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市场调查报告书
商品编码
1800232
全球基因治疗市场 - 2025 年至 2030 年预测Global Gene Therapy Market - Forecasts fom 2025 to 2030 |
基因治疗市场预计将从 2025 年的 78.76 亿美元成长到 2030 年的 184.19 亿美元,复合年增长率为 18.52%。
基因治疗市场预计将在 2025 年至 2030 年期间经历强劲增长,这得益于研发投入的增加以及癌症等疾病发病率的上升。基因治疗透过纠正或取代缺陷基因来治疗或预防疾病,由于其在治疗癌症和罕见遗传疾病等复杂疾病方面的潜力,正日益受到欢迎。免疫疗法的进步、良好的法规环境以及创新疗法资金的增加为基因治疗市场提供了支持。在巨额研发投入和高癌症发生率的推动下,美国引领市场。然而,高昂的治疗费用和复杂的法规也带来了挑战。
市场驱动因素
癌症发生率上升
癌症发生率的上升是基因治疗市场的主要驱动力。预计到2022年,美国癌症患者人数将增加至约192万,导致60.9万人死亡,凸显了对创新疗法的迫切需求。基因疗法,尤其是透过免疫疗法针对晚期肿瘤的基因疗法,因其能够提高缓解率而日益重要。不断增长的患者群体推动了对各种癌症类型提供标靶解决方案的治疗需求,例如嵌合体抗原受体T细胞(CAR-T)和基于载体的疗法。
增加研发投入
基因治疗研发的大量投入正在推动市场成长。世界卫生组织 (WHO) 报告称,2023 年,包括基因疗法在内的全球医疗保健研发支出呈上升趋势,西太平洋国家领先,占 GDP 的 0.07%。在美国,美国国立卫生研究院 (NIH) 为基因治疗研究拨出大量资金,以促进癌症和罕见疾病治疗的创新。此类投资支持溶瘤病毒疗法和基于载体的治疗方法等先进治疗方法的开发,从而推动市场渗透。
有利的法规环境
监管环境,尤其是在美国,正在支撑市场成长。 FDA 于 2023 年 5 月核准了用于治疗营养不良性大疱性先天性水疱症症的 Vyjuvek,并于 2022 年 12 月批准了用于治疗非肌肉层浸润性膀胱癌的 Adstiladrin,这体现了其致力于推进基因治疗发展的决心。这些核准,加上简化的监管途径,正在刺激创新和市场准入,支持基因治疗在各种适应症中的应用。
市场限制
基因治疗市场面临挑战,因为高昂的治疗费用(每位患者高达数百万美元)限制了基因治疗的可近性,尤其是在新兴市场。监管的复杂性,包括严格的安全性和有效性要求,导致核准延迟并增加开发成本。此外,基因疗法的生产过程(例如病毒载体)的复杂性也带来了可扩展性的挑战。透过成本优化和生产流程标准化来克服这些障碍,对于市场的持续成长至关重要。
The global gene therapy market is expected to grow from USD7.876 billion in 2025 to USD18.419 billion in 2030, at a CAGR of 18.52%.
The global gene therapy market is experiencing robust growth from 2025 to 2030, driven by increased investment in research and development (R&D) and the rising prevalence of diseases like cancer. Gene therapy, which involves modifying or replacing defective genes to treat or prevent diseases, is gaining traction due to its potential to address complex conditions such as cancer and rare genetic disorders. The market is propelled by advancements in immunotherapy, favorable regulatory environments, and growing funding for innovative treatments. The United States leads the market, supported by significant R&D investments and a high incidence of cancer. However, high treatment costs and regulatory complexities may pose challenges.
Market Drivers
Rising Prevalence of Cancer
The increasing incidence of cancer is a primary driver of the gene therapy market. In the United States, cancer cases rose to approximately 1.92 million in 2022, with 609,000 deaths, underscoring the urgent need for innovative treatments. Gene therapies, particularly those targeting advanced-stage tumors through immunotherapy, are gaining importance for their ability to improve remission rates. The growing patient pool drives demand for therapies like chimeric antigen receptor T-cell (CAR-T) and vector-based treatments, which offer targeted solutions for various cancer types.
Increased R&D Investment
Significant investments in gene therapy R&D are fueling market growth. In 2023, the World Health Organization reported that global healthcare R&D spending, including for gene therapy, continues to rise, with Western Pacific countries leading at 0.07% of GDP. In the United States, the National Institutes of Health (NIH) allocated substantial funding for gene therapy research, fostering innovation in treatments for cancer and rare diseases. These investments support the development of advanced therapies, such as oncolytic virotherapy and vector-based treatments, enhancing market penetration.
Favorable Regulatory Environment
The regulatory landscape, particularly in the United States, supports market growth. The FDA's approval of therapies like Vyjuvek in May 2023 for dystrophic epidermolysis bullosa and Adstiladrin in December 2022 for non-muscle-invasive bladder cancer demonstrates a commitment to advancing gene therapy. These approvals, coupled with streamlined regulatory pathways, encourage innovation and market entry, boosting the adoption of gene therapies for various indications.
Market Restraints
The gene therapy market faces challenges due to the high cost of treatments, often reaching millions of dollars per patient, which limits accessibility, particularly in developing regions. Regulatory complexities, including stringent safety and efficacy requirements, can delay approvals and increase development costs. Additionally, the complexity of manufacturing gene therapies, such as viral vectors, poses scalability challenges. Addressing these barriers through cost optimization and standardized production processes will be critical for sustained market growth.
Market Segmentation
By Application
The market is segmented into oncology, rare genetic disorders, neurological disorders, and others. Oncology dominates due to the high prevalence of cancer and the focus on immunotherapies like CAR-T and oncolytic virotherapy. Rare genetic disorders, such as Duchenne muscular dystrophy, are also significant, driven by therapies like RGX-202.
By Geography
The market is segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America, led by the United States, holds a dominant share due to its high cancer incidence, substantial R&D funding, and favorable regulatory environment. Asia-Pacific is expected to grow rapidly, driven by increasing healthcare investments and rising disease prevalence in countries like India. Europe, South America, and the Middle East and Africa are emerging markets, supported by improving healthcare infrastructure.
The gene therapy market is set for robust growth from 2025 to 2030, driven by rising cancer prevalence, increased R&D investment, and favorable regulations, particularly in the United States. Despite challenges from high costs and regulatory complexities, the market's outlook remains positive, with strong growth in North America and Asia-Pacific. Industry players must focus on cost-effective therapies, scalable manufacturing, and strategic collaborations to capitalize on the growing demand for innovative gene therapy solutions.
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