Probiotics Market

Probiotics are live bacterial and yeast strains used to improve gut microflora in animals and humans. The growth of the global probiotics market is driven by the increasing emphasis on improving digestive health in humans and animals. Moreover, surging demand for natural functional ingredients in application industries is fueling market growth. However, regulatory constraints regarding the manufacturing and commercialization of probiotics and probiotic products are hampering the growth of the market. Players active in the global market are expected to witness lucrative opportunities in the coming years owing to the launch of innovative products.

Probiotics are beneficial microorganisms which when administered in adequate amounts offer health benefits to the host, especially for digestive health. These live microorganisms constitute the gut microflora in animals and humans and help in enhancing gut health and functioning of the colon. The consumption of probiotics also helps in managing conditions such as chronic stomach pain, diarrhea, along with overall improvement in digestion, metabolism, and cardiac health; it also improves immunity in humans and livestock. Hectic daily schedules, long working hours, and sedentary lifestyles have impacted eating habits as well as food choices, resulting in an increased prevalence of various lifestyle-related conditions such as diabetes and obesity. A focus on improving overall health and preventive care has accelerated the demand for functional foods including probiotic products. The focus on animal health is also rising across the globe. The growing trend for precision nutrition in livestock farming has resulted in the increased demand for probiotics in the animal feed industry. These factors are expected to drive the growth of the global probiotics market during the review period.

The surging demand for probiotics in developed and developing countries is propelling manufacturers of probiotics and probiotic products to focus on innovative. New probiotics are being launched in the market that specifically cater to skin health, oral health, immunity, and respiratory health. The major areas for innovation are the delivery format of probiotics, health claims, consumer awareness, and functional properties. Probiotic formulations are also evolving to include Kosher and Halal versions, time-release delivery formats, and combinations with other ingredients. Thus, continuous investment in R&D and relaxation of regulatory norms governing the production and commercialization of probiotics are expected to pave the way for several growth opportunities for the players active in the global probiotics market.

The production and commercialization of probiotics as ingredients and end products are subject to several stringent regulations. Due to a lack of strong scientific evidence regarding the benefits of probiotics for human health, the US Food and Drug Administration (FDA) has not granted approval for the use of probiotics for preventing or treating health issues. The approvals process for manufacturing and commercializing probiotics in the US and Europe is complex in nature. In the US, the FDA regulates the use of probiotics as dietary supplements, drugs, and food ingredients. Probiotics are mostly sold as dietary supplements, which do not require FDA approval prior to commercialization. Manufacturers of probiotic products can mention the effects of probiotics on body functions or structure on their labels; however, they cannot mention any health claims on the label without the consent of the FDA. In South Africa, the term ‘probiotics’ is only permitted to be used for four species of probiotic bacteria whereas, in Brazil, the Health Regulatory Agency ANVISA prohibits the manufacturers of dietary supplements to make health claims on packaging unless scientifically proven. Thus, manufacturers market their supplements as digestive health-improving products.

In Europe, the EU legislation has resulted in declining sales of probiotic yogurt and dietary supplements. Insufficient demonstration of the claimed health effects of probiotics is the key reason for the rejection of several health claim applications submitted by manufacturers in Europe. In the majority of European countries, health claims are mandatory for probiotic products, whereas some countries prohibit the use of unspecific claims such as ‘contains live bacteria’. Moreover, probiotics can be used in healthcare products such as topical vaginal applications or tampons and hard capsules in Europe; however, this is only until the transition to the new Medical Device Regulation (EU) 2017/745 effective 2022. Thus, regulatory constraints are a vital determinant hampering the growth of the global probiotics market. However, the successful outcome of several scientific studies on probiotics is expected to provide substantial evidence regarding the health benefits of probiotics, which, in turn, would lead to the relaxation of regulatory norms.