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.
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. 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 increase in pharmaceutical RD 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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The market is primarily driven by the prevalence of cancer and other target diseases. The development of therapies for key diseases, such as cancer, has attracted significant attention. Furthermore, increasing investments of pharmaceutical companies in the development of novel drugs is also fueling the market growth. However, significant operational costs are expected to negatively impact the cell gene therapy manufacturing market thus limiting the growth.
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 RD, the costs to run crucial clinical trials, or the costs to build the commercial infrastructure necessary to provide access to patients.
In 2020, cell therapy segment dominated the cell gene therapy manufacturing services market. This can be attributed to the advent of new technologies and innovative products that have enabled several variety of cells such as hematopoietic stem cells (HSC), mesenchymal stem cells, natural killer cells, dendritic cells, and T-cells to treat diseases and conditions.
Clinical trials are the backbone of medical research and help pharmaceutical and biopharmaceutical companies develop and commercialize new cell gene therapies. In the past few years, the demand for clinical trials has risen worldwide as a result of the growing demand for novel medicines to fulfill unmet medical needs. 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.
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).
