The nutraceutical and, subsequently, excipients market for oral solid dosage forms (OSDFs) is both driven and challenged by consumer awareness. On one hand, rising healthcare costs and the growing consumer focus toward a healthy lifestyle, plus a proactive nutritional approach to avoid chronic diseases, drive the market. On the other hand, consumers are growing more conscious of the health and environmental consequences of products they consume, a trend that is driving the “clean label” movement. These and many other trends and challenges to nutraceutical oral solid dosages are analyzed in the just-published report Excipients for Nutraceutical Oral Solid Dosage Forms: Market Analysis and Opportunities. To learn reports key findings, REGISTER for our upcoming webinar.
OSDFs are the most preferred consumption format in both Europe and the United States, followed by powders and liquids. Within oral solids, tablets are favored over capsules and soft gels due to numerous advantages such as quick manufacturing, longer shelf life, and favorable taste. However, tablet forms are also the most challenged by the clean-label movement as they use quantities of excipients such as fillers, binders, and flow agents that are higher than all other OSDFs.
“Some companies are opting for clean-label excipients,” says Shilpi Mehrotra, manager of the project. “Nevertheless, the compression and heat involved to form the tablet can degrade the nutrient, resulting in possibly lower absorption of the active.”
In soft gels, the outer ribbon can be made of vegetarian polymers, but this can adversely affect the manufacturing process and the performance of certain ingredients. Capsules are currently the only solid dosage form compatible with clean-label requirements, as they use fewer excipients. They are also free of allergens, preservatives, artificial colors, lactose, and gluten and can be available with a variety of third-party certifications such as Vegan Action, Vegetarian Society, Non-GMO Project Verified, Halal, and Kosher.
Due to the growing clean-label movement, growth is forecast slightly higher for soft gels and capsules in OSDFs. However, compared to tableting, the encapsulation process is slower and complicated, which can slightly constrain the growth.
Among excipients affected by the clean-label movement are binders such as MCC and HPMC, which are being substituted with native starch; lubricants such as magnesium stearate, substituted with natural products such as rice flour and starch; and controlled release coatings such as polymethacrylate (PMA), substituted with natural xanthan gums.
The upcoming ban on titanium dioxide in France ensures that many nutraceutical and coating formulators are focusing on developing titanium-free products. Common alternatives to titanium dioxide currently being used include magnesium stearate and calcium carbonate as opacifiers, along with natural glossing agents such as mica and carnauba waxes. The ban on titanium dioxide is also expected to increase the volume consumption of few film-forming polymers, such as HPMC, in coatings for nutraceutical OSDFs.
The U.S. nutraceutical market accounts for the largest market share of more than 40% and is expected to grow at a CAGR of around 3.6% through 2024. It is the most advanced market for excipients in nutraceutical OSDFs. For example, it has a significantly higher consumption of coating excipients for nutraceuticals compared to the European market. However, the overall European market will be growing at a considerably higher rate in the forecast period. OSDFs will continue to dominate the market of nutraceutical formulation due to their ease of production and cost-effectiveness.