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Cell Line Development Services Market, 2017-2027

Cell Line Development Services Market, 2017-2027

  • July 2017
  • 278 pages
  • ID: 5079011
  • Format: PDF
  • Roots Analysis Private Ltd.

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INTRODUCTION
The growing pipeline of biological drugs has resulted in a continuous increase in the demand for different types of cell lines. More than 650 biologics have been approved till date, and over 1,500 are under clinical development. Additionally, the loss of patent exclusivity of several biologics in the coming years is likely to be followed by the entry of numerous biosimilars as many companies compete to grab a share of already established drug markets. The importance of cell lines in other areas, such as drug screening, gene functional studies, cell-based assay development, diagnostics and tissue engineering, has resulted in further increase in the demand for different types of cell lines. The rapid progression of biological drug candidates through various phases of development, coupled with the growing demand of cell lines for other applications, presents significant opportunities to cell line development service providers.

The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industry players are contributing to the production of GMP and non-GMP grade cell lines that are obtained from mammalian, microbial, insect-derived, avian, marine, reptilian and other sources. Stakeholders have entered into multiple partnerships / collaborations in order to improve and scale-up production processes, and expand their capabilities. Considering the heightened activity in this domain, we believe the market is likely to evolve at a steady pace in the mid to long term, driven primarily by the increasing demand for cell lines, and advances in technology platforms and production methodologies.

SCOPE OF THE REPORT
The ‘Cell Line Development Services Market, 2017 - 2027’ report provides an extensive study of the rapidly growing market of cell lines. Cells obtained from mammalian and microbial sources are widely used for the development and manufacturing of biotherapeutic products, such as recombinant proteins, antibodies and vaccines. Mammalian cell lines, owing to their inherent high productivity and ability to produce complex biopharmaceuticals, are relatively more preferred. At the same time, microbial cell lines are also widely used due to their less complex nature, low cost and high versatility.

As mentioned earlier, in addition to the large number of biologics that are already available in market, many are under various stages of development. In fact, close to 50% of product candidates in the current development pipeline are in the preclinical stage. Moreover, a number of important biologics, such as Aransep®, Avastin®, Herceptin®, HUMIRA®, Neulasta® and REMICADE®, are approaching patent expiration, and several companies are already engaged in the development of biosimilars and biobetters. As of May 2017, five biosimilars in the US and 28 in Europe have been approved. In addition to the US and EU, several companies based in Asia are also focused on the development of biosimilars. These developments have led to an upward surge in the demand for highly-productive and stable cell lines. High yielding cell lines, capable of producing top quality biopharmaceuticals, help in significantly reducing development and manufacturing costs. Hence, several companies have designed and developed innovative systems / technologies / proprietary manufacturing processes in order to optimize manufacturing costs and production timelines of the overall cell line development process. In addition to development-related services, several cell line manufacturers provide other services related to cell lines as a part of their respective services portfolios; examples of these services include cell line characterization, cell banking, cell bank characterization, process development and commercialization of reagents / equipment. It is also important to highlight that some of these companies offer cGMP production of biologics and fill / finish of end products as well.

This study presents an in-depth analysis of companies that are actively involved in providing cell line development services. In addition to other elements, the study features:
- A discussion on the database of cell line development service providers along with information on the location of their manufacturing facilities, distribution of cell lines based on the source from which they are obtained (mammalian, microbial, insect-derived, avian, marine and reptilian), type of cell lines (recombinant, hybridoma and primary cell lines), technology used for the production of cell lines, purpose of production (R&D, diagnostics, biomanufacturing and tissue engineering), and other associated services (cell line characterization, cell banking, cell bank characterization, process development, cGMP manufacturing of biologics, fill / finish of end products and commercialization of reagents / equipment).
- A detailed analysis of the database presented as three schematic representations; a world map depicting the most active geographies in terms of the presence of cell line development facilities, a heat map representing the distribution of database companies on the basis of their location (continent-wise distribution), year of establishment and cell line development capabilities, and a logo landscape signifying the distribution of companies based on the number of employees and the source from which cell lines are obtained.
- Elaborate profiles of key industry players that have proprietary technologies for the development of cell lines and offer cell line characterization, cell banking and cGMP production of biologics as part of their services portfolios; each profile features an overview of the company, its financial performance, information on cell line development services and proprietary technology, manufacturing facilities, expansions and collaborations, and a comprehensive future outlook.
- Profiles of non-industry players (cell line repositories) that play an active role in the development of cell lines and offer affiliated services; each profile features an overview of the repository and a brief description about its cell line development services.
- Potential future growth opportunities in the cell line development market, segmented by regions, source and grade of cell lines. For the purposes of this analysis, we took into consideration several parameters, such as the number of companies involved, price of cell lines depending upon whether they are characterized or uncharacterized, source of cell lines, and average annual cell line development projects undertaken by companies.

We have provided informed estimates of the size of the market in the short to mid-term and long term for the period 2017-2027. To account for the uncertainties associated with the development of cell lines and to add robustness to our model, we have provided three forecast scenarios portraying conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. The insights presented in this study were also influenced by discussions conducted with several key players in this domain. The report features detailed transcripts 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).

RESEARCH METHODOLOGY
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 may evolve across different regions and technology segments. Wherever 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 ten years, 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 OUTLINES
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 development services market over the coming decade.

Chapter 3 provides a general introduction to the various types of cell lines. It includes a detailed discussion on the sources, selection and maintenance conditions, key features, applications and limitations of currently available cell lines. The chapter also provides a brief description of cell line characterization and cell banking services.

Chapter 4 identifies the contract service providers that are actively involved in the development of cell lines. The chapter provides details on the cell line development capabilities of these organizations, geographic location of their facilities, information on the proprietary technology (if any) used by the company for cell line development, type of cell lines produced by the company (recombinant, hybridoma and primary) and applications of the cell lines (such as for R&D activities, biomanufacturing, diagnostics and tissue engineering). The chapter also provides the distribution of companies based on the other services that they offer; these include cell line characterization, cell bank characterization, cell banking, process development, cGMP manufacturing of biologics, fill / finish and commercialization of reagents / equipment.

Chapter 5 presents a detailed analysis of the cell line development services market landscape. It features a schematic representation on world map, highlighting the key geographical locations of cell line manufacturing facilities. Further, we have provided a heat map analysis representing the distribution of companies on the basis of their location, year of establishment and cell line development capabilities. The chapter also provides a logo landscape of companies based on their size (employee base) and source of cell lines produced.

Chapter 6 offers detailed profiles of contract cell line development service providers that have developed proprietary technology / technologies for the production of cell lines. Each profile provides an overview of the company, its financial performance, details on its proprietary technology / technologies, information on its cell line manufacturing capabilities, recent investments / expansions, relevant collaborations and partnerships that have been inked over the last few years, and a comprehensive future outlook.

Chapter 7 features profiles of additional players that offer cell line characterization, cell banking and cGMP production services, apart from cell line development services. However, the companies included in this chapter have not developed any proprietary technology / technologies for producing cell lines.

Chapter 8 features profiles of key non-industry players (cell line repositories) that are playing an active role in providing cell line development services. Each profile provides a brief overview of the organization and the services it offers.

Chapter 9 presents a 10-year sales forecast, highlighting the likely growth of the market for cell lines development services. We have segregated the broader opportunity by source of cell lines (mammalian, microbial, insect-derived and others), regions (North America, Europe, Asia and the Rest of the World) and grade of cell lines (GMP and non-GMP). Our predictions are backed by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic forecast scenarios.

Chapter 10 presents insights from a survey that we conducted for this study. The participants, who were primarily members of the Senior Management or CXO level representatives, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 11 summarizes the entire report. The chapter presents a list of key takeaways and offers our independent opinion on the current market scenario and trends that are likely to determine the future evolution of this segment of the industry.

Chapter 12 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. In this chapter, we have presented detailed transcripts of discussions held with Fan Chen (VP 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 in the report.

Chapter 14 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Over 180 companies are actively providing cell line development services to several biopharmaceutical companies. Majority of these companies are located in North America (45%) and the EU (35%).
2. Currently, more than 60% of cell line development service providers focus on the development and generation of mammalian cell lines, which are the most popular due to their ability to produce highly complex recombinant proteins, antibodies and vaccines that cannot be produced in other types of cell lines. Microbial cell lines are the second most important type; approximately 15% of the companies that we identified claim to provide microbial cell line development services.
3. Cell lines are used for several purposes such as R&D studies, biomanufacturing, diagnostics and tissue engineering. Majority of the companies (over 45%) produce cell lines for R&D purposes; this is followed by companies producing cell lines for biomanufacturing purposes (over 40%). R&D activities include the production of cell based assays, reporter cell lines, ion channel expressing cell lines, drug discovery and screening, and production of non-GMP grade antibodies and other proteins. Examples of companies providing cell lines for R&D applications include (in alphabetical order) Abcam, Altogen Labs, Applied Biological Materials, ATGCell, Bhat Bio-Tech, BPS Bioscience, CreaCell, DiscoverX, Eurofins Scientific, Euroscreen, GeneCopoeia GVK Biosciences, InvivoGen, SB Drug Discovery, System Biosciences, Trend Pharma & Tech, Vectalys, WatsonBio Sciences. Similarly, biomanufacturing involves the production of different types of therapeutic products (monoclonal and polyclonal antibodies, recombinant proteins and vaccines) and biosimilars. Examples of companies producing cell lines for biomanufacturing applications include (in alphabetical order) AbbVie, Abzena, Batavia Biosciences, Biovian, Boehringer Ingelheim BioXcellence, CMC Biologics, Cobra Biologics, FUJIFILM Diosynth Biotechnologies, Inno Biologics, LFB Biomanufacturing, MassBiologics and Patheon.
4. More than 20% of the database companies providing cell line development services also offer cell banking (stand-alone service) and approximately 15% provide cell line characterization services (stand-alone service) to their customers. Some other services included as a part of service portfolio are cGMP manufacturing of biologics, fill / finish and services related to reagents / equipments. Examples of companies offering some of the aforementioned services include (in alphabetical order) Celonic, EuBiologics, Fusion Antibodies, Goodwin Biotechnology, Lonza, Nanotherapeutics, ProBioGen, Rentschler Biotechnologie, Selexis and Syngene International.
5. The heightened competition and growing demand for cell lines has resulted in the emergence of several novel and innovative technologies, lowering of manufacturing costs and production timelines. Examples of some companies that have developed proprietary technologies for production of cell lines include (in alphabetical order) Abzena (Composite CHO™ technology), ACROBiosystems (HEKMax® Stable Cell Line Technology), BioFactura (StableFast™ Biomanufacturing Platform), Batavia Biosciences (STEP® technology), Celltheon (SMART™ expression platform), Celonic (CHOvolution™ / SEFEX platform), Cevec Pharmaceuticals (CAP®GO platform) and Selexis (SUREtechnology Platform™).
6. Stakeholders have extensively collaborated during the last few years for a variety of purposes, such as out / in licensing of technologies, development of cell lines for specific drug candidates and acquisition / development of manufacturing facilities. For instance, Progenics Pharmaceuticals (June 2016), Sanofi Biologics (February 2017) and Xencor (November 2016) collaborated with Selexis to gain access to Selexis’ CHO-M Cell Line™ technology and the SUREtechnology Platform. More recently, in February 2017, Lonza and Sanofi entered into a joint venture agreement to establish a large scale mammalian cell culture facility in Visp, Switzerland, for the production of monoclonal antibodies. Earlier, in September 2015, Abzena acquired PacificGMP with an aim to expand its cell line development services. PacificGMP was a provider of contract process development, and non-GMP and cGMP manufacturing services for biopharmaceuticals, including monoclonal antibodies, recombinant proteins, vaccines, and gene and cell therapy products.
7. We expect the cell line development services market to grow at an annualized rate of ~10% over the course of next decade; this growth will be driven by the robust pipeline of biologics, increasing number of approvals of biological drug candidates, growing adoption of biosimilars, introduction of advanced production technologies, capability and capacity expansions, and the establishment of new cell line generation facilities. As the market evolves, cell lines obtained from mammalian sources will continue to form a major portion of the overall cell line development services market (~80%). North America and EU, with ~40% and ~35% of the current market, respectively, are likely to remain the major manufacturing hubs in the coming decade.

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