Small and Midsize Biopharma Perspective on the Global Highly Potent API Manufacturing Market – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Small and Midsize Biopharma Perspective on the Highly Potent API Manufacturing Market” report has been added to ResearchAndMarkets.com’s offering.

Small and Midsize Biopharma Perspective on the Highly Potent API Manufacturing Market report explores motivations for outsourcing HPAPI, the number of small molecule assets that require high containment manufacturing that are in respondents’ pipelines and portfolios, and what percentage of high containment manufacturing activities are outsourced.

Highly potent active pharmaceutical ingredients (HPAPIs) are a growing area for biopharmaceutical companies. HPAPI manufacturing is often more complicated and resource intensive than traditional API manufacturing.

High containment facilities must be segregated, personnel must be trained and provided personal protective equipment, and employee exposure time-limits must be enforced. As a result, some sponsors are more likely to outsource HPAPI manufacturing compared to traditional small molecule drug substance because they need access to high containment facilities or scientific expertise not possessed in-house.

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.

This report provides an overview of the current market dynamics for high containment manufacturing from the perspective of small and midsize biopharmaceutical companies 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

What you will learn:

Drug Developers:

• Discover how industry peers are using service providers and which aspects of the manufacturing process have been most challenging
• Selection criteria for engaging a contract manufacturer for highly potent development and manufacturing
• The timeline for engaging a CDMO for commercial high containment manufacturing, and what really drives project satisfaction

CMOs:

• Determine how your capabilities and marketing messaging stack up against what highly potent manufacturing outsourcers regard as important
• Uncover the main reasons CDMOs lose the bid for an HPAPI project
• Better position your company to win business by understanding the dynamics of different buyer groups and develop targeted marketing to speak directly to their needs

Major Topics:

• Market Dynamics
• Outsourcing Practices
• Provider Selection and Perceptions
• Highly Potent Manufacturing Complications
• Study Data

Key Topics Covered:

How to Use this Report

Analysis Note: High Containment Requirement

Introduction

Methodology

Respondent Demographics and Qualifications

• Participant Geography
• Participant Company Size by R&D Spend

Major Sections

Market Dynamics

• Primary Section Takeaways
• High Containment Pipeline and Portfolio
• Proportion of Small Molecule Assets that are Highly Potent
• Types of Highly Potent Assets
• Highly Potent Product Requirements
• Top 10 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

Highly Potent Manufacturing Complications

• Primary Section Takeaways
• Areas of Difficulty
• Biggest Outsourcing Challenge – Unprompted

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 Technology
• 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/u4zbzr

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