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

Publisher Name :
Date:9-Nov-2012
No. of pages: 75

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

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

Table of Contents

1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8

2 Cell Culture - Introduction 9
2.1 Introduction 9

3 Cell Culture - Overview 10
3.1 Overview 10
3.2 Cell Lines 10
3.3 Application of Cell Lines 10
3.3.1 Characteristics of Cell Lines 10
3.4 Selective Cell Lines 11
3.4.1 Chinese Hamster Ovary 11
3.4.2 SP2/0 and NS0 11
3.4.3 HEK 293 and PER. C6 11
3.5 Transformational Approach of Transgenic Model 12
3.5.1 Transgenic DNA Preparation 12
3.5.2 Insertion of the Transgenic DNA into Animals 12
3.5.3 Clone and Integrity Verification of the Transgene 13
3.5.4 DNA Purification and Establishing a Screening Method 13
3.5.5 Breeding and Analysis of Transgenic Rodents 13
3.6 Stem Cell Research has Enormous Potential for Cell Culture 14
3.6.1 Applications of Stem Cell Research 14
3.6.2 Stem Cell Research Market Analysis 15
3.7 Fermentation Methods 16
3.7.1 Fed-Batch Fermentation 17
3.7.2 Important Factors for Regulating Cell Culture 18
3.8 Fermenters and Bioreactors 19
3.8.1 Bioreactor 19
3.8.2 Selection of Bioreactors 19
3.8.3 Batch Bioreactor 20
3.8.4 Continuous Bioreactor 21
3.8.5 Submerged Bioreactors — Stirred Tank 22
3.8.6 Airlift Bioreactor 22
3.8.7 Water-Jacketed Bioreactor 23
3.9 Media 23
3.9.1 Role of Media 23
3.9.2 Types of Media 23
3.10 Sera 24
3.10.1 Sources of Sera 24
3.10.2 Sera Safety and Regulations 25
3.10.3 Shift to Serum Free Media 26
3.11 Reagents 26
3.11.1 Major Types of Biologic Reagents 26
3.11.2 Reagent Safety Issues 28

4 Cell Culture - Current and Future Trends 29
4.1 Cell Culture Market Forecast 29
4.2 Media Market Forecast 30
4.3 Sera Market Forecast 31
4.4 Reagents Market Forecast 32
4.5 Drivers and Restraints for Cell Culture Market 33
4.5.1 Drivers for Cell Culture Market 33
4.5.2 Restraints for Cell Culture Market 34

5 Cell Culture - Biopharmaceuticals an Important Part of Cell Culturing 35
5.1 Genetic Modifications 35
5.1.1 Cell Culture Life-Cycle Expressions 35
5.1.2 Biotechnological Product Development Using Cell Culture Method 37
5.1.3 Cell Banking and Seed Culture 38
5.1.4 Cell Systems 39
5.1.5 Advantages and Disadvantages of Cell Culture Techniques 41
5.2 Cell Lines and Banks 41
5.2.1 Manufacturing of Biopharmaceuticals using Cell Culture Techniques 41
5.2.2 Standard Methods for Cell Culture 42
5.2.3 Validation and Quality Maintenance 43
5.2.4 Essential Guidelines for Maintaining Sterilization Standards 43
5.3 Successful Treatments from Biopharmaceuticals is Increasing the Demand for Cell Culturing 44

6 Key Players in the Culture Media, Sera and Reagents Market 45
6.1 Cell Culture Suppliers' Market Share 45
6.1.1 Life Technologies Corporation 46
6.1.2 Sigma-Aldrich Corporation 47
6.1.3 Thermo Fisher Scientific Inc. 48
6.1.4 Affymetrix, Inc. 49
6.1.5 BD Biosciences 50
6.1.6 EMD Millipore 51
6.1.7 Advanced Biotechnologies, Inc. 52
6.1.8 Amresco 53
6.1.9 Analytical Biological Services Inc. 54
6.1.10 Athena Biotechnologies, Inc. 55
6.1.11 Biochrom AG 56
6.1.12 Bioreclamation, Inc. 57
6.1.13 Cell Essentials, Inc 58
6.1.14 CellGenix Technologie Transfer GmbH 59
6.1.15 Clontech Laboratories, Inc. 60
6.1.16 Gemini Bio-Products 61
6.1.17 Lonza BioSciences Singapore Pte Ltd 62
6.1.18 Mediatech, Inc. 63
6.1.19 MP Biomedicals, LLC 64
6.1.20 PAA Laboratories GmbH 65
6.1.21 Quality Biological, Inc. 66
6.1.22 R&D Systems, Inc. 67
6.1.23 SAFC Biosciences, Inc. 68
6.1.24 Selexis SA 69
6.1.25 SeraCare Life Sciences, Inc. 70
6.1.26 Sera Laboratories International Ltd. 71

7 Cell Culture - Appendix 72
7.1 Market Definitions 72
7.2 Abbreviations 72
7.3 Bibliography 73
7.4 Research Methodology 74
7.4.1 Coverage 74
7.4.2 Secondary Research 74
7.4.3 Primary Research 75
7.4.4 Expert Panel Validation 75
7.5 Contact Us 75
7.6 Disclaimer 75

List of Tables

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

List of Figures

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

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