Increasing demand for GLP-1 drugs for the treatment of type 2 diabetes and obesity is putting greater pressure on temperature-controlled storage and logistics capacity around the world. However, as these drugs show promise for the treatment of numerous other large-patient population indications, the supply chain will be taxed further, leading to the need for innovative approaches and expert execution.
HUMIRA®, a tumor necrosis factor (TNF) blocker generally prescribed for inflammation-related conditions such as autoimmune disorders, and LIPITOR®, a cholesterol-lowering statin, are considered the most economically successful drugs of all time. However, all forecasts point to their performance being supplanted by GLP-1 (glucagon-like peptide-1) drugs in the upcoming years.
Since 2005, GLP-1 medications have been used to treat type 2 diabetes and, more recently, obesity. These drugs mimic the action of a naturally occurring hormone, GLP-1, which plays a crucial role in regulating blood sugar levels and appetite.
Given that 890 million adults worldwide are obese, 530 million have type two diabetes, and the rates of both conditions are increasing, GLP-1 drugs have substantial market opportunity.
Led by Novo Nordisk (Ozempic®, Rybelsus®, Wegovy®, Saxenda®, and Victoza®) and Eli Lilly (Mounjaro®, Zepbound®, and Trulicity®), 2023 global sales of GLP-1 drugs reached $53.6 billion. With a forecasted compound annual growth rate (CAGR) of 17.46%, they are projected to reach $119.8 billion by 2030.1
While treating obesity and type 2 diabetes presents plenty of opportunity for robust growth, research points to GPL-1 drugs being highly effective for additional large-population disease states.
GLP-1 Drugs Proving to be Effective for Additional Disease States
While additional research is in progress, GLP-1 therapeutics are showing considerable promise for treating cardiovascular disease, nonalcoholic fatty liver, Parkinson's and Alzheimer's diseases, osteoarthritis, and alcoholism.
Cardiovascular Disease
An estimated 500 million patients worldwide are inflicted with cardiovascular disease.2 GLP-1 receptor agonists regulate plaque instability and inflammation markers, preventing or minimizing cardiovascular disease by reducing lipid deposition and plaque volume on the aortic surface.
Nonalcoholic Fatty Liver Disease (NAFLD)
Given their impact on weight loss and insulin secretion, the conditions most often responsible for the development of NAFLD, GLP-1 drugs show incredible promise for the estimated 30%3 of the global population affected by this disease.
Parkinson’s Disease
With more than 10 million global patients inflicted with Parkinson’s disease,4 GLP-1 receptor agonists show promise by binding to the GLP-1 receptors located on the membrane of the midbrain’s dopaminergic neurons. This binding can protect cells from degeneration that leads to a reduction of dopamine transmission, the deposition of a-synuclein, and the presence of oxidative stress.5
Dementia
While dementia, including Alzheimer’s, tends to be multifaceted, research is pointing to insufficient insulin receptor activation, insulin availability, and insulin receptor–related mechanisms significantly contributing to Alzheimer's disease and other dementias. Evidence suggests that GLP-1 drugs would be effective in treating many of the 55 million patients worldwide who have dementia.6
Osteoarthritis
Pharmacological and preclinical data point to the effectiveness of using GLP-1 agonists to treat more than 595 million global patients7 with osteoarthritis. GLP-1 receptor agonists may help neutralize osteoarthritis in the cartilage, synovial membrane, Hoffa fat pad, and bone tissue.5
Alcoholism and Other Chemical Dependencies
GLP-1 receptor agonists act on the reward-related areas of the brain, which can cause a decrease in the compulsion of alcohol consumption by inhibiting dopamine release.
Biopharmaceutical Supply Chain Challenged by GLP-1 Drugs
Like all injectables, GLP-1 therapeutics are time- and temperature-sensitive. They must be stored at 2–8 °C, and as is common across the biopharmaceutical supply chain, they are at risk of temperature excursions during transport. However, given their rapidly growing demand and high product value, GLP-1 drugs present unique challenges.
High-Value GLP-1 Products Amplify Temperature Excursion Risks
The average list price of GLP-1 drugs exceeds $1,000 per month, posing a significant risk of financial loss due to temperature excursions and theft.
Every year, an estimated $48 billion worth of drug substances and finished products are lost due to temperature excursions and other supply chain-related challenges. Given the high value of GPL-1 drugs, significant forecasted CAGR based on the treatment of type 2 diabetes and obesity, and hundreds of millions of patients for which GPL-1 therapeutics show promise, the $48 billion figure will skyrocket unless increased experience, expertise, and rigor is applied to the storage and distribution management of these temperature-sensitive drugs.
Risks of Theft and Introduction of Counterfeit Products
The soaring demand for and the high price point of GLP-1 drugs have led to substantial illicit activity. Criminals are introducing counterfeit products into the supply chain and diverting real GLP-1 products from international markets.
In December 2023, the U.S. FDA announced that it had seized thousands of units of counterfeit Ozempic in the legitimate U.S. supply chain.8 Clearly, counterfeit Ozempic, as well as other GLP-1 drugs, entered the supply chain –– transfer points being the most likely opportunity for breaches.
The skill of the counterfeiters often makes identifying counterfeit products challenging. In many cases, they are refilling used injector pens from ethical products so the product presentation looks nearly identical. Additionally, they are often sourcing packing equipment from the same vendors as the legal innovators, making the packaging of counterfeit products difficult to discern from legitimate products.
Rapidly Growing Temperature-Sensitive Product Volumes
Considerable investments have been made to expand storage capacity for temperature-controlled biopharmaceuticals due to the forecasted growth of GPL-1 drugs and other biologics. However, even if temperature-controlled storage capacity keeps pace with the GLP-1 products’ mushrooming volume, all signs point to a lack of capacity in other critical areas of the supply chain, including life sciences–dedicated shipping capacity and the bandwidth of biopharmaceutical supply chain experts.
If all points within the biopharmaceutical supply chain cannot keep pace with the demand for and production of GLP-1 products, the industry will be challenged with escalating risks of product loss and counterfeit products entering the supply chain.
Global Production and Patient Population
GLP-1 products are produced and administered globally, with production primarily executed in Europe, the United States, China, and Brazil. North America is currently the largest patient market, followed by Europe, Asia Pacific, and Latin America.9 The global nature of both supply and demand for these products requires a well-structured supply chain to safely and securely ship drug substance and drug product to manufacturing, filling, and packaging facilities and patients around the world.
Comprehensively Tackling the Challenges of the GLP-1 Supply Chain
The Frontier Scientific Solutions team has extensive expertise in life sciences manufacturing and logistics and understands the pressing challenges of high-value, temperature-sensitive products, ensuring that products are stored and transported safely while maintaining strict regulatory and quality standards.
Reducing Risks: Temperature Excursions, Theft, and Introduction of Counterfeit Product
Supply chain risks have been dramatically curtailed by Frontier’s gateways to strategic global markets, on-airport temperature-controlled distribution facilities, and dedicated flights.
Dedicated direct flights and strategic gateways to the North American and European markets (with gateways to Latin America and Asia in the works) sharply reduce hand-off points, each of which substantially contributes to the risk of temperature deviations and security breaches.
Frontier Scientific Solutions operates cGMP on-airport, temperature-controlled distribution facilities managed by life sciences storage and distribution experts. With on-tarmac access, these facilities ensure swift loading and unloading of temperature-sensitive products, reducing tarmac time and maintaining temperature integrity. Additionally, on-tarmac access significantly reduces security risks.
Today, most life sciences air freight travels in the cargo holds of commercial planes. This construct increases the risk of on-tarmac temperature excursions due to the airline’s inconsistent cargo staging, loading, and unloading schedules. Also, air freight on commercial planes is subjected to the same delays any air traveler experiences. However, Frontier operates direct, life sciences-dedicated flights between strategic gateways, dramatically reducing temperature excursion risks and the security breaches posed by potentially corrupt commercial airline personnel.
Finally, Frontier’s facilities are proximate to international ports and interstates to efficiently manage both ocean and over-the-road freight with fewer a fewer number of transfer points.
Cost-Saving Advantages of Foreign Trade Zones
Frontier Scientific Solutions strategic gateways –` Wilmington International Airport (ILM) in North America and Shannon Airport (SNN) in the EU –– operate within Foreign Trade Zones (FTZ), known as Free Trade Zones outside the United States. This designation offers numerous benefits for companies with GLP-1 products.
One advantage of Frontier’s FTZ status is that, rather than paying duties, taxes, and fees on a large volume of international drug product all at once, companies can manage their cash by keeping the bulk of that product in the FTZ and administratively importing all or portions of the product just-in-time.
Also, FTZs simplify shipment consolidation by eliminating the need for multiple customs clearance entries. This streamlined process reduces administrative overhead, accelerates the movement of pharmaceutical products, and helps mitigate product shortage challenges.
Additionally, GPL-1 innovators can conduct manufacturing, processing, repackaging, and labeling activities within the FTZ without incurring specific customs duties, providing enhanced flexibility to meet market demands. Finally, warehousing products closer to the consumer market within the FTZ until needed increases the speed of goods to market.
Positioned to Serve the Surging Demand for Temperature-Sensitive Logistics
Given studies suggesting GLP-1 drugs successfully address indications impacting hundreds of millions of people worldwide beyond type 2 diabetes and obesity, the forecasted 17.6% CAGR could be significantly understated. Additional temperature-controlled storage and logistical capacity will be required.
Frontier offers 500,000 square feet of on-airport cGMP temperature-controlled storage capacity at its Wilmington International Airport (ILM) on-airport facility, another nearly million square feet coming online directly behind it, capacity being built at Shannon Airport (SNN), and facilities at other strategic gateways following shortly. This well positions the organization to serve this surging demand.
While temperature-controlled storage capacity, FTZ designation, strategic gateways, direct flights dedicated to life sciences, nearby international seaports, and easy access to major interstates offer many benefits, arguably Frontier’s greatest value when considering the challenges of the rapidly growing GLP-1 class of drugs is the extensive life sciences manufacturing and supply chain expertise within the organization.
References
"GLP-1 Receptor Agonist Market." Grand View Research.
"World Heart Report 2023." World Heart Federation. 2023.
Younossi, Zobair M, Golabi, Pegah, Paik, James M, Henry, Austin, Van Dongen, Catherine, Henry, Linda. “The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review.” Hepatology. 1 April 2023.
"Understanding Parkinson's Statistics" Parkinson’s Foundation
Allen, Kristin PharmD,Lovoy, Paul PharmD. "Five Unexpected New Uses for GLP-1 Receptor Agonists" Pharmacy Times. 23 May 2024.
"Dementia Facts and Figures." Alzheimer’s Disease International
"FDA Warns Consumers Not to Use Counterfeit Ozempic (Semaglutide) Found in U.S. Drug Supply Chain." U.S. Food and Drug Administration (FDA). 21 Dec 2023.
“GLP-1 Analogues Market by Product.” Markets and Markets. 1 July 2024.