Cell Line Development (CLD) Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Germany, UK, China, Japan - Size and Forecast 2024-2028

Cell Line Development (CLD) Market Forecast 2024-2028

The Cell Line Development (CLD) Market size is estimated to grow by USD 7.41 billion at a CAGR of 14.63% between 2023 and 2028. 

Vaccines are beneficial for the prevention of infectious diseases, such as diphtheria, hepatitis B, and measles. It is one of the cost-effective and successful strategies for precaution against health. Virus-based vaccines are made in living cells. Many manufacturers investigate new cell lines to develop vaccines. Additionally, the main advantage of producing vaccines is the ability to enable rapid production during an imminent pandemic. Furthermore, synthetic media can be used for cell line proliferation, which prevents the spread of transmissible spongiform encephalopathies by avoiding animal serum as growth media. An increase in the demand for vaccines for universal programs and the emergence of chronic diseases, such as pandemic influenza, will result in an increase in cell line production for vaccine synthesis, which will propel the market growth during the forecast period. 

What will be the Size of the Market During the Forecast Period?

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Market Segmentation 

The market is witnessing significant growth, driven by the demand for primary cell lines and recombinant monoclonal antibodies in biopharma businesses. This market plays a pivotal role in advancing cancer therapies and vaccine research, utilizing cell lines like the lung cancer cell line A549. Key targets such as Angiotensin-converting enzyme 2 (ACE2) and Transmembrane serine protease 2 (TMPRSS2) are crucial in drug development. Additionally, blockbuster medications like Lantus, Abilify, Namenda, and Androgel are produced through cell line development processes. As biopharma companies expand globally, there's a growing focus on hybridomas and their potential in low-income countries, highlighting the importance of cell line development in advancing healthcare worldwide.

Product analysis 

The market share growth by the media and reagents segment will be significant during the forecast period. Media and reagents include several types of media used for culturing cell lines, such as minimum essential media, reduced serum media, and serum-free media. Reagents such as supplements and growth factors, buffers and chemicals, cell dissociation reagents, and cryopreservation reagents are added in addition to the media for the stable culturing of cell lines and their safe storage for the future as they are used as pure samples in research.

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The media and reagents was the largest segment and was valued at USD 3.06 billion in 2018. Minimum essential media contains important factors required for cell growth, such as amino acids, nutrients, and minerals. Serum-free media contains chemically derived components with their exact known components, whereas serum media contains animal-derived products, such as albumin, in which the probability of contaminants, such as the lipid content of the albumin, is high. Reagents are added as additional factors to culture media to maintain the osmolarity, pH, and integrity during proliferation and when they are stored for future use. Due to the increasing use, manufacturers are introducing many new reagents. The number of reagents sold is more than the pieces of capital equipment sold, which helps companies generate more revenue. Most of the diagnostic centers rent the equipment; however, they purchase the media and reagents that are required to run a variety of tests. Hence, factors such as increased use of media and reagents for bioproduction from incubation to cell line preservation, increased affordability, ease of storage in less space, and frequent purchases will drive the growth of the segment of the market during the forecast period.

Source Analysis

The mammalian source involves the creation, optimization, and commercialization of mammalian cell lines for various applications, such as biopharmaceutical production, drug discovery, and research. It encompasses a range of products, services, and technologies aimed at facilitating the efficient and cost-effective development of mammalian cell lines. Mammalian cell lines are commonly used to produce recombinant proteins, monoclonal antibodies (mAbs), and other biopharmaceuticals. Cell lines derived from specific mammalian sources are used to study various diseases, including cancer, neurodegenerative disorders, and genetic diseases. Researchers use these cell lines to better understand disease mechanisms and develop potential treatments. Thus, factors such as improving drug development and drug screening will promote the development of the mammalian segment, which will propel the growth of the market during the forecast period.

While mammalian cell lines are widely used in biotechnology and pharmaceutical research, non-mammalian cell lines also play a crucial role in various applications. These are derived from organisms other than mammals, such as insects, plants, bacteria, and yeast. They offer unique advantages for specific research areas and applications. Non-mammalian cell lines are often chosen when specific post-translational modifications or protein folding processes are required for the desired protein product. Some non-mammalian cell lines offer eco-friendly and sustainable production platforms, making them attractive for certain biotechnological applications. Thus, the wide application in biotechnology, pharmaceutical, and medical research will propel the segment, which, in turn, will accelerate the growth of the market during the forecast period.

Regional Analysis

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North America is estimated to contribute 32% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional market trends and analysis and drivers that will shape the market during the forecast period. The cell line development market in North America is led by the US, owing to the presence of several big pharmaceutical companies that are researching to develop new drugs and vaccines using this method. The improved healthcare infrastructure is another reason for the high demand in the US, as it provides increased affordability. The presence of professionals with the knowledge to use the same for cancer diagnosis and regenerative treatment also increases the adoption of cell line development. There has been a rise in government funding and research projects in North America, owing to the increasing awareness about the high potential of regenerative medicines. Funding from the National Institutes of Health and Biomedical Advanced Research and Development Authority (BARDA) in North America contributes to the growth of the cell line development market. Such funding is aimed at progressing clinical trials and developing new medicines for various diseases, which will boost growth. 

Additionally, the increased incidences of cancers and immunological disorders in North America during the past years have been driving the growth of the regional cell line development market. For instance, as per the Centers for Disease Control and Prevention (CDC), about 1.5 million people are diagnosed with cancer every year in the US. CDC also predicts that by the end of 2021, in the US, the number of cancer cases will increase to nearly two million per year. The rise in the number of cancer cases is likely to increase the need for treatment options that make use cell line development, which will strengthen the growth of the market during the forecast period.

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Key Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 14 market companies, including:

ATCC - The company offers cell line development through CRISPR toolbox cell lines such as A549 dCas9-KRAB, 293 HEK 293 Cas9, U 87 MG dCas9 KRAB, and others.

• Boehringer Ingelheim International GmbH
• Danaher Corp.
• DNA TwoPointO Inc.
• JSR Corp.
• Lonza Group Ltd.
• MabPlex International Ltd.
• Premas Biotech
• Promega Corp.
• Sartorius AG
• Thermo Fisher Scientific Inc.
• WuXi Biologics Cayman Inc.
• General Electric Co.
• Corning Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Key Dynamics

 

The market is vital for advancing biopharmaceutical medications, especially in the context of biosimilars and innovative cancer therapies. With a focus on high productivity and cost-effectiveness, CLD services offer various cell line options, including mammalian cell lines, to meet diverse R&D activities. However, ethical concerns surrounding the use of certain cell line sources persist, particularly in low-income countries. Despite this, CLD services remain crucial for SARS-CoV-2 research and vaccine development, utilizing advanced cell culture techniques and FDA-approved reagents and media. As demand grows, the market continues to evolve, driven by the need for efficient and ethical cell line solutions to address pressing healthcare challenges. There are multiple factors influencing market growth. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. 

Key Drivers

Increased demand for monoclonal antibodies is notably driving market growth. A mAby, a pivotal protein, is meticulously developed in a laboratory, designed for binding substances in the human body, especially cancer cells. These antibodies demonstrate remarkable selectivity, binding solely to one kind of substance. Presently, various types of mAbs serve as therapeutic agents, deployed for treating different types of cancer. They are utilized either independently or in conjunction with drugs, radioactive substances, or toxins to effectively eliminate diseased cells. Despite being high-priced, mAbs provide life-saving advantages, securing a substantial share in the global pharmaceuticals industry, even with lesser sales compared to other widely distributed drugs.

Additionally, in the cancer treatment landscape, mAbs are intricately designed in conjugation with anti-cancer drugs, ensuring improved results through cleavage after delivery to the tumor site. The market's growth is fueled by increased incidences of cancer and immunological disorders, wherein mAbs find extensive applications in bioproduction, tissue engineering, regenerative medicine, toxicity testing, research, and drug discovery. This spans various geographies and cell lines, including mammalians, insects, and amphibians.

Significant  Trends

The adoption of laboratory automation is an emerging trend shaping market growth. Owing to the cost-cutting in lab fees, profitability per test is decreasing, which makes it necessary for laboratories to focus on volume rather than value. There is also heavy pressure to obtain high-quality, error-free results. This compels labs to lean toward more automated systems with effective workflow solutions. In the US, laboratories are encouraged for automation due to the heavy influx of patients with insurance coverage. Automated systems in technology in recent years have led to the rapid adoption of its wider application. Several studies have shown that these technologies have enhanced health and research centers by providing a model for cancer research, the screening of anti-cancerous drugs, the effects of cytotoxicity, and others.

Moreover, laboratories are also approaching institutes to get a valid certification of automation. In the coming years, healthcare centers and laboratories are likely to benefit from standardization and automation as fully automated molecular platforms are emerging into the marketplace as game-changers. Hence, the advancement in technologies that result in an increase in efficiency and speed for developing vigorous and extremely productive large-scale production of biologics will propel the market growth and trends during the forecast period. 

Major  Challenges

High capital associated with cell line development is a significant challenge hindering market growth. The process can be expensive, including costs for reagents, equipment, personnel, clinical trials, regulatory approvals, and facility resources. Budget constraints may negatively impact the scope and duration of projects. The drugs derived from mAbs for the treatment of diseases such as cancer, leukemia, and lymphoma are very expensive. The production of cancer MABs requires expensive biological and chemical materials, clinical trials, and quality tests. For instance, as of January 2021, according to Biopharm Services Limited, the capital equipment was estimated at USD 5.4 million, and the total capital expenditure was estimated at USD 30 million (including design, construction, and validation).

Further, the cost of biological mAbs was estimated at USD 300/g, and the cost of the binding drug was USD 4,000/g. Hence, small players are reluctant to enter the market due to the capital requirements. Moreover, the production process of these drugs is complex. Thus, these factors will impede the growth of the market during the forecast period.

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Key Market Customer Landscape

The market forecasting report includes the adoption lifecycle of the market research and growth, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the market analysis and report also include key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth and forecasting strategies.

 Customer Landscape

Segment Overview

The market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2018 to 2028. 

• Product Outlook
  • Media and reagents
  • Equipment

• Source Outlook
  • Mammalian
  • Non mammalian

• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest of World (ROW)
    • Brazil
    • Argentina 
    • Australia 

Market Analyst Overview 

The Global Cell Line Development Market is witnessing substantial growth, driven by advancements in innovative technologies, especially in mammalian and amphibian cell lines crucial for applications in tissue engineering, regenerative medicine, toxicity testing, and vaccine production. Market leaders such as the American Type Culture Collection (ATCC), Lonza Group AG, GE Healthcare, Sigma-Aldrich Corporation, and Selexis SA play pivotal roles in providing high-yielding and stable cell lines for pharmaceutical and biotechnology industries, academic research institutes, and diagnostic laboratories.

 

The market addresses a spectrum of concerns, from ethical considerations to cost-effectiveness, while catering to various types of cell lines, including mammalian cell lines. Ethical concerns often arise regarding the sources of cell lines, especially in low-income countries. The FDA plays a pivotal role in regulating these cell line types, ensuring safety and efficacy. Despite the challenges, CLD services strive to provide cost-effective solutions for research and development, particularly in areas related to cancer death. As the market continues to evolve, balancing ethical concerns with the need for innovative solutions remains paramount for driving progress in biopharmaceutical advancements.

With a focus on addressing pandemic and communicable diseases, research activities in the bioproduction segment flourish, emphasizing the importance of recombinant cell lines in manufacturing protein therapeutics. Geographically diverse, the cell line development market caters to low income countries, fostering global collaboration in diagnostics and the reagents market, ensuring a comprehensive and inclusive approach to advancements in cell line technology.

Market Scope
Report Coverage	Details
Page number	163
Base year	2023
Historic period	2018-2022
Forecast period	2024-2028
Growth momentum & CAGR	Accelerate at a CAGR of 14.63%
Market Growth 2024-2028	USD 7.41 billion
Market structure	Fragmented
YoY growth 2023-2024(%)	13.59
Regional analysis	North America, Europe, Asia, and Rest of World (ROW)
Performing market contribution	North America at 32%
Key countries	US, Germany, UK, China, and Japan
Competitive landscape	Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks
Key companies profiled	ATCC, Boehringer Ingelheim International GmbH, Danaher Corp., DNA TwoPointO Inc., JSR Corp., Lonza Group Ltd., MabPlex International Ltd., Premas Biotech, Promega Corp., Sartorius AG, Thermo Fisher Scientific Inc., WuXi Biologics Cayman Inc., General Electric Co., and Corning Inc.
Market dynamics	Parent market growth analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the forecast period.
Customization purview	If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the growth of the between 2024 and 2028
• Precise estimation of the size and its contribution of the market in focus to the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria 
• Companies landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on companies position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of companies

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