U.S. Biotechnology Industry Overview & Growth Strategy Framework

 


This study describes and analyzes the biotechnology industry, focusing on biotechnology therapeutics. The study includes a discussion of drivers, restrains, technologies, research and development, manufacturing, regulatory issues, products, partnerships and capital markets. This study also presents a startegy framework that identifies key competencies for the growth of biotech companies.

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Table of Contents

U.S. Biotechnology Industry Overview & Growth Strategy Framework, Industry OverviewExecutive Summary & IntroductionExecutive SummaryIntroductionFocus of this ReportDriversMarket DriversNon-Market DriversRestraintsMarket RestraintsNon-Market RestraintsU.S. Biotechnology Industry Overview & Growth Strategy Framework, Technology and ProcessesDrug Development TechnologiesTechnology OverviewProtein TherapeuticsMonoclonal AntibodiesGene TherapyAntisense TechnologyBrief Description of Enzyme Inhibitors Fusion Inhibitors and Other TechnologiesResearch & Development ProcessR&D OverviewThe R&D ProcessManufacturing ProcessOverview of ManufacturingBiological Therapeutics and the Manufacturing ProcessManufacturing Plants and the Cost of ProductionRecent Manufacturing ProblemsU.S. Biotechnology Industry Overview & Growth Strategy Framework, RegulatoryOverview of the FDAIntroduction to the FDAThe FDA and Biotechnology MarketsLack of Commissioner and FDA PolicyFDA ProcessFDA StructureFDA Approval ProcessFDA and the Fast Track ProcessOrphans and BiogenericsFDA Considerations U.S. Biotechnology Industry Overview & Growth Strategy Framework, MarketsProductsProduct OverviewPartnershipsOverview of PartnershipsNotable Biotech/Biotech DealsNotable Biotech/Pharma DealsCapital MarketsOverview of Capital MarketsPublic MarketsMergers & AcquisitionsVenture CapitalU.S. Biotechnology Industry Overview & Growth Strategy Framework, Strategy Framework for Biotechnology GrowthOverviewBiotechnology Business ModelsSome Reasons for Forward IntegrationChallenges of Forward IntegrationCompetencies and GrowthLeadership: Management and Board of DirectorsDrug Development PlatformIntellectual PropertyTherapeutic FocusClinical Trials ExpertisePartnership ManagementMarketing StrengthLarge Scale ManufacturingRegulatory ExpertiseAccess to Capital MarketsAwards2001 Biotechnology Company of the Year Award: AmgenGlobal Marketing Strategy Award: BiogenVertical Integration Strategy Award: GenentechTechnology Leadership Award: IDEC PharmaceuticalsTechnology Innovation Award: Trimeris




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