Biologic Sterile Injectable Drug Product Manufacturing Market Overview and Outlook

Report Overview

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.

What you will learn:

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

Major Topics:

• Market Dynamics
• Service Provider Selection and Perceptions
• Trends, Predictions and Preferences
• Study Data