The global market for transdermal drug delivery systems is projected to grow from US$ 37,230.28 million in 2022 to US$ 51,949.74 million by 2030, reflecting a compound annual growth rate (CAGR) of 4.3% during this period.
Several factors are propelling the growth of this market, including the expanding applications of transdermal drug delivery systems and the increasing incidence of spinal cord injuries. Nevertheless, complications arising from surgeries pose challenges to market expansion.
Opportunities in the Transdermal Drug Delivery Systems Market
The transdermal route for drug administration is an innovative and dependable method for sustained drug delivery. With extensive research ongoing in this area and a growing interest among scientists, numerous transdermal patches are expected to enter the market in the near future. These patches are utilized to administer medications such as nicotine, fentanyl, nitroglycerin, and clonidine for various health issues. Recently, there has been exploration into using these patches for delivering biologics across different applications. Advanced smart patches, which incorporate sensors and other technologies, are designed to monitor patient conditions and adjust drug delivery as needed. In January 2023, a leading researcher from Swansea University introduced a new smart patch capable of detecting pro-inflammatory biomarkers associated with neurodegenerative diseases like Parkinson's and Alzheimer's through microneedle technology. These smart patches feature multiple microneedles that minimally penetrate the skin barrier, allowing for the monitoring of clinically significant biomarkers. They can be self-administered for point-of-care diagnostics in general practices or at home, potentially revolutionizing early detection of neurodegenerative diseases.
An article titled "3D-Printed Products for Topical Skin Applications: From Personalized Dressings to Drug Delivery," published in the National Library of Medicine in November 2021, discusses the use of personalized 3D-printed patches that conform to the skin for delivering acetyl-hexapeptide 3 (AHP-3). This study utilized two liquid monomers?polyethylene glycol diacrylate (PEGDA) and vinylpyrrolidone (VP)?in varying ratios to enhance the mechanical strength, polymerization rate, and swelling rate of the final polymer. The optimal drug loading indicated that AHP-3 remained stable throughout the manufacturing process without affecting the physical properties of the final product. A personalized patch was designed using a 3D scanned facial model and fabricated with optimized resin via a digital light processing 3D printer. In-vitro tests of the transdermal patches demonstrated their ability to penetrate human cadaver skin while remaining intact under compression. This study is the first to showcase personalized patches made from photopolymers, introducing a new method to enhance transdermal drug delivery for effective wrinkle management.
Thus, the integration of 3D printing technology and smart patches is expected to create significant opportunities for the transdermal drug delivery systems market in the coming years.
Challenges Facing the Transdermal Drug Delivery Systems Market
Currently available transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patches can retain between 10% and 95% of the initial drug quantity as residual drug after the intended usage period. This situation raises safety concerns for patients, their families, and caregivers. For instance, adverse events can occur if a patient fails to remove a TDDS after its intended use, leading to prolonged pharmacological effects. There have been reports of fatalities in children due to accidental exposure to discarded TDDS. Below are some notable product recalls and withdrawals by manufacturers.
In February 2023, Aveva Drug Delivery Systems Inc recalled two lots of buprenorphine transdermal systems for not meeting impurity and degradation specifications. This recall, initiated voluntarily on February 15, 2023, was classified as Class III by the FDA on March 14, 2023, indicating that the product's use is unlikely to cause significant harm. In September 2020, Teva Pharmaceuticals USA recalled two lots of buprenorphine patches, affecting 32,543 cartons of buprenorphine transdermal systems. This recall was classified as Class II by the FDA, indicating that continued use could lead to temporary or reversible adverse health effects. Additionally, in April 2018, the FDA issued a Warning Letter to Phase 4 Pharmaceutical LLC for violations related to the quality of its OTC transdermal drug products. In April 2019, Alvogen, Inc. announced a nationwide recall of two lots of Fentanyl Transdermal System patches due to a labeling error. Such adverse effects and product recalls are significant factors that impede market growth.
Segment Analysis of the Transdermal Drug Delivery Systems Market
The transdermal drug delivery system market is categorized by product type into transdermal patches, gels, sprays, and others. The transdermal patch segment is further divided into drug-in-adhesive patches, reservoir membrane patches, matrix patches, and vapor patches. In 2022, the transdermal patches segment held the largest market share, while transdermal gels are projected to exhibit the highest CAGR from 2022 to 2030. A transdermal patch is a system affixed to the skin to deliver medication through the skin.
By application, the market is segmented into cardiovascular diseases, central nervous system disorders, hormonal applications, pain management, and other areas. The pain management segment is further divided into opioid and non-opioid applications. The hormonal application segment includes transdermal estrogen therapy and testosterone replacement therapy. The pain management segment dominated the market in 2022, while the central nervous system disorders segment is expected to achieve the highest CAGR during the forecast period.
Distribution channels for the transdermal drug delivery system market include hospital pharmacies, retail pharmacies, online pharmacies, and others. The hospital pharmacies segment accounted for the largest market share in 2022, but the retail pharmacies segment is anticipated to grow at the highest CAGR from 2022 to 2030.
Geographical Insights into the Transdermal Drug Delivery Systems Market
In 2022, North America held the largest share of the global transdermal drug delivery systems market, with the US being the leading contributor and expected to register the highest CAGR from 2022 to 2030. Cardiovascular disease (CVD) remains the leading cause of death in the US, with approximately 695,000 deaths attributed to CVD in 2021, according to the American Heart Association (AHA). The increasing prevalence of cardiovascular diseases, diabetes, chronic pain, and other long-term conditions is driving the demand for effective and convenient treatment options. Medical patches provide a non-invasive and patient-friendly method for medication delivery and symptom management associated with these chronic conditions. Ongoing innovations in TDDS, such as wearable sensors and flexible electronics, are enhancing the growth of the transdermal drug delivery system market by enabling more precise dosing, improved patient monitoring, and better adherence to treatment. A report titled "Recent advances in transdermal drug delivery systems," published by Biomaterials Research in 2021, highlights the significant interest in microneedles among TDDS modalities, which address the limitations of traditional application types and patch-type needles by leveraging the benefits of microneedles for enhanced treatment efficacy. These advancements in TDDS are expected to play a crucial role in managing the prevalence of cardiovascular and central nervous system diseases, diabetes, neuromuscular disorders, and localized infections.
The rising trend of personalized medicine, which tailors treatments to individual patients, has further accelerated the development of medical patches that facilitate controlled and targeted drug delivery. This customization leads to improved patient outcomes and therapeutic effectiveness. For example, in 2020, Reddy's Laboratories launched an authorized generic version of the NitroDur (nitroglycerin) transdermal infusion system in the US market. With the increasing focus on home healthcare and remote patient monitoring, medical patches present a convenient solution for medication delivery and vital sign monitoring outside conventional healthcare environments. The US transdermal drug delivery system market is shaped by factors such as the growing prevalence of chronic diseases, advancements in technology, and an increasing emphasis on personalized medicine.
Key sources referenced in the preparation of this report on the transdermal drug delivery systems market include the World Bank Data, National Health Service (NHS), FDA (Food and Drug Administration), EMA (European Medicines Agency), and WHO (World Health Organization).