Cancer Gene Therapy Market Size, Share & Trends Analysis Report By Therapy (Oncolytic Virotherapy, Gene Induced Immunotherapy), By End-use (Research Institutes, Biopharmaceutical Companies), By Region, And Segment Forecasts, 2024 - 2030

Cancer Gene Therapy Market Size & Trends

The global cancer gene therapy market size was estimated at USD 3.87 billion in 2023 and is projected to grow at a CAGR of 18.9% from 2024 to 2030. The significant growth can be mainly attributed to the increasing demand for gene therapy and the rising incidence of cancer cases worldwide. Additionally, with advancements in gene therapy, it is expected to become an effective alternative for treating all types of cancers and neoplastic disorders. For instance, in June 2024, the Food and Drug Administration (FDA) granted approval to epcoritamab-bysp (Epkinly, Genmab U.S., Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This approval marks a significant advancement in the treatment options available for individuals with FL who have exhausted other therapeutic avenues.

The increasing prevalence of cancer cases is expected to create a high demand for novel therapeutic drugs that could be effective for cancer treatment. According to the WHO, cancer affects 1 in 5 people, 1 in 12 women, and 1 in 9 men. In 2022, 20 million new cancer cases and 9.7 million deaths were reported, with 53.5 million people alive within 5 years of diagnosis.

Furthermore, the market is experiencing significant growth due to increased research and development activities, advancements in product technologies, and the introduction of new products by key industry players. This progress is propelling the healthcare infrastructure to unprecedented levels. For instance, in April 2023, an improved gene editing method was introduced, based on special cell-penetrating peptides representing a significant advancement in cell and gene therapies. This technique offers distinct advantages over current methods for editing the genomes of primary cells, particularly patients’ T-cells.

The growing strategic investments and expansion by major players has been actively developing gene therapies for various types of cancer, leveraging its expertise in genetic engineering and delivery systems. For instance, in August 2023, Astellas, and Poseida Therapeutics, announced a strategic investment to support Poseida’s commitment to redefining cancer cell therapy. This partnership aims to advance the development of innovative cell therapies for cancer treatment. This strategic investment implies a significant financial commitment towards advancing the field of cancer cell therapy. This infusion of capital is likely to enable Poseida to further develop its cutting-edge technologies and accelerate the progress of its pipeline of novel cell therapies.

Moreover, the rising prevalence rates of lifestyle disorders including diabetes and obesity, rising health-care spending, and the fast-growing diagnostic industry are driving the market expansion. For instance, as per the American Diabetes Association, around 1.2 million Americans are diagnosed with diabetes annually. In 2021, diabetes affected about 11.6% of the American population, which is equivalent to 38.4 million people. Of these, around 2 million people have type 1 diabetes, with around 304,000 of them being children and adolescents. In addition, the growing elderly population, increased demand for laboratory automation, and more awareness of preventative healthcare are driving the market growth.

Industry Dynamics

The cancer gene therapy market growth stage is high, and pace of market growth is accelerating. The market is characterized by a degree of innovation, Level of M&A activities, impact of regulations, service expansions, and regional expansions.

The market fortifies a high degree of innovation. Breakthrough technology is CAR-T cell therapy, which involves genetically modifying a patient’s T-cells to express chimeric antigen receptors (CARs) that recognize and attack cancer cells. These innovative approaches highlight the growing potential of gene-based therapies in reshaping how we combat cancer.

The level of M&A (mergers and acquisitions) activities in the market is high. Several companies are undertaking mergers and acquisitions strategies to expand biologics regulatory affairs portfolios, gain access to advanced technologies, and enhance their market presence. For instance, in November 2023, AstraZeneca announced its acquisition of Gracell Biotechnologies Inc. This strategic move by AstraZeneca is aimed at expanding its presence in the field of cell therapy, particularly in oncology and autoimmune diseases.

Regulations have a high impact on the market by shaping gene therapies' development, approval, and commercialization for cancer treatment. Regulatory frameworks set by health authorities such as the FDA in the U.S. and the EMA in Europe are designed to ensure patient safety, efficacy of treatments, and ethical standards are met. These bodies require extensive preclinical and clinical trials to demonstrate the safety and effectiveness of gene therapy products before they can be approved for use in patients. Additionally, regulatory requirements often necessitate substantial investments in compliance measures, quality control systems, and manufacturing standards to meet strict guidelines. Companies operating in this space must navigate complex regulatory landscapes that vary across regions, adding another challenge to bringing innovative gene therapies to needy patients.

Service expansion in the market is medium owing to increasing demand for specialized regulatory expertise and comprehensive support services in the biologics sector. Moreover, service providers are expanding their regulatory consulting, compliance services, and end-to-end support for biologics development to cater customer demand and broadening revenue growth opportunities. For instance, in May 2024, the Applied Gene and Cell Therapy Center was established which aims to focus on expanded clinical trials in the field of gene and cell therapy. This center, with an investment of USD 60 million, signifies a significant commitment to advancing research and development in genetic and cellular treatments.

The market is experiencing significant regional expansion, with service providers strategically expanding their presence to new geographic areas. Biologics companies are expanding into emerging markets in Asia-Pacific, Latin America, and MEA owing to growing healthcare needs and favorable regulatory environments. Thus, growing outsourcing trend for regulatory affairs due to rising need to navigate country specific regulatory requirements, and skilled expertise.

Therapy Insights

Gene induced immunotherapy segment dominated the market and accounted for 40.0% of global revenue 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 based on immunotherapy elements. For instance, PROVENGE (by Dendreon Corporation) is an autologous cellular immunotherapy designed to stimulate a subject’s immune system against prostate cancer. Moreover, advancements in gene editing technologies such as CRISPR-Cas9 have transformed the gene therapy landscape by allowing precise manipulation of genes linked to cancer immunotherapy. These technological progressions are propelling the creation of innovative gene-based immunotherapy strategies, thereby bolstering market expansion.

In 2023, oncolytic virotherapy segment is anticipated to witness a lucrative CAGR over the forecast period. The high segment growth is owing to its ability to selectively target and destroy cancer cells while sparing normal cells and the growing understanding of the complex interactions between viruses and the immune system has led to the development of novel oncolytic viruses that can stimulate anti-tumor immune responses, further enhancing their therapeutic potential. Additionally, advancements in genetic engineering techniques have enabled the design of oncolytic viruses with enhanced tumor specificity and improved safety profiles. According to the National Center for Biotechnology Information (NCBI) report published, as of June 2023, there were a total of 106 studies involving Oncolytic Virotherapy (OV) in various trial phases, according to data from ClinicalTrials.gov. Out of these studies, 33 had been completed at that time. The focus of these trials was the use of OV products for the treatment of different types of cancers.

End-use Insights

The biopharmaceutical companies segment held the largest market with a revenue share of over 50.0% in 2023 and is anticipated to grow at the fastest CAGR over the forecast period. 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 April 2023, the FDA approved Padcev in combination with Keytruda as a first-line treatment for patients with locally advanced or metastatic bladder cancer who are not eligible for cisplatin-containing chemotherapy marks a significant advancement in the management of this aggressive form of cancer.

In 2023, the diagnostic centers segment is anticipated to grow at a lucrative rate over the forecast period. The robust segment growth is owing to the increasing focus on precision medicine, and growing demand for accurate and timely genetic testing to identify specific genetic mutations that drive cancer growth. Diagnostic centers equipped with advanced technologies can provide precise molecular profiling of tumors, enabling oncologists to tailor treatment plans based on individual genetic profiles. In December 2023, the Dana-Farber Cancer Institute introduced its integrated clinic aimed at enhancing the early detection of precancerous conditions and preventing cancer in individuals at higher risk. This innovative initiative, known as the Centers for Early Detection and Interception at Dana-Farber, is likely to unite healthcare providers and researchers specializing in various cancer types. The primary goal of these Centers is to create advanced technologies and approaches for detecting cancer at its earliest stages.

Regional Insights

North America held the largest market share of 37.8% in 2023 and is anticipated to grow at the fastest CAGR over the forecast period. The regional growth is attributable 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 January 2024, the CoGenT Global program, initiated by the U.S. FDA is a pioneering pilot project aimed at fostering collaboration among global regulatory bodies for the concurrent review of gene therapy applications. This innovative initiative draws inspiration from the success of the Center for Oncology Excellence (OCE)’s Project Orbis and seeks to leverage the expertise and resources of regulatory partners worldwide to streamline the evaluation process for gene therapy products.

Moreover, according to Greenberg Trauig article published in January 2024, the FDA predicts that by 2025, it is likely to approve 10 to 20 cell and gene therapy products annually. This forecast underscores the agency’s recognition of the potential of these therapies to address unmet medical needs and revolutionize the treatment landscape. These initiatives together propels the overall market growth.

U.S. Cancer Gene Therapy Market Trends

The market in the U.S. held the largest share in North America in 2023. This growth is owed to the growing innovation in the field of cancer gene therapy and expands the range of therapies available to oncologists and patients in the U.S. Strong demand for cost-effective generic and biosimilar products in the U.S. contributing to the overall market demand. For instance, in January 2024, Ferring Pharmaceuticals announced the full availability of ADSTILADRIN (nadofaragene firadenovec-vncg) in the U.S. This announcement marks a significant milestone in the treatment options available for patients with high-grade Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).

Europe Cancer Gene Therapy Market Trends

The market in Europe is expected to grow significantly due to the presence of the EIC (European Innovation Council) Cell and Gene Therapy Symposium. This cell plays a crucial role in driving the market in Europe by facilitating collaboration, knowledge sharing, innovation showcase, networking opportunities, and international partnerships that collectively contribute to advancing research, development, and commercialization of novel therapies for cancer treatment. In October 2023, the EIC Cell and Gene Therapy Symposium was organized in the context of the 30th Annual ESGCT Congress in Brussels. This symposium is a significant event that brings together key stakeholders in cell and gene therapy to discuss the latest advancements, challenges, and opportunities in this rapidly evolving sector. It serves as a platform for researchers, clinicians, industry leaders, investors, and policymakers to exchange ideas, collaborate on innovative projects, and drive forward the development of cutting-edge therapies.

The cancer gene therapy market in Germany held the largest share in 2023 in Europe, owing to strong presence of skilled & experienced workforce is also one of the primary factors expected to drive the market in Germany. For instance, in September 2023, the scientists from the German Cancer Research Center (DKFZ), University Medical Center Mannheim (UMM), and German Cancer Consortium (DKTK) conducted a groundbreaking study where they tested a new form of cellular immunotherapy against brain tumors in mice. This study marked the first successful application of this therapy in a preclinical model for brain tumors.

The cancer gene therapy market in the UK is anticipated to grow significantly over the forecast period. The growing advancements in biotechnology and a growing understanding of genetic mutations associated with cancer are propelling the market growth. Moreover, the key factors contributing to this growth include increased investment in research and development, favorable regulatory frameworks, and the rising prevalence of cancer cases. Additionally, collaborations between academic institutions and biotech companies are accelerating the development of innovative therapies. The adoption of personalized medicine, which tailors treatments based on individual genetic profiles, further enhances the potential of gene therapies to improve patient outcomes and offers a promising avenue for the future of cancer treatment in the UK.

Asia Pacific Cancer Gene Therapy Market Trends

The Asia Pacific market is expected to grow at a lucrative rate over the forecast period. The opening of an expanded cell and gene therapy manufacturing facility at Peter Mac in July 2023 has significant implications for the market in the region. This development is poised to drive advancements in cancer treatment by enhancing the availability, accessibility, and affordability of cutting-edge gene therapies for patients across Asia Pacific.

Moreover, the growing achievement of the Cell & Gene Therapy is poised to positively influence the landscape of cancer gene therapy in the Asia-Pacific region by bolstering credibility, fostering collaborations, attracting investments, promoting innovation, and expanding market opportunities. For instance, in September 2023, Novotech was awarded the Cell & Gene Therapy CRO Excellence Award. This recognition highlights Novotech’s expertise and capabilities in supporting cell and gene therapy research and development projects.

The cancer gene therapy market in China held a significant share in 2023. The advancement in gene therapy for deafness in China can have a profound impact on the market in the country. For instance, in November 2023, China made a significant breakthrough in gene therapy for deafness. Researchers successfully used a CRISPR-based gene editing technique to restore hearing in mice with genetic deafness. This groundbreaking achievement has opened new possibilities for treating genetic hearing loss in humans.

The cancer gene therapy market in Japan is expected to grow over the forecast period due to the rising genomic sequencing project implications for the market in Japan. For instance, in January 2023, the National Cancer Center Japan launched a project to sequence the genomes of 10,000 cancer patients to evaluate the risk of recurrence. This initiative aims to identify genetic mutations associated with cancer and predict the likelihood of cancer recurrence in individual patients. By understanding the genetic makeup of tumors, doctors can tailor treatment plans to target specific mutations, leading to more personalized and effective therapies.

Key Cancer Gene Therapy Company Insights

The key market participants operating across the market focus on adopting several in-organic strategic initiatives such as mergers, partnerships, collaborations, acquisitions, etc. The prominent strategies companies adopt are service launches, mergers & acquisitions/joint ventures, mergers, partnership & agreements, expansions, and others to increase market presence & revenue and gain a competitive edge driving market growth. Hence, increasing adoption of in-organic strategic initiatives is highly anticipated to boost the market share of prominent players.

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.

Cancer Gene Therapy Market Report Scope

Global Cancer Gene Therapy Market Report Segmentation

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 2018 to 2030. For this study, Grand View Research has segmented the global cancer gene therapy market report based on therapy, end-use, and region.

• Product Therapy Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncolytic Virotherapy

  • Gene Induced Immunotherapy

  • Gene Transfer

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Research Institutes

  • Biopharmaceutical Companies

  • Diagnostic Centers

  • Others

• Region Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • Switzerland

  • Asia Pacific

    • Japan

    • China

    • Australia

  • Rest of World