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市场调查报告书
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1800245
癌症基因治疗市场-2025年至2030年的预测Cancer Gene Therapy Market - Forecasts fom 2025 to 2030 |
癌症基因治疗市场预计将从 2025 年的 34.84 亿美元成长到 2030 年的 85.61 亿美元,复合年增长率为 19.70%。
受研发投入增加和全球癌症发病率上升的推动,癌症基因治疗市场预计将在 2025 年至 2030 年期间经历强劲增长。这个创新领域专注于修改癌细胞中的遗传物质,以纠正缺陷基因、传递治疗基因或增强免疫反应,从而为晚期癌症的长期缓解提供潜力。该市场受到基因编辑、溶瘤病毒疗法和免疫疗法的进步的驱动,并得到良好的法规环境和大量资金的支持。北美,尤其是美国,凭藉其先进的医疗基础设施和较高的癌症发病率占据主导地位。挑战包括高昂的治疗费用和复杂的法律规范。
市场驱动因素
增加研发投入
大量的研发投入正在推动癌症基因治疗的进步。 2023年,美国国立卫生研究院 (NIH) 为基因治疗研究拨款超过10亿美元,反映出其对基因疗法在解决尚未满足的癌症治疗需求方面的潜力充满信心。诸如Xcell Biosciences和aCGT Vector于2023年10月达成的合作,旨在开发和测试基因疗法,这些合作正在推动创新和扩充性。此外,欧洲创新委员会 (EIC) 加速器等计画的资助正在支持溶瘤病毒疗法、嵌合体抗原受体 (CAR) T细胞疗法等的临床开发。 EIC加速器于2023年向Elicera Therapeutics AB提供了267万美元。
癌症发生率上升
全球癌症发生率的上升推动了对创新治疗方法的需求。预计到2023年,美国新增癌症病例将增加至192万,凸显了对有效治疗的迫切需求。 CAR-T疗法和溶瘤病毒疗法等基因疗法针对晚期肿瘤,提供个人化治疗方案并提高缓解率。癌症盛行率的上升,加上传统疗法的局限性,使得基因疗法成为一种创新疗法,尤其适用于非肌肉浸润性膀胱癌 (NMIBC) 和骨髓恶性肿瘤。
有利的法规环境
支持性法律规范,尤其是在美国,正在推动市场成长。 FDA 于 2023 年 12 月核准了Adstiladrin 用于治疗非肌肉层性膀胱炎 (NMIBC),并于 2023 年 5 月批准了 Vyjuvek 用于治疗营养不良性先天性水疱症,这表明该公司致力于加快创新疗法的研发。 FDA 还简审类,例如 REGENXBIO 公司于 2023 年 4 月批准了 RGX-202 用于治疗Duchenne氏肌肉失养症营养不良症,这进一步简化了研发流程并加快了市场发展。
市场限制
高昂的治疗费用,例如Bluebird Bio公司于2023年8月核准的基因疗法,其标价高达280万美元,限制了患者和医疗保健系统的可及性。基因改造需要大量的临床检验和合规性,而其复杂的法律规范和伦理担忧也阻碍了治疗进展。此外,供应链压力,包括对脂质前驱物和质体DNA等关键原料征收关税,可能会增加生产成本并减缓可扩展性。
The cancer gene therapy market is expected to grow from USD 3.484 billion in 2025 to USD 8.561 billion in 2030, at a CAGR of 19.70%.
The cancer gene therapy market is projected to experience robust growth from 2025 to 2030, driven by increasing research and development (R&D) investments and the rising global incidence of cancer. This innovative field focuses on modifying genetic material within cancer cells to correct defective genes, introduce therapeutic genes, or enhance immune responses, offering potential for long-term remission in advanced cancers. The market is propelled by advancements in gene editing, oncolytic virotherapy, and immunotherapy, supported by favorable regulatory environments and significant funding. North America, particularly the United States, dominates due to its advanced healthcare infrastructure and high cancer prevalence. Challenges include high treatment costs and complex regulatory frameworks.
Market Drivers
Increasing Research and Development Investments
Significant R&D investments are fueling advancements in cancer gene therapy. In 2023, the National Institutes of Health (NIH) allocated over $1 billion for gene therapy research, reflecting strong confidence in its potential to address unmet cancer treatment needs. Collaborations, such as the partnership between Xcell Biosciences and aCGT Vector in October 2023 to develop and test gene therapies, are enhancing innovation and scalability. Additionally, funding from programs like the European Innovation Council (EIC) Accelerator, which provided Elicera Therapeutics AB with $2.67 million in 2023, supports clinical development, particularly for oncolytic virotherapy and chimeric antigen receptor (CAR) T-cell therapies.
Rising Cancer Incidence
The global cancer burden is escalating, driving demand for innovative therapies. In the United States, new cancer cases rose to 1.92 million in 2023, underscoring the urgent need for effective treatments. Gene therapies, such as CAR-T and oncolytic virotherapy, target advanced-stage tumors and offer personalized solutions, enhancing remission rates. The growing prevalence of cancer, combined with the limitations of conventional treatments, positions gene therapy as a transformative approach, particularly for cancers like non-muscle-invasive bladder cancer (NMIBC) and hematological malignancies.
Favorable Regulatory Environment
Supportive regulatory frameworks, particularly in the United States, are accelerating market growth. The FDA's approval of therapies like Adstiladrin in December 2023 for NMIBC and Vyjuvek in May 2023 for dystrophic epidermolysis bullosa demonstrates a commitment to expediting innovative treatments. The FDA's fast-track designations, such as for REGENXBIO's RGX-202 for Duchenne muscular dystrophy in April 2023, further streamline development, encouraging market expansion.
Market Restraints
High treatment costs, such as the $2.8 million price tag for Bluebird Bio's gene therapy approved in August 2023, pose significant affordability challenges, limiting access for patients and healthcare systems. Complex regulatory frameworks and ethical concerns surrounding genetic modifications also hinder progress, requiring extensive clinical validation and compliance. Additionally, supply chain pressures, including tariffs on critical raw materials like lipid precursors and plasmid DNA, increase production costs and may delay scalability.
Market Segmentation
By Therapy Type
The market includes gene-induced immunotherapy, oncolytic virotherapy, and gene transfer therapy. Immunotherapy dominates due to its effectiveness in enhancing immune responses, with CAR-T therapies like Kymriah and Yescarta leading in hematological cancers. Oncolytic virotherapy is gaining traction for its dual action of destroying cancer cells and stimulating immunity.
By Vector Type
Viral vectors, particularly adeno-associated viruses (AAV) and lentiviruses, lead due to their high efficacy in gene delivery. Non-viral vectors, such as oligonucleotides, are emerging but hold a smaller share.
By Geography
North America, led by the United States, holds the largest market share, driven by a 36.5% valuation of $1.3 billion in 2023, robust R&D, and high cancer prevalence. Asia-Pacific is the fastest-growing region, with a projected CAGR of 27.2% in 2025, fueled by increasing healthcare investments in China, Japan, and India.
The cancer gene therapy market is set for significant growth from 2025 to 2030, driven by rising R&D investments, increasing cancer incidence, and supportive regulations. Despite challenges like high costs and regulatory complexities, advancements in immunotherapy and oncolytic virotherapy, coupled with strategic collaborations, are reshaping cancer treatment. North America leads, while Asia-Pacific's rapid growth signals global expansion. Industry players must focus on cost-effective innovations and scalable manufacturing to meet rising demand.
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