Medical Device Contract Manufacturing Market 2024 – Market Size & Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Forecast 2032

Medical device contract manufacturing is a process whereby a medical technology (MedTech) company hires a contract manufacturer that specializes in making medical tool. The contract manufacturer makes parts or assembles for the product which is then sold by another company. Contract manufacturer usually has a specific role or process. The original equipment manufacturer (OEM) company provides specifications for the product, which the contract manufacturer must meet in compliance with FDA guidelines and ISO:13485. These types of contract manufacturers typically provide design, engineering, fabrication, assembly, packaging, sterilization, quality assurance, supply chain management, and after-market services among others to produce medical devices according to specifications and requirements provided by OEMs. Such a mechanism helps MedTech companies to focus on R&D of innovative medical technologies by overcoming the barriers related to in-house manufacturing.

The global medical devices contract manufacturing market has been witnessing significant growth due to various factors such as increasing demand for innovative medical devices, cost-efficiency, regulatory complexities, and outsourcing trends among medical device companies. Contract manufacturers offer expertise in engineering, quality assurance, and supply chain management, enabling medical device companies to focus on their core competencies.

The medical device contract manufacturing market is anticipated to reach USD XXX.X million by 2032 from USD XXX.X million in 2023, at a CAGR of XX.X% during the forecast period.

Technological innovations, such as additive manufacturing, robotics, and automation, are revolutionizing the medical device manufacturing landscape. Contract manufacturers are leveraging these technologies to streamline production processes, enhance product quality, and offer customized solutions to OEMs, which is expected to further boost the medical devices contract manufacturing market during the forecast period 2024-2032.

Growth Drivers:

OEMs became highly dependent on contract manufacturers to gain cost-saving effects arising from manufacturing process, labor, and infrastructure optimization. For OEMs, outsourcing involves tapping the experience and production economies of contract manufacturers to reduce unit costs and maximize profitability. By contracting manufacturers with flexible production arrangements that align with erratic demand, the OEMs can scale the volume production up or down as demanded without having to incur high capital investment.

Agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regulate the medical devices industry and observe strict quality standards as well as compliance requirements. Outsourcing of production by firms with strong quality management systems and expertise in regulations guarantees the implementation of regulations with the purpose of maintaining product safety and effectiveness.

The medical devices contract manufacturing market is driven by a large number of suppliers focusing on specific aspects of manufacturing such as precision machines, injection molds, and sterilization. OEMs collaborate with contract manufacturers having niche expertise to enter small market segments, develop new product lines for their premium brands and gain market share over rivals.

Innovations including additive manufacturing (3D printing), robotics, and automation will soon completely transform the medical device manufacturing process. Such technologies are appropriated by contract manufacturers to improve precision, customization and efficiency, which contributes to the production of intricate and state of the art devices. Digital technology enables contract manufacturers to develop new ways of making processes more efficient, quality control and supply chain management which in turn lead to improved operational effectiveness and customer satisfaction.

Medical Device Contract Manufacturing Segmentation:

By Device:

·         Drug Delivery Devices

o   Infusion Devices and Administration Sets

o   Syringes

o   Inhalers

o   Auto-injectors & Pen Injectors

o   Others

·         IVD Devices

o   IVD Consumables

o   IVD Equipment

·         Diagnostic Imaging Devices

o   MRI

o   CT Scans

o   X-Rays

o   Others

·         Cardiovascular Devices

o   Pacemakers

o   Implantable Cardioverter-Defibrillators

o   Loop Recorders

o   Vascular Stents

o   Others

·         Respiratory Care Devices

o   Ventilators

o   Nebulizers

o   CPAP Machines

o   Oxygen Concentrators

o   Others

·         Surgical Devices

o   Scissors

o   Forceps

o   Retractors

o   Suction Devices

o   Surgical Drills

o   Others

·         Patient Monitoring Devices

o   Pulse Oximeter

o   Patient Monitor

o   ECG Monitor

o   Blood Pressure Cuff

o   Glucometer

o   Others

·         Orthopedic Devices

·         Ophthalmology Devices

·         Dental Devices

·         Patient Assistive Devices

·         Neurology Devices

·         Endoscopy and Laparoscopy Devices

·         Gynecology and Urology Devices

·         Diabetes Care Devices

·         Personal Care Devices

·         Other Devices

By Class of Device:

·         Class I Medical Device

·         Class II Medical Device

·         Class III Medical Device

By Service:

·         Airbags Device Development & Manufacturing Services

o   Device & Component Manufacturing

o   Process Development Services

o   Device Engineering Services

o   Others

·         Quality Management Services

o   Packaging Validation Services

o   Inspection & Testing Services

o   Sterilization Services

o   Others

·         Packaging & Assembly Services

o   Primary & Secondary Packaging

o   Labelling

o   Others

·         Other Services

By Region:

·         North America

·         Europe

·         Asia Pacific

·         Latin America

·         Middle East and Africa

Medical Device Contract Manufacturing Market by Device Review:

Based on the device, the medical device contract manufacturing market is segmented into seventeen segments including drug delivery devices, IVD devices, diagnostic imaging devices, cardiovascular devices, respiratory care devices, surgical devices, patient monitoring devices, orthopedic devices, ophthalmology devices, dental devices, patient assistive devices, neurology devices, endoscopy and laparoscopy devices, gynecology and urology devices, diabetes care devices, personal care devices, and other devices.

On the basis of device, the drug delivery devices segment is expected to dominate the market in terms of market share, while the XXXX segment is predicted to grow at the highest rate in terms of CAGR during the forecast period. The personal care devices segment is predicted to experience rapid growth due to increasing consumer demand for wearable health technologies, remote monitoring solutions, and personalized healthcare devices.

Medical Device Contract Manufacturing Market by Class of Device Review:

Based on the class of device, the market is segmented into class I medical device, class II medical device, and class III medical device. On the basis of class of device, the class II segment is expected to be the largest in terms of market share, while the class III segment is predicted to grow at the highest rate in terms of CAGR during the forecast period. Class III medical devices have been experiencing significant growth due to advancements in medical technology, increasing demand for innovative therapies, and a focus on more complex medical procedures.

Medical Device Contract Manufacturing Market by Service Review:

Based on the service, the market is segmented into device development & manufacturing services, quality management services, packaging & assembly services, and other services. On the basis of service, the device development & manufacturing services segment is expected to be the largest in terms of market share, while the quality management services segment is predicted to grow at the highest rate in terms of CAGR during the forecast period. With increasing regulatory scrutiny and the need for stringent quality standards in the medical device industry, demand for quality management services is on the rise.

Regional Outlook:

The medical device contract manufacturing market research report offers detailed analysis and forecasts for five major regions i.e., North America, Europe, Asia Pacific (APAC), Latin America, and the Middle East & Africa.

The North America region is forecasted to dominate the global medical device contract manufacturing market followed by Asia Pacific, Europe, Latin America, and Middle East & Africa during the forecast period 2023-2030.

The North America region is expected to retain its top position in the global medical devices contract manufacturing market, with the region forecast to hold a considerable market share of XX.X% in 2023. The market for regional medical devices contract manufacturing is driven mainly by factors that include high demand for innovative medical devices, advanced manufacturing capabilities, and a favorable regulatory environment. The area is a home of variety of top OEMs, contract manufacturers and suppliers who in turn drive innovation and growth of market. Besides, this generates a high level of healthcare spending which creates a strong domestic demand for medical devices and contract manufacturing services. In addition to this, technological progress, offshoring trends, and strategic partnerships and collaborations are expected to propel the medical devices contract manufacturing market in North America during the forecast period 2024-2032.

North America forms a major part of the global medical devices contract manufacturing market which is mainly constituted by the United States and Canada. The area benefits from mature healthcare system, advanced technological infrastructure, and rigid regulatory environment that create the best environment for innovation and market growth.

North America takes a lead in innovation, where contract manufacturers rely on modern manufacturing technologies which include additive manufacturing, robotics and automation among many others. These innovations increase production capacity, product quality, and customization possibilities, thus satisfying the ever-changing market tailoring and driving market growth.

However, OEMs in North America have the trend to outsource production activities to specialized contract manufacturers since they need to have cost efficiency, scalability, and access to expertise. OEMs now have the opportunity to focus on their core competency which is predicted to contribute to the further growth of the regional market during the forecast period 2024-2032.

The region of Asia Pacific proves to be the fast-growing market for medical devices contract manufacturing, which is triggered by the factors such as booming healthcare infrastructure, growing healthcare expenses, and growing outsourcing tendency. The countries such as China, India, and Singapore are regarded as main drivers of market expansion with cheap manufacturing and experienced labor force. Additionally, cost of labor and operation are low in the countries such as China and India which attract OEMs who are looking for cost effective manufacturing without compromising quality or compliance. However, the implementation of innovative manufacturing technologies, e.g. 3D Printing, Robotics and Automation, expands the range of capabilities of contract manufacturers that is expected to contribute to market growth in Asia-Pacific region during the forecast period 2024-2032.

Key Companies in Medical Device Contract Manufacturing Market:

The research report offers a competitive analysis of prominent companies operating in the medical device contract manufacturing market. Some of the leading players profiled in the market research report include:

·         FLEX LTD

·         Jabil, Inc.

·         Plexus Corp.

·         Sanmina Corporation

·         Celestica, Inc.

·         Integer Holdings Corporation

·         Gerresheimer AG

·         NIPRO CORPORATION

·         West Pharmaceutical Services, Inc.

·         Benchmark

·         Kimball Electronics

·         Nortech System, Inc.

·         Nemera

·         Viant 

·         Other Players