Analysis of the Global Biologics API Market

Redefining the Future of Biologics through Target-specific Drugs and Novel Technologies

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This study provides an insight into the global biologics active pharmaceutical ingredients (API) market. According to the US FDA, “Biological products, or biologics, are medical products made from a variety of natural sources (human, animal, or microorganism). Biologics are intended to treat diseases & medical conditions and prevent or diagnose diseases.” Biologic drugs are significantly derived from monoclonal antibodies, recombinant proteins, vaccines, and others (e.g., cell therapy, gene therapy, antibody drug conjugates). In this study, drivers, restraints, and the competitive landscape as well as outsourcing and market and technology trends are discussed. Estimates and forecasts for the global market a

Table of Contents

1. Executive Summary
Key Findings
Segment Growth Trends
Technology Trend and Market Activities
In-house vs. Outsourcing
CEO’s Perspective
2. Total Biologics API Market—An Overview
Market Definitions
An Overview
Monoclonal antibodies
Recombinant proteins
Biologic vaccines
Global Biologics API Product Segmentation and Therapeutic Categories
Antibody and Recombinant Protein Production Process
Vaccines and Gene Therapy Production Process
3. Market Drivers and Restraints
Market Drivers
Patent expiry of biologic drugs in the next 5 years
Rising disease population in therapeutic categories like oncology, cardiology, auto-immune, and diabetes
High priced biologic drugs along with growth in biosimilars
Market Restraints
Complexity in biologic API manufacturing
Regulatory scrutiny concerning quality policies and user fees for drug manufacturing
Regulatory Landscape—Biologics
4. Forecast and Trends
Market Engineering Measurements
Revenue Forecast
Percent Revenue Breakdown by Region
Percent Revenue Breakdown by Biologic Drug Class
5. Technology and Market Trends
Global Trends in Biologics Market
In-house vs. Outsourcing
Biosimilars Growth
Hybrid Methodology
Global Technology Trends in Biologics
Single-use Systems
Replacement Technologies
Process Analytical Technology
Continuous Manufacturing
Green Chemistry
Global Significant Expansions by Top Biopharma Companies and CMOs
Global Major Acquisitions by Top Biopharma Companies and CMOs
6. Competitive Analysis
Top Biopharmaceutical Companies and Their Future Plans by 2020
Novo Nordisk
Biologic Drug Pipeline across Therapeutic Categories and Biologic Class by Major Companies
Biologic Drugs Pipeline of Key Companies
Biologics API Market—Product Matrix
Porter’s Five Forces Analysis
7. In-house vs. Outsourcing
Global Contract Manufacturing Partnerships
Best Practices in the Biopharma Industry
The Last Word
Growth segments
Technologies for the future
Outsourcing strategy
Legal Disclaimer
8. Appendix
Major Companies
9. The Frost & Sullivan Story


List of Figures & Charts

1. Total Biologics API Market: Key Market Drivers, Global, 2016–2020
2. Total Biologics API Market: Key Market Restraints, Global, 2016–2020
3. Total Biologics API Market: Market Engineering Measurements, Global, 2015

1. Total Biologics API Market: Revenue Forecast, Global, 2012–2020
2. Total Biologics API Market: Percent Revenue by Region, Global, 2015
3. Total Biologics API Market: Percent Revenue Breakdown by Biologic Drug Class, Global, 2015
4. Total Biologics API Market: Porter’s Five Forces Analysis, Global, 2015

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