This report explores which delivery formats drug innovators are using in their pipelines and portfolios, how likely innovators are to outsource manufacturing based on delivery device, and how these proportions will shift over the next five years.

Current market dynamics and outlook of the cell & gene therapies contract manufacturing space and predictions on what the marketplace will look like in 2028. Key stats include the volume of cell therapies/gene therapies in sponsors’ pipelines, corresponding manufacturing activities that will be outsourced, average outsourcing expenditure on cell and/or gene therapies, and number of CDMOs required to complete the work.

This report will help both study sponsors and providers answer a number of questions relevant to selecting and evaluating central lab service providers. For the purpose of this report, “central lab” is defined as a vendor that supplies specimen collection kits, logistics services, safety alerts, and a wide variety of laboratory testing services as well as providing lab reports to investigators.

An overview of the current market dynamics for high containment manufacturing from the perspective of HPAPI manufacturing decision-makers at sponsor organizations at small and midsize biopharmaceutical companies and their predictions on what the market will look like in five years.

This market research report goes into depth on the manufacturing aspect of biosimilars. Manufacturing these complex products in a cost efficient manner will be a critical component to successfully commercializing biosimilars and the anticipated boom.

This market research report offers readers the opportunity to gain insight into the biopharmaceutical excipient market and where it’s heading. Remaining aware of market dynamics and expected changes will enable readers to better make key decisions regarding excipient use and to help identify where competitive advantages may be gained.

This market research report explores how the decision-making process differs among drug innovators outsourcing development activities from those outsourcing commercial manufacturing when it comes to CMO/CDMO selection criteria, use patterns, preferences and perceived leadership.

This research provides gene therapy companies and contract manufacturers with the latest insights, outsourcing trends, and best practices reported within the specific domain, as well as benchmarks for assessing service quality among the 14 CDMOs featured in the report.

This report provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CDMO service quality.

This report provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality.

This report is based on responses from 45 people involved in outsourced large molecule API projects over the last 18 months. It will help new/emerging pharma companies make informed CDMO selections, and help CDMOs better understand how they are perceived.

Sponsors can use this report to evaluate their lab selection process. Bioanalytical labs can use it to learn how their company performs against competitors. Topics covered include lab selection and perceptions, lab performance, and lab service quality profiles.

This report provides an in-depth exploration of the role and function of Chemistry, Manufacturing, and Controls (CMC) throughout the stages of product development, spanning preclinical, clinical, and commercialization phases. A specific emphasis is placed on the configuration of the CMC function within virtual and small biopharmaceutical companies.

ISR interviewed 15 CMC professionals at 14 Top 50 pharmaceutical and biotechnology companies, as well as one company outside the Top 50 to better understand the Chemistry Manufacturing and Controls function throughout the preclinical, clinical, and commercialization phases of the product development process.