Benefits offered by microbial manufacturing, such as low production costs and faster development timelines, have led many innovators to adopt microbial fermentation for next generation biologics, offering lucrative opportunities for microbial CMOs / CDMOs. Within microbial fermentation market, service providers presently claim to have most of the microbial production capacity, driving innovators to outsource their manufacturing needs and shift their focus on research and development efforts.
Microbial CMO – Current Market Landscape
Presently, more than 120 contract service providers offer various services related to microbial fermentation; these include microbial strain development, microbial cell banking, analytical validation, process development, scale-up, downstream processing, aseptic fill finish manufacturing, regulatory support. Microbial CMOs have undertaken several initiatives, such as entering into partnerships, and expanding their existing capabilities and capacities, in order to cater to the increasing demand for biologics manufactured via microbial fermentation. Notably, close to 50% of the market opportunity is created by the demand for microbial fermentation services in Europe. This can be attributed to the fact that majority of microbial fermentation facilities are present in Europe, and these occupy the major share of installed microbial fermentation capacity across the globe.
Further, as can be observed from the figure, the microbial CMO market features the presence of small, mid-sized, large and very large companies having the required expertise to offer contract manufacturing services across the globe.
Key Trends in the Microbial CMO Market
A. Collaborations in Microbial CMO Market:
Stakeholders in this domain are known to adopt a variety of partnership models in order to collaborate with other companies / organizations. Such deals are inked to not only allow companies to expand their respective service and product portfolios, but also gain additional capabilities. Notably, acquisitions emerged as the most common type of partnership model adopted by the stakeholders engaged in this domain, followed by manufacturing agreements, and process development and manufacturing agreements.
Examples of some partnerships in this domain include:
- In February 2024, 3P Biopharmaceuticals merged with Biovian to form 3PBIOVIAN. The company will offer end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for drug substances and drug products, from preclinical to clinical development and commercial production.
- In June 2022, WACKER signed an agreement with mk2 Biotechnologies and Technical University of Munich for process development and large-scale manufacturing of antimicrobial peptides.
B. Recent Expansions in Microbial CMO Market:
Owing to the increasing adoption of microbial fermentation for production of pharmaceutical biologics, several players in this domain have made significant investments in order to expand their existing facilities or establish new production plants. In December 2023, Leanbio invested Euros 20 million in its Sant Quirze del Vallès, Barcelona facility. The facility will include three production lines for manufacturing recombinant proteins and antibodies utilizing mammalian and microbial expression systems. Nearly 50% of the total number of expansion instances were focused on expanding current capacities. As can be observed in the figure, maximum number of expansions related to microbial fermentation were observed in Europe, followed by those carried out in North America, and Asia-Pacific.
The expansion instances can be categorized in three key categories, described below:
- Capacity Expansion: All those instances, wherein companies have expanded their existing capacities for providing large-scale manufacturing services, were included in this category.
- Facility Expansion: All those instances, wherein companies have expanded their existing facilities, were included in this category.
- New Facility: This category includes instances wherein a company established a new facility related to microbial fermentation.
Key Growth Drivers
1. Rising Demand for Biopharmaceuticals:
The increasing demand for biologics including vaccines, insulin, and monoclonal antibodies, is one of the key factors driving the microbial fermentation industry. Microorganisms can be genetically engineered to produce complex biologics with high efficiency and lower costs. Additionally, the microbial fermentation process is reliable and easily scalable, further driving the growth of this industry.
2. Cost-Effectiveness:
Microbial fermentation is less expensive than alternative methods such as mammalian cell cultures. Microbes multiply rapidly and require simpler nutrients, translating to lower operating and capital expenses. For companies looking to optimize their production costs, microbial fermentation offers a viable and economically attractive option. This economic advantage makes it a preferred choice for manufacturers, thereby driving market growth.
3. Ongoing Technological Advancements:
Technological advancements in microbial fermentation including, enhanced bioreactor designs, and superior control systems are driving growth of this industry. These advancements help in optimizing yields, improving purity, and reducing batch-to-batch variability. Automation and digital monitoring have further streamlined the fermentation process, reduced human error and enhanced production consistency.
Key Growth Restraints
1. Regulatory Considerations:
The production and approval of microbial fermentation products are heavily regulated to ensure safety, efficacy, and quality. Compliance with these regulations, requires substantial time and financial investment. The complexity of regulatory pathways can deter new entrants and slow down the introduction of new products to the market. Thus restraining the growth of the microbial fermentation sector.
2. Supply Chain Interruptions Disruptions:
Microbial fermentation requires a steady supply of high-quality raw materials, which can vary from simple sugars to complex nutrients. Variations in the quality or availability of these inputs can affect the fermentation process and the final product. Global supply chains are susceptible to disruptions caused by political changes, economic instability, or natural disasters, posing risks to consistent production schedules and cost efficiency.
3. Dependency on Microbial Strains:
The success of a fermentation process relies on the choice and management of microbial strains. Different strains have specific growth and production characteristics, and variations in cultivation conditions can lead to significant differences in product yield and quality. This dependency can make the production complex, impacting the reliability and scalability of the manufacturing process.
Concluding Remarks
With over 120 players offering microbial fermentation services, the market is highly fragmented, predominantly concentrated in Europe, followed by North America and Asia-Pacific. These services include microbial strain development, microbial cell banking, analytical validation, process development, scale-up, downstream processing, aseptic fill finish manufacturing, and regulatory support. Further, key initiatives in the market include partnerships and expansions, aimed at expanding portfolios and capabilities. Further, the growth drivers include the rising demand for biopharmaceuticals, cost-effective fermentation technique and technological advancements in this domain. Overall, the microbial fermentation market is poised for significant growth, driven by several advantages offered by microbial fermentation over mammalian manufacturing.
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Author Bio
Ronit Sharma
Ronit Sharma is an accomplished business research and competitive intelligence professional with more than seven years of experience in the pharmaceutical and healthcare industry. As a team leader at Roots Analysis, he has authored numerous multidisciplinary market research reports, and led the efforts on several bespoken consulting assignments, providing valuable insights into the latest innovations in healthcare and the digital transformation of the pharmaceutical industry. Ronit’s exceptional analytical skills and strategic thinking in the field contribute to the firm’s intellectual capital, empowering clients to make informed decisions in the dynamic pharmaceutical landscape. With a passion for staying at the forefront of industry advancements, Ronit specializes in identifying emerging opportunities for various stakeholders, leveraging his deep understanding of market trends and technological developments. He is committed to fostering an environment of excellence, creativity, and innovation within his team, encouraging collaboration and empowering team members to bring their best ideas to the table.
Ronit holds a B. Tech degree in Biotechnology from Lovely Professional University and his research and thought leadership can be found in his professional blog and social media profiles, where he shares the latest insights and engages in meaningful discussions with industry peers. To ensure the highest ethical standards, Ronit openly declares no conflicts of interest in his work, ensuring unbiased and trustworthy contributions. His insights undergo rigorous editorial and peer-review processes, establishing his credibility as a thought leader within the pharmaceutical and healthcare domain. Ronit’s exceptional analytical and strategic thinking skills, coupled with his commitment to excellence, make him a valuable asset to any organization in the pharmaceutical and healthcare industry.
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