Medical Coatings Market

[179 Pages Report] The global medical coatings market size is projected to grow from USD 6.0 billion in 2020 to USD 15.2 billion by 2025, at a CAGR of 20.5% during the forecast period. The growth of this market can be attributed to the rising income levels in emerging economies, a growing percentage of the geriatric population, and the increasing use of home healthcare facilities. Also, the increasing demand for minimally invasive surgical procedures is also anticipated to drive the growth of the medical coatings market.

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COVID-19 Impact on Medical Coatings Market

The medical coatings market includes major Tier I and II manufacturers like DSM, Hydromer, Surmodics, Biocoat and AST Products. These suppliers have their manufacturing facilities spread across various countries across Asia Pacific, Europe, North America, South America, and Middle East & Africa. COVID-19 has impacted their businesses as well. 

• In April 2020, Hydromer partnered with N8 Medical for the supply of coatings to manufacture CeraShield endotracheal tubes. These tubes play a crucial role in the treatment of COVID-19 patients. This development exhibits active involvement of the company in the coatings market. 

The COVID-19 pandemic is spreading rapidly. 15,236,977 positive cases have been registered as of mid-July, 2020. The European Commission recently adopted a proposal on April 3, 2020, to postpone the application date of Medical Devices Regulation (MDR) for one year. The European Commission has recently approved revised harmonized standards to expedite the production of medical face masks, gloves, containers for intravenous injections, and sterilization devices and disinfectants, and alter particular requirements for emergency and transport ventilators. FDA has also issued Emergency Use Authorizations (EUA) for medical devices, including IVD test kits to diagnose COVID-19 and PPE (gloves, gowns, and masks) needed to protect healthcare providers interacting with patients. 

Medical Coatings Market Dynamics

Driver: Increasing use of minimally invasive surgical procedures

In a minimally invasive surgery, doctors use a variety of techniques to operate with less damage to the body than with open surgery. Minimally invasive surgery is associated with less pain, a shorter hospital stay, and fewer complications. This type of surgery offers many benefits compared to traditional open surgery techniques. In many cases, it also offers a higher accuracy rate compared to traditional open surgery. The importance of less invasive medical procedures over conventional surgical procedures is increasing. The increasing prevalence of arthritis, cancer, and cardiovascular diseases, which require complex surgical treatment, has increased the demand for minimally invasive procedures. This has boosted the consumption of lightweight medical devices, such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems that can navigate through complex and sensitive parts of the body. These devices are commonly used during minimally invasive procedures in cerebrovascular, cardiovascular, and peripheral vascular systems. They often have hydrophilic and hydrophobic coatings for easy insertion of such devices into narrow vascular areas with a reduction in tissue damage. Thus, medical coatings play a major role in promoting cost efficiency and less time consumption and are highly preferred in these medical procedures. For instance, use of coatings on medical devices for cardiac and urinary catheterization procedures significantly reduces the time taken for the concerned medical or surgical procedure.

Restraint: High upfront costs and increasing raw material prices

Medical coatings manufacturing entails huge up-front and continuing costs. There are many old or expired patents in this field, and medical coating developers are not allowed to develop new coatings based on past patents to avoid royalty. Hence, up-front payments are required to access expired technology. This factor is restraining the growth of this market. Eliminating all of the up-front costs and hassles is expected to enable the explosion of technology improvements. Formulation of new medical coatings involves legal wrangling, signing nondisclosure agreements, and other expenses. The rising cost of raw materials, such as silicone rubber and PTFE, are also inhibiting the medical coatings market growth to some extent.

Opportunity: Complex design of medical devices demanding atomic layer deposition

The scope of applications of medical coatings is quite high, owing to their functional properties. There is an increasing focus on the advancements of medical devices used in treatment, mitigation, diagnosis, and prevention of diseases and abnormal physical conditions. The medical technology sector experiences continuous evolution; major focus areas are innovative imaging devices and systems, minimally invasive therapeutic products, combination device and drug/biological products, computerized devices and medical IT systems, home- and self-care products, patient monitoring systems, and artificial organs and organ-assistive products. Innovation instruments range from simple surgical instruments, such as tongue depressors and bedpans, to complex programmable pacemakers with microchip technology and laser surgical devices. Rising complexity of medical devices has led to the use of a variety of materials to manufacture these devices. However, materials used to manufacture these devices are not necessarily biocompatible and hemocompatible. To provide the desired properties to the devices, the demand for medical coatings is expected to increase. Coatings can be required to cover the entire complex structure or just part of the complex structure, and it is required to adhere to a variety of materials used within a device. Market players are developing surface treatment methods and techniques to keep up with improvements to existing substrates, as well as newly developed substrates and polymers.

The complex nature of medical devices necessitates atomic layer deposition of a coating to form a uniform layer in the targeted area of a device. Advancements in medical device designing also require the use of nanotechnology that enables deposition of multiple coating layers and helps in eliminating defects and enhance biocompatibility. Continuous developments in medical technology present an opportunity for medical coating manufacturers to develop the best solutions for critical end-use requirements.

Challenge:Stringent and time-consuming regulatory approval process

All medical devices need to undergo design verification tests to demonstrate if they meet the specifications and, therefore, require time for approval. Regulatory bodies do not approve coatings separately. Medical OEMs have different coating materials and methodology options to choose for medical devices. The involvement of the coating supplier in the early stage of product development cycle is extremely beneficial to OEMs and can positively affect the development speed, efficiency, and cost. The coated device needs to be approved or cleared by regulatory bodies. However, some coating manufacturers perform tests on their coatings to maintain high quality. Major coating manufacturers in the market also maintain a Master File with the FDA, which shows all proprietary ingredients and processes involved with the product. A device manufacturer can incorporate this by referring to their regulatory submissions. This may save time for device development. However, the regulatory approval process remains time-consuming. The approval time varies largely according to device types. On average, the FDA takes more than three months to approve a medical device. Many coating manufacturers provide regulatory services to their customers, under which they may provide regulatory filing support and coating design requirement verification and validation process. Changes in regulations can affect medical device manufacturers as well as medical coating manufacturers. FDA regulations are likely to become more complicated and expensive in the future.  

Passive coatings to be the largest coating type segment

The passive coatings segment accounts for the largest share of the overall market. Hydrophilic coatings are widely used on guidewires, catheters, and introducer sheaths to lower friction coefficient. These coatings have properties such as lubricity, durability, low friction coefficient, and low particulate count. Hydrophobic coatings are water- or fluid-repellent and hence suitable for medical equipment. Minimal invasion and easy insertion of medical devices in biological openings offered by the hydrophilic coatings and excellent water repellent properties exhibited by the hydrophobic coatings are responsible for the large market size of passive medial coatings.  

Polymers to be the fastest-growing material type segment 

Polymer-based medical coatings are used in medical devices, medical equipment & tools, protective clothing, and medical implants. They are necessary to optimize durability and corrosion resistance while minimizing the coefficient of friction. Major subtypes of polymer coatings used on medical devices, medical implants, and other applications are fluoropolymers, silicone, parylene, and polyurethanes. Easy availability, low cost, optimum performance, multifunctionality, and low particulate technology are boosting the polymer-based medical coatings market. 

Medical devices to be the fastest-growing application segment 

The medical coatings market is segmented based on application into medical devices, medical implants, medical equipment & tools, protective clothing, and others. The medical devices segment accounted for the largest market share in 2019. Increased use of medical devices in the emerging economies, such as China and India, has led to the high growth of the market. The pandemic has further increased the demand for medical devices, such as catheters, guidewires, endotracheal tubes, positive pressure breathing devices, in-vitro diagnostic devices, cannulas, ventilators, ventilator accessories, infusion pumps, respirators, and other devices. 

North America to account for the largest market share

North America accounted for the largest share of the medical coatings market in 2019. Increased spending in the healthcare industry is driving the market for medical coatings in the region. The US was the largest medical coatings market in the region in 2019. Growing exports of medical devices, along with advancements in medical technology and increasing demand for home healthcare, are fueling the market in the region.

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Key Market Players 

The medical coatings market comprises major players such DSM (Netherlands), Hydromer (US), Surmodics (US), Biocoat (US), and  AST Products (US). Hydomer is among the leading medical coatings manufacturers globally. New product launch and investment & expansion were the key strategies adopted by the company to penetrate the global medical coatings market.

Scope of the Report:

This research report categorizes the medical coatings market based on type, application, and region.

Based on coating type:

• Active coatings
• Passive coatings

Based on material type:

• Polymers
• Metals
• Others

Based on the application:

• Medical Devices
• Medical Implants
• Medical Equipment & Tools
• Protective Clothing
• Others

Based on the region:

• APAC
• Europe
• North America
• South America
• Middle East & Africa

Recent Developments

• In 2020, Hydromer partnered with N8 Medical for the supply of coatings to manufacture CeraShield endotracheal tubes. These tubes play a crucial role in the treatment of COVID-19 patients. This development exhibits active involvement of the company in the coatings market.
• In 2018, Abbott and Surmodics entered into an agreement, under which, Abbott will have exclusive worldwide commercialization rights for Surmodics' SurVeil drug-coated balloons. These balloons are under the US pivotal clinical trial to treat superficial femoral artery.
• In 2020, Biocoat launched of HYDAK UV. The new version of its original HYDAK coating is cured using ultraviolet (UV) light. This coating allows for flexible integration with industry-standard UV coating systems. This development has expanded the company’s product portfolio
• In 2016, DSM Biomedical partnered with Vention Medical, a global integrated solutions partner. The partnership offers integration of development, testing, and application of DSM’s ComfortCoat coating into the catheter manufacturing process. This development eliminates the need to transfer finished products to another supplier for development and coating application services. 

Frequently Asked Questions (FAQ):

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