Pharmaceutical Outsourcing  Post-Launch :  Contract Manufacturing, Biomanufacturing and Sales, 3rd Edition
 

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Pharmaceutical Outsourcing Post-Launch : Contract Manufacturing, Biomanufacturing and Sales, 3rd Edition Document Transcript

  • 1.    Get more info on this report!Pharmaceutical Outsourcing Post-Launch : Contract Manufacturing,Biomanufacturing and Sales, 3rd EditionJanuary 1, 2009This report is focused on two expanding pharmaceutical outsourcing markets, contractmanufacturing of prescription drugs and contract sales and marketing. Both marketsrepresent excellent post launch outsourcing opportunities for companies competing inthis fast growing pharmaceutical outsourcing sector.A major factor driving the upward trend in the number of manufacturing projects beingoutsourced is that specialized production, i.e., sterile manufacturing, biopharmaceuticalmanufacturing and specialized processes, such as chiral chemistry and improvementsin catalyst activity, is often not included in the core competency of pharmaceutical andbiotechnology drug makers.Detail on Biopharmaceutical MarketsThe growing number of biotechnology-driven protein and peptide drugs, antibiotics,chemotherapeutic agents and other compounds administered as sterile injectables, withits concomitant technological requirements, has brought about an increase in thedemand for contract sterile manufacturing services. The sheer numbers of biologics inthe pipeline are driving drug makers to outsource specialized production rather thanbuild new plants.As part of its unique coverage of the outsourcing markets for manufacturing and sales,this report includes • CMO and CSO Global Market Size and Forecasts • Total Pharmaceutical Market Statistics by Region • Overview of CMO/CSO Market and Key Drivers • Key Issues and Trends • Biopharmaceutical Manufacturing • Assessment of Key Companies in the Market
  • 2. Traditionally, large pharmaceutical companies considered sales and marketing a corecompetency, and built in-house sales teams and the infrastructure to supportpromotional activities, launches and general portfolio expansion. However, in recentyears, consistent with the "lean-and-mean" business model evolving in thepharmaceutical industry, sales and marketing is shifting—albeit slowly—from a corecompetency to a prime candidate for outsourcing.Primary and Secondary ResearchThe information for this report was gathered using both primary and secondary researchincluding comprehensive research of secondary sources such as company literature,databases, investment reports, and medical and business journals. Telephoneinterviews and email correspondence were the primary method of gathering information.For the purpose of this study Kalorama Information conducted interviews with keyindustry officials, consultants, health care providers, and government personnel. Thesesources were the primary basis in gathering information specifically relating to revenueand market share data presented in this report. Specific interviews with pharmaceuticalcompany representatives included marketing directors, division managers, and productrepresentatives.Table of ContentsCHAPTER ONE: EXECUTIVE SUMMARY • Scope and Methodology • Challenges Facing the Pharmaceutical Industry • Meeting Investor Expectations • Erosion of Blockbuster Sales • Increased Generic Competition • Pricing Pressures • Pipeline Output Slowing Compared to ROI • Strategies to address challenges • Mergers and Acquisitions • Strategic Outsourcing • Outsourcing Manufacturing Operations • Outsourcing Sales and Marketing • Contract Manufacturing • Biopharmaceutical Manufacturing • Characteristics of Biopharmaceutical Manufacturing • Biopharmaceutical Manufacturing Demand Increasing • CMOs Expanding Operations to Manufacture Biologics • Contract Primary Manufacturing • Ramping up the Technology Toolbox to Gain a Competitive Edge • Contract Primary Manufacturing Trends
  • 3. • Secondary Contract Manufacturing • Demand for Sterile Manufacturing Capabilities on Increase • Contract Manufacturing Market Analysis • Contract Sales and Marketing • Contract Sales Organizations • Drivers of Outsourcing Sales & Marketing • CSOs Offer Broad-based Portfolio of Services • Maximize Efficiency of Sales and Marketing • Speed and Flexibility • Provide Sales Team to Companies with No In-House Sales/Marketing Experience • Contract Sales Market AnalysisCHAPTER TWO: MEETING THE CHALLENGES OF A CHANGING MARKETPLACE • Challenges Facing the Pharmaceutical Industry • Meeting Investor Expectations • Erosion of Blockbuster Sales • Increased Generic Competition • Pricing Pressures • Pipeline Output Slowing Compared to ROI • Strategies to address challenges • Mergers and Acquisitions • Strategic Outsourcing • Restructuring manufacturing operations • Reducing the Size of In-house Sales ForceCHAPTER THREE: CONTRACT MANUFACTURING • Industry Overview • Major Drivers of Contract Manufacturing • Key Competing Factors for Contract Manufacturing • Biopharmaceutical Manufacturing • Characteristics of Biopharmaceutical Manufacturing • Types of Contractors Involved in Biomanufacturing • Demand for Biopharmaceutical Manufacturing Increasing • Impact of Financial Crisis on Biopharmaceutical Sector • Production Capacity for Biopharmaceutical Manufacturing • Alternative Methods of Producing Biopharmaceuticals • CMOs Expanding Operations to Manufacture Biologics • Biomanufacturing in Asia • Contract primary manufacturing • Contract Primary Manufacturing Trends • Ramping up the Technology Toolbox to Gain a Competitive Edge • Chiral Technologies • Oligonucleotides and Peptides Capabilities
  • 4. • Hi-Potency Capabilities • Specialized Niches Offer Opportunity • Dangerous Reagents • Controlled Substances • Exploring Other Growth Opportunities • Contract Secondary Manufacturing • Demand for Sterile Manufacturing Capabilities on Increase • Market Analysis • Contract Manufacturing Market and Forecast • Mergers and Acquistions • Contract Biomanufacturing • Contract Biomanufacturing Market and Forecast • Contract Secondary Manufacturing • Biologics Drive Special Manufacturing Processes • Ramping up Sterile Manufacturing • Contract Secondary Manufacturing Market and Forecast • Contract Primary Manufacturing • Expanding into High Potency API Manufacturing • Contract Primary Manufacturing Market and ForecastCHAPTER FOUR: CONTRACT SALES AND MARKETING • Contract Sales Organizations • A Brief History of the CSO Industry • Governmental and Organizational Regulations Impacting CSOs o Prescription Drug Marketing Act (PDMA) o Title 21 Code of Federal Regulations, Part 11 (21 CFR Part 11) o Office of Inspector General Guidelines (OIG) for Industry o Health Insurance Portability and Accountability Act (HIPAA) o Additional Guidelines Established by Industry and Professional Organizations • Drivers of Outsourcing Sales & Marketing • Broad-based Portfolio of Marketing and Sales Services • Maximize Efficiency of Sales and Marketing • Speed and Flexibility • Provide Sales Team to Companies with No In-House Sales/Marketing Expertise • Selecting A CSO • Wide range of Services Offered by csoS • Integrated Sales Force Recruitment, Training and Management o Implementation Services o Technical Support Service o Data Center Services o Call Center Services o Hardware Support Services o Training and Educational Services • Product, Sample and Literature Fulfillment
  • 5. • Telemarketing • Brand/Portfolio Analytics and Forecasting • Strategic and Tactical Planning • Strategic Consulting • CSO -client contracts • Improving Sales Force Effectiveness Through Technology-Based Solutions • E-detailing o Virtual Live e-Detailing o Scripted e-Detailing o Physician Portal e-Detail • Customer Relationship Management • Mobile Technology • Outsourcing CRM-related Services • Information Management • Business Intelligence & Analytics • Commercial Operations • Market Analysis: Contract Sales and Marketing • Industry Characteristics • Market Environment • CSO Market and Forecast • CSO Market Share • Strategies for Gaining Market Share • Strategic Acquisitions to Gain Market ShareCHAPTER FIVE: CONTRACT MANUFACTURING ORGANIZATIONS • AVECIA Group plc o History and Lines of Business o Contract Manufacturing Services o Financial Information • BACHEM HOLDING AG o History and Lines of Business o Contract Manufacturing Services o Financial Information • BAXTER PHARMA SOLUTIONS o History and Lines of Business o Contract Manufacturing Services o Proprietary Formulation Technologies o Financial Information • BAYER PHARMACEUTICAL MANUFACTURING SERVICES o History and Lines of Business o Contract Manufacturing o Financial Information • BEN VENUE LABORATORIES o History and Lines of Business o Contract Manufacturing Services
  • 6. o Development Services o Clinical Material Manufacturing and Commercial Production o International Services• BOEHRINGER-INGELHEIM o History and Lines of Business o Contract Manufacturing o Primary Manufacturing o Biopharmaceutical Manufacturing o Mammalian Cell Culture o Microorganisms and Yeast Fermentation o Financial Information• CAMBREX CORPORATION o History and Lines of Business o Contract Manufacturing Services o Financial Information• CATALENT PHARMA SOLUTIONS o History and Lines of Business o Financial Information• CELLTRION, INC o History and Lines of Business o Contract Manufacturing Services o Cell Culture & Harvesting o Purification and Downstream Processing o Quality Assurance/Quality Control and Product Characterization o Formulation and Finish• CHESAPEAKE BIOLOGICAL LABORATORIES o History and Lines of Business o Contract Manufacturing Services Commercial: Experimental:• COVIDIEN PHARMACEUTICAL OUTSOURCING o History and Lines of Business o Contract Manufacturing Services o Financial Information• DIOSYNTH BIOTECHNOLOGY o History and Lines of Business o Contract Manufacturing Services• DSM PHARMACEUTICALS, INC. o History and Lines of Business o Contract Manufacturing Services• DOWPHARMA o History and Lines of Business o Contract Manufacturing Services o Financial Information• GENZYME PHARMACEUTICALS o History and Lines of Business o Contract Manufacturing Services o Financial Information
  • 7. • GIRINDUS AG o History and Lines of Business o Contract Manufacturing Services • HOLLISTER-STIER LABORATORIES CONTRACT MANUFACTURING o History and Lines of Business o Contract Manufacturing Services o History and Lines of Business o Contract Manufacturing Services o Financial Information • HYALURON, INC. o History and Lines of Business Contract Manufacturing • LAUREATE PHARMA o History and Lines of Business o Contract Manufacturing Services • LONZA CUSTOM MANUFACTURING o History and Lines of Business o Contract Manufacturing Services: Lonza Biologics o Fermentation o High Yielding Cell Line o Purification o Choice of Chromatography Steps o Process Scale-Up o Process Validation o Process Transfer o Analytical Services o Development of Contaminant Assays o Product Characterization o Pre-formulation and Stability Studies o Analytical Support o Molecular Biology o Financial Information • PATHEON, INC. o History and Lines of Business o Contract Manufacturing Services o Financial Information • SIEGFRIED, INC. o History and Lines of Business o Contract Manufacturing Services o Accounting InformationCHAPTER SIX: CONTRACT SALES AND MARKETING COMPANY PROFILES • ASHFIELD IN2FOCUS LIMITED o History and Lines of Business o Contract Sales Services o Dedicated Sales Teams
  • 8. o Hotspot Teams o Vacancy Management o Co-Funded Teams • CEGEDIM DENDRITE o History and Lines of Business o Contract Sales & Marketing Services o Sales Solutions o Marketing Solutions Regulatory Compliance Clinical Solutions o Financial Information • INNOVEX, Inc. o History and Lines of Business o Contract Sales and Marketing Services • INVENTIV HEALTH, INC. o History and Lines of Business o Contract Sales, Marketing and Communication Services o inVentiv Clinical o inVentiv Communications o inVentiv Commercial o inVentiv Patient Outcomes o Financial Information • ONCALL, LLC o History and Lines of Business o Contract Sales Services o Dedicated Field Sales Teams o Shared Field Sales Teams - OnCall-Share o Medical Scientific Liaison Services o Deployment options o Telesales o Marketing Services • PROFESSIONAL DETAILING, INC. o History and Lines of Business o Contract Sales and Marketing Services o Contract Sales o Marketing Research o Medical Education and Communications o Financial Information • VANGUARD PHARMA o History and Lines of Business o Contract Sales and Marketing o National Contract Sales Forces o Recruitment and Placement Services o New Product Launches Mature Product SupportAPPENDIX: COMPANY NAMES AND ADDRESSES TABLE OF EXHIBITS
  • 9. CHAPTER ONE: EXECUTIVE SUMMARY • Exhibit 1-1: Global Pharmaceutical Sales by Region, By Percent, 2007CHAPTER TWO: MEETING THE CHALLENGES OF A CHANGING MARKETPLACE • Exhibit 2-1: Global Pharmaceutical Sales by Region, 2007 • Exhibit 2-2: Global Research and Development Spending 2002-2012 • Exhibit 2-3: Drug Patent Expirations, 2007-2009 • Exhibit 2-4: NMEs and New BLAs Filed between 1996-2007CHAPTER THREE: CONTRACT MANUFACTURING • Exhibit 3-1: Selected Contract Manufacturing Subsidiaries of Pharmaceutical and Biotechnology Companies Competing in the Outsourcing Market • Exhibit 3-2: Percent Of Respondents Projecting Production Increases Greater Than 100%by 2012 • Exhibit 3-3: Selected Top-selling Biopharmaceuticals, 2007 • Exhibit 3-4: Planned Future Capacity Expansions: 5-year Estimates, 2008 through 2012; Biotherapeutic Developers vs. CMOs • Exhibit 3-5: Selected Animal-derived Biopharmaceuticals in Research and Development • Exhibit 3-6: Selected Plant-made Biopharmaceuticals in Research and Development • Exhibit 3-7: Selected CMO’S Expanding to Meet Biopharmaceutical Demand • Exhibit 3-8: Selected Asia Biomanufacturing CMOs • Exhibit 3-9: Global Prescription Pharmaceutical Contract Manufacturing Market Primary, Secondary and Biomanufacturing 2003-2013 • Exhibit 3-10: Selected Contract Manufacturing Mergers and Acquistions, 2007 & 2008 • Exhibit 3-11: Planned Future Capacity Expansions: 5-year Estimates, Biotherapeutic Developers vs. CMOs, 2008-2012 • Exhibit 3-12: Planned Future Capacity Expansions: 5-year Estimates, Biotherapeutic Developers vs. CMOS, 2008-2012 • Exhibit 3-13: Geographic Distribution of Contract Biopharmanufactures • Exhibit 3-14: Global Contract Biomanufacturing Market, 2003-2013 • Exhibit 3-15: Global Secondary Contract Manufacturing Market, 2003-2013 • Exhibit 3-16: Global Contract Primary Manufacturing Market, 2003-2013CHAPTER FOUR: CONTRACT SALES AND MARKETING • Exhibit 4-1: Key Contract Sales Organization Solutions to Maximize ROI • Exhibit 4-2: Global CSO Market • Exhibit 4-3: CSO Market Share of Public Companies, 2007
  • 10. Available immediately for Online Download athttp://www.marketresearch.com/product/display.asp?productid=1646605  US: 800.298.5699UK +44.207.256.3920Intl: +1.240.747.3093Fax: 240.747.3004