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 Force
- 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
- Secondary Sterile Contract Manufacturing
- Demand for Sterile Manufacturing Capabilities on Increase
- Market Analysis: Contract Manufacturing
- Contract Sales and Marketing
- Contract Sales Organizations
- Governmental and Organizational Regulations
- Drivers of Outsourcing Sales & Marketing
- CSOs’ Broad-Based Portfolio of Marketing and Sales Services
- Maximizing Rate of Investment
- Services Offered by CSOs
- Market Analysis: Contract Sales and Marketing
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 Manufacturers
- Biopharmaceutical Manufacturing
- Characteristics of Biopharmaceutical Manufacturing
- Types of Contractors Involved in Biomanufacturing
- Biopharmaceutical Manufacturing Demand
- Leading Protein Products and Market Value
- Production Capacity for Biopharmaceutical Manufacturing
- Alternative Methods of Producing Biopharmaceuticals
- First Transgenically Produced Pharmaceutical Recommended for Approval
- CMOs Expanding Operations to Manufacture Biologics
- Asian CMOs Entering Biomanufacturing
- Contract Primary and Secondary Manufacturing
- Contract Primary Manufacturing
- Ramping up the Technology Toolbox to Gain a Competitive Edge
- Chiral Technologies
- Oligonucleotides and Peptides 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
- Contract Biomanufacturing
- Market Size, Growth, and Forecast
- Contract Biomanufacturing Market Share
- Contract Sterile Secondary Manufacturing
- Biologics Drive Special Manufacturing Processes
- Ramping up Sterile Manufacturing
- Market Size, Growth, and Forecast
- Contract Sterile Secondary Manufacturing Market Share
- Contract Primary Manufacturing
- Technological Innovations Fend off Sluggish Market
- Globalization Trend
- Market Size, Growth, and Forecast
- Contract Primary Manufacturing Market Share
Chapter Four: Contract Sales and Marketing
- Contract Sales Organizations
- Governmental and Organizational Regulations
- 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
- Maximizing Efficiency in Sales and Marketing
- Speed and Flexibility
- Provide Sales Team to Companies with No In-House Sales/Marketing Expertise
- Selecting a CSO
- Range of Services
- 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
- Expanding into China
- Strategic Acquisitions
Chapter Five: Contract Manufacturing Company Profiles
- Avecia Biotechnology, Inc.
- History and Lines of Business
- Contract Manufacturing
- Manufacturing DNA Medicines
- Manufacturing Biologics
- 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
- Bioreliance Corporation
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- Boehringer Ingelheim
- History and Lines of Business
- Contract Manufacturing
- Primary Manufacturing
- Biopharmaceutical Manufacturing
- Financial Information
- Cambrex Corporation
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- Cardinal Health
- History and Lines of Business
- Contract Manufacturing and Packaging Services
- Financial Information
- Chesapeake Biological Laboratories
- History and Lines of Business
- Contract Manufacturing Services
- DPT Laboratories, Ltd.
- History and Lines of Business
- Contract Manufacturing Services
- DSM Pharmaceuticals, Inc.
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- Degussa AG
- History and Lines of Business
- Contract Manufacturing
- Financial Information
- Dowpharma
- History and Lines of Business
- Contract Manufacturing Services
- Chiral Products
- Nucleic Acid Medicines
- Biopharmaceuticals
- Plant-Based Production Solution
- Financial Information
- Draxis Pharma, Inc.
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- Genzyme Pharmaceuticals
- History and Lines of Business
- Contract Manufacturing Services
- Equipment
- Capacity
- Financial Information
- Girindus AG
- History and Lines of Business
- Contract Manufacturing Services
- HollisterStier Contract Manufacturing
- History and Lines of Business
- Contract Manufacturing Services
- Hospira, Inc.
- 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 Group Ltd
- 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
- Mallinckrodt Pharmaceuticals Outsourcing
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- Patheon, Inc.
- History and Lines of Business
- Contract Manufacturing Services
- Financial Information
- Siegfried, Inc.
- History and Lines of Business
- Contract Manufacturing
- Financial Information
- Wellspring Pharmaceutical
- History and Lines of Business
- Contract Manufacturing
Chapter Six: Contract Sales and Marketing Company Profiles
- Cardinal MarketForce
- History and Lines of Business
- Contract Sales and Marketing
- Recruitment
- Syndicated sales
- Customer-segment sales
- Sales force planning
- Training and development
- Information management and reporting
- Strategic Planning
- Content development
- Execution and implementation
- Data collection and information management systems
- Medical Education Systems
- Financial Information
- Dendrite International, Inc.
- History and Lines of Business
- Contract Marketing and Sales Support Services
- Customer Relations Management Solutions:
- Information Management:
- Commercial Operations Management:
- Consumer Goods Software:
- Implementation Services:
- Technical and Hardware Support Services:
- Data Center Services:
- Call Center Services:
- Asset Management Services:
- Sales Force Support Services:
- Financial Information
- Innovex, Inc.
- History and Lines of Business
- Contract Sales and Marketing Services
- Financial Information
- Medical Affairs, Marketing & Communications
- History and Lines of Business
- Contract Marketing and Market Research
- Financial Information
- inVentiv Health, Inc.
- History and Lines of Business
- Contract Sales and Marketing Services
- inVentiv Clinical
- inVentiv Communications
- inVentiv Commercial
- 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
- PDI, 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 Directory
List of Exhibits
Chapter One: Executive Summary
- Figure 1-1: Global Pharmaceutical Sales by Region 2005
- Figure 1-2: Number of Biological Product Clinical Trials in the United States by Development Phase (Phase I through Filing) 2002-2006
- Table 1-1: Selected CMOs Upgrading/Expanding into Sterile Manufacturing,
2002-2006
- Table 1-2: Global Contract Manufacturing Market: Primary, Sterile Secondary,
and Biomanufacturing 2001-2011
- Table 1-3: Key Contract Sales Organization Solutions to Maximize ROI
- Table 1-4: Global CSO Market 2001-2011
Chapter Two: Meeting the Challenges of a Changing Marketplace
- Figure 2-1: Global Pharmaceutical Sales by Region 2005
- Table 2-1: Global Research and Development Spending 2000-2010
- Table 2-2: Selected Patent Expirations (Brand, Indication, Manufacturer,
2005 Sales) 2006
- Figure 2-2: Number of NMEs Approved 1994-2004
Chapter Three: Contract Manufacturing
- Table 3-1: Select Contract Manufacturing Subsidiaries of Pharmaceutical and Biotechnology Companies Competing in the Outsourcing Market
- Figure 3-1: Respondents' Areas of Biopharmaceutical Manufacturing Operations: “In which of the following areas does your organization currently
have production operations?" [Mammilian Cell Culture, Microbial Fermentation, Yeast, Insect Cells, Plant Cells, Other]
- Figure 3-2: Biotechnology Industry Market Capitalization 1994-2005
- Figure 3-3: Number of Biological Product Clinical Trials in the United States by Development Phase (Phase I through Filing) 2002-2006
- Figure 3-4: Number of NCE Approvals in the United States 1996-2005
- Table 3-2: Selected Protein Therapeutic Sales by Product, 2005
- Table 3-3: Selected Plant-made Biopharmaceuticals in Research and
Development
- Table 3-4: Selected Animal-Derived Biopharmaceuticals in Research and Development
- Table 3-5: Selected CMOs Expanding Biomanufacturing Capacity, 2000-2006
- Table 3-6: Selected Established Asian CMOs
- Table 3-7: Selected CMOs Upgrading/Expanding into Sterile Manufacturing,
2002-2006
- Table 3-8: Global Contract Manufacturing Market: Primary, Sterile Secondary
and Biomanufacturing 2001-2011 (revenues in $billions)
- Table 3-9: Current Capacity at Key CMOs
- Figure 3-5: Geographic Distribution of Contract Biomanufacturers
- Table 3-10: Global Contract Biomanufacturing Market
- Table 3-11: Contract Biomanufacturing Revenues and Market Share by
Leading Supplier 2005
- Table 3-12: Global Contract Sterile Secondary Manufacturing Market
2001-2011
- Table 3-13: Sterile Secondary Manufacturing Revenues and Market
Share by Leading Supplier 2005
- Table 3-14: Specific Competitors’ Strategies to Improve Production,
Improve Economics, or Expand Capacity
- Table 3-15: Global Contract Primary Manufacturing Market
- Table 3-16: Contract Primary Manufacturers Market Share
Chapter Four: Contract Sales and Marketing
- Table 4-1: Key Contract Sales Organization Solutions to Maximize ROI
- Table 4-2: Global CSO Market, Revenues and Growth Rate, 2001-2011
- Table 4-3: CSO Revenues and Market Share by Leading Competitor 2005
- Table 4-4: Summary of inVentiv Health, Inc.’s Acquisitions
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