Probiotics: an accelerating opportunity for pharmaceutical manufacturers. By Per Rehné

The pharmaceutical sector is currently witnessing major changes as its boundaries are beginning to blur in to the food and nutrition sectors. Current markets are diversifying, and new fields of growth are opening up – in particular, involving the development of probiotics and the human microbiome.

With growing interest in self-care and integrative medicine, coupled with a globally ageing and health-conscious population, recognition of the connection between diet and health has never been stronger. As a result, the market for functional food supplements that promote health benefits beyond basic nutrition is thriving and converging into existing sectors including the pharmaceutical industry. This movement is based on a rapidly expanding arena of probiotics and microbiome activity modulation; live microbial food supplements that beneficially affect an individual by improving intestinal microbial balance and creating a new and exciting market opportunity for pharmaceutical manufacturers.

The human microbiome, considered by scientists ‘as a newly discovered and largely unexplored organ’, has the power to change the way we diagnose and treat the most critical diseases of our time. Microbes defend against disease and can strengthen the immune system, so disease prevention is a natural fit for microbiome innovation. As a result, focus on the microbiome can be seen as a reappearing trend that cuts across pharmaceutical, food, wellness and nutrition sectors.

Developments in personalised medicine and the unique nature of the human microbiome offer an opportunity for pharmaceutical companies to develop 9 products that no adjacent industry has the expertise to develop.

One emerging option for pharmaceutical manufacturers is to engage in ‘Pharma Foods’. This sector is a new blurred frontier which is vastly untouched but offers the prospect of higher profit margins due to the unique and low regulatory landscape of the sector to date.

The current market
The global probiotics market is currently experiencing unprecedented year on year growth and is now estimated to be worth a total €42.5 billion, according to the International Probiotics Association, and will likely exceed more than $60 billion by 2022.

Because of growing health concerns such as obesity, cardiovascular health and diabetes, companies operating in this market are in the process of creating probiotic products that help them to assist in the management of such types of diseases. The impact of these health concerns is expected to increase in the near future, thus driving further attention on the development of probiotic products. In fact, probiotic products alone are expected to surpass a market value of $50bn by 2020 (an increase of 47 per cent since 2015).

Looking at the present and predicted scenario of the global probiotic market, it is more important than ever for the pharmaceutical industry to capitalise on this new market opportunity, provide treatments that move away from the more traditionally chemically synthesised formulations, and recognise that probiotics have a place within the pharmaceutical and medical world – not just the food supplement market.

Industry opportunity
At present, the growing trend for the pharmaceutical industry to enter the probiotics and food sector is by using strains that have been scientifically researched and tested with a known mechanism of action, and specific health benefits that have been proven in human trials.

As the industry aims to enable modulation of the human microbiome, companies have two strategic options available to utilise the power of probiotics quickly. They can acquire or partner with food supplement companies to operate at the industry standard. Alternatively, they can leverage pharmaceutical brands and quality standards to produce a probiotic strain under Good Manufacturing Practice (GMP) conditions, with the finished supplement created in-house or contracted out to qualified manufacturers.

The second significant area for the industry is in the biotherapeutic approach. This term refers to any treatment that is produced by living cells rather than synthesised chemicals. Several products are currently in development and going through legal approval. However, due to the emergent nature of the market, there is not a clear legal framework in place to manage FDA approval, positioning and commercialisation. The US FDA has recently released a guidance document on the market sector and legal developments are anticipated due to the fast-moving nature of this part of the pharmaceutical industry.

Despite the large volume of publications, patents and clinical trials that surround probiotics, there are still a lot of products in the market place with little to no evidence based on human trials. Developing products that deliver concrete results is a challenge that both food and pharmaceutical companies must resolve through evidence based probiotics. Pharmaceutical companies must learn to compete with competitors already well established in the field of consumer supplementation and self-medication and develop strategic relationships with the big retailers; an unknown territory compared with their usual pharmaceutical retail and distribution channels.

The future
In the future, we will undoubtedly witness more pharmaceutical and nutrition companies working together to produce new probiotic brands aimed at the accelerating consumer market.

Consumers’ overwhelming interest in functional foods, including probiotics, make it imperative for pharmaceutical manufacturers to stay abreast of the latest research findings. Human microbiome research is already paving the way to a new approach toward disease management and prevention, and consumers are already making nutritionally based remedies the treatment of choice.

As the global population continues to age, preventive and curative nutritional products will continue to gain market share. Pharma companies with the forethought to position themselves accordingly will be poised for healthy growth. It is also likely that we see new regulatory bodies established to cover the products created by both industries that sit along the aforementioned blurred lines.

Per Rehné
Per Rehné is Commercial Director at OptiBiotix. The aim of OptiBiotix is to discover and develop microbial strains, compounds and formulations, which modulate the human microbiome and can be used as food ingredients and supplements or active compounds for the prevention and management of human metabolic diseases, examples of which include obesity, cholesterol and lipid distribution and diabetes.