Description
Several cell culture-derived biopharmaceutical drugs were launched in the US and European markets in 2010. Biopharmaceuticals (recombinant proteins, monoclonal antibody and nucleic acid-based products) represent the fastest growing sector in the pharmaceutical industry. Driving the extraordinary interest in biopharmaceuticals is the ability of these large proteins to target diseases in a very specific manner, thus maximizing efficacy while minimizing side effects.
Growth in the development and production of biopharmaceuticals is the most significant driver of the cell culture market. Biological products are developed from large and complex protein molecules, which require equally complex manufacturing methods and an array of analytical techniques. Protein-based biopharmaceuticals are invariably produced by an initial cell culture step (upstream processing), followed by product recovery, purification and formulation into final product format (downstream processing).
This report analyzes the world market for the cell cultures used in these steps and the major trends driving this market. 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 the segments through 2015
- Competitive Market Share by leading supplier as of 2010
- 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 biopharmaceuticals
- 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.
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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 Environmen
- 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 Product Approvals
- 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 System
- 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)
- SP / , and NS
- HEK and PER. C
- 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
- Segment Analysis
- 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
- Impact of Transgenic Animals and Plants on the 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
- Molecular Biology Enzymes
- Molecular Biology Kits and Reagents
- Purification
- Biochemicals
- PCR 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
- BD Biosciences
- History and Lines of Business
- Cell Culture Products
- Financial Information
- BIOCHROM AG
- History and Lines of Business
- Cell Culture Products
- 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
- EMD Millipore
- History and Lines of Business
- Cell Culture Products
- Financial Information
- Gemini Bio-Products
- History and Lines of Business
- Cell Culture Products
- Cell Culture Sera
- Human Sera
- Specialized Media
- Irvine Scientific
- History and Lines of Business
- Cell Culture Products
- Cell Culture Products
- Custom Media Program
- Express Media Service
- R&D Development Program
- Invitria
- History and Lines of Business
- Cell Culture Products
- Cellastim
- Lacromin
- Optiferrin
- ITSE Animal-free
- Zap-CHO
- Zap-Hybridoma
- 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
- 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
- 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
- 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
- SeraCare Life Sciences, Inc.
- History and Lines of Business
- Cell Culture Products
- Financial Information
- Sera Laboratories International Ltd
- History and Lines of Business
- Cell Culture Products
- Product Categories
- Thermo Fisher Scientific, Inc.
- History and Lines of Business
- Cell Culture Products
- Financial Information
- Wisent, Inc.
- History and Lines of Business
- Cell Culture Products
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
- Exhibit 1-1 : Worldwide Cell Culture Market
- Exhibit 1-2 : Cell Culture World Market Share, by Region, 2010
CHAPTER TWO: GENETICALLY MODIFIED CELLS FOR BIOPHARMACEUTICAL DEVELOPMENT
- Exhibit 2-1 : Biopharmaceutical Development by General Indication and Development Activity (Phase III through Registration)
- Exhibit 2-2 : Biopharmaceuticals Approved in the US and/or the EU, 2010
- Exhibit 2-3 : Approximate times from Introduced Gene to Protein Production at Useable Levels
- Exhibit 2-4 : Disadvantages/Advantages of Cell Culture Systems
- Exhibit 2-5 : 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, 2005-2015
- Exhibit 4-2 : Cell Culture World Market Share, by Region, 2010
- Exhibit 4-3 : World Cell Culture Market by Segment: Media, Sera and Reagents, 2005-2015
- Exhibit 4-4 : Cell Culture Market Share, 2010
- Exhibit 4-5 : Selected Transgenic Products in Clinical Trials
