DUBLIN–(BUSINESS WIRE)–The “Highly Potent API Market Outlook” report has been added to ResearchAndMarkets.com’s offering.
Highly potent active pharmaceutical ingredients (HPAPIs) are a growing area for pharmaceutical companies.
This report provides an overview of the current market dynamics for high containment manufacturing as well as an outlook on what our survey respondents – all HPAPI manufacturing decision-makers at sponsor organizations – predict the marketplace will look like five years from now.
Key statistics include respondents’ categorizations of their companies’ high containment assets and the proportion of their small molecule portfolio that requires high containment manufacturing, the number of compounds requiring high containment that are in respondents’ development pipelines and on the market, which therapeutic areas they are designed to target, and the outsourcing prevalence of each type of high containment asset.
As a drug innovator, discover how industry peers are selecting service providers and which aspects of the manufacturing process have been most challenging. As a CDMO, determine how your capabilities and marketing messaging stack up against what highly potent manufacturing outsourcers regard as important as well as the main reasons CDMOs lose the bid for an HPAPI project.
What you will learn:
Drug Developers:
- Gain insight into where the highly potent drug substance industry is heading over the next five years with respect to the outsourcing penetration across different manufacturing activities and types of high containment compounds
- Understand the CDMO usage patterns of industry peers to identify whether additional outsourcing advantages can be obtained for your organization
- Learn the criteria used by peers to help scientifically and strategically evaluate CDMOs for highly potent drug substance projects
Contract Manufacturers:
- Pinpoint which CDMO attributes have led to successful outsourcing relationships, those that have caused service providers to lose bids and what truly drives sponsor satisfaction, then internally assess your company on these metrics
- Identify changes in demand for outsourced activities and services in order to prepare for future needs
- Better position your company to win business by understanding the dynamics of different buyer groups and developing targeted marketing to speak directly to their unique needs
Major Topics:
- Market Dynamics
- Outsourcing Practices
- Trends, Predictions, Preferences
- Study Data
- Demographics
Key Topics Covered:
How to Use this Report
Analysis Note: High Containment Requirement
Introduction
Methodology
Respondent Demographics and Qualifications
- Participant Geography
- Participant Company Size
- Participant Criteria
Major Sections
Market Dynamics
- Primary Section Takeaways
- High Containment Pipeline and Portfolio
- Proportion of Small Molecule Assets that are Highly Potent
- Small Molecule Assets
- Types of Highly Potent Assets
- Highly Potent Product Requirements
- Therapeutic Areas Targeted
- Dosage Forms
- Occupational Exposure Limits
Outsourcing Practices
- Primary Section Takeaways
- Outsourcing Drivers
- CDMO Use by Stage
- Likelihood of Outsourcing High Containment Manufacturing
- Outsourced High Containment Manufacturing Current and 5 Years Out
- Highly Potent Assets Outsourced
- Highly Potent Outsourced Manufacturing Activities
- CDMO Usage Rates for HPAPI
- Annual Outsourcing Expenditure
Provider Selection and Perceptions
- Primary Section Takeaways
- CDMO Selection Timing
- Department Influence on CDMO Selection
- Use of Preferred Providers
- Top 5 CDMO Selection Attributes
- CDMO Satisfaction Drivers
- Reasons CDMOs Lose Bids
Trends, Predictions, Preferences
- Primary Section Takeaways
- Areas of Difficulty
- Biggest Outsourcing Challenge – Unprompted
- Technology and Infrastructure Investments
Study Data
- Likelihood of Outsourcing High Containment Manufacturing
- Proportion of Small Molecule Assets that are Highly Potent
- Highly Potent Assets Projection
- Highly Potent Assets Outsourced
- OEL Limit
- Highly Potent Classification
- Highly Potent Product Requirements
- Process Analytical
- Highly Potent Dosage Forms
- Therapeutic Areas Targeted
- Outsourcing Drivers
- Outsourced High Containment Manufacturing Current and 5 Years Out
- Highly Potent Outsourced Manufacturing Activities
- CDMO Usage Rates for HPAPI
- Use of Preferred Providers
- CDMO Use by Stage
- CDMO Selection Timing
- Importance of Using the Same CDMO for Development and Commercial
- CDMO Selection Attributes
- CDMO Satisfaction Drivers
- Biggest Outsourcing Challenge
- Areas of Difficulty
- Department Influence on CMO Selection
- Technology and Infrastructure Investments
- Reasons CDMOs Lose Bids
- Annual Outsourcing Expenditure
Demographics
- Company Size and Revenue
- Office Location
- Molecule Involvement and Assets
- Decision-making Responsibility
- Highly Potent Compounds in Development
- Highly Potent Compounds on Market
- Involvement by Molecule Type
For more information about this report visit https://www.researchandmarkets.com/r/gf0vcy
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