Issue link: https://www.e-digitaleditions.com/i/1199406
Tablets & Capsules January 2020 19 derived from animals, is prone to price fluctuations, and has a relatively large carbon footprint. VSCs have faced some concerns from consumers interested in "clean label" products—defined as products containing only unprocessed or unmodified ingredi- ents—since starches are chemically modified materials. Also, carrageenan suffered f rom a long period of concerns that it was car- cinogenic, causing many food produc- ers, especially in the US, to stop using it in their products. However, the FDA considers carrageenan a generally recog- nized as safe (GRAS) material. VSC materials The most common gelatin substitutes used to make VSCs are carrageenan, modified starch, and alginate. Table 1 summarizes the market and sourcing challenges for each. Carrageenan. The global market for carrageenan is approximately 60 to 70 kilotonnes per year, with an expected compound annual growth rate (CAGR) of 4 to 5 percent [2]. Seventy to 80 per- cent of the carrageenan produced is used in the food industry for its gelling, thick- ening, and stabilizing properties, while less than 10 per- cent is used by the pharmaceutical industry. Pharma- ceutical applications, particularly soft capsules, are still considered a niche segment. As previously mentioned, the first VSCs consisted of a blend of carrageenan and modified starch (hydroxy- propyl starch), and most nutraceutical VSCs currently on the market still use carrageenan-based formulations. and suspensions for dietary and cosmetic products [1]. The capsules were made from carrageenan-modified starch (C-MS), and the encapsulation equipment sub- jected the capsules to a curing step, in which the capsules passed through a band of hot air. Later machines included die rolls designed to increase the thickness of the seal and prevent the capsule contents from leaking. The industr y has made continuous improvements to the materials, equip- ment, and processes involved in their manufacture. As a result, vegetarian soft capsules can now be produced using the same type of mixing and encapsula- tion equipment used for GSCs at similar encapsulation speeds. VSC market VSC products are currently avail- able in the nutraceutical and cosmetics markets as well as a few products in the pharmaceutical market. VSCs currently constitute approximately 10 to 15 per- cent of the nutraceutical soft capsule market in terms of revenue, and their use is expected to continue to grow due to increasingly competitive material prices and optimized processing technology as well as expansion into the pharmaceutical market. The primary market for VSCs includes consumers who demand vegetarian capsules for cultural, religious, or dietary reasons. VSCs can also be beneficial in appli- cations where gelatin is not a suitable capsule polymer, such as high-temperature encapsulation or products with high-pH fill content. Manufacturers are also looking to VSC polymers as alternatives to gelatin because gelatin is Table 1 Market and supply for gelatin substitutes in soft capsules Material Global market in 2018 (kilotonnes) Pharma usage Major pharma suppliers* Average price ($/kg) Raw material Sourcing challenges Carrageenan 60-70 7% VSC: 500 tonnes ~10-12 11-12 Red seaweeds Limited supply base and concerns with feedstock availability may occur due to climate change. Currently, no supply issue with feedstock in major producing regions. Alginates 40 8-10% GSC: unknown ~2-4 12-14 Brown seaweed Highly consolidated supply base and high entry cost for new suppliers. Modified starch 9,000-10,000 10-15% (as an excipient) ~5 4-5 Many, including: potato, corn, cassava, etc. Important to track price movement. Source: Beroe analysis * Indicates the number of suppliers who cater to pharmaceutical applications but not necessarily soft capsule shells. Vegetarian soft capsules can now be produced using the same type of mixing and encapsulation equipment used for gelatin soft capsules at similar encapsulation speeds.