Abstract
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, of the Cell Culture Media Segment Market, Sera Segment
Market and Reagent Segment 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 Media
- 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
The report contains a 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
The report also contains a discussion of Major Trends Impacting the
Market: stem cell research (including plans of major companies), cell
culture-based vaccine Production and generic biopharmaceuticals and
Profiles of Leading Suppliers and information about M&A activities in
recent years
The information for this report was gathered using both primary and secondary
research including comprehensive research of secondary sources such as company
literature, databases, investment reports, and medical and business journals.
Telephone interviews and email correspondence were the primary method of
gathering information. For the purpose of this study Kalorama Information
conducted interviews with key industry officials, consultants, and government
personnel. These sources were the primary basis in gathering information
specifically relating to revenue and market share data presented in this
report. Specific interviews with pharmaceutical company and cell culture
supply company representatives included marketing directors, division
managers, and product representatives.
Table of 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 Healthcare 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
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