Microbial Fermentation: Biologics
2024 Market Insight, CDMO Pricing and Competitor Benchmarking
Over 500 cumulative hours of qualitative and quantitative data collection and analysis have been utilized to update Nice Insight’s Microbial Cell Culture, Biologics: 2024 Market Insight, CDMO Pricing and Competitor Benchmarking study.
Here are some facts about the 2024 report:
Research Started:
March 2024
Primary & Secondary Data Collection:
March 2024 – May 2024
Collation & Analysis:
March 2024 – June 2024
Development & Validation:
June 2024 – July 2024
Report Published:
July 2024
Revised October 2024
About This Report
This year we split the 2023 Monoclonal Antibody and Recombinant Protein report by production host, so that we can dive deeper into the production of biologics in microbial systems.
We have continued our three-year pricing study and updated the pricing for 2024. We now offer a unique perspective as we can comment on trends in biomanufacturing since 2019.
This is the first time we dove into the FDA’s clinical trial database to analyze the trends in the space. For this report, we focused on insulin-based therapies and GLP-1 agonists, since they represent such a large portion of the microbial market.
We provide projections for ongoing growth of therapeutics entering the clinic and expecting approval, which will drive the need for manufacturing and analytical services.
We survey the regulatory, technical, and clinical challenges encountered by innovators and manufacturers in this enormous market.
We obtained input from subject matter experts (SMEs) from contract development and manufacturing service providers and buyers of outsourced services.
We put the manufacturing market in context of ongoing geopolitical news.
Find Out Insights and Answers to These Questions
Innovators
Who are the major manufacturers in my target region?
Which CDMOs provide full end-to-end services, including development, manufacturing, formulation, and fill/finish? ·
How much do we need to budget for a typical antibody manufacturing program?
What have been the pricing trends in the past five years?
What companies are ahead of me in the clinical pipeline?
What microbial hosts are commonly used for my type of therapeutic?
What titers can we expect, and therefore at what scale do we prepare RFPs?
Where are talent shortages most impacting CDMOs and what questions should I ask when evaluating a contractor? ·
What can we expect in the area of biosimilars?
What geopolitical news do I need to pay attention to?
Manufacturers
Who are my CDMO competitors in North America, Europe, and Asia?
What are the projected capacity expansions by my competitors, and where are they expanding?
How are competitors currently pricing their services?
Based on the trends, should I adjust our pricing strategy?
Who are the key innovators in the space, and how many projects are in their portfolios?
What microbial host should my CDMO consider developing as a service?
What is the scale required for our potential clients?
How are other firms dealing with a shortage of talent and where might we find training programs? ·
What portion of the market is expected to come from biosimilars?
How might geopolitics affect my firm?
What’s Included in This Report
Five-Year Trends in Pricing
costs for key activities performed by CDMOs in this established industry
42 CDMO Profiles
including CDMOs with microbial fermentation and refolding capacity
Analysis of Clinical Trial Landscape
to understand the current and future bispecific modalities and manufacturing requirements
Market Growth Research
including projections for approved and late-stage antibodies and their biosimilars
In-Depth Insight
from manufacturers and innovators on the IP, regulatory, technical, and financial landscape
Market Drivers
behind company expansions, layoffs, onshoring, and offshoring
Study Methodology
For the first edition of Nice Insight’s Microbial Fermentation, Biologics: 2024 Market Insight, CDMO Pricing and Competitor Benchmarking we have focused only on the microbial-based biologics from our previous reports. We updated all of our trends sections with up-to-date primary, proprietary data and a survey of secondary data from the published literature and industry databases to create a comprehensive outsourced development and manufacturing of biologics in microbial cells. The quantitative research that we performed is supplemented by direct interviews conducted with multiple SMEs with diverse roles in the sector to obtain qualitative perspectives on the dynamics of the space.
To build a dataset of insulin therapies and GLP-1 agonists, we have built our own tool to search through the database at clinicaltrials.gov. We probed the dataset in multiple queries to pull out all clinical trials, and then carefully curated and cleaned the dataset to use in our analysis.
The data from 1,964 insulin-based trials and 1,732 GLP-1 agonist-based trials was curated to focus only on the investigation of the chosen drug type. This dataset was used to analyze innovators, funding, modalities, and more.
The content included here reflects in total over 500 hours of dedicated research, interviews, analysis, and composition, both to develop the 2024 pricing study and survey of clinical trials published.
A team comprising six Ph.D.-level experts collaborated with a group of 25+ existing clients representing CDMOs within the microbial manufacturing and development sector to probe and better understand benchmarks, current challenges, and the future of the industry.
Our staff with over 100 years of industry experience worked for over four months to advise on big-picture trends shaping the industry and to unify the data into a holistic view.
Individual interviews were performed with SMEs representing leadership, manufacturing, innovators, and other operations at small and midsized CDMOs to discuss pricing for contract development and manufacturing services.