How can industry stakeholders ensure the quality and supply chain security of existing product?
The unprecedented success of glucagon-like peptide-1 agonists (GLP-1s) has created a surge in public demand, leading to widespread shortages across the globe. The popularity is certain to increase as researchers are discovering a multitude of health benefits beyond its original prescription for treating type 2 diabetes (T2D), intensifying pressure on supply chains. While plans are underway to accelerate production with billions invested in new facilities, pharma manufacturers admit it may take several years to meet growing demand.
Accessibility and affordability are also still issues for patients, as healthcare systems struggle to provide coverage, exacerbating the lack of supply and flooding the market with imitation drugs. Strategic cold chains are ready to support GLP-1 storage and distribution needs around the globe, offering a GMP-depot network and temperature-controlled vehicles in order to drive cost efficiencies and alleviate constraints caused by the rising notoriety of these groundbreaking medicines.
Accessibility and the price tag on public health
Several factors contribute to the exorbitant cost of GLP-1 drugs. Research and development expenses are a primary driver, given the complexity of drug discovery and the rigorous clinical trials required for approval. As of April 2024, over 50 GLP-1 trials1 are focused on obesity or T2D, with a percentage exploring oral formulations for the market. Beyond weight loss, GLP-1s are being studied for cardiovascular diseases, neurodegenerative disorders, and kidney disease, among other serious conditions. In addition to R&D costs, specialized manufacturing processes and stringent quality control measures for large molecule drugs, like GLP-1s, are expensive necessities that increase production costs.
Competition contributes to rising costs, as intense demand means premium prices for a certain period. Increasing demand has also led to a concerning rise in counterfeit products and unapproved generic medications. Online retailers have become breeding grounds for substandard, or even fraudulent options, posing significant risks to consumers. In 2022, the World Health Organization (WHO) issued its first warning about falsified GLP-1 drugs, followed by another one this past June.2 Despite the WHO not recommending GLP-1 medications as part of diabetes treatment due to public healthcare application fees, the accessibility of counterfeit drugs online continues to threaten consumer safety.
Cost-saving solutions for GLP-1 storage and distribution
Optimizing global storage and distribution through a precision logistics strategy offers significant cost savings. A quality-driven network of state-of-the-art GMP-depots and logistics hubs offer secure and streamlined product movement. Leveraging a leading quality management system (QMS) to ensure quality control compliance and operational excellence reduces the heavy lifting involved in distributing GLP-1 drugs worldwide, safeguarding cold chains, and minimizing costs over time. Specialty logistics providers also employ advanced technologies to implement route mapping, risk management, and real-time visibility, allowing for the seamless transport of ultra-sensitive medical products.
Supply chain operations teams are experts at finding unique solutions for substantial savings. By fostering collaboration among stakeholders, providers leverage data analytics to identify operational inefficiencies, resource misalignment, and other issues driving unnecessary expenses to optimize the supply chain model for clients.
Pharma manufacturers, meanwhile, are innovating internal processes, but rely on specialty logistics companies to provide the transport of groundbreaking, time and temperature-sensitive medicines. These organizations maintain the integrity of the cold chain, preventing disruptions that could compromise drug efficacy, harm patients and result in significant financial losses for stakeholders. By partnering with a quality logistics provider, pharma companies can ensure uninterrupted service, significantly reducing risks and improving patient outcomes.
Maximizing clinical trial success with real-time visibility
Clinical to commercial supply chain providers play a vital role in maximizing the success of clinical trials, especially as new GLP-1 studies explore additional indications. Collaboration with a single-source partner not only provides logistics, storage, and distribution solutions, but also a global nursing network of qualified healthcare professionals to support patient-centric services, leading to higher retention rates, protocol adherence, and an elevated patient experience.
A logistics network that is scalable with global capabilities provides access to diverse patient populations—an increasingly critical aspect in GLP-1 studies. This flexibility enhances trial success, offering the ability to reach patients more effectively and reflect real-world populations. The cost savings and operational efficiency that comes from choosing a reliable logistics provider with a robust global network cannot be overstated, as these partnerships accelerate trials, bringing drugs to market faster.
The promise of GLP-1s and game-changing logistics
The high price of GLP-1 drugs is a complex issue influenced by multiple factors within the broader pharmaceutical market. While research, development, manufacturing, and marketing contribute significantly to drug pricing, opportunities for cost reduction are present when paired with a capable logistics partner. These partners offer streamlined processes, integrated systems, and quality expertise that align with the pharmaceutical industry’s stringent standards, eliminating multiple touch points and expertly managing the protocols necessary for clinical to commercial success.
GLP-1 medications represent a new era in healthcare, where extraordinary results from therapies are supported by equally innovative strategies in logistics. Information sharing and data-driven approaches are becoming the most effective ways to maintain quality excellence and overcome obstacles such as shortages and inaccessibility. As demand for GLP-1 medications continue to rise, addressing these challenges is imperative for ensuring equitable access to life-changing treatments. A collaborative approach involving pharma companies, policymakers, healthcare providers, and patients will be essential for developing solutions that balance innovation, affordability and quality patient care.
About the Author
Dan Bell joined Marken in 2003 and is Senior Vice President, Innovation & Strategic Operations. He is a licensed US Customs Broker and a Certified Customs Specialist with over 25 years of experience in the life science logistics and temperature control field. His current focus is regulatory and trade compliance aspects for global life science supply chain solutions.
References
1. GlobalData Healthcare. Key opinion leaders on GLP-1 receptor agonist clinical trial design. Clinical Trials Arena. April 26, 2024. https://www.clinicaltrialsarena.com/analyst-comment/kols-glp-1-receptor-agonist-clinical-trial-design/
2. WHO issues warning on falsified medicines used for diabetes treatment and weight loss. World Health Organization. June 20, 2024. https://www.who.int/news/item/20-06-2024-who-issues-warning-on-falsified-medicines-used-for-diabetes-treatment-and-weight-loss
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