This report is focused on two expanding pharmaceutical outsourcing markets, contract manufacturing of prescription drugs and contract sales and marketing. Both markets represent excellent post launch outsourcing opportunities for companies competing in this fast growing pharmaceutical outsourcing sector.A major factor driving the upward trend in the number of manufacturing projects being outsourced is that specialized production, i.e., sterile manufacturing, biopharmaceutical manufacturing and specialized processes, such as chiral chemistry and improvements in catalyst activity, is often not included in the core competency of pharmaceutical and biotechnology 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, with its concomitant technological requirements, has brought about an increase in the demand for contract sterile manufacturing services. The sheer numbers of biologics in the pipeline are driving drug makers to outsource specialized production rather than build new plants. As part of its unique coverage of the outsourcing markets for manufacturing and sales, this report includesCMO and CSO Market Size and Forecasts Regional Market Breakout (US, Europe, Japan, Latin America, Rest of World) Overview of CMO/CSO Market and Key Drivers Key Issues and Trends Biopharmaceutical Manufacturing Assessment of Key Companies in the Market Traditionally, large pharmaceutical companies considered sales and marketing a core competency, and built in-house sales teams and the infrastructure to support promotional activities, launches and general portfolio expansion. However, in recent years, consistent with the ``lean-and-mean`` business model evolving in the pharmaceutical industry, sales and marketing is shifting'albeit slowly'from a core competency to a prime candidate for outsourcing. Primary and Secondary ResearchThe 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.
Pharmaceutical Outsourcing Opportunities Post-Launch: Contract Manufacturing and Contract Sales and Marketing, 3rd Edition
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Pharmaceutical Outsourcing Opportunities Post-Launch: Contract
Manufacturing and Contract Sales and Marketing, 3rd Edition
Published on January 2009
Report Summary
This report is focused on two expanding pharmaceutical outsourcing markets, contract manufacturing of prescription drugs and
contract sales and marketing. Both markets represent excellent post launch outsourcing opportunities for companies competing in this
fast growing pharmaceutical outsourcing sector.
A major factor driving the upward trend in the number of manufacturing projects being outsourced is that specialized production, i.e.,
sterile manufacturing, biopharmaceutical manufacturing and specialized processes, such as chiral chemistry and improvements in
catalyst activity, is often not included in the core competency of pharmaceutical and biotechnology drug makers.
Detail on Biopharmaceutical Markets
The growing number of biotechnology-driven protein and peptide drugs, antibiotics, chemotherapeutic agents and other compounds
administered as sterile injectables, with its concomitant technological requirements, has brought about an increase in the demand for
contract sterile manufacturing services. The sheer numbers of biologics in the pipeline are driving drug makers to outsource
specialized production rather than build new plants.
As part of its unique coverage of the outsourcing markets for manufacturing and sales, this report includes
CMO and CSO Market Size and Forecasts
Regional Market Breakout (US, Europe, Japan, Latin America, Rest of World)
Overview of CMO/CSO Market and Key Drivers
Key Issues and Trends
Biopharmaceutical Manufacturing
Assessment of Key Companies in the Market Traditionally, large pharmaceutical companies considered sales and marketing a
core competency, and built in-house sales teams and the infrastructure to support promotional activities, launches and general
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portfolio expansion. However, in recent years, consistent with the ``lean-and-mean`` business model evolving in the pharmaceutical
industry, sales and marketing is shifting'albeit slowly'from a core competency to a prime candidate for outsourcing.
Primary and Secondary Research
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 Content
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
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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 AnalysisCHAPTER TWO: MEETING THE CHALLENGES OF A CHANGING MARKETPLACE
Challenges Facing the Pharmaceutical Industry
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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
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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 ForecastCHAPTER FOUR: CONTRACT SALES AND MARKETING
Contract Sales Organizations
A Brief History of the CSO Industry
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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
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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
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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
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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
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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
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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
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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
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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
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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
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National Contract Sales Forces
Recruitment and Placement Services
New Product Launches Mature Product SupportAPPENDIX: COMPANY NAMES AND ADDRESSES
TABLE OF EXHIBITS
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
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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
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