TABLE OF CONTENTS
CHAPTER 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
- 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 Analysis
CHAPTER 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 Force
CHAPTER 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
- 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 Forecast
CHAPTER FOUR: CONTRACT SALES AND MARKETING
- Contract Sales Organizations
- A Brief History of the CSO Industry
- Governmental and Organizational Regulations Impacting CSOs
- Prescription Drug Marketing Act (PDMA)
- Title 21 Code of Federal Regulations, Part 11 (21 CFR Part 11)
- Office of Inspector General Guidelines (OIG) for Industry
- Health Insurance Portability and Accountability Act (HIPAA)
- 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
- Implementation Services
- Technical Support Service
- Data Center Services
- Call Center Services
- Hardware Support Services
- Training and Educational Services
- Product, Sample and Literature Fulfillment
- 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
- Virtual Live e-Detailing
- Scripted e-Detailing
- 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 Share
CHAPTER FIVE: CONTRACT MANUFACTURING ORGANIZATIONS
- AVECIA Group plc
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- BACHEM HOLDING AG
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- BAXTER PHARMA SOLUTIONS
- History and Lines of Business
- Contract Manufacturing Services
- Proprietary Formulation Technologies
- Financial Information
- BAYER PHARMACEUTICAL MANUFACTURING SERVICES
- History and Lines of Business
- Contract Manufacturing
- Financial Information
- BEN VENUE LABORATORIES
- History and Lines of Business
- Contract Manufacturing Services
- Development Services
- Clinical Material Manufacturing and Commercial Production
- International Services
- BOEHRINGER-INGELHEIM
- History and Lines of Business
- Contract Manufacturing
- Primary Manufacturing
- Biopharmaceutical Manufacturing
- Mammalian Cell Culture
- Microorganisms and Yeast Fermentation
- Financial Information
- CAMBREX CORPORATION
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- CATALENT PHARMA SOLUTIONS
- History and Lines of Business
- Financial Information
- CELLTRION, INC
- History and Lines of Business
- Contract Manufacturing Services
- Cell Culture & Harvesting
- Purification and Downstream Processing
- Quality Assurance/Quality Control and Product Characterization
- Formulation and Finish
- CHESAPEAKE BIOLOGICAL LABORATORIES
- History and Lines of Business
- Contract Manufacturing Services
Commercial:
Experimental:
- COVIDIEN PHARMACEUTICAL OUTSOURCING
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- DIOSYNTH BIOTECHNOLOGY
- History and Lines of Business
- Contract Manufacturing Services
- DSM PHARMACEUTICALS, INC.
- History and Lines of Business
- Contract Manufacturing Services
- DOWPHARMA
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- GENZYME PHARMACEUTICALS
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- GIRINDUS AG
- History and Lines of Business
- Contract Manufacturing Services
- HOLLISTER-STIER LABORATORIES CONTRACT MANUFACTURING
- History and Lines of Business
- Contract Manufacturing Services
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- HYALURON, INC.
- History and Lines of Business
Contract Manufacturing
- LAUREATE PHARMA
- History and Lines of Business
- Contract Manufacturing Services
- LONZA CUSTOM MANUFACTURING
- History and Lines of Business
- Contract Manufacturing Services: Lonza Biologics
- Fermentation
- High Yielding Cell Line
- Purification
- Choice of Chromatography Steps
- Process Scale-Up
- Process Validation
- Process Transfer
- Analytical Services
- Development of Contaminant Assays
- Product Characterization
- Pre-formulation and Stability Studies
- Analytical Support
- Molecular Biology
- Financial Information
- PATHEON, INC.
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- SIEGFRIED, INC.
- History and Lines of Business
- Contract Manufacturing Services
- Accounting Information
CHAPTER SIX: CONTRACT SALES AND MARKETING
COMPANY PROFILES
- ASHFIELD IN2FOCUS LIMITED
- History and Lines of Business
- Contract Sales Services
- Dedicated Sales Teams
- Hotspot Teams
- Vacancy Management
- Co-Funded Teams
- CEGEDIM DENDRITE
- History and Lines of Business
- Contract Sales & Marketing Services
- Sales Solutions
- Marketing Solutions
Regulatory Compliance
Clinical Solutions
- Financial Information
- INNOVEX, Inc.
- History and Lines of Business
- Contract Sales and Marketing Services
- INVENTIV HEALTH, INC.
- History and Lines of Business
- Contract Sales, Marketing and Communication Services
- inVentiv Clinical
- inVentiv Communications
- inVentiv Commercial
- inVentiv Patient Outcomes
- Financial Information
- ONCALL, LLC
- History and Lines of Business
- Contract Sales Services
- Dedicated Field Sales Teams
- Shared Field Sales Teams - OnCall-Share
- Medical Scientific Liaison Services
- Deployment options
- Telesales
- Marketing Services
- PROFESSIONAL DETAILING, INC.
- History and Lines of Business
- Contract Sales and Marketing Services
- Contract Sales
- Marketing Research
- Medical Education and Communications
- Financial Information
- VANGUARD PHARMA
- History and Lines of Business
- Contract Sales and Marketing
- National Contract Sales Forces
- Recruitment and Placement Services
- New Product Launches Mature Product Support
APPENDIX: COMPANY NAMES AND ADDRESSES
TABLE OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
- Exhibit 1-1: Global Pharmaceutical Sales by Region, By Percent, 2007
CHAPTER 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 1996-2007
CHAPTER 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, 2003-2013
CHAPTER 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