The global medical device coating market was expected to reach US$ 7,644.09 million in 2021 and it is estimated to grow at a CAGR of 7.7% from 2022 to 2028.
Rising demand for coated medical devices intended for surgical and diagnostic procedures drives the medical device coating market growth. Further, rising product launches and product developments would provide lucrative opportunities for the global market during the forecast period.
Medical devices are required for various invasive and minimally invasive surgical and diagnostic procedures including laparoscopy, biopsy, and endoscopy. Laparoscopic ureterolithotomy, a process of removing stones from the ureter, is performed using a laparoscope and catheters. The use of coated medical devices significantly reduces the time taken for cardiac and urinary catheterization. Coatings prevent infections during biopsy, excision, and cryotherapic diagnostic procedures where the contact between medical devices and body is integral. Besides, coated medical devices are significantly cost-effective. According to WHO, an estimated 2 million types of medical devices are categorized into more than 7,000 generic groups.
Disposable medical devices, such as cannulas, blades, anvils, triggers, diagnostic probes, and guide wires, need coatings for anti-infectious procedures and maneuverability improvement. The diagnosis and treatment of abdominal pain, kidney stones, varicose veins, and intestinal infections are increasing, demanding coated medical devices. As per the American Cancer Society, the number of carcinogenic cases is going to hit 27.5 million by 2040 leaping from the previous figure of 17.0 million in 2018. Such rising cases of diseases demanding medical devices for surgical procedures are propelling the growth of the medical device coating market.
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Medical Device Coating Market: Strategic Insights
Market Size Value in US$ 7,644.09 Million in 2021 Market Size Value by US$ 12,818.01 Million by 2028 Growth rate CAGR of 7.7% from 2022 to 2028 Forecast Period 2022-2028 Base Year 2021
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Medical Device Coating Market: Strategic Insights
| Market Size Value in | US$ 7,644.09 Million in 2021 |
| Market Size Value by | US$ 12,818.01 Million by 2028 |
| Growth rate | CAGR of 7.7% from 2022 to 2028 |
| Forecast Period | 2022-2028 |
| Base Year | 2021 |
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The continuous research in medical device development offers new innovative coating varieties. Product innovation and strategic activities by key market players create ample opportunities to step in new application areas. A few product launches and developments in the market are as follows:
- In April 2022, BioInteractions, a UK-based biomaterial company, announced "TridAnt," a coating technology with active and passive components for creating a non-leaching, effective, safe, and durable antimicrobial coating for medical devices and implants.
- In January 2021, LipoCoat launched LipoCoat-enabled contact lenses to develop the first coated catheters in the global market.
- In July 2020, Sahajanand Medical Technologies (SMT) Pvt Ltd signed an agreement with the Italian government for a purchase entity with Consip spa-a society of Economy & Finance Ministry (CONSIP) delivering up to 40,000 biodegradable polymer-coated DES "Supraflex" stents.
- In August 2020, Hydromer partnered with N8 Medical to supply coatings to manufacture CeraShield endotracheal tubes. These tubes play a crucial role in the treatment of COVID-19 patients. This development exhibits the company's active involvement in the medical device coatings market.
- In February 2020, Biocoat launched HYDAK UV. The new version of its original HYDAK coating is designed to be cured using ultraviolet (UV) light. This coating allows for flexible integration with industry-standard UV coating systems.
Thus, the increasing medical device coating product launches and various organic and inorganic developments are expected to provide lucrative opportunities for the medical device coating market growth during the forecast period.
The complications associated with medical device coatings and frequent product recalls limit the overall medical device coating market growth. Medical device coatings are susceptible to peeling, flaking, or shedding, which may be potentially fatal in surgical procedures. According to the Food and Drug Administration (FDA), coating separation, which may include delamination or sloughing off or degradation, may adversely impact clinical performance and result in inflammation at the access site, pulmonary embolization, pulmonary infarct, myocardial embolization, myocardial infarct, embolic stroke, cerebral infarct, tissue necrosis, or death in worst scenarios. Furthermore, various studies published by National Center for Biotechnology Information (NCBI) in 2018, 2020, and 2022 revealed that it is common for the coating material to peel off from medical devices and travel through the bloodstream to areas where plastic particles can cause inflammation or block blood flow to critical organs.
As per FDA safety communication, ~500 medical device reports (MDRs) have listed cases of coatings that peeled, flaked, shed, delaminated, or sloughed off since 2014. Various manufacturers have had major recalls of medical devices due to coating delamination. Covidien (now part of Medtronic) issued a voluntary recall of 650 of its Pipeline embolization devices and Alligator retrieval devices after quality test revealed delamination. In 2019, the US FDA reported that Cook Medical recalled a needle used in heart surgery due to a potentially lethal manufacturing fault reported to be an error related to coatings. Such events highlighting the issues of dislodging and damaging vital organs due to coated devices are hampering the growth of the global medical device coating market.
Regional Overview
China is a well-developed country in Asia Pacific and has a well-established healthcare system. It is one of the leading producers of medical devices in the region. The country has an increasing burden of diseases such as obesity, cardiovascular disorders, and orthopedic disorders owing to the presence of a large geriatric population. As per the Lancet Public Health Journal 2020, China has experienced ~4 million deaths due to cardiovascular disorders. Additionally, the medical device coating market growth is attributed to the presence of a large geriatric population prone to orthopedic conditions and joint replacement procedures, a surge in number of surgical procedures, an increase in healthcare expenditure, and rise in investments in the development of advanced coatings to avoid healthcare-associated infections and surgical site infections.
The healthcare industry in China is proliferating, which subsequently helps in the medical device coatings market growth. According to China’s National Coating Industry Association (NCIA), had proposed and drafted the medical device coating standards that people's health concern has increased significantly, due to which medical device coated products with antiviral and antibacterial properties has gained the popularity among the Chinese population. As a result, the demand for antiviral and antibacterial coatings is expected to increase in the coming years, which would promote the overall growth of the medical device coating market during the forecast period.
Material Type Based Insights
Based on material type, the medical device coating market is segmented into polymer, metal, and others. The polymer segment is estimated to hold the largest market share and register the highest CAGR from 2022 to 2028. Medical devices are made of various biocompatible materials to prevent complications caused due to the material. These devices are further coated with different materials to avoid side effects, which enhances the overall recovery process of the patient. Polymer is one of the highly used biocompatible materials for different coating, which improves the overall efficiency of the medical devices. Polymers exhibit good biocompatibility and enables the drug delivery process that can modify and can be dissolved in the body over time. For instances, Polyelectrolyte multilayers is one of the highly used polymers in medical devices coatings owing to its biocompatible nature with wide applications, which provide numerous possibilities to create various surface coatings. These layers can also be modified as drug releasing coating with balanced pH and many more. Silicon, polyethylene, polystyrene, polyurethane, and polypropylene are a few types of polymer coatings available in the market. Thus, the aforementioned factors are likely to boost the medical device coating market growth for the polymer segment from 2022 to 2028.
Medical Device Coating Market, by Material Type – 2021 and 2028
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
Companies operating in the medical device coating market adopt the product innovation strategy to meet the evolving customer demands across the world, which also permits them to maintain their brand name in the market.
Medical Device Coating Market – Segmentation
Based on material type, the medical device coating market is segmented into polymer, metal, and others. The polymer segment accounted for the largest market share in 2021 and is expected to register the highest CAGR from 2022 to 2028. Based on devices, the market is segmented into medical equipment and tools, medical implants, medical devices, and others. The medical equipment and tools segment led the market in 2021 and is expected to retain its dominance during the forecast period. Based on coatings, the market is segmented into hydrophilic coatings, antimicrobial coatings, drug-eluting coatings, anti-thrombogenic coatings, and others. The hydrophilic coating segment led the market in 2021 and is expected to retain its dominance during the forecast period. Based on application, the medical device coating market is segmented into infectious diseases, neurology, orthopedics, general surgery, and others. Based on geography, the market is primarily segmented into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America.
Company Profiles
- Koninklijke DSM NV
- Hydromer Inc.
- Surmodics Inc
- Biocoat Inc
- AST Products Inc
- Covalon Technologies Ltd
- Harland Medical Systems Inc
- Precision Coating Company Inc
- Kisco Ltd.
- Formacoat LLC.
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Material Type, Device Type, Coating, and Application
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
Medical device coating refers to using an external layer of materials such as polymers, metals, and other materials to enhance the mobility and performance of a medical device. Medical device coatings are also utilized to prevent surfaces of several medical devices, such as dentistry, neurology, general surgery, and others. There are various types of medical device coatings available, which can be grouped into hydrophilic coatings, anti-microbial coatings, drug-eluting coatings, and anti-thrombogenic coatings, among others. Applying these coatings results in proper sanitation, corrosion resistance, and biocompatibility of medical devices.
Rising demand for coated medical devices in surgical and diagnostics procedures along with a high prevalence rate of healthcare-associated infections are driving the growth of the medical device coating market.
Based on device material type, the metal segment took the forefront leaders in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.
Based on the application, general surgery segment took the forefront leaders in the worldwide market by accounting largest share in 2021.
Hydrophilic Coating segment dominated the global medical device coating market and accounted for the largest market share during the forecast period of 2022-2028.
Koninklijke DSM NV, Hydromer Inc, Surmodics Inc, Biocoat Inc, AST Products Inc, Covalon Technologies Ltd, Harland Medical Systems Inc, Precision Coating Company Inc, Kisco Ltd, and Formacoat LLC, among others are among the leading companies operating in the medical device coating market.
Global medical device coating market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. In North America, the U.S. is the largest market for medical device coating market. owing to the presence of more than 6,500 medical device companies comprising small and medium-sized enterprises (SMEs). The states in the US comprising the highest number of medical device companies involve California, Florida, New York, Pennsylvania, Michigan, Massachusetts, Illinois, Minnesota, and Georgia. Additionally, US medical device companies are highly recognized worldwide due to their innovative and high-technology products. Such factors act as a standalone factor responsible for the overall market growth of medical device coating in the US during the forecast period of 2022-2028.
The List of Companies - Medical Device Coating Market
- Koninklijke DSM NV
- Hydromer Inc
- Surmodics Inc
- Biocoat Inc
- AST Products Inc
- Covalon Technologies Ltd
- Harland Medical Systems Inc
- Precision Coating Company Inc
- Kisco Ltd
- Formacoat LLC
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
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Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
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Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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