Executive Summary
Study Methodology
Section I:
API Market Overview
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Size and Growth Rate
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Branded/Generic
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Sourcing Issues
Section II:
API Market Trends
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Leading Indications
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Orphan Drugs
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Personalized Medicine
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Highly Potent APIs
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Controlled Substances
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Novel Modalities/Mechanisms of Action/Compound Classes
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Generics
Section III:
API Development Trends
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Quality-by-Design
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High-Throughput Screening
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Scale-Down Modeling
Section IV:
API Manufacturing Trends
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Rising Complexity and Expertise and Equipment Specialization
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Green Processing
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Chiral Technologies
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Advances in Chemocatalytic Solutions
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Advances in Enzymatic Technologies
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Low-Temperature and High-Pressure Processes
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Advances in Purification – Extraction, Filtration, Crystallization
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Small-Volume Manufacturing
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Automation
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Process Intensification
Section V:
Continuous Processing API Analytical Trends
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Inline/At-line/Online Monitoring
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Digitalization of Analytical Data
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Volume and Complexity Challenges
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Multimodal View
Section VI:
API Regulatory Trends
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Quality Assurance
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Manufacturing Changes
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Risk-Based Approaches
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Traceability, Security, and Non-Corruptibility of Data
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Supply Chain Assurance
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Virtual Audits
Section VII:
API Contract Development and Manufacturing Market
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Overall Market Size and State – Clinical and Commercial
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API Outsourcing Trends – Shift to Local/Regional Suppliers
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Recent Investments
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Regional Analysis
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Competitive Landscape
Section VIII:
API Outsourced Manufacturing Pricing Study
Section IX:
APIs CDMO Overview
Appendix I:
References