Cell Line Development and Characterization Services by Sources of Cell Lines / Expression Systems, Applications of Cell Lines and Key Geographical Regions: Industry Trends and Global Forecasts (2nd Edition), 2020-2035
The cell line development services market is expected to reach USD 5.3 billion by 2035 anticipated to grow at a CAGR of 13.7% during the forecast period 2020-2035
Over the past years, the biopharmaceutical market has experienced substantial growth, emerging as a promising sector within the pharmaceutical industry. Notably, a significant portion of recently approved drugs by the FDA's Center for Drug Evaluation and Research have been biologics, highlighting their growing importance. Consequently, there has been a notable increase in the development of biologics and biosimilars, heavily reliant on living biological systems. This has led to a heightened demand for various types of cell lines, with around 84% of therapeutic proteins produced in the last five years using diverse mammalian and microbial cells. However, a recent study revealed a concerning issue: approximately 30,000 research articles published across various journals featured data derived from experiments using misidentified or contaminated cell lines. This presents a significant challenge in medical research, especially as the field increasingly depends on cell-based assays and experiments. Thus, ensuring proper characterization of cell lines has become crucial to maintain authenticity and precision in modern medical studies.
In the cost-intensive domain of pharmacological research and development, professionals continuously seek ways to enhance operational efficiencies and reduce costs. As a result, outsourcing has become a preferred business model. Numerous service providers now claim expertise in developing and characterizing cell lines, catering to the specific needs of drug developers. The technical landscape in this field is witnessing considerable innovation, particularly in automating various stages of cell line development. Additionally, advanced genome editing technologies such as CRISPR/Cas-9 are extensively used to improve the quality of recombinant cell lines. Unlike drug developers, service providers typically focus on specialized service portfolios. They prioritize staying updated with the latest equipment and infrastructure enhancements to ensure service quality. Moreover, many service providers have recently engaged in strategic partnerships or acquisitions with other entities to strengthen their service offerings and broaden their portfolios. Considering the prevalent trend of outsourcing and the ongoing efforts of service providers to enhance their services, it is expected that the contract services market for cell line development and characterization will continue to steadily evolve until 2030.
Report Coverage
Over the past years, the biopharmaceutical market has experienced substantial growth, emerging as a promising sector within the pharmaceutical industry. Notably, a significant portion of recently approved drugs by the FDA's Center for Drug Evaluation and Research have been biologics, highlighting their growing importance. Consequently, there has been a notable increase in the development of biologics and biosimilars, heavily reliant on living biological systems. This has led to a heightened demand for various types of cell lines, with around 84% of therapeutic proteins produced in the last five years using diverse mammalian and microbial cells. However, a recent study revealed a concerning issue: approximately 30,000 research articles published across various journals featured data derived from experiments using misidentified or contaminated cell lines. This presents a significant challenge in medical research, especially as the field increasingly depends on cell-based assays and experiments. Thus, ensuring proper characterization of cell lines has become crucial to maintain authenticity and precision in modern medical studies.
In the cost-intensive domain of pharmacological research and development, professionals continuously seek ways to enhance operational efficiencies and reduce costs. As a result, outsourcing has become a preferred business model. Numerous service providers now claim expertise in developing and characterizing cell lines, catering to the specific needs of drug developers. The technical landscape in this field is witnessing considerable innovation, particularly in automating various stages of cell line development. Additionally, advanced genome editing technologies such as CRISPR/Cas-9 are extensively used to improve the quality of recombinant cell lines. Unlike drug developers, service providers typically focus on specialized service portfolios. They prioritize staying updated with the latest equipment and infrastructure enhancements to ensure service quality. Moreover, many service providers have recently engaged in strategic partnerships or acquisitions with other entities to strengthen their service offerings and broaden their portfolios. Considering the prevalent trend of outsourcing and the ongoing efforts of service providers to enhance their services, it is expected that the contract services market for cell line development and characterization will continue to steadily evolve until 2030.
Report Coverage
- The report extensively examines the cell line development services market, focusing on cell line sources, applications, company sizes, geographical regions, and analyzes growth influencers such as drivers, restraints, opportunities, and challenges.
- It evaluates market prospects and challenges for stakeholders, including competitive insights into top market players.
- Forecasts segment revenue across five major regions and provides a detailed review of contract service providers, highlighting their offerings, establishment details, headquarters, cell line sources, expression systems, and services provided in R&D, biomanufacturing, diagnostics, and regenerative medicine.
- Offers a competitive analysis of major cell line development service providers based on experience, portfolios, proprietary technologies, gene expression types, and supplementary services.
- Detailed profiles of these service providers include company overviews, service portfolios, and future outlooks, along with an in-depth review of the cell line characterization services market, encompassing establishment details, services offered, accreditations, and turnaround times.
- The report also presents a competitive analysis and detailed profiles of cell line characterization service providers, highlighting their backgrounds, service portfolios, financial details, and future prospects.
- It delves into partnerships in the cell line development and characterization domain since 2015, covering agreements, collaborations, mergers, acquisitions, and relevant deals.
- Further details biorepositories' profiles and their contributions to preventing contaminated or misidentified cell lines, while also discussing regulatory requirements by different authorities concerning cell line characterization and insights from experts involved in this field through a survey analysis.
- Creative Biogene
- Creative Biolabs
- Hyprocell
- LakePharma
- Thermo Fisher Scientific
- FUJIFILM Diosynth Biotechnologies
- Lonza
- ProBioGen
- Polpharma Biologics
- Selexis
- Detai Bio-Tech
- WuXi Biologics
1. PREFACE
1.1. Scope of the Report
1.2. Key Questions Answered
1.3. Research Methodology
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Cell Culture
3.2.1. Types of Cell Cultures by Origin
3.2.1.1. Primary Cell Cultures
3.2.1.2. Secondary Cell Cultures
3.2.2. Types of Cell Cultures by Growth Properties
3.2.2.1. Adherent Cell Cultures
3.2.2.2. Suspension Cell Cultures
3.2.3. Classification by Types of Cell Lines
3.2.3.1. Finite Cell Lines
3.2.3.2. Continuous Cell Lines
3.2.3.3. Recombinant Cell Lines
3.2.3.4. Hybridoma Cell Lines
3.3.4. Classification by Sources of Cell Lines
3.3.4.1. Mammalian Cell Lines
3.3.4.2. Non-Mammalian Cell Lines
3.5. Overview of Cell Line Development
3.5.1. Recombinant Cell Line Development
3.5.1.1. Vector Construction
3.5.1.2. Transgene Delivery into Host Cells
3.5.1.3. Cell Line Selection and Gene Amplification
3.5.1.4. Clone Selection
3.5.1.5. Stability Studies
3.6.2. Hybridoma Cell Line Development
3.7. Overview of Cell Line Characterization
3.7.1. Identity Testing
3.7.1.1. Karyotype Analysis
3.7.1.2. Isozyme Analysis
3.7.1.3. Cytochrome C Oxidase 1 Barcoding Assay
3.7.1.4. Phenotype Analysis
3.7.1.5. DNA Fingerprinting
3.7.1.6. DNA Profiling
3.8.2. Genetic Stability Testing
3.8.3. Sterility / Biosafety Testing
3..3.1. MYCOPLASMA CONTAMINATION TESTING
3.6.3.2. Viral Contamination Testing
3.6.3.3. Other Sterility Testing Methods
3.7. Additional Cell Line Related Services
3.7.1. Cell Banking
3.7.1.1. Classification of Cell Banks
3.7.2. Process Development
3.7.2.1. Upstream Process Development
3.7.2.2. Downstream Process Development
3.7.3. cGMP Manufacturing
3.8. Applications of Cell Lines
3.9. Factors Affecting the Quality of Cell Lines
3.10. Need for Outsourcing Cell Line Related Operations
4. CELL LINE DEVELOPMENT SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Cell Line Development Service Providers: List of Players
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Source of Cell Line and Expression System Offered
4.2.5. Analysis by Types of Services Offered
4.2.5.1. Integrated Cell Line Characterization
4.2.5.2. Biosimilar Cell Line Development
4.2.5.3. Genetically Modified Cell Line Development
4.2.6. Analysis by Gene Delivery Method Used
4.2.7. Analysis by Type of Gene Expression
4.2.8. Analysis by Availability of Serum-Free / Animal Component Free Culturing Capabilities
4.2.9. Analysis by Types of Cell Cultures
4.2.10. Analysis by Types of Cells
4.2.11. Analysis by Applications of Cell Lines
4.2.12. Analysis by Availability of Additional Cell Line Related Services
4.2.13. Analysis by Type of Cell Bank(s) Developed
4.2.14. Geographical Presence Analysis of Companies (offering multiple cell lines) by Sources of Cell Lines and Company Size
4.2.14.1. North America
4.2.14.2. Europe
4.2.14.3. Asia-Pacific
4.2.15. Geographical Presence Analysis of Companies (offering a single cell line) by Source of Cell Line and Company Size
4.2.16. Heat Map Analysis: Analysis by Year of Establishment, Location of Headquarters and Additional Cell Line Related Services
4.2.17. Heat Map Analysis: Distribution by Location of Headquarters and Combinations of Sources of Cell Lines Offered
4.2.18. Information on Protein Yield from Cell Lines
5. CELL LINE DEVELOPMENT SERVICE PROVIDERS: COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Methodology
5.3. Assumptions / Key Parameters
5.3.1. Company Competitiveness Analysis: Cell Line Development Service Providers in North America
5.3.2. Company Competitiveness Analysis: Cell Line Development Service Providers in Europe
5.3.3. Company Competitiveness Analysis: Cell Line Development Service Providers in Asia-Pacific
5.4. Summary
6. COMPANY PROFILES: CELL LINE DEVELOPMENT SERVICE PROVIDERS
6.1. Chapter Overview
6.2. Cell Line Development Service Providers: North America
6.2.1. Creative Biogene
6.2.1.1. Company Overview
6.2.1.2. Service Portfolio
6.2.1.3. Recent Developments and Future Outlook
6.2.2. Creative Biolabs
6.2.2.1. Company Overview
6.2.2.2. Service Portfolio
6.2.2.3. Recent Developments and Future Outlook
6.2.3. Hyprocell
6.2.3.1. Company Overview
6.2.3.2. Service Portfolio
6.2.3.3. Recent Developments and Future Outlook
6.2.4. LakePharma
6.2.4.1. Company Overview
6.2.4.2. Service Portfolio
6.2.4.3. Recent Developments and Future Outlook
6.2.5. Thermo Fisher Scientific
6.2.5.1. Company Overview
6.2.5.2. Financial Information
6.2.5.3. Service Portfolio
6.2.5.4. Recent Developments and Future Outlook
6.3. Cell Line Development Service Providers: Europe
6.3.1. FUJIFILM Diosynth Biotechnologies
6.3.1.1. Company Overview
6.3.1.2. Service Portfolio
6.3.1.3. Recent Developments and Future Outlook
6.3.2. Lonza
6.3.2.1. Company Overview
6.3.2.2. Financial Information
6.3.2.3. Service Portfolio
6.3.2.4. Recent Developments and Future Outlook
6.3.3. ProBioGen
6.3.3.1. Company Overview
6.3.3.2. Service Portfolio
6.3.3.3. Recent Developments and Future Outlook
6.3.4. Polpharma Biologics
6.3.4.1. Company Overview
6.3.4.2. Service Portfolio
6.3.4.3. Recent Developments and Future Outlook
6.3.5. Selexis
6.3.5.1. Company Overview
6.3.5.2. Service Portfolio
6.3.5.3. Recent Developments and Future Outlook
6.4. Cell Line Development Service Providers: Asia-Pacific
6.4.1. Detai Bio-Tech
6.4.1.1. Company Overview
6.4.1.2. Service Portfolio
6.4.1.3. Recent Developments and Future Outlook
6.4.2. WuXi Biologics
6.4.2.1. Company Overview
6.4.2.2. Financial Information
6.4.2.3. Service Portfolio
6.4.2.4. Recent Developments and Future Outlook
7. CELL LINE CHARACTERIZATION SERVICE PROVIDERS: MARKET LANDSCAPE
7.1. Chapter Overview
7.2. Cell Line Characterization Service Providers: Overall Market Landscape
7.2.1. Cell Line Characterization Service Providers: Industry Players
7.2.1.1. Analysis by Year of Establishment
7.2.1.2. Analysis by Company Size
7.2.1.3. Analysis by Location of Headquarters
7.2.1.4. Analysis by Types of Cells Handled
7.2.1.5. Analysis by Type of Cell Line Characterization Service(s) Offered
7.2.1.6. Analysis by Type of Cell Line Identity / Stability Testing Service(s) Offered
7.2.1.7. Analysis by Type of Sterility / Biosafety Testing Service(s) Offered
7.2.1.8. Analysis by Availability of Additional Cell Line Related Services
7.2.1.9. Geographical Presence Analysis of Companies (offering multiple cell lines) by Location of Headquarters
7.2.2. Cell Line Characterization Service Providers: Non-Industry Players
7.2.2.1. Analysis by Service Location
7.2.2.2. Analysis by Types of Cells Handled
7.2.2.3. Analysis by Type of Cell Line Characterization Service(s) Offered
7.2.2.4. Analysis by Number of STR Loci Amplified
7.2.2.5. Analysis by Type of Genotyping Kit(s) Used
8. CELL LINE CHARACTERIZATION SERVICE PROVIDERS: COMPANY COMPETITIVENESS ANALYSIS
8.1. Chapter Overview
8.2. Methodology
8.3. Assumptions / Key Parameters
8.3.1. Company Competitiveness Analysis: Cell Line Characterization Service Providers in North America
8.3.2. Company Competitiveness Analysis: Cell Line Characterization Service Providers in Europe
8.3.3. Company Competitiveness Analysis: Cell Line Characterization Service Providers in Asia-Pacific
8.4. Summary
9. COMPANY PROFILES: CELL LINE CHARACTERIZATION SERVICE PROVIDERS
9.1. Chapter Overview
9.2. Cell Line Characterization Service Providers: North America
9.2.1. BioReliance
9.2.1.1. Company Overview
9.2.1.2. Service Portfolio
9.2.1.3. Recent Developments and Future Outlook
9.2.2. Charles River Laboratories
9.2.2.1. Company Overview
9.2.2.3. Financial Information
9.2.2.2. Service Portfolio
9.2.2.3. Recent Developments and Future Outlook
9.2.3. Molecular Diagnostic Services
9.2.3.1. Company Overview
9.2.3.2. Service Portfolio
9.2.3.3. Recent Developments and Future Outlook
9.3. Cell Line Characterization Service Providers: Europe
9.3.1. Eurofins BioPharma Product Testing
9.3.1.1. Company Overview
9.3.1.2. Service Portfolio
9.3.1.3. Recent Developments and Future Outlook
9.3.2. Sartorius Stedim Biotech
9.3.2.1. Company Overview
9.3.2.2. Financial Information
9.3.2.3. Service Portfolio
9.3.2.4. Recent Developments and Future Outlook
9.3.3. SGS
9.3.3.1. Company Overview
9.3.3.2. Service Portfolio
9.3.3.3. Recent Developments and Future Outlook
9.4. Cell Line Characterization Service Providers: Asia-Pacific
9.4.1. LivoGen Pharmed
9.4.1.1. Company Overview
9.4.1.2. Service Portfolio
9.4.1.3. Recent Developments and Future Outlook
9.4.2. TFBS Bioscience
9.4.2.1. Company Overview
9.4.2.2. Service Portfolio
9.4.2.3. Recent Developments and Future Outlook
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Chapter Overview
10.2. Partnership Models
10.3. Cell Line Development and Characterization Service Providers: List of Partnerships and Collaborations
10.4. Analysis by Year of Partnership
10.5. Analysis by Type of Partnership
10.6. Analysis by Types of Cells Involved
10.7. Analysis by Type of Technology Platform Used
10.8. Analysis by Type of Indication
10.9. Analysis by Year of Partnership and Type of Partner
10.10. Analysis by Type of Partnership and Type of Partner
10.11. Most Active Players: Analysis by Number of Partnerships
10.12. Regional Analysis
10.13. Intercontinental and Intracontinental Agreements
11. CELL LINE REPOSITORIES
11.1. Chapter Overview
11.2. American Type Culture Collection (ATCC)
11.2.1. Overview
11.2.2. Service Portfolio
11.3. European Collection of Authenticated Cell Cultures (ECACC)
11.3.1. Overview
11.3.2. Service Portfolio
11.4. Leibniz Institute DSMZ
11.4.1. Overview
11.4.2. Service Portfolio
11.5. Coriell Institute for Medical Research
11.5.1. Overview
11.5.1.1. Service Portfolio
12. REGULATORY RECOMMENDATIONS AND GUIDELINES
12.1. Chapter Overview
12.2. History of Cell Line Authentication
12.3. Cell Line Authentication: Prominent Regulatory Authorities
12.3.1. Role of American Type Culture Collection (ATCC)
12.3.2. Role of International Cell Line Authentication Committee (ICLAC)
12.3.3. Role of Global Biological Standards Institute (GBSI)
12.4. Guidelines Issued by International Regulatory Agencies for Cell Line Characterization
12.4.1. World Health Organization (WHO)
12.4.2. The International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use
12.5. Regulatory Guidelines for Cell Line Characterization in the US
12.6. Regulatory Guidelines for Cell Line Characterization in Europe
12.7. Regulatory Guidelines for Cell Line Characterization in Japan
13. CELL LINE DEVELOPMENT SERVICES: MARKET SIZING AND OPPORTUNITY ANALYSIS
13.1. Chapter Overview
13.2. Forecast Methodology and Key Assumptions
13.3. Overall Cell Line Development Services Market, 2020-2035
13.4. Cell Line Development Services Market, 2020-2035: Distribution by Sources of Cell Lines and Expression Systems Used
13.5. Cell Line Development Services Market, 2020-2035: Distribution by Applications
13.6. Cell Line Development Services Market, 2020-2035: Distribution by Company Size
13.7. Cell Line Development Services Market, 2020-2035: Distribution by Geography
13.7.1. Cell Line Development Services Market in North America, 2020-2035
13.7.1.1. Cell Line Development Services Market in North America, 2020-2035: Share of Small-sized Companies
13.7.1.2. Cell Line Development Services Market in North America, 2020-2035: Share of Mid-sized Companies
13.7.1.3. Cell Line Development Services Market in North America, 2020-2035: Share of Large Companies
13.7.1.4. Cell Line Development Services Market in North America, 2020-2035: Share of Research and Development Operations
13.7.1.5. Cell Line Development Services Market in North America, 2020-2035: Share of Drug Development Operations
13.7.2. Cell Line Development Services Market in Europe, 2020-2035
13.7.2.1. Cell Line Development Services Market in Europe, 2020-2035: Share of Small-sized Companies
13.7.2.2. Cell Line Development Services Market in Europe, 2020-2035: Share of Mid-sized Companies
13.7.2.3. Cell Line Development Services Market in Europe, 2020-2035: Share of Large Companies
13.7.2.4. Cell Line Development Services Market in Europe, 2020-2035: Share of Research and Development Operations
13.7.2.5. Cell Line Development Services Market in Europe, 2020-2035: Share of Drug Development Operations
13.7.2. Cell Line Development Services Market in Asia, 2020-2035
13.7.2.1. Cell Line Development Services Market in Asia, 2020-2035: Share of Small-sized Companies
13.7.2.2. Cell Line Development Services Market in Asia, 2020-2035: Share of Mid-sized Companies
13.7.2.3. Cell Line Development Services Market in Asia, 2020-2035: Share of Large Companies
13.7.2.4. Cell Line Development Services Market in Asia, 2020-2035: Share of Research and Development Operations
13.7.2.5. Cell Line Development Services Market in Asia, 2020-2035: Share of Drug Development Operations
13.7.3. Cell Line Development Services Market in Oceania, 2020-2035
13.7.3.1. Cell Line Development Services Market in Oceania, 2020-2035: Share of Small-sized Companies
13.7.3.2. Cell Line Development Services Market in Oceania, 2020-2035: Share of Mid-sized Companies
13.7.3.3. Cell Line Development Services Market in Oceania, 2020-2035: Share of Large Companies
13.7.3.4. Cell Line Development Services Market in Oceania, 2020-2035: Share of Research and Development Operations
13.7.3.5. Cell Line Development Services Market in Oceania, 2020-2035: Share of Drug Development Operations
13.7.4. Cell Line Development Services Market in Rest of the World, 2020-2035
13.7.4.1. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Small-sized Companies
13.7.4.2. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Mid-sized Companies
13.7.4.3. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Large Companies
13.7.4.4. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Research and Development Operations
13.7.4.5. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Drug Development Operations
14. CELL LINE CHARACTERIZATION SERVICES: MARKET SIZING AND OPPORTUNITY ANALYSIS
14.1. Chapter Overview
14.2. Forecast Methodology and Key Assumptions
14.3. Overall Cell Line Characterization Services Market, 2020-2035
14.4. Cell Line Characterization Services Market, 2020-2035: Distribution by Sources of Cell Lines
14.5. Cell Line Characterization Services Market, 2020-2035: Distribution by Geography
14.6. Cell Line Characterization Services Market, 2020-2035: Distribution by Type of Industry
14.7. Cell Line Characterization Services Market, 2020-2035: Distribution by Stage of Development of Biologics
15. EXECUTIVE INSIGHTS
15.1. Chapter Overview
15.2. Northway Biotech
15.2.1. Company Snapshot
15.2.2. Interview Transcript: Virgilijus Kupinas, Marketing and Business Development Coordinator (Q4 2020)
15.3. QuaCell Biotechnology
15.3.1. Company Snapshot
15.3.2. Interview Transcript: Fai Poon, Founder and President (Q3 2020)
15.4. Polpharma Biologics
15.4.1. Company Snapshot
15.4.2. Interview Transcript: Louis Boon, Chief Scientific Officer (Q3 2020)
15.5. LakePharma
15.5.1. Company Snapshot
15.5.2. Interview Transcript: Fan Chen, Former Vice President BioProcessing (Q3 2017)
15.6. ARTES Biotechnology
15.6.1. Company Snapshot
15.6.2. Interview Transcript: Michael Pointek, Founder and Managing Director (Q3 2017)
15.7. ImmunoPrecise Antibodies
15.7.1. Company Snapshot
15.7.2. Interview Transcript: Nienke Smits, Client Relations Manager (Q3 2017)
15.8. Bioceros (acquired by Polpharma Biologics)
15.8.1. Interview Transcript: Oscar Hoogteijling, Former Global Business Development Manager (Q3 2017)
16. SURVEY ANALYSIS
16.1. Chapter Overview
16.2. Overview of Respondents
16.3. Designation of Respondents
16.4. Survey Insights
16.4.1. Type of Cell Line Offered
16.4.2. Source of Cell Line
16.4.3. Applications of Cell Lines
16.4.4. Cell Line Characterization Services
16.4.5. Cell Banking Services
16.4.6. Biologics Manufacturing Services
16.4.7. Fill / Finish Services
17. CONCLUDING REMARKS
17.1. Chapter Overview
17.2. Key Takeaways
18. APPENDIX 1: TABULATED DATA
19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
1.1. Scope of the Report
1.2. Key Questions Answered
1.3. Research Methodology
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Cell Culture
3.2.1. Types of Cell Cultures by Origin
3.2.1.1. Primary Cell Cultures
3.2.1.2. Secondary Cell Cultures
3.2.2. Types of Cell Cultures by Growth Properties
3.2.2.1. Adherent Cell Cultures
3.2.2.2. Suspension Cell Cultures
3.2.3. Classification by Types of Cell Lines
3.2.3.1. Finite Cell Lines
3.2.3.2. Continuous Cell Lines
3.2.3.3. Recombinant Cell Lines
3.2.3.4. Hybridoma Cell Lines
3.3.4. Classification by Sources of Cell Lines
3.3.4.1. Mammalian Cell Lines
3.3.4.2. Non-Mammalian Cell Lines
3.5. Overview of Cell Line Development
3.5.1. Recombinant Cell Line Development
3.5.1.1. Vector Construction
3.5.1.2. Transgene Delivery into Host Cells
3.5.1.3. Cell Line Selection and Gene Amplification
3.5.1.4. Clone Selection
3.5.1.5. Stability Studies
3.6.2. Hybridoma Cell Line Development
3.7. Overview of Cell Line Characterization
3.7.1. Identity Testing
3.7.1.1. Karyotype Analysis
3.7.1.2. Isozyme Analysis
3.7.1.3. Cytochrome C Oxidase 1 Barcoding Assay
3.7.1.4. Phenotype Analysis
3.7.1.5. DNA Fingerprinting
3.7.1.6. DNA Profiling
3.8.2. Genetic Stability Testing
3.8.3. Sterility / Biosafety Testing
3..3.1. MYCOPLASMA CONTAMINATION TESTING
3.6.3.2. Viral Contamination Testing
3.6.3.3. Other Sterility Testing Methods
3.7. Additional Cell Line Related Services
3.7.1. Cell Banking
3.7.1.1. Classification of Cell Banks
3.7.2. Process Development
3.7.2.1. Upstream Process Development
3.7.2.2. Downstream Process Development
3.7.3. cGMP Manufacturing
3.8. Applications of Cell Lines
3.9. Factors Affecting the Quality of Cell Lines
3.10. Need for Outsourcing Cell Line Related Operations
4. CELL LINE DEVELOPMENT SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Cell Line Development Service Providers: List of Players
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Source of Cell Line and Expression System Offered
4.2.5. Analysis by Types of Services Offered
4.2.5.1. Integrated Cell Line Characterization
4.2.5.2. Biosimilar Cell Line Development
4.2.5.3. Genetically Modified Cell Line Development
4.2.6. Analysis by Gene Delivery Method Used
4.2.7. Analysis by Type of Gene Expression
4.2.8. Analysis by Availability of Serum-Free / Animal Component Free Culturing Capabilities
4.2.9. Analysis by Types of Cell Cultures
4.2.10. Analysis by Types of Cells
4.2.11. Analysis by Applications of Cell Lines
4.2.12. Analysis by Availability of Additional Cell Line Related Services
4.2.13. Analysis by Type of Cell Bank(s) Developed
4.2.14. Geographical Presence Analysis of Companies (offering multiple cell lines) by Sources of Cell Lines and Company Size
4.2.14.1. North America
4.2.14.2. Europe
4.2.14.3. Asia-Pacific
4.2.15. Geographical Presence Analysis of Companies (offering a single cell line) by Source of Cell Line and Company Size
4.2.16. Heat Map Analysis: Analysis by Year of Establishment, Location of Headquarters and Additional Cell Line Related Services
4.2.17. Heat Map Analysis: Distribution by Location of Headquarters and Combinations of Sources of Cell Lines Offered
4.2.18. Information on Protein Yield from Cell Lines
5. CELL LINE DEVELOPMENT SERVICE PROVIDERS: COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Methodology
5.3. Assumptions / Key Parameters
5.3.1. Company Competitiveness Analysis: Cell Line Development Service Providers in North America
5.3.2. Company Competitiveness Analysis: Cell Line Development Service Providers in Europe
5.3.3. Company Competitiveness Analysis: Cell Line Development Service Providers in Asia-Pacific
5.4. Summary
6. COMPANY PROFILES: CELL LINE DEVELOPMENT SERVICE PROVIDERS
6.1. Chapter Overview
6.2. Cell Line Development Service Providers: North America
6.2.1. Creative Biogene
6.2.1.1. Company Overview
6.2.1.2. Service Portfolio
6.2.1.3. Recent Developments and Future Outlook
6.2.2. Creative Biolabs
6.2.2.1. Company Overview
6.2.2.2. Service Portfolio
6.2.2.3. Recent Developments and Future Outlook
6.2.3. Hyprocell
6.2.3.1. Company Overview
6.2.3.2. Service Portfolio
6.2.3.3. Recent Developments and Future Outlook
6.2.4. LakePharma
6.2.4.1. Company Overview
6.2.4.2. Service Portfolio
6.2.4.3. Recent Developments and Future Outlook
6.2.5. Thermo Fisher Scientific
6.2.5.1. Company Overview
6.2.5.2. Financial Information
6.2.5.3. Service Portfolio
6.2.5.4. Recent Developments and Future Outlook
6.3. Cell Line Development Service Providers: Europe
6.3.1. FUJIFILM Diosynth Biotechnologies
6.3.1.1. Company Overview
6.3.1.2. Service Portfolio
6.3.1.3. Recent Developments and Future Outlook
6.3.2. Lonza
6.3.2.1. Company Overview
6.3.2.2. Financial Information
6.3.2.3. Service Portfolio
6.3.2.4. Recent Developments and Future Outlook
6.3.3. ProBioGen
6.3.3.1. Company Overview
6.3.3.2. Service Portfolio
6.3.3.3. Recent Developments and Future Outlook
6.3.4. Polpharma Biologics
6.3.4.1. Company Overview
6.3.4.2. Service Portfolio
6.3.4.3. Recent Developments and Future Outlook
6.3.5. Selexis
6.3.5.1. Company Overview
6.3.5.2. Service Portfolio
6.3.5.3. Recent Developments and Future Outlook
6.4. Cell Line Development Service Providers: Asia-Pacific
6.4.1. Detai Bio-Tech
6.4.1.1. Company Overview
6.4.1.2. Service Portfolio
6.4.1.3. Recent Developments and Future Outlook
6.4.2. WuXi Biologics
6.4.2.1. Company Overview
6.4.2.2. Financial Information
6.4.2.3. Service Portfolio
6.4.2.4. Recent Developments and Future Outlook
7. CELL LINE CHARACTERIZATION SERVICE PROVIDERS: MARKET LANDSCAPE
7.1. Chapter Overview
7.2. Cell Line Characterization Service Providers: Overall Market Landscape
7.2.1. Cell Line Characterization Service Providers: Industry Players
7.2.1.1. Analysis by Year of Establishment
7.2.1.2. Analysis by Company Size
7.2.1.3. Analysis by Location of Headquarters
7.2.1.4. Analysis by Types of Cells Handled
7.2.1.5. Analysis by Type of Cell Line Characterization Service(s) Offered
7.2.1.6. Analysis by Type of Cell Line Identity / Stability Testing Service(s) Offered
7.2.1.7. Analysis by Type of Sterility / Biosafety Testing Service(s) Offered
7.2.1.8. Analysis by Availability of Additional Cell Line Related Services
7.2.1.9. Geographical Presence Analysis of Companies (offering multiple cell lines) by Location of Headquarters
7.2.2. Cell Line Characterization Service Providers: Non-Industry Players
7.2.2.1. Analysis by Service Location
7.2.2.2. Analysis by Types of Cells Handled
7.2.2.3. Analysis by Type of Cell Line Characterization Service(s) Offered
7.2.2.4. Analysis by Number of STR Loci Amplified
7.2.2.5. Analysis by Type of Genotyping Kit(s) Used
8. CELL LINE CHARACTERIZATION SERVICE PROVIDERS: COMPANY COMPETITIVENESS ANALYSIS
8.1. Chapter Overview
8.2. Methodology
8.3. Assumptions / Key Parameters
8.3.1. Company Competitiveness Analysis: Cell Line Characterization Service Providers in North America
8.3.2. Company Competitiveness Analysis: Cell Line Characterization Service Providers in Europe
8.3.3. Company Competitiveness Analysis: Cell Line Characterization Service Providers in Asia-Pacific
8.4. Summary
9. COMPANY PROFILES: CELL LINE CHARACTERIZATION SERVICE PROVIDERS
9.1. Chapter Overview
9.2. Cell Line Characterization Service Providers: North America
9.2.1. BioReliance
9.2.1.1. Company Overview
9.2.1.2. Service Portfolio
9.2.1.3. Recent Developments and Future Outlook
9.2.2. Charles River Laboratories
9.2.2.1. Company Overview
9.2.2.3. Financial Information
9.2.2.2. Service Portfolio
9.2.2.3. Recent Developments and Future Outlook
9.2.3. Molecular Diagnostic Services
9.2.3.1. Company Overview
9.2.3.2. Service Portfolio
9.2.3.3. Recent Developments and Future Outlook
9.3. Cell Line Characterization Service Providers: Europe
9.3.1. Eurofins BioPharma Product Testing
9.3.1.1. Company Overview
9.3.1.2. Service Portfolio
9.3.1.3. Recent Developments and Future Outlook
9.3.2. Sartorius Stedim Biotech
9.3.2.1. Company Overview
9.3.2.2. Financial Information
9.3.2.3. Service Portfolio
9.3.2.4. Recent Developments and Future Outlook
9.3.3. SGS
9.3.3.1. Company Overview
9.3.3.2. Service Portfolio
9.3.3.3. Recent Developments and Future Outlook
9.4. Cell Line Characterization Service Providers: Asia-Pacific
9.4.1. LivoGen Pharmed
9.4.1.1. Company Overview
9.4.1.2. Service Portfolio
9.4.1.3. Recent Developments and Future Outlook
9.4.2. TFBS Bioscience
9.4.2.1. Company Overview
9.4.2.2. Service Portfolio
9.4.2.3. Recent Developments and Future Outlook
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Chapter Overview
10.2. Partnership Models
10.3. Cell Line Development and Characterization Service Providers: List of Partnerships and Collaborations
10.4. Analysis by Year of Partnership
10.5. Analysis by Type of Partnership
10.6. Analysis by Types of Cells Involved
10.7. Analysis by Type of Technology Platform Used
10.8. Analysis by Type of Indication
10.9. Analysis by Year of Partnership and Type of Partner
10.10. Analysis by Type of Partnership and Type of Partner
10.11. Most Active Players: Analysis by Number of Partnerships
10.12. Regional Analysis
10.13. Intercontinental and Intracontinental Agreements
11. CELL LINE REPOSITORIES
11.1. Chapter Overview
11.2. American Type Culture Collection (ATCC)
11.2.1. Overview
11.2.2. Service Portfolio
11.3. European Collection of Authenticated Cell Cultures (ECACC)
11.3.1. Overview
11.3.2. Service Portfolio
11.4. Leibniz Institute DSMZ
11.4.1. Overview
11.4.2. Service Portfolio
11.5. Coriell Institute for Medical Research
11.5.1. Overview
11.5.1.1. Service Portfolio
12. REGULATORY RECOMMENDATIONS AND GUIDELINES
12.1. Chapter Overview
12.2. History of Cell Line Authentication
12.3. Cell Line Authentication: Prominent Regulatory Authorities
12.3.1. Role of American Type Culture Collection (ATCC)
12.3.2. Role of International Cell Line Authentication Committee (ICLAC)
12.3.3. Role of Global Biological Standards Institute (GBSI)
12.4. Guidelines Issued by International Regulatory Agencies for Cell Line Characterization
12.4.1. World Health Organization (WHO)
12.4.2. The International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use
12.5. Regulatory Guidelines for Cell Line Characterization in the US
12.6. Regulatory Guidelines for Cell Line Characterization in Europe
12.7. Regulatory Guidelines for Cell Line Characterization in Japan
13. CELL LINE DEVELOPMENT SERVICES: MARKET SIZING AND OPPORTUNITY ANALYSIS
13.1. Chapter Overview
13.2. Forecast Methodology and Key Assumptions
13.3. Overall Cell Line Development Services Market, 2020-2035
13.4. Cell Line Development Services Market, 2020-2035: Distribution by Sources of Cell Lines and Expression Systems Used
13.5. Cell Line Development Services Market, 2020-2035: Distribution by Applications
13.6. Cell Line Development Services Market, 2020-2035: Distribution by Company Size
13.7. Cell Line Development Services Market, 2020-2035: Distribution by Geography
13.7.1. Cell Line Development Services Market in North America, 2020-2035
13.7.1.1. Cell Line Development Services Market in North America, 2020-2035: Share of Small-sized Companies
13.7.1.2. Cell Line Development Services Market in North America, 2020-2035: Share of Mid-sized Companies
13.7.1.3. Cell Line Development Services Market in North America, 2020-2035: Share of Large Companies
13.7.1.4. Cell Line Development Services Market in North America, 2020-2035: Share of Research and Development Operations
13.7.1.5. Cell Line Development Services Market in North America, 2020-2035: Share of Drug Development Operations
13.7.2. Cell Line Development Services Market in Europe, 2020-2035
13.7.2.1. Cell Line Development Services Market in Europe, 2020-2035: Share of Small-sized Companies
13.7.2.2. Cell Line Development Services Market in Europe, 2020-2035: Share of Mid-sized Companies
13.7.2.3. Cell Line Development Services Market in Europe, 2020-2035: Share of Large Companies
13.7.2.4. Cell Line Development Services Market in Europe, 2020-2035: Share of Research and Development Operations
13.7.2.5. Cell Line Development Services Market in Europe, 2020-2035: Share of Drug Development Operations
13.7.2. Cell Line Development Services Market in Asia, 2020-2035
13.7.2.1. Cell Line Development Services Market in Asia, 2020-2035: Share of Small-sized Companies
13.7.2.2. Cell Line Development Services Market in Asia, 2020-2035: Share of Mid-sized Companies
13.7.2.3. Cell Line Development Services Market in Asia, 2020-2035: Share of Large Companies
13.7.2.4. Cell Line Development Services Market in Asia, 2020-2035: Share of Research and Development Operations
13.7.2.5. Cell Line Development Services Market in Asia, 2020-2035: Share of Drug Development Operations
13.7.3. Cell Line Development Services Market in Oceania, 2020-2035
13.7.3.1. Cell Line Development Services Market in Oceania, 2020-2035: Share of Small-sized Companies
13.7.3.2. Cell Line Development Services Market in Oceania, 2020-2035: Share of Mid-sized Companies
13.7.3.3. Cell Line Development Services Market in Oceania, 2020-2035: Share of Large Companies
13.7.3.4. Cell Line Development Services Market in Oceania, 2020-2035: Share of Research and Development Operations
13.7.3.5. Cell Line Development Services Market in Oceania, 2020-2035: Share of Drug Development Operations
13.7.4. Cell Line Development Services Market in Rest of the World, 2020-2035
13.7.4.1. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Small-sized Companies
13.7.4.2. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Mid-sized Companies
13.7.4.3. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Large Companies
13.7.4.4. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Research and Development Operations
13.7.4.5. Cell Line Development Services Market in Rest of the World, 2020-2035: Share of Drug Development Operations
14. CELL LINE CHARACTERIZATION SERVICES: MARKET SIZING AND OPPORTUNITY ANALYSIS
14.1. Chapter Overview
14.2. Forecast Methodology and Key Assumptions
14.3. Overall Cell Line Characterization Services Market, 2020-2035
14.4. Cell Line Characterization Services Market, 2020-2035: Distribution by Sources of Cell Lines
14.5. Cell Line Characterization Services Market, 2020-2035: Distribution by Geography
14.6. Cell Line Characterization Services Market, 2020-2035: Distribution by Type of Industry
14.7. Cell Line Characterization Services Market, 2020-2035: Distribution by Stage of Development of Biologics
15. EXECUTIVE INSIGHTS
15.1. Chapter Overview
15.2. Northway Biotech
15.2.1. Company Snapshot
15.2.2. Interview Transcript: Virgilijus Kupinas, Marketing and Business Development Coordinator (Q4 2020)
15.3. QuaCell Biotechnology
15.3.1. Company Snapshot
15.3.2. Interview Transcript: Fai Poon, Founder and President (Q3 2020)
15.4. Polpharma Biologics
15.4.1. Company Snapshot
15.4.2. Interview Transcript: Louis Boon, Chief Scientific Officer (Q3 2020)
15.5. LakePharma
15.5.1. Company Snapshot
15.5.2. Interview Transcript: Fan Chen, Former Vice President BioProcessing (Q3 2017)
15.6. ARTES Biotechnology
15.6.1. Company Snapshot
15.6.2. Interview Transcript: Michael Pointek, Founder and Managing Director (Q3 2017)
15.7. ImmunoPrecise Antibodies
15.7.1. Company Snapshot
15.7.2. Interview Transcript: Nienke Smits, Client Relations Manager (Q3 2017)
15.8. Bioceros (acquired by Polpharma Biologics)
15.8.1. Interview Transcript: Oscar Hoogteijling, Former Global Business Development Manager (Q3 2017)
16. SURVEY ANALYSIS
16.1. Chapter Overview
16.2. Overview of Respondents
16.3. Designation of Respondents
16.4. Survey Insights
16.4.1. Type of Cell Line Offered
16.4.2. Source of Cell Line
16.4.3. Applications of Cell Lines
16.4.4. Cell Line Characterization Services
16.4.5. Cell Banking Services
16.4.6. Biologics Manufacturing Services
16.4.7. Fill / Finish Services
17. CONCLUDING REMARKS
17.1. Chapter Overview
17.2. Key Takeaways
18. APPENDIX 1: TABULATED DATA
19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
