PUBLISHER: The Insight Partners | PRODUCT CODE: 1389614
PUBLISHER: The Insight Partners | PRODUCT CODE: 1389614
The global transdermal drug delivery systems market is expected to reach US$ 51.949 billion in 2030 from US$ 37.230 billion in 2022. The market is estimated to grow with a CAGR of 4.3% from 2022 to 2030.
The key factors driving the market's growth include growing areas of application of transdermal drug delivery systems and rising cases of spinal cord injury. However, the post-surgical complications hinder the market growth.
Market Opportunities of Transdermal Drug Delivery Systems Market
A transdermal drug administration route is novel and one of the reliable means of sustained drug delivery. With significant research being conducted in this field and the increasing interest of researchers in this form of drug delivery, a large number of transdermal patches are likely to reach the marketplace in the future. Transdermal patches are used to deliver drugs such as nicotine, fentanyl, nitroglycerin, and clonidine to treat various medical conditions. Recently, these patches have been explored to deliver biologics in various applications. Smart patches are equipped with sensors and other technologies to monitor patient conditions and adjust drug delivery accordingly. In January 2023, a lead scientist at Swansea University developed a new smart patch to detect proinflammatory biomarkers of neurodegenerative diseases such as Parkinson's and Alzheimer's using the microneedle technology. These smart patches comprise numerous microneedles designed to penetrate the skin barrier in a minimally invasive manner, followed by monitoring the biomarkers of clinical significance. They can be self-administered for point-of-care diagnosis at general practices or at home. This innovative research can potentially change the landscape of early neurodegenerative disease detection.
According to 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, personalized 3D-printed patches that conform to the skin surface can be used for acetyl-hexapeptide 3 (AHP-3) delivery. In this study, two liquid monomers-polyethylene glycol diacrylate (PEGDA) and vinylpyrrolidone (VP)-were used in different proportions to improve the mechanical strength, polymerization rate, and swelling rate of the final polymer. Optimal drug loading on the resin indicated that AHP-3 remained stable throughout the manufacturing process and had no effect on the physical properties of the final polymer. Using a 3D scanned facial model, a personalized patch was designed in computer-aided design software, and it was fabricated in optimized resin using a digital light processing 3D printer. The in-vitro characterization of prepared transdermal patches has shown their ability to penetrate human cadaver skin, further remaining intact upon compression. "3D-Printed Products for Topical Skin Applications: From Personalized Dressings to Drug Delivery" is the first study demonstrating personalized patches made using photopolymers, and it has introduced a novel approach to improve the transdermal delivery of drugs for effective wrinkle management.
Thus, the adoption of 3D printing technology and smart patches is likely to offer opportunities to the transdermal drug delivery systems market in the coming years.
Factors Hampering Transdermal Drug Delivery Systems Market
Currently marketed transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patches may retain 10-95% of the initial total quantity of the drug as a residual drug after the intended use period. This raises a potential safety issue for patients, and their family members and caregivers. For example, adverse events due to a patient's failure to remove TDDS at the end of the intended use period generally result in an increased or prolonged pharmacological effect of the drug. Some children have also been reported to have died from accidental exposure to discarded TDDS. Below are some of the product recalls and withdrawals by the manufacturers.
In February 2023, Aveva Drug Delivery Systems Inc recalled two lots of buprenorphine transdermal systems for failing to meet impurity/degradation specifications. Aveva Drug Delivery Systems voluntarily initiated the recall on February 15, 2023, which was designated as a Class III recall by the FDA on March 14, 2023. Under this recall classification, the use of the product is not likely to cause any major harm. In September 2020, Teva Pharmaceuticals USA recalled two lots of buprenorphine patches. The recall affected 32,543 cartons of buprenorphine transdermal systems, 5 mcg/hour, four transdermal systems per carton (patch NDC 0093-3656-21, carton NDC 0093-3656-40), from lots 190017 and 190161. The product was manufactured by 3M Drug Delivery Systems for Teva Pharmaceuticals and distributed in the US and Puerto Rico. Followed by its voluntary recall by Teva Pharmaceuticals on September 4, 2020, the FDA designated the recall Class II on October 1, 2020. Continuing the use of Class II recall products may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm exists. Further, in April 2018, the FDA sent a Warning Letter to Phase 4 Pharmaceutical LLC. Instead of manufacturing transdermal drug types, the firm was functioning as a re-packager of over-the-counter (OTC) transdermal drug types, and the FDA found several violations of CGMP that affected the quality of its products. In April 2019, Alvogen, Inc. announced a voluntary, nationwide recall of two lots (or batches) of Fentanyl Transdermal System, 12 mcg/h transdermal patches, because of a label mix-up. Thus, adverse effects and recalls of transdermal drug delivery systems hinder the market growth.
Transdermal Drug Delivery Systems Market: Segmental Overview
Based on product, the transdermal drug delivery system market is segmented into transdermal patches, transdermal gels, transdermal sprays, and others. The transdermal patch segment is further segmented into drug-in-adhesive patches, reservoir membrane patches, matrix patches, and vapor patches. The transdermal patches segment held the largest share of the market in 2022, while transdermal gels is anticipated to register the highest CAGR during 2022-2030. A transdermal patch is a drug delivery system attached to a patient's skin to deliver medication through the skin.
The transdermal drug delivery system market, by application, has been segmented into cardiovascular diseases, central nervous system disorders, hormonal applications, pain management, and other applications. The market for the pain management segment is sub-segmented into opioid application and non-opioid application. The market for hormonal application segment is further segmented into transdermal estrogen therapy and testosterone replacement therapy. The pain management segment held the largest share of the market in 2022. Central nervous system disorders segment is expected to register the highest CAGR in the market during 2022-2030.
Based on the distribution channel, the transdermal drug delivery system market is segmented into hospital pharmacies, retail pharmacies, online pharmacies, and others. The hospital pharmacies segment held the largest share of the market in 2022. However, the retail pharmacies segment is expected to register the highest CAGR in the market during 2022-2030.
Transdermal Drug Delivery Systems Market: Geographical Overview
North America accounted for the largest share of the global transdermal drug delivery systems market in 2022. In the region, the US held the largest transdermal drug delivery systems market share and is anticipated to register the highest CAGR during 2022-2030. According to the American Heart Association (AHA), cardiovascular disease (CVD) remains the leading cause of death in the US. According to the CDC, in 2021, CVD accounted for ~695,000 deaths and ~1 in 5 deaths in the US. The rising prevalence of cardiovascular disease, diabetes, chronic pain conditions, and other chronic diseases drives the demand for effective and convenient treatment options. Medical patches offer a noninvasive and patient-friendly approach to deliver medication and manage symptoms associated with these chronic conditions. Ongoing advancements in TDDS, such as wearable sensors and flexible electronics, contribute to the growth of the transdermal drug delivery system market. These advancements allow for more accurate dosing, enhanced patient monitoring, and improved patient compliance. According to a report titled "Recent advances in transdermal drug delivery systems," published by Biomaterials Research in 2021, microneedles attract significant attention among TDDS modalities, which overcome the limitations of the existing simple application type and patch-type needles by combining the advantages of microneedles to obtain higher treatment efficiency and effects. Advances in these TDDS can provide the driving force for controlling the prevalence of cardiovascular and central nervous system diseases, diabetes, neuromuscular diseases, and infectious and localized infectious diseases.
The growing trend of personalized medicines, where treatments are tailored to individual patients, has boosted the development of medical patches that offer controlled and targeted drug delivery. This customization allows for better patient outcomes and improved therapeutic efficacy. For instance, in 2020, Reddy's Laboratories launched an authorized generic version of NitroDur (nitroglycerin) transdermal infusion system in the US market. With the growing emphasis on home healthcare and remote patient monitoring, medical patches offer a convenient solution for delivering medications and monitoring vital signs outside traditional healthcare settings. The US transdermal drug delivery system market is influenced by factors such as the increasing prevalence of chronic diseases, rising technological advancements, and growing focus on personalized medicines.
A few of the major primary and secondary sources referred to while preparing the report on the transdermal drug delivery systems market are the World Bank Data, National Health Service (NHS), FDA (Food and Drug Administration), EMA (European Medicines Agency), and WHO (World Health Organization).