NEW YORK, Dec. 18, 2017 /PRNewswire/ -- INTRODUCTION
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.
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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:
• A discussion on the current market landscape of cell line characterization service providers (industry and non-industry players), along with information on their headquarters, type of cell lines characterized (mammalian, microbial, insect-derived, avian, marine and reptilian) and the testing services offered.
• An analysis of the requirements established by various regulatory authorities, across different global regions, related to the characterization of cell lines. In addition, it provides insights from the various guideline documents that have been issued by these bodies on protocols that need to be followed and general tips for the testing of cell lines.
• A comprehensive study on cell line authentication services, highlighting the need for such services. It features a brief historical overview, discussion on the contributions of key institutes / organizations involved in this domain, a list of awareness surveys conducted by various research groups, and a schematic world map representation depicting the most active geographies, in terms of the presence of cell line authentication service providers.
• Profiles of biorepositories that offer testing services for characterization of cell lines; each profile features an overview of the repository and a brief description of its overall operations and cell line characterization services offered.
• Profiles of key industry players that offer cell line characterization services. Each profile features an overview of the company, its financial performance, overall services portfolio, cell line characterization services, and an informed future outlook.
• A detailed analysis of the database, featuring three schematic representations; these include a world map depicting the most active geographies (in terms of the presence of companies / organizations providing services for cell line characterization), a heat map featuring the distribution of companies on the basis of their location, number of employees and the source of cell lines and a spin wheel analysis of companies / organizations based on the number and type of tests offered, and location.
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.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views
While the focus has been on forecasting the market over the coming decade, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
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 characterization and 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. Over 135 organizations across the world are currently offering characterization services for cell lines to the biopharmaceutical industry and the research community. Of these, 55% of the service providers are industrial players while the rest are academic / research institutes / non-profit organizations.
2. With the presence of 33 start-ups, 17 mid-sized and 17 large-sized firms, the current market landscape of industry players is highly fragmented. North America (~55%) and Europe (~30%) are considered to be the hubs for cell line testing services. Examples of start-ups working in this domain include (in alphabetical order) Accelero Bioanalytics, Avance Biosciences, Cell Guidance Systems, Cellaria, Endeavour DNA Laboratories, EuBiologics, Multiplexion, Oxford Genetics and Protein Technologies.
3. Service providers offer a wide variety of testing services for different type cell lines; these include identity testing, sterility testing, genetic stability testing, and oncogenicity and tumorigenicity testing. Of these, identity testing or cell line authentication is the most popular type of service offered. Examples of companies that offer more than one type of service include (decreasing order of number of characterization tests) BioReliance, TFBS Bioscience, Activation Laboratories, Avance Biosciences, Charles River Laboratories, Eurofins Scientific, Livogen pharmed, Molecular Diagnostic Services, SGS and WuXi AppTec.
4. Of the available identity testing methods, STR profiling has emerged as the current gold standard. In fact, over 80% of the academic players within this market offer this service. Examples include (in alphabetical order) Johns Hopkins School of Medicine, MD Anderson Cancer Center, Sanford Burnham Preby, University of Florida and University of Pittsburgh.
5. Multiple biorepositories across the globe have also undertaken initiatives to limit the use of contaminated and / or misidentified cell lines; these include (in alphabetical order) American Type Cell Culture (US), Cell Bank Australia (Australia), Coriell Institute of Medical Research (US), Deutsche Sammlung von Mikroorganismen und Zellkulture (Germany) and Public Health England (UK).
6. Close to 88% of the contract service providers offer characterization services for mammalian cell lines. We also observed that around 26% service providers claim to have the necessary capabilities to characterize microbial cell lines, which are presently considered to be the second most popular type of in vitro model.
7. Driven by the robust pipeline of biologics, launch of biosimilars, and increasing awareness within the research community on the use of authenticated cell lines, we expect the cell line characterization services market to witness double digit growth over the next decade. As the market evolves, mammalian cell lines are likely to remain the major focus of the overall cell line characterization services market (~82%) in 2027. North America and Europe are likely to remain the primary cell line testing hubs in the coming decade.
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