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Cell and Gene Therapy Market Projected to Grow to USD 172B by 2035

12-12-2025 11:31 AM CET | Health & Medicine

Press release from: Expert Market Research

Cell and Gene Therapy Market Projected to Grow to USD 172B by 2035

What is driving the growth of the global cell and gene therapy market, and how is it expected to evolve by 2035?

The global cell and gene therapy market is witnessing rapid expansion due to increasing clinical trials, robust regulatory support, and breakthroughs in biotechnology. Valued at USD 21.43 Billion in 2025, the market is expected to grow at a CAGR of 23.17% from 2026 to 2035, reaching USD 172.22 Billion by 2035.

Cell and gene therapies are revolutionizing modern medicine by offering targeted treatments for previously untreatable diseases, including oncology, genetic disorders, neurological conditions, and cardiovascular diseases. These therapies work by repairing, replacing, or modifying cellular or genetic material to restore normal function, offering curative potential rather than symptom management.

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Market Overview and Current Landscape

Cell and gene therapies are advanced treatment modalities that leverage living cells and genetic modifications to treat complex diseases. The market is driven by technological innovations, increasing investment in clinical research, and expanding patient access to therapies.

Key Market Highlights

Market Value (2025): USD 21.43 Billion

Forecast Value (2035): USD 172.22 Billion

CAGR (2026-2035): 23.17%

Primary Growth Drivers:

Rising prevalence of cancer and genetic disorders

Growing number of clinical trials and regulatory approvals

Advancements in viral and non-viral vector delivery systems

Expansion of specialized treatment centers and research institutes

Factors Driving Market Growth

Breakthroughs in Cell and Gene Therapy Technologies

Autologous and allogeneic cell therapies allow personalized treatment approaches

Somatic and germline gene therapies enable targeted genetic modifications

Viral vectors (lentivirus, adenovirus) and non-viral techniques enhance efficiency and safety

Increasing Clinical Trials and Regulatory Approvals

Strong pipeline of therapies across oncology, hematology, and rare genetic diseases

Accelerated approval pathways by FDA, EMA, and PMDA

Expanded compassionate use programs increase patient access

Rising Prevalence of Chronic and Genetic Disorders

Oncology, neurological, cardiovascular, and hematological diseases are key targets

Genetic testing and early diagnosis improve patient eligibility for therapy

Growing awareness among patients and clinicians drives adoption

Expansion of Specialized Treatment Centers

Hospitals and cancer care centers with dedicated cell and gene therapy units

Academic and research institutes advancing clinical research

Centers of excellence ensure proper administration and patient monitoring

Technological Advancements in Delivery and Manufacturing

Ex vivo and in vivo delivery techniques enhance precision and reduce adverse effects

Scalable manufacturing of viral vectors and cellular products

Quality control and process automation improve therapy consistency

Challenges Limiting Market Growth

Despite significant growth, the market faces several challenges:

High Cost of Therapy

Cell and gene therapies are expensive due to complex manufacturing and regulatory compliance

Limited insurance coverage in some regions affects patient access

Manufacturing and Scalability Issues

Production of autologous therapies requires patient-specific processes

Viral vector production and ex vivo expansion require advanced facilities and expertise

Safety and Ethical Concerns

Potential immunogenicity, off-target effects, and long-term safety risks

Ethical considerations around germline gene therapy and genetic modifications

Regulatory Complexity

Multi-regional approvals and stringent safety standards

Need for harmonized global guidelines to streamline therapy availability

Read the Full Report with the Table of Contents - https://www.expertmarketresearch.com/reports/cell-and-gene-therapy-cgt-market.

Market Segmentation by Therapy Type

Cell Therapy Types

Autologous Cell Therapy: Uses patient's own cells, minimizing immune rejection

Allogenic Cell Therapy: Uses donor cells, allowing off-the-shelf treatment options

Gene Therapy Types

Somatic Gene Therapy: Alters non-reproductive cells to treat or cure diseases

Germline Gene Therapy: Genetic modifications are heritable, raising ethical concerns

Market Segmentation by Type

Cell Type

Stem Cells: Hematopoietic stem cells, mesenchymal stem cells, induced pluripotent stem cells

Non-Stem Cells: Immune cells (T-cells, NK cells), fibroblasts, chondrocytes

Gene Type

Antigens: Immunotherapy targets for cancer and infectious diseases

Cytokines: Enhance immune response in oncology and inflammatory diseases

Tumor Suppressor Genes: Restore normal cellular regulation

Growth Factors: Promote tissue regeneration and healing

Receptors: Targeted therapies for specific molecular pathways

Others: Novel gene constructs for rare and complex disorders

Market Segmentation by Delivery Mode

In Vivo: Direct administration into the patient, typically using viral vectors

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

Market Segmentation by Vector Type

Viral Vectors: Lentivirus, adenovirus, AAV (adeno-associated virus), retrovirus

Non-Viral Techniques: CRISPR, electroporation, lipid nanoparticles, plasmid DNA

Market Segmentation by Therapeutic Area

Oncology

CAR-T cell therapies, gene-modified T-cells, and oncolytic viruses

Rapidly growing segment due to high unmet needs in hematological and solid tumors

Cardiovascular Diseases

Gene therapies targeting heart failure, myocardial infarction, and arrhythmias

Ex vivo cell therapies for tissue repair

Neurological Disorders

Gene therapy for Parkinson's, Alzheimer's, spinal muscular atrophy, and ALS

Stem cell therapy for neurodegenerative conditions

Genetic Disorders

Rare diseases like hemophilia, cystic fibrosis, and muscular dystrophy

Personalized treatment approaches using patient-specific gene modifications

Infectious Diseases

Vaccine-based gene therapy and antigen-targeted treatments

Immunotherapies for viral infections

Hematological Disorders

Gene and cell therapy for sickle cell anemia, thalassemia, and leukemia

HSCT (hematopoietic stem cell transplantation) in combination with gene editing

Musculoskeletal Disorders

Cell therapy for osteoarthritis, cartilage regeneration, and bone repair

Others

Emerging applications in autoimmune disorders, ophthalmology, and dermatology

Market Segmentation by End User

Hospitals: Primary centers for therapy administration

Cancer Care Centers: Focus on CAR-T and immune therapies

Academic and Research Institutes: Clinical trials, novel therapies, and translational research

Others: Specialty clinics and biotech hubs providing advanced therapies

Regional Market Insights

North America

Largest market share due to strong biotech ecosystem

Regulatory support from FDA and clinical trial infrastructure

High adoption of CAR-T and gene therapies

Europe

Germany, UK, France, and Switzerland lead the market

Growing investment in clinical trials and specialized centers

Asia Pacific

Fastest-growing region with China, Japan, South Korea, and India

Expansion of manufacturing facilities and clinical research networks

Latin America

Moderate growth with focus on hematology and oncology

Emerging patient access programs and clinical trials

Middle East and Africa

Increasing healthcare infrastructure investment

Rising focus on genetic disorder therapies and oncology

Competitive Landscape

The cell and gene therapy market is highly competitive, with leading global biopharmaceutical companies and innovative biotech startups driving innovation.

Key Companies

Amgen Inc.

Novartis AG

Pfizer Inc.

Bluebird Bio, Inc.

Castle Creek Pharmaceutical Holdings

Bristol-Myers Squibb

Kite Pharma, Inc.

Vericel Corporation Inc.

Kolon TissueGene Inc.

Vertex Pharmaceuticals, Inc.

Spark Therapeutics, Inc.

CORESTEM Inc.

Biogen Inc.

Dendreon Pharmaceuticals LLC

JCR Pharmaceuticals Co. Ltd.

Strategies Adopted by Market Players

Strategic partnerships and collaborations for pipeline expansion

Investment in viral vector manufacturing and scalable ex vivo platforms

Development of novel CAR-T, TCR, and gene-editing therapies

Expansion of global treatment centers and clinical trial networks

Focus on regulatory approvals and compassionate use programs

Technological Trends in Cell and Gene Therapy

CAR-T and TCR Therapies

Engineered T-cells targeting specific cancer antigens

Personalized therapies for hematologic malignancies

CRISPR and Gene Editing

Precision editing of genetic sequences

Potential to cure rare and monogenic diseases

Advanced Viral and Non-Viral Delivery Systems

High transduction efficiency with minimal off-target effects

Improved patient safety and therapy outcomes

Ex Vivo Manufacturing Platforms

Scalable production of autologous and allogeneic cells

Automation reduces cost and improves reproducibility

Digital and AI Integration

Predictive modeling for therapy response

AI-based process optimization and patient selection

Future Outlook

The cell and gene therapy market is poised for exponential growth due to:

Increasing regulatory approvals and supportive frameworks

Expansion of clinical trials and pipeline therapies

Rising adoption of personalized and precision medicine

Growth of specialized treatment centers globally

Technological innovations in vector design, gene editing, and cell manufacturing

By 2035, the market is expected to reach USD 172.22 Billion, reflecting a CAGR of 23.17%, driven by expanding applications in oncology, rare diseases, and regenerative medicine.

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