Medical Device Contract Manufacturing Market Outlook: Innovations, M&A, and Regional Expansions Even Japan Updates

The Medical Device Contract Manufacturing Market size was valued at USD 70,739.40 million in 2021 and is estimated to reach a compound annual growth rate (CAGR) of 11.30% over the forecast period 2024 to 2031.

Key Latest Updates:

1. Soar (SACSA Group) earns ISO 13485 certification
In late October 2024, Soar a subsidiary of SACSA expanded its contract manufacturing capabilities by obtaining ISO 13485 certification, a globally recognized quality standard for medical devices. This validates their strengthened infrastructure for safely producing Class II devices under a rigorous quality management system .

2. JOHNAN exhibiting at Osaka ODM/EMS expo
In October 2024, JOHNAN showcased its medical-device OEM/ODM services (spanning wearable devices, cleaning equipment, and in-vitro diagnostic systems) at the 3rd Manufacturing ODM/EMS Expo in Osaka, demonstrating their end-to-end contract manufacturing expertise

3. Regulatory streamlining under PMD Act
A subcommittee of Japan's Ministry of Health, Labor and Welfare (MHLW) finalized proposals in January 2025 aimed at streamlining the Pharmaceuticals and Medical Devices (PMD) Act. Revisions include simplifying device registrations and enhancing conditional-approval frameworks to reduce delays and improve the regulatory environment for contract manufacturers

4. PMDA's push for global outreach
In March 2025, a senior MHLW official announced plans for Japan's PMDA to expand regulatory consultations overseas including targeted engagement for Software as a Medical Device (SaMD). This global outreach supports contract manufacturers offering advanced digital health and device technologies

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Medical Device Contract Manufacturing Market Overview

Medical device contract manufacturing refers to outsourcing the production of medical devices to specialized third-party companies. These firms handle design, development, prototyping, assembly, packaging, and sometimes regulatory support, enabling medical device brands to focus on innovation and speed to market.

Research Methodology:

The global Medical Device Contract Manufacturing Market research report is based on a combination of primary and secondary data sources. The study carefully analyzes various factors influencing the industry, including government regulations, market dynamics, competitive landscape, historical trends, current conditions, and technological progress. It also evaluates future developments, related industry trends, market volatility, growth prospects, potential obstacles, and emerging challenges.

Segment Covered in the Medical Device Contract Manufacturing Market:

By Device Type: IVD Diagnostics, Drug Delivery Devices, Diagnostic Imaging Devices, Patient Monitoring Devices, Therapeutic Patient Assistive Devices, Minimally Access Surgical Instruments, Others

By Services: Product Manufacturing and Assembly Services, Quality Management Services, Packaging and Sterilization Services, Regulatory Consulting Services, Product Design & Development Services

By Class of Device: Class II Medical Devices, Class I Medical Devices, Class III Medical Devices

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List of the Key Players in the Medical Device Contract Manufacturing Market:

Flextronics International, LTD., Jabil Inc., Benchmark Electronics, Inc., Integer Holdings Corporation (Greatbatch), West Pharmaceutical Services, Inc., Tecomet, Inc., Nortech Systems, TE Connectivity (Creganna Medical), Forefront Medical Technologies, Sanmina Corporation, and Nipro Corporation.

Regional Analysis for Medical Device Contract Manufacturing Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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The Report Includes:

➡ A descriptive analysis of demand-supply gap, market size estimation, SWOT analysis, PESTEL Analysis and forecast in the global market.

➡ Top-down and bottom-up approach for regional analysis

➡ Go-to-market Strategy.

➡ Neutral perspective on the market performance.

➡ Customized regional/country reports as per request and country level analysis.

➡ Potential & niche segments and regions exhibiting promising growth covered.

People Also Ask:

➠ What are the global sales, production, consumption, imports, and exports in the Medical Device Contract Manufacturing market?

➠ Who are the top manufacturers, and what are their capacity, production, sales, pricing, and revenue stats?

➠ What key opportunities and challenges do vendors face in the Medical Device Contract Manufacturing industry?

➠ Which product types, applications, or end-users are driving market growth, and what is their market share?

➠ What are the major growth drivers and restraints of the Medical Device Contract Manufacturing market?

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