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The shift toward scalable, virtual RCTs and AI-supported analytics is one of the most important trends to watch.
December 3, 2025
By: Douglas Kalman
PhD, MS, RD, CCRC, FACN, Co-Founder, Substantiation Sciences
By: Susan Hewlings
Co-Founder, Substantiation Sciences
As part of Nutraceuticals World’s 2026 State of the Industry review, Douglas Kalman and Susan Hewlings, Co-Founders of Substantiation Sciences, explore how GLP-1–related innovation, decentralized clinical trials, and AI-driven analytics are advancing supplement science. They also highlight the growing need for rigorous substantiation, new delivery systems, and continued investment in research to ensure responsible, evidence-based innovation.
Over the last 12 months, the rise of GLP-1 drugs has transformed the supplement weight-loss category, as evidenced by the rapid emergence of “GLP-1 companion” products — from high-protein beverages and prebiotic blends positioned as “GLP-1-friendly” to specialized nutrition offerings from major CPG players.
Analysts now project the GLP-1 nutritional support segment alone to grow from $4.1 billion in 2025 to $13 billion by 2035 on double-digit CAGR. This creates a huge opportunity, but also significant regulatory risk if products imply they enhance drug efficacy, modulate GLP-1 pharmacology, or treat obesity without adequate evidence.
Additionally, you can’t ignore the continued strength of tried-and-true ingredients like creatine and protein. They are a great example of how investment in science really pays off in the long run. The science for these ingredients supports their use across categories and populations, making them ideal for product formulations.
“For an industry that has primarily relied on small, tightly defined, underpowered studies, this shift toward scalable, virtual RCTs and AI-supported analytics is one of the most important trends to watch.”
Scientifically, the past year has marked a tipping point in the adoption of decentralized and hybrid clinical trials, digital health technologies, and real-world evidence frameworks for supplements. Recent literature shows decentralized clinical trials (DCTs) and digital measures improving recruitment, diversity, and longitudinal data capture.
At the same time, AI/ML and generative AI are increasingly used to design smarter trials, interrogate large datasets, and identify responder subgroups. For an industry that has primarily relied on small, tightly defined, underpowered studies, this shift toward scalable, virtual RCTs and AI-supported analytics is one of the most important trends to watch.
How the use of AI in substantiation and clinical trials automation will play out on the regulatory and legal side of things remains to be seen as big class action cases assessing AI derived substantiation has yet to be tested. We believe the role of the expert will remain in place — just the tools used by experts will evolve, making them more efficient and precise.
Looking ahead, we will be watching the development of new and innovative delivery technologies to overcome bioavailability challenges as well as to appeal to consumers seeking to use supplements beyond traditional pills and capsules.
How will the industry respond to consumer demand for transparency? We hope for an enhanced investment in science and regulatory awareness. With clinical trials more affordable and accessible, there is no reason not to invest in science.
We will also be watching scientific innovations to spark the development of new ingredients emerging from research in mechanisms and metabolites. Our understanding of the microbiome will reach a whole new level.
Additionally, as issues related to women’s health have been brought to the forefront and, culturally, the stigma around discussing the female lifecycle has been reduced, we anticipate expanding investment in women’s products beyond menopause. As we approach 2026, we are, as always, excited to be part of the culturally responsive, scientifically driven industry that we are proud to be considered experts in.
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