Description
Cell culture is a major foundation of biopharmaceutical development, bioprocessing and manufacturing. As the biopharmaceutical market grows, so should interest in the cell culture products market. 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.
This report, Cell Culture represents the second time that Kalorama has focused on culture used in the research and production of biopharmaceuticals, analyzing the world cell culture market and the major trends driving this market 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, the Kalorama’s exhaustive report provides specific information on:
- Market Size, growth, and forecasts of the segments through 2013
- Competitive Market Share by leading supplier as of 2008.
- Estimated Market Share by Region (North America, Europe, 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 bipharmaceuticals
- Profiles of 27 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.
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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
Impact of Shift to Serum-free Products on Cell Culture Suppliers
Impact of Shift to Serum-free Products on Research
Impact of Shift Serum-free Products on Biopharmaceutical Manufacturers
Cell Culture Market and Forecast
Trends Impacting The Cell Culture Market
CHAPTER TWO: GENETICALLY MODIFIED CELLS FOR BIOPHARMACEUTICAL DEVELOPMENT
Growing Demand for Biopharmaceuticals
Demand Increasing 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
Shift Away From Serum-Based Cell Culture
Impact of Shift to Serum-free Products on Cell Culture Suppliers
Impact of Shift to Serum-free Products on Research
Life Technologies’ End Run Around the BSE Issue
Cell Culture Market
Market Drivers
Cell Culture Market and Forecast
Segment Analysis
Media
Sera
Reagents
Market Characteristics
Market Share: Cell Culture Suppliers
Trends Impacting The Cell Culture Market
Stem Cell Research
Life Technologies
Sigma-Aldrich
Millipore Corporation
ThermoFisher Scientific
Lonza Bioscience
Cell Culture-based Vaccine Production
Generic Biopharmaceuticals
Transgenically Produced Biopharmaceuticals
CHAPTER FIVE: COMPANY PROFILES
Advanced Biotechnologies, Inc
History and Lines of Business
Cell Culture Products and Services
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
Atlanta Biologicals, Inc
History and Lines of Business
Cell Culture Products
Athena Enzyme Services
History and Lines of Business
Cell Culture Products
BD Biosciences
History and Lines of Business
Cell Culture Products
Financial Information
Biochrom AG
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
Irvine Scientific
History and Lines of Business
Cell Culture Products
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
Financial Information
Mediatech, Inc
History and Lines of Business
Cell Culture Products
Millipore Corporation
History and Lines of Business
Cell Culture Products
Financial Information
MP Biomedicals
History and Lines of Business
Cell Culture Products
PAA laboratories, Inc
History and Lines of Business
Cell Culture Products
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
SBH Sciences
History and Lines of Business
Cell Culture Products
Selexis SA
History and Lines of Business
Cell Culture Products
SeraCare Life Sciences, Inc
History and Lines of Business
Cell Culture Products
Financial Information
Sigma-Aldrich Corporation
History and Lines of Business
Cell Culture Products
Financial Information
Thermo Fisher Scientific, Inc
History and Lines of Business
Cell Culture Products
Financial Information
USB Corporation
History and Lines of Business
Cell Culture Products
Wisent, Inc
History and Lines of Business
Cell Culture Products
APPENDIX: A: COMPANY DIRECTORY
APPENDIX: B: PROFESSIONAL ORGANIZATIONS
TABLE OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: Worldwide Cell Culture Market
Figure 1-1: Cell Culture World Market Share, by Region, 2008 (US, Asia/Pacific, EU)
CHAPTER TWO: GENETICALLY MODIFIED CELLS FOR BIOPHARMACEUTICAL DEVELOPMENT
Table 2-1: Biopharmaceuticals Approved in the USA and/or the EU in 2007
Table 2-2: Approximate times from Introduced Gene to Protein Production at Useable Levels
Table 2-3: Disadvantages/Advantages of Cell Culture Systems
Table 2-4: Selected Biopharmaceuticals Produced from Bacteria, Yeast and Mammalian Cells
CHAPTER THREE: CELL CULTURE TECHNOLOGY
Table 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
Table 4-1: Selected Brandname Serum-Free Formulations of Cell Culture Products Currently on the Market
Table 4-2: Worldwide Cell Culture Market
Figure 4-1: Cell Culture World Market Share, by Region, 2008 (US, Asia, EU)
Table 4-3: World Cell Culture Market by Segment: Media, Sera and Reagents
Table 4-4: Cell Culture Market Share, 2008
