What is the current development pipeline of microbiome-based live biotherapeutics?
With over 85 products under preclinical and clinical development, 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.
Current Landscape of Microbiome-based live biotherapeutics
Who are the most likely partners (microbiome-based live biotherapeutic drug developers) for microbiome contract manufacturers?
Majority of the drug developers are based in of 29 drug developers based in North America, followed by players based in Europe and Asia-Pacific. Further, with more than 70% of the pipeline in preclinical / discovery stage, a significant surge in outsourcing activity is anticipated in the mid to long term, driving the growth in the contract manufacturing space.
Drug Developers engaged in the development of Microbiome-based live biotherapeutics
Can we measure the clinical demand?
Yes, we believe over 17,000 patients are already enrolled in clinical trials worldwide. By 2030, over 31,000 patients are estimated to be enrolled in the clinical trials involving the use of microbiome-based live biotherapeutics. Industry players are anticipated to contribute majority (over 60%) of the demand in the short-term as well as long-term. North America and Europe are the hubs with over 65% of the patient registrations.
Current Demand of microbiome-based live biotherapeutics manufacturing operations
What are the key trends shaping up the market?
Manufacturing is presently one of the biggest bottlenecks in this domain; manufacturing such products is both technically challenging and financially demanding. 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.
Key Trends Related to microbiome-based live biotherapeutics manufacturing operations
What are the recent expansions / developments in this market?
One of the leading CDMO in this domain, Arranta Bio, has undertaken a number of initiatives in the last few months. Recently in May, Arranta Bio announced the completion of its process development laboratory expansion project with the addition of early-clinical GMP capacity at its Center of Excellence for Microbiome Process Development. 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. The company plans to expand its capabilities to commercial scale manufacturing soon in 2020.
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