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How current research trends can help fuel the need for future clinical pipeline investment
The global dietary supplement market was valued at US $325.4 billion in 2022 and is forecast to reach US $572.4 billion by 2030.1
This growth can be attributed to a shift in consumer preference towards healthier lifestyles. A 2021 report from a major food ingredient producer outlines that post COVID-19, 60% of global consumers are aiming to enhance their health and wellness.2
A more informed consumer base is largely responsible for driving demand and research in the functional food space. Companies looking to compete and grow market share are investing in clinical research, with a view to highlighting their product attributes. Nutritional supplements are being used to boost a plethora of health areas including immunity, energy, cognitive, mental, digestive and heart health.
World leading Microbiome CRO, Atlantia Clinical Trials is seeing a trend towards new therapeutic areas as the market diversifies. Atlantia currently deals with an extensive array of clinical areas including healthy aging, gastrointestinal function, physical activity and sports performance, nutritional investigations, stress and cognitive health, cardiovascular health, metabolic syndrome, bone and joint health and immunity. Companies in the nutraceutical, cosmetic, medical device and pharma spaces are approaching Atlantia with a variety of research projects coming through their clinical pipelines.
Research ecosystem
Atlantia Clinical Trials has been facilitating these companies to support their science for over 10 years, since it spun out of the world-renowned APC Microbiome Institute in Cork, Ireland. Cork has developed a leading research ecosystem with major contributions to global research from institutions such as APC and Teagasc Moorepark. Atlantia plays a role in commercializing much of this research on behalf of a growing list of global companies. As Paul Ross, Director of APC, describes it as a symbiotic relationship that exists today between APC and Atlantia that provides the opportunity to tap into both networks and leverage extensive research expertise. Cutting-edge research from institutions such as these informs the industry in terms of their future pipeline coupled with the ‘mega trends’ which are driven by consumer behavior.
Microbiome movement
The microbiome is becoming of significant interest in today’s food and health-related research; however, this is not a ‘one size fits all’ category.
This complex area, backed by extensive high-level research, requires additional investment to cater to consumers' demands for innovative products. The biotics category saw significant growth in 2022 with an 83% increase in products released.3 Of this, 73% of products have a health claim on pack. As a world leading Microbiome Contract Research Organisation (CRO), Atlantia has facilitated dietary supplement companies in conducting microbiome based clinical studies in order to obtain health claims and bring products to market. 80% of the trials they run have a microbiome element attached, whereby microbiome data is collected and analyzed. A dramatic shift was seen around 2021 with an uplift of about 30% in microbiome-based trials.
Many researchers are discovering the hidden potential of the microbiome across a wide range of health areas. APC Microbiome’s Ross added that if we can manipulate the microbiome more efficiently, we could realize many benefits for the general public in both a consumer and patient capacity. This could lead to a better response to drugs and patient health outcomes.
The complex relationship between the food we eat, drugs we take, and our chosen lifestyle is becoming a major factor in human health and as such has become a primary focus in much of the clinical research being conducted. Professor Timothy Dinan, a top cited scientist in the area of the gut-brain-axis field has looked at the relationship between microbiome diversity and the role it plays in cognitive health. As Medical Director at Atlantia Clinical Trials, he oversees much of the work that Atlantia conducts in this space.
Active ageing
Healthy aging is another hot topic among the consumer base and researchers are finding ways to improve the health of ageing populations. Many new products are being developed to adopt a preventative approach to disease rather than the usual reactive one.
Paul O’Toole, a Principal Investigator at APC Microbiome Cork, Ireland is looking at the composition and function of the gut microbiota, its interaction with habitual diet, and its relationship to health, functional gastrointestinal disorders, and ageing. This is a significant area of importance as consumers are demanding ways to improve longevity and quality of life.
The rise in clinical trials
Parallel to this exponentially growing market is a growth in demand for clinical trials. Consumers and regulatory agencies alike require validated science in order to make informed decisions about purchases in the case of consumers and approvals in the case of the agencies. These regulatory agencies exist to protect and inform the public about the complex ingredient ecosystem which is now accessible to them. Consumer demand for validated scientific information plays a large part in shaping the regulatory landscape.
Regulation has solidified and tightened in many regions in recent years and this has altered the way in which the industry operates. Different sponsors focus on a variety of outcomes in their clinicals studies depending on the type of product under review.
When designing a clinical study, it is important to identify and validate the primary outcome as this needs to support the final claim that will be made for the product. Companies may choose to make a health claim whereby an application is submitted to regulatory bodies such as the European Food Safety Authority (EFSA) and the Food & Drug Administration (FDA) in the United States.
Traditionally the USA has been known to take a reactive approach, where decisions regarding their products are based on clinical evidence post market launch. In comparison, other regions, such as Europe, take a more proactive approach like the pharmaceutical industry which requires premarket approval.
Clinical trial expertise
CROs such as Atlantia Clinical Trials, with state-of-the-art facilities both in the USA and Europe, will guide sponsors on their clinical pipeline objective. Companies’ needs differ in respect to their new product development journey depending on several factors including product type, development stage and health outcome. Many companies undertake research in order to make a formal claim such as a structure/function or a qualified health claim which resonates with their consumers. Meanwhile, others conduct studies simply to support their marketing efforts through publication of results. Product development programs may include proof of concept or exploratory studies such as bioavailability or pilot studies aimed at early phase discovery on efficacy and dosing information. These types of studies often precede larger pivotal/confirmatory studies which prove a cause-and-effect relationship (efficacy) and inform about the population variability following exploratory supplementation.
Corporate investment in clinical research, driven by consumer trends and the need for market share growth, contributes to the body of evidence needed to support and enhance the functional food industry as a whole. Academic research also has a part to play in widening the frontiers of human knowledge about the food we eat and its interactions with our bacteria. Despite significant progress in recent years, many world-leading experts agree that this field is still in its infancy. The evolution of knowledge in the microbiome field over the coming years will be interesting to witness and it is fascinating to be part of these exciting discoveries.
References
1. April 2023. Nutritional Supplements Market Analysis. Coherent Market Insights.
2. Health & Wellness Lifestyle Shifts: Five Consumer Behaviors that are Reshaping Food, Beverage & Supplement Innovation. Business Wire.
3. December 2022. Health Claims. Lumina Intelligence.
