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Report Description
Cross contamination and cell line misidentification are some of the major concerns associated with the use of cell lines. According to published literature, cell lines used for scientific experiments are either misidentified or contaminated in approximately 15-25% cases. The use of such cell lines yields unreliable and irreproducible results, and leads to significant delays in research time lines and financial losses. The detrimental impact of using incorrect / misidentified cell lines poses a significant burden on the global healthcare budget. It has been estimated that a net loss of USD 28 billion is incurred every year on research that cannot be replicated due to the involvement of misidentified or contaminated cell lines in the US. Therefore, it is crucial to properly identify and authenticate cell lines used for research, both at the start of a project, as well as during the course of the study. To carry out cell line characterization, factors such as source of cell lines, their development history and the biological properties of cells determine the analytical tests required for characterization.
It is also worth highlighting that several regulatory authorities and scientific communities have undertaken different initiatives to spread awareness on the importance of cell line characterization. Various rules and standards have also been formulated, making it mandatory to characterize cell lines while submitting applications for marketing authorization, for receipt of grants / funds, or for publishing cell-based research in leading journals.
Scope of the Report
The ‘Cell Line Characterization Services Market, 2017-2027’ report features a comprehensive view on the current market landscape and future outlook of testing and / or authentication services for the characterization of cell lines. The report provides information on organizations that offer contract services for the characterization of cell lines. In addition to other elements, the report includes:
One of the key objectives of the report was to understand the existing market size and potential future growth opportunities within this domain. Based on parameters, such as number of projects involving the use of cell lines, source of cell lines, and cost of characterizing different types of cell lines, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2017-2027. To account for the uncertainties associated with the with the characterization of cell lines and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.
The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with Fan Chen (Vice President Bioprocessing, LakePharma), Michael Pointek (Managing Director, ARTES Biotechnology), Nienke Smits (Business Development, ModiQuest) and Oscar Hoogteijling (Business Development Manager, Bioceros). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
Contents
Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of the cell line characterization market in the short-mid and long term.
Chapter 3 provides a general introduction to cell cultures and cell lines. It includes details related to the various types of cell lines, based on their sources of origin, and key characteristics, applications and concerns associated with their use in research. The chapter also outlines the general concepts of cell line characterization along with a detailed description of different types of testing methods used for such purposes. In addition, it also presents an opinion on the need for outsourcing cell line characterization activities.
Chapter 4 features comprehensive study on cell line authentication, highlighting the need for such services. The chapter presents a brief historical overview of how the process has evolved over the years, and the contributions of the ATCC, ICLAC database and GBSI cell authentication alliance related to cell line authentication. It also includes a list of general awareness surveys conducted by various research groups, and an analysis of the competitive landscape, highlighting the most active geographies, in terms of the presence of companies offering such services.
Chapter 5 presents information on the current regulatory landscape of the characterization of cell lines. The chapter highlights the role of various regulatory bodies, such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) and World Health Organization (WHO), and the various regulatory standards and guidelines established / issued by them on the type of tests and general methods to use for the characterization and authentication of cell lines.
Chapter 6 provides details on the contract service providers that are actively offering cell line characterization services. The chapter includes information on their headquarters, and cell line characterization capabilities, including source of cell lines.
Chapter 7 features profiles of biorepositories that are playing an active role in providing cell line characterization services. Each profile provides a brief overview of the organization, and the cell line characterization services offered by them.
Chapter 8 features detailed profiles of the key industry players that are involved in providing services for the characterization of cell lines. Each profile includes a brief overview of the company, its financial performance, overall services portfolio, services offered related to cell line characterizationand a comprehensive future outlook.
Chapter 9 presents a comprehensive market forecast, highlighting the future potential of the market till 2027. The chapter provides detailed market segmentation based on type of cell lines (mammalian, microbial, insects and others), geographical regions (North America, Europe, Asia and rest of the world), type of organization (industry and non-industry), and stage of development (clinical and preclinical).
Chapter 10 is a compilation of key insights gathered from the study. It features a schematic representation on a world map, highlighting the key regional hubs offering cell line characterization services. Further, we have provided a heat map analysis of the distribution of companies involved in this field, based on their location (continent-wise distribution), number of employees and source of cell lines (mammalian, microbial, insect and avian). In addition, the chapter includes a spin wheel analysis of the distribution of industry players on the basis of their location, number of tests and type of tests (identity testing methods, sterility testing methods, stability testing methods and others) offered.
Chapter 11 summarizes the overall report and provides a recap of the key takeaways from the study. It also presents our independent opinion on the current market scenario and trends that are likely to determine the future evolution of this segment of the biopharmaceutical industry.
Chapter 12 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Fan Chen (Vice President Bioprocessing, LakePharma), Michael Pointek (Managing Director, ARTES Biotechnology), Nienke Smits (Business Development, Modiquest) and Oscar Hoogteijling (Business Development Manager, Bioceros).
Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 14 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Introduction to Cell Culture and Cell Lines
3.2.1. Types of Cell Culture
3.2.1.1. Primary Cell Culture
3.2.1.2. Secondary Cell Culture
3.2.2. Prerequisites for Using Cell Lines
3.2.3. 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
3.2.4. Sources of Cell Lines
3.2.4.1. Mammalian
3.2.4.2. Non-Mammalian
3.2.5. Applications of Cell Lines
3.2.6. Key Concerns Associated with Cell Lines
3.3. Cell Banks
3.3.1. Classification of Cell Banks
3.3.1.1. On the Basis of Tiers
3.3.1.2. On the Basis of GMP Status
3.4. Cell Line Characterization
3.4.1. Methods of Cell Line Characterization
3.4.1.1. Identity Testing
3.4.1.2. Sterility Testing
3.4.1.3. Genetic Stability Testing
3.5. Outsourcing of Cell Line Characterization Services
4. CELL LINE AUTHENTICATION
4.1. Chapter Overview
4.2. Need for Cell Line Authentication
4.3. Cell Line Authentication: Historical Timeline
4.4. Cell Line Authentication: Role of American Type Culture Collection (ATCC)
4.5. Cell Line Authentication: Role of International Cell Line Authentication Committee (ICLAC)
4.6. Cell Line Authentication: Role of Global Biological Standards Institute (GBSI)
4.7. Factors Contributing to Cell Line Misidentification
4.8. Awareness Surveys
4.9. STR Profiling Kits
4.10. Cell Line Authentication: Competitive Landscape
5. REGULATORY RECOMMENDATIONS AND GUIDELINE S
5.1. Chapter Overview
5.2. Guidelines Issued by International Regulatory Agencies
5.2.1. World Health Organization (WHO)
5.2.2. The International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use
5.3. Regulatory Guidelines for Cell Line Characterization in the US
5.4. Regulatory Guidelines for Cell Line Characterization in Europe
5.5. Regulatory Guidelines for Cell Line Characterization in Japan
6. COMPETITIVE LANDSCAPE
6.1. Chapter Overview
6.2. Cell Line Characterization Service Providers: Market Landscape (Industry Players)
6.2.1. Distribution by Location
6.2.2. Distribution by Type of Cell Lines
6.2.3. Distribution by Type of Testing Methods
6.3. Cell Line Characterization Service Providers: Market Landscape (Non-Industry Players)
6.3.1. Distribution by Location
6.3.2. Distribution by Type of Cell Lines
6.3.3. Distribution by Type of Testing Methods
6.3.4. Distribution by Type of STR Kits
6.4. Cell Line Characterization Service Providers: Most Prominent Hubs
7. BIOREPOSITORIES
7.1. American Type Culture Collection
7.1.1. Overview
7.1.2. Services Portfolio
7.1.3. Collaborations
7.2. Coriell Institute for Medical Research
7.2.1. Overview
7.2.2. Services Portfolio
7.3. European Collection of Authenticated Cell Cultures
7.3.1. Overview
7.3.2. Services Portfolio
7.3.3. Collaborations
7.4. DSMZ
7.4.1. Overview
7.4.2. Services Portfolio
8. COMPANY PROFILES
8.1. Chapter Overview
8.2. BioReliance (a Part of SAFC Commercial)
8.2.1. Company Overview
8.2.2. Services Portfolio
8.2.3. Future Outlook
8.3. Charles River Laboratories (CRL)
8.3.1. Company Overview
8.3.2. Financial Performance
8.3.3. Services Portfolio
8.3.4. Future Outlook
8.4. Cell Line Genetics
8.4.1. Company Overview
8.4.2. Services Portfolio
8.4.3. Future Outlook
8.5. Eurofins Scientific
8.5.1. Company Overview
8.5.2. Financial Performance
8.5.3. Services Portfolio
8.5.3.1. Services Offered by Eurofins Sinensis (The Netherlands)
8.5.3.2. Services Offered by Eurofins Lancaster Laboratories (US)
8.5.4. Future Outlook
8.6. Molecular Diagnostic Services
8.6.1. Company Overview
8.6.2. Services Portfolio
8.6.3. Future Outlook
8.7. SGS
8.7.1. Company Overview
8.7.2. Financial Performance
8.7.3. Services Portfolio
8.7.4. Future Outlook
8.8. Avance Biosciences
8.9. Biomeva (Acquired by AGC)
8.10. Creative Bioarray
8.11. Livogen Pharmed
8.12. MTI-GlobalStem (a Part of Thermo Fisher Scientific)
8.13. TFBS Bioscience
8.14. Waisman Biomanufacturing
8.15. WuXi AppTec
8.16. Other Players
8.16.1. ARTES Biotechnology
8.16.2. Bioceros
8.16.3. LakePharma
8.16.4. ModiQuest
9. MARKET OPPORTUNITY AND SIZING
9.1. Chapter Overview
9.2. Forecast Methodology
9.3. Input Data Tables and Assumptions
9.4. Cell Line Characterization Services Market Outlook, 2017-2027
9.4.1. Distribution of Future Opportunity by Type of Cell Lines
9.4.2. Distribution of Future Opportunity by Geography
9.4.3. Distribution of Future Opportunity by Type of Industry
9.4.4. Distribution of Future Opportunity by Stage of Development of Biologics
10. KEY INSIGHTS
10.1. Chapter Overview
10.2. Cell Line Characterization Service Providers: Regional Analysis
10.3. Cell Line Characterization Service Providers: Heat Map Analysis (Industry Players)
10.4. Cell Line Characterization Services: Spin Wheel Analysis (Industry Players)
11. CONCLUSION
11.1. Mishandling and Cross Contamination are the Root Causes of Cell Line Misidentification
11.2. Several Initiatives have been Launched by Various Organizations to Overcome such Challenges Associated with Cell Line Related R&D
11.3. Most Service Providers in this Domain Offer Services for the Characterization of Mammalian Cell Lines
11.4. STR Profiling is Considered to be the Current Gold Standard for Authentication of Cell Lines
11.5. Several Contract Service Providers have Added Significant Value Within this Market by Providing High-Quality Cell Line Characterization and Authentication Solutions
11.6. The Market Landscape Features a Mix of Both Industry and Non-Industry Players; the US and Europe are the Most Active Regional Hubs
11.7. Fostered by the Increased Demand for Cell Lines in Life Science Research, the Market is Likely to Witness Steady Growth in the Coming Decade
12. INTERVIEW TRANSCRIPTS
12.1. Chapter Overview
12.2. Fan Chen, Vice President BioProcessing, LakePharma
12.3. Michael Pointek, Managing Director, ARTES Biotechnology
12.4. Nienke Smits, Business Development, ModiQuest
12.5. Oscar Hoogteijling, Business Development Manager, Bioceros
13. APPENDIX 1: TABULATED DATA
14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
Figure 3.1 Primary and Secondary Cell Culture
Figure 3.2 Basic Process for Cell Line Generation
Figure 3.3 Recombinant Cell Line Development
Figure 3.4 Hybridoma Cell Line Development
Figure 3.5 Sources of Non-Mammalian Cell Lines
Figure 3.6 Applications of Cell Lines
Figure 3.7 Factors Affecting the Utility of Cell Lines
Figure 3.8 Process for Master and Working Cell Bank Production
Figure 3.9 Type of Testing Methods for Cell Line Characterization
Figure 3.10 Protocol for Karyotype Preparation
Figure 3.11 DNA Hybridization
Figure 3.12 DNA Fingerprinting
Figure 4.1 GBSI Cell Authentication Survey, 2015: Type of Authentication Tests
Figure 4.2 GBSI Cell Authentication Survey, 2015: Barriers to Cell Line Authentication
Figure 4.3 Cell Line Authentication: Historical Timeline
Figure 4.4 ICLAC Database: Distribution by Type of Cell Lines
Figure 4.5 Cell Line Authentication Service Providers
Figure 5.1 ICH Q5A (R1) Guidelines: Cell Bank Qualification
Figure 5.2 ICH Q5D Guidelines: Cell Bank Characterization
Figure 5.3 FDA Guidelines: Cell Bank Qualification
Figure 5.4 USP 63: Mycoplasma Detection in Cell Banks
Figure 5.5 CFR 610.18: Recommendations for Testing of Cell Lines
Figure 5.6 CFR 113.52: Recommendations for Testing of Cell Banks
Figure 5.7 EP 2.6.7: Recommendations for Mycoplasma Testing of Cell Banks
Figure 5.8 JP: Recommendations for Mycoplasma Testing of Cell Banks
Figure 6.1 Cell Line Characterization Service Providers (Industry Players): Distribution by Geography (Regions)
Figure 6.2 Cell Line Characterization Service Providers (Industry Players): Distribution by Geography (Countries)
Figure 6.3 Cell Line Characterization Service Providers (Industry Players): Distribution by Type of Cell Lines
Figure 6.4 Cell Line Characterization Service Providers (Industry Players): Distribution by Type of Testing Methods
Figure 6.5 Cell Line Characterization Service Providers (Industry Players) Distribution by Type of Testing Methods (Individual Methods)
Figure 6.6 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Location (Regions)
Figure 6.7 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Location (Countries)
Figure 6.8 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Type of Cell Lines
Figure 6.9 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Type of Testing Methods
Figure 6.10 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Type of STR Kits
Figure 6.11 Cell Line Characterization Services: North America, Contract Service Providers Logo Landscape
Figure 6.12 Cell Line Characterization Services: Europe, Contract Service Providers Logo Landscape
Figure 6.13 Cell Line Characterization Services: Asia Pacific, Contract Service Providers Logo Landscape
Figure 7.1 ATCC: Services Portfolio
Figure 7.2 Coriell Institute of Medical Research: Operating Segments
Figure 7.3 Coriell Institute for Medical Research: Services Portfolio
Figure 7.4 ECACC: Biological Material Collection
Figure 7.5 ECACC: Segments Overview
Figure 7.6 DSMZ: History of Establishment and Expansion
Figure 7.7 DSMZ: Biological Material Collection
Figure 7.8 DSMZ: Cell Line Characterization Services
Figure 8.1 BioReliance: History
Figure 8.2 BioReliance: Services Portfolio
Figure 8.3 BioReliance: Cell Line Characterization Services
Figure 8.4 CRL: Business Segments Overview
Figure 8.5 CRL: Annual Revenues, FY 2012-H1 2017 (USD Billion)
Figure 8.6 CRL: Revenues by Business Segments, 2016 (USD Billion)
Figure 8.7 CRL: Services Portfolio
Figure 8.8 CRL: Cell Line Characterization Services: Overview
Figure 8.9 CRL: Testing Services for Cell Lines Derived from Different Species
Figure 8.10 CRL: Manufacturing and Characterization of Mammalian Cell Bank - Timeline
Figure 8.11 CRL: Manufacturing and Characterization of Microbial Cell Bank - Timeline
Figure 8.12 Eurofins Scientific: Annual Revenues, FY 2012-Q1 2017 (EUR Billion)
Figure 8.13 Eurofins Scientific: Revenues by Geography, 2016 (%)
Figure 8.14 Eurofins Sinensis: Services Portfolio
Figure 8.15 Eurofins Sinensis: Cell Line / Bank Characterization Services
Figure 8.16 Eurofins Lancaster Laboratories: Services Portfolio
Figure 8.17 Eurofins Lancaster Laboratories: Cell Line / Bank Characterization Services
Figure 8.18 Molecular Diagnostic Services: Services Portfolio
Figure 8.19 Molecular Diagnostic Services: Microbial Cell Bank Characterization Services
Figure 8.20 Molecular Diagnostic Services: Yeast Cell Bank Characterization Services
Figure 8.21 SGS: Annual Revenues, 2012-H1 2017 (CHF Billion)
Figure 8.22 SGS: Revenues by Geography, 2016 (%)
Figure 8.23 SGS: Services Portfolio
Figure 8.24 SGS: Segments Overview
Figure 8.25 SGS: Cell Line Characterization Services
Figure 9.1 Cell Line Characterization Services Market, 2017-2027 (USD Billion)
Figure 9.2 Cell Line Characterization Services Market, 2017-2027: Distribution by Type of Cell Lines (USD Billion)
Figure 9.3 Cell Line Characterization Services Market, 2017-2027: Distribution by Geographical Regions (USD Billion)
Figure 9.4 Cell Line Characterization Services Market, 2017-2027: Distribution by Type of Industry (USD Billion)
Figure 9.5 Cell Line Characterization Services Market, 2017-2027: Distribution by Stage of Development of Biologics (USD Billion)
Figure 10.1 Cell Line Characterization Service Providers: Regional Landscape
Figure 10.2 Cell Line Characterization Service Providers: Heat Map Analysis (Industry Players)
Figure 10.3 Cell Line Characterization Service Providers: Spin Wheel Analysis (Industry Players)
Figure 11.1 Overall Cell Line Characterization Services Market: Conservative, Base and Optimistic Scenarios, 2017, 2022 and 2027 (USD Billion)
Table 3.1 Comparison of Properties of Finite and Continuous Cell line
Table 3.2 Most Common Mammalian Cell Lines
Table 3.3 Human Cell Lines and Therapeutic Protein Products
Table 3.4 Cell Lines and Viral Vaccine Products
Table 4.1 List of Journals with Mandatory Requirement of Cell Line Authentication for Research Submissions
Table 4.2 ICLAC: Partner Organizations
Table 4.3 STR Profiling Kits
Table 5.1 WHO Recommendations: Cell Bank Characterization
Table 5.2 Regulatory Documents for Cell Line Characterization in the US
Table 5.3 USP 1050: Virus Testing in Cell Banks
Table 5.4 EP 5.2.3: Testing in Cell Banks
Table 6.1 Cell Line Characterization Service Providers (Industry Players): Distribution by Geography and Type of Cell Lines
Table 6.2 Cell Line Characterization Service Providers (Industry Players): Distribution by Testing Methods
Table 6.3 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Geography and Type of Cell Lines
Table 6.4 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Type of Testing Methods
Table 7.1 ATCC: Overview
Table 7.2 ECACC: Overview
Table 7.3 DSMZ: Overview
Table 8.1 BioReliance: Company Overview
Table 8.2 CRL: Company Overview
Table 8.3 Cell Line Genetics: Company Overview
Table 8.4 Cell Line Genetics: Testing Services for Cell Lines Derived from Different Species
Table 8.5 Eurofins Scientific: Company Overview
Table 8.6 Molecular Diagnostic Services: Company Overview
Table 8.7 Molecular Diagnostic Services: Mammalian Cell Bank Characterization Services
Table 8.8 SGS: Company Overview
Table 9.1 Input Data and Assumptions: Cost of Cell Line Characterization by Type and Grade of Cell Line
Table 9.2 Input Data and Assumptions: Distribution of Source of Cell Lines by Biopharmaceuticals Produced
Table 13.1 GBSI Cell Authentication Survey, 2015: Type of Authentication Tests
Table 13.2 GBSI Cell Authentication Survey, 2015: Barriers to Cell Line Authentication
Table 13.3 ICLAC Database: Distribution by Type of Cell Lines
Table 13.4 Cell Line Characterization Service Providers (Industry Players): Distribution by Location
Table 13.5 Cell Line Characterization Service Providers (Industry Players): Distribution by Type of Cell Lines
Table 13.6 Cell Line Characterization Service Providers (Industry Players): Distribution by Type of Testing Methods
Table 13.7 Cell Line Characterization Service Providers (Industry Players) Distribution by Type of Testing Methods (Individual Methods)
Table 13.8 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Location
Table 13.9 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Type of Cell Lines
Table 13.10 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Type of Testing Methods
Table 13.11 Cell Line Characterization Service Providers (Non-Industry Players): Distribution by Type of STR Kits
Table 13.12 CRL: Annual Revenues, FY 2012 – H1 2017 (USD Billion)
Table 13.13 CRL: Revenues by Business Segments, 2016 (USD Billion)
Table 13.14 Eurofins Scientific: Annual Revenues, FY 2012 – Q1 2017 (EUR Billion)
Table 13.15 Eurofins Scientific: Revenues by Geography, 2016 (%)
Table 13.16 SGS: Annual Revenues, 2012-H1 2017 (CHF Billion)
Table 13.17 SGS: Revenues by Geography, 2016 (%)
Table 13.18 Cell Line Characterization Services Market, 2017-2027: Conservative, Base and Optimistic Scenario (USD Billion)
Table 13.19 Cell Line Characterization Services Market, 2017-2027: Distribution by Type of Cell Lines (USD Billion)
Table 13.20 Cell Line Characterization Services Market, 2017-2027: Distribution by Geographical Regions (USD Billion)
Table 13.21 Cell Line Characterization Services Market, 2017-2027: Distribution by Type of Industry (USD Billion)
Table 13.22 Cell Line Characterization Services Market, 2017-2027: Distribution by Stage of Development of Biologics (USD Billion)
Table 13.23 Cell Line Characterization Services Market, 2017, 2022 and 2027: Conservative, Base and Optimistic Forecast Scenarios (USD Billion)
The following companies and organizations have been mentioned in the report.
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