical Device Contract Manufacturing Executive Summary

 A company that produces a whole product, a single part, or a larger product is considered to be subcontracting in the medical device manufacturing industry. The medical device sector includes devices, tools, and equipment used for monitoring, treatments, and diagnostics. Implanted cardiac and diabetes monitoring are among them, as are reconstructive equipment such as hip and knee replacements. Medical device Original Equipment Manufacturers (OEMs) are businesses that often focus on a particular competency, such as molding, assembly, or R&D design. The process by which a manufacturing company produces medical devices or components of medical devices that are subsequently marketed by other businesses is known as medical device manufacturing. Also, medical device contract manufacturers can provide competency due to their continuous practice in manufacturing, as they typically specialize in a specific process or task. The unique facilities required for the manufacturing of medical devices are also provided by OEMs. For every stage of production, from design to manufacture, On-site Medical Laboratories are essential. Clean rooms are also required to ensure that no germs or other pathogens are used during the manufacturing of medical equipment.

The ‘Global Medical Device Contract Manufacturing Market’ is witnessing significant growth owing to various driving factors such increasing prevalence of chronic conditions. Chronic diseases such as diabetes, cardiovascular diseases, respiratory disorders, and kidney diseases are becoming more widespread, primarily due to aging populations, lifestyle changes, and environmental factors. This surge in chronic conditions has led to a heightened demand for medical devices that manage, monitor, and treat these long-term health issues. As a result, medical device companies are under pressure to innovate and produce more sophisticated and reliable devices, prompting them to rely on contract manufacturers for their specialized expertise and advanced production capabilities.

However, high initial investment is a significant consideration in the medical device contract manufacturing industry. Developing and producing medical devices involves substantial upfront costs, which can be a barrier for many companies, especially startups. The initial expenses include research and development (R&D), regulatory approval processes, and the establishment of manufacturing facilities.

Moreover, technological advancements are revolutionizing medical device contract manufacturing, enabling companies to produce more complex and customized devices with greater efficiency and precision. One of the most significant advancements is additive manufacturing, commonly known as 3D printing. This technology allows for creating intricate device components that would be challenging or impossible to produce using traditional manufacturing methods. For instance, in March 2022, Johnson & Johnson’s subsidiary, DePuy Synthes, launched its ATTUNE Cementless Knee System, which uses 3D printing to create customized implants tailored to individual patient anatomies.

Global Medical Device Contract Manufacturing Market Attractiveness Analysis

The Global Medical Device Contract Manufacturing Market is experiencing a scaled level of attractiveness in the North America region. North America has a prominent presence and holds the major share of the global market accounting for market share of 36.8% in 2023. The region is projected to gain incremental market value of USD 41,827.23 Million and is projected to grow at a CAGR of 12.26% between 2024 and 2031.

North America is one of the most developed regions in the world in terms of several industry sectors. The increase in chronic and infectious disease instances is one of the main factors propelling North America’s medical devices industry. Diagnostic tests are necessary for the early detection, monitoring, and treatment of chronic illnesses such as cancer, infectious disorders, and cardiovascular diseases. Furthermore, the aging population and the demand for various medical devices are being driven by the growing emphasis on early diagnosis and treatment, which are the main factors driving the market’s expansion.

Global Medical Device Contract Manufacturing Market absolute Market Opportunity

The above diagram represents the absolute market opportunity for the Global Medical Device Contract Manufacturing Market. The Medical Device Contract Manufacturing Market is estimated to gain USD 11,745.14 Million in 2025 over 2024 value and the market is projected to gain a total of USD 119,587.76 Million between 2024 and 2031.

The factors that are responsible for the market to create a potential growth opportunity in the forecasted period includeThe use of automation and robotics in production processes is another significant technical advancement. Robots increase repeatability and precision, lowering human error and increasing the final output’s quality. Automated systems can manage complex assembly operations, from small, delicate components to larger, more durable devices, ensuring consistent performance and adherence to strict quality standards.

Global Medical Device Contract Manufacturing Market Outlook

The increasing prevalence of chronic conditions drives the Medical Device Contract Manufacturing Market. Medical devices such as Blood Glucose Meters, Cardiac Pacemakers, Nebulizers, and Insulin Pumps are crucial in diagnosing and treating patients suffering from chronic conditions. Chronic diseases such as diabetes, cardiovascular diseases, respiratory disorders, and kidney diseases are becoming more widespread, primarily due to aging populations, lifestyle changes, and environmental factors. This surge in chronic conditions has led to a heightened demand for medical devices that manage, monitor, and treat these long-term health issues. As a result, medical device companies are under pressure to innovate and produce more sophisticated and reliable devices, prompting them to rely on contract manufacturers for their specialized expertise and advanced production capabilities.

High initial investment is a significant consideration in the medical device contract manufacturing industry. Developing and producing medical devices involves substantial upfront costs, which can be a barrier for many companies, especially startups. The initial expenses include research and development (R&D), regulatory approval processes, and the establishment of manufacturing facilities. According to industry reports, the R&D phase alone can account for up to 40% of the total cost of bringing a new medical device to market. This phase typically requires extensive prototyping, testing, and refinement to ensure the device meets stringent safety and efficacy standards.

Technological advancements are revolutionizing medical device contract manufacturing, enabling companies to produce more complex and customized devices with greater efficiency and precision. One of the most significant advancements is additive manufacturing, commonly known as 3D printing. This technology allows for creating intricate device components that would be challenging or impossible to produce using traditional manufacturing methods. For instance, in March 2022, Johnson & Johnson’s subsidiary, DePuy Synthes, launched its ATTUNE Cementless Knee System, which uses 3D printing to create customized implants tailored to individual patient anatomies. The precision and customization offered by 3D printing drive innovation, expanding medical device design and production possibilities.

Porter’s Five Forces Analysis

The Porters five forces analysis helps in analysing the identification of the market competitiveness by understanding several market related parameters such as bargaining power of suppliers, bargaining power of buyers, barrier to new entrants, threat of substitute and competitive rivalry. These parameters focuses on various different aspects of the Medical Device Contract Manufacturing Market. Porter’s five forces framework provides a blueprint for understanding the behaviour of competitors and a player’s strategic positioning in the respective industry. This section evaluate the different external factors that will impact competitive position over the coming year. Suppliers power helps in understanding how the market prices are driven, whereas the power of the buyers drives the prices down. If there are any possible threats for the market which helps in understanding the market trend and increase in the overall prices. The market faces threat from various global as well as local companies which depends on the government policies, initial investment in the business, trade policies and others.

Value Chain Analysis

Research and Development (R&D)The R&D phase is crucial for innovating and developing new medical devices. It involves ideation, concept design, prototyping, and initial testing. Contract manufacturers often collaborate closely with medical device companies during this stage to ensure that the designs are manufacturable and meet regulatory standards. Investments in advanced R&D capabilities and technologies, such as 3D printing and simulation, are critical to staying competitive.

Sourcing and ProcurementThis stage involves procuring raw materials, components, and subassemblies required for manufacturing medical devices. Effective sourcing strategies are vital to ensure the availability of high-quality inputs at competitive prices. Contract manufacturers typically establish relationships with multiple suppliers to mitigate risks and ensure a steady supply chain. Quality assurance and compliance with regulatory standards are paramount during this stage.

ManufacturingThe manufacturing stage is the core of the value chain, where raw materials and components are transformed into finished medical devices. This process includes various sub-stages such as machining, assembly, testing, and packaging. Advanced manufacturing technologies, including automation, robotics, and precision engineering, are employed to ensure high quality, efficiency, and consistency. Compliance with Good Manufacturing Practices (GMP) and regulatory standards is critical to ensure product safety and effectiveness.

Quality Control and AssuranceQuality control and assurance are integral throughout the entire manufacturing process. Rigorous testing and validation procedures are implemented to ensure the devices meet all regulatory and safety standards. This includes both in-process checks and final product inspections. Contract manufacturers must maintain detailed documentation and traceability to comply with regulatory requirements, which helps promptly address any potential issues.

Regulatory ComplianceRegulatory compliance is a continuous and essential value chain component. Contract manufacturers must navigate complex regulatory landscapes, including standards set by bodies like the FDA, CE, and ISO. This involves meeting current regulatory requirements and staying updated with any changes in regulations. Compliance ensures that the medical devices are safe, effective, and eligible for market approval.

Distribution and LogisticsOnce the medical devices are manufactured and have passed all quality checks, they are packaged and distributed to medical facilities, retailers, or consumers. Efficient logistics and distribution networks are crucial to ensure timely delivery and maintain product integrity. Contract manufacturers often collaborate with specialized logistics providers to handle the transportation and storage of medical devices, especially those requiring specific conditions, such as temperature control.

Aftermarket Services and SupportAftermarket services, including maintenance, repair, and customer support, are essential for ensuring customer satisfaction and loyalty. Contract manufacturers may provide these services directly or through partnerships with other service providers. This stage also involves gathering feedback for continuous improvement and addressing any issues post-distribution.

Global Medical Device Contract Manufacturing MarketSegmentation Analysis

The Global Medical Device Contract Manufacturing Market is segmented on the basis of Device Type, Class Of Device, and Geography.

Medical Device Contract Manufacturing Market, By Device Type

• IVD Devices
• Diagnostic Imaging
• Cardiovascular Devices
• Drug Delivery Devices
• Surgical Devices
• Patient Monitoring Devices
• Others

To Get a Summarized Market Report By Device Type-

Based on Device Type, The market is segmented into IVD Devices, Diagnostic Imaging, Cardiovascular Devices, Drug Delivery Devices, Surgical Devices, Patient Monitoring Devices, and Others. IVD Devices accounted for the largest market share of 25.26% in 2023, with a market value of USD 20,398.91 Million and is projected to grow at a CAGR of 12.78% during the forecast period. IVD devices, or “In Vitro Diagnostic” devices, are medical equipment that tests blood samples, urine, tissue, and other physiological fluids or substances obtained from the human body. These devices can detect diseases, disorders, or infections and are essential for diagnosing medical issues, monitoring health status, and guiding treatment decisions. Reagents and kits, analytical instruments, and software are vital components. This sector covers both IVD consumables and equipment. The market for IVD devices is growing due to increased demand for diagnostic testing, driven by the rising prevalence of chronic diseases and advances in diagnostic technology.

Medical Device Contract Manufacturing Market, By Class Of Device

• Class 1
• Class 2
• Class 3

Based on Class Of Device, The market is segmented into Class 1, Class 2, and Class 3. Class 2 accounted for the largest market share of 57.01% in 2023, with a market value of USD 46,048.32 Million and is projected to grow at a CAGR of 11.60% during the forecast period. A class II medical device has a moderate to high associated risk level. It is subject to FDA general and specific restrictions, including performance, labeling, clinical testing data, and post-market surveillance compliance requirements. Class 2 medical devices include blood pressure cuffs, pregnancy tests, syringes, infusion pumps, blood transfusion devices, powered wheelchairs, contact lenses, and some software used as diagnostic tools.Most importantly, most Class II devices enter the market through the premarket notification 510(k) process. The 510(k) is a sophisticated FDA application that proves a device’s safety and effectiveness by establishing that it is equivalent to another device on the market.

Medical Device Contract Manufacturing Market, By Geography

• North America
• Europe
• Asia Pacific
• Middle East And Africa
• Latin America