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Sterile Injectable Drug Product Manufacturing Market Overview and Outlook

  • ID: 4871991
  • Report
  • August 2019
  • Region: Global
  • Industry Standard Research (ISR)
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Current demand for sterile injectable drug product manufacturing is fed by multiple dynamics, and when the decision has been made to outsource there is a spectrum of options: niche CMOs with a sterile-injectable focus, large CMOs with end-to-end services for a variety of dosage forms, and one-stop-shops where both API and drug product manufacturing from development through commercialization can be supported. Knowing which approach is best for your organization can be tricky.

Staying in-the-know with industry practices and CMO usage patterns is essential for making informed decisions about your own outsourced sterile injectable manufacturing, whether you work at a drug innovator or a contract manufacturer. Key statistics include development-stage and marketed product volume, the proportion outsourced, and the number of CMOs required to complete the work. The publisher explores the molecule types and delivery devices in drug innovators’ pipelines and portfolios, how likely manufacturing is to be outsourced by these categories, and how these proportions will shift over the next five years.

What You Will Learn:

Drug Developers

  • Learn about the life cycle management and life cycle extension strategies currently used by industry peers with sterile injectable drug products, including insight into the time frame in which drug innovators introduce patient-centric delivery options like pre-filled syringes or cartridges
  • Improve your understanding of selection factors and satisfaction drivers for sterile injectable CMOs in addition to CMO proposal volume, use, and preference statistics with verbatim preference responses for 29 different CMOs
  • Annual outsourced sterile injectable expenditure (overall and by company size) and a prediction on how spend will change over the next five years

Contract Manufacturers

  • Understand outsourcing motivations and commercial CMO engagement timelines
  • Know which delivery formats are in drug innovators’ pipelines and portfolios and the likelihood of outsourcing drug product manufacturing by delivery device
  • Gain insight into why CMOs lose bids and the biggest challenges sponsors encounter when outsourcing sterile injectable manufacturing in order to better position your company to meet sponsor needs
  • Learn sterile injectable product volume and outsourcing propensity by company size in order to develop more targeted business development strategies

Major Topics:

  • Market Dynamics
  • Service Provider Perceptions and Selection
  • Trends, Predictions, Preferences
  • Study Data
Note: Product cover images may vary from those shown
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How To Use This Report

Analysis Note: Outsourcing Requirement

Introduction

Methodology

Respondent Demographics

Major Sections

Market Dynamics

  • Primary Section Takeaways
  • Outsourcing Drivers
  • CMO Engagement Timeline: Commercial Drug Product
  • Manufacturing Activities Outsourced for Sterile Injectable Products
  • Manufacturing Activities Outsourced by Company Size
  • Product & CMO Volume
  • Small Molecule Biologic
  • Products and Outsourcing Frequency by Delivery Device
  • Sterile Injectable Manufacturing Annual Outsourced Expenditure
  • Annual Outsourced Expenditure by Company Size

Service Provider Selection And Perceptions

  • Primary Section Takeaways
  • Department Influence on CMO Selection
  • Top 5 CMO Selection Attributes
  • CMO Satisfaction Drivers
  • Top 5 Reasons CMOs Lose Bids
  • Preferred Provider Use
  • CMO Familiarity
  • CMO Proposal Volume, Use, and Preference
  • Reasons for Service Provider Preference

Trends, Predictions And Preferences

  • Primary Section Takeaways
  • Sterile Injectable Life Cycle Management
  • Most Popular Life Cycle Extension Strategies
  • Delivery Format Conversion Timeline
  • Top 5 Sterile Injectable CMO Market Growth Drivers
  • Top 5 Factors that May Increase Outsourcing
  • Greatest Challenges Outsourcing Sterile Injectable Manufacturing
  • Manufacturing by Region

Study Data

  • Outsourcing Drivers
  • CMO Engagement Timeline: Commercial Manufacturing
  • Department Influence on CMO Selection
  • CMO Selection Attributes
  • Reasons CMOs Lose Bids
  • Use of Preferred Providers
  • Number of Preferred Providers
  • Number of Preferred Providers in 5 Years
  • Difficulty Using a Non-preferred Provider
  • Frequency of Adding New Preferred Providers
  • Frequency of Evaluating Preferred Providers
  • Number of Sterile Injectable CMOs Used
  • CMO Familiarity
  • CMOs Included in RFP Process
  • Sterile Injectable CMO Use
  • Sterile Injectable CMO Satisfaction Drivers
  • Sterile Injectable CMO Preference
  • Service Provider Preference Verbatim Responses
  • Manufacturing Activities Outsourced for Sterile Injectable Products
  • Sterile Injectable Product Volume
  • Clinical Development
  • Marketed Products
  • Marketed Products in 5 Years
  • Biologic vs. Small Molecule
  • Products in Development
  • Marketed Products
  • Marketed Products in 5 Years
  • Sterile Injectable Formulations by Delivery Device
  • Likelihood of Outsourcing by Delivery Device
  • Likelihood of Outsourcing by Delivery Device in 5 Years
  • In-house Manufacturing by Region
  • Outsourced Manufacturing by Region
  • In-house vs. Outsourced Manufacturing Breakdown
  • Small Molecule Sterile Injectables
  • Biologic Sterile Injectables
  • Sterile Injectable Manufacturing Annual Outsourced Expenditure
  • Sterile Injectable Life Cycle Management
  • Life Cycle Extension Strategies
  • Delivery Format Conversion Timeline
  • Sterile Injectable CMO Market Growth Drivers
  • Increased Outsourcing Prompts
  • Biggest Outsourcing Challenge
  • Biggest Outsourcing Challenge Verbatim Responses

Demographics

  • Company Type and Size
  • Headquarters Location
  • Office Location
  • Job Title
  • Decision-making Responsibility
  • Contract Manufacturing Activities and Responsibilities
  • Involvement in Outsourced Manufacturing
  • Years of Industry Experience
Note: Product cover images may vary from those shown
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