Highly Potent Active Pharmaceutical Ingredients (HPAPIs) Market Report 2022: Outsourced High Containment Manufacturing Current and 5 Years Outlook

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Jan 13, 2023, 10:15 ET

DUBLIN, Jan. 13, 2023 /PRNewswire/ -- 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/i0d995

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