Small and Midsize Biopharma Perspective on the Highly Potent API Manufacturing Market

Report Overview

Welcome to ISR’s Small and Midsize Biopharma Perspective on the Highly Potent API Manufacturing Market report. 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.

ISR’s 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. 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. 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

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