South & Central America Cell and Gene Therapy Manufacturing Services Market Forecast to 2030 - Regional Analysis - by Type

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.

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