New Delhi, Feb. 04, 2025 (GLOBE NEWSWIRE) -- The global cancer gene therapy market was valued at US$ 3.89 billion in 2024 and is expected to reach US$ 17.57 billion by 2033, growing at a CAGR of 19.23% from 2025–2033.
The cancer gene therapy market stands at the forefront of modern biomedical innovation, offering transformative potential for patients and investors alike. Over 140 companies are engaged in the development and application of gene therapy for cancers, indicating a robust ecosystem that continues to expand. Beyond these companies, there are more than 180 organizations actively involved in the development of over 200 gene therapies for oncology applications. This widespread involvement underscores the vast market potential, as researchers and industry leaders collaborate to address unmet needs in cancer treatment. Fueled by substantial funding and a growing number of novel technologies, the market also thrives on the increasing prevalence of cancer worldwide. The National Cancer Institute (NCI), allocating a total budget of $6.8 billion in fiscal year 2022 for cancer research, demonstrates the financial commitment to accelerating progress in gene therapy. With such investments, the market is primed for significant growth.
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In terms of growth, the cancer gene therapy market benefits from ongoing advancements in molecular biology, CRISPR-based editing, and viral vector design that make therapies safer and more precise. Demand is further bolstered by shifting disease demographics, as the number of patients projected to receive gene therapies in the United States is expected to peak at 94,696 by 2025. This surge in demand is driven by the convergence of groundbreaking clinical results and the urgent need for new cancer treatments. Moreover, the dynamic nature of the market is evidenced by the high proportion of gene therapy clinical trials focusing on oncology, with approximately two-thirds dedicated to cancer. Key applications span preventive gene editing, oncolytic viral therapies, and personalized immunotherapies that leverage the body’s immune system. Taken together, these factors highlight a market poised to revolutionize cancer care through innovative, targeted, and ultimately life-saving solutions. In sense, competitive edges continue to intensify worldwide.
Key Findings in Cancer Gene Therapy Market
| Market Forecast (2033) | US$ 17.57 Billion |
| CAGR | 19.23% |
| Largest Region (2024) | North America (62%) |
| By Therapy | Gene-Induced Immunotherapy (41%) |
| By End Users | Biopharmaceutical companies (46%) |
| Top Drivers |
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| Top Trends |
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| Top Challenges |
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Cancer Gene Therapy Market Clinical Insights: Trials, Patents, and Approvals
The landscape of clinical trials within the cancer gene therapy market is both expansive and evolving. By the end of 2023, 76 cell and gene therapies had been launched globally, and approximately two-thirds of all gene therapy trials are dedicated to oncology. The United States leads the way, conducting 64.4% of all gene therapy trials, followed by Europe at 23.7% and Asia at 6.1%. These regional disparities underscore the varying regulatory environments and funding capabilities that shape trial initiation. As of 2024, there are 500 gene therapies in the pipeline, underscoring the steady flow of projects progressing through various clinical stages. The approval process itself continues to accelerate, with 36 gene therapies gaining FDA approval by March 2024. Experts anticipate the annual approval of 10 to 20 new gene therapies, driven in part by academic-industry collaborations and breakthroughs in vector technology.
Patents also serve as a crucial indicator of innovation in the cancer gene therapy market. As of early 2023, there were 145,933 global patents related to gene therapy, reflecting the intense competition and the race to secure valuable intellectual property. Notably, the number of patent applications has risen dramatically since the first approval of an adeno-associated viral (AAV) gene therapy in 2012. Institutions such as Genzyme Corp. and the Trustees of the University of Pennsylvania lead the pack in terms of AAV vector technology filings, underscoring the clinical importance of viral vectors. Beyond patents, publications provide another window into this thriving area. Between 2016 and 2020, researchers published 4,392 papers on cancer gene therapy, with 919 appearing in 2020 alone. This spike in scholarly output highlights the growing scientific interest and the volume of discoveries fueling the pipeline. Together, these trends affirm the vibrant and competitive nature of the field. Such momentum highlights interest and accelerates potential breakthroughs globally.
Cancer Gene Therapy Market Innovations: Leading Companies and Institutions
Innovations in the market stem from a broad coalition of pioneering companies, academic institutions, and influential researchers. Over 140 companies are currently engaged in developing and applying gene therapy to treat cancers, while more than 180 are rolling out over 200 therapies, reflecting a remarkable commitment to next-generation solutions. Major players in this space range from biotech startups to established pharmaceutical giants, each leveraging unique technological platforms to deliver therapeutic vectors and enhance efficacy. Beyond industry, academic organizations like Harvard Medical School and Sichuan University have emerged as vital drivers of progress, spearheading novel research streams and mentoring the next wave of scientific talents. Meanwhile, the UK 100,000 Genomes Project has identified 330 candidate driver genes, broadening the landscape of potential therapeutic targets. This synergy among public and private sectors accelerates the journey from bench to bedside and fosters a climate of continuous innovation.
Prominent researchers and authors also shape the evolution of the cancer gene therapy market. WANG W is recognized as the most prolific author, while ZHANG Y has garnered the highest number of citations. Their leadership in scientific literature drives both fundamental research and real-world applications. Collaborations among key opinion leaders and industry stakeholders stimulate further discovery, particularly in high-impact areas like CAR-T cell therapy, which has shown immense success in treating blood cancers. Other innovative approaches include replication-incompetent viruses engineered to produce cancer antigens, tested in pancreatic cancer trials, and TCR therapies like Afami-cel targeting MAGE-A4 in synovial sarcoma. Alongside these efforts, organizations such as the Alliance for Cancer Gene Therapy and the Frederick National Laboratory for Cancer Research enable knowledge exchange, grant funding, and public-private collaborations. Combined, these alliances ensure that the pursuit of novel solutions remains both rigorous and groundbreaking, propelling the entire market forward. Industry and academia forge new frontiers.
Cancer Gene Therapy Market Technical Overview: Vectors, Targets, And Follow-Up
The technical aspect of the market is multifaceted, centering on vectors, gene targets, and long-term monitoring. Adeno-associated viral (AAV) vectors and integrating vectors are among the most commonly employed, each with its own set of advantages and limitations. AAV vectors typically involve a minimum follow-up of five years, while genome-editing therapies and integrating vectors necessitate extended monitoring of up to 15 years to evaluate both efficacy and potential risks. This prolonged observation ensures patient safety by revealing any delayed adverse events or off-target effects. Researchers and regulatory agencies emphasize robust protocols to track patient outcomes, reflecting an industry-wide commitment to evidence-based strategies. Advances in CRISPR-based editing are paving the way for more precise and controllable treatments, signifying a shift toward personalized therapy. Meanwhile, gene amplification events, exemplified by the MYC and MET genes, remain integral targets that drive oncogenesis in multiple tumor subtypes.
Targeted therapies are becoming increasingly sophisticated in the cancer gene therapy market, as highlighted by ongoing research into oncolytic viruses that selectively infect and lyse cancer cells. Trials involving replication-incompetent viruses designed to produce tumor-specific antigens for pancreatic cancer exemplify this tailored approach. CAR-T cell therapy, which modifies a patient’s T cells to target tumor-specific markers, has revolutionized hematological malignancies and is now being explored for solid tumors like glioblastoma. Further, TCR therapies such as Afami-cel target antigens like MAGE-A4, illustrating the diversity of genetic alterations under investigation. Comprehensive follow-up is paramount, not only to gauge immediate efficacy but also to monitor long-term outcomes, including durability of response and late-onset toxicities. As more advanced vectors and genome-editing strategies enter clinical trials, the cancer gene therapy market stands on the cusp of even more transformative breakthroughs. This continuous evolution underscores the interplay of cutting-edge science and clinical rigor driving patient-centric cancer care. Clinical rigor and breakthroughs transform patient outcomes in oncology.
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Cancer Gene Therapy Market Future Outlook: Funding and Opportunities
The funding landscape for market has experienced significant fluctuations and challenges in recent years, reflecting both the immense potential and the complex hurdles associated with this innovative field. In 2020, the market witnessed a peak in investment, with biotech companies developing cell, gene, and tissue-based therapies attracting nearly $20 billion in funding. However, this momentum has not been sustained uniformly, as evidenced by a notable decline in venture capital investment by 2024. This projected growth underscores the continued interest and potential in the field, despite the challenges. Major pharmaceutical companies and venture capitalists have made significant investments to capitalize on the promising potential of gene therapies. For instance, GSK plc's acquisition of Sierra Oncology for $1.9 billion in April 2022 and Ori Biotech's successful Series B funding round of over $100 million in January 2022 highlight the strategic focus on expanding capabilities and advancing novel therapeutic approaches in cancer treatment. The funding environment for cancer gene therapy is characterized by both opportunities and challenges. While the potential for long-term, durable benefits in treating hard-to-treat cancers continues to attract attention and investment, securing funding remains challenging due to the high costs associated with research and development, as well as the complex manufacturing processes required.
The cancer gene therapy market has seen a shift in investment patterns, with the overall biotech venture investment showing variability. For example, Shape Therapeutics raised $112 million in a Series B financing round in 2021, while Apollo Therapeutics secured $226.5 million in a Series C financing round in 2023, both aimed at advancing gene therapy approaches for various disorders, including cancer. However, the broader funding environment has faced headwinds, with the cell and gene therapy sector experiencing a significant drop in investment from its peak in 2021. This decline reflects broader challenges in the biotechnology sector, such as manufacturing and drug delivery hurdles, which are particularly pronounced in the development of complex therapies like those for cancer. As the field evolves, stakeholders are expected to collaborate on innovative financing models to support the development and commercialization of these therapies, ensuring that the financial ecosystem adapts to the unique demands of gene therapy.
Global Cancer Gene Therapy Market Major Players:
- Abeona Therapeutics Inc.
- Adaptimmune Limited
- Aduro Biotech
- Altor Bioscience Inc.
- Asklepios BioPharmaceutical Inc.
- BioCancell Inc.
- Bluebird bio Inc.
- Bristol Myers
- CelgeneInc
- Elevate BioInc
- Genelux Corporation
- GenVec
- GSK plc.
- Introgen TherapeuticsInc
- MerckKGaA
- Novartis AG
- OncoGenex Pharmaceuticals Inc.
- Orchard Therapeutics Plc
- Other Prominent Players
Key Segmentation:
By Therapy
- Gene Induced Immunotherapy
- Gene Transfer
- Oncolytic Virotherapy
By End-User
- Biopharmaceutical Companies
- Diagnostic centers
- Hospitals
- Research Institutes
- Others
By Region
- North America
- Europe
- Asia Pacific
- Middle East & Africa
- South America
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