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

February 2012 | 180 pages | ID: A2C147A3F79EN
Kalorama Information

Abstracts

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)

As part of Kalorama Information's coverage, several profiles are included of vaccine manufacturers and contract manufacturing organizations (CMOs). The following companies are profiled:

• 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)

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)

LIST OF EXHIBITS

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)