The market dynamics of cell line development are shaped by various factors, including technological advancements, growing demand for biopharmaceuticals, regulatory requirements, and emerging trends in the healthcare industry. This market revolves around the creation and optimization of cell lines for use in biopharmaceutical production, research, and therapeutic applications.
One significant driver of market growth is the increasing demand for biopharmaceuticals. As the prevalence of chronic diseases rises and the need for personalized medicine becomes more pronounced, pharmaceutical companies are turning to biologics as a means of developing effective treatments. This trend has led to a surge in the demand for cell lines tailored for producing biopharmaceuticals such as monoclonal antibodies, recombinant proteins, and viral vectors.
Moreover, technological advancements play a crucial role in shaping the dynamics of the cell line development market. Innovations in genetic engineering, genome editing techniques like CRISPR/Cas9, and high-throughput screening methods have revolutionized the process of cell line development, enabling researchers to create cell lines with desired characteristics more efficiently and accurately. These technological advancements not only streamline the cell line development process but also enhance the quality and productivity of cell-based biomanufacturing.
Additionally, regulatory requirements significantly influence the market dynamics of cell line development. Regulatory bodies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe have stringent guidelines for the development and characterization of cell lines used in biopharmaceutical production. Compliance with these regulations is imperative for obtaining approval for biopharmaceutical products, driving the demand for cell line development services that adhere to regulatory standards.
Furthermore, emerging trends in the healthcare industry, such as the rise of cell and gene therapies, are impacting the dynamics of the cell line development market. Cell-based therapies, including CAR-T cell therapy and gene editing-based treatments, require specialized cell lines tailored to specific therapeutic applications. As these innovative therapies gain traction and move towards commercialization, the demand for custom cell lines optimized for therapeutic efficacy and safety is expected to increase, driving further growth in the cell line development market.
The competitive landscape of the cell line development market is characterized by the presence of a diverse range of players, including contract development and manufacturing organizations (CDMOs), biotechnology companies, academic institutions, and research laboratories. CDMOs play a crucial role in providing cell line development services to pharmaceutical and biotechnology companies, offering expertise in cell line engineering, process optimization, and regulatory compliance. Biotechnology companies and academic institutions also contribute to market growth through research and development efforts aimed at creating novel cell lines and technologies.
Report Attribute/Metric | Details |
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Market Opportunities | Rising adoption of mammalian sources for antibody production Technological innovation in cell line development |
Market Dynamics | Increasing R&D in the biotechnology and pharmaceutical sectors Increasing use of cell lines in hospitals, biotech, and pharmaceutical firms |
Cell Line Development Market Size was valued at USD 6.36 Billion in 2023. The Global Cell Line Development industry is projected to grow from USD 7.11 Billion in 2024 to USD 17.38 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 12.12% during the forecast period (2024 - 2032).
Rising R&D in the biotechnology and pharmaceutical sectors and expanding use of cell lines in biotech, pharmaceutical, and hospital settings are the key market drivers enhancing the market growth.
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
The market is driven by a booming biopharmaceutical industry, increasing demand for cancer therapies and monoclonal antibodies, and expanding biosimilar manufacture due to branded treatments' patent expirations. The emerging usage of bio-therapeutics in the care of chronic diseases like cancer, diabetes, and arthritis is strongly correlated with the expansion of the cell line development industry. The need for automatic cell line development or cell line development services is increasing as a result. The use of cultured cell lines for cancer research, including tumor cells that are more amenable to culturing in vitro, is a major driving force in the cell line development industry. Products currently under development use a lot of human cell lines from the mammalian cell line development division.
Furthermore, human cell lines typically use expression systems because they generate a human protein with PTMs. The market is expanding due to the demand for regenerative therapies, a shift in focus to cutting-edge studies on cancer, and a surge in the demand for drugs having biological origins. According to FMI analysis, the rise in BPS is attributable to elements such as top corporations consistently expanding their product lines, manufacturers concentrating on fast-growing new markets such as the Asia-Pacific, and the incorporation of sizeable expenditures to support R&D. In impoverished countries like India, cell lines are frequently used as research platforms for the administration of drugs. Over the past ten years, cancer has increased in frequency due to changes in eating habits, inadequate levels of exercise, and overall changes in lifestyle.
Additionally, as vaccine production increases and technology develops, a greater demand for cell line creation will be created. The market for cell line development is anticipated to expand over the projection period due to the rising use of cell lines in manufacturing biological cancer therapeutic ingredients. In addition, increasing biosimilar production due to branded treatments' patents expiring is anticipated to fuel market expansion. Creating cell lines is crucial to the production and development of biosimilars. Biosimilars boost market competition and make it easier for patients to access life-saving drugs.
The desire for regenerative medicine, a shift in emphasis to cutting-edge cancer research, and increased demand for medicines with biological origins drive the market's growth. According to FMI analysis, factors like top companies continuously expanding their product range, manufacturers focusing on high-growth emerging markets like Asia-Pacific, and the inclusion of significant expenditures to support R&D are responsible for the increase in BPS. Cell lines have been widely employed as research mediums for medication delivery in developing nations like India.
An Increase in the Use of New Technologies Offers Profitable Opportunities for Cell Line Development; Animal cells have historically been used as the preferred substrate for synthesizing monoclonal antibodies and recombinant proteins because of their propensity for fast growth, high protein output, and the optimization of the investment system. The market for cell line development offers attractive growth prospects due to the need for cell culture, recombinant cell lines, mammalian cell lines, and related goods. The manufacture of numerous viral vaccines is predicted to be facilitated by the ongoing uses of human diploid cells. A chance to gain ground in the current industry landscape is also being presented by launching innovative therapies and biosimilars.
Throughout the projection period, it is anticipated that improvements in culture technologies will substantially influence the market growth for cell line creation. Furthermore, there are opportunities for the cell line development market to expand due to using monoclonal antibodies as therapeutic agents to treat various sick cells. Applications for stable cell lines include the manufacture of biologics, functional gene research, and drug screening. Sales in the cell line development market will continue to be driven by rising demand for monoclonal antibodies and other biological products.
Growing acceptance of innovative biopharmaceutical medicines and an increase in the prevalence of chronic diseases will fuel demand for biotechnology goods. The adoption of biopharmaceutical products and the increased frequency of chronic illnesses are expected to drive a 9.2% growth rate in the pharmacy sector by 2032. Innovative product offers will result from the expanding Application of cutting-edge technologies, such as bio-recombinant proteins, in treating many chronic illnesses. The adoption rate of biopharmaceutical products will be boosted by the safety and efficacy guaranteed by their usage and their capacity to provide treatments for ailments that were previously incurable. Biopharma companies place a strong emphasis on developing tailored medicines.
Based on type, the Cell Line Development market segmentation includes Primary Cell, Hybridoma Cell Line, Continuous Cell Line, and Recombinant Cell Line. Reagents and media share the highest growth during the forecast period 2021. Due to its widespread use in genetics, cell morphology, cell metabolism, and cell physiology, primary cell lines will see the largest increase over the predicted period of 2021. From normal, benign, and embryonic tissues, cell culture is started. Since many types of cells can be created from a single blood cell, primary cell cultures frequently contain a range of cells and develop in a lab setting. During the projected period, the demand for this Cell Line Development sector market segment is anticipated to be driven by the rising need for biologics produced in vitro.
Based on Product, the Cell Line Development market segmentation includes Equipment, Media and Reagents. Reagents and media share the highest growth during the forecast period 2021. Reagents and media made up the greatest portion of income, owing to the rise in bio-production, which requires these items for everything from incubation to preservation. Because of their high cost and frequent usage in the manufacture of biologics, these goods accounted for the biggest revenue share.
Figure 2: Cell Line Development Market by Product, 2021 & 2032 (USD Million)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Based on Source, the Cell Line Development market segmentation includes Mammalian and non-Mammalian cells. Mammalian cells share the highest growth during the forecast period. In the next years, it is anticipated that increasing the use of a mammalian source for the manufacture of monoclonal antibodies and the requirement to express complex proteins comparable to those found in humans would increase the acceptance of this Cell Line Development sector market.
Based on Application, the Cell Line Development market segmentation includes rug Discovery, Bioproduction, and Tissue Engineering. In 2021the bioproduction category had the highest revenue share thanks to the rising production of vaccines and antibiotics. The bioproduction application area includes the production of biologics-based therapeutic pharmaceuticals such as vaccines, therapeutic proteins, cell therapies, and gene therapies. The most well-known bioproduction products are antibiotics and vaccines, and demand for these products is predicted to increase rapidly in the next years due to the spread of communicable illnesses and pandemics, particularly in developing nations.
By Region, the study provides market insights into North America, Europe, Asia-Pacific and the Rest of the World. The North America Cell Line Development market accounted for USD 1.24 billion in 2021 and is expected to exhibit a significant CAGR growth during the study period. Fresh discoveries and ongoing technological advancements have led to the implementation of newer bioproduction techniques. The development is attributed to rigorous initiatives by research firms, such as Thermo Fisher Scientific Inc., American Type Culture Collection (ATCC), and Sigma-Aldrich Corporation, which offer high-quality biologics services.
Additionally, encouraging government efforts and raising awareness of the use of monoclonal antibodies in the treatment of cancer are some of the elements anticipated to propel regional industry expansion.
Further, the major countries studied in the market report are The U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 3: CELL LINE DEVELOPMENT MARKET SHARE BY REGION 2021 (%)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Due to rising healthcare spending by the public and private sectors, the Asia Pacific region's Cell Line Development sector market is predicted to expand profitably. During the projection period, it is anticipated that the biotechnology sector in emerging nations would experience substantial expansion. Government measures like public healthcare programs and enhanced healthcare infrastructure in emerging nations are fostering the sector's expansion.
For instance, agencies like the Department of Science and Technology (DST), the Department of Scientific & Industrial Research (DSIR), and the Department of Biotechnology (DBT) in India regulate the creation of biotechnology products and the rules that apply to their use.
The Cell Line Development market in Europe holds the second-largest market share as a result of reasons such as the rising use of regenerative medicine, rising healthcare spending, and an increase in investments in the biotechnology sector. Among the industry's biotechnology-based uses are gene therapy, cell culture, and drug development. Additionally, the UK Cell Line Development market grew the quickest in the European area, while Germany's market had the biggest market share.
Cell Line Development Key Market Players & Competitive Insights
Major market players are investing a lot of money in R&D to expand their product portfolios, which will spur further market growth for the Cell Line Development industry. With significant industry changes, including new product releases, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations, market participants are also undertaking various strategic activities to expand their presence. To grow and remain in a market that is becoming more competitive and growing, Cell Line Development industry competitors must provide affordable products.
Manufacturing locally to cut operational costs is one of the main business tactics used by the Cell Line Development industry to serve customers and increase the market sector. The Cell Line Development industry has recently given medicine some of the most important advantages. The Cell Line Development markets major players such as American Type Culture Collection (ATCC) (US), Lonza Group AG (Switzerland), Thermo Fisher Scientific Inc. (US), GE Healthcare (US), Sigma-Aldrich Corporation (US), Selexis SA (Switzerland), Promega Corporation (US), Corning Inc. (US), WuXiAppTec Inc. (China), Sartorius AG (Germany), and others are working on expanding the Cell Line Development sector market demand by investing in research and development activities.
Merck & Co., Inc. is an American multinational pharmaceutical company. The business creates pharmaceuticals, vaccines, biological treatments, and items for animal health. The acquisition of French-based RESOLUTION Spectra Systems by Merck, a firm specializing in bioprocess analytical monitoring, was finalized in July 2020. With the aid of this purchase, Merck was able to provide real-time monitoring for continuous and enhanced bioprocessing.
With best-in-class modular technology and highly customized solutions, Selexis SA, a JSR Life Sciences Company, is the world leader in cell line creation and enables the life sciences sector to find, develop quickly, and market novel biologic drugs and vaccines. A licensing agreement was signed between Selexis SA and SpyBiotech in March 2021 to pursue the human cytomegalovirus (HCMV) vaccine program. SpyBiotech will create stable, high-yield cell lines for human clinical trials using Selexis' SUREtechnology platform. Both businesses benefited from this, which increased their sales. Cyto-Mine®, the most recent single-cell analysis device created by Sphere Fluidics, has been included by scientists at FUJIFILM Diosynth Biotechnologies to alter their cell line development procedures.
The new processes are straightforward and effective in comparison to earlier workflows. Projects can move quickly from the initial transfection phase to the generation of extremely prolific cell lines in just ten weeks. For the benefit of biotherapeutic producers, specialized contract manufacturing and research organizations provide technical know-how and capacity in cell line and method development. CDMOs are under increasing pressure in this fiercely competitive commercial sector to deliver strong and abundant stable cell lines more quickly to hasten the transition of pharmaceutical substances to clinical research. This must be done without sacrificing the quality of biological products.
Key Companies in the Cell Line Development market include
Cell Line Development Industry Developments
October 2021: Boehringer Ingelheim International GmbH opened its large-scale cell culture (LSCC) biopharmaceutical production facility in Vienna, Austria. The construction cost the firm about USD 809 million (700 million euros). It is anticipated to increase the company's ability to produce biopharmaceuticals by around 185,000 liters. Additionally, the facility's multi-product configuration is anticipated to increase the production of a wide range of molecular forms.
June 2021: Immatics N.V. (Germany), a clinical-stage biopharmaceutical business engaged in the research and development of T-cell redirection cancer immunotherapies, was informed that Selexis SA and KBI Biopharma (US), both JSR Life Sciences subsidiaries, had inked service agreements with it.
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