According to Healthcare Experts, the global cell and gene therapy market size was USD 21.82 billion in 2024 and is expected to reach USD 187.44 billion by 2034, expanding at a compound annual growth rate (CAGR) of 24% between 2025 and 2034. The growth of the cell and gene therapy market is mainly driven by the rising initiatives to promote cell-based products, increasing R&D activities, and advancements in biotechnology.
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Market Overview
Cell and gene therapies involve the use of living cells to treat various diseases. The cell and gene therapy market is expanding rapidly with potential applications of cell therapy, including cancer types, autoimmune diseases, urinary problems, infections, reconstruction of damaged cartilage in joints, and repair and improvement of spinal cord injuries. Cell and gene therapies support patients with weakened immune systems and neurological disorders. These therapies are gaining immense traction in treating rare and serious diseases like sickle cell anemia. They can identify the underlying causes of the disease, address symptoms, and stop the disease progression. Gene therapy presents a promising approach to treating different human diseases by inserting genetic material into patients' cells. Cell and gene therapies improve the regeneration of diseased tissues by replacing damaged cells with healthy cells. In addition, the rising demand for regenerative medicine propels the growth of the market.
Major Trends in the Cell and Gene Therapy Market
Rising Area of Application:
The expansion of applications in therapeutics as well as diagnostics bolsters the market growth. Cell and gene therapies are being developed to treat a range of conditions. However, they are also gaining immense popularity in diagnostics. Gene therapy is also used to identify genetic mutations associated with certain diseases. Healthcare professionals can diagnose genetic disorders by analyzing patient’s DNA, allowing for early intervention. The rise in applications often leads to innovative treatment modalities, contributing to market growth.
Rising Prevalence of Chronic and Genetic Diseases:
The prevalence of chronic disorders (such as cancer, CVDs, and diabetes) and genetic disorders (such as sickle cell and cystic fibrosis) is rising worldwide. According to the World Health Organization (WHO), approximately 240,000 newborns die worldwide within 28 days of birth every year due to congenital disorders. In addition, chronic diseases are the leading cause of global deaths. This highlights the need for innovative treatment modalities to reduce the mortality rate of chronic and genetic disorders. Cell and gene therapies emerged as promising life-changing options for people with genetic mutations that lead to disease. These therapies replace or inactivate disease-causing genes. They also introduce new genes into the human body to treat a specific disease.
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Advancements in Technology:
Technological advances create immense opportunities in the cell and gene therapy market. Innovations in gene editing technologies make it possible to develop effective cell-based therapies tailored to patient’s needs. Recent advances in cell and gene therapy have made it possible to treat a wide range of diseases, from congenital diseases to solid cancers.
Government Initiatives and FDA Approvals:
With the growing burden of chronic diseases worldwide, governments of various nations are investing heavily in R&D activities to accelerate the development of cell and gene therapies. In addition, health regulatory bodies have recognized the importance and benefits of cell and gene therapies in effectively treating diseases. Thus, they are granting approvals for these therapies to cater to broader patients’ needs.
• For instance, in December 2023, the U.S. Food and Drug Administration (FDA) approved two innovative treatments, Casgevy and Lyfgenia. These cell-based gene therapies are intended for the treatment of sickle cell disease (SCD) in patients 12 years and older.
Regional Insights
North America’s Sustained Dominance in the Market
North America dominated the market in 2024. This is mainly due to the rise in government initiatives to support the development of cell and gene therapies. Health regulatory bodies, including the U.S. FDA, have made efforts to boost the production of cell and gene therapies to meet the overall growing demands of patients. This includes fast-track designation, breakthrough therapy designation, accelerated approval, and priority review designation. In addition, North America is home to leading pharmaceutical and biotechnology companies, supporting the market's growth.
The U.S. is a major contributor to the North American cell and gene therapy market. The rising healthcare spending is one of the major factors contributing to the market growth in the U.S. Health spending rose 7.5% in 2023 to US$ 4.9 trillion or US$ 14,570 per person. The U.S. is currently leading synthetic biology R&D, with other countries investing heavily. Moreover, there is a high demand for gene therapies due to the rising burden of chronic diseases, supporting market growth.
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Asia Pacific: The Fastest-Growing Region
Asia Pacific is emerging as the fastest-growing region in the market. The rising number of cases of chronic diseases is a major factor boosting the demand for cell and gene therapies in the region. The rapid expansion of pharmaceutical and biotechnology industries is further contributing to regional market growth. With the growing burden of chronic diseases, the demand for regenerative medicine is rising in the region. This approach involves the use of cells to restore the functions of tissues lost due to injuries or diseases.
Countries like India, China, and Japan are expected to lead the Asia Pacific cell and gene therapy market over the studied period. This is mainly due to the growing aging population, as older people are more prone to chronic diseases like diabetes and CVDs. Governments of these countries are making efforts to develop innovative cell-based therapies. This includes treatments for leukemia, hemophilia A, and sickle cell anemia.
• For instance, in April 2024, the President of India, Smt. Droupadi Murmu, launched India’s first home-grown gene therapy for cancer at IIT Bombay. The President said that the launch of India’s first gene therapy is a major breakthrough in our battle against cancer.
Market Segmentation
Therapy Type Insights
The cell therapy segment dominated the market in 2024. This is mainly due to the increased demand for stem cell therapy. This innovative approach restores the functions of diseased or injured tissues, further reducing the chances of immune rejection. Cell therapies are used to treat various diseases, such as cancer, autoimmune diseases, urinary problems, infections, reconstruction of damaged cartilage in joints, repairing spinal cord injuries, improving immune system weakness, and neurological disorders.
Therapeutic Class Insights
The infectious disease segment led the market in 2024. Cell and gene therapies have the ability to eliminate chronic infections, hepatitis, or Epstein. These therapies are an alternative treatment for a wide range of infectious diseases that do not have access to clinical management.
On the other hand, the oncology segment is projected to expand at the highest CAGR in the coming years. This is mainly due to the increasing prevalence of cancer worldwide. Gene and cell therapies are promising therapeutics for treating various cancers. These therapies target only cancer cells, reducing the chances of getting damaged to healthy cells.
Delivery Method Insights
The in vivo segment is projected to grow exponentially over the studied period. This is mainly due to its cost-effective and simple method. The in vivo method has the ability to deliver cells directly to targeted cells, enhancing treatment effectiveness and patient outcomes.
End-user Insights
The hospitals segment dominated the market with the largest share in 2024. This is mainly due to the higher adoption of cell and gene therapies in hospital settings to reduce disease-causing versions of a protein, increase the production of disease-control proteins, and generate new/modified proteins. In addition, the rise in the patient pool in these settings contributes to segmental growth.
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Competitive Landscape & Major Breakthroughs in the Market
The cell and gene therapy market continues to evolve rapidly, with 2024 witnessing significant advancements and a dynamic competitive landscape. Key players operating in the market include Alnylam Pharmaceuticals Inc., Amgen Inc., Biogen Inc., CORESTEM Inc., Dendreon Pharmaceuticals LLC., Helixmith Co. Ltd., JCR Pharmaceuticals Co. Ltd., Kolon TissueGene Inc., Novartis AG, and Pfizer Inc. These companies are making efforts to expand their business and cater to customers worldwide.
In January 2024, CPC (Colder Products Company) announced the launch of its new MicroCNX Nano Series aseptic connectors, which are designed to simplify cell and gene therapy (CGT) closed sterile processing. Troy Ostreng, Senior Product Manager for CPC's biopharmaceutical business, said, “CGT processing assemblies that include the MicroCNX Nano connectors will allow users to easily click together the connector halves to create a sterile flow path. This is a major advancement for CGT applications."
Recent Developments
• In February 2025, Cellistic announced the launch of its Allo Chassis, a ready-to-use, immune-cloaked iPSC cell lines derived from CD34+ and CD4+ T-cell primary cells.
• In November 2024, Roche announced that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc., a public clinical-stage biopharmaceutical company pioneering donor-derived CAR-T cell therapies. The agreement aims to develop off-the-shelf CAR-T cell therapies to address the medical needs of patients with haematological malignancies.
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• Automated and Closed Cell Therapy Processing Systems Market Size, Trends and Shares
• Cell Therapy Raw Materials Market Size, Trends (2024 - 2034)
• Cancer Stem Cells Market Size to Surge USD 8.04 Bn by 2034
• Induced Pluripotent Stem Cells Production Market to Surge $4.11 Bn by 2034
• Cell Culture Vessels Market to Surge USD 17.59 Bn by 2034
• Europe Cell Culture Media Market Sustainability & Ethical Considerations
• CAR T-Cell Therapies Market Size to Uplift USD 88.51 Bn by 2034
• Cell Therapy Manufacturing Market Revenue: $23.27 Bn by 2034
• U.S. Cell Therapy Market Size to Hit $ 38.08 Bn by 2033
• Circulating Tumor Cells Market Size (USD 41.27 Bn) by 2033
• Cell Separation Market Size (USD 23.56 Bn) by 2033
• Primary Cell Culture Market to Peak USD 18.85 Billion by 2033
• Cell Signaling Market to Increase by USD 13.81 Bn by 2033
• 3D Cell Culture Market Size to Surpass USD 7.02 Bn in 2034
Segments Covered in the Report
By Therapy Type
• Cell Therapy
• Stem Cells
• T Cells
• Dendritic Cells
• NK Cells
• Tumor Cells
• Gene Therapy
By Therapeutic Class
• Cardiovascular Disease
• Cancer
• Genetic Disorder
• Rare Diseases
• Oncology
• Hematology
• Ophthalmology
• Infectious Disease
• Neurological Disorders
By Delivery Method
• In Vivo
• Ex vivo
By End-Users
• Hospitals
• Cancer Care Centers
• Wound Care Centers
• Others
By Region
• North America
• Asia Pacific
• Europe
• Latin America
• Middle East and Africa (MEA)
Discover our detailed Table of Contents (TOC) for the Cell and Gene Therapy Market @ https://www.towardshealthcare.com/table-of-content/cell-and-gene-therapy-market
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