CDMO Outsourcing Models (3rd Ed.)

Description

ISR’s CDMO Outsourcing Models report takes an in-depth look at current outsourcing practices among drug innovators to gain insight into the adoption and application of different outsourcing strategies. Biopharma report buyers are encouraged to use its content to navigate the benefits and drawbacks of various outsourcing models, to understand the cost breakdown of a manufacturing project by molecule type and stage of development to see where potential savings can be optimized, and to prepare for potential difficulties and challenges that peer outsourcers have encountered when using contract manufacturers. CDMO readers will gain insight into the service provider selection process, including details on budget, the use of consultants, the timeline for engaging CDMOs, and who is involved in the selection process. Contract manufacturers will also learn sponsor drivers for choosing different outsourcing models, their satisfaction with different models, and the challenges associated with each outsourcing approach. CDMOs can use this report’s content to plan for changes in outsourcing model usage, to capture new business by zeroing in on the elements that drive the outsourcing model’s success, and to anticipate future customer needs.

 

Drug Developers:

  • Benefits and drawbacks of using each of three different outsourcing models for development and/or commercial manufacturing needs
  • Understand the cost breakdown of an outsourced manufacturing project by molecule type and stage of development to identify areas where potential savings may be gained
  • How to prepare for challenges and difficulties that peers have encountered when using contract manufacturers through various outsourcing models

Contract Manufacturers:

  • Gain insight into how sponsor experience and capacity influence outsourcing strategies as well as which drug products and components are most likely to be outsourced
  • Learn decision-making hierarchies and outsourcing drivers influencing CDMO selection then use this information to improve your sales pitch and approach
  • Use this report to plan for changes in outsourcing model usage, to understand why those changes may transpire and to capture new business by zeroing in on the elements that drive an outsourcing model’s success
  • CDMO Outsourcing Dynamics
  • Outsourcing Models: Performance, Selection and Use
  • Future Trends
  • Study Data

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CDMO Outsourcing Dynamics

Primary Section Takeaways
Current Outsourcing Practices
In-house vs Outsourced Model Allocation
Drug Development Manufacturing
Commercial Manufacturing
CDMO Selection Budget
Use of Consultants
Roles & Responsibilities that Influence CDMO Selection
Drug Development Manufacturing
Commercial Manufacturing
CDMO Engagement Timelines
Development
CDMO Engagement Timelines
Commercial
Most Helpful CDMO Information
Experience and Capacity Influence Outsourcing Strategies
Ideal Service Provider Type by Phase
Use of Same CDMO for Development and Commercial Manufacturing
Use of Same CDMO for Drug Substance and Drug Product
Outsourcing Difficulties—Unprompted
Drug Development Manufacturing
Drug Development Manufacturing Difficulties—Direct Quotes
Outsourcing Difficulties—Unprompted
Commercial Manufacturing
Commercial Manufacturing Difficulties—Direct Quotes
Manufacturing Projects’ Outsourcing Costs by Activity
Overall
Small Molecule Costs by Activity
Large Molecule Costs by Activity

Outsourcing Models: Performance, Selection and Use

Primary Section Takeaways
Outsourcing Model Performance vs Expectations
Drug Development Manufacturing
Commercial Manufacturing
Outsourcing Model Performance Scores
Drug Development Manufacturing
Commercial Manufacturing
Selection Driver Overview
Tactical Outsourcing Model
Drug Development Manufacturing
Tactical Outsourcing Model
Commercial Manufacturing
Preferred Provider Outsourcing Model
Drug Development Manufacturing
Preferred Provider Outsourcing Model
Commercial Manufacturing
Strategic Partnership Outsourcing Model
Drug Development
Strategic Partnership Outsourcing Model
Commercial Manufacturing

Future Trends

Primary Section Takeaways
Improving Outsourcing Relationships
Likelihood of Changing Service Providers Based on Trends

Study Data

Current Outsourcing Practices
Outsourcing Proportions
Drug Development Manufacturing
Commercial Manufacturing
CDMO Selection Budget
Use of Consultants
Roles & Responsibilities with Influence Over CDMO Selection
Drug Development Manufacturing
Commercial Manufacturing
CDMO Engagement Timelines
Development
CDMO Engagement Timelines
Commercial
Most Helpful CDMO Information
Ideal Service Provider Type by Phase
Use of Same CDMO for Development and Commercial Manufacturing
Use of Same CDMO for Drug Substance and Drug Product
How Capacity and Experience Influence Outsourcing Decisions
Specialty Dosage Forms
Small Molecule Drug Substance
Orphan Drugs
Generics
Oral Solid Dose
Sterile Injectables
Biologic Drug Substance
Semi-solid and Liquid Drug Products
Advanced Intermediates
Mature Products
“Blockbuster” Drugs
Outsourcing Costs by Activity
Overall
Small Molecule, Development Work, Clinical Trials Materials
Small Molecule, Commercial Production, Augment Internal Supply
Small Molecule, Commercial Production, Primary Supplier
Large Molecule, Development Work, Clinical Trial Materials
Large Molecule, Commercial Production, Augment Internal Supply
Large Molecule, Commercial Production, Primary Supplier
Outsourcing Models Used
Drug Development Manufacturing
Commercial Manufacturing
In-house vs Outsourced Model Allocation
Drug Development Manufacturing
Commercial Manufacturing
Outsourcing Model Compatibility
Drug Development Manufacturing
Commercial Manufacturing
CDMOs vs Sponsors
Drug Development Manufacturing
Commercial Manufacturing
Tactical Outsourcing for Drug Development Manufacturing
Tactical Model Use Frequency
Variations of Tactical Model Use
Tactical Model Performance
Tactical Outsourcing Model Usage Drivers
Common Tactical Model Challenges
Tactical Outsourcing for Commercial Manufacturing
Tactical Model Use Frequency
Variations of Tactical Model Use
Tactical Model Performance
Tactical Outsourcing Model Usage Drivers
Common Tactical Model Challenges
Preferred Provider Outsourcing for Drug Development Manufacturing
Preferred Provider Model Use Frequency
Preferred Provider Model Performance
Preferred Provider Model Usage Drivers
Preferred Provider Selection Frequency
Number of Preferred Providers
Common Preferred Provider Model Challenges
Preferred Provider Outsourcing for Commercial Manufacturing
Preferred Provider Model Use Frequency
Preferred Provider Model Performance
Preferred Provider Model Usage Drivers
Preferred Provider Selection Frequency
Number of Preferred Providers
Common Preferred Provider Model Challenges
Strategic Partnership Outsourcing for Drug Development Manufacturing
Strategic Partnership Model Use Frequency
Strategic Partnership Model Performance
Strategic Partnership Model Usage Drivers
Number of Strategic Partnerships
Common Strategic Partnership Model Challenges
Strategic Partnership Outsourcing for Commercial Manufacturing
Strategic Partnership Model Use Frequency
Strategic Partnership Model Performance
Strategic Partnership Model Usage Drivers
Number of Strategic Partnerships
Challenges Encountered Using a Strategic Partnership Model
Outsourcing Difficulties—Unprompted
Drug Development Manufacturing
Commercial Manufacturing
Future Trends
Improving Outsourcing Relationships
Likelihood of Changing Service Providers

Study Data

Company Type
Headquarters Location
Job Title
Exact Title
Decision-making Responsibility
Manufacturing Strategy
Manufacturing Responsibility
Knowledge of Company’s Outsourcing Models
Involvement in Outsourced Manufacturing
Years of Experience

Additional information

License

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