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HDA Research Foundation Explores Challenges and Opportunities of Cold Chain Product Distribution

The Future of the U.S. Pharmaceutical Cold Chain Offers Six Recommendations for Greater Industry Coordination and Efficiency

A new publication released today by the HDA Research Foundation and Envision Pharma Group identifies current challenges and opportunities for cold chain management in the U.S. pharmaceutical supply chain. The Future of the U.S. Pharmaceutical Cold Chain offers strategies to address the remarkable growth of temperature-sensitive products in the healthcare ecosystem — a product class that, as noted in the report, has outpaced non-cold chain therapies by 21 percent between 2018 and 2024.

“The effectiveness of cold chain depends on a high degree of coordination between supply chain stakeholders and significant investments in packaging, monitoring, workforce capacity and other supply chain logistics,” said Perry Fri, Executive Vice President of Industry Relations and Member Services, HDA; and COO of the HDA Research Foundation. “While the HDA Foundation and Envision’s latest research offers a story of success, there is room for industry-wide enhancements and collaboration to help ensure the continued safe, effective and sustainable distribution of these highly specialized, lifesaving medications to patients.”

Pharmaceutical cold chain management encompasses the processes of manufacturing, distributing and delivering temperature-regulated prescription pharmaceutical biologics (such as vaccines, injectables, cell and gene therapy and others). The report provides a real-time view of the cold chain market and presents six calls to action to assist stakeholders in ensuring ongoing coordination and communication, including:

1. Investing in the infrastructure necessary to manage expected product growth;
2.  Establishing an annual forum on cold chain distribution;
3. Enhancing distribution considerations during drug development and planning;
4. Producing a consensus-level exceptions and excursions management industry playbook;
5. Standing up a sector-wide cold chain workforce certification program; and,
6. Embracing sustainable packaging options.

Research for the report was conducted by Envision’s strategic consulting division and informed by interviews conducted with 35 cold chain experts (representing manufacturing, distribution, pharmacy, third-party logistics providers and shippers); input from an industry advisory committee; as well as a comprehensive literature and publication review on the subject.

Growth in 2–8°C products will squeeze the supply chain’s existing inventory storage capacity, adequate shipping capacity and available skilled labor. Additionally, the industry anticipates 50 FDA-approved high-dollar value cell and gene therapies by 2030, leading to concerns about storage capacity for products requiring ultra-low (-70°C) or cryogenic (-150 to -190°C) temperatures. Other areas of concern spotlighted in the report involve the management of excursions and exceptions, the difficulty of building environmental sustainability, handling staff shortages and training requirements, and the ability to optimize the cold chain with real-time monitoring and predictive analytics.

View an infographic of key findings from the report. The report will be formally presented at HDA’s upcoming Distribution Management Conference in Palm Desert by subject matter experts from Two Labs - Envision Pharma Group’s commercialization division, who brought commercial support and insight to the project.

The Future of the U.S. Pharmaceutical Cold Chain was made possible by the following sponsoring companies:

• Platinum: Cencora, Inc., DeSpir Logistics, Healthcare Distribution Alliance (HDA) and Johnson & Johnson Health Care Systems Inc.;
• Gold: AeroSafe Global, Cardinal Health, Inc., KeySource, McKesson Corporation, Merck & Co., Inc., Regeneron and Viatris;
• Silver: Sanofi US; and,
• Bronze: AstraZeneca Pharmaceuticals LP, Boyle Transportation, an Andlauer Healthcare Group company and Prodigy Health.

The report can be downloaded at www.HDA.org/publications.