市場調查報告書
商品編碼
1452617
北美細胞和基因治療製造服務市場預測至 2030 年 - 區域分析 - 按類型、適應症(癌症、骨科等)、應用(臨床製造和商業製造)和最終用戶North America Cell and Gene Therapy Manufacturing Services Market Forecast to 2030 - Regional Analysis - by Type, Indication (Cancer, Orthopedics, and Others), Application (Clinical Manufacturing and Commercial Manufacturing), and End User |
北美細胞和基因治療製造服務市場預計將從2022年的41.5327億美元成長到2030年的147.1172億美元。預計2022年至2030年CAGR為17.1%。
外包細胞和基因治療製造的日益普及推動北美細胞和基因治療製造服務市場
細胞和基因療法的製造是一個複雜的過程,這使得正確執行和監督操作至關重要。細胞和基因治療製造商了解生物和製程工程的合格人員數量有限。此外,對於經驗豐富的團隊來說,使用手動和開放製造方法來管理首次臨床試驗的嘗試,然後建立更適合商業的流程可能會很棘手。因此,這些企業選擇與合約開發和製造組織(CDMO)合作來加速其臨床研究和商業化進程。 CDMO 以合約形式向細胞和基因治療公司提供產品開發、製造、臨床試驗支援和商業化服務。與 CDMO 合作可以幫助細胞和基因療法製造商實現可擴展性、加快上市速度、無需管理成本即可獲得技術專業知識以及成本效率。 2022年4月,ThermoGenesis在美國加州建立了CDMO設施,利用其在T細胞受體(TCR)、嵌合抗原受體-T細胞(CAR-T細胞)、腫瘤等領域的專業知識,為細胞和基因治療製造商提供CDMO服務。- 浸潤白血球(TIL)、iPSC、自然殺手細胞(NK)和間質幹細胞(MSC)製造。事實證明,將細胞和基因治療製造外包給 CDMO 對於製造商來說具有成本效益。因此,越來越傾向於將不斷成長的細胞和基因治療製造外包給 CDMO,這推動了北美細胞和基因治療製造服務市場的成長。
北美細胞與基因治療製造服務市場概述
細胞和基因療法 (CGT) 治療患有嚴重和罕見疾病且治療需求未滿足的患者。製造 CGT 是一個高度複雜的過程,基礎設施和專業知識的不足是一個主要限制。與中間體和最終產品相關的物流挑戰也限制了公司的 CGT 製造能力。 CGT的製造過程包括透過「單採術」提取自體細胞,將其送往專門實驗室,然後送回診所給患者施用,所有這些都必須在嚴格的品質控制下進行。美國食品藥物管理局 (USFDA) 僅批准了 7 種 CGT 藥物,新產品管線達到約 1,200 種實驗療法。其中一半處於2 期臨床試驗中,根據2022 年《化學與工程新聞》報告的估計,細胞療法的年銷售額成長預計為15%,基因療法的年銷售額成長約為30%。2022 年3 月31 日, CELL Technologies Inc. 宣布已提交其疼痛和關節炎幹細胞計畫的臨床資料,以供加拿大衛生部批准,以幫助患者在加拿大各地獲得基於證據和監管批准的幹細胞程序。因此,預計上述因素將在預測期內促進細胞和基因治療製造服務市場的成長。因此,上述因素推動了北美細胞和基因治療製造服務市場的成長。
北美細胞和基因治療製造服務市場收入及 2030 年預測(百萬美元)
北美細胞和基因治療製造服務市場細分
北美細胞和基因治療製造服務市場分為類型、適應症、應用、最終用戶和國家。
根據類型,北美細胞和基因治療製造服務市場分為細胞治療和基因治療。 2022年,細胞治療領域在北美細胞和基因治療製造服務市場中佔據更大佔有率。細胞治療部分進一步分為自體細胞治療和同種異體細胞治療。基因治療部分進一步細分為病毒載體和非病毒載體。
根據跡象,北美細胞和基因治療製造服務市場分為癌症、骨科等。 2022年,癌症領域在北美細胞和基因治療製造服務市場中佔據最大佔有率。
根據應用,北美細胞和基因治療製造服務市場分為臨床製造和商業製造。 2022年,商業製造領域在北美細胞和基因治療製造服務市場中佔據最大佔有率。
根據最終用戶,北美細胞和基因治療製造服務市場分為製藥和生物技術公司和合約研究組織(CRO)。 2022年,製藥和生物技術公司部門在北美細胞和基因治療製造服務市場中佔據更大佔有率。
根據國家/地區,北美細胞和基因治療製造服務市場分為美國、加拿大和墨西哥。 2022年,美國在北美細胞和基因治療製造服務市場中佔據最大佔有率。
Catalent Inc、Charles River Laboratories International Inc、FUJIFILM Holdings Corp、Lonza Group AG、Merck KgaA、National Resilience Inc、Nikon Corp、Oxford BioMedica Plc、Takara Bio Inc、Thermo Fisher Scientific Inc 和 WuXi AppTec Co Ltd 是一些領先的公司在 Bio Inc、Thermo Fisher Scientific Inc 和 WuXi AppTec Co Ltd 是一些領先的公司在 Bio Inc、Thermo Fisher Scientific Inc 和 WuXi AppTec Co Ltd 是一些領先的公司在 Bio Inc、Thermo Fisher Scientific Inc 和 WuXi AppTec Co Ltd 是一些領先的公司在 Bio Inc、Thermo Fisher Scientific Inc 和 WuXi AppTec Co Ltd 是一些領先的公司在 Bio Inc、Thermo Fisher Scientific Inc 和 WuXi AppTec Co Ltd北美細胞和基因治療製造服務市場營運的公司。
The North America cell and gene therapy manufacturing services market is expected to grow from US$ 4,153.27 million in 2022 to US$ 14,711.72 million by 2030. It is estimated to grow at a CAGR of 17.1% from 2022 to 2030.
Increasing Popularity of Outsourcing Cell and Gene Therapy Manufacturing Drives North America Cell and Gene Therapy Manufacturing Services Market
Cell and gene therapy manufacturing is a complex process, which makes the proper execution and overseeing of the operation crucial. Cell and gene therapy manufacturers have a limited number of qualified personnel who know biological and process engineering. Moreover, for experienced teams, managing the attempts to reach the first clinical trial using a manual, and open manufacturing method and then building a more commercially suitable process can be tricky. Therefore, these enterprises choose to work with contract development and manufacturing organizations (CDMOs) to accelerate their clinical studies and commercialization process. CDMOs provide product development, manufacturing, clinical trial support, and commercialization services to cell and gene therapy companies on a contract basis. Partnering with a CDMO enables scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies for cell and gene therapy manufacturers. In April 2022, ThermoGenesis established a CDMO facility in California, US to provide CDMO services to cell and gene therapy manufacturers, using its expertise in T-cell receptor (TCR), chimeric antigen receptor-T cell (CAR-T cell), tumor-infiltrating leukocyte (TIL), iPSC, natural killer cell (NK), and mesenchymal stem cell (MSC) manufacturing. Outsourcing cell and gene therapy manufacturing to CDMOs proves cost-effective for manufacturers. Thus, the increasing preference for outsourcing growing cell and gene therapy manufacturing to CDMOs fuels the North America cell and gene therapy manufacturing services market growth.
North America Cell and Gene Therapy Manufacturing Services Market Overview
Cell and gene therapies (CGTs) treat patients suffering from serious and rare diseases with unaddressed therapeutic needs. Manufacturing CGTs is a highly complex process, with the insufficiency of infrastructure and expertise being a major limiting factor. Logistical challenges associated with intermediates and the final product also limit the CGT manufacturing capacity of companies. The CGT manufacturing process involves the extraction of autologous cells through "apheresis," dispatching them to specialized labs, and sending them back to clinics for administration into patients, all of which must be performed with strict quality control. The US Food and Drug Administration (USFDA) has approved only 7 CGT drugs, with the pipeline of new products reaching ~1,200 experimental therapies. Half of these are in Phase 2 clinical trials, with estimates of annual sales growth accounting for 15% for cell therapies and ~30% for gene therapies, as per the estimates of the Chemical & Engineering News report 2022. On March 31, 2022, CELL Technologies Inc. announced the submission of the clinical data of its stem cell program in pain and arthritis for approval by Health Canada to help patients access evidence-based and regulatory-approved stem cell procedures across Canada. Thus, the abovementioned factors are expected to promote the cell and gene therapy manufacturing services market growth during the forecast period. Thus, the abovementioned factors are responsible for the growth of the North America cell and gene therapy manufacturing services market.
North America Cell and Gene Therapy Manufacturing Services Market Revenue and Forecast to 2030 (US$ Million)
North America Cell and Gene Therapy Manufacturing Services Market Segmentation
The North America cell and gene therapy manufacturing services market is segmented into type, indication, application, end user, and country.
Based on type, the North America cell and gene therapy manufacturing services market is bifurcated into cell therapy and gene therapy. In 2022, the cell therapy segment registered a larger share in the North America cell and gene therapy manufacturing services market. The cell therapy segment is further segmented into autologous and allogenic. The gene therapy segment is further segmented into viral and non-viral vector.
Based on indication, the North America cell and gene therapy manufacturing services market is segmented into cancer, orthopedics, and others. In 2022, the cancer segment registered the largest share in the North America cell and gene therapy manufacturing services market.
Based on application, the North America cell and gene therapy manufacturing services market is segmented into clinical manufacturing and commercial manufacturing. In 2022, the commercial manufacturing segment registered the largest share in the North America cell and gene therapy manufacturing services market.
Based on end user, the North America cell and gene therapy manufacturing services market is bifurcated into pharmaceutical and biotechnology companies and contract research organization (CROs). In 2022, the pharmaceutical and biotechnology companies segment registered a larger share in the North America cell and gene therapy manufacturing services market.
Based on country, the North America cell and gene therapy manufacturing services market is segmented into the US, Canada, Mexico. In 2022, the US registered the largest share in the North America cell and gene therapy manufacturing services market.
Catalent Inc, Charles River Laboratories International Inc, FUJIFILM Holdings Corp, Lonza Group AG, Merck KgaA, National Resilience Inc, Nikon Corp, Oxford BioMedica Plc, 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 manufacturing services market.