Sterile Injectable Drug Product Manufacturing Market Outlook (3rd Ed.)


The current landscape for sterile injectable drug product manufacturing is shaped by multiple dynamics, and when the decision has been made to outsource there is no shortage of options: niche CMOs with a sterile-injectable focus, large CMOs with end-to-end services for a variety of dosage forms, and one-stop-shops where both API and drug product manufacturing from development through commercialization can be supported. Knowing which approach is best for your organization can be tricky. Staying in-the-know with industry practices and CMO usage patterns is essential for making informed decisions about your own outsourced sterile injectable manufacturing, whether you work at a drug innovator or a contract manufacturer. Key statistics include development-stage and marketed product volume, the proportion outsourced, and the number of CMOs required to complete the work. ISR explores which delivery formats drug innovators are using in their pipelines and portfolios, how likely innovators are to outsource manufacturing based on delivery device, and how these proportions will shift over the next five years.

Drug Developers:

  • Learn about the life cycle management and life cycle extension strategies currently used by industry peers with sterile injectable drug products, including insight into the time frame in which drug innovators introduce patient-centric delivery options like pre-filled syringes or cartridges
  • Improve your understanding of selection factors and satisfaction drivers for sterile injectable CMOs in addition to CMO proposal volume, use, and preference statistics with verbatim preference responses for 28 different CMOs
  • Annual outsourced sterile injectable expenditure (overall and by company size) and a prediction on how spend will change over the next five years

Contract Manufacturers:

  • Understand outsourcing motivations and commercial CMO engagement timelines
  • Know which delivery formats are in drug innovators’ pipelines and portfolios and the likelihood of outsourcing drug product manufacturing by delivery device
  • Gain insight into why CMOs lose bids and the biggest challenges sponsors encounter when outsourcing sterile injectable manufacturing in order to better position your company to meet sponsor needs
  • Learn sterile injectable product volume and outsourcing propensity by company size in order to develop more targeted business development strategies

Market Dynamics

Service Provider Awareness, Perception, and Selection

Trends, Predictions, and Preferences

Study Data

ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

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