Live biotherapeutics are fragile bacteria, which require ideal conditions of heat, moisture and pH of products, to survive and prevent premature germination. In fact, manufacturing is presently one of the biggest bottlenecks in this domain; manufacturing such products is both technically challenging and financially demanding. One of the biggest challenges in the development of a probiotic product is related to its stability. It is very difficult to maintain the number of live bacteria during product formulation and storage. It is not easy to find contract manufacturers with sufficient capacity and capabilities to support the manufacturing of different types of bacterial strains. In addition, there is a need for additional manufacturing facilities to accommodate microbial production operations to cater to the growing demands of sponsor companies. Another key challenge is the lengthy manufacturing timelines and the evident lack of flexibility among existing service providers. As a result, innovator firms are becoming increasingly reliant on contract service providers to access specialized facilities and optimize overall costs.
Need for outsourcing microbiome-based live biotherapeutics manufacturing
In fact, the current development pipeline of
microbiome-based live biotherapeutics has several promising candidates, which
are anticipated to get commercialized over the next few years. Hence, the
demand for R&D and manufacturing services for such products is anticipated
to increase beyond the capabilities of innovator companies alone.
Service Providers Offering Live
Over 55 contract manufacturers and in-house players are engaged in the manufacturing of microbiome-based live biotherapeutics, a new class of therapeutics which uses bacteria as drugs. The majority of these CDMOs have the expertise for anaerobic fermentation of microbial strains, which require strict environmental conditions.
List of microbiome-based live biotherapeutics manufacturers
To know about the companies (CMOs / CDMOs / In-house
players) that are engaged in the manufacturing of microbiome-based live biotherapeutics,
check out our report Live
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. Earlier, in April 2019, Lonza and Chr. Hansen have entered into a strategic agreement to establish a joint venture company (now named BacThera) for the manufacturing of live biotherapeutic products, with an investment of EUR 90 million.
Examples of manufacturing agreements between developers and
Capacity with the Companies –
Enough to Meet the Demand?
The current, annual capacity is primarily driven by players operating at the commercial scale, which represent 88% of the total manufacturing capacity. In addition, around 62% of the capacity belongs to mid-sized manufacturers. Further, around 83% of this capacity is estimated to be installed in developed regions, such as North America and Europe.
Microbiome-based live biotherapeutics– manufacturing capacity
Likely Growth of the Microbiome
Therapeutics Manufacturing Market
Future growth of the market is likely to be driven by increased demand for these therapeutics; we expect the service-based revenues to grow at an annualized rate of over 46% in the coming decade. By 2030, North America and Europe are anticipated to capture over 85% of the market opportunity.