According to Precedence Research, the global cell therapy manufacturing market size was estimated at USD 5.55 billion in 2025 and is expected to grow from USD 6.38 billion in 2026 to nearly USD 18.89 billion by 2034. The market is expected to grow at a strong CAGR of 14.61%.
Rising pharmaceutical R&D spending, government grants, support for the development of cell and gene therapies, and the increasing prevalence of cancer and other diseases are driving the market's growth.
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Cell Therapy Manufacturing Market Key Insights:
✚ By Regional Insight:
🔹 North America led the market in 2024 with a 44% market share.
🔹 Asia Pacific is expected to witness the fastest growth between 2025 and 2034.
✚ By Therapy Type:
🔹 Autologous cell therapy dominated in 2024 with a 59% share.
🔹 Allogenic cell therapy is projected to grow the fastest during the forecast period.
✚ By Technology Type:
🔹 Somatic cell technology held the largest market share in 2024.
🔹 3D cell culture technology is expected to expand at the highest CAGR.
✚ By Source:
🔹 iPSCs (induced pluripotent stem cells) dominated in 2024.
🔹 Bone marrow ranked second in market share.
✚ By Application:
🔹 Oncology accounted for the largest revenue share (35%).
🔹 Neurological therapies are expected to grow at the fastest rate.
✚ By End User:
🔹 Pharmaceutical and biotechnology companies held the dominant position in 2024.
🔹 Academic and research institutes are projected to witness the highest growth going forward.
What is Cell Therapy Manufacturing?
The cell therapy manufacturing market refers to the production, distribution, and use of cell therapy manufacturing which is the process through which cellular therapies are produced. Cell therapy manufacturing is the process of growing, modifying, and preparing living cells to treat disease. Cell therapy manufacturing is a complex, multistage process that begins with cell isolation and transitions to cell activation and expansion. Cell therapy is the transfer of a specific cell type or types into a person to treat or prevent a disease.
Cell therapy manufacturing helps reduce waste by reducing defects that result from processing and product changeovers. Since products or components move through a cell one piece at a time, operators can quickly identify and address defects.
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Major Government Initiatives for Cell Therapy Manufacturing:
🔹 National Biopharma Mission (India): Funds the development of affordable, indigenous CAR-T cell therapy by supporting both research and the establishment of GMP-grade plasmid and viral vector manufacturing facilities.
🔹 National Cancer Institute (NCI) Cancer Adoptive Cellular Therapy (Can-ACT) Network (USA): Manufactures and centralizes the production of CAR-T cell therapies in its GMP facility to support and accelerate early-phase clinical trials for cancer research.
🔹 Advanced Therapy Treatment Centres (ATTC) Network (UK): Fosters collaboration among research institutes, hospitals, and industry to develop infrastructure and standardize clinical adoption of advanced therapies.
🔹 Solutions for Manufacturing Advanced Regenerative Therapies (SMART) Cooperative Research Centre (CRC) (Australia): Bolsters domestic manufacturing capabilities and addresses technical expertise shortages to bring regenerative therapies to market.
🔹 European Medicines Agency (EMA) Joint Action Plan (European Union): Streamlines the regulatory pathway and offers scientific support to academic and non-profit developers of advanced therapy medicinal products (ATMPs).
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What are the Key Trends in the Cell Therapy Manufacturing Market?
🔹 Increased automation and closed systems: This trend involves using more automated technologies and closed-system bioreactors to reduce manual handling, thereby increasing efficiency, improving consistency, and minimizing the risk of contamination during cell therapy production.>
🔹 Shift toward allogeneic therapies: While patient-specific (autologous) therapies currently dominate, the industry is moving toward "off-the-shelf" allogeneic therapies derived from healthy donors to offer greater scalability and broader patient accessibility.
🔹 Supply chain advancements: Because cell therapies often require time-sensitive and highly specialized logistics like cryogenic shipping, the industry is adopting advanced software and logistics management to improve the tracking, management, and overall integrity of the cell therapy supply chain.
🔹 Integration of AI and machine learning: Artificial intelligence and machine learning are being integrated into manufacturing workflows to analyze complex data and optimize various production parameters, leading to faster development, enhanced quality control, and better outcomes.
🔹 Growth of decentralized manufacturing: To address the logistical and cost challenges of centralized production, manufacturers are exploring decentralized and point-of-care (POC) models that bring the manufacturing process closer to the patient, particularly for personalized therapies.
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Cell Therapy Manufacturing Market Opportunity
Development of CAR-T Therapies
The development of CAR-T therapies will provide an opportunity for the market. CAR-T cell therapy benefits include less treatment time required, two weeks of inpatient care, administered with a single infusion that may need at most, and then it's done. CAR-T cell treatment, a type of immunotherapy, has been proven especially useful for treating children with blood cancer.
CAR-T cells have shown success in treating specific cancers, mainly blood cancers like lymphoma and leukemia. CAR T-cell therapy is a newer way to treat some kinds of blood cancer when other treatments are not effective or when cancer comes back.
Cell Therapy Manufacturing Market Challenges
High Risk of Mutagenesis
High risk of mutagenesis can restrict the growth of the market. Mutagenesis is a double-edged sword; at the same time that it provides the fuel for evaluation by natural selection, it can also have deleterious effects on genome stability that can reduce fitness, promote tumorigenesis and cancer formation, or cause heritable genetic disorders.
Mutagenicity is the ability of a substance to induce mutations in the deoxyribonucleic acid (DNA) of organisms. This may lead to toxicity, a series of genetic conditions like hemochromatosis, sickle cell anemia, Huntington’s disease, cystic fibrosis, and cancer.
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Cell Therapy Manufacturing Market Report Scope
|
Report Coverage |
Details |
|
Market Size in 2025 |
USD 5.55 Billion |
|
Market Size in 2026 |
USD 6.38 Billion |
|
Market Size by 2034 |
USD 18.89 Billion |
|
Growth Rate from 2025 to 2034 |
CAGR of 14.61% |
|
Leading Region in 2024 |
North America |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
Therapy Type, Technology Type, Source, Application, and Region |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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Access to This Exclusive Report 👉 https://www.precedenceresearch.com/checkout/4283 Case Study: Kite Pharma (Gilead Sciences) – Scaling CAR-T Cell Therapy
Manufacturing Background: Kite
Pharma, a subsidiary of Gilead Sciences, is a global leader in CAR-T (chimeric
antigen receptor T-cell) therapy for blood cancers such as lymphoma and
leukemia. CAR-T therapy involves collecting a patient’s T-cells, genetically
modifying them to target cancer cells, and reintroducing them into the patient. Challenge: 🔹 CAR-T therapies are
highly personalized, requiring complex, multistage manufacturing processes. 🔹 Maintaining consistent
quality and safety while scaling production to meet growing demand is
difficult. 🔹 Logistics, including
cryogenic shipping of living cells, posed a risk to product integrity. 🔹 Regulatory compliance
across multiple markets added complexity to the manufacturing process. Solution & Approach: 🔹 Advanced Manufacturing
Facilities: Kite Pharma invested in state-of-the-art GMP-compliant facilities,
capable of handling high volumes of autologous CAR-T production. 🔹 Automation & Closed
Systems:
Implemented automated cell culture systems and closed bioreactors to reduce
contamination risks and improve reproducibility. 🔹 Decentralized Production
Model:
Developed regional manufacturing hubs to reduce turnaround times and improve
patient access. 🔹 Integration of AI &
Data Analytics: Used AI-driven process optimization to monitor cell growth, detect
anomalies, and improve overall yield. Results & Impact: 🔹 Successfully
commercialized Yescarta, one of the first FDA-approved CAR-T therapies. 🔹 Reduced production
timelines from several weeks to just a few, enabling faster treatment for
patients. 🔹 Scaled
manufacturing capacity to serve global markets while maintaining high safety
and quality standards. 🔹 Paved the way for
additional CAR-T therapies and regenerative medicine solutions in multiple
regions. Key Takeaways: 🔹 Demonstrates how
innovation in manufacturing, automation, and AI can overcome challenges in personalized cell therapy production. 🔹 Highlights the
growing importance of infrastructure, regulatory compliance, and global
partnerships in scaling advanced therapies. 🔹 Serves as a
blueprint for new entrants and established players in the Cell Therapy
Manufacturing Market. For
inquiries regarding discounts, bulk purchases, or customization requests,
please contact us at sales@precedenceresearch.com Cell
Therapy Manufacturing Market Regional Insights Government
Support Boosting North America Industry North
America dominated the global market with a major revenue share of 44% in 2025
due to government support, the growing number of clinical trials, increased investment, investment in
innovative manufacturing technologies, the increasing number of approved cell
and gene therapies, and the rising number of patients with chronic diseases in the region. The only
stem cell-based treatment that is routinely reviewed and approved by the U.S.
Food and Drug Administration (FDA) is hematopoietic stem cell transplantation. The strong R&D pipeline and a
high concentration of biopharma hubs are maturing the cell therapy
manufacturing industry in North America. The strong focus on novel
manufacturing technologies and platforms, and expanding existing facilities
fueling the region. What is
the U.S. Cell Therapy Manufacturing Market Size? According to
Precedence Research, the U.S. cell therapy manufacturing
market size is
valued at USD 1.71 billion in 2025 and is expected to surpass USD 5.87 billion
by 2034, expanding at a healthy CAGR of 14.70% from 2025 to 2034. The U.S.
Cell Therapy Manufacturing Market Trends The U.S.
dominating the regional market, as it holds the vast majority share of the
region’s manufacturing services. This dominance is driven by a strong ecosystem of biopharmaceutical
companies and
research institutions, a mature regulatory environment (including accelerated
approval pathways by the Food and Drug Administration), large venture-capital
and government funding in cell and gene therapy R&D, and advanced
manufacturing infrastructure and contract development/manufacturing
organizations (CDMOs). Note: This report is
readily available for immediate delivery. We can review it with you in a
meeting to ensure data reliability and quality for decision-making. Expanding
Healthcare Expenditure: To Boost Asian Market Asia Pacific
is anticipated to grow at the fastest rate in the market during the forecast
period because of the escalating healthcare expenditure, supportive regulatory
environment, increased investment & funding, demand for personalized medicine and regenerative medicine, integration of automation & AI,
and growing cancer burden in the region. ImmunoACT
brings transformative CAR-T cell therapy for cancer treatment in India, where a
patient’s own immune cells are genetically modified to recognize and destroy
cancer cells. Strong
regional infrastructure with integration of cutting-edge manufacturing
capabilities and addressing the restriction of patient access & clinical
development across the region. The increased research & development with
platforms like the SACT event in India and events, such as Cell & Gene
Therapy World Asia, are solidifying regional position in the global market. China
Cell Therapy Manufacturing Market Analysis China
dominates the regional market driven by several key factors: a large and
rapidly growing patient population creating strong demand for advanced
therapies; heavy government support and investment in biotechnology
infrastructure and regulatory reform; a growing number of domestic and contract
manufacturing organizations (CMOs) capable of providing cell-therapy
manufacturing and quality-control services; and cost advantages in
manufacturing coupled with increasing global partnerships and clinical trial
activity within China. The Chinese government
has made significant investments in life sciences and regenerative medicine,
implementing favorable policies, research funding programs, and regulatory
reforms that have streamlined the approval process for innovative therapies. Cell
Therapy Manufacturing Market Segmentation Therapy
Type Insights Which
Therapy Type Dominated the Cell Therapy Manufacturing Market in 2024? The autologous cell therapy segment dominated the market, held
the biggest share of 59% in 2024. Autologous cell therapy is a rapidly growing
therapeutic modality that includes regenerative medicine and immune-oncology
applications. This advanced medical procedure includes using a patient’s cells
or tissues to treat many ailments, such as cardiovascular disease and cancer.
Autologous cell therapy means cells are collected from the individual’s own
body. The cells are removed, modified outside the body, and then the processed
cells are returned to the body. The allogenic cell therapy segment is expected to grow at the
fastest rate in the market during the forecast period of 2025 to 2034. This
prevents the need for personalized cell retrieval and preparation, leading to
time and resource savings. Allogenic stem cell therapies may also provide superior
scalability to autologous treatments, rising accessibility, and potentially
lowering manufacturing and patient costs. An allogenic cell transplant uses
healthy blood stem cells from a donor to replace bone marrow that’s not
producing enough healthy blood cells.
Technology
Type Insights Which
Technology Type Lead the Cell Therapy Manufacturing Market? The somatic
cell technology segment led the market in 2024. Somatic cell technology is
accepted to treat many disorders like cystic fibrosis, cancer, muscular
dystrophy, and certain infectious diseases. A single gene disorder, such as
cystic fibrosis, hemophilia, and thalassemia, has good chances of being cured
by somatic cell gene therapy. The importance of somatic cells includes that
they make up the skin, connective tissue, bones, blood, and internal organs in
all organisms. The 3D
technology segment is projected to experience the highest growth rate in the
market between 2025 and 2034. The main benefit of using a 3D culture over a 2D
culture is the production of a more relevant cell model that resembles the 3D
physiological environment. This model has high structural complexity and the
ability to retain a steady state. 3D printed organs hold promise for various
applications, including personalized medicine, drug testing, disease modelling,
and transplantation. Cell
Therapy Manufacturing Market Size, By Technology Type, 2022 to 2024 (USD Million) Technology Type 2022 2023 2024 Somatic Cell Technology 823.2 925.9 1,045.3 Cell Immortalization Technology 461.2 515.2 577.6 Viral Vector Technology 736.8 844.3 971.5 Genome Editing Technology 692.2 786.1 896.3 Cell Plasticity Technology 418.3 461.8 511.4 3D Technology 623.6 730.3 858.1
Source
Type Insights What Made
IPSC (Induced Pluripotent Stem Cell) Lead the Cell Therapy Manufacturing
Market? The IPSC
(induced pluripotent stem cell) segment led the market. IPSCs are used to study
the molecular mechanisms and pathways important for the differentiation of
tissues during embryonic development. Differentiated IPSC can be used as models
to better understand disease mechanisms or to screen candidate drugs for
desired effects on specific cell types and tissues. IPSC can be probed into
becoming beta islet cells to treat diabetes, blood cells to create new blood
free of cancer cells for leukemia patients, or neurons to treat neurological
disorders. The bone
marrow segment is set to experience the fastest rate of market growth from 2025
to 2034. A bone marrow transplant is a procedure that infuses healthy
blood-forming stem cells into the body to replace bone marrow that’s not
producing enough healthy blood cells. Bone marrow-based MSCs, traditionally
used for bone and cartilage regeneration, these cells have been effective in
treating musculoskeletal injuries. Stem cell therapy enhances the quality and quantity of
blood cells, improving overall health. Cell
Therapy Manufacturing Market Size, By Source, 2022 to 2024 (USD Million) Source 2022 2023 2024 IPSC's (Induced pluripotent stem cell) 1,092.5 1,268.1 1,478.9 Bone marrow 801.3 914.6 1,048.3 Umbilical cord 648.2 723.2 809.6 Adipose tissue 721.2 812.6 919.0 Neural stem 492.3 545.1 604.5
Application
Insights How
Oncology Segment Dominates the Cell Therapy Manufacturing Market? The oncology segment dominated the market has
contributing the largest revenue share of 35% in 2024. Cell therapies use
cells, rather than chemical compounds or molecules, to fight cancer.
Genetically modified therapies like CAR T-cell therapy use specific cells from
a patient or donor to enhance the cells’ cancer-tracking and cancer-attacking
ability. Cell therapies can be designed to recognize and kill tumor cells that
express specific mutations while leaving healthy cells untouched. The
neurological segment is anticipated to grow with the highest CAGR in the market
during the studied years. Cell therapy is thought to be an excellent option for
many neurological disorders, acting by replacing dead cells or releasing
protective factors to the damaged cells or modulating the lesion’s
microenvironment in the nervous system. Stem cell therapy may effectively treat
many types of neuropathies, including diabetic neuropathy and chronic
inflammatory demyelinating polyneuropathy. ✚ Related Topics You May Find Useful: ➡️ Stem
Cell Manufacturing Market: Explore how scalable bioprocessing and automation are
accelerating next-generation regenerative therapies ➡️ Cell
and Gene Therapy Infrastructure and Delivery Models Market: Understand how advanced
infrastructure and decentralized delivery models are transforming patient
access ➡️ Cell
and Gene Therapy Bioanalytical Testing Services Market: Discover the rising need
for specialized analytics to ensure safety, potency, and regulatory compliance ➡️ Cell
and Gene Therapy CDMO Market: Track how outsourcing, capacity expansion, and GMP
capabilities are shaping competitive CDMO landscapes ➡️ Viral
Vectors and Plasmid DNA Manufacturing Market: Analyze demand growth driven by
gene therapies, vaccines, and advanced biologics ➡️ Personalized
Cell Therapy Market: Learn how precision medicine and autologous therapies are
redefining individualized treatment approaches ➡️ Cell
and Gene Therapy Manufacturing Market: Explore innovations in
manufacturing workflows powering the future of curative therapies Top
Companies in the Cell Therapy Manufacturing Market ➢
Gilead
Sciences, Inc. - Through its subsidiary Kite Pharma, Gilead is focused on the
research, development, and commercialization of cell therapies, particularly
CAR T-cell therapies for cancer, and operates a large, integrated in-house
manufacturing network.
➢ Bristol-Myers Squibb
Company (BMS) - BMS manufactures approved chimeric antigen receptor (CAR T)
cell therapies for hematologic malignancies and is expanding its manufacturing
capacity and innovation through in-house development and acquisitions.
➢ Novartis AG - Novartis develops
and manufactures its own cell therapies, such as the CAR T-cell therapy
Kymriah, while also operating a contract manufacturing business to provide cell
and gene therapy manufacturing services to third parties.
➢ The Discovery Labs - The Discovery Labs
offers real estate solutions and a comprehensive platform for the life sciences
industry, featuring a contract development and manufacturing organization
(CDMO) called The Center for Breakthrough Medicines, which provides
manufacturing services for cell and gene therapies.
➢ Lonza - Lonza is a contract
development and manufacturing organization (CDMO) that provides a wide array of
services and technologies for developing and manufacturing various cell and
gene therapies, including autologous, allogeneic, viral vectors, and induced
pluripotent stem cells (iPSCs).
➢ Cytiva - Cytiva provides a
full range of manufacturing platforms, equipment, software, consumables, and
media for both autologous and allogeneic cell therapy workflows to help developers
scale and automate their processes.
➢ Bio-Techne - Bio-Techne offers
reagents, analytical instruments, and custom manufacturing services to support
cell therapy development, focusing on providing high-quality, GMP-grade raw
materials and scalable solutions through partnerships like the ScaleReady
collaboration.
➢ Catalent, Inc. - As a CDMO, Catalent
provides end-to-end manufacturing and development services for cell therapies,
covering everything from process development and fill/finish to clinical and
commercial production.
➢ Thermo Fisher
Scientific
- Thermo Fisher provides a comprehensive suite of tools, consumables, reagents,
and automated systems for cell therapy development and manufacturing, along
with CDMO services for both viral vectors and cell therapies.
➢ Merck KGaA - Merck supplies the
cell therapy industry with critical materials, manufacturing tools,
technologies (including acoustic cell processing), and CDMO services to support
the entire development and production process. Recent Developments: 🔸 In October 2025, an automated contract
development and manufacturing organization (CDMO), offering to overcome one of
what they call regenerative medicine’s greatest bottlenecks: scalable,
affordable manufacturing of stem cell-derived therapies, was launched by
Officials at Mytos, which is automating cell manufacturing. The first facility,
housed in the Cell and Gene Therapy Catapult’s (CGT Catapult) Stevenage
Manufacturing Innovation Center, is targeting clinical readiness. (Source: https://www.genengnews.com)
🔸 In May 2025, to address development and
manufacturing challenges in the cell and gene industry, a new global contract
development and manufacturing organization (CDMO) was launched by Astraveus SAS
(Paris, France) announced plans to evaluate a new platform for CAR-T
manufacturing. To assess the Lakhesys Benchtop Cell Factory platform for use in
CAR-T cell therapy manufacturing, the Netherlands Center for the Clinical
Advancement of Stem Cell and Gene Therapies collaborated with Astraveus.
(Source: https://www.regmednet.com)
Segments Covered in the Report By
Therapy Type
🔹 Allogenic Cell Therapy 🔹 Autologous Cell Therapy
By Technology Type
🔹 Somatic Cell Technology 🔹 Cell Immortalization Technology 🔹 Viral Vector Technology 🔹 Genome Editing Technology 🔹 Cell Plasticity Technology 🔹 3D Technology
By Source
🔹 IPSC (Induced Pluripotent Stem Cell) 🔹 Bone Marrow 🔹 Umbilical Cord 🔹 Adipose Tissues 🔹 Neural Stem
By Application
🔹 Musculoskeletal 🔹 Cardiovascular 🔹 Gastrointestinal 🔹 Neurological 🔹 Oncology 🔹 Dermatology 🔹 Others
By Region
🔹 North America 🔹 Europe 🔹 Asia Pacific 🔹Latin America 🔹Middle East & Africa (MEA) Thanks
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