The report contains vital market statistics on three main segments of pharmaceutical contract manufacturing:

• Biopharmaceutical manufacturing, including monoclonal antibodies (MAbs), complex proteins, peptides, nucleotides, DNA vaccines, and gene therapy.
• Primary pharmaceutical manufacturing, including non-sterile and sterile active pharmaceutical ingredients (APIs), custom chemicals, certain specialized manufacturing services such as chiral-chemistry, olignonucleotides and peptides, and high-potency APIs.
• Secondary sterile manufacturing, including production functions that are necessary to take a material in its bulk manufactured form and create a finished dosage form. [In keeping with the thesis of this report, opportunities in the manufacturing marketplace for contract manufacturing organizations (CMOs), we concentrate on manufacturing opportunities driven by biologics. Therefore, this section is focused on sterile dosage forms, such as lyophilization or sterile crystallization and the filling of sterile liquid vials and syringes.]

The main market data for the manufacturing sector include:

• Contract manufacturing market size 2001 to 2005 and forecasts 2006 to 2011 by major segment (biomanufacturing, primary manufacturing, sterile secondary manufacturing)
• Market share (2005) of leading suppliers by major segment (biomanufacturing, primary manufacturing, sterile secondary manufacturing)
• Current biomanufacturing capacity data of major players and facilities
• Percentage of companies currently using various biomanufacturing techniques (mammalian cell culture, microbial fermentation, yeast, insect cells, plant cells, etc.)
• Details of manufacturing capacity expansions by major competitors
• Geographic distribution of contract biomanufacturers

Market data for the contract sales and marketing sector include:

• Global market size of CSOs 2001 to 2005 and forecasts 2006-2011
• Market share (2005) of leading CSOs

The report also includes copious amounts of background information including

• Global pharmaceutical sales by region
• Global R&D spending estimates 2000-2010
• Key patent expirations in 2006
• NME approval trends 1994-2004
• NCE approvals in the United States 1996-2005
• Biologicals in clinical trials 2002-2006

In addition, the report contains extensive discussions of the challenges faced by pharmaceutical manufacturers and the way outsourcing can address those challenges. Current thinking in evaluating outsourcing partners and the issues of capacity vs demand, alternative manufacturing methods, and competitive service offerings are also included. The report finishes with extensive profiles of the history, offerings, and financial positions of competitors in both the contract manufacturing and contract sales and marketing spaces.

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical company representatives included marketing directors, division managers, and product representatives.


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 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