Biosynthetic insulin made via recombinant DNA, the first of the class of therapies now known as biologics, was approved in 1982.
Since then, more than 700 biologic therapies (including biosimilars) have been approved for use by the FDA, bringing the value of the U.S. biologics market to more than $500 billion in 2023 with a compound annual growth rate (CAGR) of 10 percent per year from 2023 to 2030.
In this blog, we’ll look at some of the key trends driving the growth of the biologics market and what it means for cold storage needs in U.S. pharmacies.
The Shift Toward Personalized Medicine
Personalized medicine is a rapidly growing field of medicine focused on providing better outcomes for patients by tailoring medical treatments based on genetic, environmental, and lifestyle factors. Primary use cases for personalized medicine include treatment of certain cancers, rare genetic diseases, and some chronic and infectious diseases.
According to a report released by the Personalized Medicine Coalition, 20 personalized medicines were approved in 2023, representing 38 percent of all newly approved therapies in that year and accounting for more than 25 percent of approved therapies for the past nine years.
In addition, the FDA approved six new gene or cell-based therapies. Cell and gene therapies (CGT) “promise to dramatically improve care for certain patients by genetically re-engineering a patient’s own cells to combat disease.”
Along with these new approvals, 12 diagnostic testing systems were cleared or approved for new or expanded indications that will help target treatments to only those patients who will experience a benefit from those therapies, avoiding often difficult side effects of treatment.
The Advent of mRNA-Based Therapies
COVID-19 radically accelerated the approval and commercialization of mRNA vaccines. After researching mRNA-based therapies for decades, the emergency use authorization and approval of Pfizer’s Comirnaty® and Moderna’s Spikevax™ vaccines paved the way for future mRNA-based therapies.
As of January 2024, an estimated 131 unique mRNA-based therapies are undergoing clinical development. Companies are researching mRNA-based therapies for infectious diseases such as influenza, HIV, and Zika.
The global market for mRNA-based therapies is expected to reach $31 billion in 2030 with a CAGR of 17 percent. Early stage research is being conducted for applications such as cardiovascular disease, autoimmune diseases, and rare genetic disorders.
mRNA-based therapies are generally simpler and more cost effective to manufacture than recombinant protein therapies and small molecule drugs, making them an ideal first-line therapy when appropriate.
The Continued Growth of Biologic Drugs
Since the first biologic drug was approved in 1986, biologic therapies have grown to represent roughly 30 percent of the drugs approved each year by the FDA. As a percent of total approved therapies, biologics represent about one third of the U.S. pharmaceutical market, but they represented almost 45 percent of the 2023 total U.S. pharmaceutical market in dollars.
Due to the complexity of research and development and manufacturing of biologic drugs, biologics tend to command an outsized price compared to small molecule. Biologic therapies also tend to have less frequent dosing schedules than their small molecule counterparts. On average, a dose of a biologic costs 22 times more than a dose of a small molecule drug.
Many pharmaceutical companies are currently exploring biologic therapies for cardiovascular disease, neurological diseases, and oncology. As of 2024, there are more than 2,300 ongoing clinical trials for biologic drugs forming a robust pipeline for future approvals.
The Rise of Biosimilars
Biosimilars are biologic medical therapies that are similar to already approved reference products. Like generics for small-molecule drugs, biosimilars seek to reproduce the therapeutic effects of an existing therapy at a lower price point.
Biosimilars came onto the scene in the 2010s as many biologic therapies approved in the 90s lost exclusivity. Since then, biosimilars have experienced headwinds from the FDA, pharmaceutical companies, and brand-loyal providers on the grounds that, unlike generic drugs, biosimilars are not identical to the reference drugs they approximate.
As of October 2024, 61 biosimilars have been approved the FDA. Seven of these biosimilars have been granted interchangeability designation, which allows providers to interchange a biosimilar for a prescribed branded biologic without a prior authorization.
The biosimilar market continues to grow rapidly and is expected to reach $1.3 trillion by 2032 as providers and regulators grow more comfortable with this relatively new class of drug.
Pharmacies should expect to see increasing numbers of biosimilars added to hospital formularies.
What Does This Mean for Pharmacy Cold Storage?
The continued market growth of personalized medicine, mRNA therapies, and biologics and biosimilars will demand continued attention to cold storage in hospital pharmacies and laboratories.
Due to the complex nature and instability of many biologic therapies, almost all currently approved biologics, biosimilars, and mRNA therapies require some form of cold storage to maintain viability. Many of the newly minted and expanded diagnostic systems used in personalized medicine utilize components that require cold storage.
As the demand for and adoption of these products continues to grow, clinical directors in hospital laboratories and pharmacies will need to consider several factors when planning for cold storage capabilities.
First, clinical directors should plan for an increase in the number of pieces of cold storage equipment required to store biologic therapies and related diagnostic tests. As research in biologic therapies continues, new drugs and treatments will become available for more patients and more disease states, meaning a higher volume of biologic therapies will be required to be stored in hospital pharmacies.
Clinical directors should begin budgeting and planning for increased and updated equipment to meet future cold storage demands.
Second, clinical directors should mitigate monetary and operational risk by investing in appropriate cold storage solutions. Because the cost of biologics is high compared to small molecule drugs or other material requiring cold storage, the cost of inventory stored in any refrigerator or freezer will continue to increase as more biologics are kept on-site for patient treatment.
As a result, the monetary risk of a failure in one of these pieces of equipment will continue to increase. Most hospitals carry insurance to help cover loss in the event of a catastrophic equipment failure, but the cost of equipment failure isn’t just monetary, insurance reimbursements take time and inventory will need to be replaced as soon as possible to continue to provide quality care for patients.
Understanding this, clinical directors should strive to invest in cold storage equipment with a reputation for quality that is unlikely to fail and maintain, update, or replace it appropriately to avoid failure.
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Biologic Storage and GX Solutions from Helmer Scientific
Hundreds of pharmacy and lab directors across the United States are using Helmer GX Solutions cold storage equipment for the safe storage of vaccines, biologic therapies, diagnostic testing components such as assays, reagents, patient samples and DNA eluates.
Helmer's GX Solutions provide unparalleled temperature uniformity, stability, and recovery to help ensure biologics and lab materials remain viable to provide the best possible care for patients.
Made-to-order in the U.S.A., Helmer refrigerators and freezers are specifically designed to stand up to the rigors of the clinical lab and central pharmacy environments and are made from the highest-quality materials.
Protect your inventory, your workflow, and your patients by investing in Helmer GX Solutions cold storage equipment for your pharmacy or lab.
To get a quote for cold storage equipment, reach out to your Helmer representative or fill out the quote request form on our website.
