Cancer Gene Therapy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Therapy (Oncolytic Virotherapy, Gene Induced Immunotherapy, Gene Transfer, and Others), By Indication (Breast Cancer, Ovarian Cancer, Lung Cancer, Liver Cancer, Pancreatic Cancer, Prostate Cancer, and Others), By End User (Biotechnology & Pharmaceutical Companies, Academic & Research Institutions, and Others), By Region and Competition, 2020-2030F

Market Overview

Global Cancer Gene Therapy Market was valued at USD 4.52 billion in 2024 and is expected to reach USD 13.58 billion by 2030 with a CAGR of 20.12% during the forecast period. The global market for Cancer Gene Therapy is experiencing significant growth, driven by the growing demand for painless treatment at lower cost coupled with increasing aesthetic consciousness among the population significantly increase the demand for cancer gene therapy across different parts of the globe. Besides, growing awareness about advantages of using gene therapy and diagnosis along with increasing healthcare expenditure on cancer treatment across the globe is further expected to support the Cancer Gene Therapy Market during the forecast period. In 2022, an estimated 66,470 people (48,520 men and 17,950 women) will be diagnosed with head and neck cancer in the United States. Cancer is one of the deadliest diseases in the world, and it has been a significant concern for public health for decades.

Key Market Drivers

Rising Global Cancer Burden and Need for Precision Therapies

The rising global burden of cancer is a fundamental driver of the cancer gene therapy market. According to the World Health Organization (WHO), cancer is a leading cause of death globally, responsible for nearly 10 million deaths in 2020. The most common forms include lung, breast, colorectal, prostate, and stomach cancer. Traditional treatments like chemotherapy and radiation often have systemic toxicity and variable efficacy, particularly in advanced-stage or genetically complex tumors. Gene therapy offers a transformative approach to cancer treatment by directly targeting the genetic root of disease—whether through inserting therapeutic genes, editing faulty ones, or using viral vectors to trigger immune responses. This is especially critical in cancers where oncogenic mutations drive resistance to conventional therapies.

The U.S. National Cancer Institute (NCI) and similar institutions in Europe and Asia are significantly increasing funding for precision medicine and gene-based oncology research. In the U.S., the 21st Century Cures Act and initiatives like the Cancer Moonshot have allocated billions toward advanced cancer research, including gene therapy. As the prevalence of cancer continues to climb due to aging populations and environmental exposures, the demand for targeted and durable treatments like gene therapy is expected to rise. These therapies not only promise improved survival outcomes but also offer the potential for long-term remission or even cures, particularly in genetically defined cancers like hematological malignancies or glioblastomas.

Advances in Viral and Non-Viral Delivery Systems

One of the most significant advancements in accelerating cancer gene therapy is the evolution of efficient and safe gene delivery systems. Gene therapy relies heavily on the ability to deliver genetic material into patient cells. Traditional viral vectors, such as adenoviruses, retroviruses, and lentiviruses, have become increasingly sophisticated and targeted. For instance, lentiviral vectors are now widely used in CAR-T cell therapy for hematological cancers. More recently, non-viral delivery systems—such as lipid nanoparticles (LNPs), electroporation, and CRISPR-based platforms—are becoming commercially viable due to improved biocompatibility, lower immunogenicity, and higher gene payload capacity. These innovations reduce the risks previously associated with gene therapy, such as insertional mutagenesis or severe immune responses.

Global regulatory bodies have also taken note. For example, the U.S. FDA has updated its guidance for gene therapy clinical trials, encouraging innovations in delivery mechanisms while prioritizing patient safety. Similarly, the European Medicines Agency (EMA) has provided a specific regulatory framework to support the development of advanced therapy medicinal products (ATMPs), including gene therapies. These delivery systems enable precise and stable transgene expression within tumor cells or immune cells, significantly enhancing the effectiveness of gene therapy while minimizing side effects. The ability to fine-tune gene expression and target tumor-specific environments is expected to broaden gene therapy's applications across solid tumors and metastatic cancers.

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Key Market Challenges

High Cost and Limited Access to Gene Therapy

One of the primary challenges facing the global cancer gene therapy market is the high cost of treatment and the resultant limited patient access, particularly in low- and middle-income countries. Gene therapy, especially when customized for individuals, requires sophisticated manufacturing processes, skilled personnel, and stringent regulatory compliance, all of which contribute to its premium price. Approved therapies like CAR-T treatments have been priced between $350,000 to $500,000 per patient in markets like the U.S. and Europe. This cost does not account for hospitalization, supportive care, or follow-up, making the overall financial burden even higher. These prices place a significant strain on healthcare systems, especially those that operate on public insurance or low reimbursement thresholds.

Government health agencies, including the U.S. Centers for Medicare & Medicaid Services (CMS), have explored reimbursement models like outcomes-based pricing to make these therapies more sustainable. However, in many parts of Asia, Africa, and Latin America, such policies are either underdeveloped or non-existent, preventing wider adoption of gene therapy innovations. The affordability issue becomes more complex when considering the need for lifelong monitoring and potential retreatment. As gene therapies are still in the early stage of commercialization, cost reduction through economies of scale has not yet materialized. Until these therapies become more economically viable and globally accessible, their impact on global cancer care will remain uneven.

Complex Manufacturing and Logistical Barriers

Another significant challenge in the cancer gene therapy market is the complexity of manufacturing, storage, and distribution. Unlike conventional pharmaceuticals, gene therapies often require customized, small-batch production, frequently involving the extraction and reinfusion of a patient’s own cells—known as autologous therapy. This “vein-to-vein” process is highly sensitive, requiring stringent control of temperature, sterility, and timing. Manufacturing facilities must meet advanced biosafety standards, and skilled technicians are needed at every stage—from cell collection to genetic modification to reinfusion. The U.S. FDA and EMA mandate rigorous Good Manufacturing Practice (GMP) protocols, which increases the time and cost of production.

Furthermore, transportation logistics are complicated. Gene therapy products, especially those involving live cells or viral vectors, must often be stored at ultra-low temperatures and transported under carefully monitored conditions. Any breach can render the therapy ineffective or unsafe. Developing nations face even greater barriers due to a lack of specialized infrastructure, trained personnel, and regulatory harmonization. While public and private entities are working to develop centralized manufacturing hubs and automated production platforms, these solutions are still emerging.

Key Market Trends

Expansion of Personalized Cancer Gene Therapy

A major trend in the global cancer gene therapy market is the movement toward highly personalized medicine. Advances in genomics and next-generation sequencing (NGS) have enabled detailed characterization of cancer at the molecular level, identifying specific genetic mutations, epigenetic modifications, and biomarkers. This data is being used to tailor gene therapies uniquely suited to individual patients' tumor profiles. For instance, gene-editing platforms like CRISPR-Cas9 are now being explored to create bespoke cancer therapies, where genes are selectively silenced or corrected. Similarly, personalized CAR-T cell therapies—where a patient’s T-cells are genetically modified to recognize tumor-specific antigens—have already shown success in treating refractory blood cancers like leukemia and lymphoma.

Global governments are actively investing in precision oncology. For example, the U.K. has launched the Genomic Medicine Service within the NHS, integrating whole genome sequencing into cancer diagnosis and treatment planning. In the United States, the Precision Medicine Initiative supports integrating molecular data into clinical care, including gene therapy applications. This trend signifies a shift from the “one-size-fits-all” treatment paradigm to customized interventions with potentially fewer side effects and higher therapeutic success. As genomic profiling becomes more accessible, the scope for personalized gene therapy will continue to expand, reshaping the way cancer is treated across various demographics and geographies.

Rising Clinical Trials and Regulatory Approvals

Another important trend shaping the cancer gene therapy market is the increasing number of clinical trials and accelerated regulatory approvals for gene-based oncology treatments. According to the U.S. FDA, over 900 investigational new drug applications (INDs) for gene and cell therapies are currently active. A growing portion of these trials target cancer, particularly for hematological malignancies and solid tumors with poor prognoses. Gene therapies such as CAR-T (e.g., Kymriah, Yescarta) have already gained regulatory approval in the U.S., EU, and China, demonstrating the increasing comfort of regulatory bodies with complex biologics. Moreover, novel gene therapy approaches targeting p53, KRAS, and other cancer-associated mutations are being evaluated in Phase I and II trials globally.

This trend is further reinforced by government incentives. The U.S. FDA’s Orphan Drug Designation, Breakthrough Therapy Designation, and Fast Track pathways have been increasingly applied to gene therapy candidates, facilitating quicker access to patients with life-threatening cancers. Similarly, the EU offers support through its PRIME (Priority Medicines) scheme.The expanding pipeline of gene therapy candidates and more supportive regulatory environments are encouraging biotech companies and research institutions to invest in cancer gene therapy platforms. As more therapies move from experimental to commercial stages, patient access is expected to increase, contributing to market maturity and innovation diffusion.

Segmental Insights

Therapy Insights

Based on Therapy, the Gene Induced Immunotherapy segment holds the largest market share among the listed therapy types—Oncolytic Virotherapy, Gene Induced Immunotherapy, Gene Transfer, and Others. This dominance is primarily due to the rapid clinical success and adoption of CAR-T cell therapies and T-cell receptor (TCR) therapies, which are prominent forms of gene-induced immunotherapy. These therapies work by modifying a patient's immune cells (usually T-cells) to recognize and destroy cancer cells with high specificity. They have shown significant efficacy in treating hematologic malignancies such as acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL), leading to regulatory approvals and widespread clinical use, particularly in North America and parts of Europe.

Moreover, gene-induced immunotherapy has benefited from large-scale investments by public institutions and private biopharma companies. Government initiatives like the U.S. Cancer Moonshot, the EU’s Horizon Europe program, and Japan’s Immunotherapy Research Support Initiatives have further fueled innovation and commercialization. As a result, this segment has become the front-runner due to its therapeutic success, strong pipeline, and robust clinical research ecosystem. The ability of gene-induced immunotherapy to offer personalized, targeted treatment with fewer off-target effects compared to traditional cancer therapies has reinforced its dominance, making it the largest contributor to the global cancer gene therapy market.

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Regional Insights

Based on the region, North America held the largest market share in the global cancer gene therapy market, primarily due to its robust healthcare infrastructure, advanced biotechnology ecosystem, and strong investment in genetic research. The region benefits from a high concentration of leading pharmaceutical companies, academic institutions, and biotech firms engaged in developing innovative gene therapies for cancer treatment. The United States, in particular, has been at the forefront of regulatory approvals for gene-based cancer therapies such as CAR-T cell treatments, supported by agencies like the U.S. Food and Drug Administration (FDA). Additionally, government initiatives like the Cancer Moonshot and funding from the National Institutes of Health (NIH) have significantly accelerated cancer genomics and gene therapy research. The presence of established clinical trial networks and favorable reimbursement frameworks further boosts the adoption of these therapies. Moreover, high awareness among healthcare providers and patients, coupled with early adoption of advanced technologies, cements North America's position as a dominant force in the cancer gene therapy market.

Recent Developments

• In June 2024, The FDA granted accelerated approval to the combination of adagrasib and cetuximab for the treatment of patients with KRAS G12C-mutated colorectal cancer. This decision marks a significant advancement in precision medicine for colorectal cancer patients with this specific genetic mutation.
• In April 2024, India witnessed the launch of its first homegrown CAR T-cell therapy. This groundbreaking therapy was unveiled by the President of India, who hailed it as a beacon of “new hope” in the fight against cancer. CAR T-cell therapy is a form of immunotherapy that involves modifying a patient’s own immune cells to better recognize and attack cancer cells.
• In April 2024, Pfizer Inc. received approval from the U.S. FDA for BEQVEZ to treat adults with moderate to severe hemophilia B who are currently using factor IX (FIX) prophylaxis therapy, have experienced life-threatening hemorrhage in the past, or have had repeated serious spontaneous bleeding episodes. Additionally, these individuals must not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as confirmed by an FDA-approved test.

Key Market Players

• Abeona Therapeutics Inc.
• Asklepios BioPharmaceutical Inc.
• Altor Bioscience Inc.
• BioCancell Inc.
• Celgene Inc.
• Elevate Bio Inc.
• Genelux Corporation
• Introgen Therapeutics Inc.
• OncoGenex Pharmaceuticals Inc.
• Merck KGaA

Report Scope:

In this report, the Global Cancer Gene Therapy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cancer Gene Therapy Market, By Therapy:

o   Oncolytic Virotherapy

o   Gene Induced Immunotherapy

o   Gene Transfer

o   Others

• Cancer Gene Therapy Market, By Indication:

o   Breast Cancer

o   Ovarian Cancer

o   Lung Cancer

o   Liver Cancer

o   Pancreatic Cancer

o   Prostate Cancer

o   Others

• Cancer Gene Therapy Market, By End User:

o   Biotechnology & Pharmaceutical Companies

o   Academic & Research Institutions

o   Others

• Cancer Gene Therapy Market, By Region:

o   North America

§  United States

§  Mexico

§  Canada

o   Europe

§  France

§  Germany

§  United Kingdom

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Japan

§  Australia

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East and Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Cancer Gene Therapy Market.

Available Customizations:

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Company Information

• Detailed analysis and profiling of additional market players (up to five).

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