Cell and Gene Therapy Market Size and Forecast 2025 to 2034
The global cell and gene therapy market size was estimated at USD 21.85 billion in 2024 and is projected to hit around USD 119.30 billion by 2034, growing at a CAGR of 18.5% during the forecast period from 2025 to 2034. The market is driven by the rising prevalence of chronic disease, innovation in technology, such as gene editing technologies, vector delivery systems, and improved manufacturing and delivery technologies.
Key Takeaways:
- By region, North America dominated the cell and gene therapy market with a revenue share of approximately 43% in 2024.
- By region, Asia Pacific is expected to grow at the fastest CAGR in the market during the forecast period.
- By therapy type, the cell therapy segment dominated the market with the highest revenue shares of approximately 55%.
- By therapy type, the gene therapy (in vivo) segment is expected to grow at the fastest CAGR in the Cell and Gene Therapy market during the forecast period.
- By vector type, the viral vectors segment held the highest revenue shares of approximately 68% in the market in 2024.
- By vector type, the non-viral vectors (LNPs) segment is expected to grow at the fastest CAGR in the market during the forecast period.
- By application, the oncology segment held the highest market share of approximately 47% in 2024.
- By application, the rare & genetic disorders segment is expected to grow at the fastest CAGR in the market during the forecast period.
- By end user, the pharmaceutical & biotechnology companies segment led the Cell and Gene Therapy market with the largest revenue share of approximately 41% in 2024.
- By end user, the CROs & CDMOs segment is expected to grow at the fastest CAGR in the market during the forecast period.
- By delivery mode, the ex vivo administration segment held the largest market share with the biggest revenue share of approximately 58% in 2024.
- By delivery mode, the in vivo administration segment is expected to grow at the fastest CAGR in the market during the forecast period.
- By industry vertical, the biotechnology segment held the largest market share with the biggest revenue share of approximately 37% in 2024.
- By industry vertical, the pharmaceuticals segment is expected to grow at the fastest CAGR in the market during the forecast period.
Cell and Gene Therapy Market Overview:
The cell and gene therapy market encompasses technologies, products, and services involved in modifying, engineering, and delivering therapeutic cells and genetic material to treat, prevent, or potentially cure diseases. It includes autologous and allogeneic cell therapies, gene transfer and editing platforms, viral and non-viral vectors, manufacturing systems, and clinical applications spanning oncology, rare genetic disorders, cardiovascular, neurological, and infectious diseases. The market growth is driven by the rising prevalence of chronic and rare genetic diseases, along with the aging worldwide population, increasing demand for therapeutic solutions. The advancement in delivery systems, including viral vectors and non-viral methods like lipid nanoparticles, is improving the safety and efficacy of transporting genetic material into target cells. The innovation in automation and AI and strategic investments, and supportive regulations, expansion of the market growth.
Technological advancements and innovations
The AI is revolutionizing the development of delivery vectors, such as Adeno-Associated Viruses, by optimizing their capsids to be more efficient, specific, and safer. The advancement in automation, closed-loop systems, and scalable vector production is increasing the efficiency and reducing the cost of manufacturing CGTs. AI can help in enhanced quality control, real-time monitoring and control, and design more effective Chimeric Antigen Receptors by predicting the most promising candidates from extensive libraries and optimizing their function.
- In May 2025, Dyno Therapeutics announced the launch of three new Adeno-associated virus (AAV) capsids, called Dyno-4z2, Dyno-3hv, and Dyno-ahq. These are designed to deliver gene therapies more efficiently and specifically to the eye, muscles, and central nervous system (CNS).
Market Trends
- Diversification beyond oncology – While oncology remained a key focus, trials in other therapeutic areas, like rare diseases, gained momentum.
- In April 2024, Pfizer's Beqvez received Health Canada's approval for hemophilia B, demonstrating progress in non-cancer indications.
- In January 2024, Adaptimmune's afami-cel, an engineered T cell therapy for advanced synovial sarcoma, was granted priority review by the FDA
- Focus on allogeneic therapies – Research into "off-the-shelf" allogeneic therapies continued, offering potential advantages in scalability and cost over autologous therapies.
- In January 2024, AbbVie and Umoja Biopharma partnered to develop in-situ generated CAR-T cell therapy candidates utilizing a proprietary platform.
Cell and Gene Therapy Market Report Scope
Market Opportunity
Focus on rare and genetic diseases, an opportunity for the cell and gene therapy market
Gene therapy is particularly promising for rare diseases, many of which have no effective treatments. By addressing the root genetic cause of a disease, these therapies offer the potential for long-term correction or even a cure.
- In March 2024, LENMELDY™ (atidarsagene autotemcel) was approved for early-onset metachromatic leukodystrophy (MLD).
Market Challenge
High upfront cost limitations of the Cell and Gene Therapy market
Gene therapy is among the most expensive drugs on the market, with some single-treatment doses costing millions of dollars. This creates a severe financial burden for patients and healthcare systems. For smaller payers, such as self-insured employers, even one lightning strike could be financially destabilizing.
Segmental Insights
Therapy Type Insights
The cell therapy segment dominated the Cell and Gene Therapy market in 2024. The cell therapy segment dominated the market because its efficacy in oncology cell therapies, such as CAR-T treatments, demonstrated strong results in targeting and treating various cancers, especially blood cancers and solid tumors. The growing investment and funding and regulatory support, and approvals. The innovation in cell-based treatment technologies, including gene editing tools, enhances the efficacy and safety of these therapies, expansion of the market growth.
The gene therapy (in vivo) segment is the fastest-growing in the Cell and Gene Therapy market during the forecast period. The technological advancements in targeted delivery systems and pipeline development for rare and chronic diseases. The significant investment and funding are being channelled into gene therapy research, including the development of advanced gene editing technologies and improved delivery methods for in vitro applications. It is a simplified and less invasive procedure that drives market growth.
Cell and Gene Therapy Market By Therapy Type, 2021-2024 (USD Million)
Vector Type Insights
The viral vectors segment held the largest revenue share in the Cell and Gene Therapy market in 2024. It has high transduction efficiency and stable gene expression, a safer profile, and reduced immunogenicity. The widespread use of approved and late-stage therapies, application across diverse therapeutic areas, and viral vectors to treat a wide range of diseases, including genetic disorders, cancer, and infectious diseases. The increased R&D investment and regulatory support, expansion of contract manufacturing organizations boost the market growth.
The non-viral vectors (LNPs) segment is experiencing the fastest growth in the Cell and Gene Therapy market during the forecast period. The rising demand for safe and scalable gene delivery systems and innovation in LNP technology. The development and deployment of LNP-based mRNA vaccines, such as those for COVID-19, showcased the potential of non-viral carriers for safe and effective nucleic acid delivery.
Cell and Gene Therapy Market, By Vector Type (Gene Delivery Method) 2021-2024 (USD Million)
Application Insights
The oncology segment dominated the Cell and Gene Therapy market in 2024. The high global cancer prevalence and the clinical success of CAR-T cell therapies for blood cancers. This dominance was further supported by a robust oncology-focused clinical trial pipeline and significant R&D investments, which are also driving the expansion of these therapies to treat solid tumors. Favorable regulatory pathways accelerated the development and approval of new oncology CGT products, while the personalized nature of these treatments met the rising demand for targeted cancer therapies.
The rare and genetic disorders segment is the fastest-growing in the market during the forecast period. The inherent limitations of traditional treatments for many rare genetic disorders create a powerful demand for the potentially curative capabilities of CGT, which targets the root genetic causes of these conditions. This demand was met with rapid progress in gene editing, exemplified by tools like CRISPR-Cas9, and increasingly efficient delivery systems, which made CGTs safer and more precise for a broader range of disorders.
End Use Insights
The pharmaceutical & biotechnology segment dominated the cell and gene therapy market in 2024. Their immense financial power, extensive R&D capabilities, and advanced manufacturing infrastructure to drive innovation from clinical development to commercialization. Through strategic mergers and acquisitions of promising smaller biotech firms, large players expand their CGT pipelines and gain expertise. This market control is further cemented by their experience in navigating complex regulatory pathways and utilizing global commercial networks to manage supply chains and secure market access for expensive, intricate therapies.
The CROs & CDMOs segment is the fastest-growing in the market during the forecast period. The providing specialized expertise and infrastructure, they enable biopharmaceutical companies to navigate regulatory hurdles, manage costs, and accelerate development timelines. This critical support allows biotech firms to focus on innovation, ultimately driving the development of life-changing therapies to market faster and more efficiently.
Cell and Gene Therapy Market By End Use, 2021-2024 (USD Million)
Regional Insights
Which Region Dominated the Cell and Gene Therapy Market?
North America dominated the market in 2024, and the region is expected to sustain the position during the forecast period. North America dominated the market in 2024 due to its supportive regulatory environment FDA implemented initiatives, such as regenerative medicine advanced therapy and breakthrough therapy designations, to accelerate the development. The region's high investment in R&D and automation using automated, closed-loop systems to reduce human errors and contamination. The region focuses on targeted therapeutic areas, and the adoption of advanced technologies drives the market growth.
The United States Cell and Gene Therapy Market Trends
The United States market is growing due to the expansion of therapeutic areas beyond oncology, and promising clinical activity is focusing on rare genetic disorders, infectious diseases, and neurological conditions like Parkinson's and Alzheimer's. The advancement in manufacturing and delivery, and integration of artificial intelligence. AI algorithms are being used to analyse large datasets to identify new therapeutic targets and optimize gene-editing tools like CRISPR, speeding up drug discovery.
Why is Asia Pacific Significantly Growing in the Cell and Gene Therapy Market?
Asia Pacific expects significant growth in the market during the forecast period. The Asia Pacific is expected to register the fastest growth in the market due to significant investment in research and development, focus on oncology, oncology trials, especially for CAR-T cell therapies targeting hematological cancers and solid tumors, which represent a large share of the region's CGT research. Maturating biotech ecosystem and investments, increasing government and private sector funding, are attracting new companies and fostering innovation.
Cell and Gene Therapy Market, By Region, 2021-2024 (USD Million)
Cell and Gene Therapy Market Value Chain Analysis
1.R&D
Cell and Gene Therapy are neutral shells, usually made from gene therapy, cell therapy, pipeline statistics, advances in gene editing technologies, AI, and machine learning integration.
2. Formulation
Cell and Gene Therapy involves designing and optimizing a delivery vehicle (vector) to safely and effectively transport genetic material into target cells. The primary goal is to protect the vector and its genetic cargo from degradation and elicit the desired biological response.
3. Patient Support and Services
Cell and Gene Therapy are critical components that address the unique challenges of these complex, high-cost, and logistically demanding treatments. These services are essential for guiding patients and caregivers through the entire journey, ensuring access, managing logistics, and providing crucial emotional and educational resources.
Cell and Gene Therapy Market Top Companies
Recent Developments
- In April 2024, the Indian Institute of Technology, Bombay, and Tata Memorial Hospital, with industry partner ImmunoACT, led to the development of the world's most affordable CAR-T therapy, NexCAR19.
- In December 2024, the first FDA-approved mesenchymal stromal cell (MSC) therapy, indicated for treating steroid-refractory acute graft-versus-host disease (aGVHD) in pediatric patients.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the Cell and Gene Therapy market.
By Therapy Type
-
- Autologous Cell Therapy
- Allogeneic Cell Therapy
- Stem Cell Therapy (MSC, HSC, iPSC)
- T-cell Therapy (CAR-T, TCR-T, NK cells)
- Dendritic Cell Therapy
- Others
- Gene Therapy
-
- Gene Addition / Replacement
- Gene Silencing (RNAi, antisense)
- Genome Editing (CRISPR/Cas, TALEN, ZFN)
- Ex Vivo Gene Therapy
- In Vivo Gene Therapy
- Others
By Vector Type
-
- Adeno-associated Virus (AAV)
- Lentivirus
- Retrovirus
- Adenovirus
- Herpes Simplex Virus (HSV)
- Others
- Non-Viral Vectors
-
- Lipid Nanoparticles (LNPs)
- Electroporation
- Naked DNA / RNA
- Physical & Chemical Methods (polymeric nanoparticles, nanocarriers)
- Others
By Application
- Oncology (hematological malignancies, solid tumors)
- Rare & Genetic Disorders (hemophilia, SMA, DMD)
- Cardiovascular Diseases
- Neurological Disorders
- Ophthalmic Disorders
- Infectious Diseases
- Musculoskeletal Disorders
- Others
By End User
- Hospitals & Clinics
- Academic & Research Institutes
- Pharmaceutical & Biotechnology Companies
- Contract Research & Manufacturing Organizations (CROs/CDMOs)
- Others
By Delivery Mode
- In Vivo Administration
- Ex Vivo Administration
By Industry Vertical
- Pharmaceuticals
- Biotechnology
- Healthcare & Diagnostics
- Research & Academia
- Others
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
Request Customization
Get a Sample
Get a Sample
Request Customization