Cell Culture: The Market for Media, Sera and Reagents, 5th Edition

April 2013 | 152 pages | ID: C65E2E0BA82EN
Kalorama Information

Abstracts

The growth in biopharmaceuticals is creating an unprecedented increase in demand for cell culture products. Cell culture techniques have been used in biological sciences for more than 50 years; however, cell culture techniques have been applied to production systems for only about 26 years. The cell culture industry, which began in the late 1980s from the utilization of recombinant DNA technology and cell hybridization, is today a major underpinning of the biopharmaceutical market.

The choice of cells to use in biopharmaceutical production depends on a number of factors, some technical and some economic. Bacteria and yeast, for instance, are relatively simple to grow. Each cell of a bacterium or yeast is an independent organism capable of its own metabolism. Yeasts and bacteria have fairly simple nutritional needs and grow well suspended in a liquid medium, as well as in large fermentors.

This report is focused on cell culture used in the research and production of biopharmaceuticals. In the pharmaceutical industry, cell culture is a major foundation of biopharmaceutical development, bioprocessing and manufacturing. Biopharmaceutical products are developed from large, complex protein molecules, which require equally complex manufacturing methods and an array of analytical techniques. As growing cells for biopharmaceutical production is slow, expensive and complicated, optimizing cell culture development is of paramount concern to companies developing biopharmaceuticals. Forecasts and current market sizing are provided in three specific segments:

• Media,
• Sera, and
• Reagents

In addition to a thorough discussion of the technologies and techniques currently employed and emerging in the cell culture area, Kalorama's exhaustive report provides specific information on:

• Market Size, growth, and forecasts of Media market, Sera market and Reagent market through 2017
• Market Share Estimate for Animal-Derived, Component Free Media
• Market Share Estimate for Serum-Free Media
• Market Share Estimate for Chemically-Defined
• Competitive Market Share by leading supplier as of 2012
• Estimated Market by Region (North America, Europe, Asia U.S.)

Key Market Drivers and Restraints for suppliers, including discussions of biopharmaceutical pipelines, biomedical R&D directions, and the future of transgenic plant and animal production.

Review of the various expression systems (Bacteria, Yeast, Insect, and Mammal) and the biopharmaceutical product manufactured by these systems Discussion of the preferences in media types vying for dominance in the market, including the following:

• ADCF - animal derived component free media
• CD - chemically defined media
• CSFM - complete serum free medium
• PF - protein free media
• SF - serum free media
• SFM - serum free medium

Major Trends Impacting the Market: stem cell research (including plans of major companies), cell culture-based vaccine Production and generic biopharmaceuticals Profiles of Leading Suppliers and information about M&A activities in recent years .

Contents

CHAPTER ONE: EXECUTIVE SUMMARY

  Scope and Methodology
  Cells for Biopharmaceutical Production
  Bacteria and Yeasts Systems
  Animal Cell Systems
  Insect Cell Systems
  Cell Lines and Cell Banks
  Fermentors and Bioreactors
  Stirred-tank Reactors
  Airlift Fermentors
  Packed Bed Reactors
  Hollow-Fiber Reactor
  Disposable Systems
  Fermentation Processes
  Batch and Fed-Batch Fermentation
  Suspended vs. Anchored Cells
  Microencapsulation
  Cell Culture Environment
  Functions and Components of Basal Media
    pH and Osmotic Pressure
    Energy Sources
    Nutrients
  Cell Culture Media
  Lysogeny broth (LB)
  Classical Media
  Serum-free Media
  Protein-free Media
  Chemically Defined Media
  Specialty Media
  Sera
  Reagents
  Shifting Towards Non-animal Derived Reagents
  Addressing Reagent Safety Issues
  World Cell Culture Market
  Cell Culture Market and Forecast
  Current And Future Trends

CHAPTER TWO: GENETICALLY MODIFIED CELLS FOR BIOPHARMACEUTICAL DEVELOPMENT

  Growing Demand for Biopharmaceuticals
  Biopharmaceutical Market
  Development of Biopharmaceuticals
  Biopharmaceutical Growth Increases Demand for Cell Culture Products
  A Brief History of Biotechnology
  Science of Genetic Manipulation
  From Petri Dish to Biopharmaceutical
  Upstream Bioprocessing: Cell Culture Expression Systems
  Cells for Biopharmaceutical Production
    Bacteria and Yeasts Systems
    Animal Cell Systems
    Insect Cell Systems
  Advantages/Disadvantages of Cell Culture Systems
  Cell Lines and Cell Banks
  Biopharmaceuticals Produced from Cell Culture
  Cell Culture Practices and Regulatory Guidelines
  Validation of Facilities
  Maintaining Sterilization Standards

CHAPTER THREE: CELL CULTURE TECHNOLOGY

  Introduction and Overview
  Milestones in Cell Culture Development
  Cell Lines for Bioproduction
  Predominant Cell Lines
    Chinese Hamster Ovary (CHO)
    SP2/0, and NS0
    HEK 293 and PER. C6
  Sources: Largest Collections of Cell Lines
  Fermentors and Bioreactors
  Types of Bioreactors/Fermentors
    Stirred-tank Reactors
    Airlift Fermentors
    Packed Bed Reactors
    Hollow-fiber Reactor
    Disposable Systems
  Fermentation Processes
  Batch and Fed-Batch Fermentation
  Suspended vs. Anchored Cells
  Microencapsulation
  Cell Culture Environment
  Functions and Components of Basal Media
    pH and Osmotic Pressure
    Energy Sources
    Nutrients
  Cell Culture Media
  Types of Media
    Lysogeny broth (LB)
    Classical Media
    Serum-free Media
    Protein-free Media
    Chemically Defined Media
    Specialty Media
  Sera
  Sources of Sera
  Bovine Serum Safety Issues and Regulations
  Shift to Serum-free Media
  Reagents
  Major Types of Biologic Reagents
    Amino Acids
    Growth Factors and Cytokines
    Albumin
    Transferrin
    Thrombin
    Growth Supplements
    Protease Inhibitor
    Attachment Factors
  Shifting Towards Non-animal Derived Reagents
  Addressing Reagent Safety Issues

CHAPTER FOUR: CELL CULTURE MARKET CURRENT AND FUTURE TRENDS

  Overview
  Cell Culture Market
  Market Drivers
  Cell Culture Market Forecast
  Market Segment Analysis
  Media
  Sera
  Reagents
  Cell Culture Suppliers’ Market Share
  Current And Future Trends
  Shift to Serum-free and Animal Product-free Media
    Concomitant Need for Animal-derived Media
  Cell Culture-based Vaccine Production
    Cell Culture-based Vaccine on Market
  Stem Cell Research Driving Cell Culture Market
    Life Technologies
    Sigma-Aldrich
    ThermoFisher Scientific
    Lonza Bioscience
    EMD Millipore
    BD Bioscience
  Impact of Generic Biopharmaceuticals on Cell Culture Market

CHAPTER FIVE: COMPANY PROFILES

  Advanced Biotechnologies, Inc.
  History and Lines of Business
  Cell Culture Products and Services
  Affymetrix, Inc.
  History and Lines of Business
  Cell Culture Products, Reagents and Biochemicals
    Molecular Biology Enzymes
    Molecular Biology Kits and Reagents
    Purification
    Biochemicals
    PCR Reagents
    Panomics Quantitative Assays
    eBioscience Immunology Reagents
  Financial Information
  AMRESCO, Inc.
  History and Lines of Business
  Cell Culture Products
  Analytical Biological Services Inc.
  History and Lines of Business
  Cell Culture Products
    Mammalian Cell Culture
    Cell in Microtiter Plates for HTS
    Primary Cultures
    Insect Cell Culture
  Athena Enzyme Services
  History and Lines of Buiness
  Cell Culture Products
  Atlanta Biologicals, Inc.
  History and Lines of Business
  Cell Culture Products
    Animal & Human Sera
    Media & Balanced Salts
    Supplements & Reagents
    Cell Separation Products
  Athena Enzyme Systems
  History and Lines of Business
  Cell Culture Products
    Expression Media
    Cell Culture Products
    Custom Cell Culture Media
    Enzyme Assays
  BD Biosciences
  History and Lines of Business
  Cell Culture Products
    Clinical and Clinical Research Reagents, which include:
    Research Reagents, which include:
  Financial Information
  Bioreclamation Inc
  History and Lines of Business
  Cell Culture Products
  Cell Essentials, Inc.
  History and Lines of Business
  Cell Culture Products
  CellGenix Technologie Transfer GmbH
  History and Lines of Business
  Cell Culture Products and Services
  ClonTech Laboratories, inc.
  History and Lines of Business
  Cell Culture Products
  corning life sciences
  History and Lines of Business
  Cell Culture Products
  EMD Millipore
  History and Lines of Business
  Cell Culture Products
  Financial Information
  GE Heathcare Live Sciences
  History and Lines of Business
  Cell Culture Products
  Gemini Bio-Products
  History and Lines of Business
  Cell Culture Products
    Cell Culture Sera
    Human Sera
    Specialized Media
  invitria
  History and Lines of Business
  Cell Culture Products
    Cellastim
    Lacromin
    Optiferrin
    ITSE Animal-free
    Zap-CHO
    Zap-Hybridoma
  Irvine Scientific
  History and Lines of Business
  Cell Culture Products
    Cell Culture Products
    Custom Media Program
    Express Media Service
    R&D Development Program
  J R Scientific, Inc.
  History and Development
  Cell Culture Products
  Life Technologies Corporation
  History and Lines of Business
  Cell Culture Products
  Financial Information
  Lonza Bioscience
  History and Lines of Business
  Cell Culture Products and Services
    Culture Media Development
    Cell Line Creation
    Cell Banking
  MP Biomedicals
  History and Lines of Business
  Cell Culture Products
  Novozymes Biopharma US Inc
  History and Lines of Business
  Cell Culture Products
    rAlbumin
    Albucult
    Albufuse and Albufuse Flex
    Yeast Expression Technology
    Growth Factors
    Bacillus-derived Hyaluronic Acid
    Purification Ligands
    Recombinant Tansferrin
  PromoCell GmbH
  History and Lines of Business
  Cell Culture Products
  Quality Biological, Inc.
  History and Lines of Business
  Cell Culture Products
  R&D Systems, Inc.
  History and Lines of Business
  Cell Culture Products
  SAFC Biosciences
  History and Lines of Business
  Cell Culture Products
  Financial Information
  SBH Sciences
  History and Lines of Business
  Cell Culture Products
  Selexis SA
  History and Lines of Business
  Cell Culture Products and Technology
  SeraCare Life Sciences, Inc.
  History and Lines of Business
  Cell Culture Products
  Sera Laboratories International Ltd
  History and Lines of Business
  Cell Culture Products
    Product Categories
  Stemcell Technologies Inc.
  History and Lines of Business
  Cell Culture Products
    Embryonic stem cells & induced pluripotent stem (iPS) cells
    Hematopoietic stem & progenitor cells
    Neural stem & progenitor cells
    Mammary epithelial cells
    Bronchial epithelial cells
    Prostate epithelial cells
  Thermo Fisher Scientific, Inc.
  History and Lines of Business
  Cell Culture Products
  Financial Information
  Wisent Bioproducts
  History and Lines of Business
  Cell Culture Products
  LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

  Exhibit 1-1
    Worldwide Cell Culture Market, 20112

CHAPTER TWO: GENETICALLY MODIFIED CELLS FOR BIOPHARMACEUTICAL DEVELOPMENT

  Exhibit 2-1
    Top Selling Biological Drugs in 2011
  Exhibit 2-2
    Top Selling Biological Drugs in 2012
  Exhibit 2-3
    FDA Biopharmaceutical Product Approvals, 2011
  Exhibit 2-4
    FDA Biopharmaceutical Product Approvals, 2012
  Exhibit 2-5
    Approximate times from Introduced Gene to Protein Production at Useable Levels
  Exhibit 2-6
    Disadvantages/Advantages of Cell Culture Systems
  Exhibit 2-7
    Selected Biopharmaceuticals Produced from Bacteria, Yeast and Mammalian Cells

CHAPTER THREE: CELL CULTURE TECHNOLOGY

  Exhibit 3-1
    Selected Products/Companies Offering Alternatives to Animal Sera Products for Hybridoma, Myeloma and CHO cell lines

CHAPTER FOUR: CELL CULTURE MARKET CURRENT AND FUTURE TRENDS

  Exhibit 4-1
    Worldwide Cell Culture Market, 2007-2017
  Exhibit 4-2
    Cell Culture World Market Share, by Region, 2012
  Exhibit 4-3
    World Cell Culture Market by Segment: Media, Sera and Reagents, 2005-201571
  Exhibit 4-4
    Breakout of Media Market (Serum-Free, CD, ADCF)
  Exhibit 4-5
    Cell Culture Market Share, 2012