The growing pipeline of biologics that can be produced in microbial systems, such as antibody fragments and plasmid-based therapies, is anticipated to offer lucrative opportunities to service providers serving this niche, but growing market segment
Despite mammalian cell cultures being the preferred manufacturing approach for biologics, recent advances in microbial fermentation have enabled the development of versatile biomanufacturing systems, which are both robust and cost friendly. Presently, a number of service provider companies claim to offer end-to-end solutions, ranging from product development to commercial production, for microbial biologics. Given the obvious advantages of outsourcing, drug developers are likely to continue relying on contract service providers for various aspects of their respective microbial biologic development programs.
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Key Market Insights
Over 115 CMOs claim to offer manufacturing services for microbial biologics
The microbial contract biomanufacturing market is highly fragmented, featuring a mix of small, mid-sized, large and very large players. It is worth mentioning that more than 50% of CMOs mentioned in the report, have the necessary capabilities to manufacture biologics across all scales of operation (preclinical, clinical and commercial).
Presently, more than 70% of service providers use bacterial expression systems
Recently, a number of microbial biologics manufacturers are shifting to yeast-based production systems. It is also worth highlighting that close to 30% of CMOs, identified in this research, claim to have the required capabilities to manufacture biologics using both bacterial and yeast-based systems.
Europe is currently regarded as a key manufacturing hub for microbial biologics
There are more than 150 manufacturing facilities, with microbial fermentation capabilities, worldwide; of these, 43% are in Europe, followed by North America (31%). On the other hand, prominent regions in the Asia Pacific and Middle East, where microbial biologics are manufactured, include (in decreasing order of number of resident manufacturing facilities) China, India, Japan, Australia and Israel.
Several partnerships were established in this domain, during the period 2016-2020
Majority of the deals recorded in the report, were established in 2019. Further, a large number (~25%) of the partnerships were observed to be focused on the production of microbial biologics; this is followed by process development and manufacturing agreements (20%).
Further, multiple expansion initiatives were undertaken by CMOs, since 2016
More than 30% of expansion projects over the last few years were focused on the establishment of new facilities, followed by those involving the expansion of existing manufacturing facilities (28%). Further, 50% of the expansion initiatives mentioned in the report, were in undertaken by stakeholder companies in Europe, followed North America (39%).
Big pharma players have also been active in this upcoming field
Around 60% of the initiatives undertaken by big pharma were reported in the period 2016-2020. Of these, 57% involved the establishment of strategic partnerships with other industry stakeholders. It is worth highlighting that, in terms of type of biologic, close to 49% of these initiatives were focused on recombinant proteins.
North America and Europe are anticipated to capture over 80% share (in terms of service revenues) of the market, by 2030
At present, more than 60% of the total revenues are generated from commercialized microbial biologics, and this trend is unlikely to change significantly in short to mid-term. Further, it is worth mentioning that the contract biomanufacturing market for microbial biologics in the Middle East and North Africa is anticipated to grow at a relatively faster rate (10.3%), followed by Asia Pacific (9%).
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Key Questions Answered
§ Who are the leading CMOs engaged in the production of microbial biologics?
§ What are the preferred microbial systems for the development and manufacturing of biologics?
§ Which are the key microbial fermentation technology platforms currently available in the market?
§ What kind of partnership models are commonly adopted by stakeholders in this industry?
§ What are the various initiatives undertaken by the big pharma players engaged in this domain?
§ What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision related to the production of microbial biologics?
§ What are the key trends within the microbial contract biomanufacturing market?
§ How is the current and future market opportunity likely to be distributed across key market segments?
The USD 9.3 billion (by 2030) financial opportunity within the microbial contract biomanufacturing market has been analyzed across the following segments:
§ Type of Product
§ Type of Biologic
§ Growth Hormones
§ Antibody based Drugs
§ Others (plasmid DNA, probiotics, microbiome-based biologics)
§ Type of Microbial Expression System
§ Others (Algae and fungi)
§ Scale of Operation
§ Preclinical / Clinical
§ Type of End User
§ Small Companies
§ Mid-sized Companies
§ Large / Very Large Companies
§ Key Geographical Regions
§ North America
§ Asia Pacific
§ Middle East and North Africa
§ Latin America
The report features inputs from eminent industry stakeholders, according to whom, currently, over 50% operations related to both API and FDF manufacturing of microbial biologics are outsourced to third party service providers. The report includes detailed transcripts of discussions held with the following experts:
§ Gaurav Kaushik (Chief Executive Officer and Managing Director, Meteoric Biopharmaceuticals)
§ Debbie Pinkston (Vice President, Sales and Business Development, List Biological Laboratories)
§ Andrea Conforto (Sales and Marketing, Bioservices Director, Olon)
§ Max Rossetto (General Manager, Business Development, Luina Bio)
§ Rob van Dijk (Business Development Manager, WACKER Biotech)
The research covers profiles of key players (listed below); each profile features an overview of the company, information related to its microbial manufacturing focused service portfolio, production facilities and capabilities, and an informed future outlook.
§ AGC Biologics
§ Northway Biotechpharma
§ Ology Bioservices
§ Porton Biopharma
§ Stelis Biopharma
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