Cell lines are one the major tools used in research for studying the normal physiology and biochemistry of cells, the effects of drugs and toxic compounds on the cells, drug screening and development and large scale manufacturing of biological compounds. Cell culture is the process by which cells are grown under controlled conditions derived from microbial or animal cells. Cell lines are subculture of primary culture also known as sub-clone. Cell lines derived from primary cultures have a limited life span, after subsequent cultures, cells with the highest growth capacity dominate which are selected for further cell development. Primary cells are cells that are cultured directly from a subject and have a limited lifespan. An immortalized cell line can proliferate indefinitely either through random mutation or deliberate modification which are useful especially for production of therapeutics.
The cell line development service global market is expected to reach $1,702.2 million by 2028 growing at a double digit CAGR from 2020 to 2028. Increasing demand for monoclonal antibodies, recombinant proteins and vaccines, growing incidence rate of oncology, autoimmune disorders, infectious diseases & genetic disorders and growth in research activities related to the diseases and also recombinant cell lines for the production recombinant biopharmaceutical proteins are driving the market. Technological advancements in cell line engineering (gene editing tools) & cell line development technologies, screening technologies and process development are giving immense growth opportunities for the market. However, complexities in the development of stable cell lines and high risk of contamination due to complex purification methods are restraining the market. Furthermore, stringent and complex regulations and the high cost and technical requirement to adhere to accreditations such as GMP are posing threat to the industry.
Cell line development service global market is classified based on the expression system, cell line type, application and geography. Cell lines are essential for a wide range of applications including gene function studies, drug discovery assays, the production of biotherapeutics and diagnostics. The application for cell lines includes research, bioproduction and diagnostics. Among research, cell lines are used for studying disease, screening, cell-based assays are used during discovery phase and preclinical development. Cell lines are used to produce a wide range of biotherapeutics including vaccine, recombinant proteins that include peptides, cytokines, hormones and clotting factors, enzymes and monoclonal antibodies. Bioproduction is the largest & fastest growing segment and is expected to grow at a low ten CAGR from 2020 to 2028 due higher demand of biologics & biosimilars for therapeutics application and increasing collaboration between the companies for the development & production of biotherapeutics using cell line development platforms.
Biotherapeutics including monoclonal antibodies, peptides, recombinant proteins, vaccines, blood related products are produced in a wide variety of platforms, including non-mammalian expression systems (bacterial, yeast, plant and insect) and mammalian expression systems (including human cell lines). However, the most appropriate expression system to be used is dependent on the type of biopharmaceutical to be produced. Based on expression system, cell line development service global market is segmented into microbial, mammalian and others. Microbial systems are used for producing relatively simple recombinant proteins such as insulin or antibody fragments. They are attractive due to their low cost and high productivity. E. coli and S. cerevisiae are the most commonly used systems. However, many biopharmaceuticals including MABs, highly glycosylated proteins or recombinant proteins are large and complex, mammalian cell lines are the most preferred platform used for manufacturing them. Post-translational modifications including glycosylation, carboxylation, hydroxylation, sulphation, amidation are a significant factor to select the type of cells to be used. Among them, glycosylation is the most common modification. Among expression systems, Mammalian expression system is the largest & fastest growing segment and expected to grow at a double digit CAGR from 2020 to 2028 due to utilization of mammalian cell lines for most of biologics development & production and also technological advancements in mammalian cell line development plarforms for higher titer production.
The most common mammalian cell cultures used for production of biopharmaceuticals include Chinese hamster ovary (CHO) cells, baby hamster kidney (BHK21) cells and murine myeloma cells (NS0 and Sp2/0). Among cell line type, CHO cell line is the most frequently used mammalian system, which is used in the manufacture of more than 65% of currently approved biologics. CHO cells have been the industry’s cell line workhorse for production of biopharmaceuticals. These cell line has several major advantages being versatile, relatively easy to work with, having well-understood glycosylation patterns. Approximately 42 monoclonal antibodies and 8 recombinant proteins are produced using CHO cell lines. Murine Myeloma are expected to occupy second largest share is expected to grow at a double digit CAGR % from 2020 to 2028.
Based on the geography, cell line development service global market is segmented into North America, Europe, Asia-Pacific and Rest of the world. North America accounted for the largest revenue in 2020 and is expected growing at a double digit CAGR from 2020 to 2028. The Asia-Pacific is the fastest growing region in cell line development global market and is expected to grow at a low ten CAGR from 2020 to 2028.
In cell line development program, after selecting best clone, the next step is to create fully described and characterized cell banks that store cells of specific genomes complete with cell line characterization and operate in a way that minimizes contamination. According to analysis, Cell banking service market generated the revenue of $xx million in 2020 and is expected to grow at a high ten CAGR reach $xx million by 2028. Proper cell line authentication is crucial to assure that inadvertent contamination of cell lines has not occurred during the regular cell culturing work. It is particularly important to authenticate the cell line during the drug development process to ensure the quality of the biopharmaceuticals produced from them. Cell line characterization service market generated the revenue of $xx million in 2020 and is expected to grow at a low ten CAGR to reach $xx million by 2028.
The increasing demand for biologics and biosimilars has increased the demand for production cell lines. The expiration of blockbuster biologics has also driven the emergence of biosimilars. Companies are working to produce efficient and less time consuming expression systems and also using automation and robotics in screening of cell lines to speed up the process. For instance, in January 2019, FUJIFILM Diosynth Biotechnologies introduced next generation Apollo mammalian expression system (Apollo X), capable of delivering industry leading titres in excess of 10 g/L and in July 2020, cergentis’ proprietary targeted locus amplification (TLA) technology integrated into Apollo X cell-line development as a powerful tool for targeted, complete sequencing of transgenes and integration sites. This integration helps to rapid characterization of clonal cell lines during cell line development and clone selection.
The major players in cell line development service global market include Abzena PLC (U.K.), AGC Inc. (AGC Biologics) (Japan), Albany Molecular Research Inc. (AMRI) (U.S.), Boehringer Ingelheim International GmbH (Germany), Catalent Inc. (U.S.), Charles River Laboratories International Inc. (U.S.), Fujifilm Holdings Corporation (Fujifilm Diosynth Biotechnologies) (Japan), Genscript Biotech Corporation (China), JSR Corporation [JSR Life Sciences, LLC (KBI biopharma, Selexis SA, CrownBio)] (Japan), Lonza Group Ltd. (Switzerland), Rentschler Biopharma SE (Germany), Samsung Biologics Co. Ltd. (South Korea), Thermofischer Scientific Inc. (Patheon N.V.) (Brammer Bio) (U.S.), Wuxi Biologics (Cayman) Inc. (China), Sartious Group (Cellca, Bio Outsource) (Germany), Eurofins Scientific S.E (DiscoverX, GATC Biotech AG, Eurofins CDMO, Advinus) (Luxembourg).
1 Executive Summary
2 Market Dynamics
2.1 Drivers and Opportunities
2.1.1 Growing Incidence Rates of Oncology and Immunological Disorders and Increasing R&D Activities Related to the Diseases
2.1.2 Increasing Demand for Biologics and Biosimilars
2.1.3 Advanced Technologies for Screening, Cell Line Engineering and Bioprocessing
2.1.4 Increasing Number of Cros in APAC Regions
2.2 Restraints and Threats
2.2.1 Complexities in Development of Stable Cell Lines
2.2.2 High Risk of Contamination Due to Complex Purification Method
2.2.3 Stringent and Complex Regulations for Biologics in North America and Europe
2.2.4 High Cost and Technical Requirements to Obtain Gmp Certifications
3 Cell Line Development
3.1 Cell Line Construction
3.2 Host Cell Line Engineering
3.3 Expression System
3.4 Transient Gene Expression
3.5 Stable Cell Line Development
3.7 Upstream Process Development
4 Host Cell Lines
4.1 Cell Line Development Services Market, by Expression System
4.1.1 Microbial Expression Systems
4.1.2 Mammalian Expression System
4.1.3 Others (Insect and Plant Cell)
5 Cell Line Development Services, by Cell Type
5.3 Murine/Mouse Myeloma
5.4 Baby Hamster Kidney (Bhk) Cells
5.6 Human Embryonic Kidney (Hek) Cells
5.7 Human Embryonic Retinal Cells (Per.C6)
5.8 Others (E.Coli, Yeast, Insect Cell, Ht-1080, Hela Cell Line, Cap, Hkb-11, Huh-7)
6 Cell Line Development Services, by Applications
6.4 Cell Line Development Technologies
6.5 Cell Banking Services
6.6 Cell Line Characterization Services
7 Market Share Analysis
8 Key Developments
8.2 New Technology, Product and Service Launch
8.4 Other Developments
9 Company Profiles
9.1 Abzena plc
9.1.3 Service Portfolio
9.1.4 Key Developments
9.1.5 SWOT Analysis
9.2 Albany Molecular Research, Inc.
9.2.3 Service Portfolio
9.2.4 Key Developments
9.2.5 SWOT Analysis
9.3 AGC Inc.
9.3.3 Service Portfolio
9.3.4 Key Developments
9.3.5 SWOT Analysis
9.4 Boehringer Ingelheim International GmbH
9.4.3 Service Portfolio
9.4.4 Key Developments
9.4.5 SWOT Analysis
9.5 Catalent Inc.
9.5.3 Service Portfolio
9.5.4 Key Developments
9.5.5 SWOT Analysis
9.6 Charles River Laboratories
9.6.3 Service Portfolio
9.6.4 Key Developments
9.6.5 SWOT Analysis
9.7 Eurofins Scientific S.E.
9.7.3 Service Portfolio
9.7.4 Key Developments
9.7.5 SWOT Analysis
9.8 Fujifilm Holdings Corporation
9.8.3 Service Portfolio
9.8.4 Key Developments
9.8.5 SWOT Analysis
9.9 JSR Corporation
9.9.3 Service Portfolio
9.9.4 Key Developments
9.9.5 SWOT Analysis
9.10 Lonza Group Ltd.
9.10.3 Service Portfolio
9.10.4 Key Developments
9.10.5 SWOT Analysis
9.11 Rentschler Biopharma Se
9.11.3 Service Portfolio
9.11.4 Key Developments
9.11.5 SWOT Analysis
9.12 Samsung Biologics Co. Ltd.
9.12.3 Service Portfolio
9.12.4 Key Developments
9.12.5 SWOT Analysis
9.13 Sartorius Group
9.13.3 Service Portfolio
9.13.4 Key Developments
9.13.5 SWOT Analysis
9.14 Thermofisher Scientific Inc.
9.14.3 Service Portfolio
9.14.4 Key Developments
9.14.5 SWOT Analysis
9.15 Wuxi Biologics
9.15.3 Service Portfolio
9.15.4 Key Developments
9.15.5 SWOT Analysis
List of Tables
Table 1 Cell Line Development Services Market, by Region, (2019-2028) ($Mn)
Table 2 Approved Biologics and Cell Line Type (2014-2020*)
Table 3 Number of Approved Biologics by Cell Line Type (2014-2020)
Table 4 Cell Line Development Services Market, by Expression System, (2019-2028) ($Mn)
Table 5 Cell Line Development Services Market, by Cell Type, (2019-2028) ($Mn)
Table 6 Cell Line Type of Some Approved Biologics Modalities and Cell Line Type (2014 – 2020)
Table 7 Cell Line Development Services Market, by Application, (2019-2028) ($Mn)
Table 8 Cell Line Development Technologies
Table 9 Cell Line Development Services Cost
Table 10 Agreements (2019 -2020)
Table 11 New Technology, Product and Service Launch (2019-2020)
Table 12 Expansions (2019-2020)
Table 13 Others (2019-2020)
Table 14 Comparison Matrix of Cell Line Development Players and Services Offered
Table 15 AGC Inc.: Total Revenue and R&D Expenses, (2018-2020) ($Mn)
Table 16 AGC Inc.: Total Revenue, by Segments, (2018-2020) ($Mn)
Table 17 AGC Inc.: Chemicals Revenue, by Sub-Segments, (2018-2020) ($Mn)
Table 18 AGC Inc.: Total Revenue, by Geography, (2018-2020) ($Mn)
Table 19 Boehringer Ingelheim: Total Revenue and R&D Expenses, (2018-2020) ($Mn)
Table 20 Boehringer Ingelheim: Total Revenue, by Segments, (2018-2020) ($Mn)
Table 21 Boehringer Ingelheim: Total Revenue, by Geography, (2018-2020) ($Mn)
Table 22 Catalent Inc: Total Revenue and R&D Expenses (2018-2020) ($Mn)
Table 23 Catalent Inc: Total Revenue, by Segment, (2018-2020) ($Mn)
Table 24 Charles River Laboratories: Total Revenue and R&D Expenses, (2018-2020) ($Mn)
Table 25 Charles River Laboratories: Total Revenue, by Segments, (2018-2020) ($Mn)
Table 26 Charles River Laboratories: Total Revenue, by Geography, (2018-2020) ($Mn)
Table 27 Eurofins Scientific S.E. : Total Revenue and R & D Expenses (2018-2020) ($Mn)
Table 28 Eurofins Scientific S.E : Total Revenue, by Geography, (2018-2020) ($Mn)
Table 29 Fujifilm Holdings Corporation: Total Revenue and R&D Expenses, (2018-2020) ($Mn)
Table 30 Fujifilm Holdings Corporation: Total Revenue, by Segments, (2018-2020) ($Mn)
Table 31 Fujifilm Holding Corporation: Total Revenue, by Geography, (2018-2020) ($Mn)
Table 32 JSR Corporation: Total Revenue and R&D Expenses, (2018-2020) ($Mn)
Table 33 JSR Corporation: Total Revenue, by Segments, (2018-2020) ($Mn)
Table 34 JSR Corporation: Total Revenue, by Geography, (2018-2020) ($Mn)
Table 35 Lonza Group: Total Revenue & R&D Expenses (2018-2020) ($Mn)
Table 36 Lonza Group: Total Revenue, by Segment, (2018-2020) ($Mn)
Table 37 Lonza Group: Total Revenue, by Geography (2018-2020) ($Mn)
Table 38 Samsung Biologics Co. Ltd: Total Revenue (2018-2020) ($Mn)
Table 39 Samsung Biologics: Total Revenue, by Geography (2018-2020) ($Mn)
Table 40 Samsung Biologics: Contract Manufacturing Revenue, by Type (2018-2020) ($Mn)
Table 41 Sartorius : Total Revenue and R & D Expenses (2018-2020) ($Mn)
Table 42 Sartorius: Total Revenue, by Segments, (2018-2020) ($Mn)
Table 43 Sartorius: Total Revenue, by Geography, (2018-2020) ($Mn)
Table 44 Thermofisher Scientific Inc.: Total Revenue and R&D Expenses (2018-2020) ($Mn)
Table 45 Thermofisher Scientific Inc.: Total Revenue, by Segment, (2018-2020) ($Mn)
Table 46 Thermofisher Scientific Inc.: Total Revenue, by Product Type, (2018-2020) ($Mn)
Table 47 Thermofisher Scientific Inc.: Total Revenue, by Geography (2018-2020) ($Mn)
Table 48 Wuxi Biologics: Total Revenue and R&D Expenses, (2018-2020) ($Mn)
Table 49 Wuxi Biologics: Total Revenue, by Segments, (2018-2020) ($Mn)
Table 50 Wuxi Biologics: Total Revenue, by Geography, 2018-2020) ($Mn)
List of Figures
Figure 1 Market Dynamics of Cell Line Development
Figure 2 Cell Line Development Services Market, by Region, (2020 Vs 2028) (%)
Figure 3 Number of Approved Biologics by Cell Line Type (2014-2019)
Figure 4 Cell Line Development Services Market, by Expression System, (2020 V/S 2028) ($Mn)
Figure 5 Expression Systems of Some Approved Biologics
Figure 6 Cell Line Development Services Market, by Cell Type, (2020 V/S 2028) ($Mn)
Figure 7 Cell Line Type of Some Approved Biologics (No’S)
Figure 8 Cell Line Type of Some Approved Biologics Modalities and Cell Line Type
Figure 9 Cell Line Development Services Market, by Application, (2020 V/S 2028) ($Mn)
Figure 10 Cell Line Development Services Global Market Share Analysis, by Major Players, (2020) (%)
Figure 11 Key Developments of Cell Line Development Market Players, (2019-2020)
Figure 12 SWOT: Abzena plc
Figure 13 SWOT: Albany Molecular Research, Inc
Figure 14 Overview: AGC Inc.
Figure 15 SWOT: AGC Inc.
Figure 16 Boehringer Ingelheim Revenue Overview
Figure 17 SWOT: Boehringer Ingelheim
Figure 18 Overview: Catalent Inc.
Figure 19 SWOT: Catalent Inc.
Figure 20 Overview: Charles River Laboratories
Figure 21 SWOT: Charles River Laboratories
Figure 22 Overview: Eurofins Scientific
Figure 23 SWOT: Eurofins Scientific
Figure 24 Overview: Fujifilm Holding Corporation
Figure 25 SWOT: Fujifilm Holding Corporation
Figure 26 Overview: JSR Corporation
Figure 27 SWOT: JSR Corporation
Figure 28 Overview: Lonza Group
Figure 29 SWOT: Lonza Group
Figure 30 SWOT: Rentschler Biopharma
Figure 31 Overview: Samsung Biologics
Figure 32 SWOT: Samsung Biologics
Figure 33 Overview: Sartorius
Figure 34 SWOT: Sartorius Group
Figure 35 Overview: Thermofisher Scientific
Figure 36 SWOT: Thermo Fisher Scientific
Figure 37 Overview: Wuxi Biologics
Figure 38 SWOT: Wuxi Biologics
- 3P Biopharmaceuticals
- A & G Pharmaceutical Inc ( Precision Antibody)
- AbSci, LLC
- AGC Inc. (AGC Biologics)
- Albany Molecular Research Inc.
- Anthem Biosciences Private Limited.
- Applied StemCell Inc.
- Batavia Biosciences B.V.
- BioFactura, Inc.
- Biologics International Corp.
- Boehringer Ingelheim International GmbH
- BPS Bioscience, Inc.
- Catalent Inc.
- Celonic AG (Glycotope GmbH)
- CEVEC Pharmaceuticals GmbH
- Charles River Laboratories International Inc.
- Cognate Bioservices Inc.
- Creative Diagnostics
- Cytovance Biologics
- Dyadic International, Inc.
- EirGenix, Inc.
- Eurofins Scientific S.E
- Fujifilm Holdings Corporation
- Fusion Antibodies
- Genscript Biotech Corporation
- GVK Biosciences Private Limited
- Horizon Discovery Ltd.
- JHL biotech Inc.
- JSR Corporation
- Kemwell Biopharma
- Lake Pharma Inc.
- LFB Biomanufacturing
- Lonza Group Ltd.
- Merck KGaA (BioReliance)
- Minapharm Pharmaceuticals
- NeuClone Pty. Ltd.
- PanGen Biotech Inc
- Polpharma Biologics S.A
- Precision Antibody
- Premas Biotech Pvt Ltd
- Proventus Bio
- Rentschler Biopharma SE
- Samsung Biologics Co. Ltd.
- Sartious Group
- Sino Biological Inc.
- Solentim Ltd.
- Syd labs
- Syngene International Ltd.
- The Antibody lab
- Thermofischer Scientific Inc.
- Trenzyme GmbH
- Wuxi Biologics Inc.