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Pharmaceutical Outsourcing Opportunities Post-Launch: Contract Manufacturing and Contract Sales and Marketing, 2nd Edition


Published Date: September 2006
Published By: Kalorama Information
Page Count: 246
Order Code: R566-333
 
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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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