2021 pharma cold chain predictions

Minneapolis, Minnesota, USA: Pelican BioThermal has made three key predictions for 2021, driven by Covid-19.

Return to refrigerated temperatures for Covid-19 vaccines

As of December 8, 2020, 78 different Covid-19 vaccines are in clinical trials, under regulatory review for approval or approved for limited use. Though two vaccine candidates show strong promise, with one approved for emergency use in the United Kingdom, we expect the number of viable, approved Covid-19 vaccines will continue to grow in 2021.

All else equal, it is likely the market will favor vaccines that require refrigerated temperatures of 2-8 degrees Celsius. Existing infrastructure exists to more easily transport and store these vaccines around the world. Additionally, refrigerated temperatures eliminate concerns around shortages of dry ice and concerns about how it reduces the amount of available cargo space on aircraft.

This preference for refrigerated vaccines could push pharmaceutical companies with deep frozen vaccines to determine how to maintain efficacy of the vaccine at a refrigerated temperature. If this happens, we will gain knowledge that moves pharmaceuticals’ current storage and distribution temperature from minus 80 degrees Celsius to easier-to-distribute ranges of minus 50 or minus 20 degrees Celsius, or even refrigerated temperatures.

Outsourcing the cold chain
Pharmaceutical supply chains continue to reach new levels of complexity that challenge even the most seasoned logistics and supply chain professionals. Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) offer expertise in manufacturing and development of therapies, allowing pharmaceutical companies to focus on their areas of expertise. 

This year we expect to see even more pharmaceutical companies outsource these capabilities to CMOs and CDMOs, which will help them reduce overall costs. We also believe CMOs and CDMOs will expand to include more services. This will include cold chain, working with partners like us. Offering end-to-end expertise will help reduce complexity by standardizing as many pieces of the supply chain as possible.

Growth in direct-to-patient and direct-from-patient brings cold chain to the last mile
Over the past several years, clinical trials have become increasingly complex. They require extensive data collection, utilize complicated drug regimens and enroll global patient populations. Frequent travel to a clinical site for routine drug administration, sample collection and simple tests can deter patients from participating. This is especially true when patients do not live close to a medical facility.

Currently, 24% of clinical trials offer home-based solutions that allow patients to receive medical care in their homes or ship study samples from their homes to a medical facility. We expect to see this number increase out of necessity, but also out of a desire for continued convenience. 

Covid-19 also increases the chances home-based offerings will grow outside of clinical trials. Over the past year, healthcare companies and consumers learned that it is possible to receive healthcare at home. We expect that a subset of the population will continue to prefer home-based healthcare for its convenience, driving more companies to offer this service. 

Services like phlebotomy, drug administration and sample collection that require refrigeration will require cold chain solutions. We anticipate a drive toward solutions that require little training and are easy for home healthcare professionals and patients to operate. We should also see more assessment and evaluation of the cold chain for home-based care in 2021.

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