市場調查報告書
商品編碼
1452635
南美洲和中美洲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South & Central 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 |
南美洲和中美洲細胞和基因治療製造服務市場預計將從2022年的2.8683億美元成長到2030年的9.8118億美元。預計2022年至2030年CAGR為16.6%。
外包細胞和基因治療製造的日益普及推動了南美洲和中美洲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。此外,2020年3月,Fujifilm Cellular Dynamics(FCDI)投資2,100萬美元建造符合cGMP的生產設施,該設施將用於製造FCDI使用誘導多能幹細胞(iPSC)的再生醫學療法的管道並提供CDMO服務用於生產iPSC 和iPSC 衍生的分化細胞。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。此外,他們還可以獲得 CDMO 技術先進的基礎設施和專業知識。 CDMO 採用適當的、映射的流程來製造細胞和基因療法。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,推動了南美洲和中美洲細胞和基因治療製造服務市場的成長。
南美洲和中美洲細胞和基因治療製造服務市場概述
《法律商業研究2020》發表的題為《巴西批准首個基因治療產品》的報告顯示,巴西是拉丁美洲家中第一個批准銷售基因治療產品的國家。具體來說,巴西衛生監管局(ANVISA)授予諾華基因治療產品Luxturna和Zolgensma的上市許可。這兩款產品均獲得了巴西生物安全技術委員會(CTNBio)的批准,該委員會負責評估巴西基因改造生物的生物安全性。根據 Clinical Trials Arena 的數據,2021 年,巴西佔全球臨床試驗活動的 1.7% 佔有率。 2022 年 7 月,波士頓 CRO 收購了位於裡約熱內盧的 Instituto Brasil de Pesquisa Clinica (IBPClin),並將其描述為在拉丁美洲採用分散式臨床試驗交付模式的第一步。該公司聲稱已開展了 160 多項行業資助的研究,在巴西 12 個州招募了 7,000 多名參與者。
南美洲和中美洲細胞和基因治療製造服務市場收入及 2030 年預測(百萬美元)
南美洲和中美洲細胞和基因治療製造服務市場細分
南美洲和中美洲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,南美洲和中美洲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,細胞治療領域在南美洲和中美洲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,南美洲和中美洲細胞和基因治療製造服務市場分為癌症、骨科等。 2022年,癌症領域在南美洲和中美洲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,南美洲和中美洲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,商業製造領域在南美洲和中美洲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,南美洲和中美洲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南美洲和中美洲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,南美洲和中美洲細胞和基因治療製造服務市場分為巴西、阿根廷以及南美洲和中美洲其他地區。 2022年,巴西在南美洲和中美洲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、Lonza Group AG、Merck KgaA、Nikon Corp、Takara Bio Inc 和 Thermo Fisher Scientific Inc 是南美洲和中美洲細胞和基因治療製造服務市場的一些領先公司。
The South & Central America cell and gene therapy manufacturing services market is expected to grow from US$ 286.83 million in 2022 to US$ 981.18 million by 2030. It is estimated to grow at a CAGR of 16.6% from 2022 to 2030.
Increasing Popularity of Outsourcing Cell and Gene Therapy Manufacturing Drives South & Central 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. Further, in March 2020, Fujifilm Cellular Dynamics (FCDI) invested US$ 21 million in the cGMP-compliant production facility, which would be used for manufacturing FCDI's pipeline of regenerative medicine therapies using induced pluripotent stem cells (iPSCs) and to provide CDMO services for production of iPSCs and iPSC-derived differentiated cells. Outsourcing cell and gene therapy manufacturing to CDMOs proves cost-effective for manufacturers. Moreover, they gain access to the technologically advanced infrastructure and expertise of CDMOs. CDMOs employ proper, mapped processes for manufacturing cell and gene therapies. Thus, the increasing preference for outsourcing growing cell and gene therapy manufacturing to CDMOs fuels the South & Central America cell and gene therapy manufacturing services market growth.
South & Central America Cell and Gene Therapy Manufacturing Services Market Overview
According to a report titled "First Gene Therapy Products Approved in Brazil," published by Law Business Research 2020, Brazil is the first among the Latin American countries to approve the marketing of gene therapy products. Specifically, the Brazilian Health Regulatory Agency (ANVISA) granted marketing authorization for Novartis' gene therapy products Luxturna and Zolgensma. Both products have been approved by the Brazilian Technical Commission of Biosafety (CTNBio), which is responsible for evaluating the biosafety of genetically modified organisms in Brazil. According to Clinical Trials Arena, in 2021, Brazil accounted for a 1.7% share of the global clinical trials activity. In July 2022, Boston CRO acquired Rio de Janeiro-based Instituto Brasil de Pesquisa Clinica (IBPClin), describing it as the first step toward adopting its decentralized clinical trial delivery model in Latin America. It claims to have conducted more than 160 industry-sponsored research studies, enrolling more than 7,000 participants across 12 Brazilian states.
South & Central America Cell and Gene Therapy Manufacturing Services Market Revenue and Forecast to 2030 (US$ Million)
South & Central America Cell and Gene Therapy Manufacturing Services Market Segmentation
The South & Central America cell and gene therapy manufacturing services market is segmented into type, indication, application, end user, and country.
Based on type, the South & Central 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 South & Central 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 South & Central 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 South & Central America cell and gene therapy manufacturing services market.
Based on application, the South & Central 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 South & Central America cell and gene therapy manufacturing services market.
Based on end user, the South & Central 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 South & Central America cell and gene therapy manufacturing services market.
Based on country, the South & Central America cell and gene therapy manufacturing services market is segmented into Brazil, Argentina, and the Rest of South & Central America. In 2022, Brazil registered the largest share in the South & Central America cell and gene therapy manufacturing services market.
Catalent Inc, Charles River Laboratories International Inc, Lonza Group AG, Merck KgaA, Nikon Corp, Takara Bio Inc, and Thermo Fisher Scientific Inc are some of the leading companies operating in the South & Central America cell and gene therapy manufacturing services market.