This whitepaper looks at the challenges and strategies for defining protocols for manufacturing in the microbiome therapeutics industry.
Interest in microbial therapeutics has grown substantially in the last few years. Backed by Big Pharma, investment and innovation in this space have been quite robust, making it one of the fastest growing biologics markets. Indeed, more than 120 microbiome therapeutic drugs are currently in development pipelines, aiming to reach the market in a few years.
As such, the microbiome therapeutic market was valued at over USD 350 million in 2018 (Azoth Analytics, January 2020) with an estimated Compound Annual Growth Rate (CAGR) of 14.2% for 2018-2022 (360 Research Reports (January 2020).
But the simplicity of the word microbiome hides a very complex concept. At its core, the term microbiome encompasses the community of microorganisms (such as bacteria, fungi and viruses) found in a specific environment. It could be those found in humans, animals and even the environment around us. Some researchers have gone even further, including microbiomes found in homes, factories and farms as part of the microbiome therapeutic space.
While the exact role of individual microorganisms is not totally understood, we have a basic understanding of each category. Bacteria usually play an important role in defending the body against pathogens, carcinogens and other toxins, and as such are often the subject of research and investments by pharmaceutical companies. Viruses found in the microbiome are usually bacteriophages, and usually contribute to mucosal barriersi. As for fungi, their role is still largely a mystery, but they are thought to be a possible component of neurological disease.ii
For a long time, microbiome therapeutics were directly linked to the gut microbiome and its impact on the gut-brain axis. Recent research in other spaces such as the oral and skin microbiome have splintered a once relatively uniform research sector. As such, it might make more sense to start talking about human microbiomes rather the singular microbiome, to address both the rapidly forking submarkets as well as the specificity of the human market versus other physical markets.
The current paper will explore current challenges around data collection and sequencing in the microbiome space, as well the growing role of pharmaceutical companies in regulatory approval frameworks, and conclude with challenges and opportunities for the manufacturing sector.