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.
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)
Sales estimates for the vaccine market and for market segment represent global
revenues and are expressed in current dollars. Spending also represents global
spending and expressed in current dollars.
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.
Table of Contents
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)
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 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)
Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts) published by Kalorama Information in February 1, 2012. This report consists of 180 Pages and the price starts from US $ 2500.
Press Release
Kalorama: Weak Flu Season Shouldn't Affect Vaccine Sales
April 10th, 2012
Global Information Inc. would like to present a new market research report, "Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts)" by Kalorama Information.
Last year, Kalorama projected the world vaccine market at $25.3 billion, with influenza as one of the major growth segments for the market. This years flu season is weaker than last years, with reports of influenza cases down, according to the Centers for Disease Control. But according to Kalorama Information, this does not mean that pharmaceutical companies need to be panicking when it comes time to report revenues. The healthcare market research publisher, who conducts a yearly look at the vaccine marketplace, says the dynamics of vaccine sales means the weakness of the season may not destroy their expected revenues.
"A weak flu season will impact doses or shots used, but probably wouldnt affect sales, as purchasers often place their orders well in advance of the beginning of flu season," said Bruce Carlson, publisher of Kalorama Information.
Kalorama says that vaccine makers such as Novartis, Glaxo Smith Kline, Sanofi Aventis and others may end up with extra, unused doses if fewer consumers come out for vaccination, but sales probably wouldnt be significantly impacted. Kalorama also asserts that consumers will often get shots anyway at the beginning of the season, and its only later, when the stats about severity come out that the industry gets a read on the number of caseloads that actually materialized.
Kalorama suggests there is more impact in the reverse direction when the flu season is severe. In periods of high severity, more consumers will come out for shots and this could create a shortage or sometimes some last-minute ordering. Weak severity impacts usage/sales to the downside less than high severity could influence demand/sales to the upside. Generally, vaccine makers still need to stock up for next year.
The impact on retail drug outlets is much greater than on the suppliers of the vaccine, now that fees for these shots are a part of their expected revenues, Kalorama finds. Carlson notes that retail drug outlets such as Walgreens have been reporting poor results in the first few months of 2012, citing flu shot revenue woes.
