Small and Midsize Biopharma Perspective on the Global Highly Potent API (HPAPI) Manufacturing Market, 2022-2027: Outsourcing Practices, Provider Selection and Perceptions, Manufacturing Complications

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Jan 18, 2023, 11:00 ET

DUBLIN, Jan. 18, 2023 /PRNewswire/ -- 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/vqbpvy

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