Roots Analysis has announced the addition of the “Microbial ContractBiomanufacturing Market, 2020-2030” report to its listof offerings.
Despite mammaliancell cultures being the preferred manufacturing approach for biologics, recent advancesin microbial fermentation have enabled the development of versatilebiomanufacturing systems, which are both robust and cost friendly. Presently, anumber 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 tocontinue relying on contract service providers for various aspects of theirrespective microbial biologic development programs.
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Key Market Insights
Over115 CMOs claim to offer manufacturing services for microbial biologics
The microbial contractbiomanufacturing market is highly fragmented, featuring a mix of small,mid-sized, large and very large players. It is worth mentioning that more than50% of CMOs mentioned in the report, have the necessary capabilities tomanufacture biologics across all scales of operation (preclinical, clinicaland commercial).
Presently, more than 70% of service providers use bacterialexpression systems
Recently, a number ofmicrobial biologics manufacturers are shifting to yeast-based production systems.It is also worth highlighting that close to 30% of CMOs, identified in thisresearch, claim to have the required capabilities to manufacture biologics usingboth bacterial and yeast-based systems.
Europe is currently regarded as a key manufacturing hub formicrobial biologics
There are more than150 manufacturing facilities, with microbial fermentation capabilities, worldwide;of these, 43% are in Europe, followed by North America (31%). On the otherhand, prominent regions in the Asia Pacific and Middle East, where microbial biologicsare manufactured, include (in decreasing order of number of resident manufacturingfacilities) China, India, Japan, Australia and Israel.
Severalpartnerships were established in this domain, during the period 2016-2020
Majorityof the deals recorded in the report, were established in 2019. Further, a largenumber (~25%) of the partnerships were observed to be focused on the productionof microbial biologics; this is followed by process development andmanufacturing agreements (20%).
Further,multiple expansion initiatives were undertaken by CMOs, since 2016
More than 30% of expansionprojects over the last few years were focused on the establishment of newfacilities, followed by those involving the expansion of existing manufacturingfacilities (28%). Further, 50% of the expansion initiatives mentioned in thereport, were in undertaken by stakeholder companies in Europe, followed NorthAmerica (39%).
Big pharma playershave also been active in this upcoming field
Around 60% of the initiativesundertaken by big pharma were reported in the period 2016-2020. Of these, 57% involvedthe establishment of strategic partnerships with other industry stakeholders. It is worth highlighting that, in terms of type ofbiologic, close to 49% of these initiatives were focused on recombinantproteins.
NorthAmerica and Europe are anticipated to capture over 80% share (in terms ofservice revenues) of the market, by 2030
At present, more than60% of the total revenues are generated from commercialized microbialbiologics, and this trend is unlikely to change significantly in short tomid-term. Further, it is worth mentioning that the contract biomanufacturing marketfor microbial biologics in the Middle East and North Africa is anticipated togrow at a relatively faster rate (10.3%), followed by Asia Pacific (9%).
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§ Who are the leading CMOs engaged in the production ofmicrobial biologics?
§ What are the preferred microbial systems for the developmentand manufacturing of biologics?
§ Which are the key microbial fermentation technologyplatforms currently available in the market?
§ What kind of partnership models are commonly adopted bystakeholders in this industry?
§ What are the various initiatives undertaken by the bigpharma players engaged in this domain?
§ What are the key factors influencing the make (manufacturein-house) versus buy (outsource) decision related to the production of microbialbiologics?
§ What are the key trends within the microbial contractbiomanufacturing market?
§ How is the current and future market opportunity likely tobe distributed across key market segments?
The USD 9.3 billion (by 2030) financial opportunitywithin the microbial contract biomanufacturing market has been analyzed acrossthe following segments:
§ Typeof Product
§ Typeof Biologic
§ Antibodybased Drugs
§ Others(plasmid DNA, probiotics, microbiome-based biologics)
§ Type of Microbial Expression System
§ Others(Algae and fungi)
§ Scaleof Operation
§ Preclinical/ Clinical
§ Typeof End User
§ Large/ Very Large Companies
§ KeyGeographical Regions
§ MiddleEast and North Africa
The report featuresinputs from eminent industry stakeholders, according to whom, currently, over50% operations related to both API and FDF manufacturing of microbial biologicsare outsourced to third party service providers. The report includes detailedtranscripts of discussions held with the following experts:
§ Gaurav Kaushik (ChiefExecutive Officer and Managing Director, MeteoricBiopharmaceuticals)
§ Debbie Pinkston (VicePresident, Sales and Business Development, List Biological Laboratories)
§ Andrea Conforto(Sales and Marketing, Bioservices Director, Olon)
§ Max Rossetto (GeneralManager, Business Development, LuinaBio)
§ Rob van Dijk(Business Development Manager, WACKERBiotech)
The research coversprofiles of key players (listed below); each profile features anoverview of the company, information related to its microbial manufacturingfocused service portfolio, production facilities and capabilities, and aninformed future outlook.
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