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The global cell and gene therapy market was valued at USD 17.4 billion in 2023, driven by robust regulatory support and growth in clinical trials for cell and gene therapies across the globe. The market size is anticipated to grow at a CAGR of 23.17% during the forecast period of 2024-2032 to achieve a value of USD 113.53 billion by 2032.
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Cell therapy works on the principle of alteration, implantation, or restoration of cells or by extrapolating cells to carry the treatment through the body. In cell therapy, cells are modified outside the body, that is, in ex-vivo conditions, and then injected into the patient. On the other hand, gene therapy works by incorporating, deactivating, or displacing the genes into cells, which can occur both inside (in vivo) and outside (ex vivo) of the body. In the healthcare sector, some of the major treatments and curative remedies are developed using cell and gene modifications. Cell and gene therapy works by modifying the genes in particular cells and injecting them into the body. The essential resemblance between cell and gene therapy is the ability to mitigate the underlying cause of genetic disorders. There are enormous cell and gene therapies based on the origin or destination as per the treatment requirements.
The cell and gene therapy market is characterized by a strong pipeline activity indicated by a considerable increase in the number of clinical trials. The rising innovations in CRISPR and other gene-editing technologies are anticipated to fuel the market share. The emerging cell and gene therapies seem promising in commercial aspects. Key market leaders will be the gene therapy companies that will provide fast and effective treatment for debilitating diseases. Gene therapies developed by small, medium, and big biotech and pharmaceutical companies also tend to attract the attention of investors, which is likely to stimulate growth and innovation in the market.
Robust Regulatory Support to Affect the Market Landscape Significantly
According to the Food and Drug Administration’s estimation, around 10 to 20 new cell and gene therapies are anticipated to be approved by 2025. In June 2023, the U.S. Food and Drug Administration approved the first gene therapy called Elevidys. It is intended for the treatment of pediatric patients aged 4 through 5 years who are suffering from Duchenne muscular dystrophy (DMD) and have confirmed mutations in the DMD gene. This therapy can be used for patients who do not have any pre-existing medical conditions that prevent treatment with this therapy. The rise in such regulatory approvals is anticipated to contribute significantly to the cell and gene therapy market share.
Along with Elevidys, the U.S. FDA has given approval to a total of 6 cell and gene therapies including Vyjuvek, ARCT-154, and Qalsody among other therapies. Besides supportive regulatory frameworks, advanced technologies and better healthcare infrastructure facilities are the additional factors aiding in the development of this market.
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The market is witnessing several trends and developments to improve the current global scenario. Some of the notable trends are as follows:
Key Trends | Impact |
Improvements in Manufacturing and Scalability | The market share is positively influenced by the rising use of automation and standardization in manufacturing processes which helps in improving scalability and reducing costs of cell and gene therapies. Additionally, the increased adoption of closed-system manufacturing to mitigate safety risks and contamination is also poised to elevate the market value. |
Advancements in CAR-T and Other Cell Therapies | One of the major market trends is the rising advancements in CAR-T cell therapies such as the increased focus on next-generation CAR-T cells that exhibit higher efficacy and safety profiles. For example, Yescarta® was cleared by the FDA as the first CAR-T cell therapy for initial treatment of relapsed or refractory large B-cell lymphoma (LBCL). In addition, the development of other cell therapies like stem cell-based therapies is likely to augment the cell and gene therapy market demand. |
Increased Funding and Investments | The rising influx of substantial venture capital investments into biotechnology companies involved in cell and gene therapies is a major market trend projected to bolster market growth. Further, the increased public funding and grants for accelerating research and development in this field are also expected to aid market expansion. |
Expansion of Allogeneic Therapies | The market is experiencing notable growth in allogeneic or donor-derived cell therapy. Such therapies are produced in large quantities and can be stored for off-the-shelf use. Thus, compared to autologous (patient-specific) therapies, allogeneic therapies can be manufactured at lower manufacturing costs and are likely to boost market demand. |
Market Breakup by Therapy Type
Market Breakup by Type
Market Breakup by Delivery Mode
Market Breakup by Vector Type
Market Breakup by Therapeutic Area
Market Breakup by End User
Market Breakup by Region
Market Segmentation Based on Therapy Type is Anticipated to Witness Substantial Growth
Based on the therapy type, the market is broadly segmented into cell therapy types and gene therapy types. The cell therapy types segment is further divided into autologous cell therapy and allogenic cell therapy whereas the gene therapy types include somatic and germline gene therapy. The gene therapy segment holds a high market value owing to the increase in regulatory approvals of several gene therapies such as Zolgensma (onasemnogene abeparvovec-xioi) approved by the FDA to treat spinal muscular atrophy in pediatric patients. Further, the development of innovative gene-editing technologies, such as CRISPR, is likely to expand the applications of the segment.
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Based on regional analysis, North America is expected to dominate the market due to the presence of key market players in the region. The United States of America has witnessed a substantial increase in biopharmaceutical companies performing clinical trials in cell and gene therapy. More than 1000 companies worldwide have been working on the development of cell and gene therapies across the globe, out of which, more than 500 companies are based in the United States.
The key features of the market report comprise clinical trial analysis, grant analysis, funding and investment analysis, and strategic initiatives by the leading key players. The major companies in the market are as follows:
Amgen Inc.
California-based Amgen Inc. is a multinational biopharmaceutical company and is known for its innovative human therapeutics for serious illnesses. The company heavily invests in next-generation technologies such as gene editing to expand its offerings in the field of cell and gene therapy.
Novartis AG
Swiss multinational pharmaceutical corporation Novartis AG is a prominent player in the market. One of its key products KYMRIAH (autologous T cell immunotherapy) is used for the treatment of Bâcell precursor acute lymphoblastic leukemia (ALL) in patients up to 25 years of age.
Pfizer Inc.
Biopharmaceutical giant Pfizer Inc. is actively involved in gene therapy research and development and significantly contributes to the cell and gene therapy market growth. The multinational pharmaceutical corporation leverages strategic partnerships to develop gene therapies for genetic diseases.
Bluebird Bio, Inc.
Headquartered in Massachusetts (United States), Bluebird Bio, Inc. is a standalone commercial gene therapy company. This biotech firm is known for developing gene therapies for severe genetic diseases.
Other key players in the market include Castle Creek Pharmaceutical Holdings, Bristol-Myers Squibb, Kite Pharma, Inc., Vericel Corporation Inc., Kolon TissueGene Inc., Vertex Pharmaceuticals, Inc., Spark Therapeutics, Inc., CORESTEM Inc., Biogen Inc., Dendreon Pharmaceuticals LLC, and JCR Pharmaceuticals Co. Ltd., among others.
REPORT FEATURES | DETAILS |
Base Year | 2023 |
Historical Period | 2017-2023 |
Forecast Period | 2024-2032 |
Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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Breakup by Therapy Type |
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Breakup by Type |
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Breakup by Delivery Mode |
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Breakup by Vector Type |
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Breakup by Therapeutic Area |
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Breakup by End User |
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Breakup by Region |
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Market Dynamics |
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Supplier Landscape |
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Companies Covered |
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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