Arnaud Verhaeghe Head of Oral DosageRoquette Pharma Solutions
The distinction between the nutraceutical and pharmaceutical markets is not as stark as many assume. Representing two sides of the healthcare coin, the sectors approach the shared goal of improving individuals’ quality of life from different angles. In pharma, precision and consistency is everything. Every process, active ingredient and final product must adhere to the strictest regulatory standards to ensure efficacy, as well as patient safety. Pharmaceuticals are also largely reactive – focusing on treating a specific condition. Nutraceuticals, on the other hand, typically represent a preventative approach to health – aimed at maintaining general wellbeing rather than targeting illness.
While they are subject to regulations from health authorities, dietary supplements are not held to the same rigorous testing and approval processes as prescription drugs. In addition, the nutra space characterizes its target audience as “consumers”, in contrast with pharma’s “patients”. These differences present a challenge for brands working across both sectors; they require two contrasting tones of voice, two very different regulatory landscapes and two sets of industry updates with which to keep up.
The good news is, the core goal remains the same – help people live longer, happier and healthier lives. Here are some key trends defining both sides of the healthcare coin in 2023:
Patient Compliance
A permanent fixture since the dawn of modern medicine, medical non-compliance remains one of the toughest challenges facing the pharma industry. Estimates suggest that medication non-adherence accounts for 50% of treatment failures in the US alone, resulting in an alarming 125,000 deaths each year.1 The issue is particularly serious for the oldest and youngest patients, as well as anyone suffering from health conditions that make traditional medications difficult to take – such as dysphagia.
An aging population in many regions and growing instances of chronic disease worldwide have intensified the search for alternative drug delivery formats to help curb noncompliance. 2,3 Orally dispersible tablets and films (ODTs & ODFs) are great examples of oral dosage forms that are well suited to the task of improving patient compliance. Formulated to dissolve on contact with saliva in the mouth rather than in the stomach, they are ideal for patients who have difficulty swallowing conventional tablets and capsules. This simple step of removing some of the discomfort associated with taking medications can have a profound impact on compliance rates and treatment success.
Multifunctional pharmaceutical excipients are an essential component of all ODT and ODF formulations. To create a successful end product, pharma producers need excipients that exhibit an excellent dispersibility profile, good mechanical strength and a pleasant taste and texture – the latter being especially important for delivery forms that dissolve in the mouth. Such features aid manufacturers in producing medications that patients may even look forward to taking.
New Dimensions
The topic of 3D printed medications is only getting hotter as more evidence emerges of its benefits for patients and drug producers. The technology has featured in the nutraceutical sector for around half a decade in the form of personalized gummy “stacks”, customized to individual health goals.4 With proof of concept in hand, the pharma industry is seriously considering 3D printing as a way to tailor dosing and treatment requirements to different patients—especially vulnerable groups, such as children and the elderly.
While there are still questions to overcome, particularly regarding processing safety and regulation, the future seems bright for 3D printed pharmaceuticals and dietary supplements. Commentators predict that, eventually, patients could ‘build-their-own’ non-prescribed self-medications by selecting the formulation type, flavor, texture, color, shape and size – with serious implications for medication compliance.4,5
For manufacturers, adding 3D printing to their processing methods could significantly reduce time to prototype for new medications and nutraceuticals, unlocking faster entry into first-in-human (FIH) clinical trials and with it, lower cost of development.6 The consequences – particularly for the development of rare disease treatments that are often hampered by steep manufacturing requirements – could be considerable.
Clearer Claims
Switching over to the nutraceuticals segment, ‘trust’ and ‘transparency’ are key themes to consider for dietary supplement manufacturers operating in 2023. The nutraceuticals sector is heavily influenced by food industry trends, and the current clean-label, plant-based renaissance is no exception. Driven by a desire to take control of what they consume – for their own health and that of the planet – shoppers are moving away from overly processed food, animal-derived products and any solutions that claim a long list of vague benefits. In Germany, for instance, more than a third of consumers say products that make many claims are less trustworthy than those with a few specific ones.7
While they might be trending, plant-based ingredients can be difficult to deliver, especially in softgel formats, due to complex development and formulation challenges. The most prominent of these are perceived cost, seal strength, encapsulation speed and consistent capsule performance from batch to batch.
Excipient suppliers are taking on these challenges by developing 100% plant-based solutions, of which pea starch technology is one of the most exciting. Exhibiting improved process efficiency and flexibility, pea starch softgel systems can accommodate a wide range of fills while overcoming the temperature limitations associated with traditional gelatin. For today’s skeptical consumers, sourcing data is almost as important as the supplement itself. As such, manufacturers should look for ingredients’ partners equipped with a vertically integrated supply chain. Not only can they provide a complete picture of an ingredient’s origin from field to final product, they are also better equipped to predict and protect against ingredient shortages.
Happy Gut, Happy Brain
Commentators are predicting that 2023 will be another great year for gut health supplements. Consumers have been turning to ingredients like pro-, post- and prebiotics for years to address digestive discomfort, but now most are very cognizant of the gut’s role in regulating other bodily functions, including sleep quality, mood, focus, and immunity.8
It is unsurprising therefore that two out of five US consumers report taking some kind of supplement over the last 12 months aimed at supporting their gut health.9 Encouraging shoppers to seek out probiotics and other ingredients associated with feeding the gut microbiome is therefore not an issue for supplement brands. Rather, the challenge is securing repeat customers by ensuring tablets, capsules or chews deliver on their promised benefits – and that means bioavailability must become a priority.
While each bacterial strain exhibits a unique bioavailability profile, most do not fare well if exposed to the highly acidic environment of the stomach. To ensure strains remain active until they reach their intended site of action – the small intestine – probiotic supplements often feature some sort of protective coating or delayed release functionality. An enteric coating is the most common form of protective encapsulation seen on the market today, but due to its synthetic chemical make-up and concerns surrounding efficacy, some brands are beginning to explore alternatives.
Extended-release dosage forms or delivery methods designed to control the release of the active ingredient within the body provide alternatives. Controlled release formats offer several advantages regardless of application, from more consistent dosing to improved patient compliance. In the context of gut health supplements, this delayed release profile can help ensure that sensitive APIs, like live bacteria, reach the small intestine intact. Further research is underway in this area, as gut health supplements command a growing presence in the nutraceuticals market. For example, we envision innovative plant-based coating technologies replacing synthetic enteric encapsulation to offer consumers naturally effective solutions.
Virtue of Variety
The impact of pill fatigue – or people feeling overwhelmed by multiple daily tablets – is not confined to pharma applications. Consumers are looking for a wider variety of nutraceutical dosage formats to make taking non-prescription medicines more convenient – if not enjoyable. According to research conducted by the UK Food Standards Agency, older and younger consumers were most likely to welcome alternative supplement formats, explicitly because they are different from the typical pharmaceutical medications they find difficult to take.10 The desire for greater variety is also present within specific supplement categories, with 27% and 25% of those who regularly consume probiotics doing so via meal replacement bars and wellness drinks, respectively.11 Formats like medicated confectionery (gummies), powder sachets and sticks or chewable tablets should therefore be a focus for brands looking to give consumers more choices.
Replicating the taste, texture and fun associated with traditional candy, without filling the space between the required shape and the necessary ingredients in the recipe with sugar, serves as the main challenge here. The latest market research points to a 6.2% CAGR for the sugar-free products market over the next six years, meaning the sector could end the decade with a valuation of $65.31B.13
Demand for no-added sugar and sugar-free dietary supplements is predicted to be one of the significant growth drivers, making it all the more imperative for manufacturers to get this balance right. This is where an experienced, flexible excipients partner can truly add value. Many key ingredients used in the production of pharma and nutraceuticals exhibit a naturally sweet flavor profile, but are sugar and calorie free. Mannitol, hydroxypropyl betacyclodextrin (HPβCD), maltodextrin and various plant-based starches are just some examples of these versatile ingredients, ideal for creating delicious, sugar-reduced or even sugar-free supplements. With this wide range of potential solutions at their fingertips – and the support of an expert supply partner – brands can make sure they are set to address current consumer demand and adapt quickly to the trends to come.
Two Sectors, One Goal
Though they often have very different focus areas and requirements, the pharma and nutra markets are fundamentally focused on improving people’s health and quality of life through effective and enjoyable products. No matter the end application or trends, quality excipients, supplied by an expert partner, can help manufacturers realize this goal. As we look to the rest of 2023 and beyond, players in both segments have a lot to gain by taking on a more holistic, cross-sector approach to healthcare solutions. After all, pharma and nutra may be on opposite sides, but it takes both to make a complete coin.
References
1. Elephant in the Room, US Pharm. 2018;43(1)30-34, https://www. uspharmacist.com/article/medication-adherence-the-elephant-in-theroom
2. World Health Organization, Ageing and health, 4 October 2021, https://www.who.int/news-room/fact-sheets/detail/ageing-and-health
3. PWC, Chronic diseases and conditions are on the rise, https:// www.pwc.com/gx/en/industries/healthcare/emerging-trends-pwchealthcare/ chronic-diseases.html
4. Fast Company, This company 3D-prints your favorite vitamins into a single gummy, 5 November 2021, https://www.fastcompany. com/90634244/this-company-3d-prints-your-favorite-vitamins-into-asingle- gummy
5. Alomari M, Mohamed FH, Basit AW, et al. Personalised dosing: Printing a dose of one’s own medicine. International Journal of Pharmaceutics. 2015;494:568–77. doi:10.1016/j.ijpharm.2014.12.006
6. Genome UK: The future of healthcare. Gov.uk. 2020.https://www.gov. uk/government/publications/genome-uk-the-future-of-healthcare/ genome-uk-the-future-of-healthcare (accessed Mar 2022).
7. The Pharmaceutical Journal, 3D printing of pharmaceuticals and the role of pharmacy, 30 March 2022, https://pharmaceutical-journal. com/article/research/3d-printing-of-pharmaceuticals-and-the-role-ofpharmacy
8. Mintel, Presentation at Food Ingredients Europe 2022, https://www. nutraingredients.com/Article/2022/12/16/Trends-for-2023-Caring-formental- physical-and-sexual-health#
9. International Food Information Council, Consumer Insights on Gut Health & Probiotics, April 2022, https://foodinsight.org/wpcontent/ uploads/2022/04/IFIC-Gut-Health-and-Probiotics-Survey.pdf
10. Food Standards Agency, Food Supplements Consumer Research, May 2018, 3.3.2 ‘Formats’,https://www.food.gov.uk/sites/default/files/ media/document/food-supplements-consumer-research.pdf
11. Ibid, International Food Information Council, Consumer Insights on Gut Health & Probiotics, April 2022, https://foodinsight.org/wpcontent/ uploads/2022/04/IFIC-Gut-Health-and-Probiotics-Survey.pdf
12. Ibid, International Food Information Council, Consumer Insights on Gut Health & Probiotics, April 2022, https://foodinsight.org/wpcontent/ uploads/2022/04/IFIC-Gut-Health-and-Probiotics-Survey.pdf
13. Meticulous Research, Sugar-free Products Market Worth $65.31 Billion by 2029 - Exclusive Report by Meticulous Research ® , September 2022, https://www.globenewswire.com/en/newsrelease/ 2022/09/20/2519113/0/en/Sugar-free-Products-Market- Worth-65-31-Billion-by-2029-Exclusive-Report-by-Meticulous- Research.html