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Cells are the basic building blocks of all living organisms and genes are small sections of DNA, found within cells that carry genetic information. Cell and gene therapy represent overlapping fields of biomedical research with similar therapeutic goals, which target DNA or RNA in the body. Both of the approaches aim to modify genetic material present to improve its functioning or to immunize or fight against a certain disease and disorder. Precisely, gene therapy utilizes genetic material to engineer the patient’s cells for treatment of an inherited or acquired disease. On the other hand, cell therapy is transplantation of a set of whole new cells into the patient for the treatment of the disease. This therapy finds its application in the development of regenerative medicines. Headway is also being made for cell therapies derived from stem cells to maybe one day treat diseases like autoimmune diseases, Alzheimer’s, and Parkinson’s. The success of cell and gene therapies is not only credited to their capability of offering the desired therapeutic benefits, but also to effective utilization of all supply chain requirements which highlights the fact that supply chain holds significant share in growth and development of the cell and gene therapies and their distribution.
COVID – 19 scenario analysis:
The entry of such treatment options with freedom to choose from has led to a paradigm shift in drug development, production and consumption. In addition, such therapies have actually enabled healthcare providers to treat several difficult-to-treat clinical conditions. The spending on healthcare sector has also increased with advancements in medical field leading to better diagnosis, treatment and increasing prevalence of diseases, both inherited and acquired. According to World Health Organization, the global healthcare expenditure is on a rise to be $8.5 trillion in 2020, owing to an increasing burden of chronic diseases, which are estimated to constitute almost 43% of the global economic burden. The ever increasing demand for better treatment, increased pool of patients with various diseases, favorable regulatory support and special designations for cell and gene therapy products and increasing funding for cell and gene therapy R&D activities is leading to an ascending need for preventive, precise healthcare and tailored medication.
Advanced therapy biomedical products, such as cell and gene therapies, have revolutionized healthcare sector and services. More than 30 such therapy products have been approved in the last two decades; recent approvals include Zolgensma, RECELL system, AmnioFix, EpiFix, EpiBurn, Alofisel, LUXTURNA, Yescarta and Kymriah. Further, according to a report by The Alliance for Regenerative Medicine in 2019, more than 1,000 clinical trials are being conducted globally by over 900 companies. In 2018, around $ 13 billion was invested in cell and gene therapies, representing 73% increase in capital investments, compared to the last year. It is important to notice that, based on an analysis of the current pipeline of cell and gene therapies and the past clinical success of similar products, it is possible that around 10-20 advanced therapies would be approved by the US FDA each year, till 2025. The National Cancer Institute projects that nearly five million more U.S. citizens are expected to survive cancer in 2026 than in 2016. Henceforth, these developments in the therapies would mean an immense scope for supply chain.
The advanced therapy medicinal products supply chain is comparatively more complex than conventional pharmaceutical supply chain. Hence risks like operational inefficiencies, capacity scheduling concerns, process delays leading to capital losses and deliverable tracking-related issues. These concerns multiply in some situations, like the current ongoing COVID – 19 pandemic situation. This has created an urgency and a need for technological solutions, which can be integrated into existing processes to enable the engaged stakeholders to oversee and manage the various aspects of the cell and gene therapies supply chain, in compliance to global regulatory standards.
Over the period of time, several advanced, innovative, software-enabled systems, offering supply chain orchestration and needle-to-needle traceability, have been developed. The market has also witnessed the establishment of numerous strategic partnerships between therapy developers and software solutions providers. Further, given the growing demand for cost-effective personalized medicinal products, and a myriad of other benefits of implementing such software solutions would see supply chain market grow significantly. For instance, TrakCel collaborating with supply chain services provider McKesson and WuXi to address supply chain challenges. In 2019, biotech major Lonza partnered with supply chain services provider Cryoport for logistics of cell and gene therapies globally.
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