High Operational Costs In Cell & Gene Therapy Manufacturing Services

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.

Nilkanth Rathod
3 min readMar 1, 2022

However, the high operational costs associated with cell & gene therapy manufacturing are expected to restrain the growth of cell & gene therapy manufacturing services market to a certain extent.

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.

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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.

Most pharmaceutical companies continue to invest heavily in the development of novel drugs and devices. The pharmaceutical industry, in particular, is R&D-intensive. Pharmaceutical companies invest in R&D to deliver high-quality and innovative products to the market.

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.

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.

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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.

In addition to this, according to data released by CGT Catapult, there were 154 ATMP clinical trials ongoing in the UK in 2020 compared to the 127 trials reported in 2019, indicating an increase of more than 20%. This significant growth in the number of cell & gene therapy clinical trials is expected to drive the demand for manufacturing services and, in turn, propel growth in the cell & gene therapy manufacturing services market.

Based on application, the Cell & Gene Therapy Manufacturing Services Market is segmented into pharmaceutical & biotechnology companies, academic & research institutes, and other end users. In 2020, the pharmaceutical & biotechnology companies segment is expected to register the highest CAGR during the forecast period.

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Nilkanth Rathod

Medical Technique, Healthcare Industry, IoT, AI, technology