Over 700 cumulative hours of qualitative and quantitative data collection and analysis have been utilized to update Nice Insight’s Sterile Fill Finish: Market Insight, CDMO Pricing and Competitor Benchmarking study.
Here are some facts about the report:
Research Started:
November 2024
Primary & Secondary Data Collection:
November 2024–December 2024
Collation & Analysis:
December 2024
Development & Validation:
December 2024
Report Published:
January 2025
We have continued our pricing study and updated the pricing for 2024. We now offer a unique perspective as we can comment on trends in sterile injectable manufacturing since 2022.
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 burgeoning 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.
Who are the major manufacturers in my target region?
Which CDMOs provide full end-to-end services, including development, manufacturing, formulation, and fill/finish?
What have been the pricing trends in the past three years?
Where are talent shortages most impacting CDMOs and what questions should I ask when evaluating a contractor?
What geopolitical news do I need to pay attention to?
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?
Based on the trends, should I adjust our pricing strategy?
How are other firms dealing with a shortage of talent and where might we find training programs?
How might geopolitics affect my firm?
costs for key activities performed by CDMOs in this established industry from 2022 and 2024
that offer sterile fill/finish as a standalone service
to understand the current and future manufacturing requirements
including projections for subsectors of the sterile market
from manufacturers and innovators on the IP, regulatory, technical, and financial landscape
behind company expansions, layoffs, onshoring, and offshoring
Nice Insight has compiled primary and secondary data to provide a view on the continued success of sterile injectable drugs, including those formulated using novel delivery technologies, and their development, manufacturing, and commercialization. Sources include market research reports, published articles, and interviews with industry experts. References are provided at the end of the report.
Throughout the report, both specific pieces of information and overall assessments based on sets of collected data are presented. References are provided where specific information is listed. In many cases, the references contain additional insights that might be of interest to the reader.
For the latest edition of Nice Insight’s Sterile Fill Finish: Market Insight, CDMO Pricing and Competitor Benchmarking study we have focused only on the sterile injectable CDMO market. 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 landscape of outsourced sterile injectables manufacturing.
A team comprising six Ph.D.-level experts collaborated with a group of 25+ existing clients representing CDMOs within the sterile injectable manufacturing and development sector to probe and better understand benchmarks, current challenges, and the future of the industry.
Our staff with over 45 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.