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Key Inclusions
A detailed review of the current landscape of companies offering contract manufacturing services for biologics, using microbial expression systems, along with information on their year of establishment, company size, location of headquarters, number and location of their production facilities, scale of operation (preclinical, clinical and commercial), type of biologic(s) manufactured (peptides / proteins, antibodies, vaccines, biosimilars, oligonucleotides, plasmid DNA and others), type of microbial expression system(s) used (bacterial, yeast and others), type of fermenter(s) employed (single-use fermenters, stainless steel fermenters and others), type of manufacturing service(s) offered (cell banking, process development and characterization, analytical method development and testing, quality assurance and control, scale-up, downstream processing and regulatory support), and regulatory accreditations / certifications received (if any).
A region-wise, company competitiveness analysis, highlighting key players engaged in microbial based contract manufacturing based on their experience (considering the year of establishment of the firm) and expertise (taking into account their service portfolio, number of different types of biologics manufactured and number of distinct expression system(s) used).
An analysis of the various partnerships signed within this domain, with a focus on microbial contract biomanufacturing, since 2016, based on several relevant parameters, such as year of partnership, type of partnership model adopted, scale of operation, type of biologic, focus area, therapeutic area, most active players (in terms of number of partnerships signed), and geography. Further, it features a detailed analysis of the various mergers and acquisitions that were carried out in this domain, highlighting the trend in terms of number of players acquired between 2016-2020 (till May), along with the geographical distribution of this activity.
An elaborate analysis of the various expansion initiatives undertaken by contract manufacturers using microbial expression systems in order to augment their capabilities, over the period 2016-2020 (till May), taking into consideration several relevant parameters, such as year of expansion, type of expansion (capability expansion, capacity expansion, facility expansion and new facility), scale of operation of manufacturing facility, type of biologic and location of manufacturing facility.
A review of the varied microbial based manufacturing initiatives undertaken by big pharma players (shortlisted from the top 20 pharmaceutical companies as of 2019), highlighting trends across various parameters, such as number of initiatives, year of initiative and type of initiative.
A detailed proprietary 2×2 representation that was developed to assess the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments.
Elaborate profiles of key players that offer contract biomanufacturing services using microbial expression systems across different geographies, namely North America, Europe and Asia Pacific. Each profile features a brief overview of the company, information related to its service portfolio, manufacturing capabilities and facilities, recent developments and an informed future outlook.
A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field. It also includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.
A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
An insightful discussion on the impact of COVID-19 outbreak on the overall microbial contract biomanufacturing market, and the key initiatives undertaken by CMOs to combat the challenges posed due to ongoing situation.
The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:
Type of Product
API
FDF
Type of Biologic
Proteins
Enzymes
Growth Hormones
Antibody based Drugs
Others (plasmid DNA, probiotics, microbiome-based biologics)
Type of Microbial Expression System
Bacteria
Yeast
Others (Algae and fungi)
Scale of Operation
Commercial
Preclinical / Clinical
Type of End User
Small Companies
Mid-sized Companies
Large / Very Large Companies
Key Geographical Regions
North America
Europe
Asia Pacific
Middle East and North Africa
Latin America
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Key Questions Answered
Who are the leading CMOs with expertise in production of microbial biologics?
What are the preferred microbial expression systems used in biologic development and manufacturing?
What are the key microbial fermentation technology platforms?
Who could be the potential partners for the microbial CMOs?
What kind of partnership models are commonly adopted by stakeholders engaged in this domain?
What type of expansion initiatives are being carried out by CMOs in this domain?
What initiatives are being undertaken by big pharma players in this domain?
What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision related to microbial fermentation?
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?
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Gaurav Chaudhary
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