Cell & Gene Therapy Market to Reach USD 105.83 Billion by 2033 at 21.5% CAGR | North America Leads | Key & Emerging Players: Novartis, Gilead, BMS - Emerging: Editas, Intellia, Regenxbio

The Global Cell and Gene Therapy Market reached US$ 13.90 billion in 2024 and is projected to reach US$ 105.83 billion by 2033, growing at a CAGR of 21.5% during the forecast period 2025-2033. Growth is fueled by the increasing adoption of advanced therapeutic modalities capable of treating chronic, inherited, and previously incurable diseases. Cell and gene therapy can also be combined to form gene-modified cell therapies, such as CAR-T cell therapy, where a patient's T cells are genetically altered to recognize and destroy cancer cells. These innovative approaches offer disease-modifying and potentially curative outcomes by targeting the root cause of conditions rather than just managing symptoms.

Demand for cell and gene therapies continues to accelerate due to rising regulatory approvals, expanding clinical pipelines, and strong investments in research. According to the American Society of Cell and Gene Therapy, the field maintained strong momentum in early 2024, with notable product approvals and significant growth across all clinical stages. More than 4,000 gene, cell, and RNA-based treatments are currently in development, with Phase I programs showing the highest expansion. This surge highlights the sector's potential to address unmet medical needs, particularly for life-threatening diseases where effective treatment options remain limited.

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The Cell and Gene Therapy Market refers to the industry developing treatments that modify genes or cells to cure, treat, or prevent diseases at their biological source.

Key Developments
✅ October 2025: Leading biopharma companies in the U.S. expanded manufacturing capacity for autologous and allogeneic cell therapies, adopting automated closed-system bioprocessing technologies to reduce production time and contamination risk.

✅ September 2025: Global regulatory agencies advanced harmonized guidelines for gene-editing therapies, accelerating approvals for CRISPR-based treatments targeting rare genetic disorders.

✅ August 2025: European clinical centers integrated AI-enabled patient-matching tools to optimize eligibility screening for CAR-T and gene therapy trials, improving enrollment efficiency.

✅ July 2025: Asia-Pacific governments invested heavily in national cell therapy biobanking programs to support long-term storage and distribution of stem-cell-based therapeutic materials.

✅ May 2025: Biotechnology innovators launched next-generation viral vector platforms with enhanced transduction efficiency aimed at reducing vector dose requirements for gene therapy applications.

✅ March 2025: Hospitals globally expanded use of point-of-care cell processing labs, enabling faster preparation of personalized regenerative medicine treatments.

Mergers & Acquisitions
✅ November 2025: A major U.S. gene therapy developer acquired a European viral-vector manufacturing company to strengthen its in-house vector production and accelerate clinical pipeline timelines.

✅ August 2025: A leading global pharma partnered with an AI-driven cell engineering startup to co-develop programmable cell therapies for oncology and immune disorders.

✅ June 2025: A North American regenerative medicine company acquired a CAR-T technology firm to expand its portfolio into next-generation allogeneic cell therapies.

Key Players
Novartis AG | Gilead Sciences, Inc. | Bristol Myers Squibb Company | Vertex Pharmaceuticals Incorporated | Sarepta Therapeutics, Inc. | CSL Behring LLC | Amgen, Inc. | Orchard Therapeutics Group | Krystal Biotech, Inc. | bluebird bio, Inc.

Emerging Players
Editas Medicine | Intellia Therapeutics | Rocket Pharmaceuticals | Regenxbio | Affinia Therapeutics

Key Highlights
Novartis AG - Holds a 16.5% share, driven by its strong gene therapy pipeline, commercialization of Zolgensma, and expanding investments in next-generation genomic platforms.

Gilead Sciences, Inc. - Holds a 13.8% share, supported by its leadership in cell therapy, CAR-T technologies, and continuous expansion in advanced genetic treatments.

Bristol Myers Squibb Company - Holds a 12.4% share, fueled by robust CAR-T therapy development, oncology-focused genetic research, and strategic acquisitions.

Vertex Pharmaceuticals Incorporated - Holds a 11.9% share, driven by pioneering gene-editing programs, partnerships with CRISPR Therapeutics, and progress in treating rare genetic disorders.

Sarepta Therapeutics, Inc. - Holds a 10.6% share, supported by its dominance in gene therapies for neuromuscular diseases, including Duchenne muscular dystrophy.

CSL Behring LLC - Holds a 9.2% share, boosted by leadership in plasma-derived and gene-based therapies, and a fast-expanding rare-disease treatment portfolio.

Amgen, Inc. - Holds a 10.1% share, driven by investments in next-gen gene editing, viral vector platforms, and precision genetic medicines.

Orchard Therapeutics Group - Holds a 7.3% share, supported by its expertise in hematopoietic stem cell gene therapy and successful commercialization of ultra-rare disease treatments.

Krystal Biotech, Inc. - Holds a 4.9% share, fueled by progress in topical genetic therapies and FDA approval of Vyjuvek.

bluebird bio, Inc. - Holds a 7.0% share, driven by its focus on severe genetic diseases and commercialization of gene therapies for beta-thalassemia and CALD.

Emerging Player Highlights
Editas Medicine - Holds a 3.1% share, recognized for its CRISPR-based gene-editing pipeline and advancements in in-vivo editing.

Intellia Therapeutics - Holds a 3.6% share, driven by first-in-human in-vivo CRISPR trials and strong partnerships in genetic medicine.

Rocket Pharmaceuticals - Holds a 2.9% share, supported by its AAV and LVV-based gene therapies for rare pediatric conditions.

Regenxbio - Holds a 3.3% share, fueled by its NAV Technology AAV platform and strong clinical pipeline in ophthalmology and neurology.

Affinia Therapeutics - Holds a 2.2% share, driven by engineered AAV vectors designed for precision targeting and improved gene-delivery efficiency.

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Market Drivers

• Growing prevalence of cancer, rare genetic disorders, and chronic diseases accelerating adoption of advanced cell and gene therapies.

• Increasing approvals of gene therapies, CAR-T therapies, and regenerative medicines by global regulatory authorities.

• Rising investments from pharmaceutical companies, biotech firms, and venture capital in next-generation therapy development.

• Expansion of clinical trials focused on gene editing, stem cell therapy, and personalized immunotherapies.

• Advancements in viral vectors, CRISPR technology, and non-viral delivery systems enhancing therapeutic efficiency.

• Strong demand for personalized and targeted treatment approaches offering long-term or curative outcomes.

• Government support and funding for regenerative medicine research and advanced therapy manufacturing infrastructure.

Industry Developments

• Launch of next-generation CAR-T therapies with improved safety, reduced toxicity, and enhanced efficacy.

• Development of in vivo gene editing platforms using CRISPR, TALENs, and base-editing technologies.

• Strategic collaborations between biotech companies, CDMOs, and research institutes to expand therapy development capabilities.

• Expansion of GMP-compliant manufacturing facilities for viral vectors, cell processing, and gene therapy production.

• Increasing approvals and commercialization of gene therapies targeting rare genetic diseases.

• Growth of allogeneic (off-the-shelf) cell therapy platforms improving scalability and production efficiency.

• Integration of AI and digital platforms for patient selection, therapy design, and real-time clinical insights.

Regional Insights

North America - 48% share: "Driven by strong regulatory support, high investments in cell and gene therapy R&D, advanced manufacturing capabilities, and large-scale clinical trials."

Europe - 30% share: "Supported by expanding regenerative medicine initiatives, strong biotech ecosystem, and increasing approvals for advanced therapy medicinal products."

Asia Pacific - 17% share: "Fueled by rapid expansion of biotech companies, government-funded genomic programs, and increasing clinical trial activity in cell and gene therapy."

Latin America - 3% share: "Boosted by rising adoption of advanced oncology treatments and the gradual expansion of cell therapy research programs."

Middle East & Africa - 2% share: "Driven by growing healthcare modernization, increasing focus on rare disease treatments, and expanding partnerships for regenerative medicine research."

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Key Segments

➥ By Therapy Type
Cell Therapy
Involves the administration of live cells to repair, replace, or regenerate damaged tissues. Widely used in regenerative medicine, oncology, musculoskeletal repair, and immune system modulation.

Gene Therapy
Delivers genetic material into a patient's cells to correct genetic defects, regulate gene expression, or introduce new therapeutic functions. Essential for treating hereditary disorders, rare diseases, and targeted cancer therapies.

➥ By Application
Oncology
Cell and gene therapies used for tumor suppression, immune activation (CAR-T), targeted tumor elimination, and personalized cancer treatment strategies.

Musculoskeletal Conditions
Includes regenerative treatments for cartilage repair, bone regeneration, tendon healing, and management of chronic orthopedic disorders.

Ophthalmology
Gene therapies designed to treat inherited retinal diseases, vision loss, and degenerative eye conditions through targeted genetic correction.

Blood Disorders
Therapeutics for hemoglobinopathies, bone marrow disorders, and hematologic malignancies including sickle cell disease, thalassemia, and certain leukemias.

Immunodeficiency Disorders
Gene-correction approaches restoring immune function in patients with congenital or acquired immune system deficiencies.

Graft-Versus-Host Disease (GVHD)
Cell-based immunotherapies used to modulate immune response, reduce inflammation, and prevent or treat post-transplant complications.

Rare Diseases
Highly targeted cell and gene therapies addressing ultra-rare genetic conditions with limited treatment options.

Others
Additional applications spanning neurology, metabolic disorders, regenerative medicine research, and emerging gene-editing therapies.

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