Insights on the Live Biotherapeutic Products and Microbiome Manufacturing Market to 2035 – Industry Trends and Global Forecasts

The “Live Biotherapeutic Products and Microbiome Manufacturing Market by Type of Product Manufactured, Type of Formulation, Type of Primary Packaging Used, Scale of Operation, Company Size and Key Geographical Regions: Industry Trends and Global Forecasts, 2022 – 2035” report has been added to’s offering.

This report features an extensive study on the in- house and contract manufacturing organizations within the microbiome industry. The study also includes an elaborate discussion on the future potential of this evolving market.

Given the advancement of several promising microbiome-based live biotherapeutic products through clinical pipeline, this upcoming therapeutic segment is anticipated to become one of the fastest growing markets within the pharmaceutical industry in the coming years. Specifically, in 2020, around 575 IND applications were filed for such therapies, targeting a myriad of diseases indications, including autoimmune, gastrointestinal, infectious, metabolic and oncological disorders, indicating remarkable scientific progress of these breakthrough drug candidates.

It is also worth highlighting that SER-109, a microbiome-based therapy developed by Seres Therapeutics, is expected to receive marketing approval from the US Food and Drug Administration (FDA) in 2022; this is further likely to propel the growth in this domain. Further, over 640 patents focused on microbiome therapeutics were granted approval in the year 2020. In addition, during the same time frame, USD 1.5 billion was invested for the development of microbiome-based therapeutics.

Although a lot has been achieved in terms of development of live biotherapeutic products, there are certain challenges associated with the complexity of the process. Other key concerns shared by contemporary innovators include limited availability of expertise, lack of specialized infrastructure, requirement for exorbitant capital investment, and constraints associated with ensuring compliance to good manufacturing practices (GMP) and capacity.

In order to address the technical and operational challenges outlined above, several microbiome developers prefer to rely on contract manufacturing organizations (CMOs). It is worth highlighting that, currently, over 50 players engaged in the manufacturing of microbiome-related products carry out operations either in-house or on contract basis. The current market landscape of microbiome contract manufacturers is highly fragmented, featuring a mix of start-ups, mid-sized firms and established players. Moreover, in recent years, several players engaged in this domain have forged strategic alliances and / or acquired other players, in order to further enhance their respective service offerings and operate as one-stop-shops. As stakeholders strive to mitigate existing challenges and focus on innovation to improve the microbiome production process, we believe that the microbiome manufacturing market is expected to witness significant growth over the next decade.

The authored article shared with Prittle Prattle News  exclusively

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