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.
More than 750 trials of cell & gene therapy (CGT) in almost 30,000 patients were underway as of June 2020, and CGT products account for some 12% of the pharmaceutical industry’s clinical pipeline and at least 16% of its preclinical pipeline.
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. In an article published by Nature Biotechnology, the CEO of Flagship Pioneering (US) stated that lab productivity at many of its research-based setups was running at just 30–50% capacity, and even upholding that rate was a challenge.
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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.
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.
One of the areas that need to be accelerated is viral capacity. 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.
The high growth rate in this segment can be attributed to the increasing expenditure on R&D by pharmaceutical & biotechnology companies, rising collaborations between pharmaceutical and biotechnology companies, and the growing number of cell & gene therapies in the R&D pipeline.
Key Market Players
Key players in the cell & gene therapy manufacturing services market include Thermo Fisher Scientific (US), Merck KGaA (Germany), Charles River Laboratories (US), Lonza (Switzerland), Catalent (US), WuXi AppTec (China), Takara Bio Inc. (Japan), Nikon Corporation (Japan), FUJIFILM Holdings Corporation (Japan), F. Hoffmann-La Roche Ltd. (Switzerland), Oxford Biomedica plc (UK), and Cell and Gene Therapy Catapult (UK).
