Medical Device Coatings Market

Global Medical Device Coating Market Overview

The global medical device coating market is estimated to be worth USD 7.7 billion in 2023, growing at compounded annual growth rate (CAGR) of 7.7% during the forecast period. According to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. It is also worth highlighting that, since 2020, the Food and Drug Administration (FDA) has approved 125 new medical devices. The growing demand for complex medical devices, including implants, surgical equipment, catheters, and other invasive devices, has prompted the medical device developers to innovate and introduce biocompatible, high-performance medical device coatings that can meet the operational, clinical, and engineering requirements for these devices. Presently, multiple types of medical device coatings are available in the market to accommodate the multifunctionality of novel medical devices. In addition, various medical device manufacturers are using novel surface modification technologies to enhance the physiochemical properties, frictional resistance, and, in certain cases, layout of the substrate, adding on to the device properties. Driven by the surge in demand for various types of medical devices and the need for a wide array of medical coatings for these devices, the medical device coating market is anticipated to witness a steady growth during the forecast period.

Key Market Insights

The Medical Device Coating Market: Distribution by Type of Medical Device (Class I, Class II, Class III), Type of Coating Material (Metal Coatings, Polymer Coatings, and Other Coatings), Company Size (Very Small, Small, Mid-sized, and Very Large), and Key Geographies (North America, Europe, Asia and Rest of the World) – Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future potential of medical device coating and surface modification technologies, over the forecast period. The report answers many key questions related to one of the key segments of the medical coatings market.

Need for Medical Device Coating Companies 

The coating of medical devices is a complex process that requires an adequate working environment (to prevent uneven coatings and chances of flaking), stringent coating protocols (to comply with the established regulatory standards), trained workforce (to satisfactorily handle the coating equipment) and expensive infrastructure. Driven by the growing demand for medical devices and unique coating requirements for each type of medical device, an increasing number of medical device companies are leveraging the superior technical expertise and experience of medical coating companies. The medical device coating companies will witness market growth, primarily driven by the innovations in the types of medical coating, their applications and coating technologies.

Current Market Landscape of Medical Device Coating Companies

Presently, more than 85 medical device coating companies claim to offer various types of medical grade coatings, including parylene, silicone, and fluoropolymers for multiple applications. It is worth highlighting that, majority of these players offer novel coatings as well as services associated with medical device coatings. Most of these players are mid-sized companies based in the US, the UK, and Germany. Additionally, more than 115 surface modification technologies and coating solutions are available in the market to enhance the physiochemical features of medical devices, including antimicrobial properties, corrosion resistance and thermal stability. 

Companies manufacturing medical device coatings are also expanding into the coating equipment business, making such companies a full-service provider in the medical device coating market. US based company Biocoat, considered one of the leaders in hydrophilic coatings, launched their coating equipment business unit in April 2022. The company started providing EMERSE, a line of hydrophilic dip coating equipment, to complement its hydrophilic coatings and custom coating services units.

Global Medical Device Coating Market Size

Owing to the surge in the number of medical devices and their associated risks of infections, the global medical device coating market is projected to grow at a steady pace during the forecast period. Currently, in terms of type of medical device coated, class III devices capture the majority share of the overall medical device coating market. Class III devices include high-risk devices such as pacemakers, defibrillators, cochlear implants, renal stents and coronary stents.

In terms of geography, North America currently holds the largest share of the medical device coating market. This is expected to change as the market in Asia is likely to grow at a relatively faster CAGR during the forecast period.

Antimicrobial Coatings Will Drive the Global Market for Medical Coatings

Surface coatings that provide antibacterial or antimicrobial properties, have escalated in popularity over the years. Hospital-acquired infections (HAIs) are infections that patients acquire during treatment at a hospital / medical facility. According to published data, HAIs affect 5-15% of the hospitalized patients in developed countries, also contributing significantly to the healthcare costs. As per the “2021 National and State Healthcare-Associated Infections Progress Report” published by the Centers for Disease Control and Prevention (CDC) in the US, there was an overall increase in the HAI cases from 2020 to 2021.  A number of medical equipment manufacturers are collaborating with medical coating companies on the application of antimicrobial coatings on medical devices with the aim of preventing HAIs. As an example, China based CEMMA Medical Company Limited and Netherlands based LipoCoat BV are co-developing a coated central venous catheter (CVC) to prevent the HAIs caused by catheter bacterial contamination. 

Another UK based company, BioInteractions launched its antimicrobial coating technology, TridAnt for medical devices and implants in April 2022. A rise in the cases of chronic diseases and infectious diseases requiring hospitalizations and surgical procedures, along with an aging global population will be some factors driving the market growth for coated medical devices.

Medical Device Coating Market Trends

In recent years, the medical device coatings market has witnessed various innovations, in terms of coating techniques as well as coating materials. In fact, novel coating techniques, including low-temperature atmospheric plasmas, physical vapor deposition, thermal curing and microblasting, offer several advantages over conventional methods. Some of these advantages include uniform application of thick coatings, improved adherence of the coating material onto the substrate, and a higher rate of efficiency. Additionally, stakeholders in this segment of the medical coatings market have forged several strategic alliances in order to enhance their existing product portfolios and consolidate their presence within the medical device industry. It is worth highlighting that most of these agreements are mergers and acquisitions of other key players in the market. In September 2021, the US based Precision Coating announced merger with N2 Biomedical. Their complimentary portfolios helped increase the value proposition for clients in the interventional, orthopedic, and advanced surgical markets.

Key Companies Engaged in Medical Device Coating Market 

Examples of key players engaged in the medical device coating industry (which have also been captured in this report) include Aculon, Biocoat, Carmeda, Covalon Technologies, DSM, Evonik Health Care, Freudenberg, HZO, Microban International, and N2 Biomedical. In addition to the listed companies, detailed information on parameters such as product portfolio, services, technologies, partnerships and collaborations and more have been captured for all the companies mentioned in the report.

Recent Developments in Medical Device Coating Market 

Several recent developments have taken place in the field of medical device coating. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In August 2023, Asep Medical entered into a licensing agreement with the University of British Columbia to develop and commercialize medical device coating technology.      
• In June 2023, Surmodics announced the receipt of the FDA approval for SurVeil™ drug-coated balloon (DCB) which will be used for the treatment of patients suffering from peripheral artery disease.
• In February 2023, Concept Medical received the Investigational Device Exemption (IDE) from the US FDA for its Magic Touch Sirolimus Coated Balloon used for the treatment of Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease

Scope of the Report

The study presents an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in the medical device coating market, across different segments as defined in the below table:

Key Report Attributes	Details
Forecast Period	2023 – 2035
Base Year	2022
Market Size 2023	$7.7 billion
CAGR	7.7%
Type of Medical Device Coated	Class I Devices, Class II Devices, Class III Devices
Type of Coating Material	Polymer Coatings, Metal Coatings, Other Coatings
Company Size	Very Small Companies, Small Companies, Mid-sized Companies, Large Companies, Very Large Companies
Key Geographical Regions	North America, Europe, Asia, Rest of the World
Key Companies Profiled	Biocoat, Evonik Health Care, Formacoat, Harland Medical Systems, Para-Coat Technologies, Specialty Coating Systems, SurModics, TUA Systems
Customization Scope	15% Free Customization Option (equivalent to 5 analyst working days)
Excel Data Packs	Complimentary: Market Landscape Analysis, Company Competitiveness Analysis, Partnership and Collaborations Analysis, PESTLE Analysis, Market Forecast and Opportunity Analysis

Amongst other elements, the market report includes:

• An executive summary of the insights captured during our research. It offers a high-level view on the current state of medical device coatings and surface modification technologies market and its likely evolution in the mid-long term.
• A general overview of medical device coatings and surface modification technologies, featuring information on the various types of medical coatings and surface modification technologies, and highlighting their advantages and challenges. Further, the chapter emphasizes on the growing need for outsourcing the process of coating of medical devices to service providers, along with details on the services offered by third-party service providers. Additionally, the chapter features a discussion on the regulatory considerations in this domain.
• A detailed assessment of the overall market landscape of medical coating companies, based on several relevant parameters, such as year of establishment, company size (based on the number of employees), location of headquarters, type of company (coating provider and service provider), type of medical device(s) coated (auditory devices, catheters, medical implants, ophthalmic devices, stents, surgical equipment, and other types of medical devices), nature of coating material(s) (natural and synthetic), type of coating material(s) (heparin, hydroxyapatite, hydrogel polymers, silicone, nylon, parylene, and other types of coating materials), type of coating(s) (hydrophilic and hydrophobic), type of coating function(s) (broad substrate compatibility, enhanced lubricity, antimicrobial properties, thermal stability, and corrosion resistance), type of compatible substrate(s) (fluoropolymers, metals, polyurethanes, polyolefins, and other types of substrates), service(s) offered (analytical testing services, coating services, customizability services, research and development services, and other key services), and additional feature(s) offered (durability and thin film coatings).
• A detailed competitiveness analysis of various medical device coating companies, based on several relevant parameters, such as supplier power (in terms of number of years of experience of a company), and service portfolio strength (in terms of type of company, type of medical device(s) coated, nature of coating material, type of coating materials(s), type of coating, type of compatible substrate material(s), type of coating function(s), and service(s) offered).
• A detailed assessment of the overall market landscape of medical device surface modification technologies and coating solutions, based on several relevant parameters, such as type of medium(s) for modification (coating solution and technology), type of trademark right (registered trademark and trademark), type of surface modification process(s) employed (chemical vapor deposition, covalent bonding, plasma enhanced chemical vapor deposition, plasma treatment, physical vapor deposition, thermal curing, UV curing, and other types of processes), type of device(s) coated (invasive devices and non-invasive devices), type of medical device(s) coated (catheters, diagnostic devices, implants, stents, surgical instruments, and other types of medical devices), nature of coating material(s) (synthetic and natural / API), type of coating(s) applied (hydrophilic and hydrophobic), type of resistance(s) offered (corrosion resistance, microbial resistance, thermal stability / resistance, and thrombogenic resistance), type of compatible substrate(s) (fluoropolymers, metals, polyurethanes, polyamides, polyolefins, and other types of substrates), and type of compatible substrate(s) (metals, fluoropolymers, polyurethanes, polyamides, polyolefins, and other types of substrates), additional feature(s) offered (customizability, durability, enhanced lubricity and thin layering).
• A detailed product competitiveness analysis of the various surface modification technologies and coating solutions, based on several relevant parameters, such as the developer power (in terms of number of years of experience of a company), and product competitiveness (in terms of medium(s) for modification, type of trademark right, type of process(s) employed, type of compatible substrate(s), nature of coating material(s), type of coating(s) applied, type of device(s) coated, type of medical device(s) coated, type of resistance(s) offered, and additional feature(s) offered).
• Elaborate profiles of prominent companies (shortlisted based on a proprietary criterion) offering medical device coatings. Each profile features a brief overview of the company, along with recent developments and an informed future outlook.
• An insightful analysis of the recent partnerships that have been inked within the surface modification technologies and medical device coating industry, since 2018, based on several relevant parameters, such as year of partnership, type of partnership (mergers and acquisitions, product commercialization agreements, product development agreements, product distribution agreements, product licensing and supply agreements,  product manufacturing agreements, service alliances, and others), type of partner (industry and non-industry), geographical location of the companies involved, and most active players (in terms of number of partnerships).
• An insightful analysis of the leading medical coating companies, considering the affiliated factors, key drivers, and challenges under the PESTLE framework, highlighting the relative effect of each factor of PESTLE parameter on the medical device coating providers. 

One of the key objectives of the market research report was to estimate the current market size and the future opportunity for the medical device coatings market, over the forecast period. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of medical device(s) coated (Class I devices, Class II devices, and Class III devices), type of coating material (polymer coatings, metal coatings, and other coatings), company size (very small, small, mid-sized, large, and very large) and key geographical regions (North America, Europe, Asia, and Rest of the World). 

In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified. 

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. This market report features detailed transcripts of interviews held with the following individuals:

• Mark Eberhardt (Senior Director of Marketing, Biocoat)
• Carl Genberg (Chief Scientific Officer, N8 Medical)
• David Wayne (Director of Sales and Marketing, VaporTech)

Frequently Asked Questions

Question 1: What is medical device coating?

Answer: Medical device coating is the process of coating medical devices ranging from orthopedic prosthetics to dental implants with various hydrophilic coating or hydrophobic coating materials based on application.  

Question 2: What are the different types of coatings offered by big industry players involved in the medical device coatings market?

Answer: In order to tap the lucrative opportunity in this rapidly growing market, big industry players are offering several types of coatings to medical device manufacturers, including antimicrobial, lubricious, and hydrophilic coatings.

Question 3: What is the need for medical device coating?

Answer: Coatings on biomedical implants can affect the biological interaction between the implant and host, mitigate joint wear, and combine the properties of several materials to enhance device performance.  Medical device coatings also endow properties like lubrication, anti-fouling nature, as well as enhanced durability to the surface of the device.

Question 4: What is the growth rate of the global medical device coating market?

Answer: The global medical device coating market is expected to grow at a compound annual growth rate (CAGR) of 7.70% from 2023 to 2035.

Question 5: Which region has the highest growth rate in medical device coating market?

Answer: Asia Pacific is growing at the highest CAGR over the forecast period 2023-2035.

Question 6: Which segment, in terms of type of medical device coated, accounts for the largest share in the medical device coating market?

Answer: Class III devices, presently, dominate the medical device coating market with a share of close to 70% in 2023. This can be attributed to the rising number of medical implants and prosthesis coupled with the demand for the consistent supply of these novel interventions for various conditions.

Question 7: Which type of partnership models are commonly adopted by companies in the medical device coating market?

Answer: Mergers / acquisitions and product commercialization agreements are common types of partnerships inked by stakeholders in the medical device coatings and surface modification technologies market. 

Question 8: What type of coating materials are being used for medical devices?

Answer: Various types of materials used for coating medical devices include metals, polyurethanes, polyolefins, and fluoropolymers.

Question 9: Who are the key companies in medical device coating market?

Answer: Examples of key players engaged in this domain (which have also been captured in this report) include Aculon, Biocoat, Carmeda, Covalon Technologies, DSM, Evonik Health Care, Freudenberg, HZO, Microban International, and N2 Biomedical.