Enhancing drug efficacy using sustained-release coatings

By Vikash Kumar & Annirban Bhattacharya, MarketsandMarkets Research Private Ltd.

The sustained-release coatings market is projected to grow from $478 million in 2019 to $660 million by 2024, a CAGR of 6.6% durin

The sustained-release coatings market is projected to grow from $478 million in 2019 to $660 million by 2024, a CAGR of 6.6% during this forecast period, driven by the adoption of dietary supplements, healthy lifestyles and disease prevention among consumers.
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 Annirban Bhattacharya

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Vikash Kumar

A sustained-release coating is used to form a microcapsule, which consists of active material in the internal phase, surrounded by a coating. The internal phase is called the core and the outer coating is called the shell. The diameter of the microcapsule may range from several microns to 1mm and the shell acts as a protector or controller of the activity of the core material. The market for sustained-release coatings is growing globally at a significant rate due to their numerous applications and multiple advantages over other technologies. Some of the significant benefits of sustained-release coatings are the protection of the core material from various environmental conditions, flow control of active ingredients, targeting of specific actions, and masking characteristics.

The various active materials that are formulated into microcapsules include drugs, biosimilars, enzymes, vitamins, and catalysts, among others. These are encapsulated in many polymeric materials, including ethyl- and methylcellulose, polyvinyl and cellulose acetate, methacrylic acid, and polyethylene glycol (PEG).

North America accounted for a significant market share of 36% in 2019, followed by Europe, with a share of 28% of the overall market. The US dominated the global sustained-release coatings market with a share of 80% of the North American market in 2019. Several factors, including the increase in the production of generics, growth in the adoption of dietary supplements, rise in per capita pharmaceutical spending, and the ageing population, along with the rising incidence of chronic diseases, support market growth in the US, while the strong presence of pharmaceutical manufacturing companies in the US also makes North America a dominant market for sustained-release coatings.

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In-vitro application set to dominate
Continuous innovation in the area of sustained-release coating designs for core phase materials drive the growth of this market. The core materials are encapsulated to prevent active ingredients undergoing various reactions or protect them from damage caused by environmental factors, such as light, moisture, pH, temperature, and oxygen. Core materials are also microencapsulated to improve shelf life and for the controlled release of active ingredients. There are two main applications areas for sustained release coatings — in vitro and in vivo research and usage.
In vitro application is the area where all therapeutic research happens outside the human body and is the domain of pharmaceutical companies, government laboratories, contract research organizations, and many private research organizations. Ethyl- and methylcellulose and PEG are the primary polymer type materials used in in-vitro applications, and for many disease conditions, a sustained-release coating is used in such applications, for example, in hormone therapy. Ethylcellulose is used for encapsulated therapeutics such as Triptorelin acetate poly (caprolactone) nanoparticles, while methylcellulose is used for encapsulating Verapamil hydrochloride based therapeutics.


Development of mini-tablets a key trend
Sustained-release coating facilitates better-controlled release and targeted delivery compared to the use of electrical and molecular tagging and sensors. This is an emerging market with significant potential. However, regulatory approval remains a considerable challenge for this market. The opportunity for growth mainly lies in the development of advanced sustained-release coating systems for targeted delivery of difficult-to-use ingredients and for formulating pharmaceuticals as tablets and capsules.
Tablets are the most frequently used form of solid oral dosage. They are made up of multiple substances, including active drugs, which cause it to break down rapidly when moistened. Tablets are hard and compressed drugs with or without a coating, further segmented into chewing tablets and lozenges. These substantial oral dosages disintegrate in the mouth in the presence of saliva. They are usually used for local and systematic effects and are also more chemically stable, convenient, and safer than most other dosage forms. Tablets differ from each other in terms of size and weight, depending on the drug.
The development of mini-tablets is a key trend in this market segment. This type of tablet has garnered considerable attention due to its advantages — no need for solvents during production, ease of manufacturing, less coating material required, less risk of dose dumping, and less inter- and intra-subject variability. Versatile sustained release, immediate-release tablet systems, modified-release tablet formulations, and excipient technologies are other advances driving this market.
Advanced technologies to tap into niche markets
With the increasing demand for microencapsulated products, significant R&D activities are being carried out by various companies in this market sector. New technologies are needed to tap into niche markets, such as the use of Phase Change Materials(PCMs) in energy applications, cancer and brain tumour-specific drug delivery. Market players in PCMs are working on new product development, sustained release coating technologies, enhancements to latent heat storage capacity, and the evaluation of different phase change temperature options for enhancing product performance. However, there are no technologies available for the use of microencapsulated PCMs above 932°F (500°C), as required by the energy sector, and addressing this need is expected to provide further market opportunities.
According to the WHO, tumour and cancer incidences globally are estimated to increase to 15 million by 2020. The World Cancer Report also shows that cancer and tumours are spreading at an alarming rate worldwide. This issue needs to be addressed with the help of an efficient drug delivery system. Presently, there is a lack of targeted drug delivery technologies that deliver therapeutics to the location of a brain tumour as crossing the blood-brain and brain-tumour barriers to achieve high drug concentration at the tumour site is a major challenge for targeted drug deliveries. Current therapies in this area are based on the local controlled delivery of anti-cancer agents through biodegradable polymers. Thus, the need for more advanced targeted delivery therapies, especially for the treatment of brain tumours, offers an excellent opportunity for the growth of the global sustained-release coatings market.
The market also offers opportunities for the development of technologies for products used for animal care, which is expected to have significant scope in the future, while in the pharmaceutical industry, there is a limited presence of organ-specific drugs and the development of these drugs would also provide a significant market opportunity. Furthermore, the market offers opportunities in terms of reducing capsule size, increasing bioavailability, and providing multi-component delivery systems.
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