Cell and Gene Therapy Market Size & Share 2026-2035

Cell and Gene Therapy Market Size

The global cell and gene therapy market was valued at approximately USD 12.2 billion in 2025. The market is expected to grow from USD 15.5 billion in 2026 to USD 120.9 billion in 2035, growing at a CAGR of 25.7% between 2026 and 2035, as per the latest report published by Global Market Insights Inc. The market growth is driven by the increasing commercialization of novel therapies, expanding clinical pipelines, and rising investments in regenerative medicine.

The cell & gene therapy (CGT) industry encompasses all biological therapies that involve the use of living cells, genetic material, or gene-editing tools to treat, prevent, or cure diseases. This includes cell therapies such as immunotherapies (CAR-T, TCR-T, NK cells), stem cell therapies, dendritic cell therapies, and gene therapies.

Key players in the cell and gene therapy market include companies such as Novartis, Gilead Sciences, Bristol Myers Squibb, Bluebird Bio, and Johnson & Johnson. These companies are driving market growth through extensive research and development activities, strategic collaborations, manufacturing capacity expansion, and commercialization of approved therapies. Their continued efforts in securing regulatory approvals, improving manufacturing efficiencies, and expanding patient access are shaping the competitive landscape and accelerating the adoption of advanced therapies worldwide.

The market growth is primarily attributed to the growing number of approved cell and gene therapy products, advancements in viral vector and cell engineering technologies, and favorable regulatory support for innovative therapies. For instance, as of August 2024, 46 CGTs have been approved by the FDA for 31 distinct indications. Globally, by the first quarter of 2025, 104 CGTs have been approved, and 3,120 are in development, reflecting the accelerating momentum of this field.

The rising burden of chronic, genetic, and life-threatening diseases continues to create significant demand for cell and gene therapies. Conditions such as hematological malignancies, spinal muscular atrophy (SMA), β-thalassemia, sickle cell disease, hemophilia, inherited retinal disorders, and certain forms of leukemia and lymphoma have become major targets for these advanced treatments. According to the World Health Organization (WHO), in 2022, 10 million people died of cancer worldwide. That is 1 out of every 6 deaths. Further, over 626,000 cancer deaths are projected in the U.S. in 2026. Similarly, according to Rare Diseases International, more than 300 million individuals worldwide are estimated to be living with a rare disease. Cell and gene therapies offer the potential for long-term disease modification or even curative outcomes through a single administration, making them increasingly attractive alternatives to conventional therapies.

Between 2022 and 2024, the cell and gene therapy market experienced substantial growth, growing from USD 6.5 billion in 2022 to USD 9.8 billion in 2024. The growth is supported by a surge in clinical development activities and multiple regulatory approvals. During this period, several landmark therapies targeting hematological cancers, inherited blood disorders, and rare genetic diseases received approval in major markets. Growing partnerships between biotechnology innovators and large pharmaceutical companies further strengthened product pipelines and accelerated the transition of therapies from clinical development to commercial deployment.

Cell and Gene Therapy Market Trends

• A key trend shaping the cell and gene therapy industry is the increasing number of regulatory approvals and late-stage clinical successes for advanced therapies.
• For instance, by Q3 2024, the global number of CGT clinical trials reached 4,099, marking increases of 5% in gene therapy trials, 56% in RNA therapy trials, and 13% in cell therapy trials compared to 2021.
• Another significant trend is the growing adoption of gene-editing technologies such as CRISPR/Cas9, base editing, and prime editing. These technologies enable precise genetic modifications and are expanding the therapeutic potential of cell and gene therapies for inherited diseases, hematological disorders, and cancer.
• The market is also witnessing a strong shift toward personalized medicine. Autologous cell therapies, particularly CAR-T therapies, are designed using a patient's own cells, providing highly targeted treatment approaches with improved efficacy. Advances in genomic sequencing and biomarker identification are further supporting the development of individualized therapies.
• Significant investments from biotechnology companies, pharmaceutical manufacturers, venture capital firms, and government organizations continue to accelerate innovation and product development.
• According to the Alliance for Regenerative Medicine, total investment in North America surpassed USD 11.8 billion in 2024. Additionally, the increasing availability of contract development and manufacturing organizations (CDMOs), improvements in vector production technologies, and investments in cold-chain logistics are enhancing the commercial scalability of these therapies.
• Thus, with a growing number of approved products, a robust clinical pipeline, continuous technological advancements, and expanding therapeutic indications, the market is expected to witness strong growth throughout the forecast period.

Cell and Gene Therapy Market Analysis

Based on the therapy type, the cell and gene therapy market is divided into cell therapy and gene therapy. The cell therapy segment includes CAR-T cell therapy, TCR-T cell therapy, TIL (Tumour-Infiltrating Lymphocyte) therapy, stem cell therapy, dendritic cell therapy, and other cell-based therapies. The cell therapy segment dominated the market in 2025, with revenue of USD 9 billion.

• The cell therapy segment is driven by a larger number of commercialized products, broader clinical adoption, and expanding regulatory approvals compared to gene therapies.
• The segment has witnessed significant momentum with the launch of multiple CAR-T therapies, including Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Carvykti, and Aucatzyl in major markets. Beyond CAR-T therapies, the approval of innovative cell-based treatments such as Amtagvi (TIL therapy) and Tecelra (TCR-T therapy) has expanded the therapeutic scope of cell therapy, particularly in oncology.
• Additionally, the robust clinical pipeline, increasing investments in manufacturing infrastructure, and ongoing research into next-generation allogeneic, NK-cell, and stem cell therapies continue to strengthen the segment's leadership and support its substantial share of the overall cell and gene therapy market.
• The gene therapy segment is anticipated to witness growth at a CAGR of 26.2% supported by the growing number of approved one-time treatments targeting rare genetic disorders, hematological diseases, and neuromuscular conditions.
• The segment's growth has been driven by the commercialization of products such as Zolgensma, Luxturna, Hemgenix, Roctavian, Elevidys, and Casgevy.
• Moreover, substantial investments in viral vector manufacturing, advances in gene-editing technologies such as CRISPR, and a robust late-stage pipeline continue to strengthen the segment's market position.

Based on the indication, the cell and gene therapy market is segmented into oncology, hematological disorders, rare genetic disorders, neurological disorders, ophthalmological disorders, dermatological disorders, immunological disorders, and other indications. The oncology segment dominated the market in 2025 with a market share of 51.9%.

• The dominance of oncology segment is driven by the increasing global burden of cancer and the rapid commercialization of innovative therapies such as CAR-T and gene therapies.
• According to the International Agency for Research on Cancer (IARC), approximately 20 million new cancer cases and 9.7 million cancer-related deaths were reported worldwide in 2022, with the annual number of new cancer cases projected to reach 35 million by 2050, representing a 77% increase.
• Lung cancer alone accounted for approximately 2.5 million new cases globally, followed by breast cancer (2.3 million cases) and colorectal cancer (1.9 million cases).
• Additionally, oncology represents the largest share of the global CGT clinical pipeline, supported by substantial R&D investments, favorable regulatory designations, and expanding clinical evidence. These factors collectively reinforce the dominance of the oncology segment in the cell and gene therapy market.
• On the other hand, the hematological disorders segment holds a market share of 20.5%, driven by the increasing adoption of gene therapies and engineered cell therapies for conditions such as sickle cell disease, beta-thalassemia, hemophilia A, hemophilia B, leukemia, lymphoma, and multiple myeloma.
• The rare genetic disorders segment is projected to witness rapid growth at a CAGR of 26.7% in the cell and gene therapy market due to the increasing availability of one-time, potentially curative gene therapies targeting the underlying genetic cause of disease.

Based on end use, cell and gene therapy market is classified into hospitals, specialty clinics, academic and research institutions, and other end users. The hospital segment dominated the market in 2025 and is anticipated to grow at a CAGR of 25.8% over the forecast timeframe.   

• Hospitals are the key end users of cell and gene therapy products, serving as a primary setting for the administration and delivery of these advanced treatments.
• Hospitals offer specialized infrastructure, skilled healthcare professionals, and supportive care required to manage the complex procedures and monitoring associated with these therapies.
• Many hospitals are increasingly collaborating with biotech firms and participating in clinical trials, further strengthening their position in the cell and gene therapy ecosystem.
• On the other hand, the specialty clinics segment held the second largest market share of 18.4% in 2025, owing to the increasing number of cell and gene therapies being administered at specialized treatment centers. The availability of trained specialists and dedicated facilities for advanced therapies, especially in developed regions, has supported the growth of this segment.
• The academic and research institutions segment is anticipated to grow at a CAGR of 25.2% over the analysis period, driven by increasing research activities, clinical studies, and investments in the development of novel cell and gene therapies.

North America Cell and Gene Therapy Market

In 2025, North America dominated the cell and gene therapy industry with a market share of 61.8% and is expected to maintain its dominance throughout the forecast period.

• North America benefits from a highly developed biotechnology ecosystem, strong research infrastructure, and the presence of leading cell and gene therapy manufacturers and academic institutions.
• The region receives substantial support from government agencies and private investors for advanced therapy development. For instance, in 2023, NIH awarded Yale School of Medicine a USD 40 million grant to support CRISPR-based gene therapy development, supporting innovation across the sector.
• The U.S. represents the largest market within the region owing to the presence of numerous approved therapies, favorable reimbursement frameworks, and a robust clinical trial landscape.
• The U.S. cell and gene therapy market was valued at USD 3.8 billion and USD 4.6 billion in 2022 and 2023, respectively. The market size reached USD 7 billion in 2025, growing from USD 5.6 billion in 2024.
• The U.S. continues to dominate the cell and gene therapy market, driven by its robust biotechnology ecosystem, substantial research funding, and a favourable regulatory environment.
• The country is home to several leading pharmaceutical and biotech companies and benefits from a strong pipeline of innovative gene therapy candidates and cutting-edge technologies.
• Additionally, the presence of leading research institutions and extensive clinical trial activities further accelerate the development and commercialization of new therapies.

Europe Cell and Gene Therapy Market

Europe contributes substantially to the cell and gene therapy industry owing to its strong biotechnology research base, favorable regulatory environment, and growing commercialization of advanced therapies.

• The region holds a significant share due to its strong healthcare system, increasing government support, and growing investment in biotechnology development.
• The region benefits from a collaborative ecosystem involving academic institutions, research organizations, and pharmaceutical companies, that accelerates the development and adoption of gene therapies.
• Rising adoption of personalized medicine, increasing approvals of advanced therapies, and growing investment in rare disease treatment continue to support market expansion throughout Europe.

Asia Pacific Cell and Gene Therapy Market

The Asia Pacific cell and gene therapy industry is anticipated to witness the fastest growth at a CAGR of 27.2% during the forecast period.

• Asia Pacific has emerged as a major center for cell and gene therapy research, driven by increasing healthcare expenditure, expanding biotechnology industries, and favorable government initiatives.
• Countries such as China, Japan, South Korea, and India are making significant investments in regenerative medicine, gene-editing technologies, and cell therapy manufacturing infrastructure.
• China has become one of the world's largest markets for cell and gene therapy clinical research, with a rapidly growing number of clinical trials focused on CAR-T therapies, stem cell therapies, and gene-editing approaches.
• Japan continues to benefit from an accelerated regulatory framework for regenerative medicine products, encouraging innovation and commercialization of advanced therapies.
• Furthermore, growing outsourcing activities, lower manufacturing costs, increasing patient populations, and rising prevalence of cancer and rare genetic disorders are driving demand for cell and gene therapies across the region.

Latin American Cell and Gene Therapy Market

Latin America is witnessing steady growth in the cell and gene therapy industry due to expanding biotechnology capabilities, increasing clinical research activities, and improving healthcare infrastructure.

• Countries such as Brazil, Mexico, and Argentina are investing in biotechnology research and advanced healthcare technologies to strengthen domestic innovation capabilities.
• Growing prevalence of cancer, genetic disorders, and chronic diseases is increasing demand for innovative treatment options, including cell and gene therapies.
• Further, increasing collaborations between regional healthcare institutions and global biotechnology companies are supporting market growth.

Middle East and Africa Cell and Gene Therapy Market

The Middle East & Africa cell and gene therapy industry is expected to experience gradual growth over the forecast period.

• Countries such as Saudi Arabia, the UAE, and South Africa are increasing investments in biotechnology research, precision medicine programs, and healthcare modernization initiatives.
• Government-led healthcare transformation programs and increasing focus on rare disease diagnosis and treatment are creating opportunities for cell and gene therapy adoption.
• The region is witnessing growing collaborations between healthcare providers, academic institutions, and international biotechnology companies aimed at expanding access to advanced therapies.
• Although commercialization remains at an early stage compared to North America and Europe, rising healthcare expenditure, improving regulatory frameworks, and increasing awareness of advanced therapeutics are expected to support long-term market growth.

Cell and Gene Therapy Market Share

The competitive landscape of the cell and gene therapy industry is characterized by the presence of large biopharmaceutical companies, specialized cell therapy developers, and emerging biotechnology firms focused on next-generation therapeutic platforms. Leading players such as Novartis, Gilead Sciences, Bristol Myers Squibb, Johnson & Johnson, and Bluebird Bio collectively account for ~55% market share of the global market, supported by commercial products including Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Carvykti, Casgevy, and Zolgensma. These companies continue to invest heavily in clinical development, manufacturing capacity expansion, and next-generation technologies to strengthen their market positions.

The market is also witnessing increasing strategic collaborations, licensing agreements, and acquisitions aimed at expanding cell and gene therapy pipelines and improving manufacturing capabilities. In addition, emerging biotechnology companies are driving innovation in areas such as allogeneic cell therapies, TCR-T therapies, TIL therapies, gene editing, and in vivo gene delivery platforms.

Cell and Gene Therapy Market Companies

Prominent players operating in the cell and gene therapy industry are as mentioned below:

• BioMarin Pharmaceutical
• bluebird bio
• Bristol Myers Squibb
• CRISPR Therapeutics
• Gilead Sciences
• Johnson & Johnson
• Krystal Biotech
• Novartis
• Orchard Therapeutics
• Pfizer
• Roche / Spark Therapeutics
• Sarepta Therapeutics
• uniQure
• Vertex Pharmaceuticals

• Novartis

Novartis is a key player in the cell and gene therapy market. The company is primarily known for its groundbreaking treatment Zolgensma, used to combat spinal muscular atrophy (SMA). The company’s strong focus on rare genetic disorders and its robust manufacturing capabilities have positioned it at the forefront of gene therapy innovation and commercialization.

• Gilead Sciences

Gilead Sciences is a leading player in the cell therapy market through its subsidiary, Kite Pharma. The company markets the CAR-T therapies Yescarta and Tecartus, which are approved for the treatment of various hematological malignancies. Gilead continues to expand its cell therapy portfolio through ongoing clinical development and investments in manufacturing capabilities.

Cell and Gene Therapy Industry News

• In August 2024, The U.S. FDA approved Tecelra (afamitresgene autoleucel), a gene therapy developed by Adaptimmune, for the treatment of adults with unresectable or metastatic synovial sarcoma. This approval applies to patients who have received prior chemotherapy, possess specific HLA antigens, and whose tumors express the MAGE-A4 antigen, as determined by FDA-authorized companion diagnostic devices.
• In January 2024, Biogen and Ginkgo Bioworks announced the completion of their gene therapy collaboration involving AAV based vectors. This is expected to fuel the demand for gene therapies in the coming years.
• In December 2023, the Swiss Agency for Therapeutic Products granted approval to Libmeldy for the treatment of early-onset metachromatic leukodystrophy.
• In June 2023, the U.S. FDA granted approval to Sarepta for ELEVIDYS gene therapy to treat DMD in children of age 4-5 years.
• In May 2023, the FDA approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB) and mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

The cell and gene therapy market research report includes in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2022 - 2035 for the following segments:

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Market, By Therapy Type

• Cell therapy            
  • CAR-T cell therapy  
  • TCR-T cell therapy
  • TIL (Tumor-Infiltrating Lymphocyte) therapy     
  • Stem cell therapy    
  • Dendritic cell therapy         
  • Other cell-based therapies 
• Gene therapy          
  • By type        
    • In vivo gene therapy
    • Ex vivo gene therapy
  • By vector      
    • Viral vectors
    • Non-viral vectors

Market, By Indication

• Oncology
• Hematological disorders
• Rare genetic disorders
• Neurological disorders
• Ophthalmological disorders
• Dermatological disorders
• Immunological disorders
• Other indications

Market, By End Use

• Hospitals
• Specialty clinics
• Academic and research institutions
• Other end users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea

• Latin America
  • Brazil
  • Mexico
  • Argentina

• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE