The demand for health products and services has never been greater, and the average consumer is growing increasingly savvy when it comes to identifying best-in-class health products. Consumers want relatable proof from their nutraceutical products, and they want it to be more accessible than ever before. A survey done by TrustPilot shows that “72% of Gen Zers were more likely to purchase based on social proof versus 66% of millennials, 65% of Gen Xers, and 63% of baby boomers.

This data shows that trust signals are becoming even more important, as the next generation of shoppers clearly embraces them more than past consumers, and continues to age into greater spending and purchasing power.”

This presents a unique challenge for nutraceutical companies in particular – conducting quality research and collecting product outcomes has traditionally been difficult due to high costs and unnecessary because of different regulations on nutraceutical product development. Examining the evolution of the nutraceutical industry presents a number of clues as to why that is, and how we might combat it. 

 

What are nutraceuticals? 

Searching for a concrete definition of nutraceuticals is a futile exercise – market research companies, legal firms, and regulatory bodies all have different definitions of nutraceuticals based on a multitude of variables. However, generally speaking, a nutraceutical (or nutraceutic) is a “food or part of a food that provides medical or health benefits, including the prevention and/or treatment of a disease” according to a publication in the National Library of Medicine. The term “nutraceutical” is not endorsed by the FDA, and the FDA uses the term “dietary supplement” to reference the majority of the products the consumer market deems as nutraceuticals. 

 

How different are nutraceuticals and pharmaceuticals?

Nutraceuticals and pharmaceuticals have dramatic differences in how they are developed, marketed, regulated, consumed, and sold. The most significant difference between nutraceuticals and pharmaceuticals is that nutraceuticals do not have to be FDA approved before they hit shelves and online stores. This is not to say that nutraceutical regulation is non-existent. The Federal Trade Commission (FTC) is responsible for ensuring that advertising/marketing efforts are not claiming to treat, cure, or reduce the risk of disease – as this is the role of pharmaceuticals. Recently, the FTC banned multiple companies from the supplement industry for baseless marketing claims. 

As mentioned, the approach to regulation is the largest difference between nutraceuticals and pharmaceuticals – if you’re interested in diving into the details, check out our post dedicated to nutraceutical marketing and its regulatory landscape.

Given the complex nature of the industry, it comes as no surprise that nutraceutical companies face a plethora of looming challenges as consumer demands and industry regulations evolve. The consumer is becoming increasingly discerning when evaluating nutraceutical products, and clinical proof, social proof and real-world product efficacy are becoming more important than ever before. 

 

Challenges facing the nutraceutical industry

One of the biggest challenges for any product is standing out. In a post-Covid world, individuals are increasingly focused on health and illness prevention – the global market for Nutraceuticals, which was estimated at $278.8 billion in the year 2020, is projected to reach a revised size of $441.7 billion by 2026 according to Report Linker. With this substantial influx of demand, we see a rapidly increasing supply of new products rushing to market. As companies race to get their product out the door, there are many concerns with ingredient quality, authentic sourcing, contaminations, and more. 

The National Library of Medicine provides a practical example of an issue with a common nutraceutical ingredient, ginseng:

 “Ginseng has several varieties such as California ginseng, wild ginseng, prickly ginseng, Pacific ginseng, Malaysian ginseng, Indian ginseng, Peruvian ginseng, Southern ginseng, Brazilian ginseng, and wild-red ginseng. All of these are sold as ginseng, but none of these belongs to the genus Panax, which contains real ginseng including Korean ginseng (P. ginseng), South China ginseng (P. notoginseng) and American ginseng (P. quinquefolius)”

As one can imagine, it would be important for someone using any nutraceutical to have confidence they are ingesting the intended therapeutic ingredients – so it’s no secret that high quality and transparent ingredient sourcing can be a deciding factor for someone to click that “add to cart button.”

Another massive challenge facing the nutraceutical industry is the lack of clinically-tested, proven products and ingredients. Every nutraceutical company wants to be able to make a unique claim about the benefits of their product as a competitive advantage in the marketing department, but the reality is that many of these companies are unfamiliar with the lengthy process required to generate scientific claims.

This results in most of this work being outsourced to CROs or other vendors, distancing those developing and marketing the products from those generating clinically valid claims. Arguably, the most significant factor contributing to the difficulty of clinical validation in the nutraceutical industry is the cost and intensiveness of resources required to conduct a study at scale.

 

Large scale clinical research is historically very expensive and a resource consuming initiative 

Companies historically needed to hire a research team in-house, or outsource the work to a contract research organization. Depending on the product or the desired outcome, there may be a need to conduct a pilot and feasibility study ahead of the actual product efficacy study, which adds additional cost and time to the clinical process. Often, by outsourcing this work, researchers within the nutraceutical industry are losing valuable opportunities to collect more data, explore new indications or understand potential side effects earlier.

 

Nutraceutical companies need to recruit a large, targeted population of patients

Recruitment for nutraceutical studies is a difficult task – screening for participants often entails a significant assessment as lifestyle choices are a bigger factor in altering nutraceutical study results versus pharmaceutical trials. In addition, depending on the study budget and population, there may be a need to only recruit remote participants with access to smartphones or wearable technology (like a BYOD clinical trial).

 

Great clinical research needs great data

Data for these studies needs to come from a homogenous group such that the intended audience for the product is participating in the study, but heterogenous enough that results could be extrapolated out to a broad population of consumers. Clinical study diversity is a massively pressing topic in clinical research and proving to be a challenge for the largest companies in the world – it’s no wonder that smaller nutraceutical companies would struggle to collect the same level of data quality. 

 

Don’t you forget about me

With an enormous market size, by no means could one say that nutraceuticals has been ‘forgotten;’ but when we look at the expanding reach of nutraceuticals into consumer lives and the growing demand for clinically-backed commercial claims from consumer, it’s easy to see that the tools haven’t kept up with the demands of this growing industry.

That’s where technology like what our team is building at Smart Omix by Sharecare comes in. Our hope is to expand the rapid collection of rich, affordable real-world data from patients and healthy participants across the companies and products that can actually affect an individual’s health and well-being. That includes pharmaceuticals, digital therapeutics, medical devices and nutraceuticals.

To learn more about how Smart Omix is lowering the barriers to real-world data collection, check out our list of nutraceutical-specific features, like eConsent or electronic patient-reported outcomes.



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