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Cellular and genetic therapies (CGTs) are a minor part of commercial business, but a growing part of research activity
The 11th edition of the Biopharma Cold Chain Sourcebook has been published by Pharmaceutical Commerce. The annual edition forecasts an overall market for cold chain services (packaging, transportation and data services) of $17.2 billion in 2020, up from 2019’s $15.7 billion. By 2024, the out year of the 11th edition forecast, these services will be a $21.3 billion market globally.
The Sourcebook’s analysis of cold chain trends is based on a close review of the medication labels of current and newly launched pharma products, separating those requiring (generally) 2-8°C storage and shipping, from those that are room temperature. In 2020, the former will constitute $341 billion worth of products, and will show 48% growth between 2018 and 2024. Non-cold-chain products are currently $959 billion, rising by 27% in value by 2024 (Fig. 1). By comparison, the relative numbers for growth through 2023 published in the 2019 edition were 59% and 25%, respectively—thus, the 2X (or more) growth of past years.
A key element slowing down projected biologic growth in future years is the effect of biosimilars, which are beginning to ramp up in the US as they have done for several years now in Europe. On the other hand, 6 of 38 new molecular entities (NMEs) approved by FDA in 2019 were cold-chain biologics, as were 21 of 22 biologic license approvals (BLAs) from FDA in 2019 (which includes diagnostics as well as therapies). Adding more momentum, cellular and genetic therapies (CGTs) have generated enormous activity in research, and are progressing into Phase III trials. The Alliance for Regenerative Medicine, in its annual report on the CGT and tissue engineering field, counted 94 Phase III trials among the 1,066 trials it is tracking. The number of commercial entities remains small; moreoever, most CGTs today are for rare diseases and thus represent relatively small logistics flows.
Packaging and materials
Of the $17.2 billion to be spent this year on biopharma cold chain logistics (Fig. 2), about $5 billion will be spent on packaging—the parcel-size containers for small shipments, as well as pallet-scale units often used in air cargo. Here, the Sourcebook finds two significant trends: an increased number of container-reuse services (which require a commercially viable returns network, in addition to the physical integrity of the package), and the introduction of more recyclable containers—the operative phrase being “curbside recyclable” (i.e., can be disposed in municipal waste-recycling systems). Neither of these is truly novel, but both are becoming more attractive to shippers who want to demonstrate better sustainability practices, and to relieve customers of the disposal difficulties of expanded polystyrene (EPS).
Another trend, which started earlier but has intensified in 2019, is using electronics to provide end-to-end tracking of shipments, their conditions and location. Newer, lower-cost sensors with some form of telecommunications (often, Bluetooth) combined with Big-Data-type networking, enable shippers to track their shipments in near-real time. (Last month, one of the pioneering innovators in this field, On Asset Intelligence, announced the capability to report on a shipment while in the hold of an aircraft—one of the “dropouts” that prevented real-time tracking of air cargo). There remain some complexities in working out the data-sharing arrangements among packaging vendors, carriers and data services, but the technology trend is becoming clearer.
The Sourcebook’s data collection wrapped up just as the Covid-19 pandemic took hold globally; little of its data reflects the dramatic shifts that have occurred since then. The pandemic is affecting both the supply of healthcare products (including pharmaceuticals) as well as logistics practices on the ground, in the air or at sea. It is expected that the latter will dominate biopharma cold-chain trends in the near term; in the long term, as vaccine research (hopefully!) creates viral countermeasures, the cold chain logistics market will be positively impacted.
The 2020 Biopharma Cold Chain Sourcebook is available for sale from Pharmaceutical Commerce. Inquire at firstname.lastname@example.org for details.