Contract Development and Manufacturing Outsourcing Models

  • ID: 4410749
  • Report
  • 132 pages
  • Industry Standard Research (ISR)
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It is no surprise that with only one-third of pharmaceutical manufacturing conducted in house, the practice of outsourcing manufacturing activities has evolved over the past 25 years and continues to do so. The Contract Development and Manufacturing 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. This report explores how sponsor organizations use contract manufacturers through various outsourcing models, including Tactical or Transactional Outsourcing, Preferred Providers and Strategic Partnerships to streamline costs, better manage capacity, improve efficiencies and decrease time to market.

What You Will Learn:

Drug Developers

Benefits and drawbacks of using 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 CMO selection and 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

Major Sections:

1. Drug Development and Manufacturing Outsourcing Dynamics
2. Outsourcing Models: Performance, Selection, and Use
3. Future Trends
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1. Introduction

2. Methodology
Participant Criteria

3. Respondent Demographics
4 Major Sections

4. Drug Development And Manufacturing Outsourcing Dynamics
Primary Section Takeaways
Manufacturing projects’ outsourcing costs broken out by activity
Overall
Small molecule
Large molecule
Outsourcing difficulties-unprompted
Drug development manufacturing
Drug development manufacturing difficulties-direct quotes
Commercial manufacturing
Commercial manufacturing difficulties-direct quotes
In-house vs outsourced model allocation
Drug development manufacturing
Commercial manufacturing
Experience and capacity influence outsourcing strategies
Preferred service provider type by phase
Roles & responsibilities that influence service provider selection
Drug development manufacturing
Commercial manufacturing

5. 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
Commercial manufacturing
Preferred provider outsourcing model
Drug development manufacturing
Commercial manufacturing
Strategic partnership outsourcing model
Drug development manufacturing
Commercial manufacturing

6. Future Trends
Primary Section Takeaways
Improving outsourcing relationships
Likelihood of changing service providers based on trends
Interest in working with a development specialist
Differentiating development specialists from the competition

7. Study Data
Current outsourcing practices
Current level of outsourcing-drug development manufacturing
Current level of outsourcing-commercial manufacturing
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
Reasons to change outsourcing models-unprompted
Outsourcing difficulties-unprompted
Drug development manufacturing
Commercial manufacturing
Preferred service provider type by phase
Roles & responsibilities that influence service provider selection
Drug development manufacturing
Commercial manufacturing
Outsourcing models used
Drug development manufacturing
Commercial manufacturing
In-house vs outsourced model allocation
Drug development manufacturing
Commercial manufacturing
How experience and capacity influence outsourcing decisions
Specialty dosage form drug products
Small molecule drug substance
Orphan drugs
Generic drug products
Oral solid dose drug products
Sterile injectable drug products
Biologic drug substance
Semi-solid and liquid drug products
Advanced intermediates
Mature products
“Blockbuster” drug products
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
Tactical provider performance vs expectations
Drivers for using a tactical outsourcing model
Challenges encountered using a tactical model
Tactical outsourcing for commercial manufacturing
Tactical model use frequency
Tactical provider performance vs expectations
Drivers for using a tactical outsourcing model
Challenges encountered using a tactical model
Preferred provider outsourcing for drug development manufacturing
Preferred provider model use frequency
Preferred provider performance vs expectations
Drivers for using a preferred provider model
Preferred provider selection frequency
Number of preferred providers
Challenges encountered using a preferred provider model
Preferred provider outsourcing for commercial manufacturing
Preferred provider model use frequency
Preferred provider performance vs expectations
Drivers for using a preferred provider model
Preferred provider selection frequency
Number of preferred providers
Challenges encountered using a preferred provider model
Strategic partnership outsourcing for drug development manufacturing
Strategic partnership model use frequency
Strategic partnership performance vs expectations
Drivers for using a strategic partnership model
Number of strategic partnerships
Challenges encountered using a strategic partnership model
Strategic partnership outsourcing for commercial manufacturing
Strategic partnership model use frequency
Strategic partnership performance vs expectations
Drivers for using a strategic partnership model
Number of strategic partnerships
Challenges encountered using a strategic partnership model
Future Trends
Improving outsourcing relationships
Likelihood of changing service providers
Interest in a drug development specialist
Drug development specialists differentiation

8. Demographics
Company type
Headquarters location
Job title
Decision-making responsibility
Manufacturing strategy
Manufacturing responsibility
Knowledge of company’s outsourcing models
Involvement in outsourced manufacturing
Years of experience
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