Biologic Sterile Injectable Drug Product Manufacturing Market Overview and Outlook

Description

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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

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Biologic Sterile Injectable CMO Selection Attributes

Market Dynamics

Primary Section Takeaways
Outsourcing drivers
Commercial CMO engagement timeline
Sterile injectable outsourcing frequency
Outsourcing frequency by company size
Product & CMO volume
Sterile injectable products and outsourcing frequency by category
Sterile injectable products and outsourcing frequency by delivery device
Annual expenditure for sterile injectable manufacturing
Annual spend by company size
In-house vs outsourced sterile injectable manufacturing spend

Service Provider Selection and Perceptions

Primary Section Takeaways
CMO selection influence
Top 5 CMO selection attributes
Service provider satisfaction drivers
Top 5 reasons CMOs lose bids
Use of preferred providers
CMO familiarity
CMO Proposal Volume, Use, and Preference
Reasons for development-stage service provider preference
Reasons for commercial-scale service provider preference

Trends, Predictions and Preferences

Primary Section Takeaways
Sterile injectable life cycle management
Top 5 life cycle extension strategies
Top 5 growth drivers
Manufacturing by region

Study Data

Outsourcing Drivers
Sterile injectable product volume—development
Sterile injectable product volume—marketed products
Sterile injectable product volume—5 years out
Biologic vs small molecule sterile injectable products in development
Biologic vs small molecule marketed sterile injectable products
Biologic vs small molecule sterile injectable products in five years
In-house manufacturing by region
Outsourced manufacturing by region
Commercial CMO engagement phase
Development-stage sterile injectable outsourcing
Marketed sterile injectable product outsourcing
Marketed sterile injectable product outsourcing 5 years out
Biologic sterile injectable drug product portfolio composition
Likelihood of outsourcing products in development by category
Proportion of marketed products outsourced by category
Likelihood of outsourcing marketed products by category in 5 years
Outsourced sterile injectable manufacturing activities
Sterile injectable formulations by delivery device
Likelihood of outsourcing by delivery device
Likelihood of outsourcing by delivery device 5 years out
Number of sterile injectable manufacturers used
Use of preferred providers
Number of preferred providers
Number of preferred providers 5 years out
Difficulty using a non-preferred provider
CMO selection attributes
Rank of sterile injectable CMO satisfaction drivers
Reasons CMOs lose bids
Annual expenditure for sterile injectable manufacturing
In-house vs outsourced sterile injectable manufacturing spend
In-house vs outsourced sterile injectable manufacturing spend in 5 years
CMO familiarity
CMOs included in RFP process for development-stage projects
Development-stage CMO use
CMO preference for development-stage sterile injectable projects
Verbatim replies for development-stage service provider preference
CMOs included in RFP process for commercial-scale projects
Commercial-scale CMO use
CMO preference for commercial-scale sterile injectable projects
Verbatim responses for commercial-scale service provider preference
Sterile injectable life cycle management
Life cycle extension strategies
Growth drivers
Department influence on CMO selection

Demographics

Company size
Headquarters location
Office location
Job title
Decision-making responsibility
Sterile injectable manufacturing visibility
Outsourcing influence
Contract manufacturing activities and responsibilities
Involvement in outsourced manufacturing
Years of industry experience

Additional information

License

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