Microbiome Contract Manufacturing: Time to Push the Increase Capacity Button

The interest in the trillions of microbiome present in the human body has attracted a lot of research effort in the microbiome domain. The first such effort at a large scale was The Human Microbiome Project, conducted by the National Institutes of Health in the United States, which characterized the microbial communities at five major body sites. Post that, there has been a prominent spike in the investments to further elucidate the nature of the microbiome.

How many players are working in the microbiome space?

As per a recent market research report by Roots Analysis, currently, more than 120 players are developing over 260 microbiome therapies. In addition, these players have attracted over USD 600 million in investments from various VC firms.

What is the likely market size of microbiome-based therapies?

As per Roots Analysis’ estimates, the microbiome-based therapeutics market is expected to be worth over USD 1.5 billion by 2030. This represents an annualized growth rate of over 30% between 2020 and 2030.

What are the key hurdles in this space?

Despite the evident interest in this field, the manufacturing of live microbial therapeutics remains a largely unaddressed area of concern. The lack of sufficient manufacturing capacity is one of the major impediments to the commercialization of such products. Roots Analysis interviewed multiple stakeholders to identify key challenges.

I believe that a lot of start-ups have entered the market, however, only a few companies have established their own facilities to manufacture microbiome-based products. This is primarily due to the fact that the cost of establishing an LBP production facility is high, and therefore, requires significant capital investment. As a result, companies have demonstrated preference to outsource manufacturing operations

Vice President, Sales and Business Development, a US based Small-sized Company

Have we seen any recent CDMO activity?

One of the leading CDMO in this domain, Arranta Bio, has undertaken a number of initiatives in the last few months. In November, last year, the company acquired microbiome process development and clinical contract manufacturer, Captozyme. The acquisition allowed the company to establish a Center of Excellence for process and analytical development for its clients. In addition, in the last month, the company announced an investment of around USD 100 million. The investment aimed at building an end-to-end capacity for microbiome manufacturing.

How many CMOs offer microbiome manufacturing services?

Presently, over 40 players claim to have the capabilities for manufacturing live biotherapeutics. The majority of these CDMOs have the expertise for anaerobic fermentation of microbial strains, which require strict environmental conditions.