Market Introduction

The global cancer gene therapy market was valued at USD 2.80 billion in 2023 and grew at a CAGR of 20% from 2024 to 2033. The market is expected to reach USD 17.33 billion by 2033. The increasing incidence and prevalence of cancer will drive the growth of the global cancer gene therapy market.

Cancer gene therapy is a relatively new approach for cancer treatment. it basically entails the modification of genes within the body of a patient. The primary objective of gene therapy is to treat cancer through the alteration of genetic material. It is believed that many forms of cancer are a result of mutation or a defect in certain governor genes that regulate cell division and growth, apoptosis and DNA repair. Several strategies have been used in the processes of cancer gene therapy. One of the approaches is to transplant tumour-suppressor genes to replace mutated proteins that can control cell division. Another one goes to cancer cells to modify them to become more receptive to treatments such as chemotherapy or radiation. Moreover, cancer gene therapy may also activate the immune function by introducing genes that help immune cells find and destroy cancer cells. Transgene delivery can be done through vectors, which are vehicles that transport the therapeutic genes in a patient’s body. These vectors are normally engineered viruses and these are bio-safely designed to be genial and efficient at transferring genome. While promising results have been found for cancer gene therapy, which has come to phase III clinical trials, the therapy remains experimental with active research directed at solutions like enhancing the methods of gene delivery, reducing immune reactions, and matters of long-term toxicity.

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Recent Development

• A cellular therapy known as afamitresgene autoleucel, or afami-cel (Tecelra), was licensed by the Food and Drug Administration (FDA) to treat some patients with metastatic synovial sarcoma, a subtype of soft tissue sarcoma. This is the first time the agency has authorized a cancer medication known as T-cell receptor (TCR) therapy. Patients who have received chemotherapy and whose tumors show positive results for MAGE-A4 and specific HLA protein types are eligible to use Afami-cel. 44 patients with metastatic synovial sarcoma participated in the clinical trial that served as the basis for the approval. Nineteen people (43%) had their tumors shrunk by the therapy, and the median length of response (the amount of time the treatment prevented tumors from developing) was six months. The manufacturer of the medication, Adaptimmune, funded the trial.

Market Dynamics

Drivers

The increasing incidence and prevalence of cancer – The emergence of new cases of cancer across the world is one of the major reasons as to why cancer gene therapy has become popular. There is an ever-increasing pool of people requiring cancer care because of ageing population, increased incidence due to unhealthy lifestyle, poor diets, no exercise, smoking and exposure to carcinogenic agents among others. WHO states that cancer is the second most cause of death, estimated at 9.6 million people in 2018. This ever-increasing burden puts tremendous pressure on healthcare ministries/facilities to develop new treatments to overcome the problems of the traditional treatments such as surgery, chemotherapy, and radiation. Conventional therapy methods are frequently associated with multiple adverse effects on the patient’s healthy cells and tissues and organs and have difficulty eradicating advanced-stage cancers or tumours with particular genetic characteristics. One of the greatest benefits of cancer gene therapy is that it can be a perfect cure because it uses the gene problem as the primary solution to cancer, not the growths or diseases themselves. Unlike other cancer treatments involving general administration of a cure throughout a patient’s body, gene therapy involves changing the genes within a cancerous cell, thereby halting or even reversing the progress of cancer. It is especially important in case of cancers which do not initially respond to traditional treatments, for example, advanced or metastasizing cancers. Cancer incidence therefore provides the stimulus for research and development in the area of cancer gene therapy because the demand for improved, targeted treatments is on the rise.

Restraints

High costs of cancer gene therapy – Gene therapies are complicated and resource-demanding procedures which increase costs associated with their development and administration. The development of such therapies also involves the utilization of sophisticated biotechnological systems, laboratories and man power, all of which are capital intensive. As opposed to orthodox chemical treatments, cancer gene therapies frequently require a unique approach especially under the molecular medicine where the treatment plan focuses on specific genes that prompt cancer. This tendency for greater individualisation means that each of these therapies might have to be developed anew making costs rise even higher. Moreover, the process of gene therapy calls for further stages starting with the preclinical research followed next by clinical trials, and the final phase of getting regulatory approval, all of which require huge capital investment. Clinical trials for gene therapies are relatively costly as they are complicated in terms of design, duration and as most individuals receiving the trial therapy must be monitored for any side effects. Consequently, cancer gene therapies can be very costly which can hamper the market’s growth.

Opportunities

Technological advancements improving the efficacy of cancer gene therapy – New gene editing tools have boosted cancer gene therapy by improving the accuracy, speed and possibility of gene therapies. Some of them include the creation of CRISPR-Cas9 which is a versatile tool that can be used to alter a particular gene. With this, it has become possible for researchers to alter or even fix mutations within cancer cells, or to insert tumour-suppressor genes or make cancer cells responsive to other treatments such as chemotherapy or immunotherapy. Also, advances in the new gene-editing technology have made it possible to work on more targeted cancer therapies.

Segment Analysis

Regional segmentation analysis

The regions analyzed for the market include North America, Europe, South America, Asia Pacific, the Middle East, and Africa. North America emerged as the most significant global cancer gene therapy market, with a 44% market revenue share in 2023.

The region has sophisticated hospital and clinical experimental and research centres. They are capable of providing intricate treatments like gene therapies. This infrastructure supports cost efficient delivery of therapies such as the CAR T-cell treatments. The availability of such research infrastructure increases the pace at which technologies such as the CRISPR-based gene editing and Immune-based treatments are developed. Furthermore, the high chance of contracting cancer in North America increases the need for innovative therapeutic products, resulting in the demand for gene therapies. The region also receives considerable public/private finance for its anatomic and molecular growth and for clinical research.

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• The first cell and gene therapy facility in New York, the Roswell Park GMP Engineering and Cell Manufacturing Facility, was opened at the Roswell Park Comprehensive Cancer Centre in Buffalo, with a celebration led by Governor Kathy Hochul. The $98 million facility will greatly expand Roswell's established research capabilities, help support the research and development of life-saving cell and gene therapies, generate new jobs, and position Roswell as one of the country's leading cell therapy discovery and development institutions. Additionally, the expansion fulfils Governor Hochul's 2023 State of the State pledge to strengthen the state's leadership in the rapidly expanding CGT industry by creating an Upstate cell and gene therapy hub to spur its expansion in western New York.

Therapy type Segment Analysis

The therapy type segment is divided into gene transfer therapy and gene editing therapy. The gene transfer therapy segment dominated the market, with a market share of around 57% in 2023. This therapy involves transferring of genetic material into a patient’s cells in order to replace damaged gene, correct a gene mutation or add new gene that can assist in combating cancer. Gene transfer therapies make use of viruses and they have been noted to have high transfer efficiency. Gene transfer therapies have become one of the leading treatments of cancer due to their proven efficacy for treating hematologic cancers such as leukaemia. This type of treatment is focused on attacking the particular cell and disease on its molecular level which is what makes it much more personal and can be considered more efficient compared to average treatment methods, such as chemotherapy or radiation. Importantly, CAR T-cell therapies – a form of gene transfer therapy – has gained an approval and success for the treatment of blood cancers thus transforming this field. These therapies have shown very high success rates in clinical trials, further increasing the occurrence and innovation of gene transfer-based therapies.

• At the Indian Institute of Technology (IIT) Bombay in Mumbai, President Smt. Droupadi Murmu introduced India's first domestic anti-cancer CAR-T cell treatment and dedicated it to the country in front of Maharashtra Governor Shri Ramesh Bais. According to the President, one of the most amazing developments in medical science is CAR-T cell treatment. Although it has long been accessible in affluent countries, the majority of patients worldwide cannot afford it due to its high cost. She was pleased to learn that the treatment being introduced today is the most reasonably priced CAR-T cell therapy available.

Cancer type Segment Analysis

The cancer type segment is divided into leukaemia, lung cancer, breast cancer, and melanoma. The leukaemia segment dominated the market, with a market share of around 45% in 2023. Leukaemia takes over half of the market share in the cancer gene therapy due to the advances which have occurred in the gene treatment of cancers especially the hematologic malignancy. Cancer of the blood and bone marrow called leukaemia has attracted a lot of groundbreaking treatments, including cell-gene therapies such as CAR T-cell therapy. These therapies include altering a patient’s T-cells so that they may better identify and destroy leukaemia cells, which are very personalized and efficient. As to the reason why leukaemia dominates this market, the idea here is that immune cells can be easily harvested from the body and genetically engineered and administered back into the body compared to the challenges posed when dealing with gene delivery in solid tumour cells.

Delivery method Segment Analysis

The delivery method segment is divided into viral vectors and non-viral vectors. The viral vectors segment dominated the market, with a market share of around 56% in 2023. Viral vectors have become the most widely used system for delivering genetic material in cancer gene therapy because of their high transduction efficiency. These vectors, usually virus derived, are designed to introduce therapeutic genes into cancer cells without eliciting disease symptoms which makes them ideal for gene transfer. The basic advantage of using viral vectors is the fact that viruses are created to penetrate and introduce genetic material into cells. This intrinsic characteristic is used to guarantee that the therapeutic genes get to the cancer cells and are incorporated into its genome in a bid to facilitate genetically engineered therapies for cancer. The ability of viral vectors to specifically home in on cancers cells and the ability of these vectors to transfer large genes makes them ideal for clinical and research gene therapy.

• The novel photosensitizer Ce6-GFFY is used as a treatment for colorectal cancer, according to a recent article in Genes & Diseases. This work created a new photosensitizer called Ce6-GFFY, which is based on the photo-responsive molecule chlorin e6 (Ce6) and the self-assembling peptide GFFY. Ce6-GFFY has a half-life of 10 hours, generates macroparticles with a diameter of around 160 nm, and is highly effective at targeting tumors in mice models. When exposed to 660 nm laser radiation, Ce6-GFFY efficiently enters cells and produces a large number of reactive oxygen species. Reactive oxygen species inhibit the growth of primary and metastatic tumors following therapy by encouraging the increase of cytotoxic T lymphocytes and the reduction of myeloid-derived suppressor cells in the tumor microenvironment through immunogenic cell death.

End user Segment Analysis

The end user segment is divided into hospitals, research institutes, and clinics. The hospitals segment dominated the market, with a market share of around 38% in 2023. Hospitals spearhead the global cancer gene therapy end-users’ market due to their overall responsibility when it comes to providing intricate and specialized therapies. Because gene therapies for cancer entails sophisticated strategies that need specialized equipment and human resource, and close monitoring of patients’ condition, it is usually administered in hospitals. Many of these approved therapies, especially those using cell-based treatments such as the CAR T-cell therapy, demands equipment and facilities for that are more common in hospital settings such as cell collectors, modifiers. The cancer gene therapies are also invasive, as much as the cancers they target, and require the coordinated input of oncologists, immunologists, geneticists and other personnel often found in hospitals. Furthermore, hospitals are more prepared in case of side effects or any other effects resulting from gene therapies when compared to other treatments because gene therapies are mostly new treatments or therapies.

Some of the Key Market Players

• Gilead Sciences
• Novartis International AG
• Bristol-Myers Squibb
• Bayer AG
• Bluebird Bio
• Sangamo Therapeutics
• Celgene Corporation
• Cellectis
• Kite Pharma (a Gilead Company)
• Amgen Inc.
• MedImmune (AstraZeneca)
• Intellia Therapeutics
• Adaptimmune Therapeutics
• Editas Medicine
• Spark Therapeutics

Report Description

• Market Introduction
• Market Dynamics
• Segment Analysis
• Some of the Key Market Players