Medical Device Contract Manufacturing Market by Services (Device Development & Manufacturing Services, Final Goods Assembly Services, Quality Management Services), Class of Device (Class I Medical Devices, Class II Medical Devices, Class III Medical Devic

Medical Device Contract Manufacturing Market by Services (Device Development & Manufacturing Services, Final Goods Assembly Services, Quality Management Services), Class of Device (Class I Medical Devices, Class II Medical Devices, Class III Medical Devices), Device Type, Application, End User - Global Forecast 2024-2030

The Medical Device Contract Manufacturing Market size was estimated at USD 110.41 billion in 2023 and expected to reach USD 121.29 billion in 2024, at a CAGR 9.99% to reach USD 215.06 billion by 2030.

Medical device contract manufacturing is the process where companies outsource the production of medical devices or components to specialized third parties. This model enables original equipment manufacturers (OEMs) to leverage contract manufacturers' expertise, sophisticated technologies, and production capabilities, facilitating scalability, cost efficiency, and quicker time-to-market for medical devices. Global prevalence of chronic diseases and the aging population drive demand for medical devices, fueling the growth of contract manufacturing services. The increasing complexity of medical devices and stringent regulatory standards across global markets have amplified the demand for contract manufacturing services. These services span across various stages of the production process, including design and development, regulatory compliance support, manufacturing, assembly, and packaging. However, the reliance on medical device contract manufacturing may raise issues related to intellectual property protection, variability in quality assurance across different contract manufacturers, and potential supply chain vulnerabilities. Nevertheless, adopting advanced manufacturing technologies such as 3D printing, automation, and robotics presents opportunities for enhancing efficiency, reducing costs, and customizing medical devices. The ongoing globalization of healthcare markets and the rising demand for personalized medical solutions also present fertile ground for expansion.

Regional Insights

The American market, particularly the United States, is one of the most significant for medical device contract manufacturing, driven by technological advancements, an aging population, and a strong focus on research and development (R&D). The U.S. leads in innovation and demand for medical devices, while Brazil and Mexico are witnessing growth due to increasing healthcare expenditures and a growing middle class requiring medical care. The EMEA region presents a diverse market environment, with Europe leading in terms of market maturity and innovation. The Middle East & Africa are emerging markets with significant growth potential, driven by increasing healthcare investments and an expanding healthcare infrastructure. Medical Device Regulation (MDR) in Europe is significantly impacting the market, requiring enhanced documentation and compliance. Asia Pacific is rapidly emerging as a hub for medical device contract manufacturing. Countries including China, India, and Singapore are investing heavily in healthcare and medical technology, spurred by growing populations and an increasing burden of diseases.

Market Insights

Market Dynamics

The market dynamics represent an ever-changing landscape of the Medical Device Contract Manufacturing Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

Market Drivers

Increasing number of CMOs and rising non-invasive surgical procedures
Growing investments in medical device research and development and manufacturing activities
Increasing support and and approval process from regulatory authorities related to contract manufacturing services

Market Restraints

Lack of constant innovation and high costs of services

Market Opportunities

Ongoing technological advancements and innovations in medical device modalities
Rising uptake of automation and robotics by medical device manufacturers

Market Challenges

Stringent government policies for trade and export of medical devices

Market Segmentation Analysis

Services: Reliance on device development & manufacturing services for end-to-end process
Class of Device: Proliferation of Class III medical device manufacturing owing to high risk devices and regulatory oversight

Market Disruption Analysis

Porter’s Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis

FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Medical Device Contract Manufacturing Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Medical Device Contract Manufacturing Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments

A Joint Venture Between Visura and YKK Corporation to Support Medical Device Manufacturing

Visura Technologies Inc., headquartered in Minneapolis, Minnesota, and the YKK Corporation of America, a branch of the global YKK Corp., have collaborated with the establishment of Evevo Manufacturing LLC. This venture signifies a notable commitment to bolstering the growth of emerging medical device enterprises within the Minneapolis area. Spearheaded by the combined expertise of YKK’s robust manufacturing legacy and Visura's innovative prowess, Evevo Manufacturing is dedicated to addressing the unique challenges faced by startups and developing companies in securing reliable contract manufacturing partnerships.

VitaTek Secures Series A Funding to Elevate its Comprehensive Medical Device Manufacturing Capabilities

VitaTek has to secure USD 50 million through a Series A Funding round. This financial endeavor aims at acquiring I-Tek, enhancing its headquarters by 70,000 square feet, establishing a 13,000-square-foot clean facility, and procuring advanced manufacturing technology.

NN, Inc. Launches NN Medical to Bolster its Global Medical Device Manufacturing Capabilities

NN, Inc. has announced the establishment of NN Medical, a new division dedicated to enhancing its presence within the medical device sector. Using its substantial expertise in high-precision manufacturing and leveraging an extensive global footprint, NN Medical aims to significantly grow its medical components business.

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Medical Device Contract Manufacturing Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

Key Company Profiles

The report delves into recent significant developments in the Medical Device Contract Manufacturing Market, highlighting leading vendors and their innovative profiles. These include Advantech Plastics, LLC, American Urethane, Inc., Angiplast Private Limited, Benchmark Electronics Inc., Britech Industries, C&J Industries, Cadence, Inc., Carclo PLC, Celestica Inc. by Onex Corporation, Cirtronics Corp., D&K Engineering, Digicom Electronics, Inc., Enercon Technologies, Federal Electronics, Flex, Ltd., Forefront Medical Technologies, Gerresheimer AG, Hankscraft OEM, HDA Technology, Integer Holdings Corporation, Jabil Inc., KDI Manufacturing, Kimball Electronics Inc., MME Group, Inc. by Seaway Plastics Engineering, Nipro Corporation, Nordson Corp., Petro Extrusion Technologies, Inc., Phillips Medisize by Molex LLC, Plexus Corp., Poly Medicure Ltd., Precipart, Qualitel Corporation, Recipharm AB, Remington Medical, Inc., RSP, Inc., Sanbor Medical, Sanmina Corporation, Scapa Healthcare by SWM International, SeaskyMedical, SGS Tekniks, Sino Mould, SMC Ltd., Spectrum Solution, Steripack Group Ltd., TE Connectivity, Tessy Plastics Corp., Tricor Systems, Inc., Viant Technology LLC by Time Inc., West Pharmaceutical Services, Inc., and Wuxi AppTech.

Market Segmentation & Coverage

This research report categorizes the Medical Device Contract Manufacturing Market to forecast the revenues and analyze trends in each of the following sub-markets:

Services
Device Development & Manufacturing Services
Device Engineering Services
Device Manufacturing Services
Process Development Services
Final Goods Assembly Services
Quality Management Services
Inspection & Testing Services
Packaging Validation Services
Class of Device
Class I Medical Devices
Class II Medical Devices
Class III Medical Devices
Device Type
Cardiovascular Devices
Dental Devices
Diabetes Care Devices
Diagnostic Imaging Devices
Drug Delivery Devices
Autoinjectors & Pen Injectors
Infusion Devices & Administration Sets
Inhalers
Syringes
Endoscopy Devices
IVD Devices
IVD Consumables
IVD Equipment
Ophthalmology Devices
Orthopedic Devices
Application
Diagnostic Devices
Patient Monitoring Devices
Surgical Devices
Therapeutic Device
End User
Ambulatory Surgical Centers
Hospitals & Clinics
Medical Research Institutes
Pharmaceutical Companies
Region
Americas
Argentina
Brazil
Canada
Mexico
United States
California
Florida
Illinois
New York
Ohio
Pennsylvania
Texas
Asia-Pacific
Australia
China
India
Indonesia
Japan
Malaysia
Philippines
Singapore
South Korea
Taiwan
Thailand
Vietnam
Europe, Middle East & Africa
Denmark
Egypt
Finland
France
Germany
Israel
Italy
Netherlands
Nigeria
Norway
Poland
Qatar
Russia
Saudi Arabia
South Africa
Spain
Sweden
Switzerland
Turkey
United Arab Emirates
United Kingdom

Please Note: PDF & Excel + Online Access - 1 Year