Cancer Gene Therapy Market By Therapy Type (Gene Insertion {Suicide Gene Therapy, Tumor Suppressor Gene Therapy}, Gene Modification {Oncolytic Virotherapy, Antisense and RNAi}, Immunotherapy Based Gene Therapy, Others), By Indication (Breast Cancer, Ovarian Cancer, Liver Cancer, Pancreatic Cancer, Lung Cancer, Prostate Cancer, Others), By End-user (Hospitals, Oncology Institutes, Research Institutes, Biopharmaceutical Companies, Diagnostic Centers, Other), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Cancer Gene Therapy market accounted for USD 3.22 Billion in 2024 and is expected to reach USD 28.96 Billion by 2035, growing at a CAGR of around 22.1% between 2025 and 2035.  Cancer gene therapy is an advanced treatment strategy that uses genetic engineering to modify the genes of the patient's cells in an endeavor to combat or prevent cancer. This therapy seeks to edit abnormal genes, bring in other functional ones to enhance the body's defense system, or utilize viruses that selectively destroy cancer cells.

It has the prospect of offering patients custom-tailored therapies that are less toxic to the body than most conventional techniques such as chemotherapy and radiation. The market for cancer gene therapy is steadily growing because of developmental improvements in gene editing tools and a surge in clinical interest in oncology research.

Report Scope:

Market Dynamics

Rising Prevalence of Cancer Globally Fuels Demand for Advanced Treatments

The growing incidence of cancer worldwide has become one of the strongest indicators of the need for high-tech treatments such as gene therapy. Estimation of WHO suggests that there is likely to be over 35 million new cases of Cancer in 2050 an increase from 20 million estimated in 2022 by 77%. The rapid growth in the incidence of cancer resulting from a growing aging populace, modifications in lifestyles, and environmental issues has led to the low efficacy of conventional treatments such as chemotherapy and radiotherapy. This has led to an increased demand for more specific kinds of therapies and treatments.

Gene therapy is the practice that promises the approach to more accurate medicine, the intervention exactly influencing tumor cells, not affecting the surrounding tissue. As more and more patients turn to complementary and effective treatment the market for innovative methods such as gene therapy has become a high priority for the healthcare and pharma sectors.

Technological Advancements in Gene Editing and CAR-T Therapies Drive Innovation

The emergence of the new generation of gene editors such as CRISPR and CAR-T (Chimeric Antigen Receptor T-cell) therapies has boosted the pace of change in cancer treatment. In Crispr, the modification of genes can occur, so treatments can be developed that can work on genetic mutations in cancer cells that were previously untreatable.

One of the most successful CAR-T therapies is the one that takes a patient's T-cells and retunes them to recognize and destroy cancer cells more effectively – this has already been successfully used to treat blood cancers such as leukemia and lymphoma. These novelties are changing the cancer treatment scene, providing additional directions for the therapies, which would be more efficient and tailored. These technologies are predicted to further develop advancements to gene therapy in the management of cancer by broadening the possibilities.

The high cost of gene therapy treatments limits accessibility for many patients

There are several challenges towards the uptake of gene treatments including the fact that they are expensive. Some of these therapies include intricate, individualized treatments that need advanced technology and a wide amount of information that are much costlier than usual cancer treatments. For instance, while CAR-T has already demonstrated promising effects, it can run to hundreds of thousands of dollars per patient and therefore has restricted availability to people who can contribute to it themselves or else those with adequate insurance. This is a unique pricing problem because in low-income areas, especially in developing countries, there are constrained healthcare budgets and often patients cannot afford financial support.

In addition, other costs involved include clinical trials, regulatory approval as well as the cost of manufacture. As much as gene therapies are effective their costs are very expensive, this is because they are inaccessible to many across the globe, which makes it difficult to make such gene therapies affordable for the treatment of cancer.

Expanding Healthcare Access in Emerging Markets Presents Growth Potential

Cancer gene therapy has a large growth opportunity since developing economic markets including China, India, and some Latin countries are steadily enhancing their healthcare systems. As the incidences of cancer in these areas increase, there is likely to be increasing demand for better treatments such as gene therapy. The awareness of health and life sciences, combined with technical and scientific progress, is today creating new resources to enhance the efficiency of health systems in many countries and to enable them to offer more and better treatments.

Increasing access to health care as well as the growth of the middle class along with a growing knowledge of new therapies creates great entrance for gene therapy companies in these markets. Moreover, governments are working towards bringing expensive techniques into the healthcare system affordably pushing the market prospect higher. Thanks to the new directions in medical practice shifting towards personalization, cancer gene therapies are promising segments in these countries.

Collaborations and Partnerships Among Biotech Firms Foster Innovation in Gene Therapy

The relationships and cooperation between the different biotech suppliers are obligatory to drive innovation in the field of cancer gene therapy. Top drug manufacturers always engage with other small biotechnology businesses, university research institutions, and other research institutions by sharing capabilities, technologies, and knowledge.

These collaborations aid in overcoming the numerous problems associated with gene therapy development including the question of delivery systems as well as that of patient safety. These partnerships enhance the development of new therapies like CAR-T and CRISPR gene-editing cancer therapies which seem to deliver effective outcomes. This multiple-party method accelerates the development of new and effective therapies for people with cancer and contributes to the constant advancement of the cancer gene therapy market.

Industry Experts Opinion

"We see great potential for gene therapies, as more products are approved, it will gain attraction, and more companies will look to expand their therapies into other therapeutic indications. This progress presents tremendous potential to change more patients' lives across many different diseases."

• Leslie Johnston, senior vice president of biotech delivery for Parexel

"There is a lot of excitement that Gene Therapy could potentially make a big difference for the treatment of human disease"

• Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the FDA

Segment Analysis

Based on the therapy type, the cancer gene therapy market has been classified into Gene Insertion, Gene Modification, Immunotherapy Gene Therapy, and others. Gene insertion includes suicide gene therapy, which specifically kills cancer cells, and tumor suppressor gene therapy, which seeks to increase the working of tumor-suppressing genes.

Gene modification includes oncolytic virotherapy which involves the use of viruses that selectively target and kill cancer cells while antisense RNA and RNA interference (RNAi) involve the identification of genes that when locked off, halt the multiplication of cancer cells. Immunotherapy-based gene therapy is attracting increased interest because it can enhance the recipient's immune response to tumors. The other section summarises other less frequent or developing treatments.

Based on indication, the cancer gene therapy market has been divided into Breast Cancer, Ovarian Cancer, Liver Cancer, Pancreatic Cancer, Lung Cancer, Prostate Cancer, and others. These cancers have specific genetic characteristics that determine the direction for creating a range of therapies to target them, with more development being dedicated to enhancing the results.

Breast and lung cancers are among the most common, hence more efforts have been made on gene therapy for these applications. Cancer of the ovary, liver, pancreas, and other organs are less frequently diagnosed but carry a lower survival rate, which makes these diseases prospective for new gene therapies. Another focus is the molecular study of prostate cancer, which is as multifaceted as the nuances of the molecular profiles of the disease. As the idea of gene therapy moves forward, vectors are being tailored to become more specific and clinical development, as well as targeted therapies are increasing in each of these signals.

Regional Analysis

North America is currently the largest cancer gene therapy market, because of better health facilities, more investment in research and development, and early embracing of technologically enhanced treatments. Leading gene therapy players like Novartis, Gilead Sciences, and Bristol Myers Squibb are based in the United States, thus making this market significant for future development. The sites and clinics with clinical trials and research centers significantly influence the speed of development and the subsequent registration and launch of new therapies.

Moreover, regulatory authorities including the FDA are encouraging new treatments and giving fast-track designations and approvals to promised therapies such as CAR-T and gene-editing treatments. The large patient pool and high expenditure on health care also provide a solid background for the market to experience constant growth and requirements of superior cancer treatment.

The Asia Pacific has the highest growth rate for the cancer gene therapy market due to the increase in growth rates in cancer incidences, the development of healthcare infrastructures, and increasing funding in the biotechnology sector. China, India, and Japan are presently the most emerging markets in Asia since they have started adopting the expensive treatment, and the rate value is growing fast with enhanced government support for the new cure.

The clinical trial activity in these regions is increasing, and most of the global pharmaceutical and biotech majors have partnered with local firms to launch gene therapies with unprecedented speed. Due to advances in healthcare accessibility and specifically, increased availability in rural regions, there is great potential for Gene Therapy to revolutionize cancer treatment within the region. In addition, more awareness creation and better financial access to the products have also been deemed to have aided the growth of the market.

Competitive Landscape

The competitive dynamics of the cancer gene therapy market remain active, and healthcare organizations continue to concentrate on the use of new gene-engineering techniques, including CRISPR, CAR-T cell therapy, and oncolytic viruses. Large pharma and Bio-tech firms such as Novartis, Gilead Sciences, and Bristol Myers Squibb are also funding large clinical trials, and making acquisitions to build up gene therapies.

The market competition in this field is still quite high with a focus on strategic partnerships, mergers & acquisitions due to the desire of companies to extend capacity in gene therapy development. Furthermore, increasing research activities are being done by young-tech firms and biotechnology companies such as Bluebird Bio and Sangamo Therapeutics. The rising number of FDA approvals and growing research in immuno-oncology is raising competitive pressure, fuelling innovation, and expanding the market.

Cancer Gene Therapy Market, Company Shares Analysis, 2024

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Recent Developments:

• In September 2024, Vironexis Biotherapeutics received clearance for its investigational new drug (IND) application from the FDA for VNX-101, an adeno-associated virus (AAV) vector-based gene therapy, which enabled phase 1/2 clinical trial in CD19+ acute lymphoblastic leukemia.

Report Coverage:

By Therapy Type

• Gene Insertion
  • Suicide Gene Therapy
  • Tumor Suppressor Gene Therapy
• Gene Modification
  • Oncolytic Virotherapy
  • Antisense and RNAi
• Immunotherapy Based Gene Therapy
• Others

By Indication

• Breast Cancer
• Ovarian Cancer
• Liver Cancer
• Pancreatic Cancer
• Lung Cancer
• Prostate Cancer
• Others

By End-user

• Hospitals
• Oncology Institutes
• Research Institutes
• Biopharmaceutical Companies
• Diagnostic Centers
• Other

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Novartis International
• Gilead Sciences, Inc.
• Bluebird Bio, Inc.
• Bristol Myers Squibb Company
• Genmab
• Amgen Inc.
• Spark Therapeutics, Inc.
• Kite Pharma, Inc.
• Zymeworks Inc.
• Sangamo Therapeutics, Inc.
• Autolus Therapeutics
• Adaptimmune Therapeutics
• Celyad Oncology
• Cogent Biosciences
• Merck
• Intellia Therapeutics, Inc.
• CRISPR Therapeutics

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