![]() |
市場調查報告書
商品編碼
1764840
2031年北美細胞和基因治療市場預測—區域分析—按類型、服務、規模、服務提供者和最終用戶North America Cell and Gene Therapy Market Forecast to 2031 - Regional Analysis - by Type, Services, Scale, Service Providers, and End User |
2023 年北美細胞和基因治療市值為 21.5908 億美元,預計到 2031 年將達到 140.4906 億美元;預計 2023 年至 2031 年的複合年成長率為 26.4%。
細胞和基因療法獲批數量的增加推動了北美細胞和基因治療市場的發展
生物技術的進步使得個人化治療得以應用於各種疾病。幹細胞療法正被用於治療癌症、神經系統疾病、遺傳性疾病和其他慢性疾病。此外,細胞療法的優點還包括標靶治療、快速有效的恢復以及較少的副作用。由於美國食品藥物管理局 (FDA) 批准了多種細胞療法產品,因此該療法在世界各地都已廣泛應用。本文提到了 FDA 近年來批准的一些細胞和基因治療產品;2024 年 4 月,FDA 批准輝瑞公司使用 BEQVEZ 治療正在接受因子 IX (FIX) 預防治療的中度至重度血友病 B 成人患者。 FIX 缺乏會導致血友病 B(一種罕見的遺傳性出血性疾病)患者比健康人出血更頻繁、出血時間更長。這種疾病會阻礙正常的血液凝固。 2023年,FDA批准了Krystal Biotech公司生產的VYJUVEK,用於治療6個月及以上患有營養不良性大皰性表皮鬆解症(VII型膠原α1鏈(COL7A1)基因突變)患者的傷口。 2023年,Ferring Pharmaceuticals A/S公司生產的腺病毒ADSTILADRIN獲得FDA核准。這種重組腺病毒(rAd-IFNa/Syn3)可將人類干擾素α-2b cDNA遞送至膀胱上皮,用於治療某些類型的膀胱癌患者。 2023年,Janssen Biotech公司生產的CARVYKTI也獲得了FDA批准,這是一種利用慢病毒改造的自體CAR-T細胞,用於攻擊表達BCMA的腫瘤細胞,用於治療某些類型的複發性或難治性多發性骨髓瘤。 2023 年,FDA 批准了 CSL Behring LLC 生產的 HEMGENIX,這是一種重組 AAV5,可遞送 F9,用於治療某些類型的血友病 B 患者。 2021 年 3 月,美國 FDA 批准首個用於治療復發或抗藥性多發性骨髓瘤的抗 BCMA CAR-T 細胞療法 Abecma (idecabtagene vicleucel),供百時美施貴寶和藍鳥生物使用。 2020 年 4 月,FDA 授予諾華公司的 Kymriah 再生醫學先進療法稱號,用於治療成人難治性 (r/r) 濾泡性淋巴瘤 (FL)。 2020 年 7 月,FDA 批准了一種用於治療套細胞淋巴瘤患者的 CAR-T 細胞療法 brexucabtagene autoleucel (Tecartus)。這是FDA批准的首個用於治療套細胞淋巴瘤的CAR-T細胞療法,並根據加速核准程序獲得批准。 Tecartus也獲得了孤兒藥資格認定,該資格旨在鼓勵罕見疾病藥物的研發。其他核准的癌症CAR-T細胞療法包括用於治療急性淋巴性白血病的Kymriah和用於治療瀰漫大B細胞淋巴瘤的Yescarta。因此,細胞和基因療法獲批數量的增加提升了生產能力,推動了北美細胞和基因治療市場的成長。
北美細胞和基因治療市場概覽
北美的細胞和基因治療市場分為美國、加拿大和墨西哥。 2023 年,美國佔據了北美最大的細胞和基因療法市場。美國細胞和基因治療市場的成長歸因於幹細胞、基因和免疫療法等細胞療法的日益普及。遺傳和細胞疾病的發生率不斷上升,導致對細胞療法的需求增加。根據美國基因與細胞治療學會 (ASGCT) 的數據,目前有 3,633 種療法正在研發中,其中 55% 為基因療法,22% 為非基因改造細胞療法,23% 為 RNA 療法,這些療法處於臨床前到預註冊階段。這些療法針對各種疾病和病症,從癌症到遺傳性疾病再到神經系統疾病。截至 2024 年 2 月,美國已批准 19 種細胞和基因療法產品,用於治療癌症、眼部疾病和罕見遺傳性疾病。此外,美國正在經歷越來越多的細胞療法創新新創公司。此外,政府日益成長的支持也促進了細胞療法的發展,影響市場的發展。例如,美國基因與細胞治療學會(ASGCT)是一個公共組織,為從事基因和細胞療法的科學家、醫生、專業人士和患者權益倡導者提供會員資格。 ASGCT 旨在提升人們對細胞和基因療法臨床應用的認知、教育和認知。
北美細胞和基因治療市場收入及預測(2031年)(百萬美元)
北美細胞和基因治療市場細分
北美細胞和基因治療市場按類型、服務、規模、最終用戶和國家分類。
根據類型,北美細胞和基因治療市場分為細胞治療和基因治療。 2023年,細胞治療佔據了更大的市場。此外,細胞治療細分市場又細分為同種異體載體、自體載體和病毒載體。基因治療細分市場又細分為非病毒載體和病毒載體。
就服務而言,北美細胞和基因治療市場分為製程開發、cGMP製造、監管服務和生物測定服務。製程開發領域在2023年佔據了最大的市場。
按規模分類,北美細胞和基因治療市場分為商業化前/研發生產和商業化規模生產。 2023年,商業化前/研發生產領域佔據了更大的市場佔有率。
根據最終用戶,北美細胞和基因治療市場細分為合約研究組織 (CRO)、製藥和生物製藥公司以及學術和研究機構。 CRO 在 2023 年佔據了最大的市場佔有率。
按國家/地區分類,北美細胞和基因治療市場分為美國、加拿大和墨西哥。 2023年,美國佔據了北美細胞和基因治療市場的主導地位。
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. 和無錫藥明康德股份有限公司是北美細胞和基因治療市場的一些領先公司。
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.