Executive Summary
Study Methodology
Section I:
Sterile Injectables Market Overview
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Sterile Injectables Market Trend
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Market Size and Growth Rate
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Major Indications for Sterile Injectable Biologics
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Biologics vs. Small Molecules
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The Importance of Generics/Biosimilars
Section II:
Sterile Injectables Market Trends
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Novel Therapies and Vaccines
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Patient-Centric Focus
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Rise in Self-Administration
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Growing Interest in Prefilled Syringes
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Orphan Drugs and Precision Medicine Drive Demand
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Large-Volume Injectables Remain Important
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Growing Demand for Highly Potent Injectables
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Challenges to Sterile Injectable Storage and Distribution
Section III:
Sterile Injectables Formulation Trends
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Managing Increasing Viscosity
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Growing Interest in Complex, Long-Acting Sterile Injectable Products
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Using Nanoemulsions and Suspensions to Overcome Poor Solubility
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The Emergence of Lipid Nanoparticles
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Use of Polymeric Nano/Microparticles for Targeted Delivery
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Increasing Importance of Excipients and Excipient Selection
Section IV:
Sterile Injectables Manufacturing Trends
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Capacity Issues and Increased Outsourcing
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Increasing Adoption of Single-Use Technologies
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Growing Use of Automation
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The Debate about Cleanrooms, Ballrooms, RABS and Isolators
Section V:
Sterile Injectables Fill/Finish Trends
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Terminal Sterilization Trends
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Aseptic Fill/Finish
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Increasing Complexity
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Rising Demand for Small-Volume Fill/Finish
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Increasing Outsourcing of Sterile Fill/Finish
Section VI:
Sterile Injectables Device and Packaging Trends
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Injectable Drug Delivery Device Market Overview
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Trends in Pharmaceutical Glass for Sterile Injectables
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Plastic Packaging Making Inroads
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Patient Centricity Increasingly Important
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Growing Need for Customized Delivery Devices
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Device Challenges Created by High-Viscosity and Large-Volume Injectable Drug Self-Administration
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Continued Advances in Wearable Injectors
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Increasing Connectivity of Injection Devices
Section VII:
Sterile Injectables Regulatory Trends
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Strengthening Inspections and Regulations
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Prefilled Syringes Present Compliance Challenges
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Rapidly Evolving Regulatory Standards for Drug-Device Combination Products
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Potential Impacts of COVID-19 on Sterile Injectable Regulations
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A Note about 503B Compounding
Section VIII:
Sterile Injectables Contract Development and Manufacturing Market
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Sterile Injectables Contract Manufacturing Market Size
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Sterile Injectables Outsourcing Trends
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Recent Investments
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Regional Analysis
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Competitive Landscape
Section IX:
Sterile Injectables Outsourced Manufacturing Pricing Study
Section X:
Sterile Injectables CDMOs Overview
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Service Summary
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Company Profile
Appendix II: References