Get a Sample
Schedule a Meeting
Get a Sample
Table Of Content
July 2025
The global cell and gene therapy market is expected to grow from USD 8.94 billion in 2025 to USD 39.61 billion by 2034, at a CAGR of 17.98%. North America leads the market, driven by high clinical trial activity and corporate R&D. Cell therapy for infectious diseases is the dominant segment, with innovations like gene editing tools and strategic partnerships fueling growth. However, high costs, regulatory challenges, and safety concerns remain key hurdles.
The global cell and gene therapy market size was estimated at USD 7.79 billion in 2024 and is predicted to increase from USD 8.94 billion in 2025 to approximately USD 39.61 billion by 2034, expanding at a CAGR of 17.98% from 2025 to 2034.
The U.S. cell and gene therapy market size was estimated at USD 3.59 billion in 2024 and is predicted to be worth around USD 16.93 billion by 2034, at a CAGR of 17.10% from 2025 to 2034.
A significant number of ongoing clinical trials and a rise in corporate involvement in gene and cell therapy R&D are the primary drivers of regional market expansion. The North America region accounted for more than 50.26% of revenue share in 2024.
North America scored first for having the greatest number of gene therapy clinical trials, with more than 400 enterprises in the region actively engaged in the development of cell and gene therapy products for a variety of disorders.
Numerous brand-new collaborative research and innovation initiatives have been launched across Europe under the Horizon 2021 initiative. One of these endeavors is testing gene therapy utilizing viral vectors. This is expected to accelerate the growth of cell and gene therapy manufacturing services across Europe. The rise of the market is anticipated to be aided by the developed infrastructure and skilled labor force in European countries.
Cell and gene therapies (CGTs) provide substantial advancements in patient care by treating or perhaps curing a variety of illnesses that have previously been untreatable by small molecule and biological medicines. The FDA in the United States has approved more than 20 CGTs during the past 20 years, and many of these one-time therapies range in price from US$37,500 to US$2 million per shot. Given the high financial outlay and patient expectations of these life-saving pharmaceuticals, it is essential that manufacturers provide integrated services across the whole supply chain to enable efficient biomanufacturing processes and smooth logistics and minimize uptake barriers.
High-profile mergers and acquisitions, such as those involving bluebird bio/BioMarin, Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis and the CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics, have been made recently as a result of the CGT market's expansion.
Many bio/pharma businesses have re-invested in R&D, In order to standardize vector manufacturing and purification, utilize forward engineering approaches in cell therapies, improve cryopreservation of cellular samples, and explore the development of off-the-shelf allogeneic cell solutions.
In order to increase their manufacturing capabilities, pharmaceutical companies are now closely examining their internal capabilities and either investing in their own manufacturing facilities or outsourcing to contract development and manufacturing organizations (CDMOs) or contract manufacturing organizations (CMOs).
Lack of money, infrastructure, and capacity forces small biotech companies developing cell and gene therapies to form strategic collaborations with contract manufacturers. This has fueled cell and gene therapies (CGTs) market expansion. Additionally, investments in this area are growing enormously, which further fuels the market.
| Report Coverage | Details |
| Market Size by 2034 | USD 39.61 Billion |
| Market Size in 2025 | USD 8.94 Billion |
| Market Size in 2024 | USD 7.79 Billion |
| Growth Rate from 2025 to 2034 | CAGR of 17.98% |
| Largest Market | North America |
| Base Year | 2024 |
| Forecast Period | 2025 to 2034 |
| Segments Covered | Therapy Type, Therapeutic class, End User, Delivery Method, Region |
| Regions Covered | Asia Pacific, North America, Europe, Latin America, Middle East and Africa |
The COVID-19 impact, which had earlier resulted in restrictive containment measures involving social estrangement, remote work, and the closure of commercial activities that resulted in operational challenges, is largely to blame for the growth. The companies are now resuming their operations and adjusting to the new normal while recovering from the impact.
The market has been primarily driven by an exponential increase in the clinical pipeline and an increase in the number of regulatory approvals for innovative medicines.
Market participants are working hard to increase their market presence as they take into account the significant growth opportunities in the contract development of cellular and gene-modified medicines. Additionally, bio producers are forming strategic partnerships with contract producers to quicken the R&D of their candidate programs. The emergence of several new competitors and the expansion of product development capabilities as a result of the growing demand for CMO/CDMO services have had a favorable impact on market revenue.
In order to advance the production of cell and gene therapies, several novel techniques are being introduced. For instance, the potential of single-use technology in production workflows is being investigated by the makers. This method is becoming more popular in this field since it can expedite development while also cutting costs and production times. In the upcoming years, market growth is predicted to be supported by such technological developments in space.
The growing demand for cutting-edge treatments has increased market competition among participants. Companies that manufacture cell therapies and CDMOs are inking agreements in order to hasten the development of their products and acquire a competitive edge. Additionally, ongoing clinical research projects have driven the contract manufacturing segment's revenue growth. Additionally, increase in outsourcing of the manufacturing process for cell and gene therapy also supports segment growth.
There are many difficulties in the development, including safety and efficacy problems, drawn-out clinical study protocols, strict regulatory frameworks, and high prices of cell and gene therapy. Some of the key elements include the capacity to simultaneously treat heterogeneous systems with a variety of cells, high gene transfer efficiency, low cell toxicity, single cell specificity to the intended target, and single cell specificity.
Several CAR T-cell therapies have been approved, but according to data from the World Health Organization (WHO), one in five cancer patients who are qualified for them die as they wait for a production facility. In contrast to the past, when many of these autologous products took about a month to generate, some of them may now be made in less than two weeks.
The development of more sophisticated gene-transfer tools with CARs (such as transposon, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), among others) and the use of centralized organization with standardized apheresis centers are two approaches being investigated by the health sector (collection and reinfusion).
A number of gene treatments have received approval, mostly for the treatment of rare diseases Numerous businesses, including Astellas Gene Therapies, Bayer, ArrowHead Pharmaceuticals, Bluebird Bio, Intellia Therapeutics, Krystal Biotech, MeiraGTx, Regenxbio, Roche, Rocket Pharmaceuticals, Sangamo Therapeutics, Vertex Pharmaceuticals, Verve Therapeutics, and Voyager Therapeutics, are researching novel gene therapy vectors to boost levels of gene expression/protein production, decrease immunogenicity, and improve durability.
How did the Cell Therapy Segment Dominate the Cell and Gene Therapy Market in 2024?
The cell therapy segment held the largest share of the market in 2024, due to the increased need for faster and visible results of the disorders testing globally. Moreover, the individuals are actively shifting towards cell therapies as awareness of early diagnosis is growing, specifically in chronic disease conditions such as cancer and others. Furthermore, therapies such as the CAR T and others have gained immense industry attention and public trust in the past few years.
The gene therapy segment is expected to grow at a notable rate during the predicted timeframe, akin to its unique characteristics, such as the gene therapy can focus on correcting the root cause of genetic diseases, which is contributing to the segment growth in the current period. Furthermore, by offering a one-time and potentially permanent solution, gene therapy is expected to gain major industry share in the upcoming years.
Cell and Gene Therapy Market By Therapy Type, 2022-2024 (USD Million)
| Therapy Type | 2022 | 2023 | 2034 |
| Cell Therapy | 3,766.3 | 4,271.5 | 4,854.2 |
| Autologous Cell Therapy | 1,587.6 | 1,785.0 | 2,010.8 |
| Allogeneic Cell Therapy | 745.4 | 859.5 | 992.8 |
| Stem Cell Therapy | 574.7 | 654.9 | 747.7 |
| Hematopoietic Stem Cells (HSC) | 240.8 | 270.9 | 305.3 |
| Mesenchymal Stem Cells (MSC) | 225.5 | 260.0 | 300.3 |
| Induced Pluripotent Stem Cells (iPSC) | 108.4 | 124.0 | 142.2 |
| Immune Cell Therapy | 376.9 | 432.2 | 496.7 |
| CAR-T Cell Therapy | 167.9 | 193.4 | 223.2 |
| TCR (T-cell Receptor) Therapy – targets intracellular antigens | 82.3 | 95.5 | 111.1 |
| TIL (Tumor Infiltrating Lymphocyte) Therapy | 44.2 | 50.2 | 57.0 |
| NK (Natural Killer) Cell Therapy | 59.0 | 67.2 | 76.6 |
| Macrophage Therapies | 23.5 | 26.0 | 28.8 |
| Dendritic Cell Therapy | 139.4 | 157.7 | 178.7 |
| Others | 342.4 | 382.2 | 427.5 |
| Gene Therapy | 2,244.0 | 2,564.2 | 2,936.0 |
| In-vivo Gene Therapy | 1,025.5 | 1,178.1 | 1,356.1 |
| Ex-vivo Gene Therapy | 599.4 | 681.2 | 775.7 |
| Gene Editing Therapies | 269.1 | 313.7 | 366.3 |
| RNA-Based Therapies | 217.4 | 242.3 | 270.4 |
| Others | 132.6 | 148.9 | 167.5 |
Based on application, the market is divided into cardiovascular disease, cancer, genetic disorders, rare diseases, oncology, hematology, ophthalmology, infectious disease, neurological disorders. Among these, the infectious disease segment dominates the market in 2024. The oncology segment held a revenue share in 2024. Research and treatment in the biomedical domains of cell therapy and gene therapy. Both treatments have the ability to lessen the underlying cause of hereditary disorders and acquired diseases. Both therapies aim to treat, prevent, or perhaps cure diseases. By repairing or changing specific cell types, or by employing cells to transport a medication across the body, cell therapy tries to treat diseases. Cell therapy involves growing or modifying cells outside of the body before injecting them into the patient. The cells may come from a donor (allogeneic cells) or the patient (autologous cells)6. By replacing, deactivating, or introducing genes into cells, either inside the body (in vivo) or outside the body, gene therapy seeks to treat disorders (ex vivo).
The market for genetic disorders is expanding as a result of factors like the high prevalence of genetic and chronic disease cases and the growing government initiatives to raise public knowledge of genetic testing and diagnosis. Researchers are developing novel techniques for screening, diagnosing, and treating patients for a variety of cardiac diseases as they investigate the genetic roots of heart and vascular illness. Some researchers are looking for new ways to size patients who are at risk for sudden cardiac death. Others are examining how medicines that could postpone or obviate the need for cardiac surgery could benefit patients with uncommon illnesses.
The intricacy of mitochondrial genetics and the diverse clinical and biochemical symptoms of primary mitochondrial disorders (PMDs) have shown to be a significant obstacle to the development of effective disease-modifying medications. A successful clinical transition of genetic medicines for PMDs is possible, according to encouraging evidence from gene therapy trials in patients with Leber hereditary optic neuropathy and improvements in DNA editing tools.
Why does the Oncology Segment Dominate the Cell and Gene Therapy Market by Indication Type?
The oncology segment held the largest share of the cell and gene therapy market in 2024, owing to these cell and gene therapies having gained the most success in the detection and treatment of the various types of cancers in recent years. Moreover, cancers such as leukemia and lymphoma have provided immense industry attention to cell and gene therapy in recent times, as per the current market survey.
On the other hand, the genetic disorders segment is expected to grow at a notable rate due to the increased need for a permanent fix for the diseases inherited globally in recent years. Moreover, health professionals are seen under the heavy recommendation of cell and gene therapy for rare diseases such as spinal muscular atrophy and others in recent times. Furthermore, individuals are more aware of advanced therapies, which can lead to the segment's growth in the upcoming years.
The viral vector segment dominated the market with the largest share in 2024, due to its being considered the most effective segment for delivering therapeutic genes in the cells. Moreover, having unique properties such as targeting specific tissues and long-lasting effects, the viral vectors have gained immense industry attention in recent years, as per the current market survey.
The non-viral vector segment is expected to grow at a significant rate because it is considered safer, easier to produce at scale compared to viral ones. Also, by avoiding the risk of immunogenic reactions and insertional mutations, the non-viral vector is likely to get an immense industry share during the forecast period. Moreover, the rising need for low-risk delivery can contribute immediately to the future segment growth as per the future industry expectations.
The in-house (biotech/pharma-owned facilities) segment held the largest share of the cell and gene therapy market in 2024, because large pharmaceutical and biotech companies prefer to maintain full control over quality, process, and intellectual property during production. These therapies are highly complex, so in-house operations ensure better management, security, and speed during trials and commercial production.
On the other hand, the contract development and manufacturing organizations segment is expected to grow at a notable rate because many startups and small biotech firms lack the resources to build their own facilities. As more cell and gene therapies enter trials and the market, outsourcing manufacturing to specialized CDMOS helps companies reduce costs, save time, and ensure regulatory compliance.
The hospitals and specialty clinics segment held the largest share of the cell and gene therapy market in 2024, because they are the primary sites where advanced therapies are administered. These treatments require close patient monitoring, skilled staff, and special handling, which general clinics often lack. Major hospitals also participate in clinical trials and have direct access to patients who need such therapies. With specialized infrastructure and support from pharma companies, these settings are best suited for early-stage and complex therapy delivery.
The government and public bodies segment is expected to grow at a significant rate, as they ramp up investments in universal access and rare disease treatment. To make therapies more affordable and widespread, governments are establishing national funding programs, research grants, and collaborations with manufacturers.
Cell and Gene Therapy Market By End Use, 2022-2024 (USD Million)
| By End Use | 2022 | 2023 | 2024 |
| Hospitals and Specialty Clinics (administering therapies) | 4,676.4 | 5,295.5 | 6,008.5 |
| Government/Public Health Bodies (NIH, EMA programs) | 817.5 | 945.6 | 1,095.7 |
| Others | 516.4 | 594.6 | 686.0 |
By Therapy Type
By Therapeutic class
By Delivery Method
By End-Users
By Region
For inquiries regarding discounts, bulk purchases, or customization requests, please contact us at sales@precedenceresearch.com
No cookie-cutter, only authentic analysis – take the 1st step to become a Precedence Research client
July 2025
January 2025
January 2025
January 2025