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

Vaccines are among the top revenue earners in recent years, and in some cases have assisted major pharmaceutical companies to revenue growth. But this is not without some trade-offs. Vaccines involve a complex production process. Is vaccine-making profitable? How much is the industry spending? How much is handed off to other companies and how much is made by the branded manufacturers? How many doses are produced by the industry? These are the type of questions that Kalorama Information has taken on in this report.

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)
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.

All Kalorama reports advertise the single user price, which limits access to one user. We also feature department and global pricing for reports that will be utilized by more than one user at your company. Please ask your sales representative or select the correct license on our website.

For Kalorama's take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information's Key Point Blog at http://kaloramakeypoint.blogspot.com/


Growth of Vaccines Calls for Better, Faster Production

What a difference a decade has made in vaccines. According to a new market research report from healthcare publisher Kalorama Information, ten years ago the vaccine market was $5.7 billion dollars. Now, driven partially by the adult influenza vaccine market, and new brands such as Gardasil and Prevnar, the vaccine market has soared to over $27 billion. This kind of growth has strained vaccine production capacity and will drive new investment and innovation in this area. The firm published its findings in its recent report, Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts).

"It's an industry that needs to change production to match the demand," said Bruce Carlson, publisher of Kalorama Information. "The industry will continue to move from egg-based to cell-based, plant-based and insect-based production technologies."

Many adult and pediatric vaccines are produced by efficient cell-based technologies. Influenza uses a production system based on growing vaccines in chicken eggs, a technology that has been used since the middle of the last century. Novel vaccine production techniques are underway but the major technology is still egg-based. Flu vaccines are among the few that confer no long-term immunity and must be administered annually. A huge global effort is required each year by infectious disease monitoring organizations, biologics manufacturers, finish and fill suppliers, government regulatory agencies, distributors, and primary healthcare providers. These issues will become important, as production capacity is increasing. Kalorama indicates that the vaccine industry overall produced an estimated 23 billion doses in 2010, and demand should increase that number to 35 billion doses by 2015.

Kalorama also projects a small but growing opportunity for CMOs, contract manufacturing organizations who can help branded makers with clinical trial batches, new products where existing facilities won't cope, and increased pandemic demand.

"Quality control and tight regulation have made it so that, in most cases, vaccine companies do the manufacturing work themselves," said Carlson. "You don't see the outsourcing you do in other industries. However, there are some partnerships now and we expect more as makers cope with increased demand."

For more information, including estimates of industry vaccine production spending and profiles of vaccine makers and CMOs, see Kalorama's new report, Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts).

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)

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