KSM-66 Ashwagandha the Gold Standard of Ashwagandha

Ancient roots Withania somnifera , widely known as ashwagandha, is one of the most trusted and revered herb in Ayurveda, the ancient Indian system of medicine. The botanical’s health benefits have been recognized for over 4,000 years and are steadily being evidenced by science. Ayurvedic practitioners, sages and rishis have confidently recommended and dispensed only ashwagandha roots and their preparations for internal use. The name ‘ashwagandha’ itself references the root, as it smells reminiscent of a horse, symbolizing vigor. In the thousands of years of traditional usage, there is no widespread mention, instruction or practice with the ashwagandha leaf. In fact, an ancient text from Ayurvedic scripture defines the use of the ashwagandha leaf as: “Leaf of the ashwagandha herb is used for topical applications. Usage of this leaf is limited to the external applications.” As an adaptogenic herb, ashwagandha is known for helping the body adapt to stress and maintain balance, or homeostasis, by modulating the release of stress hormones like cortisol which can help reduce feelings of overwhelm. In addition to links with improving sexual function in men and women, studies also link it to cognitive health, promoting focus and alertness, reducing stress, and improving sleep quality, and as well enhancing cardiovascular function. In the sports and active nutrition space, ashwagandha is valued for supporting glucose metabolism and improving performance and recovery. While rooted in ancient traditional Ayurvedic wisdom – literally meaning ‘science of life’ from Sanskrit – ashwagandha bridges ancient practices with modern demand for science-backed, plant-based solutions. To better understand its power and meteoric rise in the herbal supplements space, let’s dive into the latest market data and consumer insights. Market trends The rise of Ashwagandha in Vitamins, Minerals & Supplements (VMS) Ashwagandha has surged in popularity as more consumers seek natural ways to manage stress, sleep, and other health needs, aligning with the modern wellness movement and shift toward holistic health. Ranking among the top-selling herbal supplements in the US, it is positioned as the leading choice for health-conscious consumers seeking natural solutions and holistic support to help manage busy, high-pressure lifestyles. [#1] VMS Ashwagandha is growing across Brick & Mortar and Amazon; Amazon growth has been especially significant, closing the $ gap vs Brick & Mortar. [ref Slide 15] [Title] Brick & Mortar 2023: $274M 2024: $288M +5% increase [Design: Arrow up] [Title] Amazon 2023: $158M 2024: $224M +42% increase [Design: Arrow up] [#2] Ashwagandha has gained significant momentum in VMS over the past year, outpacing the Total VMS Department since August 2024. [ref: Slide 17] Brick & Mortar sales of Ashwagandha grew by 24% between July and December 2024. [#3] More than half of Ashwagandha VMS sales are coming from Branded Extracts; Growth in Branded Extracts is driven exclusively by KSM-66 [ref: Slide 18] KSM-66 accounts for 93% of all branded Ashwagandha extract sales. Top Branded Extracts KSM-66 $249.6M sales 92.5% Share of Branded Extracts $ dollar % Change +21.5% [#4] 8 of the top 10 fastest-growing brands utilize KSM-66 Ashwagandha in their products [ref Slide 19] [#5] KSM-66 is also the leading Branded Extract utilized across top selling items, present in 7 of the top 10 VMS Ashwagandha items. [ref Slide 20] [#6] VMS Ashwagandha products using Root extracts represent 81% of dollar share and are outpacing Root and Leaf offerings, up +13% vs 2023. [ref Slide 21] [Design: chart] Root 81% Dollar Share +12.7% Dollar % Change vs YA Root & Leaf 19% Dollar Share -7.9% Dollar % Change vs YA [#7] Brands that use Root Extract tend to see growth vs 2023. Meanwhile, Root & Leaf Extract Brands are seeing declines [ref Slide 22] [#8] Gummies are the fastest growing form likely due to their approach to convenience [ref Slide 23] 53% of Ashwagandha Buyers have consumed VMS gummies (+14.6% growth) 58% of Ashwagandha Buyers have consumed VMS tablets (+2.7% growth) [#9] On Amazon, KSM-66 contributes to 60% of branded extract sales [ref Slide 25] Branded vs Generic Extracts [Design: pls recreate the chart below] [#10] In fact, only 50% of the top-selling Ashwagandha-only products on Amazon feature a branded ingredient and all of them use KSM-66 [Ref Slide 26] [#11] Among Amazon’s Best Sellers for Ashwagandha-only products, KSM-66 is the only branded ingredient used [ref Slide 27] [#12] The Rise of Ashwagandha in VMS: Amazon [ref Slide 28] Fastest Growing Forms – Ranked by Abs. Dollar Growth [DESIGN: Chart] Fastest Growing Forms and Market Share and % Change Capsules 40% (+55% YOY) Veg Capsule 24% (+11% YOY) Gummy 16% (+100% YOY) Gummies are the fastest growing VMS Ashwagandha form on Amazon, while Capsules lead market share. Similarities of VMS Ashwagandha Trends in Brick & Mortar vs Amazon [ref Slide 29] KSM-66 is the #1 largest Branded Ashwagandha Extract across both Brick & Mortar and Amazon. Root Extracts make up the majority of $ share and are growing across both Channels. Gummies are among the fastest growing forms of Ashwagandha, likely in part due to their convenience. Mood Support is the #1 fastest-growing health focus: Hair, Skin, and Nails is among the fastest-growing health focuses vs 2023. Gold standard As consumer interest in ashwagandha has exploded in recent years, there has been a parallel rise in the scale of research and clinical trials looking into the effects of the herb. Between 2019 and 2024, the number of scientific studies available on ashwagandha in the PubMed database more than doubled, from 95 to 201.1 Randomized, double-blind, placebo-controlled trials have demonstrated that daily supplementation significantly reduces serum cortisol levels and perceived stress.2 Similar findings have been replicated in meta-analyses, which confirm moderate-to-large effect sizes for anxiety reduction.3 Evidence also supports its role in improving sleep quality, with participants in a study experiencing significant improvements in sleep efficiency and latency compared to placebo.4 In the domain of physical performance, supplementation has been shown to increase maximal oxygen consumption (VO2 max), muscle strength, and recovery in both athletic and untrained populations.5,6 Cognitive function may also be enhanced, with studies reporting improvements in attention, information processing speed, and executive functioning in older adults.7 In addition, research suggests that ashwagandha can also help with hormonal balance, menopause symptoms, sexual wellness, weight management, and improve skin health, hydration, texture, and promote healthy hair growth. Ixoreal is playing its part in this growth of research by conducting a total of 70 studies, 48 of which are published, 12 additional studies being completed and in peer review, and a further 10 ongoing studies. Specifically, the company is concentrating its research on healthy populations; studies conducted on individuals who already have health issues may not be broadly applicable to a larger, healthier customer base. This means that any benefits discovered in healthy individuals are more relevant to everyday wellness and prevention. Such ‘gold-standard’ studies are carried out by independent researchers and physicians, with an importance placed on strong academic and clinical backgrounds to ensure the quality of the findings. Through the support of these individuals, research on KSM-66 Ashwagandha is regularly published in peer-reviewed, Pub-Med–indexed publications, deepening the understanding of ashwagandha and its ability to support public health. References: Root vs. leaves For over 4,000 years, Ayurvedic medicine has relied exclusively on the root of the ashwagandha plant for its therapeutic applications. This traditional knowledge is not coincidental – root-based preparations were revered for their balancing, adaptogenic properties, and their alignment with Ayurvedic principles of safety, efficacy, and long-term use. The scientific rationale for this traditional preference is now clear. The root contains a distinct and well-characterized profile of active compounds, primarily withanolides that deliver the adaptogenic, anti-stress, and restorative benefits associated with ashwagandha.1 In contrast, the leaves – though cheaper and more readily available – contain different withanolides, such as Withaferin A and Withanone, a cytotoxic compound known for its potential to damage healthy cells in higher concentrations.2 This has raised significant safety concerns in both the scientific and regulatory communities. Reflecting this, the Government of India has issued a formal advisory discouraging the use of ashwagandha leaves in supplements.3 The divergence in phytochemistry between roots and leaves also results in different physiological effects, limiting the interchangeability of these plant parts for wellness-focused outcomes. Modern independent scientific research has overwhelmingly centered on root-based formulations. Most peer-reviewed studies evaluating the efficacy and safety of ashwagandha are based solely on root extracts, further reinforcing the case for root-only use in clinical and commercial settings.4 Formulators seeking consistency, safety, and proven efficacy therefore prioritize root extract for product development. Furthermore, sourcing roots supports the economic livelihood of farming communities in India, as root cultivation commands higher value and ensures more equitable trade practices.5 Sustainable trade practices are generated by providing higher economic returns to farmers, who invest more time and labor in its cultivation compared to leaves. This incentivises sustainable sourcing, reduces reliance on industrial shortcuts, and helps preserve the integrity of the supply chain. However, the rising global demand for ashwagandha has triggered a wave of adulteration, with some products including undeclared leaf material to cut costs.6 This not only dilutes efficacy but also introduces potential safety risks for consumers. Ensuring root-only formulations is critical to maintaining product integrity, protecting consumer trust, and honoring the wisdom of both traditional medicine and modern science. This is why KSM-66 Ashwagandha is a full spectrum, root-only extract. The Ayurvedic Pharmacopoeia of India, United States Pharmacopoeia, British Pharmacopoeia, Indian Pharmacopoeia, and WHO monographs focus solely on ashwagandha root. Reflecting this, the Government of India has issued a formal advisory discouraging the use of ashwagandha leaves in supplements.3 In addition, regulators in European countries, including Poland and Hungary, legally permit only the usage of the root of ashwagandha in supplements. The divergence in phytochemistry between roots and leaves also results in different physiological effects, limiting the interchangeability of these plant parts for wellness-focused outcomes. Safety assured Ensuring safety in ashwagandha supplements is paramount, given the herb’s ability to influence health and the varying regulatory standards applied to such products. KSM‑66 stands out here through rigorous toxicological testing and compliance with Good Laboratory Practice (GLP) standards, current Good Manufacturing Practices (cGMP), and Good Packaging Practices (GPP), assuring its safety as a product. With Ixoreal’s focus on research, there is a wealth of clinical evidence for KSM‑66’s safety in adult populations. Previous long-term observational studies carried out by Ixoreal reported stable hepatic, renal, and thyroid function, and improved quality of life – without serious adverse events. Safety validation goes beyond individual trials – it extends across five continents through regulatory review and real‑world use. In the US, KSM‑66 has achieved self‑affirmed GRAS (Generally Recognized As Safe) status for use in food and beverage products. Regulators in Canada have assigned KSM‑66 a Natural Product Number (NPN), enabling claims for stress relief, athletic support, and healthy testosterone at clinically substantiated doses, after evaluating both safety and efficacy. KSM‑66 is also accepted by authorities in the EU, South Korea, and Australia. KSM-66 is featured in over 4,500 products globally, spanning supplements, functional foods, and personal care. It is widely used in capsules, tablets, and increasingly in gummies, thanks to its heat stability and neutral taste. Products featuring KSM-66 are sold in regions including North America, Europe, Asia, and Australia, underscoring its global reach and versatility across wellness, sports nutrition, and beauty categories. This widespread adoption reflects both consumer trust and strong formulation flexibility. Fully controlled supply A stable and resilient supply chain is critical to the reliable production of ashwagandha extract. Cultivation is subject to seasonal cycles and natural variations, and external shocks such as floods, droughts, or logistical disruptions can compromise availability. To mitigate these risks, long-term raw material planning – such as maintaining extended stock reserves – is increasingly recognized as a best practice. It ensures business continuity, maintains product consistency, and protects against price volatility for both manufacturers and consumers. This is why Ixoreal maintains 11 months of raw materials at all times. KSM-66 is cultivated on 1,600 acres of certified organic farmland in Rajasthan, India. By February or March, when plants are ready for harvest, several hundred women carefully pull up the plants and remove the aerial parts by hand, ensuring that only roots are used, in strict accordance with Ayurvedic tradition and pharmacopoeial guidelines. Amid widespread adulteration with cheap leaf material, KSM-66 avoids this entirely by maintaining exclusive root use and tight quality control protocols. After harvest, the roots are washed, sun-dried, and hand-sorted for quality before being transported to state-of-the-art manufacturing facilities. There, KSM-66 is produced using a proprietary aqueous-based extraction process. Beyond security of supply, vertically integrated production models offer significant advantages. When cultivation, processing, and extraction are managed by a single entity, the result is greater transparency, traceability, and control. It removes variability introduced by intermediaries or outsourced operations, helping ensure the extract remains true to its specifications batch after batch. This integrated approach also supports rigorous quality control. Since the roots are grown and processed within a single controlled system, strict selection and sorting criteria can be enforced at every stage – from harvest to final extract. It also facilitates the use of proprietary extraction methods that optimize the active compound profile while preserving safety and stability. KSM-66 is the only ashwagandha extract made through a fully vertical integrated model, where every step is owned and managed in-house by the manufacturer. Production systems adhering to internationally recognized standards, such as cGMP guidelines and organic certification, further strengthen trust in the finished ingredient. Independent verification through third-party certifications – covering everything from safety and sustainability to clean-label compliance – has become an essential differentiator for Ixoreal in a growing, globalized market. Finally, vertical integration extends all the way back to the soil. Direct ownership and oversight of agricultural operations allow for careful control of growing conditions and post-harvest handling. This ensures ashwagandha roots are harvested at peak potency, dried under optimal conditions, and processed without compromise. By managing the full agricultural cycle, manufacturers can preserve the integrity of the herb while supporting more resilient and transparent supply practices. For Ixoreal, this level of control is crucial for ashwagandha production as consumer demand surges and supply chain pressure continues to mount. Having a vertically integrated production model allows the company to navigate these challenges and ensure consistency of supply. Social impact Ixoreal has spent millions of dollars in recent years on social initiatives within education, healthcare, skill development, women empowerment, veterinary care, and cultural and spiritual promotion. Education Ixoreal provides scholarships to more than 1600 students every year and free educational support to over 2,000 students from financially weaker backgrounds. The company invests in building infrastructure and facility improvements in schools and extends financial assistance to teachers. Alongside education, Ixoreal invests in research in biotechnology, medicinal plants, and sustainable agriculture, promoting innovation while remaining rooted in traditional wisdom. Healthcare Ixoreal funds the Primary Health Care Center, providing free outpatient care to over 150 patients daily, including prenatal and pediatric clinics. Medicines and essential health services are provided free of charge for underserved populations. Additionally, Ixoreal operates a thalassemia center that caters to the health needs of approximately 450 children. During COVID-19, Ixoreal administered over 20,000 vaccinations on gratis. Animal Welfare KSM-66’s social impact extends to animal welfare, providing dedicated veterinary care for abandoned and handicapped cattle. Thousands of rescued cows are given safe shelter, nutritious feed, and essential healthcare, ensuring they receive not just treatment but also compassion at every step. Specially-abled Through “Saksham”, a non-profit organization, Ixoreal supports 40+ centers and empowers hundreds of specially-abled individuals by providing education, training, and employment opportunities. These initiatives give these individuals a chance to learn, grow, and build independent lives. Cultural heritage Ixoreal supports culture and heritage by helping build and strengthen community centers that promote traditional learning, value-based education, and cultural practices. These initiatives preserve heritage, create spaces for collective growth, and ensure that cultural knowledge is passed down to future generations. Women empowerment Investing in women in agricultural and processing roles creates ripple effects that extend across households and wider communities, ultimately improving livelihoods and social inclusion. At Ixoreal, 80% of the workforce comprises women who are trained, employed, and empowered across various roles, and they earn 10-20% more than the regional average, even in years of poor harvests. Certifications As ashwagandha’s popularity continues to rise, the market has become flooded with products of varying quality, many lacking transparency, traceability, and clinical substantiation. In this landscape, certifications have become the gold standard for separating clinically validated, high-quality extracts from unproven alternatives. KSM-66® Ashwagandha, a root-only extract, stands as the most certified botanical ingredient in the world, with over 46 certifications spanning manufacturing, safety, ethics, and efficacy. These certifications are not just badges – they’re a testament to the extract’s unwavering commitment to quality, integrity, and scientific rigor. Some for the certifications include: [ Design: Can we create the list below into a design feature to reduce scrolling] GMP Certifications USP, NSF, NPA-UL, WHO – affirming pharmaceutical-grade manufacturing standards. Organic Certifications USDA, EU, Canada, India, Regenerative Organic – meeting global organic requirements. Food Safety & Clean Label GRAS, FSMA-FSVP, FSSC 22000, BRC, SQF, HACCP, Non-GMO Project Verified, Gluten-Free, Certified R.A.W, C.L.E.A.N., Vegecert, Glyphosate Residue Free. ISO Standards ISO 9001, 14001, 22000, 45001 – ensuring excellence in quality, environment, food safety, and worker health. Efficacy Certification Strong Science – third-party verification of clinical substantiation. Sports Certifications BSCG Certified Drug-Free, Informed Ingredient – safe for elite athletes, free from banned substances. Cosmetic Grade COSMOS Certified/Approved – suitable for personal care applications with sustainable sourcing. Sustainability Friend of the Earth, For Life, Fair for Life, Tru-ID, ID Verified – supporting ecological balance and fair trade. Traceability Blockchain-enabled TagOne system offers seed-to-shelf transparency. Pet Health NASC Preferred Supplier – meeting the highest standards in the animal supplement industry. Every KSM-66 product delivers more than just efficacy, it offers traceability, safety, and verified quality that resonates with brand partners and health-conscious consumers alike. Its certifications reflect not just compliance, but leadership in shaping a more accountable, transparent, and trustworthy nutraceutical industry. To find out more how KSM-66® Ashwagandha can be utilized as a standalone or as a complementary ingredient in herbal, phytopharmaceutical, and dietary supplement formulations, get in touch with Ixoreal directly.