The global sales of cancer gene therapy is estimated to be worth USD 1,822.2 million in 2024 and anticipated to reach a value of USD 3,142.2 million by 2034. Sales are projected to rise at a CAGR of 5.6% over the forecast period between 2024 and 2034. The revenue generated by oncolytic Virotherapy in 2023 was USD 850.7 million.
The market for gene therapy in cancer has been growing in recent years is driven by increased demand for personalized medicines, together with recent targeted therapies and drugs. Gene therapy employs a new approach to treatment that targets the genetic alterations responsible for the development of cancer. Traditional therapies such as chemotherapy or radiation are less precision-oriented, as they generally aim for the cancer cells more globally, increasing toxicity to normal cells and treatment side effects.
Also, the increasingly prevalence of cancer globally, in combination of increasing financial investments in clinical phase natural gene therapy research are driving a rapid manifolds of clinical trial protocols phase I, II, and III to regulatory approval endpoints. Growth on research and development pathways, along with investments unique to various players aligned to the gene therapy manufacturing industry, is increasing interest in the catalysis of gene therapies for cancer patients.
Global Cancer Gene Therapy Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2023 | USD 1,725.6 million |
| Estimated Size, 2024 | USD 1,822.2 million |
| Projected Size, 2034 | USD 3,142.2 million |
| Value-based CAGR (2024 to 2034) | 5.6% |
The gene therapy market has gone through a progression of changes in the past years. The first successful medicine for gene therapy carried the indication of a monogenetic disease and gained a lot of attention, however, recently, the gene therapy market for cancer has gained much popularity. Cancer gene therapy is a treatment for cancer disease agents where therapeutic DNA is delivered to the body to treat the cancer patient.
Cancer can spread via multiple mutations that may occur in a single cell. Cancer cells can invade a "new" cell, have rapid metabolic activity, and change shapes constantly. Cancer can be treated via surgery options, radiation treatment or chemotherapy. The use of gene therapy is opted for when the above treatments do not give the expected efficacy.
Gene therapy is the genetic introduction of a functional gene into the cancer cell of a patient. Essentially, therapeutic DNA is delivered to the cancer patient for the purpose of modifying metabolism, repairing or changing acquired genetic defects, or adding new functions to the patient's cells.
Gene therapy has primarily been developed and studied over the last 20 years. For example, as of January 28, 2018, there have been ten gene treatments approved for marketing licensed by at least one country. In fact, recent predictions claim that there will be 12-14 gene therapy approvals in the next few years, and close to 40 new gene medicines will be approved by the end of 2022.
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The below table presents the expected CAGR for the global cancer gene therapy market over several semi-annual periods spanning from 2024 to 2034. In the first half (H1) of the decade from 2023 to 2033, the business is predicted to surge at a CAGR of 6.3%, followed by a slightly lower growth rate of 6.0% in the second half (H2) of the same decade.
| Particular | Value CAGR |
|---|---|
| H1 | 6.3% (2023 to 2033) |
| H2 | 6.0% (2023 to 2033) |
| H1 | 5.6% (2024 to 2034) |
| H2 | 5.1% (2024 to 2034) |
The above table presents the expected CAGR for the global cancer gene therapy market over several semi-annual periods spanning from 2024 to 2034. In the first half (H1) of the decade from 2023 to 2033, the business is predicted to surge at a CAGR of 6.3% , followed by a slightly lower growth rate of 6.0% in the second half (H2) of the same decade.
Moving into the subsequent period, from H1 2024 to H2 2034, the CAGR is projected to decrease slightly to 5.6% in the first half and decrease moderately at 5.1% in the second half. In the first half (H1) the market witnessed a decrease of 70 BPS while in the second half (H2), the market witnessed a decrease of 90 BPS.
Growing Lifestyle-Related Cancer Cases and Advancements in Gene Therapy Techniques Propel Market Growth
Several important elements drive the cancer gene therapy market. Approximately one-third of all mortality from cancer are attributable to nutritional and behavioral risks, including low nutritious food intake, high body mass index, smoking, low physical activity, and alcohol consumption etc.
Because of these growing oncology cases, there is demand for therapies such as gene therapy. Gene therapy encompasses multiple methods of treatment, including oncolytic viral therapy, gene transfer, and gene-induced immunotherapy, and is exceedingly adaptable, since its applications involve the replacement of defective genes, alteration of gene regulation, or introducing new genes in order to modify cell function and survivability.
Techniques such as electroporation, magnetofection, plasmid vectors, and gene guns are improving the efficacy of transgene delivery with respect to cancer treatment. In addition to the somatic factors above, significant investments in research and development (R&D) are also driving the cancer gene therapy market. A USD 39.8 million in funding for 78 research grants has recently being issued by The American Cancer Society in recent years, furthering strengthening cancer research activities.
Overall, the growing incidence of cancer due to lifestyle factors, combined with advancements in gene therapy techniques and substantial R&D investments, is significantly driving the expansion of the cancer gene therapy market, positioning it as a promising avenue for future cancer treatments.
Rising Success of Gene Therapies and Untapped Emerging Markets is Creating Opportunities for Cancer Gene Therapy Industry
The growing success rates of new therapies, heightened ethical acceptance of gene therapy for cancer and unexploited markets in emerging markets represent valuable opportunities to the organizations in the cancer gene therapy sector.
The capacity of gene therapy to provide personalized and targeted treatment is transforming cancer care, and it is becoming increasingly accepted - especially in populations in which their needs are unique, such, as the elderly. Experts regularly emphasize the safety and efficacy of cancer gene therapy and consider it credible in elderly patients without risk, including those at low to intermediate risk of cancer.
A significant event to illustrate this opportunity occurred in 2017 when the USFDA approved Kymriah™ (tisagenlecleucel), the first gene therapy for children with acute lymphoblastic leukemia. This discovery served as the first approved gene therapy by the FDA in regards to cancer, which must be considered a breakthrough gene therapy and cancer treatment gaining momentum.
The progress towards gene therapy has increased in the last few years. In March of 2021 the FDA approved Breyanzi (lisocabtagene maraleucel) as a new CAR T-cell option for relapsed or refractory large B-cell lymphoma further increasing the use of gene therapy in cancer treatment. Governments and healthcare organizations are showing a willingness to consider advanced treatments, creating brilliant prospect for companies to bolster their positioning in meeting increasing demand from patients needing innovative cancer therapies.
Higher Costs of Antimicrobial Coated Catheters Limit Adoption and Market Growth of Cancer Gene Therapy Industry
Factors that are anticipated to limit the growth of cancer gene therapy throughout the forecast period include the substantial costs related to gene therapy and the potential for serious immune reactions. The obligation to develop, produce, and administer gene therapies can be complex and costly and may result in significant treatment costs that limit access in particular for lower-income regions.
Additionally, immune reactions can occur against viral vectors that are employed in gene therapies and represent a potentially serious complications affecting the overall treatment efficacy and thus, limiting market growth.
The availability of more traditional cancer treatments that have been around for decades, including chemotherapy, surgery, and radiation therapy, also will serve as a barrier to the significant uptake of gene therapy. Conventional therapies will be more widely known and accepted and less expensive to administer.
A major impediment to cancer gene therapy, particularly in developing countries, is the ability to staff qualified medical staff. In India, for example, there are less than 1,600 oncologists attempting to treat an estimated 1 million cancer patients, according to government data, the Indian Medical Association and cancer predictions suggest cases will rise by 20%.
These challenges, including high costs, potential immune complications, the availability of established treatments, and limited access to qualified medical professionals, are significant barriers that may hinder the widespread adoption of cancer gene therapy, particularly in lower-income and developing regions.
The global cancer gene therapy industry recorded a CAGR of 4.7% during the historical period between 2019 and 2023. The growth of cancer gene therapy industry was positive as it reached a value of USD 1,725.6 million in 2023 from USD 1,436.0 million in 2019.
The cancer gene therapy industry has come a long way since its inception in human patients in the historical years as a research/experimental process. Progress was slow because of safety concerns and regulatory hurdles, as well as early-on technological limitations. However, breakthroughs in molecular biology, genomics, and biotechnology, most of which involved viral and non-viral vector technologies and gene-editing tools such as CRISPR-have invigorated the field.
The market has grown tremendously in the last few years, highlighted by the approval of two landmark CAR T-cell therapies, Kymriah™ (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel). These therapeutics have performed remarkably well against hematologic malignancies and without any treatment resistant forms to worry about, in relapsed forms of these cancers. With a healthy influx of cash for R&D, and technology advancements involving gene transfer methods, the market will rapidly increase.
Presently, the cancer gene therapy market has entered a significant growth phase in developed markets, such as the USA and Europe, fueled by a favorable regulatory pathway and the robust healthcare infrastructure of these regions. Emerging markets will also present opportunities for tremendous growth in the next phase as awareness increases and non-viral delivery methods further enhance the market.
Tier 1 companies comprise market leaders with a market revenue of above USD 100 million capturing significant market share of 26.2% in global market. These market leaders are characterized by high production capacity and a wide product portfolio.
These market leaders are distinguished by their extensive expertise in manufacturing and a broad geographical reach, underpinned by a robust consumer base. Prominent companies within tier 1 include Merck KGaA, Novartis AG, AstraZeneca Plc., Amgen, Bristol-Myers Squibb and GlaxoSmithKline PLC.
Tier 2 companies include mid-size players with revenue of USD 50 to 100 million having presence in specific regions and highly influencing the local market and holds around 31.7% market share. These are characterized by a strong presence overseas and strong market knowledge. EffRx Pharmaceuticals S.A., Vicore Pharma AB, BIOCAD, Crinetics Pharmaceuticals, Inc., Adaptimmune Therapeutics plc, and Genelux Corporation are a few of the well-known tier 2 firms.
Finally, Tier 3 companies, such as Euroscreen S.A., Achieve Life Science Inc., BioCanCell Ltd., Cell Genesys Inc., Advantagene Inc. and GenVec Inc. among others are essential for the market.
The section below covers the industry analysis for the cancer gene therapy market for different countries. Market demand analysis on key countries in several regions of the globe, including North America, Asia Pacific, Europe, and others, is provided. The United States is anticipated to remain at the forefront in North America, and is projected to witness a CAGR of 3.0% by 2034. In Asia Pacific, South Korea is projected to witness a CAGR of 7.5% by 2034.
| Countries | Value CAGR (2024 to 2034) |
|---|---|
| Canada | 5.1% |
| UK | 3.4% |
| France | 4.8% |
| China | 9.5% |
| Japan | 3.9% |
| South Korea | 7.5% |
| Spain | 5.5% |
United States cancer gene therapy market is poised to exhibit a CAGR of 3.0% between 2024 and 2034. Currently, it holds the highest share in the North American market, and the trend is expected to continue during the forecast period.
There has also been an increase in the number of people working with cancer gene therapies, as well as scientific outcomes focused on new, targeted drugs. With so many cases diagnosed in females each year, the USA cancer gene therapy market is projected to continue to grow steeply over the forecasted years. The development of these drugs often has the support of pharmaceutical companies.
As technology improves, cancer geneticists will be better able to fully comprehend cancer genetics which will create new possibilities for the treatment of breast cancer. As research and development investments continue to increase with a supportive regulatory environment, that growth will encourage even more rapid market development. As demand for these new effective and personalized treatment options grows, even more relevant developments will continue to fuel the USA cancer gene therapy sector just as it continues to impact patients with breast cancer and their continuing outcome.
East Asia, spearheaded by China c anticipated to grow at a CAGR of 9.5% throughout the forecast period.
China's national health, science, and technology authorities have recently introduced the "Regulation on the Administration of Clinical Application of New Biomedical Technology" and the "Regulation on the Administration of Safety Management of Biotechnology Research and Development" which represent a considerable advancement of China's regulatory environment.
These regulations seek to establish extensive oversight, enhance legal accountability, and facilitate the healthy development of biotechnology research, applications, and related industries. With a more rational supervision mechanism, China is poised to support the clinical environment for gene therapy.
Such regulation advances are expected to spur innovation and investment, given companies will have more clarity and confidence in the operating environment. Regulatory advances with continue to increase the safety and efficacy of gene therapies, thus generating further interest and application within the clinical sector. Therefore, the gene therapy market in China will begin gain significant momentum in the projected years. These regulatory frameworks show the commitment to the advancement of biomedicine to allow successful commercialized growth.
The first gene therapy was approved in Europe in 2012, marking a monumental event that took nearly twenty years to achieve and renewed interest and funding in gene therapy.
In Germany, it has given rise to demand among the manufacturers, hope among healthcare providers, and hope among patients, about the establishment of clear paths through the regulatory agencies for accessing timely, and meaningful therapies. This supportive environment encourages further investment and innovation in the gene therapy landscape.
Payers are now scrutinizing these new treatments to assess their added benefits, paving the way for potential reimbursement models that will facilitate broader access. With ongoing advancements in gene treatments, Germany is poised to experience substantial growth in the adoption of cancer gene therapy.
As stakeholders collaborate to enhance treatment options, the synergy between research, regulation, and healthcare will drive progress in combating cancer, ultimately benefiting patients in need of effective and personalized therapies. This momentum positions Germany as a key player in the evolving gene therapy market.
The section contains information about the leading segments in the industry. In 2024, the Oncolytic Virotherapy segment emerges as the revenue leader, commanding 49.3% of the market share.
| Therapy | Oncolytic Virotherapy |
|---|---|
| Value Share (2024) | 49.3% |
The utilization of oncolytic viral therapy as a novel and remarkably innovative approach to cancer therapy. This therapeutic regimens employ oncolytic viruses, which are viruses that occur in nature as well as modified genetically, that can specifically infect, and replicate in, cancer cells. The infection and replication of the virus are antitumor mechanisms that cause the cancer cells to lyse, thus resulting in cell death while sparing normal tissues and/or causing little tissue damage.
The selective nature of the virus not only can cause lysis of tumor cells but can also potentiate the patient's immune system to oversee recognizable tumor cells, thus providing an additional site of antitumor effect in cancer. Furthermore, some oncolytic viruses can be modified to carry additional therapeutic genes, such that a dual approach is provided that sees virus oncolytic coupled with targeted gene therapy.
| Indication | Breast Cancer |
|---|---|
| Value Share (2024) | 24.5% |
The breast cancer segment will account for a market share of over 24.5% in the cancer gene therapy market by 2024 end.
Governments in low-income nations are actively taking measures to encourage research efforts for the generation of cancer gene therapy and treatment regimens. These actions tend to be initiated due to an ongoing need to deal with rising cancer frequencies, mortality, and morbidity rates.
Through investing in research and development, governments also tend to develop home-grown effective and accessible methods for their own citizens to receive modern and innovative cancer treatments without the expense of travel abroad.
Beyond just developing research funding, there are governmental support systems established to stimulate broader collaborative efforts between universities and colleges, biotechnology companies, and clinicians in many cancer research and treatment regimens. This ultimately leads to organized and well-planned collaborative efforts while creating specialized centers for cancer treatment and research in local communities, which then only boosts local awareness and knowledge.
Substantial investments in the cancer gene therapy market are increasingly focused on collaboration and expansion to drive growth and strengthen market presence. Companies are prioritizing the acquisition of innovative technologies and products to enhance their offerings, while also pursuing strategic partnerships to expand their global footprint.
Recent Industry Developments in Cancer Gene Therapy Market
The global cancer gene therapy industry is projected to witness CAGR of 5.6% between 2024 and 2034.
The global cancer gene therapy industry stood at USD 1,725.6 million in 2023.
The global cancer gene therapy industry is anticipated to reach USD 3,142.2 million by 2034 end.
India is set to record the highest CAGR of 10.8% in the assessment period.
The key players operating in the global cancer gene therapy industry include Merck KGaA, Novartis AG, AstraZeneca Plc., BIOCAD, Crinetics Pharmaceuticals, Inc., EffRx Pharmaceuticals S.A., Euroscreen S.A., Vicore Pharma AB, Amgen, Bristol-Myers Squibb, Cell Genesys Inc., Adaptimmune Therapeutics plc., Achieve Life Science Inc., BioCanCell Ltd., Genelux Corporation, Advantagene Inc., GenVec Inc., GlaxoSmithKline PLC, Amgen Inc.
In terms of therapy, the industry is divided into gene induced immunotherapy, oncolytic Virotherapy, gene transfer among others.
In terms of indication, the industry is segregated into breast cancer, ovarian cancer, liver cancer, pancreatic cancer, lung cancer, prostate cancer.
In terms of service provider, the industry is segregated into hospitals, clinical research laboratory, oncology institutes.
Key countries of North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe and Middle East & Africa have been covered in the report.
Cancer Gene Therapy Market
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