Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts)

The considerable revenue growth in the vaccine market over the past ten years suggests the amount of vaccine production and the techniques of vaccine production will need to adapt to match a revived industry.

This report, Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts) examines the market for vaccine manufacturing and production technologies. The focus is on current production methods and new methods in development. While there may be some overlap for technologies in development, the emphasis of the report is process rather than product development. (Detailed product market segment forecast by disease for current vaccines are covered in Kalorama's report "Vaccines 2011." )

As part of its analysis of vaccine manufacturing, the report includes:

• Doses Produced: 2010-2015
• Estimates of Vaccine Production Spending
• Finished Vaccine Markets and Top Selling Categories
• Market Potential for Contract Vaccine Manufacturing
• Top Vaccine Companies Market Share
• Production Challenges for Categories of Vaccines
• Discussion of Cell, Insect and Plant Production
• Recent Influenza Production Trends
• Vaccine Approval Challenges
• Profiles of Major Vaccine Marketers
• Profiles of Major Contract Manufacturers
• Production Methods for Common Vaccines (Oral polio, Tetanus, Measles, Influenza, Diphtheria, Pertussis, BCG, Hep. B, Hib, MMR)

• GlaxoSmithKline Biopharmaceuticals
• Sanofi-Aventis
• Merck KgaA
• Pfizer-Pfizer CenterSource
• Novartis AG
• Baxter International
• Teva
• Crucell (Johnson &Johnson)
• CSL Biotherapies
• Intercell
• MedImmune/Astra Zeneca
• MassBioLogics
• Lonza
• Boehringer Ingelheim
• Fujifilm Diosynth Biotechnology
• Catalent Pharma Solutions
• Patheon
• DSM Pharmaceutical
• Cambrex (Lonza)
• IDT Biologika
• Charles River Biopharmaceutical Services (BPS)

Information for this report was gathered from a wide variety of published sources including company reports and filings, government documents, legal filings, trade journals, newspapers and business press, analysts' reports and other sources. Interviews with company representatives and other experts were conducted to capture the perspectives from industry participants' point of view and assess trends, and form the basis of the forecasting and competitive analysis.

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Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY
Scope and Methodology
Production Technology
Legacy Technologies
Innovative Technologies
Manufacturing
Originator and Big Pharma
Contract Manufacturing Organizations
Profitability of The Vaccine Industry
Major Vaccine Manufacturers
Conclusions
Scope and Methodology

CHAPTER TWO: THE VACCINE INDUSTRY: TRENDS, MAJOR PLAYERS AND MARKETS
Overview
Types of Vaccines
Attenuated (Weakened) Live Viruses
Killed (Inactivated) Viruses
Toxoid Vaccines
Genetically Engineered/Modified Vaccines
Subunit Vaccines
Conjugate Vaccines
DNA Vaccination
Major Vaccine Manufacturers
Vaccine Approval Process
Government and NGO Investment
Manufacturing and Infrastructure Building
Centers for Innovation in Advanced Development and Manufacturing
BARDA Influenza & Emerging Disease Program
WHO
The cycle of Vaccine Procurement
Public/Private Partnerships
Bush Administration/Homeland Security
Project GreenVax
Vaccine Research Center Production Programs
Production, Prices and Other Profit Considerations
Negotiated Prices
Production Expenses
Sales and Marketing Expenses

CHAPTER THREE: VACCINE PRODUCTION: SPENDING, INNOVATIONS, AND CHALLENGES
Vaccine Production Estimates
Main Vaccine Types
Inactivated Vaccines or Live attenuated vaccines
Acellular / Component Vaccines
Live, Attenuated Vaccines
Toxoid Vaccines
Analogue Vaccines
Vaccines through Genetic Engineering
Reformulation
Thiomersal
Influenza Vaccine Production
Influenza Vaccine Production
Egg Production
Unique Aspects of Manufacturing Influenza Vaccine
Rate-Limiting Steps in the Seasonal Vaccine Process
Cellular Production
WHO Annual Flu Vaccine Guidelines
Pandemics
History and Shortages
HIN Pandemic of /
The Vaccine Industry's Role
A Decade of Pandemic Preparations
WHO Pandemic Influenza Vaccine Manufacturing Process and Timeline
Activities at regulatory agencies - regulatory approval
Mammalian Cell Culture
Background
Cell - Mammalian
Cell Culture Influenza Vaccines
Advantages
Ideal cell lines for production
Specific Cell Lines
Madin Darby Canine Kidney (MDCK)
Vero Cells
PER.C cells
DNA Vaccines
Concerns
Novartis and Medicago Open Non-Traditional Vaccine Operations
Vaccine Distribution
Estimates of Vaccine Production Spending
Contract Vaccine Manufacturing
Contract Manufacturing Market

CHAPTER FOUR: COMPANY PROFILES
GlaxoSmithKline Biopharmaceuticals
Sanofi-Aventis
Merck KgaA
Pfizer-Pfizer CenterSource
Novartis AG
Baxter International
Teva
Crucell (Johnson &Johnson)
CSL Biotherapies
Intercell
MedImmune/Astra Zeneca
MassBioLogics

CHAPTER FIVE: VACCINE CONTRACT MANUFACTURERS
Lonza
Boehringer Ingelheim
Fujifilm Diosynth Biotechnology
Fujifilm Diosynth Biotechnology
Catalent Pharma Solutions
Patheon
DSM Pharmaceutical
Cambrex (Lonza)
IDT Biologika
Charles River Biopharmaceutical Services (BPS)

CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: The Major Vaccine Development Categories
Table 1-2: World Vaccines Market (Pediatric and Adult)
Table 1-3: Technologies with the Greatest Promise for Producing Vaccines, 2011
Figure 1-1: Vaccine Industry Production Spending, 2008-2015
Figure 1-2: Discount for Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
Table 1-4: Largest Vaccine Manufacturers
CHAPTER TWO: THE VACCINE INDUSTRY: TRENDS, MAJOR PLAYERS AND MARKETS
Table 2-1: Top Vaccine Sellers, 2011: Revenues in US$ millions
Table 2-2: Vaccine-Preventable Diseases, August 2011
Table 2-3: World Vaccines Market Manufacturer's Market Shares, 2009
Table 2-4: Major Vaccine Merger & Acquisition Activity
Table 2-5: Vaccines Approved by FDA for US Sales, July, 2011
Table 2-6: HHS/ BARDA Vaccine Advanced Development Milestones
Table 2-7: Documents Required to Determine Eligibility for WHO Prequalification
Table 2-8: Private Sector Price versus Negotiated Price For Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
Figure 2-1: Private Sector Price versus Negotiated Price ( cost in US dollars)
Figure 2-2: Discount for Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
Figure 2-3: Vaccine Companies vs. Traditional Pharma: Production and Sales Costs
CHAPTER THREE: VACCINE PRODUCTION: SPENDING, INNOVATIONS, AND CHALLENGES
Figure 3-1: Doses of Vaccine Produced Worldwide, 2010-2015
Table 3-1: Vaccine Classes and Associated Industrial Challenges (Oral Polio, Rabies, Acellular pertussis, Pneumococcal, Hepatitis B, Japanese encephalitis)
Table 3-2: Production Methods for Common Vaccines (Oral polio, Tetanus, Measles, Influenza, Diphtheria, Pertussis, BCG, Hep. B, Hib, MMR)
Table 3-3: Inactivated or Attenuated Vaccine Examples
Table 3-4: Acelluar/Component Vaccine Examples
Table 3-5: Attenuated Vaccine Examples
Table 3-6: Toxoid Vaccine Examples
Table 3-7: Thiomersal Content of Vaccines Routinely Recommended for Children
Table 3-8: Preservatives Used in U.S. Licensed Vaccines
Table 3-9: Annual Influenza Statistics
Table 3-10: Cell-based Vaccine Advantages
Table 3-11: Activities at WHO Collaborating Centers
Table 3-12: Activities at Vaccine Manufacturers
Figure 3-1: Vaccine Approval Timeline
Table 3-13: Advantages of Cell Culture Vaccines
Figure 3-2: Spending on Vaccine Production, Estimated (2008-2015) (billions of US Dollars Spent)
Table 3-14: Top Vaccine Contract Manufacturers, 2011
Figure 3-3: Estimated Outsourcing Market for Vaccines (2008-2015)

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