Cell and Gene Therapy Market Size Analysis - Market Share, Forecast Trends and Outlook Report 2025-2034

Cell and Gene Therapy Market Overview

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.

Cell and Gene Therapy Market Growth Drivers

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.

Cell and Gene Therapy Market Trends

Cell and Gene Therapy Market Segmentation

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Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Cell and Gene Therapy Market Share

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.

Cell and Gene Therapy Market Analysis by Region

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.

Leading Players in the Global Cell and Gene Therapy Market

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.

Key Questions Answered in the Cell and Gene Therapy Market Report

• What was the cell and gene therapy market value in 2024?
• What is the cell and gene therapy market forecast outlook for 2025-2034?
• What are the regional markets covered in the EMR report?
• What is market segmentation based on therapy type?
• What is the market breakup based on type?
• What is the market segmentation by delivery mode?
• What is the market breakup by vector type?
• What is market segmentation based on the therapeutic area?
• Who are the major end users in the market?
• What are the major factors aiding the global cell and gene therapy market demand? 
• How has the market performed so far and how is it anticipated to perform in the coming years?
• What are the market's major drivers, opportunities, and restraints? 
• Which regional market is expected to lead the market share in the forecast period? 
• Which country is expected to experience expedited growth during the forecast period? 
• How do the prevalence and incidence of chronic diseases and genetic disorders affect the market landscape?
• What are the major global cell and gene therapy market trends?
• How does the rise in the geriatric population impact the market size?
• Which therapy type will dominate the market share? 
• Which type is expected to have a high market value in the coming years?
• Which delivery mode will experience the highest demand in the market segment?
• Which vector type is poised to dominate the market segment?
• Which therapeutic area is expected to lead the market share in the forecast period?
• Which end user is projected to contribute to the highest market growth?
• Who are the key players involved in the cell and gene therapy market?
• What are the current unmet needs and challenges in the market?
• How are partnerships, collaborations, mergers and acquisitions among the key market players shaping the market dynamics?

Cell and Gene Therapy Report Snapshots

Cell and Gene Therapy Companies