A Detailed Analysis of the Cell Line Development Market Based on the Growing Rate of Chronic Illnesses, New Product Launches, and Increasing Demand for Biopharmaceuticals.
Report ID: PMRREP33909
Number of Pages: 129
Format: PPT*, PDF, EXCEL
Industry: Healthcare
Published Date: January-2024
The global Cell Line Development market is forecast to expand at a CAGR of 6.0% and thereby increase from a value of US$3.68 billion in 2023 to US$5.53 billion by the end of 2030.
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Attributes |
Key Insights |
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Cell Line Development Market Size (2023E) |
US$3.68 billion |
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Projected Market Value (2030F) |
US$5.53 billion |
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Global Market Growth Rate (CAGR 2023 to 2030) |
6.0% |
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Historical Market Growth Rate (CAGR 2018 to 2022) |
3.5% |
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Revenue Share of Top Four Countries (2022E) |
43% |
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Innovative and focused treatment approaches are frequently needed for chronic diseases, such as diabetes, cancer, cardiovascular disorders, and autoimmune diseases. Biopharmaceuticals such as recombinant proteins and monoclonal antibodies that are created utilizing cell lines are essential to meet the therapeutic demands of patients with chronic diseases. Treatments are being tailored based on unique patient features in an increasingly popular approach known as personalized medicine. This strategy calls for creating particular cell lines replicating conditions unique to a patient, enabling more precise drug testing and individualized treatment plans. Globally, cancer is one of the main causes of morbidity and death. The need for biopharmaceuticals has surged due to the rising incidence of cancer, and the development of cancer medicines, such as immunotherapies and monoclonal antibodies, depends heavily on cell lines.
The development of biopharmaceuticals for insulin generation and other diabetes-related medicines has been fueled by the rise in type 2 and type 1 diabetes cases worldwide. The effective and reliable production of these biopharmaceuticals depends on cell lines. A hyperactive immune system is a hallmark of autoimmune illnesses, which are on the rise. Developing biopharmaceuticals using cell line technology is essential for offering autoimmune disease-specific treatments that can control symptoms and enhance patient outcomes. As obesity rates rise, so does the frequency of associated chronic illnesses like metabolic disorders, non-alcoholic fatty liver disease, and cardiovascular diseases. These related health issues are partly addressed by biopharmaceuticals made from cell lines.
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Recombinant proteins and monoclonal antibodies are examples of biopharmaceuticals that frequently offer more focused and efficient therapy when compared to conventional medications. Specialized cell lines customized to meet the demands of individual patients are in greater demand as the trend toward personalized treatment continues. Biopharmaceuticals are a growing number of products in various phases of development. As a result, biologics are taking up more and more space in the pipeline of the pharmaceutical business. Production success in this growing pipeline depends on high-yielding, efficient cell lines. The patents for a number of biologic medications expiring have prompted the development and approval of biosimilars. High-quality and reasonably priced cell lines must be established to produce biosimilars and support market expansion successfully.
In addition, the biotechnology and pharmaceutical sectors persist in allocating substantial resources to research and development to introduce pioneering biopharmaceuticals to the market. Improvements to cell line creation techniques and technology are part of this commitment. As the world's population ages, the prevalence of age-related disorders rises, which increases the need for pharmacological therapies. Cell lines are essential for developing biologics tailored to the unique requirements of geriatric populations. Continuous developments have improved cell lines' precise and effective creation in genetic engineering technologies, such as CRISPR/Cas9. This, in turn, makes it easier to create cell lines that have the necessary traits and increased productivity. The increasing number of biopharmaceutical production facilities across the globe has led to the globalization of these facilities, which has made it necessary to develop dependable and repeatable cell lines to meet the increasing demand for biopharmaceutical products.
High Development Costs to Hinder Market Growth
Research and development associated with cell line development requires a significant financial commitment. This covers the price of the supplies, labor, equipment, and other resources needed in the lab to investigate and optimize cell line properties. The establishment and upkeep of the sophisticated genetic engineering tools and automation systems needed for cell line generation come with significant upfront and recurring expenses. This could be a challenge for smaller businesses with tighter budgets. Hiring and keeping a highly qualified staff in fields like genetic engineering, bioprocessing, and cell biology is costly. The skills needed for successful cell line development increase the overall expense burden.
Genetic and Phenotypic Variability
Genetic and phenotypic variations can cause batch-to-batch variability in cell lines. This discrepancy could affect how easily trials can be repeated, making developing new products more difficult and posing maintenance issues. Cell line performance might be variable due to genetic and phenotypic heterogeneity. It is challenging to anticipate cell behavior, growth rates, and productivity with accuracy because of this unpredictability, which makes it challenging to guarantee consistent and dependable results. The quality of biopharmaceutical products can be directly impacted by cell line variability. Variations in protein expression amounts, glycosylation patterns, and other important characteristics could impact the therapeutic product's safety and effectiveness.
Rising Advancements in 3D Cell Culture Technology
3D cell culture systems better mimic the in vivo environment than traditional 2D cultures. This increased physiological relevance enhances the predictive value of preclinical studies, allowing for a more accurate assessment of cell behavior and drug responses. The development of intricate cell structures and connections is facilitated by 3D cell culture, which enhances cell differentiation and functionality. This is especially important for creating specialized cell lines required for certain therapeutic uses. 3D cell culture technology makes it possible to create more realistic tumor models for cancer research. This is useful for researching the biology of tumors, how drugs work, and creating cell lines that closely resemble cancer cells in vivo. The 3D cell culture model offers a more realistic depiction of organ and tissue reactions to potential drugs. This helps drug discovery and screening by making it easier to find possible leads and impacting the creation of cell lines specifically designed for drug testing.
Moreover, stem cell research has benefited greatly from 3D cell culture technologies. It makes it possible to grow stem cells in environments more similar to their native habitat, which helps to create cell lines with improved pluripotency and differentiation potential. With the help of 3D cell culture techniques and advancements in microfluidics technology, precise control over the cellular microenvironment is possible. This makes it possible for scientists to establish physiologically appropriate and dynamic environments, which can impact the formation of cell lines for certain uses. The use of 3D cell culture technologies makes disease modeling more accurate. This is especially important for researching complicated illnesses and creating cell lines that mimic the pathogenic characteristics of different diseases to aid in creating new drugs.
The Cell Line Development (CLD) is expected to have a robust future due to multiple important variables. Cell line engineering is expected to undergo a radical transformation due to technological breakthroughs, especially in genome editing instruments like CRISPR-Cas9. The development of cell lines for the manufacturing of biopharmaceuticals is anticipated to become much more accurate and efficient due to this invention. A major factor that will shape the CLD industry is the trend toward personalized treatment. The need to create specialized cell lines that can meet the needs of specific patients will expand along with the demand for personalized therapies. This change is likely to encourage more in the way of field study and growth.
The increasing incidence of chronic illnesses is another factor driving the pharmaceutical industry's search for new treatment approaches and driving market expansion. The increasing demand for biopharmaceuticals has made it critical to have scalable and effective cell line development procedures. Strategic alliances and collaborations within the sector would spur innovation and hasten the launch of new goods. These kinds of partnerships make sharing knowledge, assets, and technological advancements easier, making the market more competitive and dynamic.
Supply-side Dynamics
North America, with an expected 45% of the global cell line development market in 2023 and a strong projection to hold onto during the forecast period, currently holds the greatest share of the market. Leading cell line development companies such as Thermo Fisher Scientific, Lonza, Charles River Laboratories, ATCC, and MilliporeSigma are based in the United States. These businesses provide a broad range of services, from creating unique cell lines to offering equipment and technology for internal growth. The United States of America has a robust healthcare system and substantial public and private investments in biotech R&D, driving the market's expansion. China's cell line development industry is driven by its rapid growth. Businesses concentrating on affordable solutions, such as WuXi AppTec and Shanghai Biopharmaceutical Base, are becoming more popular in particular markets. Japan's PeproTech and South Korea's CellGenTek
provide high-quality cell lines for specialized research areas.
The three regions with the highest R&D spending are North America, Europe, and Japan. This results in greater use of cell line creation for disease modeling, toxicological testing, and medication discovery. High consumption is probably seen in these regions in countries like the US, Germany, and the UK that have robust academic and pharmaceutical sectors.
Which Products Are Expected to Benefit the Most from Revenue Generation?
Immunotherapy Cell Lines Category Due to Rise in Immunotherapy Research
The product segment is segmented into immunotherapy cell lines, GPCR cell lines, cell signaling pathway cell lines, gene knockout cell lines, ion channel cell lines, cancer cell lines, and others. The immunotherapy cell lines segment is expected to dominate the market. The growing body of immunotherapy research has increased the need for specialized cell lines. Scientists are currently working to create and refine cell lines to investigate the workings of immunotherapies and identify possible treatment targets. Nonetheless, the GPCR cell lines segment of the cell line development market is expanding at the quickest rate. GPCRs have been linked to a multitude of illnesses, such as malignancies, heart problems, and neurological conditions. GPCR cell line creation is essential for understanding these receptors in the disease context and locating possible treatment avenues.
What Application Will Be Targeted the Most Category?
Highest Percent Share Attributed to Toxicity Screening Owing to Early Detection of Adverse Effects
The application segment is bifurcated into drug discovery & development, basic research, toxicity screening, biopharmaceutical production, tissue engineering, and forensic testing. The toxicity screening market segment is the largest for cell line development. Researchers can identify and manage side effects before incurring expensive and time-consuming clinical studies by using cell lines for toxicity screening early in the drug development. This helps to create a drug development pipeline that is more productive and economical. Nevertheless, the market segment exhibiting the most rapid growth is tissue engineering. They are creating engineered tissues by cell line development, which aids in advancing organ-on-a-chip technologies. By mimicking the actions of organs, these microfluidic devices enable controlled studies of tissue reactions to toxins, medicines, and other stimuli.
Which Area of End-User Should Be Focused on the Most Regarding Sales?
Biopharmaceutical Companies Gauging End-User Due to Monoclonal Antibody Development
The end-user segment is sub-segmented into biopharmaceutical companies, contract research organizations, academic & research institutes, forensic science laboratories, and diagnostic laboratories. Biopharmaceutical companies represent the greatest market segment for the cell line development industry. Biopharmaceuticals make extensive use of monoclonal antibodies (mAbs). Monoclonal antibodies treat various illnesses, such as cancer and autoimmune disorders, and their formation and production depend on cell lines. On the contrary, contract research organization is the market segment characterized by the most rapid growth. CROs provide biopharmaceutical businesses that might need more internal resources or experience with outsourced cell line development services for this specialized activity. The development, improvement, and characterization of cell lines for diverse uses are among these services.
Rising Technological Advancements in Genetic Engineering to Drive Market Growth
Cutting-edge genetic engineering instruments, including CRISPR/Cas9, allow for targeted and accurate changes to cell lines. This degree of accuracy is essential for customizing cell lines to fulfill certain needs and improve their functionality and productivity. Genetic engineering advancements make knockout and knock-in methods more effective. This capacity is crucial for modifying the genes in cell lines to improve protein expression, streamline manufacturing procedures, and create cell lines with desired traits. The cell line development process is expedited by the effectiveness and speed provided by cutting-edge genetic engineering methods. This holds special importance in addressing the growing need for biopharmaceuticals, shortening the duration of product development, and expediting product launches. Developments in genetic engineering allow genes to be incorporated into cell lines more precisely and efficiently. This feature aids in creating high-yielding, stable cell lines essential for the large-scale manufacture of biopharmaceuticals.
What Opportunities Lie in Asia Pacific for Manufacturers?
Growing Focus on Rare Diseases and Orphan Drugs to Advance Marker Growth
In Asia Pacific, there is a significant unmet medical demand for efficient treatments for uncommon diseases. To meet these unmet demands, developing cell lines specifically designed for these uncommon situations is essential. As rare diseases become more prevalent, governments throughout the Asia-Pacific area realize how important it is to address them. Government initiatives and assistance foster an atmosphere favorable to research and development activities, including creating cell lines for orphan medications. The Asia-Pacific area has a growing awareness of and advocacy for rare diseases. Cell lines for orphan pharmaceuticals are being developed thanks to the active promotion of research and development efforts by advocacy groups, patient groups, and medical professionals.
Prominent organizations, including Thermo Fisher Scientific Inc. and Lonza, are at the vanguard of this sector; Thermo Fisher provides a broad spectrum of cell line development options, from immortalization to optimization, by utilizing its recognizable Gibco® brand, which is well-known for its media, reagents, and equipment for cell culture. They meet various research and production demands by offering integrated workflows that cover cell line engineering, cryopreservation, characterization, and scale-up. They go beyond offering individual products. Thermo Fisher provides custom cell line development services through partnerships and acquisitions, such as those with CCRM and OriGene, in recognition of the demand for individualized solutions. Thermo Fisher aggressively works to expand its products and gain access to state-of-the-art technology through partnerships with top biotech businesses and academic institutions. They make significant investments in this area, emphasizing automation, cutting-edge cell culture technology, and high-throughput screening techniques for cell line selection.
Lonza has an extensive global network of cutting-edge facilities ideally positioned to service clients worldwide, guaranteeing timely project delivery and effective execution. They customize their products and services to fit the unique needs of various markets and regulatory frameworks. Lonza actively seeks prospects in developing nations that hold great promise for the production of biopharmaceuticals. Throughout the cell line generation process, Lonza prioritizes close engagement with its clients to ensure alignment with their unique demands and goals. They cultivate enduring relationships and fruitful project outcomes by offering clients committed technical support and knowledgeable guidance.
New Product Launch
ProBioGen and Granite Bio will collaborate to provide GMP manufacturing and cell line development services in July 2022. Granite Bio's leading candidate for treating autoimmune and certain cancer indications is a new monoclonal antibody through the DirectedLuck transposase.
Market Impact: Granite Bio's development timeframe for their new mAb may have been expedited by ProBioGen's experience with cell line generation, specifically with the DirectedLuck transposase. This might make it easier for patients to receive novel therapy alternatives. ProBioGen's market share and presence increased due to the partnership, which gave them additional chances to meet the rising demand for high-quality GMP manufacturing and cell line development services. DirectedLuck transposase is a novel way to generate cell lines that could help other mAb developers and lead to additional developments in this industry.
FUJIFILM Corporation stated in June 2022 that it would invest USD 1.6 billion to improve and extend the cell culture production capabilities of FUJIFILM Diosynth Biotechnologies, a world-class contract development and manufacturing organization (CDMO) and a subsidiary of FUJIFILM Corporation.
Market Impact: With the addition of new bioreactors and production facilities, the investment greatly enhanced FUJIFILM Diosynth's capacity and may have contributed to the company's increased market share and overall growth. Due to this investment, new clients may be drawn to FUJIFILM Diosynth by its enhanced reputation and capabilities, especially those that need innovative technologies or large-scale manufacturing. The investment significantly increased job prospects in the areas where FUJIFILM Diosynth works, boosting the local economy.
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Forecast Period |
2023 to 2030 |
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Historical Data Available for |
2018 to 2022 |
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Market Analysis |
US$ Million for Value |
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Key Regions Covered |
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Key Countries Covered |
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Key Market Segments Covered |
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Key Companies Profiled |
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Report Coverage |
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Customization & Pricing |
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The market is anticipated to grow at a CAGR of 6.0% during the projected period.
The cell line development market was valued at USD 3,680.5 million in 2023.
The United States held the largest market share in 2023.
The prominent players in the market are BPS Bioscience, Inc., Thermo Fisher Scientific Inc., ATCC (American Type Culture Collection), Sigma-Aldrich (Merck Group Company), Lonza, STEMCELL Technologies, BioIVT LLC, Novus Biologicals, Rockland Immunochemicals, GenScript, BiologicsCorp, Horizon Discovery, Synthego, AcceGen, Promega, FenicsBIO, InvivoGen, Abcam plc., Eurofins DiscoverX, and others.
The GPCR cell lines segment is expected to grow fastest during the forecast period.
