The global cancer gene therapy market size was accounted for USD 2.95 billion in 2023 and it is increasing around USD 18.11 billion by 2033
The global cancer gene therapy market size was accounted for USD 2.95 billion in 2023 and it is increasing around USD 18.11 billion by 2033 with a CAGR of 19.9% from 2024 to 2033, according to a new report by Nova One Advisor.
Cancer Gene Therapy Market Overview
Cancer is a group of diseases that involve abnormal cell growth which can spread to respective parts of the body. Cancer can spread throughout the human body. Gene therapy is a kind of treatment in which the genes that are not normal or are missing in the patient’s cells are replaced with normal genes. Cancer gene therapy is a technique for treating cancers where the therapeutic DNA is introduced in the gene of the individual suffering from cancer.
Due to a high success rate in preclinical as well as clinical trials, cancer gene therapy is gaining high popularity all over the world. There are numerous techniques utilized in cancer gene therapy. In one of the gene therapy techniques, either the mutated gene is replaced with a healthy gene, or the gene is inactivated if its function is abnormal. In a newly developed technique, new genes can be introduced in the body of the patient to help fight against cancer cells.
Further, the ongoing extensive research and development (R&D) strategies implemented by biopharmaceutical firms for producing novel therapeutic drugs are driving the market growth notably.
The market players can aim towards expansions, collaborations, joint ventures, acquisitions, and partnerships to advance capabilities in gene therapy. This would help in yielding effective therapeutic drugs for treating different kinds of cancers. In April 2022, GSK plc announced the acquisition of Sierra Oncology for £1.6 billion ($1.9 billion). This acquisition would help GSK plc in enhancing its capabilities with respect to targeted therapies for treating rare forms of cancer.
Biotechnology firms are evaluating novel gene therapy vectors for increasing levels of protein production/gene expression, reducing immunogenicity, and improving durability.
The top cancers in terms of the count of new cases in 2020 all over the world were Lung Cancer (2,206,771 cases), Breast Cancer (2,261,419 cases), Prostate Cancer (1,414,259 cases), Colorectal Cancer (1,931,590 cases), Stomach Cancer (1,089,103 cases), and Liver cancer (905,677 cases). In 2018, there were around 134,632 new cancer cases and 89,042 cancer-related fatalities. Breast and liver cancers were among the most common tumors in terms of incidence and mortality. The high prevalence of breast cancer cases enhances the scope for CRISPR/Cas9-based gene editing for breast cancer therapy and VISA-claudin4-BikDD gene therapy.
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Key Takeaways:
- North America accounted for the largest share of over 61.15% in 2023.
- Europe is estimated to be the fastest-growing region over the forecast period
- Gene induced immunotherapy dominated the market with a revenue share of over 41.9% in 2023.
- Oncolytic virotherapy is expected to grow at the fastest rate over the forecast period
- Biopharmaceutical companies led the market with a revenue share of over 50.0% in 2023.
- The biopharmaceutical companies segment is projected to grow at the fastest rate over the forecast period.
Cancer Gene Therapy Market Size in U.S. 2024 to 2033
The U.S. cancer gene therapy market size was valued at USD 1.25 billion in 2023 and is anticipated to reach around USD 7.94 billion by 2033, growing at a CAGR of 20.31% from 2024 to 2033.
North America accounted for the largest share of over 61.15% in 2023. This is attributed to the conducive environment facilitated by the government and the National Cancer Institute that supports research and development activities to enhance cancer therapeutics. Further, the presence of key market players in the region, their research efforts in devising gene therapy for cancer treatment, and collaborative efforts among market players to enhance research are boosting the market growth in the region. For instance, in August 2022, Merck & Co., Inc., collaborated with Orna Therapeutics Inc., for discovery, development, and commercialization of multiple programs, inclusive of utilization of mRNA for cancer gene therapy.
Europe is estimated to be the fastest-growing region over the forecast period due to increase in research funding for novel therapeutics by government bodies and increasing demand for novel therapeutics that could help combat the growing incidence of cancer cases across the region. Moreover, The European Union’s ‘Horizon Europe Mission on Cancer’ was launched in September 2023 so as to offer funds to a broad spectrum of activities that are intended to lower Europe’s cancer burden by accelerating research and innovation in cancer therapeutics. The mission is anticipated to help over 3 million cancer survivors by the year 2033.
The cancer gene therapy market in the Asia Pacific (APAC) region is segmented into India, China, Japan, South Korea, and the rest of the Asia Pacific (APAC) region. China dominated the Asia Pacific region followed by Japan and India in 2023.
The Latin America, Middle East, and African (LAMEA) cancer gene therapy market is segmented into North Africa, South Africa, Saudi Arabia, Brazil, Argentina, and the Rest of LAMEA. The Middle East and the Latin America region are anticipated to have notable growth in the cancer gene therapy market during the forecast period. Brazil held the largest share in the LAMEA region in 2023. Due to low literacy, uncertainty, and civil war in African countries, the cancer gene therapy market in Africa is expected to grow at a comparatively slow rate.
What are the importance of Cancer Gene Therapy?
- Targeted Treatment: Gene therapy enables the targeting of specific cancer-causing genes or pathways, allowing for more precise treatment that minimizes damage to healthy cells.
- Potential for Personalization: Gene therapy can be tailored to individual patients based on their genetic makeup and the specific mutations driving their cancer, offering the potential for personalized medicine approaches.
- Overcoming Drug Resistance: Cancer cells can develop resistance to traditional treatments like chemotherapy. Gene therapy presents alternative strategies to overcome drug resistance by targeting different mechanisms involved in cancer growth and survival.
- Reduced Side Effects: By targeting cancer cells specifically, gene therapy can potentially reduce the side effects commonly associated with traditional cancer treatments such as chemotherapy and radiation therapy, which often affect healthy cells as well.
- Long-Term Benefits: Gene therapy has the potential to provide long-lasting or even permanent effects, as modified genes can continue to function to suppress or eliminate cancer cells over time.
- Treatment of Incurable Cancers: For certain types of cancers that are difficult to treat using conventional methods, such as certain types of brain tumors, gene therapy offers new hope for effective treatment options.
- Combination Therapy: Gene therapy can be used in combination with other treatments, such as chemotherapy or immunotherapy, to enhance their effectiveness and improve overall treatment outcomes.
- Research and Innovation: Continued research and development in cancer gene therapy pave the way for innovative treatment approaches and contribute to a deeper understanding of the molecular mechanisms underlying cancer progression.
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Types of gene therapy for cancer
Gene therapy aims to control the altered genes or genetic mutations of a cancer to prevent the cancer’s growth. This approach to using our own cells and genes to treat cancer is called somatic gene therapy. This type of gene therapy does not impact germ-line cells in the reproductive system, meaning none of the genetic changes can be passed on to other family members.
There are four types of somatic gene therapy: gene editing; gene replacement; gene addition; and gene inhibition.
Gene editing is correcting the cell’s gene to fix the imbalance – by snipping out the faulty part of the gene and changing the cancer’s DNA. This type of gene therapy may correct the alteration rather than trying to remove it. Gene replacement is just that: replacing the faulty or nonworking gene with a healthy copy of it. This type of gene therapy is another form of trying to fix the genetic change rather than trying to remove it.
Gene addition is adding novel genetic code to a different cell – usually an immune system fighter cell – to help it combat the protein linked to the damaged gene. CAR T-cell therapy is an example of gene addition. This form of gene therapy isn’t adding a copy of an already-existing gene but rather an entirely new gene – usually with the intent of killing the cancer cell via the immune system. Doctors may also add a new gene directly to the cancer cell that causes the cancer cell to commit apoptosis (kill itself).
Gene inhibition simply shuts down the faulty gene. This can either kill the cell or prevent it from acting in a cancerous manner, such as growing and replicating exponentially.
Steps of gene therapy
Gene therapy is a new and potentially curative approach to treating cancer, but researchers still have so much to learn. While the steps below may seem straightforward, each part of the process requires years of study to develop the technologies.
Researchers must first identify the gene and protein linked to the cancer. The next steps are:
- Create or isolate a normal copy of the gene
- Develop a viral vector to carry genetic material into cells
- Insert the gene-carrying vector into the body
- The viral vector delivers the gene to the tumor microenvironment or immune system cells
- The vector inactivates to avoid any further (potentially harmful) activity
- The inserted gene either inactivates, fixes, replaces, or attacks the faulty gene
Steps of CAR T-cell therapy
CAR T-cell therapy has a slightly different process than more direct forms of gene therapy. CAR T cells are lab-generated fighter cells with specific, anti-cancer genetic code. Adding this genetic code is the gene therapy component of CAR T-cell therapy. CAR stands for “chimeric antigen receptor,” which is the new genetic code added to the T cells.
There are six CAR T-cell therapy agents approved by the U.S. Food and Drug Administration for different blood cancers. These approvals validate CAR T cells as an effective form of cancer gene therapy to improve patient life expectancy.
Doctors first draw blood from a patient and separate the T cells, which are white blood cells leading the immune system’s defense against viruses, diseases and more unwanted intruders. T cells aim to protect the body from cancer, but they’re often ineffective at doing so.
The process of drawing blood from patients and separating the T cells is called apheresis.
After removing T cells from the body, the steps of CAR T-cell therapy are:
- Identify a protein biomarker (overexpressed protein) on the genetically damaged cancer cells
- Create a RNA strand called a chimeric antigen receptor (CAR) coded to look for the protein biomarker
- Add the chimeric antigen receptors to the extracted T cells
- Multiply the new CAR T cells in the laboratory
- Reinsert the newly motivated CAR T cells into the body through infusion
A similar process occurs for CAR NK-cell therapy. Scientists create chimeric antigen receptors to strengthen natural killer (NK) cells, another white blood cell of the immune system.
How long does CAR T-cell therapy take?
There are six CAR T-cell therapies approved for types of three blood cancers: myeloma, leukemia and lymphoma. CAR T-cell therapy infusions can take place in an inpatient or outpatient care setting, but the patient must be closely monitored at all times.
CAR T-cell therapy can lead to side effects, most notable cytokine release syndrome.
The entire CAR T-cell process lasts approximately one month, not including the recovery time after treatment:
- First, doctors must remove the patient’s T cells, work on them in a lab, and infuse them back into the body. This step usually takes a few weeks to add the CAR to the T cells and multiply them.
- The CAR T cells are frozen and returned to the hospital or cancer center where the patient is treated.
- Infusion of CAR T cells back into the patient takes around one hour, according to the Mayo Clinic’s website.
- After receiving the CAR T-cell infusion, the medical staff monitors the patient for the next few weeks to watch for side effects caused by the enhanced T cells rapidly expanding in the body and killing the cancer cells.
For the first seven days after receiving the CAR T-cell infusion, patients must remain under medical supervision. For weeks 2-4 of the post-infusion timeline, patients must remain within a short drive of their medical facility to respond to any issues.
The total recovery period from CAR T-cell therapy is usually 2-3 months following infusion, according to the Dana-Farber Cancer Institute.
There are several studies for CAR T-cell therapies for cancer. Participating in a clinical trial helps advance cell and gene therapy research and can advance much-needed therapies to more patients in need.
Therapy Insights
Gene induced immunotherapy dominated the market with a revenue share of over 41.9% in 2023. The dominance of the segment can be attributed to research studies aiming to lower the proliferation of various types of cancer by strengthening the immune system. Many gene therapies for cancers are designed on the basis of immunotherapy elements. For instance, PROVENGE (by Dendreon Corporation) is an autologous cellular immunotherapy designed to stimulate a subject’s immune system against prostate cancer.
Oncolytic virotherapy is expected to grow at the fastest rate over the forecast period owing to the favorable outcomes and the level of efficacy offered by oncolytic virotherapy. Oncolytic viruses can combat cancer cells without disturbing the healthy cells in vicinity by stimulating natural killer cells. Moreover, there are lucrative research grants for the research on oncolytic virotherapy. For instance, in July 2022, the researchers at the Center for Nuclear Receptors and Cell Signaling at the University of Houston received a USD 1.8 million grant from the National Institutes of Health to work on oncolytic virotherapy.
End-use Insights
Biopharmaceutical companies led the market with a revenue share of over 50.0% in 2023. This is attributed to the increasing global prevalence of different types of cancers owing to various hereditary, environmental, and lifestyle risk factors. Moreover, the market is driven by increasing adoption of elemental gene therapy options by biopharmaceutical giants to design cancer therapeutic regimes. Many novel therapeutic drugs are under different phases of trials and firms are striving to market them in different regions across the globe. For instance, in January 2020, bluebird bio, Inc. launches its drug, ZYNTEGLO in Germany to be used as a one-time gene therapy solution for patients aged 12 years and above.
The biopharmaceutical companies segment is projected to grow at the fastest rate over the forecast period. The increasing global prevalence of malignant tumors is a key factor driving the market. Moreover, an increased interest in oncology therapeutics research and development is resulting in a rise in the number of FDA approvals of gene therapy drugs. For instance, there are 6 FDA-approved cancer gene therapy drugs with Tecratus, Abcema, and Kymriah being the recent approvals.
Recent Developments:
- In December 2022, Scientists in the United Kingdom used a revolutionary new type of gene therapy for treating a young patient with relapsed T-cell leukaemia. The administration of this new type of gene therapy raised hopes that it can tackle other childhood cancers as well as serious diseases.
- In December 2022, the U.S. Food and Drug Administration (FDA) approved Adstiladrin, a non-replicating adenoviral vector based gene therapy indicated for treating adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
Some of the prominent players in the Cancer gene therapy market include:
- Abeona Therapeutics Inc.
- Asklepios BioPharmaceutical Inc.
- Altor Bioscience Inc.
- Bluebird bio Inc.
- BioCancell Inc.
- CelgeneInc.
- Elevate BioInc.
- GlaxoSmithKlineInc.
- Genelux Corporation
- GenVec
- Introgen TherapeuticsInc.
- MerckKGaA
- OncoGenex Pharmaceuticals Inc.
Segments Covered in the Report
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2023 to 2033. For this study, Nova one advisor, Inc. has segmented the global cancer gene therapy market.
Therapy
- Oncolytic Virotherapy
- Gene Induced Immunotherapy
- Gene Transfer
End-use
- Hospitals
- Research Institutes
- Biopharmaceutical Companies
- Diagnostic Centers
- Others
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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