Biologic Sterile Injectable Drug Product Manufacturing Market Overview and Outlook


Current demand for sterile injectable drug product manufacturing is fed by multiple dynamics, and when the decision has been made to outsource there is a spectrum 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. This report provides an overview of the current biologic sterile injectable market dynamics as well as what our survey respondents—all outsourcing decision-makers—predict the market will look like in 2022. Key statistics include development-stage and marketed product volume, the proportion outsourced, and the number of CMOs required to complete the work. ISR explores the biologic categories and delivery devices in drug innovators’ pipelines and portfolios, how likely manufacturing is to be outsourced by these categories, and how these proportions will shift over the next five years.

Biologic Sterile Injectable Drug Product Manufacturing

Drug Developers

  • Contract manufacturer selection factors and satisfaction drivers; CMO perception, use, and preference statistics, including verbatim preference responses for 22 different CMOs
  • Life cycle management and life cycle extension strategies utilized by industry peers, in addition to biologic sterile injectable market growth factors
  • Annual biologic sterile injectable expenditure and the proportion of spend in-house vs outsourced and how those figures will change over the next five years

Contract Manufacturers

  • Familiarize your company with outsourcing drug innovators’ portfolio composition and outsourcing likelihood by biologic drug category and delivery device and whether these practices will evolve in the next five years
  • Understand outsourcing motivations and commercial CMO engagement timelines for secondary manufacturing
  • Gain insight into why a CMO may lose a bid, preferred provider use and difficulty levels in using a CMO who is not on a preferred provider list
  • Learn biologic drug product project volume and outsourcing proportion by company type and development-stage vs commercial scale in order to better target sales and marketing efforts
  • Market Dynamics
  • Service Provider Selection and Perceptions
  • 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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Biologic Sterile Injectable CMO Selection Attributes

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