The Cell and Gene Therapy Market is undergoing a remarkable transformation, reshaping the future of medicine. Valued at USD 17.40 billion in 2024, the market is projected to grow at an impressive CAGR of 23.17% from 2025 to 2034, reaching a value of USD 139.83 billion by 2034. This surge is being driven by strong regulatory backing, rapid technological advancements, and the expansion of clinical trials worldwide.

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What Are Cell and Gene Therapies?

Cell and gene therapies are cutting-edge treatment approaches that modify or manipulate genetic material or cells to fight disease. According to Wikipedia, cell therapy involves the transplantation of human cells to replace or repair damaged tissue, while gene therapy alters genetic instructions to treat or prevent diseases. These therapies are revolutionizing treatment for conditions once thought incurable, such as certain cancers, genetic disorders, and rare diseases.

Market Trends Driving Growth

. Increased Regulatory Approvals

A significant market trend is the growing number of FDA and EMA approvals for novel cell and gene therapies. The U.S. Food and Drug Administration has established expedited pathways, such as Regenerative Medicine Advanced Therapy (RMAT) designation, to accelerate product development.

. Surge in Clinical Trials

Global clinical trials in the CGT space have surged, especially in oncology and rare diseases. According to BioPharma Dive, over 2,000 CGT clinical trials are currently underway, reflecting an innovation-heavy pipeline.

. Strategic Collaborations

Pharma giants are increasingly forming partnerships and licensing agreements to bolster their CGT capabilities. These collaborations aim to share risks, pool expertise, and fast-track development.

. Personalized Medicine Push

Cell and gene therapies support the shift toward personalized medicine, offering tailored treatments based on a patient’s genetic profile—particularly relevant in oncology and inherited conditions.

Key Market Drivers

  • Technological Advancements: Innovations in viral and non-viral vectors, CRISPR-Cas9, and cell expansion techniques are pushing the boundaries of therapeutic possibilities.

  • Growing Disease Burden: Rising prevalence of chronic and genetic diseases is fueling demand for more effective, curative solutions.

  • Robust Funding: Investment from venture capital and government agencies continues to increase, especially in biotech hubs across North America and Europe.

  • Global Healthcare Infrastructure: Improved access to advanced therapies and specialist treatment centers is boosting adoption in developed and emerging markets alike.

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Market Segmentation

By Therapy Type

  • Cell Therapy:

    • Autologous Cell Therapy (cells from the patient)

    • Allogenic Cell Therapy (donor-derived cells)

  • Gene Therapy:

    • Somatic Gene Therapy

    • Germline Gene Therapy (restricted in most countries due to ethical concerns)

By Type

  • Cell Type: Stem Cell, Non-Stem Cell

  • Gene Type: Antigen, Cytokine, Tumor Suppressor, Growth Factors, Receptors, Others

By Delivery Mode

  • In Vivo: Gene editing occurs inside the body.

  • Ex Vivo: Cells are modified outside the body and then reintroduced.

By Vector Type

  • Viral Vectors: Lentivirus, adenovirus

  • Non-Viral Techniques: Liposomes, electroporation

By Therapeutic Area

  • Oncology

  • Cardiology Diseases

  • Neurological Disorders

  • Genetic Disorders

  • Infectious Diseases

  • Hematological Disorders

  • Musculoskeletal Disorders

  • Others

By End User

  • Hospitals

  • Cancer Care Centers

  • Academic and Research Institutes

  • Others

By Region

  • North America

  • Europe

  • Asia Pacific

  • Latin America

  • Middle East and Africa

Leading Players in the Market

Several prominent firms are shaping the competitive landscape of the Cell and Gene Therapy Market:

  • Amgen Inc.

  • Novartis AG – Notable for CAR-T therapy Kymriah.

  • Pfizer Inc.

  • Bluebird Bio, Inc.

  • Castle Creek Pharmaceutical Holdings

  • Bristol-Myers Squibb

  • Kite Pharma, Inc. – Developer of Yescarta.

  • Vericel Corporation Inc.

  • Kolon TissueGene Inc.

  • Vertex Pharmaceuticals, Inc.

  • Spark Therapeutics, Inc. – Known for Luxturna, a gene therapy for inherited retinal disease.

  • CORESTEM Inc.

  • Biogen Inc.

  • Dendreon Pharmaceuticals LLC

  • JCR Pharmaceuticals Co. Ltd.

Case Studies & Industry News

One landmark case in the CGT field was the approval of Zolgensma, a gene therapy developed by Novartis for spinal muscular atrophy (SMA), which CNN Health reported as a “breakthrough treatment” and one of the most expensive drugs ever approved.

Another notable case is Kymriah, developed by Novartis, the first FDA-approved CAR-T therapy that has paved the way for newer CAR-T therapies in hematologic malignancies.

These examples underscore how the market is not only expanding in size but also reshaping clinical practice and pharmaceutical investment strategies.

Future Growth Outlook

With projected market size reaching nearly USD 140 billion by 2034, the future of the Cell and Gene Therapy Market is highly promising. Key growth opportunities include:

  • Expansion into chronic and infectious diseases

  • Lower manufacturing costs through automation

  • Emerging markets adoption

  • Increased public-private partnerships for R&D

As healthcare systems continue to embrace advanced therapeutics, the CGT market is set to play a central role in the future of Healthcare and Pharmaceuticals.

For more in-depth market analysis, visit Expert Market Research.

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