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市场调查报告书
商品编码
1764840
2031年北美细胞和基因治疗市场预测—区域分析—按类型、服务、规模、服务提供者和最终用户North America Cell and Gene Therapy Market Forecast to 2031 - Regional Analysis - by Type, Services, Scale, Service Providers, and End User |
2023 年北美细胞和基因治疗市值为 21.5908 亿美元,预计到 2031 年将达到 140.4906 亿美元;预计 2023 年至 2031 年的复合年增长率为 26.4%。
细胞和基因疗法获批数量的增加推动了北美细胞和基因治疗市场的发展
生物技术的进步使得个人化治疗得以应用于各种疾病。干细胞疗法正被用于治疗癌症、神经系统疾病、遗传性疾病和其他慢性疾病。此外,细胞疗法的优点还包括标靶治疗、快速有效的恢復以及较少的副作用。由于美国食品药物管理局 (FDA) 批准了多种细胞疗法产品,因此该疗法在世界各地都已广泛应用。本文提到了 FDA 近年来批准的一些细胞和基因治疗产品;2024 年 4 月,FDA 批准辉瑞公司使用 BEQVEZ 治疗正在接受因子 IX (FIX) 预防治疗的中度至重度血友病 B 成人患者。 FIX 缺乏会导致血友病 B(一种罕见的遗传性出血性疾病)患者比健康人出血更频繁、出血时间更长。这种疾病会阻碍正常的血液凝固。 2023年,FDA批准了Krystal Biotech公司生产的VYJUVEK,用于治疗6个月及以上患有营养不良性大疱性表皮鬆解症(VII型胶原α1链(COL7A1)基因突变)患者的伤口。 2023年,Ferring Pharmaceuticals A/S公司生产的腺病毒ADSTILADRIN获得FDA核准。这种重组腺病毒(rAd-IFNa/Syn3)可将人类干扰素α-2b cDNA递送至膀胱上皮,用于治疗某些类型的膀胱癌患者。 2023年,Janssen Biotech公司生产的CARVYKTI也获得了FDA批准,这是一种利用慢病毒改造的自体CAR-T细胞,用于攻击表达BCMA的肿瘤细胞,用于治疗某些类型的复发性或难治性多发性骨髓瘤。 2023 年,FDA 批准了 CSL Behring LLC 生产的 HEMGENIX,这是一种重组 AAV5,可递送 F9,用于治疗某些类型的血友病 B 患者。 2021 年 3 月,美国 FDA 批准首个用于治疗復发或抗药性多发性骨髓瘤的抗 BCMA CAR-T 细胞疗法 Abecma (idecabtagene vicleucel),供百时美施贵宝和蓝鸟生物使用。 2020 年 4 月,FDA 授予诺华公司的 Kymriah 再生医学先进疗法称号,用于治疗成人难治性 (r/r) 滤泡性淋巴瘤 (FL)。 2020 年 7 月,FDA 批准了一种用于治疗套细胞淋巴瘤患者的 CAR-T 细胞疗法 brexucabtagene autoleucel (Tecartus)。这是FDA批准的首个用于治疗套细胞淋巴瘤的CAR-T细胞疗法,并根据加速审批程序获得批准。 Tecartus也获得了孤儿药资格认定,该资格旨在鼓励罕见疾病药物的研发。其他核准的癌症CAR-T细胞疗法包括用于治疗急性淋巴性白血病的Kymriah和用于治疗瀰漫大B细胞淋巴瘤的Yescarta。因此,细胞和基因疗法获批数量的增加提升了生产能力,推动了北美细胞和基因治疗市场的成长。
北美细胞和基因治疗市场概览
北美的细胞和基因治疗市场分为美国、加拿大和墨西哥。 2023 年,美国占据了北美最大的细胞和基因疗法市场。美国细胞和基因治疗市场的成长归因于干细胞、基因和免疫疗法等细胞疗法的日益普及。遗传和细胞疾病的发生率不断上升,导致对细胞疗法的需求增加。根据美国基因与细胞治疗学会 (ASGCT) 的数据,目前有 3,633 种疗法正在研发中,其中 55% 为基因疗法,22% 为非基因改造细胞疗法,23% 为 RNA 疗法,这些疗法处于临床前到预註册阶段。这些疗法针对各种疾病和病症,从癌症到遗传性疾病再到神经系统疾病。截至 2024 年 2 月,美国已批准 19 种细胞和基因疗法产品,用于治疗癌症、眼部疾病和罕见遗传性疾病。此外,美国正在经历越来越多的细胞疗法创新新创公司。此外,政府日益增长的支持也促进了细胞疗法的发展,影响市场的发展。例如,美国基因与细胞治疗学会(ASGCT)是一个公共组织,为从事基因和细胞疗法的科学家、医生、专业人士和患者权益倡导者提供会员资格。 ASGCT 旨在提升人们对细胞和基因疗法临床应用的认知、教育和认识。
北美细胞和基因治疗市场收入及预测(2031年)(百万美元)
北美细胞和基因治疗市场细分
北美细胞和基因治疗市场按类型、服务、规模、最终用户和国家分类。
根据类型,北美细胞和基因治疗市场分为细胞治疗和基因治疗。 2023年,细胞治疗占据了更大的市场。此外,细胞治疗细分市场又细分为同种异体载体、自体载体和病毒载体。基因治疗细分市场又细分为非病毒载体和病毒载体。
就服务而言,北美细胞和基因治疗市场分为製程开发、cGMP製造、监管服务和生物测定服务。製程开发领域在2023年占据了最大的市场。
按规模划分,北美细胞和基因治疗市场分为商业化前/研发生产和商业化规模生产。 2023年,商业化前/研发生产领域占据了更大的市场份额。
根据最终用户,北美细胞和基因治疗市场细分为合约研究组织 (CRO)、製药和生物製药公司以及学术和研究机构。 CRO 在 2023 年占据了最大的市场份额。
按国家/地区划分,北美细胞和基因治疗市场分为美国、加拿大和墨西哥。 2023年,美国占据了北美细胞和基因治疗市场的主导地位。
Catalent Inc.、Charles River Laboratories International Inc.、F. Hoffmann-La Roche Ltd、FUJIFILM Holdings Corp、Lonza Group AG、Lotte Corp、Merck KGaA、Takara Bio Inc、Thermo Fisher Scientific Inc. 和无锡药明康德股份有限公司是北美细胞和基因治疗市场的一些领先公司。
The North America cell and gene therapy market was valued at US$ 2,159.08 million in 2023 and is projected to reach US$ 14,049.06 million by 2031; it is estimated to record a CAGR of 26.4% from 2023 to 2031.
Increase in Number of Approval of Cell and Gene Therapies Boosts North America Cell and Gene Therapy Market
The advancements in biotechnology have led to the adoption of personalized treatments for a wide range of indications. Stem cell therapies are being used to treat cancer, neurological disorders, genetic disorders, and other chronic diseases. Further, the advantages of cell therapy include targeted treatment, rapid and efficient recovery, and reduced side effects. Cell therapies are widely adopted worldwide owing to the availability of Food and Drug Administration (FDA) approved products. A few of the cell and gene therapy products approved by the FDA in recent years are mentioned; In April 2024, the FDA approved BEQVEZ for use by Pfizer Inc. to treat adults suffering from moderate to severe hemophilia B who are on factor IX (FIX) prophylaxis therapy. A FIX deficiency causes people with hemophilia B, a rare genetic bleeding illness, to bleed more frequently and for longer periods than healthy people. The disease hinders normal blood clotting. In 2023, the FDA approved VYJUVEK, manufactured by Krystal Biotech, Inc., for the treatment of wounds in patients ages 6 months and above with dystrophic epidermolysis bullosa, showing mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. In 2023, ADSTILADRIN, an adenovirus manufactured by Ferring Pharmaceuticals A/S, was approved by the FDA. This recombinant adenovirus (rAd-IFNa/Syn3) delivers human interferon alfa-2b cDNA into the bladder epithelium to treat patients with certain types of bladder cancer. In 2023, CARVYKTI, manufactured by Janssen Biotech, Inc.-an autologous CAR-T cell engineered with lentivirus to attack BCMA-expressing tumor cells for the treatment of certain kinds of relapsed or refractory multiple myeloma-was also approved by the FDA. In 2023, the FDA approved HEMGENIX, manufactured by CSL Behring LLC, which is a recombinant AAV5 that delivers F9 to treat patients with certain kinds of Hemophilia B. In March 2021, the first anti-BCMA CAR T cell therapy for relapsed or resistant multiple myeloma, called Abecma (idecabtagene vicleucel), has been approved by the US FDA for use by Bristol Myers Squibb and Bluebird Bio. In April 2020, the FDA awarded regenerative medicine advanced therapy designation to Novartis' Kymriah to treat refractory (r/r) follicular lymphoma (FL) in adults. In July 2020, the FDA approved a CAR T-cell therapy brexucabtagene autoleucel (Tecartus) for patients with mantle cell lymphoma. It is the first FDA-approved CAR T-cell therapy for mantle cell lymphoma, and it was approved under the accelerated approval pathway. Tecartus also received Orphan Drug designation, which encourages the development of drugs for rare diseases. The other approved CAR-T cell therapies for cancer are Kymriah for acute lymphoblastic leukemia and Yescarta for diffuse large B-cell lymphoma. Therefore, the increasing number of approvals of cell and gene therapies enhances manufacturing capabilities, which fuels the North America cell and gene therapy market growth.
North America Cell and Gene Therapy Market Overview
The cell and gene therapy market in North America is segmented into the US, Canada, and Mexico. The US held the largest North American cell and gene therapy market share in 2023. The cell and gene therapies market growth in the US is attributed the growing adoption of cell therapies such as stem cell, gene, and immune therapies. Growing incidences of genetic and cellular disorders are leading to increasing demand for cell therapies. According to the American Society of Gene & Cell Therapy (ASGCT), there are currently 3,633 therapies in the pipeline-55% are gene, 22% are non-genetically modified cells, and 23% are RNA-from preclinical through pre-registration. These are focused on various diseases and conditions varying from cancer to genetic disorders to neurological conditions. As of February 2024, 19 cell and gene therapy products have been approved in the US for treating cancer, eye diseases, and rare hereditary diseases. Also, the country is experiencing an increasing number of start-ups innovating cell therapies. In addition, growing support from the government is promoting the growth of cell therapies, influencing the development of the market. For instance, the American Society of Gene & Cell Therapy (ASGCT), a public organization, offers memberships to scientists, physicians, professionals, and patient advocates who are engaged in gene and cell therapies. ASGCT aims to enhance knowledge, education, and awareness regarding the clinical application of cell and gene therapies.
North America Cell and Gene Therapy Market Revenue and Forecast to 2031 (US$ Million)
North America Cell and Gene Therapy Market Segmentation
The North America cell and gene therapy market is categorized into type, services, scale, end user, and country.
Based on type, the North America cell and gene therapy market is bifurcated into cell therapy and gene therapy. The cell therapy segment held a larger market share in 2023. Furthermore, the cell therapy segment is sub segmented into allogeneic, autologous, viral vectors. Additionally, the gene therapy segment is divided into non-viral vectors and viral vectors.
In terms of services, the North America cell and gene therapy market is categorized process development, cGMP manufacturing, regulatory services, and bioassay services. The process development segment held the largest market share in 2023.
By scale, the North America cell and gene therapy market is bifurcated into pre-commercial/R&D manufacturing and commercial scale manufacturing. The pre-commercial/R&D manufacturing segment held a larger market share in 2023.
Based on end user, the North America cell and gene therapy market is segmented into contract research organizations, pharmaceutical and biopharmaceutical companies, and academic and research institutes. The contract research organizations segment held the largest market share in 2023.
By country, the North America cell and gene therapy market is segmented into the US, Canada, and Mexico. The US dominated the North America cell and gene therapy market share in 2023.
Catalent Inc., Charles River Laboratories International Inc., F. Hoffmann-La Roche Ltd, FUJIFILM Holdings Corp, Lonza Group AG, Lotte Corp, Merck KGaA, Takara Bio Inc, Thermo Fisher Scientific Inc., and WuXi AppTec Co Ltd are some of the leading companies operating in the North America cell and gene therapy market.