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.
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.
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.
The trend suggests that the top pharma companies are increasing their R&D efficiencies through heavy R&D investments to see returns on their investment in the long run and through collaborative R&D efforts. According to an EvaluatePharma report, the worldwide pharmaceutical R&D spending was valued at USD 136 billion in 2012; this increased to USD 186 billion in 2019.
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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Most viral vectors are produced using adherent manufacturing, which is expensive to operate—a vial of 20 million cells can cost USD 20,000 to USD 30,000 to make. 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.
According to a 2020 PhRMA report on the cell & gene therapy pipeline in 2018, there were 289 cell & gene therapies in clinical development by biopharmaceutical companies. This number increased by 25% in 2020, with 362 cell & gene therapies in clinical development. 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%.