Need for High Permeability and Painless Transdermal Administration Boost Microneedle Drug Delivery Market
Nearly 16 billion injections are transdermally administered worldwide, annually. However, the traditional approach of transdermal delivery through hypodermic needles deters the application potential of this essential device due to the pain perception, risks involved with needle-stick injuries, and transport barrier limit of the outermost skin layer, stratum corneum.
Designed as a painless and minimally invasive system, microneedle arrays (MNAs) are the most sought-after resources to attain optimal systemic effects by transdermal delivery of drugs. With technological superiority to bypass the stratum corneum, it supersedes alternatives, viz. subcutaneous injections and other transdermal delivery systems such as nano and microparticles, or chemical enhancers.
The key objective of this technology is to achieve penetration smaller than holes by hypodermic needles to disrupt the stratum corneum. It thereby aims to create a larger transport pathway of micron size which is larger than molecular dimensions to allow large molecules to pass through, thereby increasing the permeability.
An Array of Benefits Push Adoption of Novel Microneedle Systems
Microneedle drug delivery system offers multiple benefits such as self-administration, better patient compliance, faster onset of action, and improved permeability and efficacy. Alongside improved therapeutic advantages, microneedles give highly accurate reproducible results with minimum inter-subject variability in bioavailability. As a painless drug delivery mechanism, microneedle systems help to tackle fear of needles, i.e., trypanophobia, thus driving adoption in mass immunisation programmes and in the pediatrics segment.
The rate of drug delivery can be controlled more effectively by this system as compared to that by other transdermal drug delivery methods. Faster healing at injection site than with a hypodermic needle is a peculiar benefit that it offers. Enhanced drug efficacy may result in good tolerability and dose reduction. Like any other technology, MNA also possesses some limitations. Possibility of allergy or skin irritation to sensitive skin or instances like breaking of microneedle tips may hinder optimal growth.
Diverse Application Base Makes Microneedles an Attractive R&D Space
In the past few decades, there has been high growth in demand for therapies (antibodies, antigens, proteins, and other biotechnological) wherein active substances are not adequately absorbed when administered orally. Also, newer technologies for encapsulation of these drugs in micro and nanoparticles have been developed. These molecules have become the most interesting candidates for microneedle drug delivery. The number of patents registered in recent years also shows a steady growth trail of MNA as a transdermal drug delivery system.
Transdermal administration is considered as a promising immunisation route and ovalbumin (OVA) is the most commonly used protein antigen for immunisation studies using MNA. Various therapies such as protein, insulin, vitamin, antibiotic, and natural compounds are also administered via microneedle drug delivery system.
At present, cosmeceuticals are probably one of the most tested ingredient groups in clinical trials, in combination with MNA. Recently, significant interest has also grown around the application of microneedle-based devices in the field of diagnostics. Microneedles have a promising potential to penetrate the wearable epidermal diagnostic devices segment due to their painless and noninvasive attributes. Microneedle-based transdermal drug delivery and the success of these minimally invasive devices would open up a wide range of therapeutic opportunities for oral, buccal, ocular, and rectal drug delivery.
Solid Microneedles Capture a Significant Market Share
On the basis of fabrication, microneedles are typically classified in four categories, viz. solid (coated and uncoated), dissolving, hydrogel, and hollow microneedles. Solid microneedle is a time-tested technology and marketed for longer duration. Solid microneedles are primarily made of metal and silicon materials. Polymers are slowly yet steadily catching up as a preferred material for solid microneedles. There is an upsurge in polymer-based microneedle publications (~68%) compared to that in other materials over the past five years.
Hollow and hydrogel microneedles remain the prominent segments, of which the former delivers higher API quantity compared to other microneedles. Moreover, the ease of manufacturing, low cost, and precise drug release control from the liquid penetration are some of the advantages of hollow microneedles. Nowadays, dissolving microneedles manufactured using biodegradable materials are catching attention in the market, as they enable eco-friendly API delivery without creating bio-contaminated and non-degradable waste.
Companies Focus on Collaborations and R&D Initiatives for Long-term Growth
NanoPass Technologies Ltd. recently announced to partner with globally leading vaccine and immunotherapy companies to share its proprietary MicronJet microneedle device to facilitate a safe, effective, and affordable COVID-19 vaccine development. Corium, Inc. is investigating MicroCor PTH (1-34) product candidate with Eli Lilly’s Forteo® (teriparatide [rDNA origin] injection), which is approved for the treatment of osteoporosis.
3M, Microdermics, Zosano Pharma Corporation (ZSAN), Nitto Denko Corporation, Becton, Dickinson and Company, Vaxxas Pty Ltd, Valeritas (Zealand Pharma A/S), Corium, Inc., TheraJect, Inc., LTS Lohmann Therapie-Systeme AG, Alza Corporation, and NanoPass Technologies Ltd. are some of the most prominent players actively participating in the global microneedle drug delivery market landscape.