Cell Culture - Rising Demand for Biologics and Growing Visibility of Approval Pathway for Biosimilars will Create Growth Opportunities

Jan 22, 2013, 07:23 ET from Reportlinker

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Cell Culture - Rising Demand for Biologics and Growing Visibility of Approval Pathway for Biosimilars will Create Growth Opportunities


Cell Culture - Rising Demand for Biologics and Growing Visibility of Approval Pathway for Biosimilars will Create Growth Opportunities

Summary GBI Research, the leading business intelligence provider, has released its latest research "Cell Culture - Rising Demand for Biologics and Growing Visibility of Approval Pathway for Biosimilars will Create Growth Opportunities", which provides in-depth analysis on the processes, drivers and barriers of the cell culture market. The report analyzes the role of biopharmaceutical products that basically provide enhancement to media, sera, reagents and cell culture market. Major manufacturing technologies involved in the cell culture technology have been detailed in the report. Furthermore, the report provides competitive benchmarking for the leading players that shape the global media, sera, reagent and overall cell culture market.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

Cell culture technology is used to carry out processes external to the natural environment by maintaining controlled environments which enable the growth of various cell cultures for use in medicine and research. The processes is related to methods involved in the development of tissue or organ cultures. Multicellular eukaryotic cells from animals are usually preferred for cell culture as they provide standard characteristics for growing environments. Plant cells are the second choice for culture technology, while fungi, bacteria, protists and others are also used for the developmental process.

The development of recombinant methods involves genetic manipulation and restructuring of DNA or genes. Genetic recombination usually takes place in a biological environment, while DNA recombination occurs either during a repair response or experiments using in vitro studies. This is also known as genetic engineering technology and was developed at the end of the twentieth century. This method was further developed for large-scale cell culture production and was found to be helpful in protein synthesis processes, such as insulin production.

GBI Research indicates that the cell culture market is growing continuously due to increased demand for biopharmaceutical products. The introduction of biosimilars across various geographies in the forecast period on a large scale will boost the cell culture market, rapidly. Despite concerns about low flexibility for manufacturing quantities and other factors, the higher efficacy of the end products will drive its growth in the future.

Scope - Analysis of various technologies involved in cell culture and the key associated manufacturing processes involved

- Key drivers and barriers that have a significant impact on the cell culture market.

- Major equipment, cell banks and cell lines for cell culture development have been analyzed

- Annualized market data for the media, sera, reagents and global cell culture market from 2004 to 2011, forecast forward to 2018, have been provided in the report.

- Major players in the cell culture market are enlisted providing their company overview and company roles in the market.

Reasons to buy - Align your product portfolio to the markets with high growth potential

- Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth

- Develop strategic initiatives by understanding the key focus areas of leading companies

- Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps

1 Table of Contents1 Table of Contents 51.1 List of Tables 71.2 List of Figures 82 Cell Culture - Introduction 92.1 Introduction 93 Cell Culture - Overview 103.1 Overview 103.2 Cell Lines 103.3 Application of Cell Lines 103.3.1 Characteristics of Cell Lines 103.4 Selective Cell Lines 113.4.1 Chinese Hamster Ovary 113.4.2 SP2/0 and NS0 113.4.3 HEK 293 and PER. C6 113.5 Transformational Approach of Transgenic Model 123.5.1 Transgenic DNA Preparation 123.5.2 Insertion of the Transgenic DNA into Animals 123.5.3 Clone and Integrity Verification of the Transgene 133.5.4 DNA Purification and Establishing a Screening Method 133.5.5 Breeding and Analysis of Transgenic Rodents 133.6 Stem Cell Research has Enormous Potential for Cell Culture 143.6.1 Applications of Stem Cell Research 143.6.2 Stem Cell Research Market Analysis 153.7 Fermentation Methods 163.7.1 Fed-Batch Fermentation 173.7.2 Important Factors for Regulating Cell Culture 183.8 Fermenters and Bioreactors 193.8.1 Bioreactor 193.8.2 Selection of Bioreactors 193.8.3 Batch Bioreactor 203.8.4 Continuous Bioreactor 213.8.5 Submerged Bioreactors — Stirred Tank 223.8.6 Airlift Bioreactor 223.8.7 Water-Jacketed Bioreactor 233.9 Media 233.9.1 Role of Media 233.9.2 Types of Media 233.10 Sera 243.10.1 Sources of Sera 243.10.2 Sera Safety and Regulations 253.10.3 Shift to Serum Free Media 263.11 Reagents 263.11.1 Major Types of Biologic Reagents 263.11.2 Reagent Safety Issues 284 Cell Culture - Current and Future Trends 294.1 Cell Culture Market Forecast 294.2 Media Market Forecast 304.3 Sera Market Forecast 314.4 Reagents Market Forecast 324.5 Drivers and Restraints for Cell Culture Market 334.5.1 Drivers for Cell Culture Market 334.5.2 Restraints for Cell Culture Market 345 Cell Culture - Biopharmaceuticals an Important Part of Cell Culturing 355.1 Genetic Modifications 355.1.1 Cell Culture Life-Cycle Expressions 355.1.2 Biotechnological Product Development Using Cell Culture Method 375.1.3 Cell Banking and Seed Culture 385.1.4 Cell Systems 395.1.5 Advantages and Disadvantages of Cell Culture Techniques 415.2 Cell Lines and Banks 415.2.1 Manufacturing of Biopharmaceuticals using Cell Culture Techniques 415.2.2 Standard Methods for Cell Culture 425.2.3 Validation and Quality Maintenance 435.2.4 Essential Guidelines for Maintaining Sterilization Standards 435.3 Successful Treatments from Biopharmaceuticals is Increasing the Demand for Cell Culturing 446 Key Players in the Culture Media, Sera and Reagents Market 456.1 Cell Culture Suppliers' Market Share 456.1.1 Life Technologies Corporation 466.1.2 Sigma-Aldrich Corporation 476.1.3 Thermo Fisher Scientific Inc. 486.1.4 Affymetrix, Inc. 496.1.5 BD Biosciences 506.1.6 EMD Millipore 516.1.7 Advanced Biotechnologies, Inc. 526.1.8 Amresco 536.1.9 Analytical Biological Services Inc. 546.1.10 Athena Biotechnologies, Inc. 556.1.11 Biochrom AG 566.1.12 Bioreclamation, Inc. 576.1.13 Cell Essentials, Inc 586.1.14 CellGenix Technologie Transfer GmbH 596.1.15 Clontech Laboratories, Inc. 606.1.16 Gemini Bio-Products 616.1.17 Lonza BioSciences Singapore Pte Ltd 626.1.18 Mediatech, Inc. 636.1.19 MP Biomedicals, LLC 646.1.20 PAA Laboratories GmbH 656.1.21 Quality Biological, Inc. 666.1.22 R&D Systems, Inc. 676.1.23 SAFC Biosciences, Inc. 686.1.24 Selexis SA 696.1.25 SeraCare Life Sciences, Inc. 706.1.26 Sera Laboratories International Ltd. 717 Cell Culture - Appendix 727.1 Market Definitions 727.2 Abbreviations 727.3 Bibliography 737.4 Research Methodology 747.4.1 Coverage 747.4.2 Secondary Research 747.4.3 Primary Research 757.4.4 Expert Panel Validation 757.5 Contact Us 757.6 Disclaimer 75

1.1 List of Tables

Table 1: Cell Culture, Basal-Media Components, 2011 18Table 2: Cell Culture, Examples and Applications of Specialty Media, 2011 24Table 3: Cell Culture, Validation Test for Sera Approval, 2011 25Table 4: Cell Culture, Global, Revenue ($bn), 2004-2011 29Table 5: Cell Culture, Global, Revenue ($bn), 2011-2018 29Table 6: Cell Culture, Media Market Revenues, Global ($m), 2004-2011 30Table 7: Cell Culture, Media Market Revenues, Global ($m), 2011-2018 30Table 8: Cell Culture, Sera Market Revenues, Global ($m), 2004-2011 31Table 9: Cell Culture, Sera Market Revenues, Global ($m), 2011-2018 31Table 10: Cell Culture, Reagent Market Revenues, Global ($bn), 2004-2011 32Table 11: Cell Culture, Reagent Market Revenues, Global ($bn), 2011-2018 32Table 12: Cell Culture, Manufacturing Models, 2011 35Table 13: Cell Culture, Comparison of Therapeutic Protein Production across Different Systems, 2011 35

1.2 List of Figures

Figure 1: Cell Culture, Transgenic Model, Process Steps, 2011 12Figure 2: Cell Culture, Applications of Stem Cell Research, 2011 14Figure 3: Cell Culture, Stem Cell Research, Porter's Five Force Analysis, 2011 15Figure 4: Cell Culture, Fermentation Cycle, 2011 16Figure 5: Cell Culture, Batch and Fed-Batch Fermentation, 2011 17Figure 6: Cell Culture, Upstream Processing in Biopharmaceuticals, Tray Bioreactor, 2011 20Figure 7: Cell Culture, Upstream Processing in Biopharmaceuticals, Stirred Tank Bioreactor, 2011 21Figure 8: Cell Culture, Global, Revenue ($bn), 2004-2018 29Figure 9: Cell Culture, Media Market Revenues, Global ($m), 2004-2018 30Figure 10: Cell Culture, Sera Market Revenues, Global ($m), 2004-2018 31Figure 11: Cell Culture, Reagent Market Revenues, Global ($m), 2004-2018 32Figure 12: Cell Culture, Market, Drivers and Restraints, 2011 33Figure 13: Cell Culture, Cell Bank System, 2011 38Figure 14: Cell Culture, Suppliers Market Share, Global, 2011 45Figure 15: Cell Culture, Life Technologies Corporation, Business Overview, 2011 46Figure 16: Cell Culture, Sigma-Aldrich Corporation, Business Overview, 2011 47Figure 17: Cell Culture, Thermo Fisher Scientific Inc., Business Overview, 2011 48Figure 18: Cell Culture, Affymetrix, Inc., Business Overview, 2011 49Figure 19: Cell Culture, BD Biosciences, Business Overview, 2011 50Figure 20: Cell Culture, EMD Millipore, Business Overview, 2011 51Figure 21: Cell Culture, Advanced Biotechnologies, Inc., Business Overview, 2011 52Figure 22: Cell Culture, Amresco Inc., Business Overview, 2011 53Figure 23: Cell Culture, Analytical Biological Services Inc., Business Overview, 2011 54Figure 24: Cell Culture, Athena Biotechnologies, Inc., Business Overview, 2011 55Figure 25: Cell Culture, Biochrom AG, Business Overview, 2011 56Figure 26: Cell Culture, Bioreclamation, Inc, Business Overview, 2011 57Figure 27: Cell Culture, Cell Essentials, Inc., Business Overview, 2011 58Figure 28: Cell Culture, CellGenix Technologie Transfer GmbH, Business Overview, 2011 59Figure 29: Cell Culture, Clontech Laboratories, Inc., Business Overview, 2011 60Figure 30: Cell Culture, Gemini Bio-Products, Business Overview, 2011 61Figure 31: Cell Culture, Lonza BioScience Singapore Pte Ltd, Business Overview, 2011 62Figure 32: Cell Culture, Mediatech, Inc., Business Overview, 2011 63Figure 33: Cell Culture, MP Biomedicals, LLC, Business Overview, 2011 64Figure 34: Cell Culture, PAA Laboratories GmbH, Business Overview, 2011 65Figure 35: Cell Culture, Quality Biological, Inc., Business Overview, 2011 66Figure 36: Cell Culture, R&D Systems, Inc., Business Overview, 2011 67Figure 37: Cell Culture, SAFC Biosciences, Inc., Business Overview, 2011 68Figure 38: Cell Culture, Selexis SA, Business Overview, 2011 69Figure 39: Cell Culture, SeraCare Life Sciences, Business Overview, 2011 70Figure 40: Cell Culture, Sera Laboratories International Ltd., Business Overview, 2011 71

Companies mentioned

Life Technologies Corporation

Sigma-Aldrich Corporation

Thermo Fisher Scientific Inc.

Affymetrix, Inc.

BD Biosciences

EMD Millipore

Advanced Biotechnologies, Inc.


Analytical Biological Services Inc.

Athena Biotechnologies, Inc.

Biochrom AG

Bioreclamation, Inc.

Cell Essentials, Inc

CellGenix Technologie Transfer GmbH

Clontech Laboratories, Inc.

Gemini Bio-Products

Lonza BioSciences Singapore Pte Ltd

Mediatech, Inc.

MP Biomedicals, LLC

PAA Laboratories GmbH

Quality Biological, Inc.

R&D Systems, Inc.

SAFC Biosciences, Inc.

Selexis SA

SeraCare Life Sciences, Inc.

Sera Laboratories International Ltd.

To order this report:: Cell Culture - Rising Demand for Biologics and Growing Visibility of Approval Pathway for Biosimilars will Create Growth Opportunities

Nicolas Bombourg


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