Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities

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This report has two key objectives; to carry out a detailed industry analysis identifying key drivers for growth, restraints and the challenges faced by the industry. Secondly, to provide detailed quantification of the supply and demand for manufacturing capacities, which has increasingly become a cause of much speculation and is, considered to be a crucial issue that will affect the industry’s progression.

Table of Contents

Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Executive SummaryExecutive Summary Executive Summary Industry IndustryCapacity – Supply and Demand Capacity – Supply and Demand Future Prospects Future Prospects Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Project Design Project Design Project Design Purpose and Objective Purpose and Objective Scope of the Project Scope of the Project Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Introduction to the Biopharmaceutical IndustryIntroduction to the Biopharmaceutical IndustryIntroductionWhat are Biopharmaceuticals?What are Biopharmaceuticals?Why Biopharmaceuticals? Why Biopharmaceuticals? Technology Technology Protein Therapeutics Recombinant DNA Monoclonal Antibodies Gene Therapy Antisense Technology Protein Types Protein Types Expression Systems Expression Systems The Manufacturing Process The Manufacturing Process Drug Development and Approval Process Drug Development and Approval Process Pre-clinical Studies Investigational New Drug Application (IND) Clinical Trials – Phase I: Safety Phase II – Safety and Efficacy Phase III – Controlled Safety and Efficacy Approved Therapeutic Products Approved Therapeutic Products Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Industry Overview Industry Overview Industry Overview Industry and Competitive Structure Industry and Competitive Structure Research and Development Companies Contract Manufacturing Organizations (CMO) Integrated Biopharmaceuticals Companies Key Market Drivers Key Market Drivers Technological Developments Scientific Data Sharing Financial Profits and Growth FDA Product Approvals Disease Growth Demographic Changes Technology – Other Applications New Manufacturing Techniques Globalization Business Opportunities High Exit Barriers—Customers Bio-Terrorism Orphan Drug Statue Key Market Restraints Key Market Restraints Lack of Adequate Funding High Entry Barriers – Competitors Clinical Trials and Approval Expensive Drugs Bioinformatics Requirements Negative Perception of Industry Technology Gap Challenges Challenges Manufacturing Capacities Intellectual Property and Patents Moderate Success Health Insurance Information Technology Needs Drug Delivery Human Resources Management Portfolio of Technologies Immediate Economic Conditions Thin Product Lines Late Failure in Clinical Trials New Forms of Diseases Industry Review Global North America Europe Asia Australia Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Production Capacities – Supply Introduction Introduction Key Market Drivers Of Supply Key Drivers Of Supply Demand for Capacity Drugs in Clinical Trials Expression System – Fixed Requirements MAb’s and Vaccines Under Developments Key Drug Approvals Cost Advantages and Flexibility Industry Entry Vehicle Growth Vehicle Issues In Capacity - Supply Issues In Capacity - Supply Yields and Runs per Year Biogenerics Globalization Financial Cost of New Facility Long Time Scales Requirements Mismatch Support Functions Employees New Expression Systems – Transgenic Previous Experience Assumptions Assumptions Captive Use Manufacturing Captive Use Manufacturing Contract Manufacturing Contract Manufacturing Future Outlook - Industry Supply Future Outlook - Industry Supply Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Market Forecasts - Demand Introduction Introduction Key Drivers Of Demand Key Drivers Of Demand Drug Approvals Growth of Diseases Demographic Changes Previously Untreated Patients No Alternative Therapies Monoclonal Antibodies Issues For Capacity – Demand Issues For Capacity – Demand Unforeseen Demand Global Patent Protection Biogenerics Reactor Volumes Drug Competition FDA Approvals Transgenics Assumptions Assumptions Current Demand Current Demand Future Outlook Future Outlook Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Conclusion – Industry Capacity Conclusion – Industry Capacity Conclusion – Industry Capacity Capacity Forecasts Capacity Forecasts Implications Supply of Capacity Demand for Capacity Industry Growth Industry Structure Mergers and Acquisitions Prices The Manufacturing Operations R and D Product Availability SWOT Analysis SWOT Analysis Biopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Future ProspectsFuture ProspectsIntroductionNew ProductsTechnologyExpression SystemsBiogenericsRegulations (U.S FDA)ScenariosScenario I—The BioworldScenario II—The Rise Of The ClonesConclusionBiopharmaceuticals Industry Analysis - Quantification of Supply and Demand of Manufacturing Capacities, Appendix List Of Abbreviations List Of Abbreviations Glossary of Terms Glossary of Terms




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