Medical Device Contract Manufacturing Market

Global Medical Device Contract Manufacturing Market Size (2024 to 2029)

The global medical device contract manufacturing market is predicted to grow to USD 133.59 billion by 2029 from USD 86.15 billion in 2024, growing at a CAGR of 9.12% from 2024 to 2029.

The process of giving a contract to manufacture medical devices to a firm by firm that has complete ownership of the idea of the medical device is called medical device contract manufacturing. It is subcontracting, where a company produces a finished product, a single part, or a larger product. An agreement between medical device companies and contract manufacturing partners benefits both. Through this arrangement, medical device companies have cost efficiencies, streamlined supply chains, and logistical alignment, enabling them to deliver commercial products to market while ensuring that all industry requirements are met. In addition, medical device contract manufacturers specialize in a specific process that can offer expertise from the frequent practice of their manufacturing.

MARKET DRIVERS

The growing demand for medical devices and growing usage are primarily driving the medical device contract manufacturing market.

Medical device original equipment manufacturers (OEMs) are companies that manufacture a product and contract out the manufacturing to companies that manufacture medical devices and specialize in a particular process, including molding, assembly, or R&D design. Medical device contract manufacturing refers to the process by which a manufacturer creates medical devices or components for medical devices with international standards and FDA criteria. It increases the life expectancy of humans. Between 2000 and 2019, the average lifespan increased by more than six years, from 66.8 years in 2000 to 73.4 years in 2019. This results in a decrease in mortality rates, specifically in the elderly age group. The aforementioned factors are anticipated to favor the growth rate of the medical device contract manufacturing market.

Growing advancements in healthcare analytics is estimated to support the medical device contract manufacturing market growth.

Medical device companies use healthcare providers' data to make better product and service decisions. In addition, companies can develop and quickly respond to evolving needs due to customer feedback and information about the medical environment.

Furthermore, the growing prevalence of various lifestyle-related diseases, increasing start-ups, and increasing focus on research and innovation are significant opportunities for the market in the coming years. The increasing prevalence of various diseases, such as cardiovascular diseases, played an important role in the demand for contract-manufacturer medical devices in recent years. Hypertension affects nearly one in two persons in the United States. Approximately 1 in 5 adults with hypertension in the United States is recommended lifestyle modifications only. The rising popularity of in vitro diagnostic devices cost optimization and focus on product branding are the other factors that drive the market forward.

MARKET RESTRAINTS

On the other hand, lack of product quality, regulatory compliance, government support issues, lack of data security, and increasing cost of product development are some of the major restraints to the growth of the global medical device contract manufacturing market. In addition, a lack of awareness and skilled professionals for operating devices are further anticipated to hinder the market's growth rate.

REGIONAL ANALYSIS

SEGMENTAL ANALYSIS

Global Medical Device Contract Manufacturing Market Analysis By Type

Based on type, the IVD device segment had a significant share of the global medical device contract manufacturing market in 2023. This segment is also anticipated to register a substantial share in the worldwide market during the forecast period owing to the increasing IVD tests, growing availability of IVD kits, and the rising number of hospitals & clinical laboratories. In addition, the market for IVD manufacturing has suddenly increased because of the COVID-19 pandemic.

Global Medical Device Contract Manufacturing Market By Service

Based on the service, the device development and manufacturing services segment dominated the market in 2023 and is estimated to occupy a substantial share of the global market during the forecast period due to the increasing adoption of contract manufacturing services and improving device development. According to ISO:13485 and FDA regulations, the product is created according to the requirements provided by the OEM company.

Global Medical Device Contract Manufacturing Market By Class of Device

Based on the class of device, the class II medical devices segment occupied the leading share of the market in the global medical device contract manufacturing market in 2023.

REGIONAL ANALYSIS

In 2023, the APAC region was the leader among all the regions in the worldwide market. The Japanese market in this region has contributed significantly. One of the market participants in Japan, Nipro Corporation, a company that produces and sells generic medications and medical devices, especially dialyzers used in hemodialysis, holds the largest market share in Japan. The company's policy is to set up a structure to increase production in line with the demand in the Pharma Packaging industry and to establish a worldwide production structure for contract manufacturing of pharmaceuticals for other businesses in the Pharmaceutical-Related business. Every year, a significant number of medical equipment is imported from China into the US. Due to the COVID-19 pandemic's increased demand for Chinese-made products, such as some personal protective equipment, this figure has risen significantly over the past year.

On the other hand, the North American region is also expected to have a substantial share of the global market during the forecast period. U.S. & Canada leads this region by accounting for most of the share, owing to the rigorous efforts to improve the quality of medical devices by collecting information from the population. Increased openness will allow manufacturers to make decisions based on past information to avoid faults, errors, and re-calls. In addition, open communication and consultation exercises are important to improve health outcomes. More than 6,500 medical device companies, primarily small and medium-sized businesses, are in the United States.

KEY MARKET PARTICIPANTS

Integer Holdings Corporation, Flex Ltd., Jabil Inc., West Pharmaceutical Inc., Benchmark Electronics Inc., Tecomet Inc., Nortech Systems Inc., TE Connectivity, and Nordson Corporation are a few of the promising companies operating in the global medical device manufacturing market profiled in this report.

RECENT HAPPENINGS IN THIS MARKET

• In 2021, Nemera announced an agreement to acquire Copernicus. Copernicus, based in Szczecin, Poland, is a leader in developing and manufacturing injection devices.
• In 2021, An affiliate of New Mountain Capital, LLC (“New Mountain”) announced an agreement to acquire Flexan, a leading medical device contract design and manufacturing organization specializing in silicone, thermoplastic, and specialty rubber components and devices.

DETAILED SEGMENTATION OF THE GLOBAL MEDICAL DEVICE CONTRACT MANUFACTURING MARKET INCLUDED IN THIS REPORT

This research report on the global medical device contract manufacturing market has been segmented based on the device type, service, class of device, and region.

By Type

• IVD Devices
• Diagnostic Imaging Devices
• Cardiovascular Devices
• Drug Delivery Devices
• Orthopedic Devices
• Dental Devices
• Endoscopy Devices

By Service

• Device Development and Manufacturing Services
  • Device Manufacturing Services
  • Process Development Services
  • Device Engineering Services
• Quality Management Services
  • Packaging Validation Services
  • Inspection and Testing Services
  • Sterilization Services

By Class of Device

• Class I Medical Devices
• Class II Medical Devices
• Class III Medical Devices

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa