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New Horizons Unfolding in the Cell and Gene Therapy Market

The cell and gene therapy market is on the cusp of significant evolution, driven by pioneering technological shifts and novel therapeutic applications. These emerging opportunities promise to enhance treatment efficacy, broaden patient access, and address complex diseases in entirely new ways, signaling a dynamic future for stakeholders.

• The Dawn of In Vivo Gene Editing Therapies: A transformative trend is the rapid advancement of in vivo gene editing, where therapeutic edits to a patient's DNA occur directly within the body. This approach simplifies treatment logistics and opens doors to addressing a wider range of genetic disorders. Companies are making significant strides; for instance, Intellia Therapeutics' NTLA-2002, an in vivo CRISPR therapy for hereditary angioedema, is progressing through late-stage clinical trials in 2025. Editas Medicine also demonstrated preclinical proof-of-concept for its in vivo gene editing strategy at the end of 2024. The development of advanced delivery systems, such as lipid nanoparticles (LNPs), is critical to this progress, enabling precise targeting of tissues like the liver and hematopoietic stem cells. This shift towards direct, one-time curative treatments represents a monumental opportunity to reshape care for numerous genetic diseases.
• Automated and Decentralized Manufacturing Solutions: To overcome the significant logistical and cost hurdles of current manufacturing paradigms, the cell and gene therapy market is increasingly focused on automation and decentralization. There are now 38 FDA-approved cell and gene therapies, many produced through manual processes that are difficult to scale. The future points towards purpose-built, automated systems that can handle smaller, personalized batches efficiently. This includes a trend toward decentralized manufacturing, moving production closer to clinical centers to reduce turnaround times and costs. In October 2024, Cellular Origins partnered with Fresenius Kabi to integrate its robotics into a new manufacturing platform. Similarly, in April 2024, Multiply Labs and Stanford Medicine began a collaboration to demonstrate automation's potential in cell therapy production. These innovations are crucial for making therapies more accessible and commercially viable.

Allogeneic "Off-the-Shelf" Therapies Signal A New Era of Accessibility

The cell and gene therapy market is experiencing a pivotal shift with the rise of allogeneic, or "off-the-shelf," therapies. Derived from healthy donor cells, these treatments can be manufactured in large batches, stored, and made available on-demand for multiple patients. This contrasts sharply with autologous therapies, which are patient-specific and involve a lengthy, costly manufacturing process. The move towards allogeneic solutions promises to democratize access, reduce treatment delays, and significantly lower production costs. In 2025, Lonza expanded its commercial production of allogeneic cell therapies using closed-system automation, a key step toward cost-effective scaling.

The clinical pipeline for these universal therapies is rapidly advancing. Poseida Therapeutics' P-BCMA-ALLO1, an allogeneic CAR-T therapy for multiple myeloma, is currently in Phase 1 trials and showing promising early data. TC BioPharm's lead candidate, OmnImmune, is an unmodified allogeneic gamma-delta T cell therapy now in Phase 2/3 trials for acute myeloid leukemia. In a notable 2024 study involving 16 patients, the allogeneic CAR T-cell therapy CTX130 showed a reassuring safety profile in patients with advanced kidney cancer. Furthermore, a Phase 1 trial for relapsed multiple myeloma reported an 86% overall response rate among 35 patients treated with an allogeneic CAR T therapy. In another trial, seven patients have been treated at Houston Methodist with an allogeneic CAR T-cell therapy since April 2024, with three achieving complete remission. These developments underscore the immense potential of allogeneic platforms in the cell and gene therapy market.

Manufacturing and CDMO Expansion Surges to Meet Unprecedented Market Demand

The rapid growth of the cell and gene therapy market is fueling a massive expansion in manufacturing capabilities and the supporting Contract Development and Manufacturing Organization (CDMO) ecosystem. As more therapies advance through clinical trials, the need for specialized, GMP-compliant production facilities has become paramount. This has triggered a wave of investment in new infrastructure and technologies designed to handle the unique complexities of producing viral vectors and cell-based medicines at scale. This surge is critical for alleviating production bottlenecks and ensuring that a steady supply of these transformative treatments can reach patients.

Recent activities highlight the scale of this expansion in the cell and gene therapy market. In 2025, Matica Biotechnology, a specialized CDMO, secured over 10 new manufacturing projects in the first half of the year alone. In June 2025, CDMO Vector BioMed partnered with a research hospital in India to expand access to CAR T-cell therapy. Infrastructure investments are also significant. Lonza opened a new viral vector facility in Massachusetts in 2024 to support late-stage trials. Thermo Fisher launched Gibco CTS DynaCellect in 2024 for automated T-cell selection and plans to introduce closed modular platforms for lentiviral production in 2025. Catalent enhanced its Maryland gene therapy site in 2024 and in 2025 launched turnkey viral vector services. Furthermore, Pharmaron is undertaking a £151M expansion of its UK-based gene therapy CDMO site, which includes 3,500 sqM of future GMP commercial-scale space and quadruples its process development capacity.

Segmental Analysis 

Cell Therapy Spearheads Market Growth with Record Approvals and Funding

The cell therapy segment held a significant revenue share in the cell and gene therapy market in 2024, a leadership position fueled by a wave of regulatory approvals and substantial investment. In 2024 alone, the FDA approved 7 new cell and gene therapy products, with projections indicating an increase to 10-20 approvals annually by 2025. This brings the total number of FDA-approved cell and gene therapies to 38 as of 2024. The sector's growth is further evidenced by the approximately 2,000 active clinical trials and the presence of around 3,000 developers in 2024. Financially, the market is robust, with investments reaching $15.2 billion in 2024.

The strong market position of cell therapy is also supported by significant engagement from major pharmaceutical companies, with 13 of the top 15 investing in this area. The deal-making landscape is vibrant, with 101 transactions recorded in the third quarter of 2024 alone, and early-stage financing nearly doubling in the same period. The collaborative spirit is also strong, with over 120 new partnerships forged between biotech firms and academic institutions in 2024. This collaborative and well-funded environment is a clear indicator of the cell therapy segment's current dominance and future potential in the broader cell and gene therapy market.

• Growing Pipeline: The development pipeline for cell therapies is expanding rapidly, with a significant number of candidates in preclinical and clinical development for a wide range of diseases.
• Technological Advancements: Innovations in cell engineering and manufacturing are making cell therapies more effective, safer, and more accessible.
• Increasing Adoption: As more cell therapies receive regulatory approval and demonstrate real-world efficacy, their adoption by healthcare providers and patients continues to grow.

Beyond Cancer: Infectious Diseases Claiming Largest Therapeutic Market Share

The infectious disease segment is expected to hold the largest market share in the cell and gene therapy market in 2024, driven by the increasing application of these advanced treatments for a range of infectious conditions. The use of RNA-based therapies, in particular, is on the rise for treating infectious diseases. A notable development in 2025 was the announcement of a new collaboration aimed at creating next-generation therapies for serious infectious diseases. The market is also seeing the emergence of new biotech startups specifically focused on this therapeutic area.

The potential of cell and gene therapies to offer long-term or even curative solutions for chronic infections is a significant factor driving research and investment. For instance, in August 2024, antisense technology received a "Sakigake Designation" in Japan for the development of a Hepatitis B treatment. Furthermore, the second quarter of 2024 saw the approval of an mRNA vaccine for the respiratory syncytial virus (RSV). The exploration of gene-editing technologies like CRISPR for treating infectious diseases is intensifying, and several preclinical studies are assessing the use of CAR-T cells to target viral reservoirs in the cell and gene therapy market.

• Targeting Latent Viruses: Research is intensifying on using gene editing to target and eliminate latent viruses like HIV and herpes simplex virus.
• Boosting Immune Response: Cell therapies are being developed to enhance the body's natural immune response against a variety of pathogens.
• Novel Vaccine Platforms: Gene-based vaccine technologies are being explored for their potential to provide broad and durable protection against a range of infectious agents.

In Vivo Methods Drive Revenue Leadership with Unmatched Therapeutic Efficiency

The in vivo delivery method captured the biggest revenue share in the cell and gene therapy market in 2024, primarily due to its efficiency and the potential for broader applications. A significant milestone was the development and delivery of a bespoke in vivo CRISPR therapy to a patient in just six months in 2025, highlighting the potential for rapid personalized treatment. The in vivo segment is projected to be the fastest-growing in the gene therapy market, with its ability to deliver systemic treatments that can reach multiple organs being a key advantage.

The cell and gene therapy market is seeing a substantial push into in vivo cell therapy applications from leading biotech firms, with companies like Capstan Therapeutics advancing in vivo CAR-T candidates to clinical studies in 2024. The approval of the first in vivo gene therapy, Luxturna, in 2017 paved the way for the current wave of innovation. Investment in novel in vivo delivery technologies, including advanced viral vectors and non-viral methods, is a prominent trend. There is also growing interest in the development of redosable in vivo therapies, which could expand their utility. The advancement of in vivo gene editing is a major focus for many companies in 2025, as it is considered crucial for expanding gene therapy to more common diseases.

• Targeting Specific Tissues: Researchers are developing new viral and non-viral vectors that can more precisely target specific cells and tissues in the body.
• Improving Safety Profiles: Efforts are underway to develop in vivo delivery methods with lower immunogenicity and improved safety profiles.
• Non-viral Delivery Systems: There is a growing focus on the development of non-viral delivery systems, such as lipid nanoparticles, to overcome the limitations of viral vectors.

Why Cancer Care Centers Command the Major End-User Market Share

The cancer care centers segment generated the major market share in the cell and gene therapy market in 2024, a reflection of the high concentration of cancer treatments within the cell and gene therapy landscape. The average number of patients treated with these therapies by oncologists annually increased from 17 to 25 in 2025, indicating growing experience and adoption. The pipeline for oncology remains robust, with 178 new drug candidates entering late-stage development in the past year. The rising prevalence of cancer, with over 3 million people living with the disease in the UK in 2024 and a projected increase to 3.5 million by 2025, underscores the demand for innovative treatments.

These specialized centers are essential for the administration of complex therapies like CAR-T, with 7 such products having received FDA approval. However, the number of qualified treatment centers in the U.S. remained unchanged from 2024 to 2025, pointing to challenges in expanding access. Leading institutions like the OSUCCC – James were among the first to offer CAR T-cell therapy, demonstrating the pioneering role of these centers. The success of these therapies across the cell and gene therapy market relies heavily on the infrastructure and expertise within these centers, and data on patient outcomes from these facilities is crucial for securing reimbursement.

• Specialized Infrastructure: Cancer care centers are investing in the specialized infrastructure needed to safely and effectively administer cell and gene therapies.
• Multidisciplinary Teams: The delivery of these therapies requires a multidisciplinary team of experts, including oncologists, nurses, and pharmacists, who are typically based in cancer care centers.
• Patient Management: These centers are developing protocols for managing the unique side effects associated with cell and gene therapies.

Regional Analysis 

North America’s Dominance Defines the Global Cell and Gene Therapy Market

North America commands the market, holding a dominant share of over 39.50%. The region's leadership is anchored by a robust and unparalleled innovation ecosystem. In 2024, the U.S. FDA approved nine new cell and gene therapy products, underscoring a favorable and proactive regulatory environment. This climate fosters a massive research pipeline, with over 2,500 active Investigational New Drug (IND) applications for cell and gene therapies currently on file with the agency. Substantial financial backing fuels this progress; the U.S. National Institutes of Health (NIH) allocated over $6 billion to cell and gene therapy research in 2024 alone.

The commercial infrastructure supporting the cell and gene therapy market is also expanding rapidly. The North American cell therapy manufacturing automation market reached a notable $710 million in 2024, reflecting the intense focus on scalable production. Canada is also making significant contributions, with a single project investment of over $580 million to create the country's largest cell and gene therapy manufacturing facility, which opened in October 2024. The Canadian government further committed to a research hub with a nearly $140 million investment to accelerate drug development. The U.S. boasts over 400 enterprises actively developing these therapies, supported by a specialized automation market valued at $490 million in 2024.

Europe’s Expanding Infrastructure Cements Its Strong Market Position

Europe is solidifying its position as a critical hub in the cell and gene therapy market, driven by strategic investments in manufacturing and a growing research base. Germany leads with 660 biotech companies, a significant number of which are focused on CGT development. The country has conducted over 50 clinical studies in gene therapy, demonstrating its deep commitment to advancing the field. The United Kingdom is also a major player, with the Cell and Gene Therapy Catapult operating pioneering pre-GMP sandbox environments to help developers scale manufacturing. In a significant infrastructure development, Bristol Myers Squibb is completing a 200,000-square-foot cell therapy facility in Leiden, Netherlands, which became operational at the end of 2024. In another key expansion, Ferring Pharmaceuticals opened a new gene therapy manufacturing site in Finland in October 2024 to bolster the global supply of its bladder cancer therapy.

Asia Pacific Emerges as a Dynamic and Rapidly Accelerating Market

The Asia Pacific region is the fastest-growing cell and gene therapy market, propelled by an explosion in clinical trial activity and strong government support. There are now over 650 cell and gene therapy clinical trials underway across the APAC region. China is at the forefront, conducting over 2,000 cell therapy trials, which accounts for one-third of all such trials globally. As of August 2024, investigator-initiated trials in China numbered 2,519. In a significant policy shift, China began permitting foreign investment in cell and gene therapy in four key free trade zones in September 2024. South Korea is also making substantial investments, with the government setting aside over $1.2 billion for regenerative medicine projects. In early 2024, Korean biotech firm GeneEdit secured $35 million in a Series B funding round. India is another rapidly emerging player; its domestic gene therapy market was valued at $472.24 million in 2024.

Strategic Investments and Acquisitions Fueling Consolidation and Growth in the Cell and Gene Therapy Market

1. BioNTech Acquires Pionyr Immunotherapeutics (January 2025): BioNTech completed its acquisition of Pionyr and its pipeline of novel myeloid-targeting antibody therapies, strengthening its oncology portfolio.
2. Astellas Acquires Propella Therapeutics (February 2025): Astellas acquired Propella for approximately $175 million to gain access to its steroid receptor modulator, PRL-02, for treating prostate cancer.
3. Gilead Sciences Acquires CymaBay Therapeutics (March 2024): In a major $4.3 billion deal, Gilead acquired CymaBay to add its primary biliary cholangitis drug candidate, seladelpar, to its liver disease portfolio.
4. AstraZeneca Acquires Amolyt Pharma (March 2024): AstraZeneca purchased Amolyt, a specialist in rare endocrine diseases, for up to $1.05 billion, bolstering its rare disease pipeline.
5. Bristol Myers Squibb Acquires Karuna Therapeutics (March 2024): BMS completed its $14 billion acquisition of Karuna, gaining its promising schizophrenia treatment KarXT and expanding its neuroscience portfolio.
6. AbbVie Acquires ImmunoGen (February 2024): AbbVie finalized its $10.1 billion acquisition of ImmunoGen, securing its flagship antibody-drug conjugate (ADC) ELAHERE for ovarian cancer.
7. Novartis Acquires MorphoSys (February 2024): Novartis announced plans to acquire MorphoSys for €2.7 billion, aiming to add a promising late-stage oncology asset to its portfolio.
8. Johnson & Johnson Acquires Ambrx (January 2024): Johnson & Johnson announced a $2 billion deal to acquire Ambrx Biopharma to gain access to its portfolio of ADC candidates for various cancers.

Top Companies in the Cell and Gene Therapy Market

• ALLOGENE THERAPEUTICS
• Amgen Inc.
• Astellas Pharma Inc.
• Atara Biotherapeutics, Inc.
• Bayer AG
• Biomarin
• Bluebird Bio, Inc.
• Bristol-Myers Squibb Company
• Celgene Corporation
• Cellectis
• Gilead Sciences, Inc.
• Hoffmann-La Roche Ltd
• ImmunoACT
• Johnson & Johnson
• Krystal Biotech, Inc
• Novartis AG
• Orchard Therapeutics plc
• Sana Biotechnology
• uniQure NV.
• Vericel Corporation
• Other Prominent Players

Market Segmentation Overview

By Therapy Type

• Cell Therapy
  • Stem Cell Therapy
  • T-Cells
  • Dendritic Cells
  • NK Cells
• Gene Therapy
  • In-vivGene Therapy
  • Ex-vivGene Therapy
  • Gene Editing Therapies
  • RNA-Based Therapies
  • Others

By Indication / Therapeutic Area

• Oncology
• Solid Tumors
• Genetic Disorders
• Neurological Disorders
• Cardiovascular Diseases
• Ophthalmology
• Musculoskeletal / Orthopedic Disorders
• Infectious Diseases
• Metabolic Disorders
• Others

By Vector Type (Gene Delivery Method)

• Viral Vectors
  • Adeno-Associated Virus (AAV)
  • Lentivirus
  • Retrovirus
  • Herpes Simplex Virus (HSV)
  • Adenovirus
  • Others
• Non-Viral Vectors
  • Lipid Nanoparticles (LNPs)
  • Naked DNA/RNA Plasmids
  • Electroporation
  • Gene gun / microinjection
  • CRISPR-Cas Delivery Systems (non-viral)
  • Others

By Manufacturing Type

• In-house
• Contract Development & Manufacturing Organizations (CDMOs)
• Hybrid Models (e.g., early stage in-house, scale-up outsourced)
• Others

By End User

• Hospitals and Specialty Clinics
• Academic and Research Institutes
• Biopharma and Biotech Companies
• CDMOs and CROS
• Government/Public Health Bodies
• Others

By Region

• North America
  • The US
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia and New Zealand
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of MEA
• South America
  • Argentina
  • Brazil
  • Rest of South America