Cell Line Development and Characterization Services

Cell Line Development and Characterization Services

INTRODUCTION

Over the years, the biopharmaceutical market has grown into a promising, high value vertical within the overall pharmaceutical industry. In fact, nearly 29% and 25% of the total number of novel drugs approved by the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in 2018 and 2019, respectively, were biologics. As a result, the pipeline of biologics and biosimilars is growing at a commendable pace. Given that the development and manufacturing of such therapies require living biological systems, there has been a surge in demand for different types of cell lines. In fact, around 84% of the therapeutic proteins marketed in the last five years, were produced using various mammalian and microbial cells. A recent study revealed that over 30,000 research articles published in 33,000 journals featured data generated from experiments that used misidentified or contaminated cell lines. This is a genuine concern in the field of medical research, which is becoming increasingly dependent

on cell-based assays and experimentation. Therefore, in modern medical research, proper cell line characterization is a necessity in order to preserve the authenticity and accuracy of experimental research.

Given the cost intensive nature of pharmacological R&D, medical researchers / drug developers are consistently on the lookout for ways to optimize operational efficiencies, as well as reduce affiliated costs; in this context, outsourcing has emerged as a preferred business model. Presently, there are several contact service providers that claim to have the necessary expertise to develop and characterize cell lines. The technical aspect of this field is also witnessing a lot of innovation, especially with regard to automating various steps of the cell line development process. New genome editing technologies, such as the CRISPR/Cas-9, are also being extensively used to improve the quality of recombinant cell lines. Unlike drug developers, the capabilities of service providers are usually more focused to their respective service portfolios. Moreover, such companies ensure that they have the latest upgrades in equipment and infrastructure, in order to improve the quality of services offered. In fact, in the recent past, a number of service providers offering cell lines-related services, have forged strategic alliances with and / or acquired other players, in order to further enhance their respective portfolios. Considering the growing trend of outsourcing and the ongoing efforts of service providers to improve / expand their offerings, we believe the contract services market for cell line development and characterization is likely to evolve at a steady pace, till 2030.

The “Cell Line Development and Characterization Services Market (2nd Edition), 2020-2030” report features an extensive study on the current market landscape, offering an informed opinion on the likely evolution in this industry, over the next ten years. The study underlines an in-depth analysis of the services offered for the development and characterization of cell lines, which are intended for use in various R&D and / or therapeutic purposes. In addition to other elements, it includes:

A detailed review of the overall landscape of the cell line development services market, highlighting the contributions of contract service providers, along with the information on year of establishment, company size, location of headquarters, sources of cell lines and expression systems offered (mammalian, microbial, insect and avian), integrated cell line characterization, biosimilar cell line development and gene editing cell line development services offered, gene delivery method used (physical, chemical, biological and non-biological), type of gene expression (stable and transient), usage of serum-free / animal component free cell culture media, types of cell cultures (suspension and mixed growth properties), types of cells offered (recombinant, hybridoma and primary), applications of cell lines (R&D, biomanufacturing, diagnostics and cell therapy / regenerative medicine / tissue culture). In addition, the chapter includes information on additional cell line related services (bio-analytical / protein purification, cell banking, cell bank characterization, process development, GMP manufacturing and fill-finish), types of cell banks developed (master cell banks, working cell banks, research cell banks and end-of-production cell banks) and protein yield from cell lines.

A company competitiveness analysis, highlighting prominent cell line development service providers based in different regions, taking into consideration their supplier strength (experience of the service provider), and portfolio specifications (sources of cell lines and expression systems handled, availability of proprietary / licensed technology platform, type of gene expression and availability of additional cell line related services).

Elaborate profiles of cell line development service providers. Each company profile features a brief overview of the company, its financial information (if available), cell line development and complementary services portfolio and an informed future outlook.

A detailed review of the overall landscape of the cell line characterization services market, highlighting the contributions of industry and non-industry players along with the information on year of establishment, company size, location of headquarters, types of cells handled (mammalian, microbial, insect and others), types of cell line characterization services offered (identity / stability testing, sterility / biosafety testing, expression testing and oncogenicity / tumorigenicity testing), types of cell line identity / stability testing services offered (analysis of cell morphology, cytochrome c oxidase 1 barcoding assay, DNA fingerprinting / profiling, gene copy number analysis, isozyme analysis, karyotype analysis, nucleic acid sequencing, southern blotting and viability testing) types of sterility / biosafety testing services offered (mycoplasma contamination testing, microbial contamination testing, viral / adventitious agents contamination testing, retroviral contamination testing and rodent virus testing / in-vivo biosafety testing), availability of other cell line related services (cell line development, cell banking and mycoplasma clearance service), information on regulatory accreditations / certifications and overall turnaround time. In addition, it lists the non-industry players and provides information on number of STR loci amplified, type of genotyping kit used and service fee charged.

A company competitiveness analysis, highlighting prominent cell line characterization service providers based in different regions, taking into consideration their supplier strength (experience of the service provider), and portfolio specifications (sources of cell lines and expression systems handled and size of the service portfolio.)

Elaborate profiles of cell line characterization service providers. Each company profile features a brief overview of the company, its financial information (if available), cell line characterization services portfolio and an informed future outlook.

A detailed analysis of the partnerships that have been established in the cell line development and characterization domain since 2015, covering technology platform utilization agreements, R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, process development agreements, clinical trial agreements, and other relevant deals.

Detailed profiles of the biorepositories across the globe that play an important role in developing cell lines and have also undertaken initiatives to limit the use of contaminated and / or misidentified cell lines. Each profile features a brief overview of the repository and its cell line characterization service portfolio.

An elaborate discussion on the requirements established by various regulatory authorities, across different regions, related to 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. It also features a brief historical overview and discussion on the contributions of key institutes / organizations involved in this domain.

A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing cell line development and / or cell line characterization services.

One of the key objectives of the report was to estimate the existing market size and future growth opportunities for cell line development and characterization service providers. Based on multiple parameters, such as the number of projects completed annually, price of the projects, the overall R&D expenditure available to CROs and the overall growth of the biologics market, we have developed informed estimates on the financial evolution of the market over the period 2020-2030.

For cell line development services market, our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] sources of cell lines and expression systems (mammalian, microbial, insect and avian), [B] applications of cell lines (R&D operations and drug development), [C] company size (small, mid-sized and large) and key geographies (North America, Europe, Asia, Oceania and Rest of the World).

For cell line characterization services market, our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] sources of cell lines and expression systems (mammalian, microbial and others), [B] applications of cell lines (R&D operations and drug development), [C] type of service provider (industry players and non-industry players) and [D] key geographies (North America, Europe, Asia, Middle East & North Africa (MENA), Latin America (LATAM) and Rest of the World (RoW)).

To account for the uncertainties associated with this industry 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 this study were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following industry stakeholders (in reverse chronological order):

Fai Poon (Founder and President, Quacell Biotechnology)

Louis Boon (Chief Scientific Officer, Polpharma Biologics)

Fan Chen (Former Vice President BioProcessing, LakePharma)

Michael Pointek (Founder and Managing Director, ARTES Biotechnology)

Nienke Smits (Client Relations Manager, Immunoprecise Antibodies)

Oscar Hoogteijling (Former Global Business Development Manager, Polpharma Biologics)

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.

KEY QUESTIONS ANSWERED

Who are the leading players offering cell line development services?

What kind of CDMO support is available for cell line development, across different regions?

What are the common sources, gene delivery methods, protein yield and affiliated services offered by the cell line development service providers?

Who are the leading industry and non-industry players offering cell line characterization services?

What are the most popular services offered for characterization of cell lines?

Which partnership models are commonly adopted by stakeholders in this industry?

How is the current and future opportunity likely to be distributed across key market segments?

What are the anticipated future trends related to cell line development and characterization market?

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 will evolve across different regions and 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 till 2030, the report also provides our independent view on various 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 and characterization services market in the mid to long term.

Chapter 3 provides a general introduction to cell cultures and cell lines, including details related to various types of cell lines, based on their sources of origin, and key characteristics, applications and concerns associated with their use in drug development and research. The chapter also elaborates the recombinant and hybridoma cell line development process workflow. Further, it 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 the advantages and associated risks related to outsourcing of cell line development and characterization operations. In this chapter, we have briefly discussed the most common services offered by the service providers, along with cell line development and characterization services.

Chapter 4 provides an overview of the overall cell line development services landscape. It includes information related to over 220 contract service providers that are currently active in this domain. It features an in-depth analyses of the market, information on year of establishment, company size, location of headquarters, sources of cell lines and expression systems offered (mammalian, microbial, insect and avian), integrated cell line characterization, biosimilar cell line development and gene editing cell line development services offered, gene delivery method used (physical, chemical, biological and non-biological), type of gene expression (stable and transient), usage of serum-free / animal component free cell culture media, types of cell cultures (suspension and mixed growth properties), types of cells offered (recombinant, hybridoma and primary), applications of cell lines (R&D, biomanufacturing, diagnostics and cell therapy / regenerative medicine / tissue culture). In addition, the chapter includes information on additional cell line related services (bio-analytical / protein purification, cell banking, cell bank characterization, process development, GMP manufacturing and fill-finish), types of cell banks developed (master cell banks, working cell banks, research cell banks and end-of-production cell banks) and protein yield from cell lines.

Chapter 5 provides an insightful competitiveness analysis of the cell line development service providers that we came across during our research. The analysis compares the companies on the basis of supplier strength (experience of the service provider) and service portfolio strength (considering sources of cell lines and expression systems offered, availability of proprietary / licensed technology platform, type of gene expression and availability of additional cell line related services).

Chapter 6 features detailed profiles of some of the key players that are active in the cell line development domain. Each profile presents a brief overview of the company, its cell line development and complementary services portfolio, financial information (if available), recent developments and an informed future outlook.

Chapter 7 provides an overview of the overall cell line characterization services landscape. It includes information related to over 140 industry and non-industry contract service providers that are currently active in this domain. It features in-depth analyses of the market, based on a number of relevant parameters, such as year of establishment, company size, location of headquarters, types of cells handled (mammalian, microbial, insect and others), types of cell line characterization services offered (identity / stability testing, sterility / biosafety testing, expression testing and oncogenicity / tumorigenicity testing), types of cell line identity / stability testing services offered (analysis of cell morphology, cytochrome c oxidase 1 barcoding assay, DNA fingerprinting / profiling, gene copy number analysis, isozyme analysis, karyotype analysis, nucleic acid sequencing, southern blotting and viability testing) types of sterility / biosafety testing services offered (mycoplasma contamination testing, microbial contamination testing, viral / adventitious agents contamination testing, retroviral contamination testing and rodent virus testing / in-vivo biosafety testing), availability of other cell line related services (cell line development, cell banking and mycoplasma clearance service), information on regulatory accreditations / certifications and overall turnaround time. For non-industry players, the report features additional information on number of STR loci amplified, type of genotyping kit used and service fee charged.

Chapter 8 provides an insightful competitiveness analysis of the cell line characterization service providers that we came across during our research. The analysis compares the companies on the basis of supplier strength (in terms of experience of the service provider) and service portfolio strength (considering sources of cell lines and expression systems handled and size of the service portfolio).

Chapter 9 features detailed profiles of some of the key players that are active in the cell line characterization domain. Each profile presents a brief overview of the company, its cell line characterization services portfolio, financial information (if available), recent developments and an informed future outlook.

Chapter 10 features an in-depth analysis and discussion on the various partnerships that have been inked between the players in the cell line development and characterization market in the time period between 2015 and 2020 (till September). It includes a brief description of partnership models (such as technology platform utilization agreements, R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, process development agreements, clinical trial agreements and other relevant deals) adopted by the stakeholders.

Chapter 11 features detailed profiles of the biorepositories across the globe that play an important role in developing cell lines and have also undertaken initiatives to limit the use of contaminated and / or misidentified cell lines. Each profile features a brief overview of the repository and its cell line characterization service portfolio.

Chapter 12 presents an elaborate discussion on the requirements defined by various regulatory authorities, across different 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. It also features a brief historical overview and discussion on the contributions of key institutes / organizations involved in this domain.

Chapter 13 presents a comprehensive market forecast analysis, highlighting the likely growth of cell line development services market till the year 2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of sources of cell lines / expression systems (mammalian, microbial, insect and avian), applications of cell lines (R&D operations and drug development), company size (small, mid-sized and large) and key geographical regions (North America, Europe, Asia, Oceania and Rest of the World).

Chapter 14 presents a comprehensive market forecast analysis, highlighting the likely growth of cell line characterization services market till the year 2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of sources of cell lines (mammalian, microbial and others), applications of cell lines (R&D operations and drug development), type of player (industry and non-industry) and key geographies (North America, Europe, Asia, Middle East & North Africa (MENA), Latin America (LATAM), Rest of the World (RoW)).

Chapter 15 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Fai Poon (Founder and President, Quacell Biotechnology), Louis Boon (Chief Scientific Officer, Polpharma Biologics), Fan Chen (Former Vice President BioProcessing, LakePharma), Michael Pointek (Founder and Managing Director, ARTES Biotechnology), Nienke Smits (Client Relations Manager, Immunoprecise Antibodies) and Oscar Hoogteijling (Former Global Business Development Manager, Polpharma Biologics).

Chapter 16 presents insights from the survey conducted for this study. The participants, who were primarily Directors / CXO level representatives, helped us develop a deeper understanding on the nature of their services and their associated commercial potential.

Chapter 17 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario.

Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 19 is an appendix, which provides the list of companies and organizations mentioned in the report.