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High Operational Costs Associated With Cell & Gene Therapy Manufacturing

Growth in cell & gene therapy manufacturing services market is primarily driven by the high incidence of cancer and other target diseases, increasing investments in pharmaceutical R&D, investments in advanced technologies by CDMOs, and increasing partnerships & agreements between pharmaceutical companies and CDMOs. 

 

COVID-19 impact on the Cell & Gene Therapy Manufacturing Services

The pandemic slowed the economic growth of various countries, including the US, Germany, the UK, India, and China. It also resulted in control measures that impacted operations in life science organizations, such as production and research. 

 

According to GEP Worldwide, more than 1,200 clinical trials across the globe were disrupted by June 2020. Nearly 61% of clinical trials were disrupted due to the suspension of patient enrolment. The impact varied due to changes in COVID-19 case volumes throughout the year, but the worst effect was seen in April 2020. Trials involving respiratory disease, oncology, ID/anti-infectives, and cardiovascular disease were the worst-hit during this time. 

 

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The increase in pharmaceutical R&D has resulted in a sharp increase in the number of cell & gene therapy candidates under development. This has made it necessary to outsource manufacturing services to develop cost-effective and efficient cell & gene therapies. 

 

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Currently, there are 1,200 cell & gene therapies in trials worldwide. There are more than 700 investigational cell & gene therapies in clinical development in the US alone. However, manufacturing facilities have not kept up. It has been estimated that hundreds of facilities will be needed to manufacture the treatments that are now in clinical trials. 

 

The cost of manufacturing for gene therapy can be between USD 500,000 and USD 1 million, excluding the costs for R&D, the costs to run crucial clinical trials, or the costs to build the commercial infrastructure necessary to provide access to patients. 

 

The cell & gene therapy manufacturing services market is broadly segmented into cell therapy and gene therapy. In 2020, cell therapy accounted for the largest share of the cell & gene therapy manufacturing services market. This can primarily be attributed to factors such as increasing awareness about cell therapy, growing funding for new cell lines, increasing partnerships and acquisitions, and the development of advanced genomics methods for cell analysis.