Antimicrobial Medical Device Coatings Market

Market Overview

The global antimicrobial medical device coatings market size was valued at USD 2.38 billion in 2022. It is estimated to reach USD 4.35 billion by 2031, growing at a CAGR of 6.92% during the forecast period (2023–2031). The global market is experiencing growth due to an escalation in the target population affected by healthcare-associated infections (HAIs).

Antimicrobial coatings are applied to medical devices to prevent the growth of microbes. The Antimicrobial medical device coatings include various materials used for coating and a wide range of medical devices on which the coating is applied. Coating materials vary from metals and non-metals, which include silver, copper, zinc, nickel, titanium, polymers, and organic and inorganic substances. Medical devices like catheters, implantable devices, and surgical instruments are exclusively applied with antimicrobial coatings.

Market Dynamics

Global Antimicrobial Medical Device Coatings Market Drivers

Availability of Companies Providing Coating Systems

Medical surface coating equipment is necessary to protect devices from corrosion and provide lubricity, durability, and biocompatibility. Coating equipment is used to apply and cure a variety of coatings, from lubricant coatings that reduce friction to antimicrobial coatings that resist contamination. Several companies are also featuring coating equipment apart from coating materials and solutions. Companies that produce coating equipment collaborate with coating technology manufacturers to develop advanced coating equipment for medical device customers. For instance, OakRiver Technology, Inc. and SurModics, Inc. have agreed to work together on developing, producing, distributing, and supporting advanced coating equipment for the medical device industry.

Furthermore, leading surface modification and drug delivery technology suppliers to the healthcare sector include SurModics, Inc. OakRiver equipment platform will utilize SurModics' PhotoLink coating technology, which is ideal for coating catheters, guide wires, pacing leads, and other similar medical devices. SurModics and OakRiver will jointly market the coating equipment to medical device customers. Moreover, more partnerships and collaborations can benefit companies' revenue, resources, product offerings, and market presence. This will enable them to get more customers, boosting market growth during the forecast period.

Emergence of Nanoparticle Coating Technology

Advancements in nanotechnology have resulted in the development of high-performance, multifunctional bioactive materials for biomedical devices. These materials have appropriate mechanical and tribological properties, making nanomaterial coatings more multifunctional and biocompatible. Moreover, the need for nanoparticle coating technology will rise due to fewer drawbacks, reducing the advent of infectious diseases.

Various metals, polymers, and other materials have been nano-engineered to obtain cost-effective, functional surface coatings. Several companies opt for nanoparticle coatings due to their reduced cost and great surface-to-volume areas. Thus, applying to a wide range of products, the demand for nanoparticle coating technology will likely increase in the upcoming years, especially in healthcare industries, which drive antimicrobial medical device coatings market growth.

Global Antimicrobial Medical Device Coatings Market Restraint

Stringent and Time-consuming Regulatory Approval Process

The device to be coated should undergo regulatory approval. However, the process for approval by regulatory bodies varies depending on the device. An approved medical device takes the FDA more than three months to approve. Coatings from companies that provide coating technology undergo a battery of testing to ensure they are of high quality. Many coating manufacturers provide regulatory services to their customers, including regulatory filing support and coating design requirement verification and validation process. Antimicrobial coatings often struggle to prove better health outcomes through their incorporation. Moreover, challenges regarding antimicrobial efficacy, durability, and FDA/regulatory approval are still evolving. Companies such as HeiQ that have made antiviral claims must undergo further testing and validation to warrant these claims.

Furthermore, changes in regulatory bodies' protocols might affect the manufacturers of medical devices and coatings. FDA regulations are expected to get more complicated and expensive in the future. Companies face difficulties complying with the rigorous process of verifying medical devices and coatings and adhering to regulatory rules, which is necessary. The market will likely undergo a major loss as companies' revenue might face a serious downfall if such conditions persist, restricting market growth during the forecast period.

Global Antimicrobial Medical Device Coatings Market Opportunities

Rising Prevalence of HAIs

Healthcare-associated infections (HAIs) are ventilator-associated pneumonia, central line-associated bloodstream infections, catheter-associated infections, and surgical site infections (SSIs). HAIs can occur at any healthcare facility, hospital, ambulatory surgical center, dialysis clinic, or long-term facility. About one in 25 inpatients are prone to infections associated with hospital care. HAIs can lead to significant patient illness and death, increased duration of hospital stay, and require additional diagnostic and therapeutic interventions, which generates additional costs. Therefore, to overcome the threat of high-risk HAIs occurring during medical procedures or using medical devices, novel methods should be employed in addition to appropriate cleaning, antibiotics, and disinfectants. One such major approach is the introduction of coating technologies.

Furthermore, the medical coatings market is driven by stringent regulations pertaining to HAIs, healthcare awareness, and increasing adoption among end-users. Moreover, end-users such as hospitals, diagnostic centers, ambulatory surgical centers, medical institutes, and research laboratories are prominently leading the medical coatings market. Antimicrobial coatings made it the largest product segment, accounting for over 40% of global demand, whereas drug-eluting coatings constituted the second-largest market share. Overall, hydrophilic coatings are expected to grow very rapidly during the forecast period. Therefore, an increase in the target population with HAIs contributes to the growth of the antimicrobial medical device coatings market worldwide.

Regional Analysis

North America Dominates the Global Market

Based on region, the global antimicrobial medical device coatings market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global antimicrobial medical device coatings market shareholder and is anticipated to exhibit a CAGR of 6.29% during the forecast period. The region is expected to have a rise in demand for antimicrobial coatings due to a successful reduction in HAIs and the growing expenditure on medical equipment in the healthcare sector. Moreover, the market in the region is growing due to the increasing exports of medical devices, medical technology advancements, and the rising need for healthcare services provided at home.

North America has the highest concentration of medical coating manufacturers compared to other regions. Market expansion is propelled by a few organizations forming strategic partnerships with manufacturers. The strong partnership between the US and Canadian medical device industries on account of relatively similar quality, geographic proximity, and safety standards should stimulate regional antimicrobial coatings market growth.

Europe is estimated to exhibit a CAGR of 6.71% over the forecast period. The elderly population of 65 years and above continuously increases in European countries such as Germany, France, the UK, Italy, and Spain. These countries have also been witnessing the risk of HAIs among the aging population for many years; however, according to various studies, the usage of antimicrobial coatings was reported to reduce the infection rate to an extent. Therefore, the demand for such coatings will likely increase during the forecast period, eventually boosting the region's market growth.

Furthermore, government bodies have also focused on increasing healthcare spending to reduce nosocomial infections. Germany has the largest healthcare expenditure among EU member states. France, Italy, and Spain followed the UK, which recorded the second-highest. Moreover, the healthcare expenditure of a country will define quality healthcare at an affordable cost to society and the people. This will improve medical technologies, promote bactericidal coatings, and reduce the prevalence of HAIs.

The Asia-Pacific region is the third-largest global antimicrobial medical device coatings market. Countries such as China, South Korea, Japan, Australia, and India are the major revenue contributors in the European market. Among all the countries, China is the major revenue generator for the region's antimicrobial medical device coatings market. Moreover, risks of HAIs in countries of the Asia-Pacific region have been estimated to be 2-20 times higher compared to other developed countries across the world.

For instance, around 25% of hospitalized patients reported having acquired infections. Although infection prevention and control are well recognized in the region, there are inconsistencies in the quality of evidence and dedicated resources to enhance current infection prevention practices, surveillance, and patient safety.

In Latin America, countries such as Brazil, Mexico, and Argentina are the major revenue contributors. Factors like the prevalence of chronic diseases in aging populations, increased healthcare expenditures, enhanced usage of medical devices, and many more contribute to this region's market growth. Healthcare expenditures per capita for Chile are reported to be USD 1,281 per person, and for Mexico, are USD 583 per person. Countries of Latin America spend around 8% of their GDP on health, with expenditures divided into public and private sectors.

Additionally, most countries in the region are focused on providing better medical facilities, reducing the prevalence of infections, and minimizing the longer stay of patients in hospitals. Countries have also been interested in investing in R&D activities and innovating medical settings to raise patients' dependency on healthcare and provide them with better care. Thus, the demand for antimicrobial medical device coatings will likely increase in Latin America during the forecast period.

Segmental Analysis

The global antimicrobial medical device coatings market is segmented by material and product. 

Based on material, the global market is bifurcated into metallic (silver coatings, copper coatings, and others) and non-metallic. 

The metallic segment dominates the global market and is projected to exhibit a CAGR of 7.19% over the forecast period. Metallic antimicrobials demonstrate better sustainability toward infectious diseases. The goal of antimicrobials is to provide high efficacy at a very low dosage level without the development of resistance. It has been known for a decade that metals are more effective than other substances against biofilm-forming microorganisms. Moreover, metals have shown some efficacy on persister cells and the dormant variant of regular cells that were resistant to antibiotics.

Furthermore, antimicrobial agents fabricating antibacterial surfaces for medical devices consist of organic molecules and inorganic metal ions. Metals such as silver, copper, zinc, and gold are well known for their antimicrobial activities and are used in various in vitro and in vivo applications. The antibacterial activity of the surface can be achieved through two different strategies. One approach is releasing a chemical or antibacterial agent from the biomedical device surface, and another is to graft the antibiotic molecules on the surface of the device to prevent bacterial attachment or kill the attached bacteria.

Non-metallic coatings constituted the second-largest share in the antimicrobial medical device coatings market. These coatings include materials such as polymers, organic substances, iodine, ceramics, calcium phosphate, nitric oxides, and other inorganic compounds. Polymeric coatings are extensively used on various materials ranging from surgical equipment to catheters and medical device circuits. Parylene coatings are the most popular and cost-effective coating application for medical devices. Organic coatings involve silicone or silica-based and drug-releasing coatings, which are popular in this market.

Based on product, the global market is divided into catheters, implantable devices, intraocular lenses, and others. 

The catheter segment is the largest revenue contributor to the market and is anticipated to exhibit a CAGR of 7.10% throughout the forecast period. Various catheter-associated infections are observed in patients employed with catheters due to the growth of microbial flora and biofilm formation. These microorganisms include gram-positive and gram-negative bacteria, which attack especially indwelling catheters like UCs and CVCs. These bacteria lead to serious infections, which extend hospital stays, increase the burden on the patient, and may lead to death. Therefore, most catheters are coated with antimicrobial coatings to prevent such infections.

Silver is the most common antibacterial agent, although others can be used to coat these catheters. Silver and silver nanoparticles have been demonstrated to reduce microbial growth and prevent biofilms on catheters. Other antibiotic coatings impregnated on catheters include rifampin, gentamicin, vancomycin, and many more. Such precautions can control the prevalence of catheter-associated infections.

Recent Developments

• September 2023- Microban International unveiled its newest technological innovation, known as Ascera. This innovative antibacterial technique is now awaiting patent approval and utilizes a bio-inspired active ingredient. It is specifically formulated for application in olefinic polymers and solvent-based coatings.